XENOVA - INFORMATIONS-THREAD Nr.1 (Stand 17.09.2000) - 500 Beiträge pro Seite
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Leider habe ich in der Überschrift eine kleinen Fehler gemacht! Es muss natürlich heißen: "..Stand: ab 17.09.00.."
Wird in den Folgethreads hoffentlich nicht mehr vorkommen. Hoffe ihr habt Verständniss!
Ciao
cikei
Wird in den Folgethreads hoffentlich nicht mehr vorkommen. Hoffe ihr habt Verständniss!
Ciao
cikei
Und noch ein Fehler: "..Verständniss.." mit "..ss" !! Entschuldigung!
cikei
cikei
Hi XENOVA-Fans,
wenn ich keinen Fehler gemacht habe hat sich XNVA beim US-Patentamt, dem wichtigsten BioTech-Markt, derzeit 13 Forschungs-"Ergebnisse" patentieren lassen. Die beiden neuesten Registraturen sind vom 05.09. & 29.08.2000.
Patent Issued Title (To sort a column, click ) Score
US05935955 08/10/1999 Pharmaceutical piperazine compounds 83%
US06114332 09/05/2000 Bis(acridinecarboxamide) and bis(phenazinecarboxamide) as antitumor agents 80%
US06111109 08/29/2000 Process for the preparation of N-[2-(dimethylamino)ethyl]acridine-4-carboxamide 80%
US05902812 05/11/1999 Pharmaceutical piperazine compounds 80%
US05891886 04/06/1999 Treatment of cancers 80%
US05891877 04/06/1999 Pharmaceutical compounds 80%
US05861400 01/19/1999 Pharmaceutical compounds 80%
US05852018 12/22/1998 Pharmaceutical piperazine compounds 80%
US05750530 05/12/1998 Pharmaceutical diketopiperazine compounds 80%
US05700804 12/23/1997 Pharmaceutical compounds 80%
US05696131 12/09/1997 Treatment of cancers 80%
US05565486 10/15/1996 Sesquiterpenes, their preparation and their use as inhibitors acting on the gaba-benzodiazepine receptor 80%
US05306732 04/26/1994 Tumor necrosis factor antagonist
Ciao BigLinus
wenn ich keinen Fehler gemacht habe hat sich XNVA beim US-Patentamt, dem wichtigsten BioTech-Markt, derzeit 13 Forschungs-"Ergebnisse" patentieren lassen. Die beiden neuesten Registraturen sind vom 05.09. & 29.08.2000.
Patent Issued Title (To sort a column, click ) Score
US05935955 08/10/1999 Pharmaceutical piperazine compounds 83%
US06114332 09/05/2000 Bis(acridinecarboxamide) and bis(phenazinecarboxamide) as antitumor agents 80%
US06111109 08/29/2000 Process for the preparation of N-[2-(dimethylamino)ethyl]acridine-4-carboxamide 80%
US05902812 05/11/1999 Pharmaceutical piperazine compounds 80%
US05891886 04/06/1999 Treatment of cancers 80%
US05891877 04/06/1999 Pharmaceutical compounds 80%
US05861400 01/19/1999 Pharmaceutical compounds 80%
US05852018 12/22/1998 Pharmaceutical piperazine compounds 80%
US05750530 05/12/1998 Pharmaceutical diketopiperazine compounds 80%
US05700804 12/23/1997 Pharmaceutical compounds 80%
US05696131 12/09/1997 Treatment of cancers 80%
US05565486 10/15/1996 Sesquiterpenes, their preparation and their use as inhibitors acting on the gaba-benzodiazepine receptor 80%
US05306732 04/26/1994 Tumor necrosis factor antagonist
Ciao BigLinus
Hi XENOVA-Fans,
weltweit hat sich XNVA derzeit 21 Forschungs-"Ergebnisse" patentieren lassen. Das Erste vom 13.06.1991 ist nachfolgend nicht aufgeführt.
Patent Issued Title (To sort a column, click ) Score
WO09816833A1 04/23/1998 DOUBLE LABEL IMMUNOASSAY 80%
WO00002839A1 01/20/2000 CYTOKINE PRODUCTION AND TYROSINE KINASE INHIBITORS 77%
WO09817661A1 04/30/1998 CYTOKINE PRODUCTION INHIBITORS 77%
WO09817650A1 04/30/1998 BIS(ACRIDINECARBOXAMIDE) AND BIS(PHENAZINECARBOXAMIDE) AS ANTITUMOUR AGENTS 77%
WO09817649A1 04/30/1998 PROCESS FOR THE PREPARATION OF N-[2-(DIMETHYLAMINO)ETHYL]ACRIDINE-4-CARBOXAMIDE 77%
WO09817648A1 04/30/1998 ANTHRANILIC ACID DERIVATIVES AS MULTI DRUG RESISTANCE MODULATORS 77%
WO09620190A1 07/04/1996 PIPERAZINE 2,5 DIONE DERIVATIVES AS MODULATORS OF MULTI-DRUG RESISTANCE 77%
WO09620180A1 07/04/1996 PIPERAZINE-2,5-DIONE DERIVATIVES AS MODULATORS OF MULTIDRUG RESISTANCE 77%
WO09620179A1 07/04/1996 PIPERAZINE-2,5-DIONE DERIVATIVES AS MODULATORS OF MULTI-DRUG RESISTANCE 77%
WO09532190A3 11/30/1995 PHARMACEUTICAL DIKETOPIPERAZINE COMPOUNDS 77%
WO09532190A2 11/30/1995 PHARMACEUTICAL DIKETOPIPERAZINE COMPOUNDS 77%
WO09521832A1 08/17/1995 PHARMACEUTICAL PIPERAZINE COMPOUNDS 77%
WO09521831A1 08/17/1995 PHARMACEUTICAL PIPERAZINE COMPOUNDS 77%
WO09521830A1 08/17/1995 PHARMACEUTICAL PIPERAZIN COMPOUNDS 77%
WO09521829A1 08/17/1995 PHARMACEUTICAL PIPERAZINE COMPOUNDS 77%
WO09414814A1 07/07/1994 SESQUITERPENES, THEIR PREPARATION AND THEIR USE AS INHIBITORS ACTING ON THE GABA-BENZODIAZEPINE RECEPTOR 77%
WO09404513A1 03/03/1994 PHARMACEUTICALLY ACTIVE DIKETOPIPERAZINES 77%
WO09404512A1 03/03/1994 PHARMACEUTICALLY ACTIVE DIKETOPIPERAZINES 77%
WO09318173A2 09/16/1993 CD4 BINDING AGENTS AND INHIBITORS OF COLLAGENASE AND PROTEIN KINASE C 77%
WO09216517A1 10/01/1992 PHARMACEUTICAL XANTHONE DERIVATIVES
Ciao BigLinus
weltweit hat sich XNVA derzeit 21 Forschungs-"Ergebnisse" patentieren lassen. Das Erste vom 13.06.1991 ist nachfolgend nicht aufgeführt.
Patent Issued Title (To sort a column, click ) Score
WO09816833A1 04/23/1998 DOUBLE LABEL IMMUNOASSAY 80%
WO00002839A1 01/20/2000 CYTOKINE PRODUCTION AND TYROSINE KINASE INHIBITORS 77%
WO09817661A1 04/30/1998 CYTOKINE PRODUCTION INHIBITORS 77%
WO09817650A1 04/30/1998 BIS(ACRIDINECARBOXAMIDE) AND BIS(PHENAZINECARBOXAMIDE) AS ANTITUMOUR AGENTS 77%
WO09817649A1 04/30/1998 PROCESS FOR THE PREPARATION OF N-[2-(DIMETHYLAMINO)ETHYL]ACRIDINE-4-CARBOXAMIDE 77%
WO09817648A1 04/30/1998 ANTHRANILIC ACID DERIVATIVES AS MULTI DRUG RESISTANCE MODULATORS 77%
WO09620190A1 07/04/1996 PIPERAZINE 2,5 DIONE DERIVATIVES AS MODULATORS OF MULTI-DRUG RESISTANCE 77%
WO09620180A1 07/04/1996 PIPERAZINE-2,5-DIONE DERIVATIVES AS MODULATORS OF MULTIDRUG RESISTANCE 77%
WO09620179A1 07/04/1996 PIPERAZINE-2,5-DIONE DERIVATIVES AS MODULATORS OF MULTI-DRUG RESISTANCE 77%
WO09532190A3 11/30/1995 PHARMACEUTICAL DIKETOPIPERAZINE COMPOUNDS 77%
WO09532190A2 11/30/1995 PHARMACEUTICAL DIKETOPIPERAZINE COMPOUNDS 77%
WO09521832A1 08/17/1995 PHARMACEUTICAL PIPERAZINE COMPOUNDS 77%
WO09521831A1 08/17/1995 PHARMACEUTICAL PIPERAZINE COMPOUNDS 77%
WO09521830A1 08/17/1995 PHARMACEUTICAL PIPERAZIN COMPOUNDS 77%
WO09521829A1 08/17/1995 PHARMACEUTICAL PIPERAZINE COMPOUNDS 77%
WO09414814A1 07/07/1994 SESQUITERPENES, THEIR PREPARATION AND THEIR USE AS INHIBITORS ACTING ON THE GABA-BENZODIAZEPINE RECEPTOR 77%
WO09404513A1 03/03/1994 PHARMACEUTICALLY ACTIVE DIKETOPIPERAZINES 77%
WO09404512A1 03/03/1994 PHARMACEUTICALLY ACTIVE DIKETOPIPERAZINES 77%
WO09318173A2 09/16/1993 CD4 BINDING AGENTS AND INHIBITORS OF COLLAGENASE AND PROTEIN KINASE C 77%
WO09216517A1 10/01/1992 PHARMACEUTICAL XANTHONE DERIVATIVES
Ciao BigLinus
Anbei ein Auszug vom YAHOO-US-Board, bei welchen Konferenzen XENOVA vertreten sein wird. Offensichtlich stammt die Antwort direkt von Mrs. Hillary Reid Evans, XENOVA:
Here`s a response directly from XNVA to my inquiry about upcoming events (and why this info is NOT more readily available on their website).
"Thank you for your interest in Xenova. We are currently proposing to announce our Q3 results on Thursday 9 November, but this date is still subject to confirmation. Xenova has just 1attended the Communitech Cancer Progress Conference in New York and the VIII Congress of the Metastasis Society. Four posters were presented at the latter conference. We do not maintain our conferences schedule on our website since this schedule is subject to constant review and amendment. However, as of today`s date and looking through to year end, Xenova will be attending the Biopartnering Europe and Abbott Biotech Symposium Conferences in London (Oct 16-17 and 17-18)and present at the latter. Xenova will also attend the Global Venture Forum in Osaka (Oct 19-20) and will present. 4 abstracts have been submitted for the NCI/EORTC meeting in Amsterdam (Nov 7-10)and Xenova
will certainly attend. In November Xenova will attend the BIA CEO conference (London, Nov 16-17) and the Robertson Stephens conference in New York Nov 27-29. We do not predict dates for announcements since it is the company`s policy to abide by the BIA`s Best Practice Guidelines and announce trial results and other significant events as soon as they become available.
Since the end point for trials is dependent on recruitment rates and
review meetings precise dates are naturally virtually impossible to predict. We have nevertheless publically stated that we anticipate releasing further news regarding Phase II trials for XR5000 and XR9576 by year end 2000.
Please do not hesitate to contact me if you have any further queries
about Xenova or its products.
Yours sincerely
Hilary Reid Evans
Head of Corporate Communications"
Hopefully this gives some of you some milestones to look for by year-end.
Here`s a response directly from XNVA to my inquiry about upcoming events (and why this info is NOT more readily available on their website).
"Thank you for your interest in Xenova. We are currently proposing to announce our Q3 results on Thursday 9 November, but this date is still subject to confirmation. Xenova has just 1attended the Communitech Cancer Progress Conference in New York and the VIII Congress of the Metastasis Society. Four posters were presented at the latter conference. We do not maintain our conferences schedule on our website since this schedule is subject to constant review and amendment. However, as of today`s date and looking through to year end, Xenova will be attending the Biopartnering Europe and Abbott Biotech Symposium Conferences in London (Oct 16-17 and 17-18)and present at the latter. Xenova will also attend the Global Venture Forum in Osaka (Oct 19-20) and will present. 4 abstracts have been submitted for the NCI/EORTC meeting in Amsterdam (Nov 7-10)and Xenova
will certainly attend. In November Xenova will attend the BIA CEO conference (London, Nov 16-17) and the Robertson Stephens conference in New York Nov 27-29. We do not predict dates for announcements since it is the company`s policy to abide by the BIA`s Best Practice Guidelines and announce trial results and other significant events as soon as they become available.
Since the end point for trials is dependent on recruitment rates and
review meetings precise dates are naturally virtually impossible to predict. We have nevertheless publically stated that we anticipate releasing further news regarding Phase II trials for XR5000 and XR9576 by year end 2000.
Please do not hesitate to contact me if you have any further queries
about Xenova or its products.
Yours sincerely
Hilary Reid Evans
Head of Corporate Communications"
Hopefully this gives some of you some milestones to look for by year-end.
US-Investoren: Offensichtlich sind Lehmans in XENOVA eingestiegen.
http://www.insidertrader.com/freestuff/ticker_summary.asp?search=1&criteria=xnva &Submit2=GO
http://www.insidertrader.com/freestuff/ticker_summary.asp?search=1&criteria=xnva &Submit2=GO
NEUE OPTIONEN FÜR DIE DIREKTOREN zum Preis von 0,92 Pfund.
Anbei Press-Release:
RNS Number:4438S
Xenova Group PLC
12 October 2000
Xenova Group plc (XEN)
Directors` Dealings
On 11 October 2000 the Company`s recent Savings-Related Share Option Scheme 1999
offer closed. The following Directors of the Company are being granted options
to subscribe for ordinary shares under the offer, exercisable at #0.92p between
1 December 2003 and 31 May 2004.
Director´...............Number of Options.........Resultant Total Number of Options
Daniel Abrams......................-..................305,000
David Oxlade.....................3,875...............582,856
John Waterfall.......................-..................174,725
Michael Moore...................4,211...............247,820
Anbei Press-Release:
RNS Number:4438S
Xenova Group PLC
12 October 2000
Xenova Group plc (XEN)
Directors` Dealings
On 11 October 2000 the Company`s recent Savings-Related Share Option Scheme 1999
offer closed. The following Directors of the Company are being granted options
to subscribe for ordinary shares under the offer, exercisable at #0.92p between
1 December 2003 and 31 May 2004.
Director´...............Number of Options.........Resultant Total Number of Options
Daniel Abrams......................-..................305,000
David Oxlade.....................3,875...............582,856
John Waterfall.......................-..................174,725
Michael Moore...................4,211...............247,820
LONDON (AFX) - Fulcrum Pharma PLC said the current year has started well and it views the future with confidence.
The AIM-listed independent drug development company said it will continue to expand its client base in Europe, U.S. and Japan.
It expects that revenues and profit will be enhanced in the forthcoming period based on contracts already in place, on bids submitted and from its global business development activities.
Meanwhile, Fulcrum Pharma announced that it has signed a multi-year development agreement with Xenova Group PLC for the further development of a next-generation oncology product currently undergoing pre-clinical evaluation and anticipated to enter human clinical trials in 2001.
The comments came as the company posted its first set of results for the full year to Aug 31, since its flotation on AIM in March.
Chairman Sir Charles George said the company had a successful start and that it entered profit ahead of internal forecasts in its first period of trading, which allows it to take on further staff, expand its Japanese Office and update its information systems.
The group posted a pretax profit of 24,000 stg on sales of 1.8 mln stg while earnings per share were 0.07 pence.
Gruß Bogo!
The AIM-listed independent drug development company said it will continue to expand its client base in Europe, U.S. and Japan.
It expects that revenues and profit will be enhanced in the forthcoming period based on contracts already in place, on bids submitted and from its global business development activities.
Meanwhile, Fulcrum Pharma announced that it has signed a multi-year development agreement with Xenova Group PLC for the further development of a next-generation oncology product currently undergoing pre-clinical evaluation and anticipated to enter human clinical trials in 2001.
The comments came as the company posted its first set of results for the full year to Aug 31, since its flotation on AIM in March.
Chairman Sir Charles George said the company had a successful start and that it entered profit ahead of internal forecasts in its first period of trading, which allows it to take on further staff, expand its Japanese Office and update its information systems.
The group posted a pretax profit of 24,000 stg on sales of 1.8 mln stg while earnings per share were 0.07 pence.
Gruß Bogo!
Noch zu dem Beitrag von bogo01 :COMPANIES & FINANCE UK: Fulcrum in Xenova deal NEWS DIGEST
Financial Times, Oct 17, 2000, 92 words
Fulcrum in Xenova deal
The flotation on Aim in March of Fulcrum Pharma left the drug development company with Pounds 716,000 in cash at the end of its first six months as a listed company and allowed it to claim it had made pre-tax profits of Pounds 24,000. Of that, Pounds 11,000 was operating profit while Pounds 13,000 was interest received.
Sales were Pounds 1.8m in the six months to August 31.
The company, which plans drug development programs for pharmaceutical and biotechnology companies, announced a contract to provide Xenova with infrastructure and expertise as it developed a cancer treatment. David Firn
Copyright © The Financial Times Limited
Sliderman
Financial Times, Oct 17, 2000, 92 words
Fulcrum in Xenova deal
The flotation on Aim in March of Fulcrum Pharma left the drug development company with Pounds 716,000 in cash at the end of its first six months as a listed company and allowed it to claim it had made pre-tax profits of Pounds 24,000. Of that, Pounds 11,000 was operating profit while Pounds 13,000 was interest received.
Sales were Pounds 1.8m in the six months to August 31.
The company, which plans drug development programs for pharmaceutical and biotechnology companies, announced a contract to provide Xenova with infrastructure and expertise as it developed a cancer treatment. David Firn
Copyright © The Financial Times Limited
Sliderman
Xenova boosted by drug progress
(Adds share price reaction)
LONDON, Oct 18 (Reuters) - Biotech company Xenova Group Plc (LSE: XEN.L - news) on Wednesday reported positive news for one of its products, a potential treatment for cancer, giving its shares a boost.
Xenova said a positive outcome had been confirmed in the second of three phase IIa pharmacokinetic trials for its XR9576 product, which is designed to address the problems of multi-drug resistance in cancer, in combination therapy with doxorubicin.
The stock -- which has languished well below peaks above 470p set in the general mania for technology stocks earlier this year -- gained seven pence or 6.8 percent to 109-1/2p by 0710 GMT
A third phase IIa study, in which XR9576 is being administered in combination with another leading cancer drug, vinorelbine, is scheduled for completion shortly, the company said.
"Multi-drug resistance remains one of the major barriers to treatment in many forms of cancer. We are delighted by the continued progress of XR9576," said Xenova Chief Executive David Oxlade.
The news marked progress for Xenova, which in June disappointed the market with an admission that patients in a phase II trial of cancer treatment XR5000 had shown no response to the drug.
(Adds share price reaction)
LONDON, Oct 18 (Reuters) - Biotech company Xenova Group Plc (LSE: XEN.L - news) on Wednesday reported positive news for one of its products, a potential treatment for cancer, giving its shares a boost.
Xenova said a positive outcome had been confirmed in the second of three phase IIa pharmacokinetic trials for its XR9576 product, which is designed to address the problems of multi-drug resistance in cancer, in combination therapy with doxorubicin.
The stock -- which has languished well below peaks above 470p set in the general mania for technology stocks earlier this year -- gained seven pence or 6.8 percent to 109-1/2p by 0710 GMT
A third phase IIa study, in which XR9576 is being administered in combination with another leading cancer drug, vinorelbine, is scheduled for completion shortly, the company said.
"Multi-drug resistance remains one of the major barriers to treatment in many forms of cancer. We are delighted by the continued progress of XR9576," said Xenova Chief Executive David Oxlade.
The news marked progress for Xenova, which in June disappointed the market with an admission that patients in a phase II trial of cancer treatment XR5000 had shown no response to the drug.
...die selbe Information, jedoch etwas ausführlicher...
Xenova Group plc: XR9576 Phase II Cancer Program Update Further Positive Phase IIa Trial Results
SLOUGH, England, Oct 18, 2000 /PRNewswire via COMTEX/ -- Xenova Group plc
(Nasdaq: XNVA) (London Stock Exchange: XEN) today announced a program update for
its Phase II clinical trial candidate, XR9576.
A positive outcome has been confirmed in the second of three Phase IIa PK
(pharmacokinetic) trials, in which XR9576 was administered in combination
therapy with doxorubicin, one of the world`s most frequently used cytotoxic
drugs. XR9576 is a P-glycoprotein pump (P-gp) inhibitor, designed to address the
problems of multi-drug resistance in cancer. It is estimated that, depending on
the type of cancer, between 30% and 80% of cancer patients develop resistance to
anti-cancer drugs. The most common form of this resistance is the
over-production of a membrane protein, known as P-gp, which pumps anti-cancer
drugs out of cells.
This XR9576/doxorubicin study is the second to be completed in a series of three
trials designed to assess the level of drug:drug interaction, if any, between
XR9576 and the cytotoxic in question. The positive results of a Phase IIa PK
study, in which XR9576 was administered with paclitaxel, the world`s leading
selling cancer drug, and which was carried out in relapsed ovarian cancer
patients, were reported in March 2000. In the paclitaxel study, XR9576 showed no
clinically significant PK interaction, allowing paclitaxel to be administered at
its full clinical dose.
Commenting on the doxorubicin study, principal investigator Dr David Ferry, of
the Queen Elizabeth Medical Centre, Birmingham, UK said: "We are very pleased
with the outcome of this study. P-gp has been a difficult area to work in, with
variable and in some cases significant interactions observed between many of the
previously investigated P-gp inhibitors and the co- administered cytotoxics.
However, this trial has shown XR9576 to have only minor and predictable effects
when used with doxorubicin. XR9576`s lack of variable and clinically significant
PK interaction should provide an advantage in clinical practice, in that it
could allow many different cytotoxic drugs to be used at or close to their
normal doses."
Dr Hilary Thomas, Professor of Oncology at the Royal Surrey Hospital, Guilford,
UK and principal investigator for the paclitaxel/ovarian trial, commented
saying: "Ideally, multi-drug resistance modulators should allow cytotoxic drugs
to be administered at or as close as possible to their normal dosing levels. In
the study, which we completed earlier this year in relapsed ovarian patients,
XR9576 showed no sign of toxicity associated with XR9576 itself and no sign of
clinically significant effects on paclitaxel levels. This allowed us to use
paclitaxel at its full normal dosing levels, a potentially important and
differentiating capability."
A third Phase IIa study, in which XR9576 is being administered in combination
with vinorelbine, another leading cancer drug, is scheduled for completion
shortly. This study is being carried out at the National Cancer Institute in the
USA.
As previously reported, it is expected that XR9576 will be ready to enter
pivotal Phase III clinical trials by the end of 2000. The positive outcome of
the doxorubicin PK study, as announced today, provides additional clinical
options for the design of these Phase III studies.
Commenting, David Oxlade, Chief Executive Officer of Xenova Group plc said:
"Multi-drug resistance remains one of the major barriers to treatment in many
forms of cancer. We are delighted with the continued progress shown by XR9576."
Xenova Group plc is a London Stock Exchange techMARK listed company.
Notes to Editors
Xenova Group plc is an emerging bio-pharmaceutical company specialising in the
development of new small molecule drugs. The company`s strategy is to develop
commercially attractive new drugs, primarily in the area of cancer therapeutics.
In addition to its two Phase II program drugs (XR9576 and topoisomerase I and II
inhibitor XR5000) Xenova is also currently undertaking cancer research projects
targeting MRP-related multi-drug resistance, further next generation
topoisomerase inhibitors, telomerase (with Brunel University) and plasminogen
activator inhibitor-1 (PAI-1). Xenova has a drug development agreement with
Lilly, based on small molecule inhibitors of PAI-1, to develop novel
antithrombotic drugs for chronic use.
Xenova Group plc: XR9576 Phase II Cancer Program Update Further Positive Phase IIa Trial Results
SLOUGH, England, Oct 18, 2000 /PRNewswire via COMTEX/ -- Xenova Group plc
(Nasdaq: XNVA) (London Stock Exchange: XEN) today announced a program update for
its Phase II clinical trial candidate, XR9576.
A positive outcome has been confirmed in the second of three Phase IIa PK
(pharmacokinetic) trials, in which XR9576 was administered in combination
therapy with doxorubicin, one of the world`s most frequently used cytotoxic
drugs. XR9576 is a P-glycoprotein pump (P-gp) inhibitor, designed to address the
problems of multi-drug resistance in cancer. It is estimated that, depending on
the type of cancer, between 30% and 80% of cancer patients develop resistance to
anti-cancer drugs. The most common form of this resistance is the
over-production of a membrane protein, known as P-gp, which pumps anti-cancer
drugs out of cells.
This XR9576/doxorubicin study is the second to be completed in a series of three
trials designed to assess the level of drug:drug interaction, if any, between
XR9576 and the cytotoxic in question. The positive results of a Phase IIa PK
study, in which XR9576 was administered with paclitaxel, the world`s leading
selling cancer drug, and which was carried out in relapsed ovarian cancer
patients, were reported in March 2000. In the paclitaxel study, XR9576 showed no
clinically significant PK interaction, allowing paclitaxel to be administered at
its full clinical dose.
Commenting on the doxorubicin study, principal investigator Dr David Ferry, of
the Queen Elizabeth Medical Centre, Birmingham, UK said: "We are very pleased
with the outcome of this study. P-gp has been a difficult area to work in, with
variable and in some cases significant interactions observed between many of the
previously investigated P-gp inhibitors and the co- administered cytotoxics.
However, this trial has shown XR9576 to have only minor and predictable effects
when used with doxorubicin. XR9576`s lack of variable and clinically significant
PK interaction should provide an advantage in clinical practice, in that it
could allow many different cytotoxic drugs to be used at or close to their
normal doses."
Dr Hilary Thomas, Professor of Oncology at the Royal Surrey Hospital, Guilford,
UK and principal investigator for the paclitaxel/ovarian trial, commented
saying: "Ideally, multi-drug resistance modulators should allow cytotoxic drugs
to be administered at or as close as possible to their normal dosing levels. In
the study, which we completed earlier this year in relapsed ovarian patients,
XR9576 showed no sign of toxicity associated with XR9576 itself and no sign of
clinically significant effects on paclitaxel levels. This allowed us to use
paclitaxel at its full normal dosing levels, a potentially important and
differentiating capability."
A third Phase IIa study, in which XR9576 is being administered in combination
with vinorelbine, another leading cancer drug, is scheduled for completion
shortly. This study is being carried out at the National Cancer Institute in the
USA.
As previously reported, it is expected that XR9576 will be ready to enter
pivotal Phase III clinical trials by the end of 2000. The positive outcome of
the doxorubicin PK study, as announced today, provides additional clinical
options for the design of these Phase III studies.
Commenting, David Oxlade, Chief Executive Officer of Xenova Group plc said:
"Multi-drug resistance remains one of the major barriers to treatment in many
forms of cancer. We are delighted with the continued progress shown by XR9576."
Xenova Group plc is a London Stock Exchange techMARK listed company.
Notes to Editors
Xenova Group plc is an emerging bio-pharmaceutical company specialising in the
development of new small molecule drugs. The company`s strategy is to develop
commercially attractive new drugs, primarily in the area of cancer therapeutics.
In addition to its two Phase II program drugs (XR9576 and topoisomerase I and II
inhibitor XR5000) Xenova is also currently undertaking cancer research projects
targeting MRP-related multi-drug resistance, further next generation
topoisomerase inhibitors, telomerase (with Brunel University) and plasminogen
activator inhibitor-1 (PAI-1). Xenova has a drug development agreement with
Lilly, based on small molecule inhibitors of PAI-1, to develop novel
antithrombotic drugs for chronic use.
Hi XENOVA-Fans,
hier eine Übersetzung meines Übersetzungsprogrammes zu o.g. Pressemitteilung. Das `schlechte` Deutsch möchte ich gleich entschuldigen, denn ich habe aus Zeitmangel den Übersetzungsvorschlag nicht überarbeitet.
Plc Gruppe Xenova: Xr9576 KrebsProgrammAktualisierungsvorgang Der Phase II Weitere Positive Resultate Versuch Der Phase IIa
Fotorezeptor Newswire
Mittwoch Oktober 18 2:00am
SLOUGH, England, Okt. 18 / PRNewswire / -- plc Gruppe Xenova (Nasdaq: Xnva ) (Börse Londons: XEN) verkündete heute einen Programmaktualisierungsvorgang für seinen klinischen Probeanwärter der Phase II, XR9576.
Ein positives Resultat ist in der Sekunde von drei (pharmakokinetischen) Versuchen der Phase IIa PK, in denen XR9576 in der Kombination Therapie mit doxorubicin ausgeübt wurde, eine der benutzten cytotoxischen Drogen der Welt am häufigsten bestätigt worden. XR9576 ist ein Hemmnis der P-Glucoproteidpumpe (PGP), entworfen, um die Probleme Multidrogewiderstand im Krebs zu adressieren. Es wird geschätzt, daß, abhängig von der Art des Krebses, zwischen 30% und 80% der Krebspatienten Widerstand zu den krebsbekämpfenden Drogen entwickeln Sie. Das allgemeinste Formular dieses Widerstandes ist die Überproduktion eines Membrane Proteins, bekannt als PGP, das krebsbekämpfende Drogen aus Zellen heraus pumpt.
Diese XR9576-/doxorubicinstudie ist die in einer Reihe von drei Versuchen durchzuführende Sekunde, die entworfen werden, um die Stufe der drug:drug-Abhängigkeit, wenn irgendeine, zwischen XR9576 und dem cytotoxischen in der Frage festzusetzen. Die positiven Resultate einer Phase IIa PK studieren, in der XR9576 mit paclitaxel, die führende verkaufende Krebsdroge der Welt ausgeübt wurde und in der bei zurückgefallenen ovarian Krebspatienten durchgeführt wurde, wurden berichtet im März 2000. In der paclitaxelstudie zeigte XR9576 keine klinisch bedeutende PK-Abhängigkeit und erlaubte, daß paclitaxel an seiner vollen klinischen Dosis ausgeübt wird.
Kommentierend die doxorubicinstudie, sagte allgemeine Fähre des Forschers Dr David, der medizinischen Mitte der Königin Elizabeth, Birmingham, Großbritannien: " wir sind mit dem Resultat dieser Studie sehr erfreut. PGP ist ein schwieriger Bereich zum innen Arbeiten gewesen, wenn der Variable und in einigen Fällen bedeutende Abhängigkeiten zwischen vielen der vorher nachgeforschten PGP-Hemmnisse und dem Co-ausgeübten cytotoxics beobachtet sind. Jedoch hat dieser Versuch XR9576 gezeigt, um nur geringe und vorhersagbare Effekte zu haben, wenn er mit doxorubicin verwendet wird. XR9576`s-Mangel an Variable und klinisch bedeutende PK-Abhängigkeit sollte einen Vorteil in der klinischen Praxis zur Verfügung stellen, dadurch, daß er erlauben könnte, daß viele unterschiedliche cytotoxische Drogen werden benutzt an oder nah an ihren normalen Dosen. ",
Dr Hilary Thomas, Professor von Onkologie am königlichen Surreykrankenhaus, Guilford, Großbritannien und allgemeiner Forscher für den paclitaxel-/ovarianversuch, kommentiertes Sagen: " ideal, sollten Multidrogewiderstand Modulatoren erlauben, daß cytotoxische Drogen an oder so nahe ausgeübt werden, wie möglich zu ihren normalen Dosisniveaus. In der Studie der wir früh dieses Jahr bei zurückgefallenen ovarian Patienten durchführten, zeigte XR9576 kein Zeichen von Giftigkeit dazugehörig mit XR9576 selbst und kein Zeichen der klinisch bedeutenden Effekte auf paclitaxelstufen. Dieses erlaubte uns, paclitaxel an seinen vollen normalen Dosisniveaus, an einem möglicherweise wichtigem und am Unterscheiden Fähigkeit zu benutzen. ",
Eine dritte Studie der Phase IIa, in der XR9576 im Verbindung mit vinorelbine ausgeübt wird, eine andere führende Krebsdroge, wird für Beendigung kurz eingeplant. Diese Studie wird am nationalen Krebsinstitut in den USA durchgeführt.
Wie vorher berichtet, wird es erwartet, daß XR9576 betriebsbereit ist, Angelklinische Versuche der phase III Ende 2000 einzutragen. Das positive Resultat der Studie des doxorubicin PK, wie heute verkündet, stellt zusätzliche klinische Optionen für das Design von diesen Studien der Phase III zur Verfügung.
Kommentierend, sagte David Oxlade, Generaldirektor von plc Gruppe Xenova: " Multi-Drogewiderstand bleibt eine der Hauptsperren zur Behandlung in vielen Formen des Krebses. Wir werden mit dem anhaltenden Fortschritt erfreut, der gezeigt wird von XR9576. ",
Plc Gruppe Xenova ist eine ausgedruckte Firma der Börse Londons techMARK.
Anmerkungen zu den Herausgebern
Plc Gruppe Xenova ist eine auftauchende Bio-pharmazeutische Firma, die auf die Entwicklung der neuen kleinen Moleküldrogen sich spezialisiert. Die Strategie der Firma ist, kommerziell attraktive neue Drogen, hauptsächlich im Bereich der Krebstherapeutik zu entwickeln.
Zusätzlich zu seinen Zweiphasen-Drogen des Programms II (XR9576 und topoisomerase I und II Hemmnis XR5000) nimmt sich Xenova auch aktuell die Krebsforschungprojekte auf, die MRP-relatedMultidrogewiderstand, weitere folgendes Erzeugung topoisomerasehemmnisse zielen, telomerase (mit Universität Brunel) und plasminogenaktivator inhibitor-1 (PAI-1). Xenova hat eine Drogeentwicklung Vereinbarung mit Lilly, basiert auf kleinen Molekülhemmnissen von PAI-1, um antithrombotische Drogen des Romans für chronischen Gebrauch zu entwickeln.
Für weitere Informationen über Xenova und seine Produkte bitte Besuch das website Xenova an http://www.xenova.co.uk .
Ciao BigLinus
hier eine Übersetzung meines Übersetzungsprogrammes zu o.g. Pressemitteilung. Das `schlechte` Deutsch möchte ich gleich entschuldigen, denn ich habe aus Zeitmangel den Übersetzungsvorschlag nicht überarbeitet.
Plc Gruppe Xenova: Xr9576 KrebsProgrammAktualisierungsvorgang Der Phase II Weitere Positive Resultate Versuch Der Phase IIa
Fotorezeptor Newswire
Mittwoch Oktober 18 2:00am
SLOUGH, England, Okt. 18 / PRNewswire / -- plc Gruppe Xenova (Nasdaq: Xnva ) (Börse Londons: XEN) verkündete heute einen Programmaktualisierungsvorgang für seinen klinischen Probeanwärter der Phase II, XR9576.
Ein positives Resultat ist in der Sekunde von drei (pharmakokinetischen) Versuchen der Phase IIa PK, in denen XR9576 in der Kombination Therapie mit doxorubicin ausgeübt wurde, eine der benutzten cytotoxischen Drogen der Welt am häufigsten bestätigt worden. XR9576 ist ein Hemmnis der P-Glucoproteidpumpe (PGP), entworfen, um die Probleme Multidrogewiderstand im Krebs zu adressieren. Es wird geschätzt, daß, abhängig von der Art des Krebses, zwischen 30% und 80% der Krebspatienten Widerstand zu den krebsbekämpfenden Drogen entwickeln Sie. Das allgemeinste Formular dieses Widerstandes ist die Überproduktion eines Membrane Proteins, bekannt als PGP, das krebsbekämpfende Drogen aus Zellen heraus pumpt.
Diese XR9576-/doxorubicinstudie ist die in einer Reihe von drei Versuchen durchzuführende Sekunde, die entworfen werden, um die Stufe der drug:drug-Abhängigkeit, wenn irgendeine, zwischen XR9576 und dem cytotoxischen in der Frage festzusetzen. Die positiven Resultate einer Phase IIa PK studieren, in der XR9576 mit paclitaxel, die führende verkaufende Krebsdroge der Welt ausgeübt wurde und in der bei zurückgefallenen ovarian Krebspatienten durchgeführt wurde, wurden berichtet im März 2000. In der paclitaxelstudie zeigte XR9576 keine klinisch bedeutende PK-Abhängigkeit und erlaubte, daß paclitaxel an seiner vollen klinischen Dosis ausgeübt wird.
Kommentierend die doxorubicinstudie, sagte allgemeine Fähre des Forschers Dr David, der medizinischen Mitte der Königin Elizabeth, Birmingham, Großbritannien: " wir sind mit dem Resultat dieser Studie sehr erfreut. PGP ist ein schwieriger Bereich zum innen Arbeiten gewesen, wenn der Variable und in einigen Fällen bedeutende Abhängigkeiten zwischen vielen der vorher nachgeforschten PGP-Hemmnisse und dem Co-ausgeübten cytotoxics beobachtet sind. Jedoch hat dieser Versuch XR9576 gezeigt, um nur geringe und vorhersagbare Effekte zu haben, wenn er mit doxorubicin verwendet wird. XR9576`s-Mangel an Variable und klinisch bedeutende PK-Abhängigkeit sollte einen Vorteil in der klinischen Praxis zur Verfügung stellen, dadurch, daß er erlauben könnte, daß viele unterschiedliche cytotoxische Drogen werden benutzt an oder nah an ihren normalen Dosen. ",
Dr Hilary Thomas, Professor von Onkologie am königlichen Surreykrankenhaus, Guilford, Großbritannien und allgemeiner Forscher für den paclitaxel-/ovarianversuch, kommentiertes Sagen: " ideal, sollten Multidrogewiderstand Modulatoren erlauben, daß cytotoxische Drogen an oder so nahe ausgeübt werden, wie möglich zu ihren normalen Dosisniveaus. In der Studie der wir früh dieses Jahr bei zurückgefallenen ovarian Patienten durchführten, zeigte XR9576 kein Zeichen von Giftigkeit dazugehörig mit XR9576 selbst und kein Zeichen der klinisch bedeutenden Effekte auf paclitaxelstufen. Dieses erlaubte uns, paclitaxel an seinen vollen normalen Dosisniveaus, an einem möglicherweise wichtigem und am Unterscheiden Fähigkeit zu benutzen. ",
Eine dritte Studie der Phase IIa, in der XR9576 im Verbindung mit vinorelbine ausgeübt wird, eine andere führende Krebsdroge, wird für Beendigung kurz eingeplant. Diese Studie wird am nationalen Krebsinstitut in den USA durchgeführt.
Wie vorher berichtet, wird es erwartet, daß XR9576 betriebsbereit ist, Angelklinische Versuche der phase III Ende 2000 einzutragen. Das positive Resultat der Studie des doxorubicin PK, wie heute verkündet, stellt zusätzliche klinische Optionen für das Design von diesen Studien der Phase III zur Verfügung.
Kommentierend, sagte David Oxlade, Generaldirektor von plc Gruppe Xenova: " Multi-Drogewiderstand bleibt eine der Hauptsperren zur Behandlung in vielen Formen des Krebses. Wir werden mit dem anhaltenden Fortschritt erfreut, der gezeigt wird von XR9576. ",
Plc Gruppe Xenova ist eine ausgedruckte Firma der Börse Londons techMARK.
Anmerkungen zu den Herausgebern
Plc Gruppe Xenova ist eine auftauchende Bio-pharmazeutische Firma, die auf die Entwicklung der neuen kleinen Moleküldrogen sich spezialisiert. Die Strategie der Firma ist, kommerziell attraktive neue Drogen, hauptsächlich im Bereich der Krebstherapeutik zu entwickeln.
Zusätzlich zu seinen Zweiphasen-Drogen des Programms II (XR9576 und topoisomerase I und II Hemmnis XR5000) nimmt sich Xenova auch aktuell die Krebsforschungprojekte auf, die MRP-relatedMultidrogewiderstand, weitere folgendes Erzeugung topoisomerasehemmnisse zielen, telomerase (mit Universität Brunel) und plasminogenaktivator inhibitor-1 (PAI-1). Xenova hat eine Drogeentwicklung Vereinbarung mit Lilly, basiert auf kleinen Molekülhemmnissen von PAI-1, um antithrombotische Drogen des Romans für chronischen Gebrauch zu entwickeln.
Für weitere Informationen über Xenova und seine Produkte bitte Besuch das website Xenova an http://www.xenova.co.uk .
Ciao BigLinus
Auszug aus UK-Zeitungen vom 19.10.2000 bzgl. XENOVA:
Independet: Partner needed to give stability
Financial Times: talks are underway
Independet: Partner needed to give stability
Financial Times: talks are underway
Daily Telegraph: shares remain highly speculative (vom 19.10.2000)
GLOBAL BIOTECH INVEVESTOR: ...man solle sich nicht von Kursabschlägen irritieren lassen!
Sonstiges:
Fulcrum Pharma pushed 1/4 higher to 9 3/4, supported by news of its development deal with XENOVA Group - with the company saying the current year has started well and it plans continued expansion of it client base in Europe and the U.S.
GLOBAL BIOTECH INVEVESTOR: ...man solle sich nicht von Kursabschlägen irritieren lassen!
Sonstiges:
Fulcrum Pharma pushed 1/4 higher to 9 3/4, supported by news of its development deal with XENOVA Group - with the company saying the current year has started well and it plans continued expansion of it client base in Europe and the U.S.
WICHTIGE ERGEBNISSE ZU XR9576 mit Vinorelbine vom 24.10.2000:
(Diese Daten wurden noch nicht offiziell veröffentlich! Eine Kurssteigerung könnte aufgrund dessen noch eintreten!)
zu finden unter http://clinicalstudies.info.nih.gov/detail/A_2000-C-0044.htm…">http://clinicalstudies.info.nih.gov/detail/A_2000-C-0044.htm…
(Diese Daten wurden noch nicht offiziell veröffentlich! Eine Kurssteigerung könnte aufgrund dessen noch eintreten!)
zu finden unter http://clinicalstudies.info.nih.gov/detail/A_2000-C-0044.htm…">http://clinicalstudies.info.nih.gov/detail/A_2000-C-0044.htm…
1.) HSBC steigt auch mit Zweigbetriebe in XENOVA ein:
Anscheinend will HSBC XENOVA-Aktien kaufen. Über die Anzahl der Aktien ist leider nichts bekannt. Anbei original-Bericht vom 19.10.2000:
Xenova Group PLC - Holding in Company
100% match; RNS; Oct 26, 2000
LETTER TO XENOVA GROUP PLC
Part VI Companies Act 1985
We hereby notify you in accordance with Part VI Companies Act 1985 ("the Act")
that as at close of business on 23 October 2000 HSBC Investment Bank plc ceased
to have a notifiable interest in the ordinary shares of Xenova Group plc ("the
Shares").
HSBC Investment Bank Holdings plc as HSBC Investment Bank plc`s parent and HSBC
Holdings plc, our ultimate parent company, also ceased to have a notifiable
interest in the above mentioned Shares.
LETTER FROM HSBC INVESTMENT BANK PLC
2.)Investmentbericht zu XENOVA aus UK:
The Investment Column: Xenova
100% match; The Independent - United Kingdom; Oct 19, 2000
YESTERDAY`S COLLAPSE of the genital warts collaboration between Cantab Pharmaceuticals and SmithKline Beecham is a reminder of the potential hurdles ahead for Xenova, the cancer specialist.
Xenova is making good progress with its lead compound, a drug designed to enable cancer patients to have chemotherapy more than once. A decent set of trial results for the compound, XR9576, sent the shares up 7 per cent yesterday morning, although they closed down 3p at 99.5p as Cantab`s woes contaminated the sector.
XR9576 can be used safely alongside drugs that treat breast, kidney and prostate cancer, Xenova said. Previously, the compound`s only known safe application was ovarian cancer.
But while Cantab has just lost a partner, Xenova has yet to find one. Further trials are required to establish whether XR9576 is actually effective - and that will cost at least pounds 10m. David Oxlade, the chief executive, says he`s talking to several pharmaceutical firms with a view to clinching a deal that will pave the way for trials early next year. But given the flimsy clinical data published to date, nothing is guaranteed. If Xenova secures a partner, XR9576 will still have to deliver if the group is to avoid Cantab`s fate.
Despite yesterday`s good news, the shares remain highly speculative.
Business 24
Anscheinend will HSBC XENOVA-Aktien kaufen. Über die Anzahl der Aktien ist leider nichts bekannt. Anbei original-Bericht vom 19.10.2000:
Xenova Group PLC - Holding in Company
100% match; RNS; Oct 26, 2000
LETTER TO XENOVA GROUP PLC
Part VI Companies Act 1985
We hereby notify you in accordance with Part VI Companies Act 1985 ("the Act")
that as at close of business on 23 October 2000 HSBC Investment Bank plc ceased
to have a notifiable interest in the ordinary shares of Xenova Group plc ("the
Shares").
HSBC Investment Bank Holdings plc as HSBC Investment Bank plc`s parent and HSBC
Holdings plc, our ultimate parent company, also ceased to have a notifiable
interest in the above mentioned Shares.
LETTER FROM HSBC INVESTMENT BANK PLC
2.)Investmentbericht zu XENOVA aus UK:
The Investment Column: Xenova
100% match; The Independent - United Kingdom; Oct 19, 2000
YESTERDAY`S COLLAPSE of the genital warts collaboration between Cantab Pharmaceuticals and SmithKline Beecham is a reminder of the potential hurdles ahead for Xenova, the cancer specialist.
Xenova is making good progress with its lead compound, a drug designed to enable cancer patients to have chemotherapy more than once. A decent set of trial results for the compound, XR9576, sent the shares up 7 per cent yesterday morning, although they closed down 3p at 99.5p as Cantab`s woes contaminated the sector.
XR9576 can be used safely alongside drugs that treat breast, kidney and prostate cancer, Xenova said. Previously, the compound`s only known safe application was ovarian cancer.
But while Cantab has just lost a partner, Xenova has yet to find one. Further trials are required to establish whether XR9576 is actually effective - and that will cost at least pounds 10m. David Oxlade, the chief executive, says he`s talking to several pharmaceutical firms with a view to clinching a deal that will pave the way for trials early next year. But given the flimsy clinical data published to date, nothing is guaranteed. If Xenova secures a partner, XR9576 will still have to deliver if the group is to avoid Cantab`s fate.
Despite yesterday`s good news, the shares remain highly speculative.
Business 24
A.
Ein Interview vom 01.11.2000 von CEO David Oxlade könnt Ihr unter www.ceocast.com. Einfach mal registrieren, kostet nichts und somit erhält ihr weitere Interviews zu eueren gewünschten Aktien!
B.
Älterer Bericht unter http://hiv.medscape.com/reuters/prof/2000/03/03.21/sc03210e.…
(wenn nicht klappt, dann unter www.medscape.com/reuters/prof/2000/03/03.21/sc03210e.html):
(Registrierung erforderlich)
Anbei Auszug:
HIV Protease Inhibitor Concentrations May Be Enhanced in `Sanctuary Sites`
--------------------------------------------------------------------------------
WESTPORT, Mar 21 (Reuters Health) - Researchers from Vanderbilt University may have found a way to increase the penetration of protease inhibitors into the CNS and other "sanctuary sites" in HIV-infected individuals. Specifically, they have found that a compound called LY-335979 appears to inhibit the activity of P-glycoprotein, a major barrier to HIV in the brain and testes.
At the annual meeting of the American Society for Clinical Pharmacology and Therapeutics in Los Angeles last week, Dr. Edna Choo presented "proof-of-concept" that protease inhibitor concentrations can be enhanced in sanctuary sites by pharmacologically inhibiting P-glycoprotein.
P-glycoprotein is a membrane efflux transporter located in the capillary endothelium that prevents HIV protease inhibitor penetration into the CNS and testes, two sanctuary sites of the virus. Therefore, Dr. Choo and her colleagues in Nashville, Tennessee, speculated that inhibition of P-glycoprotein would increase protease inhibitor levels in these tissues.
They tested this hypothesis by injecting radiolabeled-nelfinavir into a mouse model. LY-335979 was administered 30 minutes before nelfinavir and again concurrently with nelfinavir injection. Two hours after nelfinavir administration, blood and tissue samples from the mice were evaluated.
After administration of 1 to 50 mg/kg of LY-335979, Dr. Choo found that nelfinavir concentrations increased in a dose-dependent manner by 37-fold in the brain and by 4-fold in the testes. However, plasma nelfinavir concentrations increased only minimally.
At the highest dose of LY-335979, Dr. Choo estimated that P-glycoprotein was inhibited by about 75% in the brain and 90% in the testes.
Based on these findings, she suggests that pharmacologic inhibition of P-glycoprotein may provide a new therapeutic strategy for patients with HIV infection.
Vermutung: Das P-glycoprotein könnte ein Stoppen des HIV-Virus bewirken. Da nun XENOVA mit P-glycoprotein arbeitet, bestünde auch die Möglichkeit für XENOVA, sich durch XR9576 an der Bekämpfung des HIV-Virus beizutragen.
Weitere Kommentare von Board-Teilnehmern könnt Ihr lesen unter:
Pro:http://messages.yahoo.com/bbs?.mm=FN&action=m&board=7077399&…
Contra/Fragen:
http://messages.yahoo.com/bbs?.mm=FN&action=m&board=7077399&…
Antworten: http://messages.yahoo.com/bbs?.mm=FN&action=m&board=7077399&…
Diese Diskussion stammt aus dem Yahoo-Board und sollte als Denkanstoß dienen. Es gibt derzeit keine definitive Beziehung zwischen XR9576 und HIV. Also, bitte nicht groß bewerten!
Ein Interview vom 01.11.2000 von CEO David Oxlade könnt Ihr unter www.ceocast.com. Einfach mal registrieren, kostet nichts und somit erhält ihr weitere Interviews zu eueren gewünschten Aktien!
B.
Älterer Bericht unter http://hiv.medscape.com/reuters/prof/2000/03/03.21/sc03210e.…
(wenn nicht klappt, dann unter www.medscape.com/reuters/prof/2000/03/03.21/sc03210e.html):
(Registrierung erforderlich)
Anbei Auszug:
HIV Protease Inhibitor Concentrations May Be Enhanced in `Sanctuary Sites`
--------------------------------------------------------------------------------
WESTPORT, Mar 21 (Reuters Health) - Researchers from Vanderbilt University may have found a way to increase the penetration of protease inhibitors into the CNS and other "sanctuary sites" in HIV-infected individuals. Specifically, they have found that a compound called LY-335979 appears to inhibit the activity of P-glycoprotein, a major barrier to HIV in the brain and testes.
At the annual meeting of the American Society for Clinical Pharmacology and Therapeutics in Los Angeles last week, Dr. Edna Choo presented "proof-of-concept" that protease inhibitor concentrations can be enhanced in sanctuary sites by pharmacologically inhibiting P-glycoprotein.
P-glycoprotein is a membrane efflux transporter located in the capillary endothelium that prevents HIV protease inhibitor penetration into the CNS and testes, two sanctuary sites of the virus. Therefore, Dr. Choo and her colleagues in Nashville, Tennessee, speculated that inhibition of P-glycoprotein would increase protease inhibitor levels in these tissues.
They tested this hypothesis by injecting radiolabeled-nelfinavir into a mouse model. LY-335979 was administered 30 minutes before nelfinavir and again concurrently with nelfinavir injection. Two hours after nelfinavir administration, blood and tissue samples from the mice were evaluated.
After administration of 1 to 50 mg/kg of LY-335979, Dr. Choo found that nelfinavir concentrations increased in a dose-dependent manner by 37-fold in the brain and by 4-fold in the testes. However, plasma nelfinavir concentrations increased only minimally.
At the highest dose of LY-335979, Dr. Choo estimated that P-glycoprotein was inhibited by about 75% in the brain and 90% in the testes.
Based on these findings, she suggests that pharmacologic inhibition of P-glycoprotein may provide a new therapeutic strategy for patients with HIV infection.
Vermutung: Das P-glycoprotein könnte ein Stoppen des HIV-Virus bewirken. Da nun XENOVA mit P-glycoprotein arbeitet, bestünde auch die Möglichkeit für XENOVA, sich durch XR9576 an der Bekämpfung des HIV-Virus beizutragen.
Weitere Kommentare von Board-Teilnehmern könnt Ihr lesen unter:
Pro:http://messages.yahoo.com/bbs?.mm=FN&action=m&board=7077399&…
Contra/Fragen:
http://messages.yahoo.com/bbs?.mm=FN&action=m&board=7077399&…
Antworten: http://messages.yahoo.com/bbs?.mm=FN&action=m&board=7077399&…
Diese Diskussion stammt aus dem Yahoo-Board und sollte als Denkanstoß dienen. Es gibt derzeit keine definitive Beziehung zwischen XR9576 und HIV. Also, bitte nicht groß bewerten!
XENOVA hat heute die Quartalszahlen veröffentlicht:
Anbei Bericht:
Xenova Group plc Third Quarter Results Announcement
SLOUGH, England, Nov 9, 2000 /PRNewswire via COMTEX/ -- Xenova Group plc
(Nasdaq: XNVA) (London Stock Exchange: XEN) today announced its results for the
nine-month period to 30 September 2000.
Commenting on the results, Chief Executive Officer David Oxlade said: "Xenova`s
product pipeline has generally made good progress in the first nine months of
this year. Following positive clinical trial results from the Phase IIa trials,
in which XR9576 was administered in combination with paclitaxel and doxorubicin
respectively, we anticipate that XR9576 will be ready to enter Phase III around
the end of this year. XR11576, our next generation cytotoxic drug candidate, has
entered preclinical development and we have identified a further novel
topoisomerase I and II cytotoxic drug candidate, known as XR5944."
Operational Highlights
Product Development
Both of Xenova`s lead drug candidates, XR9576 (which targets the reversal of
multi-drug resistance in cancer) and XR5000 (a novel cytotoxic designed to kill
cancer cells), have continued to progress through Phase II clinical trials.
These Phase II studies are expected to complete by the end of calendar year
2000.
XR9576 (P-glycoprotein modulator) -- The successful conclusion of a Phase IIa
pharmacokinetic study in relapsed ovarian patients was announced in March 2000.
This study was carried out in patients with ovarian cancer recurring more than 6
months after previous treatment with a variety of cytotoxic drugs.
No clinically significant drug interaction between XR9576 and paclitaxel in
plasma was observed. By contrast with the performance of some other compounds in
development by competitors, this allows paclitaxel to be administered at its
full normal clinical dose when used with XR9576.
Further positive data was announced in October for a second Phase IIa trial, in
which XR9576 was administered in combination therapy with doxorubicin. The trial
showed that limited and predictable interaction occurred, allowing doxorubicin
to be administered at or close to the normal clinical dose, potentially
providing an advantage in clinical practice.
A further Phase IIa clinical trial, in which XR9576 is being studied in
combination therapy with vinorelbine, is currently underway in the US and is
being carried out in conjunction with the National Cancer Institute. It is
anticipated that results from this trial will be announced before the end of
2000. Paclitaxel, vinorelbine and doxorubicin are three of the world`s
highest-selling cytotoxic drugs.
It is expected that XR9576 will be ready to enter pivotal Phase III clinical
trials around the end of this year. The company anticipates that expenses for
Phase III pivotal registration studies will be assumed by a partner.
XR5000 (Topoisomerase I and II inhibitor) -- Three Phase II clinical trials are
also underway at a number of European centers for the novel cytotoxic XR5000, a
topoisomerase I and II inhibitor for the treatment of common solid tumors. The
Phase II trials are being conducted on an "open label" basis and target three
cancer types -- ovarian, non small cell lung and glioblastoma. In preclinical
studies, XR5000 was shown to be effective in cases where a tumor had already
shown resistance to treatment with existing cytotoxic drugs.
The results of a fourth Phase II trial, in which the efficacy of XR5000 was
investigated in patients with colorectal cancer, were announced in June 2000. At
the study dose level of 3010mg/m(2) no complete or partial responses to
treatment were observed. This study is complete and no further recruitment is
therefore planned for this indication.
Final data from all three remaining studies are expected to be available by the
end of this year. Results from these trials will help determine the future
development strategy for this compound.
Development of Xenova`s pipeline of preclinical compounds continued
satisfactorily in the nine months to 30 September 2000. All preclinical
compounds currently in development have been derived from Xenova`s own R&D
capability.
XR11576 -- A novel, orally active next generation topoisomerase I and II
inhibitor, XR11576 is undergoing final pharmacological and toxicity testing,
prior to its planned entry into clinical development. XR11576 is structurally
dissimilar to XR5000, with a significant improvement in its profile including
oral bioavailability and a marked enhancement of potency, while retaining
certain advantageous characteristics of XR5000. The XR11576 series of compounds
is protected by a priority patent application in the UK.
XR5944 -- Xenova has discovered a further novel inhibitor of topoisomerase I and
II that has shown exceptionally high potency as a cytotoxic agent in preclinical
studies with a number of tumor cell lines. XR5944 is structurally distinct from
both XR5000 and XR11576 and has been shown to be unaffected by atypical
multi-drug resistance.
A UK priority patent application relating to the XR5942 second generation drug
leads has been filed by Xenova. XR5944 forms part of this family of drug leads.
Patents granted pursuant to these applications, if any, would expire in 2017.
PAI-1 Inhibitors (Anti-Thrombotic) -- Research continues in this drug
development program, in which Xenova established a partnership with Lilly in
February 1998. The partnership is based on compounds from Xenova`s XR334 series
that are capable of oral absorption and are active in both venous and arterial
models of thrombosis.
PAI-1 Inhibitors (Anti-Cancer) -- Research has continued in this program, in
which Xenova is collaborating with the Institute for Cancer Research. PAI-1 is
believed to play a role in the spread of cancer (metastasis) and it has been
demonstrated that monoclonal antibodies to PAI-1 inhibit tumor cell migration
and invasion in vitro. A poster was presented at the VIII Congress of Metastasis
Society, in London in September 2000, demonstrating that antibodies to PAI-1
suppress angiogenesis in vitro.
Multi-Drug Resistant Protein (MRP) -- Xenova is conducting a research program
for MRP during 2000. Should this be successful, it is expected that compounds
will enter preclinical development during 2001. MRP acts as a pump, which, like
P-gp, expels small molecules (such as cytotoxins) out of cells and thus can help
protect tumor cells from certain chemotherapeutic agents.
Xenova is also exploring the potential application of MRP inhibitors in the
prevention of lung inflammation in asthma patients. Xenova is currently
evaluating drug leads from its MRP cancer program in the search for new classes
of anti-asthmatic drug candidates.
Telomerase -- Telomerase is an enzyme known to play a role in cancer
progression. On 7 February 2000 Xenova signed an exclusive collaborative
research agreement, to last for a minimum of two years, for the discovery and
development of novel classes of apoptosis inducing telomerase inhibitors with
Professor Rob Newbold and his team at Brunel University. Professor Newbold and
his team are acknowledged as being amongst the world`s leading experts in this
field.
Management
Stephen B. Howell, Professor of Medicine at the University of California, San
Diego, joined Xenova`s Scientific Advisory Board (SAB) in January 2000.
Peter Gillett joined Xenova as a non-executive Director in February 2000. Peter
Gillett chairs Xenova`s Audit Committee. Until June 2000 he was a partner in
Ernst & Young, the audit and professional services firm.
Financial Review
The Group`s financial position has been strengthened by a successful August
placing and open offer, which raised 10m pounds before expenses. A further 9.8m
pounds before expenses will be raised, assuming full exercise of associated
warrants, between 1 January and 31 October 2001.
Nil revenues (1999: 0.8m pounds, $1.1m) occurred for the quarter to 30 September
2000. Total revenue for the nine months to 30 September 2000 of 0.1m pounds
($0.1m) (1999: 2.6m pounds, $3.8m) was primarily derived from the sale of a
software license, following the 1999 sale of the majority of the assets and the
transfer of the employees of MetaXen, Xenova`s San Francisco-based subsidiary,
to Exelixis. The decrease in turnover is primarily attributable to the transfer
to Lilly of work in connection with the ongoing PAI-1 cardio-vascular research
and development program.
Operating expenses for the quarter to 30 September 2000 totaled 2.5m pounds
($3.7m) (1999: 2.8m pounds, $4.2m) and included research and development costs
of 2.1m pounds ($3.1m) (1999: 2.2m pounds, $3.3m). Research and development
costs for continuing operations were 2.1m pounds ($3.1m) (1999: 1.9m pounds,
$2.8m), reflecting the increased costs of Phase II clinical trials for XR5000
and XR9576. These trials are expected to complete by the end of 2000.
Administrative expenses for the quarter were 0.4m pounds ($0.6m) (1999: 0.6m
pounds, $0.9m). The operating loss for the quarter to 30 September 2000 was 2.5m
pounds ($3.7m) (1999: 2.1m pounds, $3m). The total operating loss before
exceptional items for the nine months to 30 September 2000 was 6.4m pounds
($9.5m) (1999: 8.3m pounds, $12.2m), representing a 23% reduction against the
same period in 1999.
In September 2000, the shareholders of TerraGen Discovery Inc ("TerraGen")
approved the sale of TerraGen to Cubist Pharmaceuticals ("Cubist"). The
allocation of Cubist shares to Xenova at completion was 88,668 in exchange for
its equity and convertible loan note. The immaterial difference from the 91,048
shares reported at the time of Xenova`s interim statement results from changes
in the exchange rate between sterling and the Canadian dollar. Based upon a
Cubist share price of 34 pounds (US$50) per share at the date of acquisition the
value of the investment held in Cubist is not materially different to the net
book value of the TerraGen investment.
Treasury -- Cash and investments at 30 September 2000 totaled 13.3m pounds
($19.7m) (31 December 1999: 10.1m pounds, $14.9m). In a placing and open offer
Xenova issued 2,885,108 units on August 9, 2000, each unit comprising 5 new
shares and 4 warrants, at 345p per unit. Assuming full exercise of the warrants
at 85p per warrant by the expiry date of 31 October 2001, the company will raise
a further 9.8m pounds before expenses. Shares in issue at 30 September 2000 were
69,242,577.
Net interest received in the nine months to 30 September 2000 was 0.5m pounds
($0.7m) (1999: 0.4m pounds, $0.6m).
CONTACT: UK: Xenova Group plc
CONTACT: David A Oxlade, Chief Executive Officer, Daniel Abrams, Group
Finance Director, or Hilary Reid Evans, Corporate Communications, all of
Xenova Group plc, +44-0-1753 706600; David Yates or Sophie Pender-Cudlip of
Financial Dynamics, +44-0-207 831 3113; or Tony Ho Loke of Noonan-Russo
Communications Inc., 212-696-4455, for Xenova Group plc
Anbei Bericht:
Xenova Group plc Third Quarter Results Announcement
SLOUGH, England, Nov 9, 2000 /PRNewswire via COMTEX/ -- Xenova Group plc
(Nasdaq: XNVA) (London Stock Exchange: XEN) today announced its results for the
nine-month period to 30 September 2000.
Commenting on the results, Chief Executive Officer David Oxlade said: "Xenova`s
product pipeline has generally made good progress in the first nine months of
this year. Following positive clinical trial results from the Phase IIa trials,
in which XR9576 was administered in combination with paclitaxel and doxorubicin
respectively, we anticipate that XR9576 will be ready to enter Phase III around
the end of this year. XR11576, our next generation cytotoxic drug candidate, has
entered preclinical development and we have identified a further novel
topoisomerase I and II cytotoxic drug candidate, known as XR5944."
Operational Highlights
Product Development
Both of Xenova`s lead drug candidates, XR9576 (which targets the reversal of
multi-drug resistance in cancer) and XR5000 (a novel cytotoxic designed to kill
cancer cells), have continued to progress through Phase II clinical trials.
These Phase II studies are expected to complete by the end of calendar year
2000.
XR9576 (P-glycoprotein modulator) -- The successful conclusion of a Phase IIa
pharmacokinetic study in relapsed ovarian patients was announced in March 2000.
This study was carried out in patients with ovarian cancer recurring more than 6
months after previous treatment with a variety of cytotoxic drugs.
No clinically significant drug interaction between XR9576 and paclitaxel in
plasma was observed. By contrast with the performance of some other compounds in
development by competitors, this allows paclitaxel to be administered at its
full normal clinical dose when used with XR9576.
Further positive data was announced in October for a second Phase IIa trial, in
which XR9576 was administered in combination therapy with doxorubicin. The trial
showed that limited and predictable interaction occurred, allowing doxorubicin
to be administered at or close to the normal clinical dose, potentially
providing an advantage in clinical practice.
A further Phase IIa clinical trial, in which XR9576 is being studied in
combination therapy with vinorelbine, is currently underway in the US and is
being carried out in conjunction with the National Cancer Institute. It is
anticipated that results from this trial will be announced before the end of
2000. Paclitaxel, vinorelbine and doxorubicin are three of the world`s
highest-selling cytotoxic drugs.
It is expected that XR9576 will be ready to enter pivotal Phase III clinical
trials around the end of this year. The company anticipates that expenses for
Phase III pivotal registration studies will be assumed by a partner.
XR5000 (Topoisomerase I and II inhibitor) -- Three Phase II clinical trials are
also underway at a number of European centers for the novel cytotoxic XR5000, a
topoisomerase I and II inhibitor for the treatment of common solid tumors. The
Phase II trials are being conducted on an "open label" basis and target three
cancer types -- ovarian, non small cell lung and glioblastoma. In preclinical
studies, XR5000 was shown to be effective in cases where a tumor had already
shown resistance to treatment with existing cytotoxic drugs.
The results of a fourth Phase II trial, in which the efficacy of XR5000 was
investigated in patients with colorectal cancer, were announced in June 2000. At
the study dose level of 3010mg/m(2) no complete or partial responses to
treatment were observed. This study is complete and no further recruitment is
therefore planned for this indication.
Final data from all three remaining studies are expected to be available by the
end of this year. Results from these trials will help determine the future
development strategy for this compound.
Development of Xenova`s pipeline of preclinical compounds continued
satisfactorily in the nine months to 30 September 2000. All preclinical
compounds currently in development have been derived from Xenova`s own R&D
capability.
XR11576 -- A novel, orally active next generation topoisomerase I and II
inhibitor, XR11576 is undergoing final pharmacological and toxicity testing,
prior to its planned entry into clinical development. XR11576 is structurally
dissimilar to XR5000, with a significant improvement in its profile including
oral bioavailability and a marked enhancement of potency, while retaining
certain advantageous characteristics of XR5000. The XR11576 series of compounds
is protected by a priority patent application in the UK.
XR5944 -- Xenova has discovered a further novel inhibitor of topoisomerase I and
II that has shown exceptionally high potency as a cytotoxic agent in preclinical
studies with a number of tumor cell lines. XR5944 is structurally distinct from
both XR5000 and XR11576 and has been shown to be unaffected by atypical
multi-drug resistance.
A UK priority patent application relating to the XR5942 second generation drug
leads has been filed by Xenova. XR5944 forms part of this family of drug leads.
Patents granted pursuant to these applications, if any, would expire in 2017.
PAI-1 Inhibitors (Anti-Thrombotic) -- Research continues in this drug
development program, in which Xenova established a partnership with Lilly in
February 1998. The partnership is based on compounds from Xenova`s XR334 series
that are capable of oral absorption and are active in both venous and arterial
models of thrombosis.
PAI-1 Inhibitors (Anti-Cancer) -- Research has continued in this program, in
which Xenova is collaborating with the Institute for Cancer Research. PAI-1 is
believed to play a role in the spread of cancer (metastasis) and it has been
demonstrated that monoclonal antibodies to PAI-1 inhibit tumor cell migration
and invasion in vitro. A poster was presented at the VIII Congress of Metastasis
Society, in London in September 2000, demonstrating that antibodies to PAI-1
suppress angiogenesis in vitro.
Multi-Drug Resistant Protein (MRP) -- Xenova is conducting a research program
for MRP during 2000. Should this be successful, it is expected that compounds
will enter preclinical development during 2001. MRP acts as a pump, which, like
P-gp, expels small molecules (such as cytotoxins) out of cells and thus can help
protect tumor cells from certain chemotherapeutic agents.
Xenova is also exploring the potential application of MRP inhibitors in the
prevention of lung inflammation in asthma patients. Xenova is currently
evaluating drug leads from its MRP cancer program in the search for new classes
of anti-asthmatic drug candidates.
Telomerase -- Telomerase is an enzyme known to play a role in cancer
progression. On 7 February 2000 Xenova signed an exclusive collaborative
research agreement, to last for a minimum of two years, for the discovery and
development of novel classes of apoptosis inducing telomerase inhibitors with
Professor Rob Newbold and his team at Brunel University. Professor Newbold and
his team are acknowledged as being amongst the world`s leading experts in this
field.
Management
Stephen B. Howell, Professor of Medicine at the University of California, San
Diego, joined Xenova`s Scientific Advisory Board (SAB) in January 2000.
Peter Gillett joined Xenova as a non-executive Director in February 2000. Peter
Gillett chairs Xenova`s Audit Committee. Until June 2000 he was a partner in
Ernst & Young, the audit and professional services firm.
Financial Review
The Group`s financial position has been strengthened by a successful August
placing and open offer, which raised 10m pounds before expenses. A further 9.8m
pounds before expenses will be raised, assuming full exercise of associated
warrants, between 1 January and 31 October 2001.
Nil revenues (1999: 0.8m pounds, $1.1m) occurred for the quarter to 30 September
2000. Total revenue for the nine months to 30 September 2000 of 0.1m pounds
($0.1m) (1999: 2.6m pounds, $3.8m) was primarily derived from the sale of a
software license, following the 1999 sale of the majority of the assets and the
transfer of the employees of MetaXen, Xenova`s San Francisco-based subsidiary,
to Exelixis. The decrease in turnover is primarily attributable to the transfer
to Lilly of work in connection with the ongoing PAI-1 cardio-vascular research
and development program.
Operating expenses for the quarter to 30 September 2000 totaled 2.5m pounds
($3.7m) (1999: 2.8m pounds, $4.2m) and included research and development costs
of 2.1m pounds ($3.1m) (1999: 2.2m pounds, $3.3m). Research and development
costs for continuing operations were 2.1m pounds ($3.1m) (1999: 1.9m pounds,
$2.8m), reflecting the increased costs of Phase II clinical trials for XR5000
and XR9576. These trials are expected to complete by the end of 2000.
Administrative expenses for the quarter were 0.4m pounds ($0.6m) (1999: 0.6m
pounds, $0.9m). The operating loss for the quarter to 30 September 2000 was 2.5m
pounds ($3.7m) (1999: 2.1m pounds, $3m). The total operating loss before
exceptional items for the nine months to 30 September 2000 was 6.4m pounds
($9.5m) (1999: 8.3m pounds, $12.2m), representing a 23% reduction against the
same period in 1999.
In September 2000, the shareholders of TerraGen Discovery Inc ("TerraGen")
approved the sale of TerraGen to Cubist Pharmaceuticals ("Cubist"). The
allocation of Cubist shares to Xenova at completion was 88,668 in exchange for
its equity and convertible loan note. The immaterial difference from the 91,048
shares reported at the time of Xenova`s interim statement results from changes
in the exchange rate between sterling and the Canadian dollar. Based upon a
Cubist share price of 34 pounds (US$50) per share at the date of acquisition the
value of the investment held in Cubist is not materially different to the net
book value of the TerraGen investment.
Treasury -- Cash and investments at 30 September 2000 totaled 13.3m pounds
($19.7m) (31 December 1999: 10.1m pounds, $14.9m). In a placing and open offer
Xenova issued 2,885,108 units on August 9, 2000, each unit comprising 5 new
shares and 4 warrants, at 345p per unit. Assuming full exercise of the warrants
at 85p per warrant by the expiry date of 31 October 2001, the company will raise
a further 9.8m pounds before expenses. Shares in issue at 30 September 2000 were
69,242,577.
Net interest received in the nine months to 30 September 2000 was 0.5m pounds
($0.7m) (1999: 0.4m pounds, $0.6m).
CONTACT: UK: Xenova Group plc
CONTACT: David A Oxlade, Chief Executive Officer, Daniel Abrams, Group
Finance Director, or Hilary Reid Evans, Corporate Communications, all of
Xenova Group plc, +44-0-1753 706600; David Yates or Sophie Pender-Cudlip of
Financial Dynamics, +44-0-207 831 3113; or Tony Ho Loke of Noonan-Russo
Communications Inc., 212-696-4455, for Xenova Group plc
XENOVA wird der Renner: Patente:
1 6,114,332 Bis(acridinecarboxamide) and bis(phenazinecarboxamide) as antitumor agents
2 6,111,109 Process for the preparation of N-[2-(dimethylamino)ethyl]acridine-4-carboxamide
3 6,107,088 XAF genes and polypeptides: methods and reagents for modulating apoptosis
4 6,060,247 Post-mitotic neurons containing adenovirus vectors that modulate apoptosis and growth
5 5,935,955 Pharmaceutical piperazine compounds
6 5,902,812 Pharmaceutical piperazine compounds
7 5,891,886 Treatment of cancers
8 5,891,877 Pharmaceutical compounds
9 5,861,400 Pharmaceutical compounds
10 5,852,018 Pharmaceutical piperazine compounds
11 5,750,530 Pharmaceutical diketopiperazine compounds
12 5,700,804 Pharmaceutical compounds
13 5,696,131 Treatment of cancers
14 5,565,486 Sesquiterpenes, their preparation and their use as inhibitors acting on the gaba-benzodiazepine receptor
1 6,114,332 Bis(acridinecarboxamide) and bis(phenazinecarboxamide) as antitumor agents
2 6,111,109 Process for the preparation of N-[2-(dimethylamino)ethyl]acridine-4-carboxamide
3 6,107,088 XAF genes and polypeptides: methods and reagents for modulating apoptosis
4 6,060,247 Post-mitotic neurons containing adenovirus vectors that modulate apoptosis and growth
5 5,935,955 Pharmaceutical piperazine compounds
6 5,902,812 Pharmaceutical piperazine compounds
7 5,891,886 Treatment of cancers
8 5,891,877 Pharmaceutical compounds
9 5,861,400 Pharmaceutical compounds
10 5,852,018 Pharmaceutical piperazine compounds
11 5,750,530 Pharmaceutical diketopiperazine compounds
12 5,700,804 Pharmaceutical compounds
13 5,696,131 Treatment of cancers
14 5,565,486 Sesquiterpenes, their preparation and their use as inhibitors acting on the gaba-benzodiazepine receptor
Hier noch eine Veröffentlichung vom RNService (14.11):Xenova Group PLC - Holding in Company
RNS, Nov 14, 2000
As at 9th November 2000 the following entities had a material interest(s) in
shares of:
Xenova Group
BriTel Fund Trustees Limited
The Trustees of BT Pension Scheme
Registered Holders: BriTel Fund Nominees Ltd 2,326,617
2,326,617 shares 3.360 %
Amount of shares on loan / returned: 961,600 shares 1.389 %
Direct Holding: 2,326,617 shares 3.360 %
London Stock Exchange Regulatory News Service All Material Subject to Copyright
Tschau
Sliderman
RNS, Nov 14, 2000
As at 9th November 2000 the following entities had a material interest(s) in
shares of:
Xenova Group
BriTel Fund Trustees Limited
The Trustees of BT Pension Scheme
Registered Holders: BriTel Fund Nominees Ltd 2,326,617
2,326,617 shares 3.360 %
Amount of shares on loan / returned: 961,600 shares 1.389 %
Direct Holding: 2,326,617 shares 3.360 %
London Stock Exchange Regulatory News Service All Material Subject to Copyright
Tschau
Sliderman
Hi XENOVA-Fans,
hier eine schlechte Übersetzung der Quartalszahlen vom 09.11.2000 (1. Teil).
Drittes Trimester plc Gruppe Xenova resultiert Ansage
SLOUGH, England, November 9 / PRNewswire / -- plc Gruppe Xenova (Nasdaq: XNVA - Nachrichten ; Börse Londons: XEN) verkündete heute seine Resultate während der neunmonatigen Periode bis September 30 2000.
Kommentierend die Resultate, sagte Generaldirektor David Oxlade: ``Xenova`s-Produktrohrleitung hat im Allgemeinen guten Fortschritt in den ersten neun Monaten dieses Jahres gebildet. Nach positivem klinischem Versuch aus den Versuchen der Phase IIa, in denen XR9576 im Verbindung mit paclitaxel und doxorubicin beziehungsweise ausgeübt wurde, resultieren wir vorwegnehmen, daß XR9576 betriebsbereit ist, Phase III um das Ende dieses Jahres zu erreichen. XR11576, unser folgendes Erzeugung cytotoxischer Drogeanwärter, hat preclinical Entwicklung eingetragen und wir haben ein weiteres Romantopoisomerase I und II der cytotoxische Drogeanwärter gekennzeichnet, bekannt als XR5944. ` `,
Funktionsfähige Höhepunkte
ProduktEntwicklung
Beide von Drogeanwärtern Leitung Xenova, XR9576 (das die Umlenkung zielt
vom Multidrogewiderstand im Krebs) und in XR5000 (ein cytotoxischer Roman entwarf zu
beenden Sie Krebszellen), sind fortgefahren, durch Phase II weiterzukommen klinisch
Versuche. Diese Studien der Phase II werden erwartet, um Ende durchzuführen
Kalenderjahr 2000.
XR9576 (P-Glucoproteidmodulator) -- die erfolgreiche Zusammenfassung einer pharmakokinetischen Studie der Phase IIa bei zurückgefallenen ovarian Patienten wurde im März 2000 verkündet. Diese Studie wurde bei Patienten mit dem ovarian Krebs durchgeführt, der mehr als 6 Monate nach vorhergehender Behandlung mit einer Vielzahl der cytotoxischen Drogen wiederkehrt.
Keine klinisch bedeutende Drogeabhängigkeit zwischen XR9576 und paclitaxel im Plasma wurde beobachtet. Durch Kontrast mit der Leistung einiger anderer Mittel in der Entwicklung durch Konkurrenten, erlaubt dieses, daß paclitaxel an seiner vollen normalen klinischen Dosis ausgeübt wird, wenn es mit XR9576 verwendet wird.
Weitere positive Daten wurden im Oktober für einen zweiten Versuch der Phase IIa verkündet, in dem XR9576 in der Kombination Therapie mit doxorubicin ausgeübt wurde. Der Versuch zeigte, daß begrenzte und vorhersagbare Abhängigkeit auftrat und erlaubte, daß doxorubicin oder nah an an der normalen klinischen Dosis ausgeübt wird und möglicherweise einen Vorteil in der klinischen Praxis bereitstellt.
Ein weiterer klinischer Versuch der Phase IIa, in dem XR9576 in der Kombination Therapie mit vinorelbine studiert wird, ist aktuell unterwegs in den US und wird in Verbindung mit dem nationalen Krebsinstitut durchgeführt. Es wird vorweggenommen, daß Resultate von diesem Versuch vor dem Ende von 2000 verkündet werden. Paclitaxel, vinorelbine und doxorubicin sind drei der hoch-highest-selling cytotoxischen Drogen der Welt.
Es wird erwartet, daß XR9576 betriebsbereit ist, Angelklinische Versuche der phase III um das Ende dieses Jahres einzutragen. Die Firma nimmt vorweg, daß Unkosten für AngelStudien ausrichtung der Phase III von einem Partner angenommen werden.
XR5000 (Topoisomerase I und II Hemmnis) -- drei klinische Versuche der Phase II sind auch unterwegs an einer Anzahl von europäischen Mitten für den Roman cytotoxisches XR5000, ein topoisomerase I und II Hemmnis für die Behandlung der allgemeinen festen Tumoren. Die Versuche der Phase II werden auf ``open Kennsatz ` ` Grundlage und zielen drei ovarian Krebsarten --, nicht kleinen Zelle Lungenflügel und glioblastoma geleitet. In den preclinical Studien wurde XR5000 gezeigt, um wirkungsvoll zu sein, in den Fällen wo ein Tumor bereits Widerstand zur Behandlung mit existierenenden cytotoxischen Drogen gezeigt hatte.
Die Resultate eines 4. Versuches der Phase II, in dem die Wirksamkeit von XR5000 bei Patienten mit colorectal Krebs nachgeforscht wurde, wurden im Juni 2000 verkündet. Auf dem Studie Dosisniveau 3010mg/m(2) keiner kompletten oder teilweisen Antworten zur Behandlung wurden beobachtet. Diese Studie ist komplett und keine weitere Verstärkung wird folglich für diese Anzeige geplant.
Abschließende Daten von allen drei restlichen Studien werden erwartet, um Ende dieses Jahres vorhanden zu sein. Resultate von diesen Versuchen helfen, die zukünftige Entwicklung Strategie für dieses Mittel festzustellen.
Entwicklung der Rohrleitung Xenova der preclinical Mittel fuhr zufriedenstellend in den neun Monaten bis September 30 2000 fort. Alle preclinical Mittel aktuell in der Entwicklung sind von Xenova besitzen Fähigkeit R & D berechnet worden.
XR11576 -- ein Roman, mündlich aktives folgendes Erzeugung topoisomerase I und II Hemmnis, XR11576 macht abschließendes pharmakologisches und Giftigkeit prüfend, vor seinem geplanten Eintrag in klinische Entwicklung durch. XR11576 ist strukturell zu XR5000, mit einer bedeutenden Verbesserung in seinem Profil einschließlich der Mundlebenskraft und einer markierten Verbesserung der Kraft, beim Beibehalten bestimmter vorteilhafter Eigenschaften von XR5000 ungleichartig. Die Reihe XR11576 der Mittel wird durch eine Priorität Patentanfrage in Großbritannien geschützt.
XR5944 -- Xenova hat ein weiteres Romanhemmnis von topoisomerase I und II entdeckt, das außergewöhnlich hohe Kraft als cytotoxisches Mittel in den preclinical Studien mit einer Anzahl von Tumorzelle Zeilen gezeigt hat. XR5944 ist strukturell von XR5000 und von XR11576 eindeutig und ist gezeigt worden, um unberührt zu sein durch atypischen Multidrogewiderstand.
Eine BRITISCHE Priorität Patentanfrage in bezug auf ist die Drogeleitungen des Erzeugung XR5942 zweites ist von Xenova archiviert worden. Formulare XR5944 zerteilen von dieser Familie der Drogeleitungen. Die Patente, die gemäß diesen Anwendungen, wenn irgendwelche bewilligt wurden, würden in 2017 ablaufen.
Forschung der Hemmnisse PAI-1 (antithrombotisch) -- fährt in diesem Drogeentwicklungsprogramm fort, in dem Xenova eine Teilhaberschaft mit Lilly im Februar 1998 herstellte. Die Teilhaberschaft basiert auf Mitteln von den Serien Xenova XR334, die zur Mundabsorption fähig sind und in den venösen und arteriellen Modellen von Thrombosis aktiv sind.
Forschung der Hemmnisse PAI-1 (krebsbekämpfend) -- ist in diesem Programm fortgefahren, in dem Xenova mit dem Institut für Krebsforschung zusammenarbeitet. PAI-1 wird geglaubt, um eine Rolle in der Verbreitung des Krebses (metastasis) zu spielen und es ist demonstriert worden, daß monoclonal Antikörper zu PAI-1 Tumorzelle Migration und Invasion in vitro hemmen. Ein Plakat wurde auf dem Kongreß VIII der Gesellschaft Metastasis, in London im September 2000 dargestellt und zeigte, daß Antikörper zu PAI-1 angiogenesis in vitro unterdrücken.
Beständiges Protein Multi-Drug (MRP) -- Xenova leitet ein Forschung Programm für MRP während 2000. Wenn dieses erfolgreich ist, wird es erwartet, daß Mittel preclinical Entwicklung während 2001 eintragen. Mrp dient als eine Pumpe, die, wie PGP, kleine Moleküle (wie cytotoxins) aus Zellen heraus wegtreibt und folglich helfen kann, Tumorzellen vor bestimmten chemotherapeutischen Mitteln zu schützen.
Xenova erforscht auch die mögliche Anwendung der MRP-Hemmnisse in der Verhinderung der Lungenflügelentzündung bei Asthmapatienten. Xenova wertet aktuell Drogeleitungen von seinem MRP-Krebsprogramm in der Suche für neue Kategorien der Anti-asthmatischen Drogeanwärter aus.
Telomerase -- Telomerase ist ein Enzym, das bekannt ist, um eine Rolle in der Krebsweiterentwicklung zu spielen. Am Februar 7 2000 schloß Xenova einen exklusiven gemeinschaftlichen Forschung Vertrag, dauern für ein Minimum von zwei Jahren, für die Entdeckung und die Entwicklung der Romankategorien von apoptosis telomerasehemmnisse mit Professor Rob Newbold und sein Team an der Universität Brunel verursachend. Professor Newbold und sein Team werden als bestätigt, seiend unter den führenden Experten der Welt auf diesem Gebiet.
Management
Stephen B. Howell, Professor von Medizin an der Universität von Kalifornien, San Diego, verbindende wissenschaftliche Beratungsstelle Xenova (SAB) im Januar 2000.
Peter Gillett verband Xenova als non-executive Direktor im Februar 2000. StuhlXenova Peter Gillett Ausschuß für innere Revision. Bis Juni 2000 war er ein Partner in den Jungen & Ernst, die Revision und professionelle Dienstleistungen machen fest.
Finanzielle Zusammenfassung
Die Finanzlage der Gruppe ist bis zum einem erfolgreichen plazierenden August verstärkt worden und Angebot öffnet, das lbs 10m vor Unkosten anhob. Weitere 9.8m-Pfund, bevor Unkosten angehoben werden, anmaßende volle Übung der dazugehörigen Ermächtigungen, zwischen 1 Januar und Oktober 31 2001.
Ciao BigLinus
hier eine schlechte Übersetzung der Quartalszahlen vom 09.11.2000 (1. Teil).
Drittes Trimester plc Gruppe Xenova resultiert Ansage
SLOUGH, England, November 9 / PRNewswire / -- plc Gruppe Xenova (Nasdaq: XNVA - Nachrichten ; Börse Londons: XEN) verkündete heute seine Resultate während der neunmonatigen Periode bis September 30 2000.
Kommentierend die Resultate, sagte Generaldirektor David Oxlade: ``Xenova`s-Produktrohrleitung hat im Allgemeinen guten Fortschritt in den ersten neun Monaten dieses Jahres gebildet. Nach positivem klinischem Versuch aus den Versuchen der Phase IIa, in denen XR9576 im Verbindung mit paclitaxel und doxorubicin beziehungsweise ausgeübt wurde, resultieren wir vorwegnehmen, daß XR9576 betriebsbereit ist, Phase III um das Ende dieses Jahres zu erreichen. XR11576, unser folgendes Erzeugung cytotoxischer Drogeanwärter, hat preclinical Entwicklung eingetragen und wir haben ein weiteres Romantopoisomerase I und II der cytotoxische Drogeanwärter gekennzeichnet, bekannt als XR5944. ` `,
Funktionsfähige Höhepunkte
ProduktEntwicklung
Beide von Drogeanwärtern Leitung Xenova, XR9576 (das die Umlenkung zielt
vom Multidrogewiderstand im Krebs) und in XR5000 (ein cytotoxischer Roman entwarf zu
beenden Sie Krebszellen), sind fortgefahren, durch Phase II weiterzukommen klinisch
Versuche. Diese Studien der Phase II werden erwartet, um Ende durchzuführen
Kalenderjahr 2000.
XR9576 (P-Glucoproteidmodulator) -- die erfolgreiche Zusammenfassung einer pharmakokinetischen Studie der Phase IIa bei zurückgefallenen ovarian Patienten wurde im März 2000 verkündet. Diese Studie wurde bei Patienten mit dem ovarian Krebs durchgeführt, der mehr als 6 Monate nach vorhergehender Behandlung mit einer Vielzahl der cytotoxischen Drogen wiederkehrt.
Keine klinisch bedeutende Drogeabhängigkeit zwischen XR9576 und paclitaxel im Plasma wurde beobachtet. Durch Kontrast mit der Leistung einiger anderer Mittel in der Entwicklung durch Konkurrenten, erlaubt dieses, daß paclitaxel an seiner vollen normalen klinischen Dosis ausgeübt wird, wenn es mit XR9576 verwendet wird.
Weitere positive Daten wurden im Oktober für einen zweiten Versuch der Phase IIa verkündet, in dem XR9576 in der Kombination Therapie mit doxorubicin ausgeübt wurde. Der Versuch zeigte, daß begrenzte und vorhersagbare Abhängigkeit auftrat und erlaubte, daß doxorubicin oder nah an an der normalen klinischen Dosis ausgeübt wird und möglicherweise einen Vorteil in der klinischen Praxis bereitstellt.
Ein weiterer klinischer Versuch der Phase IIa, in dem XR9576 in der Kombination Therapie mit vinorelbine studiert wird, ist aktuell unterwegs in den US und wird in Verbindung mit dem nationalen Krebsinstitut durchgeführt. Es wird vorweggenommen, daß Resultate von diesem Versuch vor dem Ende von 2000 verkündet werden. Paclitaxel, vinorelbine und doxorubicin sind drei der hoch-highest-selling cytotoxischen Drogen der Welt.
Es wird erwartet, daß XR9576 betriebsbereit ist, Angelklinische Versuche der phase III um das Ende dieses Jahres einzutragen. Die Firma nimmt vorweg, daß Unkosten für AngelStudien ausrichtung der Phase III von einem Partner angenommen werden.
XR5000 (Topoisomerase I und II Hemmnis) -- drei klinische Versuche der Phase II sind auch unterwegs an einer Anzahl von europäischen Mitten für den Roman cytotoxisches XR5000, ein topoisomerase I und II Hemmnis für die Behandlung der allgemeinen festen Tumoren. Die Versuche der Phase II werden auf ``open Kennsatz ` ` Grundlage und zielen drei ovarian Krebsarten --, nicht kleinen Zelle Lungenflügel und glioblastoma geleitet. In den preclinical Studien wurde XR5000 gezeigt, um wirkungsvoll zu sein, in den Fällen wo ein Tumor bereits Widerstand zur Behandlung mit existierenenden cytotoxischen Drogen gezeigt hatte.
Die Resultate eines 4. Versuches der Phase II, in dem die Wirksamkeit von XR5000 bei Patienten mit colorectal Krebs nachgeforscht wurde, wurden im Juni 2000 verkündet. Auf dem Studie Dosisniveau 3010mg/m(2) keiner kompletten oder teilweisen Antworten zur Behandlung wurden beobachtet. Diese Studie ist komplett und keine weitere Verstärkung wird folglich für diese Anzeige geplant.
Abschließende Daten von allen drei restlichen Studien werden erwartet, um Ende dieses Jahres vorhanden zu sein. Resultate von diesen Versuchen helfen, die zukünftige Entwicklung Strategie für dieses Mittel festzustellen.
Entwicklung der Rohrleitung Xenova der preclinical Mittel fuhr zufriedenstellend in den neun Monaten bis September 30 2000 fort. Alle preclinical Mittel aktuell in der Entwicklung sind von Xenova besitzen Fähigkeit R & D berechnet worden.
XR11576 -- ein Roman, mündlich aktives folgendes Erzeugung topoisomerase I und II Hemmnis, XR11576 macht abschließendes pharmakologisches und Giftigkeit prüfend, vor seinem geplanten Eintrag in klinische Entwicklung durch. XR11576 ist strukturell zu XR5000, mit einer bedeutenden Verbesserung in seinem Profil einschließlich der Mundlebenskraft und einer markierten Verbesserung der Kraft, beim Beibehalten bestimmter vorteilhafter Eigenschaften von XR5000 ungleichartig. Die Reihe XR11576 der Mittel wird durch eine Priorität Patentanfrage in Großbritannien geschützt.
XR5944 -- Xenova hat ein weiteres Romanhemmnis von topoisomerase I und II entdeckt, das außergewöhnlich hohe Kraft als cytotoxisches Mittel in den preclinical Studien mit einer Anzahl von Tumorzelle Zeilen gezeigt hat. XR5944 ist strukturell von XR5000 und von XR11576 eindeutig und ist gezeigt worden, um unberührt zu sein durch atypischen Multidrogewiderstand.
Eine BRITISCHE Priorität Patentanfrage in bezug auf ist die Drogeleitungen des Erzeugung XR5942 zweites ist von Xenova archiviert worden. Formulare XR5944 zerteilen von dieser Familie der Drogeleitungen. Die Patente, die gemäß diesen Anwendungen, wenn irgendwelche bewilligt wurden, würden in 2017 ablaufen.
Forschung der Hemmnisse PAI-1 (antithrombotisch) -- fährt in diesem Drogeentwicklungsprogramm fort, in dem Xenova eine Teilhaberschaft mit Lilly im Februar 1998 herstellte. Die Teilhaberschaft basiert auf Mitteln von den Serien Xenova XR334, die zur Mundabsorption fähig sind und in den venösen und arteriellen Modellen von Thrombosis aktiv sind.
Forschung der Hemmnisse PAI-1 (krebsbekämpfend) -- ist in diesem Programm fortgefahren, in dem Xenova mit dem Institut für Krebsforschung zusammenarbeitet. PAI-1 wird geglaubt, um eine Rolle in der Verbreitung des Krebses (metastasis) zu spielen und es ist demonstriert worden, daß monoclonal Antikörper zu PAI-1 Tumorzelle Migration und Invasion in vitro hemmen. Ein Plakat wurde auf dem Kongreß VIII der Gesellschaft Metastasis, in London im September 2000 dargestellt und zeigte, daß Antikörper zu PAI-1 angiogenesis in vitro unterdrücken.
Beständiges Protein Multi-Drug (MRP) -- Xenova leitet ein Forschung Programm für MRP während 2000. Wenn dieses erfolgreich ist, wird es erwartet, daß Mittel preclinical Entwicklung während 2001 eintragen. Mrp dient als eine Pumpe, die, wie PGP, kleine Moleküle (wie cytotoxins) aus Zellen heraus wegtreibt und folglich helfen kann, Tumorzellen vor bestimmten chemotherapeutischen Mitteln zu schützen.
Xenova erforscht auch die mögliche Anwendung der MRP-Hemmnisse in der Verhinderung der Lungenflügelentzündung bei Asthmapatienten. Xenova wertet aktuell Drogeleitungen von seinem MRP-Krebsprogramm in der Suche für neue Kategorien der Anti-asthmatischen Drogeanwärter aus.
Telomerase -- Telomerase ist ein Enzym, das bekannt ist, um eine Rolle in der Krebsweiterentwicklung zu spielen. Am Februar 7 2000 schloß Xenova einen exklusiven gemeinschaftlichen Forschung Vertrag, dauern für ein Minimum von zwei Jahren, für die Entdeckung und die Entwicklung der Romankategorien von apoptosis telomerasehemmnisse mit Professor Rob Newbold und sein Team an der Universität Brunel verursachend. Professor Newbold und sein Team werden als bestätigt, seiend unter den führenden Experten der Welt auf diesem Gebiet.
Management
Stephen B. Howell, Professor von Medizin an der Universität von Kalifornien, San Diego, verbindende wissenschaftliche Beratungsstelle Xenova (SAB) im Januar 2000.
Peter Gillett verband Xenova als non-executive Direktor im Februar 2000. StuhlXenova Peter Gillett Ausschuß für innere Revision. Bis Juni 2000 war er ein Partner in den Jungen & Ernst, die Revision und professionelle Dienstleistungen machen fest.
Finanzielle Zusammenfassung
Die Finanzlage der Gruppe ist bis zum einem erfolgreichen plazierenden August verstärkt worden und Angebot öffnet, das lbs 10m vor Unkosten anhob. Weitere 9.8m-Pfund, bevor Unkosten angehoben werden, anmaßende volle Übung der dazugehörigen Ermächtigungen, zwischen 1 Januar und Oktober 31 2001.
Ciao BigLinus
Hier eine Nachricht aus dem citywire vom 30.11.00
10:58, Thur 30 Nov 2000
CSFB (England) hat xenova auf BUY gesetzt mit Kursziel 305p
mfg
Sliderman
10:58, Thur 30 Nov 2000
CSFB (England) hat xenova auf BUY gesetzt mit Kursziel 305p
mfg
Sliderman
Ach so CSFB steht für CREDIT SUISSE FIRST BOSTON !!!!!!!!
SLIDERMAN
SLIDERMAN
Na, mal wieder eine deutsche Bewertung von XENOVA:
05.12.2000
Xenova halten
Berliner Börsenbrief
Die Aktie der Xenova Group plc (WKN 890281) ist für das Researchteam vom Berliner Börsenbrief eine „Halteposition“.
Das britische Unternehmen habe zwar in den ersten neun Monaten de facto keinen Umsatz gehabt, daher sei dies nicht für eine Bewertung geeignet. Die Briten führten jedoch ein gutes Kostenmanagement und hätten ihre Barbestände ausgebaut.
Im Rahmen eines aufgelegten Partnerschafsprogramm rechne der Vorstand mit Zahlungen zwischen 10 und 15 Millionen USD in den ersten sechs Monates des kommenden Jahres. Zu den Partner gehöre unter anderem Eli Lilly. Zusammen arbeite man an einem innovativen Thrombosemittel. Insgesamt würden hier 35 Millionen USD plus Lizenzzahlungen fließen.
Die Gesellschaft rechne damit, erst im Jahre 2004 profitabel zu werden. Gegen Ende des Jahres stünden weitere Testergebnisse an. Bei Forschungserfolgen sollten diese den Aktienkurs beflügeln können, so die Experten.
Panospana
05.12.2000
Xenova halten
Berliner Börsenbrief
Die Aktie der Xenova Group plc (WKN 890281) ist für das Researchteam vom Berliner Börsenbrief eine „Halteposition“.
Das britische Unternehmen habe zwar in den ersten neun Monaten de facto keinen Umsatz gehabt, daher sei dies nicht für eine Bewertung geeignet. Die Briten führten jedoch ein gutes Kostenmanagement und hätten ihre Barbestände ausgebaut.
Im Rahmen eines aufgelegten Partnerschafsprogramm rechne der Vorstand mit Zahlungen zwischen 10 und 15 Millionen USD in den ersten sechs Monates des kommenden Jahres. Zu den Partner gehöre unter anderem Eli Lilly. Zusammen arbeite man an einem innovativen Thrombosemittel. Insgesamt würden hier 35 Millionen USD plus Lizenzzahlungen fließen.
Die Gesellschaft rechne damit, erst im Jahre 2004 profitabel zu werden. Gegen Ende des Jahres stünden weitere Testergebnisse an. Bei Forschungserfolgen sollten diese den Aktienkurs beflügeln können, so die Experten.
Panospana
Die Optionen von XENOVA, welche im August herausgegeben wurdne, sind nun seit dem 01.01.2001 einlösbar. Somit wird XENOVA neue Aktien herausgeben und dafür weiteres Geld erhalten. Anbei die Mitteilung:
RNS Number:7546W
Xenova Group PLC
5 January 2001
Application for Admission of New Shares
Slough, UK, 5th January, 2001 - Xenova Group plc (^Xenova^) today announced that
a block listing application has been made to the UK Listing Authority for up to
11,828,129 new ordinary shares to be admitted to the Official List. These new
ordinary shares may be issued as a result of exercises of warrants issued by
Xenova in August 2000. These warrants, which are each exercisable into 1 new
ordinary share each at 85p per share, are exercisable between 1st January 2001
and 31st October 2001. A block listing application has been made for the new
ordinary shares to be admitted to trading on the London Stock Exchange. These
applications are expected to become effective on 10th January 2001.
Panospana
RNS Number:7546W
Xenova Group PLC
5 January 2001
Application for Admission of New Shares
Slough, UK, 5th January, 2001 - Xenova Group plc (^Xenova^) today announced that
a block listing application has been made to the UK Listing Authority for up to
11,828,129 new ordinary shares to be admitted to the Official List. These new
ordinary shares may be issued as a result of exercises of warrants issued by
Xenova in August 2000. These warrants, which are each exercisable into 1 new
ordinary share each at 85p per share, are exercisable between 1st January 2001
and 31st October 2001. A block listing application has been made for the new
ordinary shares to be admitted to trading on the London Stock Exchange. These
applications are expected to become effective on 10th January 2001.
Panospana
Hallo zusammen,
weiß einer von Euch was über die "19th Annual Healthcare Conference", January 8-11, 2001,Westin St. Francis, San Francisco, California ?
Xenova hält morgen (11.01.01)um 9:30a dort einen Vortrag ?
Worum gehts da ?
Danke für eine Antwort
Cia Sliderman
weiß einer von Euch was über die "19th Annual Healthcare Conference", January 8-11, 2001,Westin St. Francis, San Francisco, California ?
Xenova hält morgen (11.01.01)um 9:30a dort einen Vortrag ?
Worum gehts da ?
Danke für eine Antwort
Cia Sliderman
RNS Number:9181W
Xenova Group PLC
9 January 2001
Letter to Xenova Group plc
Companies Act 1985 (as amended):
Disclosure of Interests in Shares
In accordance with Part VI of the Companies Act 1985 (as amended) (the ^Act^),
we write to inform you that Prudential plc and all its subsidiary companies, no
longer have a notifiable interest in the issued share capital of your company.
For the purposes of S210 of the Act, the address for companies identified herein
is Laurence Pountney Hill London EC4R 0HH.
Letter from M&G Investment Management Limited for and on behalf of Prudential
plc
Percentage holdings are calculated using an issued share capital of 69,242,577
ORD GBP0.10 shares
END
Xenova Group PLC
9 January 2001
Letter to Xenova Group plc
Companies Act 1985 (as amended):
Disclosure of Interests in Shares
In accordance with Part VI of the Companies Act 1985 (as amended) (the ^Act^),
we write to inform you that Prudential plc and all its subsidiary companies, no
longer have a notifiable interest in the issued share capital of your company.
For the purposes of S210 of the Act, the address for companies identified herein
is Laurence Pountney Hill London EC4R 0HH.
Letter from M&G Investment Management Limited for and on behalf of Prudential
plc
Percentage holdings are calculated using an issued share capital of 69,242,577
ORD GBP0.10 shares
END
FRONT PAGE - COMPANIES & MARKETS: Biotech listing rules to be eased
Financial Times; Jan 18, 2001
By JAMES MACKINTOSH
Rules restricting the listing of biotechnology companies and internet incubator funds on the Stock Exchange are to be relaxed. The move may lead to dozens of new companies raising money in the market.
The Financial Services Authority, which took over regulation of the exchange last year, also set out plans for unlimited fines on companies and directors breaching listing rules. At present it can only issue a public censure, which has prevented it taking serious action against directors dealing in shares just before corporate announcements.
The FSA said the rule changes should make it easier for new companies to raise cash, and had been requested by companies and investors.
"I would expect a number of extra listings," said Paul Geradine, director of listings at the FSA.
The FSA put forward plans to remove the requirement for biotech companies to have achieved at least one of four significant "commercial milestones" - such as having two products in advanced development - before listing. Instead, companies hoping to list will have to provide extra information on their development in the listing prospectus.
The watchdog will also remove the demand for internet incubators - stars of the internet boom that fell to earth with a crunch when the boom ended - to have a three-year trading record. This will put the companies on a par with other investment funds.
Daniel Abrams, finance director of Xenova and chairman of the Bioindustry Association`s finance committee, welcomed the moves and said they would help the UK compete with Germany`s Neuer Markt. But the FSA said it had not acted directly because of the threat to the UK biotech industry from the Neuer Markt, which has fewer restrictions and has attracted a wave of biotech companies.
An für sich nichts direkt betreffendes für XENOVA, aber interessant die Konkurrenz Deutschland - England zu betrachten
Panospana
Financial Times; Jan 18, 2001
By JAMES MACKINTOSH
Rules restricting the listing of biotechnology companies and internet incubator funds on the Stock Exchange are to be relaxed. The move may lead to dozens of new companies raising money in the market.
The Financial Services Authority, which took over regulation of the exchange last year, also set out plans for unlimited fines on companies and directors breaching listing rules. At present it can only issue a public censure, which has prevented it taking serious action against directors dealing in shares just before corporate announcements.
The FSA said the rule changes should make it easier for new companies to raise cash, and had been requested by companies and investors.
"I would expect a number of extra listings," said Paul Geradine, director of listings at the FSA.
The FSA put forward plans to remove the requirement for biotech companies to have achieved at least one of four significant "commercial milestones" - such as having two products in advanced development - before listing. Instead, companies hoping to list will have to provide extra information on their development in the listing prospectus.
The watchdog will also remove the demand for internet incubators - stars of the internet boom that fell to earth with a crunch when the boom ended - to have a three-year trading record. This will put the companies on a par with other investment funds.
Daniel Abrams, finance director of Xenova and chairman of the Bioindustry Association`s finance committee, welcomed the moves and said they would help the UK compete with Germany`s Neuer Markt. But the FSA said it had not acted directly because of the threat to the UK biotech industry from the Neuer Markt, which has fewer restrictions and has attracted a wave of biotech companies.
An für sich nichts direkt betreffendes für XENOVA, aber interessant die Konkurrenz Deutschland - England zu betrachten
Panospana
NEUIGKEITEN bei XENOVA!!
Xenova Group plc Preliminary Results for the Year Ended 31 December 2000
SLOUGH, England, Feb 19, 2001 /PRNewswire via COMTEX/ -- Xenova Group plc
(Nasdaq: XNVA; London Stock Exchange: XEN) today announces its results for the
year to 31 December 2000.
Announced Today
* Merger with Cantab Pharmaceuticals plc
* XR9576: Phase II Multi-Drug Resistance Programme
-- Third Phase IIa study shows positive interim results
-- Positive responses noted in a number of patients
-- Licensing discussions underway with potential partners
* Completion of Phase II First Generation Dual Topoisomerase Inhibitor
Programme
-- No further development planned for XR5000
* Significant progress with Second Generation Dual Topoisomerase
Inhibitors
-- Phase I/II trials planned for H2 2001
Financial Highlights
* Operating loss from continuing operations unchanged at
9.4m pounds sterling (pounds)
* Total operating expenses decline to 9.5m pounds (1999:13.6m pounds)
Commenting on the results, David Oxlade, Chief Executive Officer of Xenova Group
plc said: "We have made substantial progress in 2000. We are delighted with the
positive Phase IIa clinical trial results for our MDR inhibitor XR9576. The
first generation dual topoisomerase inhibition programme has provided much
useful information which can be applied to speedily advance our second
generation compounds, XR11576 and XR5944. These are progressing well and we
expect one or other of these compounds to enter clinical trials in 2001."
Proposed Merger with Cantab Pharmaceuticals plc
Xenova Group plc and Cantab Pharmaceuticals plc today announce that they have
agreed terms for a merger of their businesses. The merger will be effected
through an all share offer to be made by Nomura International plc on behalf of
Xenova Group plc plc for all of the issued (and to be issued) share capital of
Cantab Pharmaceuticals plc. The offer is being made outside the United States
and is not being made into, and may not be accepted from, the United States. If
Xenova Group plc receives acceptances under the offer in respect of, and/or
otherwise acquires, 90 per cent. or more of the Cantab Pharmaceuticals plc
shares, Xenova Group plc intends to exercise its rights under the Companies Act
1985 to acquire compulsorily the remaining Cantab Pharmaceuticals plc shares.
Chief Executive`s Review
Product Development
Both of Xenova`s lead drug candidates, the multidrug resistance modulator XR9576
and the novel cytotoxic XR5000, continued to progress through a total of seven
Phase II clinical trials during the course of 2000. A number of preclinical
programmes were also progressed, and the product pipeline extended with the
signing of a research agreement with Brunel University for the development of
novel telomerase inhibitors.
XR9576 -- Xenova`s P-glycoprotein modulator, which targets the reversal of
multi-drug resistance in cancer, progressed through a series of three separate
Phase IIa clinical trials during 2000. These trials were designed to assess the
extent of pharmacokinetic (PK) interaction, if any, between XR9576 and the
marketed cytotoxics paclitaxel, doxorubicin and vinorelbine. The desired outcome
of these trials was to show limited or no clinically significant interaction.
This outcome would allow the marketed cytotoxic to be administered at or close
to its normal therapeutic dose when given in combination with XR9576. Each of
the three trials achieved the desired outcome.
Previously Announced Trial Results
The successful conclusion of the paclitaxel trial, which was conducted in
relapsed ovarian cancer patients who had previously been treated with a variety
of cytotoxic drugs, was announced in March 2000. Although not designed as an
efficacy study, complete or partial responses were observed in 6 out of 12
patients.
Further positive data was announced in October 2000 for the second of the Phase
IIa trials, in which XR9576 was administered in combination with doxorubicin.
Patients participating in this trial suffered from a number of differing
relapsed cancers.
Announced Today
Positive interim data has been obtained from the third and final Phase IIa PK
interaction study for XR9576, which was given in combination therapy with the
cytotoxic drug, vinorelbine (Navelbine). The study has confirmed that, at dose
levels of vinorelbine of 15mg and 20mg/m(2), no clinically significant PK
interaction was observed and the administration of XR9576 with vinorelbine was
well tolerated. Positive responses in several of the patients in the study have
been obtained, providing some further anecdotal evidence of efficacy in addition
to that obtained in the earlier reported trials.
This open label study, which is being conducted under a US investigational new
drug (IND) at the National Cancer Institute, Washington DC, USA, has
investigated rising doses of vinorelbine with a single, fixed, once daily
administration of 150mg of XR9576 given intravenously. 16 patients have received
the combination at dose levels of 15 and 20mg/m(2). The positive PK and toxicity
data confirms that XR9576 can be used with the cytotoxic drug vinorelbine
administered close to its normal clinical dose, as has been previously reported
with prior Phase IIa studies involving XR9576 with paclitaxel and doxorubicin.
A further 12 patients are completing the PK study using a slightly higher dose
of vinorelbine of 22.5mg/m(2) and the full results of this Phase IIa vinorelbine
study will be presented at the American Society for Clinical Oncology (ASCO)
meeting in San Francisco, USA, in May 2001.
Dr Tito Fojo of the National Cancer Institute, and Principal Investigator for
the vinorelbine trial, commented:
"The ideal multi-drug resistance modulator should allow cytotoxic drugs to be
administered at or as close as possible to their normal dose. XR9576 itself is
non-toxic and leaves cytotoxic drug levels largely unaffected. Assays have
indicated that a single dose of XR9576 is sufficient to block the action of the
P-gp pump for in excess of 24 hours and imaging studies have also indicated that
XR9576 can effectively block the P-gp mediated efflux from tumours.
Additionally, it is encouraging to see a number of positive responses amongst
patients taking part in this study."
Licensing discussions in relation to XR9576 are currently underway with a number
of potential partners, with the objective of taking XR9576 into
partner-supported Phase III registration studies during 2001.
XR5000 -- Four Phase II clinical trials were carried out during the course of
2000 for the first generation dual topoisomerase inhibitor known as XR5000.
XR5000 is licensed from the Cancer Research Campaign. Along with the second
generation compounds XR11576 and XR5944, which are in preclinical devlopment,
XR5000 forms part of Xenova`s cytotoxic inhibitor programme for the treatment of
common solid tumours. Topoisomerases are enzymes which are critically involved
in the replication of DNA during the process of cell division and which
therefore play a key role in the proliferation of cancer cells. The trials for
XR5000 were conducted on an `open label` basis in conjunction with the European
Organisation for the Research and Treatment of Cancer.
Previously Announced Trial Results
The results of the first trial, in which the efficacy of XR5000 was investigated
in patients with colorectal cancer, were announced in June 2000. At the study
dose no complete or partial responses to treatment were observed and as a result
no further recruitment took place in this study.
Announced Today
A further three investigative Phase II studies in ovarian, glioblastoma and non
small cell lung cancer patients, which are being carried out with the European
Organisation for the Research and Treatment of Cancer (EORTC) are close to
completion for XR5000.
Although a number of minor responses have been observed in patients during the
course of these studies, the level of these responses has been judged unlikely
to provide XR5000 with a commercially attractive profile in the four tumour
types studied. Xenova will, therefore, focus its resources going forward on the
further development of its second generation dual topoisomerase inhibitor
compounds, XR11576 and XR5944. No further development of XR5000 is currently
planned.
Pre-Clinical Development
XR11576 -- A novel, orally active second generation dual topoisomerase
inhibitor, XR11576 has been undergoing final pharmacological and toxicity
testing prior to its planned entry into clinical development. XR11576 has a
significantly improved biological profile when compared with XR5000, including
oral bioavailability and a marked enhancement of potency. It is structurally
dissimilar to XR5000.
XR5944 -- XR5944 is a further novel inhibitor of topoisomerases I and II and has
shown exceptionally high potency as a cytotoxic in preclinical studies with a
number of cell lines. XR5944 is structurally distinct from both XR5000 and
XR11576 and has been shown to be unaffected by atypical multi-drug resistance.
Both XR11576 and XR5944 are the product of Xenova`s in-house research and
development. Patents have been applied for with respect to both compounds.
It is currently planned that one of these second generation compounds will enter
Phase I/II clinical trials during 2001.
PAI-1 Inhibitors (Anti-Thrombotic) -- Research continued throughout 2000 on this
programme, which is based on compounds from Xenova`s in-house research. These
compounds are active in both venous and arterial models of thrombosis and are
orally absorbed. Xenova established a partnership with Lilly for this
pre-clinical research area in February 1998.
PAI-1 Inhibitors (Anti-Cancer) -- Research is also continuing on this programme
in which Xenova is collaborating with the Institute for Cancer Research. PAI-1
is believed to play a role in the spread (metastasis) of cancer. A poster was
presented at the VIIIth Congress of the Metastasis Society in September 2000,
demonstrating that antibodies to PAI-1 suppress the growth of blood vessels in a
solid tumour in vitro.
Multi-Drug Resistance Protein (MRP) -- Research continued during 2000 and it is
expected that compounds will enter preclinical development during 2001. Like
P-gp, MRP acts as a pump and expels small molecules such as cytotoxics out of
cells. Xenova is also exploring the potential application of MRP inhibitors in
the prevention of lung inflammation in asthma patients.
Telomerase -- Telomerase is an enzyme known to play a role in cancer
progression. In February 2000 Xenova entered into an exclusive collaborative
research agreement with Professor Rob Newbold and his team at Brunel University,
UK. Professor Newbold and his team are acknowledged as being amongst the world`s
leading experts in the field of telomerase inhibition.
Management
Peter Gillett joined Xenova`s Board as a non-executive Director in February
2000. He chairs Xenova`s Audit Committee and was until June 2000 a partner in
Ernst & Young, the audit and professional services firm.
Stephen B. Howell, Professor of Medicine at the University of California, San
Diego, joined Xenova`s Scientific Advisory Board in January 2000.
Financial Summary
Operating Performance
Turnover for the year was 0.1m pounds ($0.1m) (1999: 2.7m pounds ($4.0m)). There
was no turnover in the six months to 31 December 2000 (1999: 0.9m pounds
($1.3m)), with the decrease for the year attributable to the transfer in-house
to Lilly during 1999 of work in connection with the ongoing Xenova/Lilly
strategic cardiovascular research and development programme.
Operating expenses declined to 9.5m pounds ($14.1m) (1999: 13.6m pounds
($20.3m)) and comprised 7.4m pounds ($11.1m) (1999: 11.3m pounds ($16.9m)) of
research and development costs and 2.0m pounds ($3.0m) (1999: 2.3m pounds
($3.4m)) of administrative expenses. Research and development costs for
continuing operations remained in line with 1999 at 7.4m pounds ($11.1m) (1999:
7.8m pounds ($11.7m)) reflecting further progress through clinical trials by
XR9576, XR5000 and the pre-clinical development of the second generation
topoisomerase programme in the second half of the year. Continuing
administrative costs were 2.0m pounds ($3.0m) (1999: 2.0m pounds ($3.0m)). The
operating loss for the year in respect of continuing operations was 9.4m pounds
($14.0m) (1999: 9.4m pounds ($14.0m)) and for the six months to 31 December 2000
was 5.5m pounds ($8.2m) (1999: 5.0m pounds ($7.4m)).
Treasury
In August 2000 Xenova made a placing and open offer of 2,885,108 Units at 345p
raising an initial 9.8m pounds ($14.6m). The exercise of warrants linked to this
placing and open offer could potentially raise a further 9.8m pounds ($14.6m)
net of expenses in 2001. The exercise period for warrants runs from 1 January to
31 October 2001.
Capital expenditure during the year was 0.4m pounds ($0.6m) (1999: 0.1m pounds
($0.2m). There were no proceeds from disposals of tangible fixed assets (1999:
0.2m ($0.3m)) pounds.
Net interest of 0.7m pounds ($1.0m) was earned in the year (1999: 0.5m pounds
($0.7m)). Cash (10.5m pounds ($15.7m)) and liquid resources (1.7m pounds
($2.6m)) at year-end totalled 12.2m pounds ($18.3m) (1999: 10.1m pounds
($15.1m)).
Called up shares at 31 December 2000 were 69,242,577.
The Directors do not recommend the payment of a dividend (1999: nil).
Contacts:
UK: US:
Xenova Group plc Noonan/Russo Communications Inc
Tel: +44-1753-706600 Tel: 212-696-4455
David A Oxlade, Chief Executive Officer Tony Ho Loke
Daniel Abrams, Group Finance Director Amy Martini
Hilary Reid Evans, Corporate Communications
Financial Dynamics
Tel: +44-207-831-3113
David Yates/Sarah Mehanna
Xenova Group plc is a London Stock Exchange techMARK listed company.
Notes to Editors
Xenova Group plc is a bio-pharmaceutical company specialising in the development
of new small molecule drugs. The group`s strategy is to develop commercially
attractive new drugs, primarily in the area of cancer therapeutics.
In addition to its Phase II programme for p-glycoprotein pump inhibitor XR9576,
which is nearing completion, Xenova is also currently undertaking cancer
research projects targeting next generation topoisomerase inhibitors,
MRP-related multi-drug resistance, telomerase (with Brunel University) and
plasminogen activator inhibitor-1 (PAI-1). Xenova has a drug development
agreement with Lilly, based on small molecule inhibitors of PAI-1, to develop
novel antithrombotic drugs for chronic use.
For further information about Xenova and its products please visit the Xenova
website at http://www.xenova.co.uk
Safe Harbor Statement under the US Private Securities Litigation Reform Act of
1995: Some or all of the statements in this document that relate to future
plans, expectations, events, performances and the like are forward-looking
statements, as defined in the US Private Securities Litigation Reform Act of
1995. Actual results of events could differ materially from those described in
the forward-looking statements due to a variety of factors, including those set
forth in the Company`s filings with the US Securities and Exchange Commission.
Consolidated Profit and Loss Account (unaudited)
Unaudited Unaudited Unaudited Audited
Year ended Year ended 6 mths ended Year ended
31 December 31 December 31 December 31 December
2000 2000 2000 1999
notes $000 Thousands of pounds
Turnover
Continuing operations 117 78 -- 383
Discontinued operations -- -- -- 2,310
117 78 -- 2,693
Operating expenses
Research and development costs
Continuing
operations (11,087) (7,422) (4,260) (7,793)
Discontinued
operations -- -- -- (3,501)
(11,087) (7,422) (4,260) (11,294)
Administrative expenses
Continuing
operations (3,037) (2,033) (1,237) (2,002)
Discontinued
operations -- -- -- (323)
(3,037) (2,033) (1,237) (2,325)
Total operating
expenses (14,124) (9,455) (5,497) (13,619)
Operating loss
Continuing
operations (14,007) (9,377) (5,497) (9,412)
Discontinued
operations -- -- -- (1,514)
(14,007) (9,377) (5,497) (10,926)
Profit / (loss) on
sale of businesses:
Profit on disposal 2 -- -- -- 271
Adjustment to Discovery
consideration 2 (1,911) (1,279) (1,279) --
Loss on ordinary
activities
before interest (15,918) (10,656) (6,776) (10,655)
Interest (net) 987 661 371 541
Loss on ordinary
activities
before taxation (14,931) (9,995) (6,405) (10,114)
Tax on loss on
ordinary
activities 3 1,031 690 690 --
Loss on ordinary activities
after taxation
attributable
to members of
Xenova Group plc (13,900) (9,305) (5,715) (10,114)
Loss per share
(basic and diluted) (23c) (15p) (9p) (22p)
Shares used in computing
net loss per
share (thousands) 60,486 60,486 66,187 46,870
Statement of Total Recognised Gains and Losses (unaudited)
Unaudited Unaudited Unaudited Audited
Year ended Year ended 6 mths ended Year ended
31 December 31 December 31 December 31 December
2000 2000 2000 1999
$000 Thousands of pounds
Loss attributable
to members of
Xenova Group plc (13,900) (9,305) (5,715) (10,114)
Unrealised profit
on sale of business -- -- -- 2,167
Translation difference 81 54 44 7
Total recognised gains
and losses in the
period attributable to
members of Xenova
Group plc (13,819) (9,251) (5,671) (7,940)
US Dollar amounts have been translated at the closing rate on 31 December
2000 (1.00 pounds: $1.4938) solely for information.
Consolidated Balance Sheet (unaudited)
Unaudited Unaudited Unaudited Audited
As at As at As at As at
31 December 31 December 30 June 31 December
2000 2000 2000 1999
notes $000 Thousands of pounds
Fixed Assets
Tangible fixed assets 811 543 335 328
Investments 2 -- -- 1,500 1,500
811 543 1,835 1,828
Current Assets
Debtors:
Due within one year 2,256 1,510 563 462
Due after more
than one year -- -- 1,500 1,500
2,256 1,510 2,063 1,962
Investments 2 2,571 1,721 -- 514
Cash at bank
and in hand 15,702 10,512 6,246 9,567
20,529 13,743 8,309 12,043
Creditors: amounts
falling due
within one year (3,570) (2,390) (1,858) (2,251)
Net current assets 16,959 11,353 6,451 9,792
Total assets less
current liabilities 17,770 11,896 8,286 11,620
Provisions for liabilities
and charges (30) (20) -- --
Total net assets 17,740 11,876 8,286 11,620
Capital and reserves
Called up share capital 10,343 6,924 5,482 5,463
Share premium account 111,708 74,781 66,980 66,762
Other reserves 26,742 17,902 17,902 17,902
Profit and loss
deficit (131,053) (87,731) (82,078) (78,507)
Shareholders` funds -
equity interests 4 17,740 11,876 8,286 11,620
US Dollar amounts have been translated at the closing rate on 31 December
2000 (1.00 pounds: $1.4938) solely for information.
Consolidated Cash Flow Statement (unaudited)
Unaudited Unaudited Unaudited Audited
Year ended Year ended 6 mths ended Year ended
31 December 31 December 31 December 31 December
2000 2000 2000 1999
notes $000 Thousands of pounds
Net cash outflow
from operating
activities 5 (13,973) (9,354) (5,079) (11,101)
Returns on investments
and servicing of finance
Interest received 905 606 316 552
Interest element of
finance lease
rental payments -- -- -- (35)
Net cash inflow from
returns on investments
and servicing
of finance 905 606 316 517
Capital expenditure
and financial
investment
Purchase of tangible
fixed assets (453) (303) (207) (102)
Proceeds on disposal
of tangible fixed assets -- -- -- 220
Net cash (outflow) /
inflow from capital
expenditure and
financial investment (453) (303) (207) 118
Acquisitions and disposals
Net cash received
from businesses sold -- -- -- 937
Management of Liquid Resources
Net sale / (purchase)
of Investments 768 514 (5) (6)
Net cash outflow
before financing (12,753) (8,537) (4,975) (9,535)
Financing
Issue of ordinary
share capital net
of expenses
Repurchase of shares
by subsidiary
undertaking 14,162 9,480 9,243 8,375
-- -- -- (2)
Capital element of
finance lease
rental payments -- -- -- (159)
Net cash inflow
from financing 14,161 9,480 9,243 8,214
Increase / (decrease)
in cash during
the period 1,409 943 4,268 (1,321)
Reconciliation of Net Cash Flow to Movement in Net Funds (unaudited)
Unaudited Unaudited Unaudited Audited
Year ended Year ended 6 mths ended Year ended
31 December 31 December 31 December 31 December
2000 2000 2000 1999
notes $000 Thousands of pounds
Increase / (decrease)
in cash during the
period 1,409 943 4,268 (1,321)
Capital element of
finance lease payments
Change in liquid resources -- -- -- 159
(768) (514) 5 6
Change in net funds
resulting from
cash flows 641 429 4,273 (1,156)
Disposal of finance
leases in respect of
discontinued operations -- -- -- 675
Transfer of fixed
asset to current
asset investments 2 2,571 1,721 1,721 --
Translation difference 3 2 (7) (19)
Change in net funds 3,215 2,152 5,987 (500)
Net funds at 1 January /
1 July 15,059 10,081 6,246 10,581
Net funds at
31 December 18,274 12,233 12,233 10,081
US Dollar amounts have been translated at the closing rate on 31 December
2000 (1.00 pounds: $1.4938) solely for information.
Notes to the Preliminary Statement
1 Basis of preparation
These unaudited preliminary statements, which do not constitute statutory
accounts within the meaning of Section 240 of the Companies Act 1985, have been
prepared using the accounting policies set out in the Group`s 1999 Annual Report
and Accounts. The 1999 Annual Report and Accounts received an unqualified
auditor`s report and have been delivered to the Registrar of Companies. There
have been no changes to the Group`s accounting policies in 2000.
2 Profit / (loss) on sale of business
On 8 April 1999 Xenova completed the sale of substantially all the assets of its
Discovery business to TerraGen Diversity Inc (`TerraGen`) and TerraGen`s wholly
owned subsidiary TerraGen Discovery (UK) Limited. Under the terms of the
agreement Xenova received 1,000,000 pounds in the period to December 1999.
Xenova also acquired a 6% equity interest in TerraGen comprising one million
class B preferred shares valued at 1,500,000 pounds based upon the issued share
price of C$3.75 per share. Xenova additionally received an interest bearing
convertible loan note of 1,500,000 pounds. The loan note carried interest at 1%
above LIBOR and was convertible to TerraGen equity at the option of either party
after 24 months or automatically after 36 months.
Of the net gain on disposal, 800,000 pounds was taken to the profit and loss
account for the year and the unrealised element of 2,167,000 pounds was taken to
the Statement of Recognised Gains and Losses.
In September 2000, the shareholders of TerraGen approved the sale of TerraGen to
Cubist Pharmaceuticals (`Cubist`). The allocation of 88,668 Cubist shares to the
Group, in exchange for the Group`s equity (1,500,000 pounds) and convertible
loan note (1,500,000 pounds) held in TerraGen, was recorded within `Fixed assets
- Investments` at the net book value of the TerraGen investments previously
owned (3,000,000 pounds).
To reflect the intentions of the Group not to hold this investment for
continuing use in the business, this investment has been included within current
assets and written down at the year-end (1,279,000 pounds) to the net realisable
value (1,721,000 pounds), reflecting the listed market price of the Cubist
shares at 31 December 2000.
3 Taxation
Following the changes introduced as part of the Finance Act 2000 in respect of
Scientific Research Allowances (now renamed `Research and Development
Allowances`), the Group has recognised the payable R&D tax credit to be received
in 2001.
4 Reconciliation of movement in shareholders` funds
Unaudited Unaudited Audited
As at As at As at
31 December 30 June 31 December
2000 2000 1999
Thousands of pounds
At start of period 11,620 11,620 11,181
Allotments of shares
in the period 10,252 327 8,462
Expenses on issue of shares (772) (90) (87)
Repurchase of shares
by subsidiary -- -- (2)
Shares to be issued under
long term incentive scheme 27 9 6
Retained loss for the period (9,305) (3,590) (10,114)
Unrealised profit on
sale of business -- -- 2,167
Exchange movement 54 10 7
At end of period 11,876 8,286 11,620
5 Reconciliation of operating loss to net cash outflow from operating
activities
Unaudited Unaudited Audited
Year ended 6 months ended Year ended
31 December 31 December 31 December
2000 2000 1999
Thousands of pounds
Operating loss (9,377) (5,497) (10,926)
Depreciation 212 123 580
Loss on disposal of
tangible fixed assets -- -- 83
Provision for liabilities
and charges 47 38 (134)
(Increase) / decrease in debtors (253) (152) 502
Increase / (decrease) in creditors 17 409 (1,206)
Net cash outflow from
operating activities (9,354) (5,079) (11,101)
6 Going concern
The Group is an emerging pharmaceutical business and as such expects to absorb
cash until products are commercialized. The Directors have a reasonable
expectation that the Group has, or can reasonably expect to obtain, adequate
cash resources to enable it to continue in operational existence for the
foreseeable future, and have therefore prepared the financial statements on the
going concern basis.
SOURCE Xenova Group plc
CONTACT: UK - David A Oxlade, Chief Executive Officer, Daniel Abrams,
Group Finance Director or Hilary Reid Evans, Corporate Communications, all of
Xenova Group plc, +44-1753-706600; or US - Tony Ho Loke or Amy Martini, both
of Noonan-Russo Communications Inc, 212-696-4455; David Yates or Sarah
Mehanna, both of Financial Dynamics, +44-207-831-3113
Xenova Group plc Preliminary Results for the Year Ended 31 December 2000
SLOUGH, England, Feb 19, 2001 /PRNewswire via COMTEX/ -- Xenova Group plc
(Nasdaq: XNVA; London Stock Exchange: XEN) today announces its results for the
year to 31 December 2000.
Announced Today
* Merger with Cantab Pharmaceuticals plc
* XR9576: Phase II Multi-Drug Resistance Programme
-- Third Phase IIa study shows positive interim results
-- Positive responses noted in a number of patients
-- Licensing discussions underway with potential partners
* Completion of Phase II First Generation Dual Topoisomerase Inhibitor
Programme
-- No further development planned for XR5000
* Significant progress with Second Generation Dual Topoisomerase
Inhibitors
-- Phase I/II trials planned for H2 2001
Financial Highlights
* Operating loss from continuing operations unchanged at
9.4m pounds sterling (pounds)
* Total operating expenses decline to 9.5m pounds (1999:13.6m pounds)
Commenting on the results, David Oxlade, Chief Executive Officer of Xenova Group
plc said: "We have made substantial progress in 2000. We are delighted with the
positive Phase IIa clinical trial results for our MDR inhibitor XR9576. The
first generation dual topoisomerase inhibition programme has provided much
useful information which can be applied to speedily advance our second
generation compounds, XR11576 and XR5944. These are progressing well and we
expect one or other of these compounds to enter clinical trials in 2001."
Proposed Merger with Cantab Pharmaceuticals plc
Xenova Group plc and Cantab Pharmaceuticals plc today announce that they have
agreed terms for a merger of their businesses. The merger will be effected
through an all share offer to be made by Nomura International plc on behalf of
Xenova Group plc plc for all of the issued (and to be issued) share capital of
Cantab Pharmaceuticals plc. The offer is being made outside the United States
and is not being made into, and may not be accepted from, the United States. If
Xenova Group plc receives acceptances under the offer in respect of, and/or
otherwise acquires, 90 per cent. or more of the Cantab Pharmaceuticals plc
shares, Xenova Group plc intends to exercise its rights under the Companies Act
1985 to acquire compulsorily the remaining Cantab Pharmaceuticals plc shares.
Chief Executive`s Review
Product Development
Both of Xenova`s lead drug candidates, the multidrug resistance modulator XR9576
and the novel cytotoxic XR5000, continued to progress through a total of seven
Phase II clinical trials during the course of 2000. A number of preclinical
programmes were also progressed, and the product pipeline extended with the
signing of a research agreement with Brunel University for the development of
novel telomerase inhibitors.
XR9576 -- Xenova`s P-glycoprotein modulator, which targets the reversal of
multi-drug resistance in cancer, progressed through a series of three separate
Phase IIa clinical trials during 2000. These trials were designed to assess the
extent of pharmacokinetic (PK) interaction, if any, between XR9576 and the
marketed cytotoxics paclitaxel, doxorubicin and vinorelbine. The desired outcome
of these trials was to show limited or no clinically significant interaction.
This outcome would allow the marketed cytotoxic to be administered at or close
to its normal therapeutic dose when given in combination with XR9576. Each of
the three trials achieved the desired outcome.
Previously Announced Trial Results
The successful conclusion of the paclitaxel trial, which was conducted in
relapsed ovarian cancer patients who had previously been treated with a variety
of cytotoxic drugs, was announced in March 2000. Although not designed as an
efficacy study, complete or partial responses were observed in 6 out of 12
patients.
Further positive data was announced in October 2000 for the second of the Phase
IIa trials, in which XR9576 was administered in combination with doxorubicin.
Patients participating in this trial suffered from a number of differing
relapsed cancers.
Announced Today
Positive interim data has been obtained from the third and final Phase IIa PK
interaction study for XR9576, which was given in combination therapy with the
cytotoxic drug, vinorelbine (Navelbine). The study has confirmed that, at dose
levels of vinorelbine of 15mg and 20mg/m(2), no clinically significant PK
interaction was observed and the administration of XR9576 with vinorelbine was
well tolerated. Positive responses in several of the patients in the study have
been obtained, providing some further anecdotal evidence of efficacy in addition
to that obtained in the earlier reported trials.
This open label study, which is being conducted under a US investigational new
drug (IND) at the National Cancer Institute, Washington DC, USA, has
investigated rising doses of vinorelbine with a single, fixed, once daily
administration of 150mg of XR9576 given intravenously. 16 patients have received
the combination at dose levels of 15 and 20mg/m(2). The positive PK and toxicity
data confirms that XR9576 can be used with the cytotoxic drug vinorelbine
administered close to its normal clinical dose, as has been previously reported
with prior Phase IIa studies involving XR9576 with paclitaxel and doxorubicin.
A further 12 patients are completing the PK study using a slightly higher dose
of vinorelbine of 22.5mg/m(2) and the full results of this Phase IIa vinorelbine
study will be presented at the American Society for Clinical Oncology (ASCO)
meeting in San Francisco, USA, in May 2001.
Dr Tito Fojo of the National Cancer Institute, and Principal Investigator for
the vinorelbine trial, commented:
"The ideal multi-drug resistance modulator should allow cytotoxic drugs to be
administered at or as close as possible to their normal dose. XR9576 itself is
non-toxic and leaves cytotoxic drug levels largely unaffected. Assays have
indicated that a single dose of XR9576 is sufficient to block the action of the
P-gp pump for in excess of 24 hours and imaging studies have also indicated that
XR9576 can effectively block the P-gp mediated efflux from tumours.
Additionally, it is encouraging to see a number of positive responses amongst
patients taking part in this study."
Licensing discussions in relation to XR9576 are currently underway with a number
of potential partners, with the objective of taking XR9576 into
partner-supported Phase III registration studies during 2001.
XR5000 -- Four Phase II clinical trials were carried out during the course of
2000 for the first generation dual topoisomerase inhibitor known as XR5000.
XR5000 is licensed from the Cancer Research Campaign. Along with the second
generation compounds XR11576 and XR5944, which are in preclinical devlopment,
XR5000 forms part of Xenova`s cytotoxic inhibitor programme for the treatment of
common solid tumours. Topoisomerases are enzymes which are critically involved
in the replication of DNA during the process of cell division and which
therefore play a key role in the proliferation of cancer cells. The trials for
XR5000 were conducted on an `open label` basis in conjunction with the European
Organisation for the Research and Treatment of Cancer.
Previously Announced Trial Results
The results of the first trial, in which the efficacy of XR5000 was investigated
in patients with colorectal cancer, were announced in June 2000. At the study
dose no complete or partial responses to treatment were observed and as a result
no further recruitment took place in this study.
Announced Today
A further three investigative Phase II studies in ovarian, glioblastoma and non
small cell lung cancer patients, which are being carried out with the European
Organisation for the Research and Treatment of Cancer (EORTC) are close to
completion for XR5000.
Although a number of minor responses have been observed in patients during the
course of these studies, the level of these responses has been judged unlikely
to provide XR5000 with a commercially attractive profile in the four tumour
types studied. Xenova will, therefore, focus its resources going forward on the
further development of its second generation dual topoisomerase inhibitor
compounds, XR11576 and XR5944. No further development of XR5000 is currently
planned.
Pre-Clinical Development
XR11576 -- A novel, orally active second generation dual topoisomerase
inhibitor, XR11576 has been undergoing final pharmacological and toxicity
testing prior to its planned entry into clinical development. XR11576 has a
significantly improved biological profile when compared with XR5000, including
oral bioavailability and a marked enhancement of potency. It is structurally
dissimilar to XR5000.
XR5944 -- XR5944 is a further novel inhibitor of topoisomerases I and II and has
shown exceptionally high potency as a cytotoxic in preclinical studies with a
number of cell lines. XR5944 is structurally distinct from both XR5000 and
XR11576 and has been shown to be unaffected by atypical multi-drug resistance.
Both XR11576 and XR5944 are the product of Xenova`s in-house research and
development. Patents have been applied for with respect to both compounds.
It is currently planned that one of these second generation compounds will enter
Phase I/II clinical trials during 2001.
PAI-1 Inhibitors (Anti-Thrombotic) -- Research continued throughout 2000 on this
programme, which is based on compounds from Xenova`s in-house research. These
compounds are active in both venous and arterial models of thrombosis and are
orally absorbed. Xenova established a partnership with Lilly for this
pre-clinical research area in February 1998.
PAI-1 Inhibitors (Anti-Cancer) -- Research is also continuing on this programme
in which Xenova is collaborating with the Institute for Cancer Research. PAI-1
is believed to play a role in the spread (metastasis) of cancer. A poster was
presented at the VIIIth Congress of the Metastasis Society in September 2000,
demonstrating that antibodies to PAI-1 suppress the growth of blood vessels in a
solid tumour in vitro.
Multi-Drug Resistance Protein (MRP) -- Research continued during 2000 and it is
expected that compounds will enter preclinical development during 2001. Like
P-gp, MRP acts as a pump and expels small molecules such as cytotoxics out of
cells. Xenova is also exploring the potential application of MRP inhibitors in
the prevention of lung inflammation in asthma patients.
Telomerase -- Telomerase is an enzyme known to play a role in cancer
progression. In February 2000 Xenova entered into an exclusive collaborative
research agreement with Professor Rob Newbold and his team at Brunel University,
UK. Professor Newbold and his team are acknowledged as being amongst the world`s
leading experts in the field of telomerase inhibition.
Management
Peter Gillett joined Xenova`s Board as a non-executive Director in February
2000. He chairs Xenova`s Audit Committee and was until June 2000 a partner in
Ernst & Young, the audit and professional services firm.
Stephen B. Howell, Professor of Medicine at the University of California, San
Diego, joined Xenova`s Scientific Advisory Board in January 2000.
Financial Summary
Operating Performance
Turnover for the year was 0.1m pounds ($0.1m) (1999: 2.7m pounds ($4.0m)). There
was no turnover in the six months to 31 December 2000 (1999: 0.9m pounds
($1.3m)), with the decrease for the year attributable to the transfer in-house
to Lilly during 1999 of work in connection with the ongoing Xenova/Lilly
strategic cardiovascular research and development programme.
Operating expenses declined to 9.5m pounds ($14.1m) (1999: 13.6m pounds
($20.3m)) and comprised 7.4m pounds ($11.1m) (1999: 11.3m pounds ($16.9m)) of
research and development costs and 2.0m pounds ($3.0m) (1999: 2.3m pounds
($3.4m)) of administrative expenses. Research and development costs for
continuing operations remained in line with 1999 at 7.4m pounds ($11.1m) (1999:
7.8m pounds ($11.7m)) reflecting further progress through clinical trials by
XR9576, XR5000 and the pre-clinical development of the second generation
topoisomerase programme in the second half of the year. Continuing
administrative costs were 2.0m pounds ($3.0m) (1999: 2.0m pounds ($3.0m)). The
operating loss for the year in respect of continuing operations was 9.4m pounds
($14.0m) (1999: 9.4m pounds ($14.0m)) and for the six months to 31 December 2000
was 5.5m pounds ($8.2m) (1999: 5.0m pounds ($7.4m)).
Treasury
In August 2000 Xenova made a placing and open offer of 2,885,108 Units at 345p
raising an initial 9.8m pounds ($14.6m). The exercise of warrants linked to this
placing and open offer could potentially raise a further 9.8m pounds ($14.6m)
net of expenses in 2001. The exercise period for warrants runs from 1 January to
31 October 2001.
Capital expenditure during the year was 0.4m pounds ($0.6m) (1999: 0.1m pounds
($0.2m). There were no proceeds from disposals of tangible fixed assets (1999:
0.2m ($0.3m)) pounds.
Net interest of 0.7m pounds ($1.0m) was earned in the year (1999: 0.5m pounds
($0.7m)). Cash (10.5m pounds ($15.7m)) and liquid resources (1.7m pounds
($2.6m)) at year-end totalled 12.2m pounds ($18.3m) (1999: 10.1m pounds
($15.1m)).
Called up shares at 31 December 2000 were 69,242,577.
The Directors do not recommend the payment of a dividend (1999: nil).
Contacts:
UK: US:
Xenova Group plc Noonan/Russo Communications Inc
Tel: +44-1753-706600 Tel: 212-696-4455
David A Oxlade, Chief Executive Officer Tony Ho Loke
Daniel Abrams, Group Finance Director Amy Martini
Hilary Reid Evans, Corporate Communications
Financial Dynamics
Tel: +44-207-831-3113
David Yates/Sarah Mehanna
Xenova Group plc is a London Stock Exchange techMARK listed company.
Notes to Editors
Xenova Group plc is a bio-pharmaceutical company specialising in the development
of new small molecule drugs. The group`s strategy is to develop commercially
attractive new drugs, primarily in the area of cancer therapeutics.
In addition to its Phase II programme for p-glycoprotein pump inhibitor XR9576,
which is nearing completion, Xenova is also currently undertaking cancer
research projects targeting next generation topoisomerase inhibitors,
MRP-related multi-drug resistance, telomerase (with Brunel University) and
plasminogen activator inhibitor-1 (PAI-1). Xenova has a drug development
agreement with Lilly, based on small molecule inhibitors of PAI-1, to develop
novel antithrombotic drugs for chronic use.
For further information about Xenova and its products please visit the Xenova
website at http://www.xenova.co.uk
Safe Harbor Statement under the US Private Securities Litigation Reform Act of
1995: Some or all of the statements in this document that relate to future
plans, expectations, events, performances and the like are forward-looking
statements, as defined in the US Private Securities Litigation Reform Act of
1995. Actual results of events could differ materially from those described in
the forward-looking statements due to a variety of factors, including those set
forth in the Company`s filings with the US Securities and Exchange Commission.
Consolidated Profit and Loss Account (unaudited)
Unaudited Unaudited Unaudited Audited
Year ended Year ended 6 mths ended Year ended
31 December 31 December 31 December 31 December
2000 2000 2000 1999
notes $000 Thousands of pounds
Turnover
Continuing operations 117 78 -- 383
Discontinued operations -- -- -- 2,310
117 78 -- 2,693
Operating expenses
Research and development costs
Continuing
operations (11,087) (7,422) (4,260) (7,793)
Discontinued
operations -- -- -- (3,501)
(11,087) (7,422) (4,260) (11,294)
Administrative expenses
Continuing
operations (3,037) (2,033) (1,237) (2,002)
Discontinued
operations -- -- -- (323)
(3,037) (2,033) (1,237) (2,325)
Total operating
expenses (14,124) (9,455) (5,497) (13,619)
Operating loss
Continuing
operations (14,007) (9,377) (5,497) (9,412)
Discontinued
operations -- -- -- (1,514)
(14,007) (9,377) (5,497) (10,926)
Profit / (loss) on
sale of businesses:
Profit on disposal 2 -- -- -- 271
Adjustment to Discovery
consideration 2 (1,911) (1,279) (1,279) --
Loss on ordinary
activities
before interest (15,918) (10,656) (6,776) (10,655)
Interest (net) 987 661 371 541
Loss on ordinary
activities
before taxation (14,931) (9,995) (6,405) (10,114)
Tax on loss on
ordinary
activities 3 1,031 690 690 --
Loss on ordinary activities
after taxation
attributable
to members of
Xenova Group plc (13,900) (9,305) (5,715) (10,114)
Loss per share
(basic and diluted) (23c) (15p) (9p) (22p)
Shares used in computing
net loss per
share (thousands) 60,486 60,486 66,187 46,870
Statement of Total Recognised Gains and Losses (unaudited)
Unaudited Unaudited Unaudited Audited
Year ended Year ended 6 mths ended Year ended
31 December 31 December 31 December 31 December
2000 2000 2000 1999
$000 Thousands of pounds
Loss attributable
to members of
Xenova Group plc (13,900) (9,305) (5,715) (10,114)
Unrealised profit
on sale of business -- -- -- 2,167
Translation difference 81 54 44 7
Total recognised gains
and losses in the
period attributable to
members of Xenova
Group plc (13,819) (9,251) (5,671) (7,940)
US Dollar amounts have been translated at the closing rate on 31 December
2000 (1.00 pounds: $1.4938) solely for information.
Consolidated Balance Sheet (unaudited)
Unaudited Unaudited Unaudited Audited
As at As at As at As at
31 December 31 December 30 June 31 December
2000 2000 2000 1999
notes $000 Thousands of pounds
Fixed Assets
Tangible fixed assets 811 543 335 328
Investments 2 -- -- 1,500 1,500
811 543 1,835 1,828
Current Assets
Debtors:
Due within one year 2,256 1,510 563 462
Due after more
than one year -- -- 1,500 1,500
2,256 1,510 2,063 1,962
Investments 2 2,571 1,721 -- 514
Cash at bank
and in hand 15,702 10,512 6,246 9,567
20,529 13,743 8,309 12,043
Creditors: amounts
falling due
within one year (3,570) (2,390) (1,858) (2,251)
Net current assets 16,959 11,353 6,451 9,792
Total assets less
current liabilities 17,770 11,896 8,286 11,620
Provisions for liabilities
and charges (30) (20) -- --
Total net assets 17,740 11,876 8,286 11,620
Capital and reserves
Called up share capital 10,343 6,924 5,482 5,463
Share premium account 111,708 74,781 66,980 66,762
Other reserves 26,742 17,902 17,902 17,902
Profit and loss
deficit (131,053) (87,731) (82,078) (78,507)
Shareholders` funds -
equity interests 4 17,740 11,876 8,286 11,620
US Dollar amounts have been translated at the closing rate on 31 December
2000 (1.00 pounds: $1.4938) solely for information.
Consolidated Cash Flow Statement (unaudited)
Unaudited Unaudited Unaudited Audited
Year ended Year ended 6 mths ended Year ended
31 December 31 December 31 December 31 December
2000 2000 2000 1999
notes $000 Thousands of pounds
Net cash outflow
from operating
activities 5 (13,973) (9,354) (5,079) (11,101)
Returns on investments
and servicing of finance
Interest received 905 606 316 552
Interest element of
finance lease
rental payments -- -- -- (35)
Net cash inflow from
returns on investments
and servicing
of finance 905 606 316 517
Capital expenditure
and financial
investment
Purchase of tangible
fixed assets (453) (303) (207) (102)
Proceeds on disposal
of tangible fixed assets -- -- -- 220
Net cash (outflow) /
inflow from capital
expenditure and
financial investment (453) (303) (207) 118
Acquisitions and disposals
Net cash received
from businesses sold -- -- -- 937
Management of Liquid Resources
Net sale / (purchase)
of Investments 768 514 (5) (6)
Net cash outflow
before financing (12,753) (8,537) (4,975) (9,535)
Financing
Issue of ordinary
share capital net
of expenses
Repurchase of shares
by subsidiary
undertaking 14,162 9,480 9,243 8,375
-- -- -- (2)
Capital element of
finance lease
rental payments -- -- -- (159)
Net cash inflow
from financing 14,161 9,480 9,243 8,214
Increase / (decrease)
in cash during
the period 1,409 943 4,268 (1,321)
Reconciliation of Net Cash Flow to Movement in Net Funds (unaudited)
Unaudited Unaudited Unaudited Audited
Year ended Year ended 6 mths ended Year ended
31 December 31 December 31 December 31 December
2000 2000 2000 1999
notes $000 Thousands of pounds
Increase / (decrease)
in cash during the
period 1,409 943 4,268 (1,321)
Capital element of
finance lease payments
Change in liquid resources -- -- -- 159
(768) (514) 5 6
Change in net funds
resulting from
cash flows 641 429 4,273 (1,156)
Disposal of finance
leases in respect of
discontinued operations -- -- -- 675
Transfer of fixed
asset to current
asset investments 2 2,571 1,721 1,721 --
Translation difference 3 2 (7) (19)
Change in net funds 3,215 2,152 5,987 (500)
Net funds at 1 January /
1 July 15,059 10,081 6,246 10,581
Net funds at
31 December 18,274 12,233 12,233 10,081
US Dollar amounts have been translated at the closing rate on 31 December
2000 (1.00 pounds: $1.4938) solely for information.
Notes to the Preliminary Statement
1 Basis of preparation
These unaudited preliminary statements, which do not constitute statutory
accounts within the meaning of Section 240 of the Companies Act 1985, have been
prepared using the accounting policies set out in the Group`s 1999 Annual Report
and Accounts. The 1999 Annual Report and Accounts received an unqualified
auditor`s report and have been delivered to the Registrar of Companies. There
have been no changes to the Group`s accounting policies in 2000.
2 Profit / (loss) on sale of business
On 8 April 1999 Xenova completed the sale of substantially all the assets of its
Discovery business to TerraGen Diversity Inc (`TerraGen`) and TerraGen`s wholly
owned subsidiary TerraGen Discovery (UK) Limited. Under the terms of the
agreement Xenova received 1,000,000 pounds in the period to December 1999.
Xenova also acquired a 6% equity interest in TerraGen comprising one million
class B preferred shares valued at 1,500,000 pounds based upon the issued share
price of C$3.75 per share. Xenova additionally received an interest bearing
convertible loan note of 1,500,000 pounds. The loan note carried interest at 1%
above LIBOR and was convertible to TerraGen equity at the option of either party
after 24 months or automatically after 36 months.
Of the net gain on disposal, 800,000 pounds was taken to the profit and loss
account for the year and the unrealised element of 2,167,000 pounds was taken to
the Statement of Recognised Gains and Losses.
In September 2000, the shareholders of TerraGen approved the sale of TerraGen to
Cubist Pharmaceuticals (`Cubist`). The allocation of 88,668 Cubist shares to the
Group, in exchange for the Group`s equity (1,500,000 pounds) and convertible
loan note (1,500,000 pounds) held in TerraGen, was recorded within `Fixed assets
- Investments` at the net book value of the TerraGen investments previously
owned (3,000,000 pounds).
To reflect the intentions of the Group not to hold this investment for
continuing use in the business, this investment has been included within current
assets and written down at the year-end (1,279,000 pounds) to the net realisable
value (1,721,000 pounds), reflecting the listed market price of the Cubist
shares at 31 December 2000.
3 Taxation
Following the changes introduced as part of the Finance Act 2000 in respect of
Scientific Research Allowances (now renamed `Research and Development
Allowances`), the Group has recognised the payable R&D tax credit to be received
in 2001.
4 Reconciliation of movement in shareholders` funds
Unaudited Unaudited Audited
As at As at As at
31 December 30 June 31 December
2000 2000 1999
Thousands of pounds
At start of period 11,620 11,620 11,181
Allotments of shares
in the period 10,252 327 8,462
Expenses on issue of shares (772) (90) (87)
Repurchase of shares
by subsidiary -- -- (2)
Shares to be issued under
long term incentive scheme 27 9 6
Retained loss for the period (9,305) (3,590) (10,114)
Unrealised profit on
sale of business -- -- 2,167
Exchange movement 54 10 7
At end of period 11,876 8,286 11,620
5 Reconciliation of operating loss to net cash outflow from operating
activities
Unaudited Unaudited Audited
Year ended 6 months ended Year ended
31 December 31 December 31 December
2000 2000 1999
Thousands of pounds
Operating loss (9,377) (5,497) (10,926)
Depreciation 212 123 580
Loss on disposal of
tangible fixed assets -- -- 83
Provision for liabilities
and charges 47 38 (134)
(Increase) / decrease in debtors (253) (152) 502
Increase / (decrease) in creditors 17 409 (1,206)
Net cash outflow from
operating activities (9,354) (5,079) (11,101)
6 Going concern
The Group is an emerging pharmaceutical business and as such expects to absorb
cash until products are commercialized. The Directors have a reasonable
expectation that the Group has, or can reasonably expect to obtain, adequate
cash resources to enable it to continue in operational existence for the
foreseeable future, and have therefore prepared the financial statements on the
going concern basis.
SOURCE Xenova Group plc
CONTACT: UK - David A Oxlade, Chief Executive Officer, Daniel Abrams,
Group Finance Director or Hilary Reid Evans, Corporate Communications, all of
Xenova Group plc, +44-1753-706600; or US - Tony Ho Loke or Amy Martini, both
of Noonan-Russo Communications Inc, 212-696-4455; David Yates or Sarah
Mehanna, both of Financial Dynamics, +44-207-831-3113
Einzelheiten zum Merger mit Cantab Pharmaceuticals plc
Part 1
CANTAB PHARMACEUTICALS PLC XENOVA GROUP PLC
Under Embargo - not to be released until 0700 19 February 2001
Not for release, distribution or publication in or into the United States,
Canada, Australia or Japan
Recommended Merger of Xenova Group plc with Cantab Pharmaceuticals plc
The Boards of Xenova and Cantab today announce that they have agreed terms for
a recommended merger of their businesses.
Transaction Highlights
The Merger:
* Creates an Enlarged Group with one of the largest clinical development
pipelines within the European biopharmaceutical sector, with four product
candidates in Phase II and three in Phase I.
* Broadens and enhances the product portfolio with a key area of focus on
cancer, where both companies have substantial expertise and exciting
product opportunities.
* Brings together the complementary drug discovery and development skills
of the two companies with which to develop current and future drug
candidates.
* Establishes an Enlarged Group with a number of valuable partnerships
with major pharmaceutical companies and with the potential for more
partnerships to follow.
* Strengthens and broadens the experience of the management team.
* Values the Enlarged Group at #123.7 million based on the Closing Price
of Xenova Shares on 16 February 2001 on the assumption that the Merger
Offer is accepted in full.
Details of the Merger Offer
The Merger will be achieved through a recommended all share offer to be made
by Nomura, on behalf of Xenova, for all of the issued (and to be issued) share
capital of Cantab.
* The Merger Offer will be made on the basis of 11 New Xenova Shares for
every 7 Cantab Shares.
* The Merger Offer values each Cantab Share at approximately 140 pence and
the entire existing issued share capital of Cantab at #62.1 million
(before taking account of the exercise of any options under the Cantab
Share Option Schemes) based on the Closing Price of 89 pence per Xenova
Share on 16 February 2001, the business day immediately prior to the date
of this announcement.
* The Merger Offer represents a premium of 16.5 per cent. to the Closing
Price of 120 pence per Cantab Share on 16 February 2001 based on the
Closing Price of Xenova Shares on the same date.
* The Cantab Directors, who have been so advised by their financial
advisers, Credit Suisse First Boston, consider the terms of the Merger
Offer to be fair and reasonable. In providing its advice to the Cantab
Directors, Credit Suisse First Boston has taken into account the
commercial assessment of the Cantab Directors. Accordingly, the Cantab
Directors will be unanimously recommending Cantab Shareholders to accept
the Merger Offer, as they have undertaken to do in respect of their own
aggregate holdings of 196,006 Cantab Shares, representing approximately
0.44 per cent. of Cantab`s existing issued share capital.
* In view of its size, the Merger Offer is conditional, inter alia, on the
approval of Xenova Shareholders. The Xenova Directors, who have received
financial advice from Nomura in relation to the Merger Offer, consider the
Merger Offer to be in the best interests of the Xenova Shareholders as a
whole. In providing its advice to the Xenova Directors, Nomura has taken
into account the Xenova Directors` commercial assessment of the Merger.
Accordingly, the Xenova Directors will be unanimously recommending Xenova
Shareholders to vote in favour of the Merger Offer as they have undertaken
to do in respect of their own beneficial holdings of, in aggregate,
314,916 Xenova Shares, representing approximately 0.45 per cent. of
Xenova`s existing issued share capital.
Management
Following the Merger Offer becoming or being declared unconditional in all
respects, the executive directors of the Enlarged Group will be:
Name Position
David A Oxlade Chief Executive Officer
Nicholas L Hart* Commercial Director
Daniel Abrams Chief Financial Officer
Stephen C Inglis* Research Director
Michael Moore Chief Scientific Officer
John St Clair Roberts* Medical Director
John Waterfall Development Director
* Current Cantab Directors
John Jackson, Chairman of Xenova, will continue in his role as non-executive
Chairman. Simon Duffy, Chairman of Cantab, will join as non-executive Deputy
Chairman and Gerard Fairtlough will join as non-executive director from the
Cantab Board. Upon completion of the Merger, Paul Bevan will resign as a
non-executive director from the Xenova Board and Jeremy Curnock Cook and
Michael Redmond will resign as non-executive directors from the Cantab Board.
Commenting on the Merger, David Oxlade, Chief Executive Officer of Xenova,
said:
^The merger of our two companies creates a larger, stronger biotechnology
group with a broad pipeline of products in development and a number of
valuable partnerships with major pharmaceutical companies. Shareholders will
benefit from the improved risk-reward profile that comes through a broadening
and deepening of the product pipeline.^
Simon Duffy, Chairman of Cantab, commented:
^In announcing a strategic review in October 2000, we recognised the need for
consolidation in the industry. We believe that the merger with Xenova
represents good value for our shareholders and provides a foundation for the
further development of our pipeline, technologies and expertise.^
Nick Hart, Acting Chief Executive Officer of Cantab, added:
^The enlarged group brings together two companies with a joint focus on cancer
and complementary technologies in drug discovery, providing a foundation for
the continued development of innovative medicines with high commercial
potential.^
THIS SUMMARY SHOULD BE READ IN CONJUNCTION WITH THE FULL TEXT OF THE FOLLOWING
ANNOUNCEMENT ABOUT THE MERGER OFFER
A presentation for analysts will be held at the offices of Financial Dynamics,
Holborn Gate, 26 Southampton Buildings, London WC2A 1PB, at 9.30am today, 19
February 2001. Coffee will be available from 9.15am.
Please call Mo Noonan for further details on 020 7269 7116.
Enquiries:
Xenova David Oxlade Tel: 01753 706 600
Daniel Abrams Tel: 020 7831 3113 (Financial
Dynamics)
Hilary
Reid-Evans
Nomura David Porter Tel: 020 7521 2000
Cantab Nick Hart Tel: 01223 423 413
Andy Burrows Tel: 020 7831 3113 (Financial
Dynamics)
Tel: 01223 436 503
Credit Suisse First Chris Lloyd Tel: 020 7888 1000
Boston Stephanie
Leouzon
Asim Mullick
Financial Dynamics David Yates Tel: 020 7831 3113
Nomura, which is regulated in the United Kingdom by The Securities and Futures
Authority Limited, is acting for Xenova and no one else in connection with the
Merger Offer and will not be responsible to anyone other than Xenova for
providing the protections afforded to customers of Nomura, or for providing
advice in relation to the Merger Offer or the New Xenova Shares.
Credit Suisse First Boston, which is regulated in the United Kingdom by The
Securities and Futures Authority Limited, is acting for Cantab and no one else
in connection with the Merger Offer and will not be responsible to anyone
other than Cantab for providing the protections afforded to customers of
Credit Suisse First Boston, or for providing advice in relation to the Merger
Offer.
This announcement does not constitute an offer or an invitation to purchase
any securities.
This announcement does not constitute an offer of securities for sale in the
United States and the New Xenova Shares have not been, and will not be,
registered under the United States Securities Act of 1933, as amended, nor
under any laws of any state of the United States, and the relevant clearances
have not been and will not be obtained from the relevant authorities in
Canada, Australia or Japan. Accordingly, New Xenova Shares may not be offered,
sold or delivered, directly or indirectly, in or into the United States,
Canada, Australia or Japan except pursuant to exemptions from applicable
requirements of such jurisdictions.
The Merger Offer will not be made, directly or indirectly, in or into, by use
of mails or any means of instrumentality (including, without limitation,
facsimile transmissions, telex, telephone or e-mail) of interstate or foreign
commerce of, or any facilities of a securities exchange of, the United States
nor is it being made in or into Canada, Australia, or Japan and the Merger
Offer will not be capable of acceptance by any such use, means,
instrumentality or facilities or from or within the United States, Canada,
Australia or Japan. Accordingly, copies of this press announcement are not
being, and must not be, mailed or otherwise distributed or sent in, into or
from the United States, Canada, Australia or Japan and persons receiving this
press announcement (including custodians, nominees and trustees) must not
distribute or send it in, into or from the United States, Canada, Australia or
Japan.
Appendix 3 contains the definitions and a glossary of terms used in this
announcement.
Not for release, distribution or publication in or into the United States,
Canada, Australia or Japan
Recommended Merger of Xenova Group plc with Cantab Pharmaceuticals plc
1. Introduction
The Boards of Xenova and Cantab today announce that they have agreed terms for
a proposed merger of their businesses. The Merger will be achieved through a
recommended all share offer to be made by Nomura, on behalf of Xenova, for all
of the issued (and to be issued) share capital of Cantab.
The Merger Offer will be made on the basis of 11 New Xenova Shares for every 7
Cantab Shares and so in proportion for any other number of Cantab Shares held.
The Merger Offer will value each Cantab Share at approximately 140 pence and
the entire existing issued share capital of Cantab at #62.1 million (based on
the Closing Price of 89 pence per Xenova Share on 16 February 2001 (the
business day immediately prior to this announcement)).
2. Recommendation and undertakings
The Cantab Directors, who have been so advised by their financial
advisers, Credit Suisse First Boston, consider the terms of the Merger
Offer to be fair and reasonable. In providing its advice to the Cantab
Directors, Credit Suisse First Boston has taken into account the
commercial assessment of the Cantab Directors.
Accordingly, the Cantab Directors will be unanimously recommending Cantab
Shareholders to accept the Merger Offer, as they have undertaken to do in
respect of their own aggregate holdings of 196,006 Cantab Shares,
representing approximately 0.44 per cent. of Cantab`s existing issued
share capital.
The Xenova Directors, who have received financial advice from Nomura in
relation to the Merger Offer, consider the Merger Offer to be in the best
interests of Xenova Shareholders as a whole. In providing its advice to
the Xenova Directors, Nomura has taken into account the Xenova Directors`
commercial assessment of the Merger.
Given its size, the Merger Offer is conditional, inter alia, upon the
approval of Xenova Shareholders.
The Xenova Directors will be unanimously recommending Xenova Shareholders
to vote in favour of the resolutions necessary to effect the Merger Offer
as they have undertaken to do in respect of their own beneficial holdings
of, in aggregate, 314,916 Xenova Shares, representing approximately 0.45
per cent. of Xenova`s existing issued share capital.
3. Merger Offer
On behalf of Xenova, Nomura will offer to acquire, subject to the
conditions and further terms set out in Appendix 1 of this announcement
and to be set out in the Offer Document and Form of Acceptance, all the
Cantab Shares on the following basis:
For every 7 Cantab Shares 11 New Xenova Shares
and so in proportion for any other number of Cantab Shares held.
On the basis of the Closing Price of 89 pence per Xenova Share on 16
February 2001 (the business day immediately prior to the date of this
announcement), the Merger Offer values each Cantab Share at approximately
140 pence and the entire existing issued share capital of Cantab at #62.1
million. Based on the Closing Price of Xenova Shares on that date, the
Merger Offer represents a premium of 16.5 per cent. over the Closing Price
of 120 pence per Cantab Share on the same date and a premium of 52.0 per
cent. over the Closing Price of 92 pence per Cantab Share on 31 October
2000, the day before Cantab announced it had received a number of
approaches that might or might not lead to the sale or merger of Cantab.
Full acceptance of the Merger Offer (without taking into account the
exercise of any options under the Cantab Share Option Schemes) would
result in the issue of 69.8 million New Xenova Shares to Cantab
Shareholders, representing 50.2 per cent. of the enlarged issued ordinary
share capital of Xenova.
The Merger Offer will extend to all Cantab Shares unconditionally allotted
or issued as at the date on which the Merger Offer is made and any further
Cantab Shares unconditionally allotted or issued while the Merger Offer
remains open for acceptance.
The Cantab Shares that are the subject of the Merger Offer will be
acquired by Xenova fully paid and free from all liens, charges,
encumbrances, rights of pre-emption and any other third party rights of
any nature whatsoever and together with all rights attaching thereto,
including the right to receive all dividends and other distributions (if
any), declared, made or paid after the date of this announcement. The
Cantab Board has not declared or recommended any dividends since
incorporation.
The New Xenova Shares to be issued pursuant to the Merger Offer will be
issued credited as fully paid and will rank pari passu in all respects
with the existing Xenova Shares.
4. Reasons for and benefits of the Merger
Both the Xenova Directors and the Cantab Directors believe that the Enlarged
Group created by the Merger will have enhanced prospects of introducing
commercially important new drugs to the healthcare market. Key features of the
Enlarged Group will include: a significant portfolio of potential
first-in-class and innovative products, including seven products in clinical
development; valuable partnerships with major pharmaceutical companies
including Celltech, Eli Lilly, GlaxoSmithKline and Pfizer, with the potential
for further collaborations in the current year; strong drug discovery and
development capabilities in both the biopharmaceutical and medicinal chemistry
fields; and a significantly strengthened proprietary technology base.
The Enlarged Group will have the benefit of an internationally experienced
management team to drive the focus and development of the extended portfolio
of programmes. The proposed combined management team has a proven track record
in identifying, developing and partnering innovative products and
technologies.
The Xenova Directors and the Cantab Directors believe that the expanded
product pipeline and broader technology platform of the Enlarged Group will
increase the chances of successfully bringing new products to market and
reduce the overall risk profile, thereby increasing the potential to unlock
inherent values within Xenova and Cantab. Furthermore, the Merger will create
a broader shareholder base that should ensure greater liquidity and therefore
promote a broader level of interest in the equity of the Enlarged Group.
A broad range of potential first-in-class and innovative products
The principal therapeutic areas of focus for the Enlarged Group will be
cancer, infectious diseases and addiction, with both companies combining their
expertise in the area of cancer where each company has a number of exciting
product opportunities. The Enlarged Group will have one of the largest
clinical pipelines among public companies within the European
biopharmaceutical sector, with four product candidates in Phase II and three
in Phase I, and a further five in pre-clinical development. Of particular
importance is the potential for the Enlarged Group to bring product candidates
into Phase III registration clinical trials through the involvement of
corporate partners for late stage development and commercialisation. Details
of the Enlarged Group`s product candidates are outlined in paragraph 5 below.
Strong drug discovery and development capabilities
The Xenova Directors and the Cantab Directors consider that the two companies
have highly complementary research and development skill sets. Xenova has
significant expertise in the discovery and clinical development of small
molecule drug candidates and has capabilities in the areas of bioinformatics,
medicinal chemistry and computer modelling. Cantab has strengths in the areas
of virology, immunology and gene therapy. The Enlarged Group will therefore
have an enhanced range of technologies with which to develop its current and
future products. It will also benefit from important relationships established
by both companies with leading academic centres and institutions in their
respective fields, providing access to expertise, new intellectual property
and new product opportunities.
Research and development for the Enlarged Group`s programmes will be located
within state-of-the-art facilities in Slough and Cambridge, with 163 employees
involved in areas including research and development, medical, quality
assurance, quality control and manufacturing.
Corporate partnerships
The Enlarged Group intends to continue the corporate collaborations of each of
Xenova and Cantab with their existing partners, Celltech, Eli Lilly,
GlaxoSmithKline and Pfizer. The Xenova Directors and the Cantab Directors
expect that the Enlarged Group has the potential to enter into further
partnerships with these and other pharmaceutical companies for the further
development and commercialisation of products that each company is currently
developing.
Financial position
Xenova and Cantab on a combined basis had cash and liquid investments of #27.5
million as at 31 December 2000 (before taking into account any merger costs).
In addition, Cantab received #5.75 million in January 2001 from
GlaxoSmithKline arising from the regulatory requirement by the US Federal
Trade Commission for GlaxoSmithKline to return the prophylactic rights to the
DISC-PRO programme following the merger of GlaxoWellcome plc with SmithKline
Beecham plc. The financial position of the Enlarged Group may also benefit
during 2001 from the exercise of the Xenova Warrants (exercisable at 85 pence
per Xenova Share) which, if fully exercised, would raise additional funds of #
9.8 million during the period to 31 October 2001. It may also benefit from any
upfront payments from the licensing of existing programmes.
As an additional benefit of the Merger, the Xenova Directors and the Cantab
Directors anticipate cost efficiencies by eliminating duplication from the
combined infrastructure.
5. Enlarged Group`s products
The Enlarged Group will focus on the therapeutic areas of cancer, infectious
diseases and addiction. The principal clinical development programmes,
including those expected to enter clinical trials during 2001, in each of
these therapeutic areas are described below:
Cancer
* XR9576 (P-gp MDR inhibitor) is potentially a first-in-class drug to
combat multi-drug resistance in cancer. The Xenova Directors expect that a
corporate partnership agreement to fund Phase III clinical trials as well
as the marketing of this product will be entered into during 2001.
* TA-HPV (Vaccinia vector HPV 16/18 vaccine) is an immunotherapeutic
vaccine, consisting of a live recombinant vaccinia virus, designed to
prevent the recurrence of cervical cancer. This vaccine is currently in
Phase II clinical trials.
* TA-CIN (HPV16 fusion protein vaccine) is a recombinant fusion protein,
derived from the HPV16 protein, designed as a treatment for women with
cervical dysplasia. Phase I clinical trials have been completed.
* DISC-GMCSF (DISC vectored GMCSF immunotherapeutic) is an
immunotherapeutic vaccine comprising a DISC-HSV vector expressing human
GMCSF. It is designed as a treatment for a broad range of solid tumours
and is currently in Phase I clinical trials.
* XR 11576 (Dual topoisomerase I/II inhibitor) a second generation
intravenous and oral cytotoxic drug candidate and XR5944 (Dual
topoisomerase I/II inhibitor), a second generation intravenous drug
candidate, one of which is expected to enter Phase I/II clinical trials
during 2001. This replaces the first generation candidate, XR5000, which
failed to demonstrate competitive efficacy in an initial Phase II clinical
trial. No further work on XR5000 is planned.
Infectious diseases
* TA-HSV (Herpes simplex therapeutic vaccine) is a vaccine designed for
the treatment of recurrent genital herpes and is in Phase II clinical
trials with partner GlaxoSmithKline.
* DISC-PRO (Herpes simplex prophylactic vaccine) is a prophylactic vaccine
designed to prevent genital and oro-labial herpes. Phase I clinical trials
are complete and preparations are under way for a clinical immunogenicity
study and Phase III registration studies for which the Xenova Directors
and the Proposed Directors intend to identify a corporate partner.
Addiction
* TA-CD (Cocaine conjugate vaccine) is a vaccine for the treatment of
cocaine addiction for which a Phase IIa clinical trial, supported by NIDA,
has been completed. Results from recently completed toxicology and
clinical studies are due to be submitted to the FDA in the near future and
further Phase II studies are expected to commence later in the current
year.
* TA-NIC (Nicotine conjugate vaccine) is a vaccine designed as a treatment
for nicotine dependence. Phase I clinical trials are scheduled to begin in
2001.
Other programmes
The Enlarged Group will also have a strong pipeline of earlier stage product
programmes and technologies to progress to clinical development or with which
to form corporate partnerships. These include:
* OX40/OX40L - a platform for the creation of multiple product candidates
targeting cancer and autoimmune disease. A partnership has already been
established with Celltech to develop an antibody-based product against
OX40 for treatment of autoimmune disease.
* DISC Vaccine technology - applicable to multiple disease targets. A
product candidate for prevention of bovine herpes (DISC-BHV) is in
development in partnership with Pfizer.
* PAI-1 inhibitor technology - a platform for the development of drugs
targeting cancer and cardiovascular disease. Research in the
cardiovascular area is being carried out in collaboration with Eli Lilly.
* VP22 technology - a novel technology for enhancing delivery of
gene-based therapeutics, being developed under a joint venture, Phogen
Limited, with Marie Curie Cancer Care.
6. Information on Xenova
Xenova is a biopharmaceutical company based in Slough with approximately
60 employees, specialising in the discovery and development of novel drugs
in which it creates and retains ownership of the intellectual property.
Xenova`s key area of focus is the development of novel cancer drugs that
address clear unmet clinical needs and offer attractive commercial
opportunities. Xenova currently has one key product in clinical
development, which is designed to address the problems of multi-drug
resistance in cancer. Xenova is currently in discussions with a number of
potential corporate partners with the intention of funding the product
candidate through Phase III clinical trials and into sales and marketing.
Xenova has a further five products at the preclinical and research stages
involving cancer projects targeting MRP-related multi-drug resistance,
topoisomerase inhibitors, telomerase and PAI-1, as well as a drug
development agreement with Eli Lilly, based on small molecule inhibitors
of PAI-1, to develop novel antithrombotic drugs for chronic use. Xenova
has a total of 54 granted patents and a further 100 individual patent
applications.
Xenova has the ability to access new targets for drug screening and lead
identification research through collaborations with various academic
research centres and by utilising its own diverse synthetic small molecule
library.
Xenova seeks to commercialise its development products through partnering
with major pharmaceutical companies. It considers the optimal timing for
partnering on a project by project basis following an assessment of the
scientific and commercial risks and returns for each individual project.
However, in general, a licensing partner will be sought to assist with the
Phase III trials and to take on the marketing and distribution.
Xenova announces its unaudited preliminary results for the year ended 31
December 2000 today. For the year ended 31 December 2000, Xenova incurred
a loss on ordinary activities before taxation and R&D tax credits of #10.0
million (1999: #10.1 million) and as at that date had net assets of #11.9
million (1999: #11.6 million) and cash and liquid investments of #12.2
million (1999: #10.1 million).
7. Information on Cantab
Cantab is a biotechnology company based in Cambridge with over 130
employees, focused on the development of novel human biopharmaceuticals
using its innovative expertise in vaccines, immunotherapy and gene
delivery.
Cantab currently has six products in clinical development and a further
seven at the preclinical and research stages. These products fall into the
categories of vaccines (prophylactic and therapeutic), immunotherapeutics
and gene therapeutics. Cantab`s product portfolio addresses areas of high
unmet clinical need and significant commercial potential, such as
infectious disease, cancer and drug addiction. In addition, Cantab has
developed novel proprietary platform technologies for vaccine construction
and gene therapy and through Phogen Limited, its joint venture with Marie
Curie Cancer Care, for enhanced gene and drug delivery. This product and
technology pipeline is supported by a strong intellectual property
portfolio with 66 patents granted and a further 134 individual patent
applications.
Cantab also operates a pilot plant for manufacture of clinical grade
material that has capacity available for contract manufacturing for other
biotechnology companies without such facilities.
Cantab announces its unaudited preliminary results for the year ended 31
December 2000 today. For the year ended 31 December 2000, Cantab incurred
a loss on ordinary activities before taxation and R&D tax credits of #5.1
million (1999: #8.7 million) and as at that date had net assets of #28.4
million (1999: #31.7 million) and cash and liquid investments of #15.3
million (1999: #26.1 million).
8. Directors, management and employees
Following the Merger Offer becoming or being declared unconditional in all
respects, the board of the Enlarged Group will be:
Non-executives
John BH Jackson Chairman
Simon P Duffy* Deputy Chairman
Gerard H Fairtlough* Non-executive Director
Peter L Gillett Non-executive Director
Adrian L Harris Non-executive Director
T Ronald Irwin Non-executive Director
Howard S Wachtler Non-executive Director
Executives
David A Oxlade Chief Executive Officer
Nicholas L Hart* Commercial Director
Daniel Abrams Chief Financial Officer
Stephen C Inglis* Research Director
Michael Moore Chief Scientific Officer
John St Clair Roberts* Medical Director
John Waterfall Development Director
*Proposed Directors who will join the Xenova Board from Cantab upon the
Merger Offer becoming or being declared wholly unconditional in all
respects
Upon the Merger Offer becoming or being declared unconditional in all
respects, Paul Bevan will resign as a non-executive director from the
Xenova Board and Jeremy Curnock Cook and Michael Redmond will resign as
non-executive directors from the Cantab Board.
The Proposed Directors will join the Xenova Board upon the Merger Offer
becoming or being declared wholly unconditional in all respects. It is
currently anticipated that shortly after Nicholas Hart, Stephen Inglis and
John St Clair Roberts are appointed to the Xenova Board, their respective
basic annual salaries will be adjusted to #140,000, #120,000 and #115,000
respectively, and that each will be entitled to a bonus of up to 40 per
cent. of his basic salary. Otherwise it is intended that the current terms
of service of the Proposed Directors will not be changed significantly
upon their appointment to the Xenova Board, although these arrangements
will be reviewed after such appointment and where appropriate salary and
benefits arrangements may be altered to integrate them appropriately into
the Xenova Board structure.
The Xenova Directors and the Proposed Directors have confirmed that the
existing employment rights, including the pension rights, of all
management and employees of Cantab will be fully safeguarded following
completion of the Merger.
9. Cantab Share Option Schemes
All options under the Cantab Share Option Schemes will become exercisable
once the Merger Offer becomes or is declared unconditional in all
respects.
Optionholders who decide to exercise their options will be able to accept
the Merger Offer (while it remains open for acceptance) in respect of the
Cantab Shares they receive on exercise. However, it may not be in the
interests of all Cantab optionholders to exercise their options, depending
on the relevant option exercise price and the value of the Xenova Shares.
Xenova will write to Cantab optionholders in more detail on this subject
in due course.
10. Settlement, listing and dealing
Application will be made for the New Xenova Shares to be admitted to the
Official List and to be admitted to trading on the London Stock Exchange`s
market for listed securities. It is expected that listing will become
effective and that dealings, for normal settlement, will begin on the
first business day following the day on which the Merger Offer becomes or
is declared unconditional in all respects (save for any condition relating
to admission to the Official List).
After the Merger Offer becomes or is declared unconditional in all
respects, Xenova intends to procure the making of an application by Cantab
to delist the Cantab Shares from the Official List. It is anticipated that
such cancellation will take effect no earlier than 20 business days after
the Merger Offer becomes or is declared unconditional in all respects.
If Xenova receives acceptances under the Merger Offer in respect of, and/
or otherwise acquires, 90 per cent. or more of the Cantab Shares to which
the Merger Offer relates, Xenova will exercise its rights pursuant to the
provisions of sections 428 to 430F of the Companies Act 1985 to acquire
compulsorily the remaining Cantab Shares to which the Merger Offer
relates.
Certificates for New Xenova Shares to be issued to Cantab Shareholders and
cheques in respect of fractional entitlements will be despatched no later
than 14 days after the Merger Offer becomes or is declared unconditional
in all respects. No certificates for New Xenova Shares will be issued in
respect of the entitlements of those Cantab Shareholders who hold their
shares in uncertificated form in CREST, settlement for which will be made
through the applicable CREST procedure (unless Xenova decides otherwise).
Further details on settlement, listing and dealing will be included in the
formal documents to be sent to Cantab Shareholders and Xenova Shareholders
in due course.
11. Overseas shareholders
The availability of the Merger Offer to persons not resident in the UK may
be affected by the laws of the relevant jurisdictions. In particular, the
Merger Offer will not be made, directly or indirectly, in or into the
United States, Canada, Australia or Japan. Cantab Shareholders who are not
resident in the UK should inform themselves about and observe any
applicable requirements.
Further details in relation to overseas shareholders will be contained in
the Offer Document.
12. General
Save for the irrevocable undertakings obtained from Cantab Directors referred
to in paragraph 2 above of this announcement, neither Xenova, nor any of its
directors, nor, so far as Xenova is aware, any person deemed to be acting in
concert with it, owns or controls any Cantab Shares or has any option to
acquire any Cantab Shares, or has entered into any derivative referenced to
securities of Cantab which remains outstanding. However, it has not been
possible to ascertain holdings of certain parties who may be deemed to be
acting in concert with Xenova for the purposes of the Merger Offer in respect
of Cantab Shares. Any such holdings would be included in the Offer Document.
The formal Offer Document, setting out full details of the Merger Offer,
together with Listing Particulars and a Form of Acceptance, will be posted to
Cantab Shareholders as soon as practicable. The Offer Document and the Listing
Particulars will also be despatched to Cantab optionholders for information
only. A circular containing a notice convening an Extraordinary General
Meeting of Xenova Shareholders to approve the Merger, together with the
Listing Particulars (and the Offer Document for information only), will be
despatched at the same time to Xenova Shareholders and to Xenova optionholders
and warrantholders for information only.
Enquiries:
Xenova David Oxlade Tel: 01753 706 600
Daniel Abrams Tel: 020 7831 3113 (Financial
Dynamics)
Hilary
Reid-Evans
Nomura David Porter Tel: 020 7521 2000
Cantab Nick Hart Tel: 01223 423 413
Andy Burrows Tel: 020 7831 3113 (Financial
Dynamics)
Tel: 01223 436 503
Credit Suisse First Chris Lloyd Tel: 020 7888 1000
Boston
Stephanie
Leouzon
Asim Mullick
Financial Dynamics David Yates Tel: 020 7831 3113
Nomura, which is regulated in the United Kingdom by The Securities and Futures
Authority Limited, is acting for Xenova and no one else in connection with the
Merger Offer and will not be responsible to anyone other than Xenova for
providing the protections afforded to customers of Nomura, nor for providing
advice in relation to the Merger Offer or the New Xenova Shares.
Credit Suisse First Boston, which is regulated in the United Kingdom by The
Securities and Futures Authority Limited, is acting for Cantab and no one else
in connection with the Merger Offer and will not be responsible to anyone
other than Cantab for providing the protections afforded to customers of
Credit Suisse First Boston, or for providing advice in relation to the Merger
Offer.
This announcement does not constitute an offer or an invitation to purchase
any securities.
This announcement does not constitute an offer of securities for sale in the
United States and the New Xenova Shares have not been, and will not be,
registered under the United States Securities Act of 1933, as amended, nor
under any laws of any state of the United States, and the relevant clearances
have not been and will not be obtained from the relevant authorities in
Canada, Australia or Japan. Accordingly, New Xenova Shares may not be offered,
sold or delivered, directly or indirectly, in or into the United States,
Canada, Australia or Japan except pursuant to exemptions from applicable
requirements of such jurisdictions.
The Merger Offer will not be made, directly or indirectly, in or into, by use
of mails or any means of instrumentality (including, without limitation,
facsimile transmissions, telex, telephone or e-mail) of interstate or foreign
commerce of, or any facilities of a securities exchange of, the United States
nor is it being made in or into Canada, Australia, or Japan and the Merger
Offer will not be capable of acceptance by any such use, means,
instrumentality or facilities or from or within the United States, Canada,
Australia or Japan. Accordingly, copies of this press announcement are not
being, and must not be, mailed or otherwise distributed or sent in, into or
from the United States, Canada, Australia or Japan and persons receiving the
press announcement (including custodians, nominees and trustees) must not
distribute or send it in, into or from the United States, Canada, Australia or
Japan.
Appendix 3 contains the definitions and glossary of terms used in the
announcement.
Part 2
APPENDIX 1
CONDITIONS OF THE MERGER OFFER
The Merger Offer will comply with the rules and regulations of the City Code,
the UKLA and the London Stock Exchange and will be subject to the following
conditions:
a. valid acceptances being received (and not, where permitted, withdrawn) by
not later than 3.00 p.m. (London time) on the first closing date of the
Merger Offer (or such later time(s) and/or date(s) as Xenova may, subject
to the rules of the City Code, decide) in respect of not less than 90 per
cent. (or such lower percentage as Xenova may decide) in nominal value of
the Cantab Shares to which the Merger Offer relates, provided that this
condition will not be satisfied unless Xenova and/or its wholly owned
subsidiaries shall have acquired or agreed to acquire (whether pursuant to
the Merger Offer or otherwise) Cantab Shares carrying in aggregate more
than 50 per cent. of the voting rights then normally exercisable at a
general meeting of Cantab, including for this purpose (except to the
extent otherwise agreed by the Panel) any such voting rights attaching to
any Cantab Shares that are unconditionally allotted or issued before the
Merger Offer becomes or is declared unconditional as to acceptances,
whether pursuant to the exercise of any outstanding subscription or
conversion rights or otherwise; and for this purpose:
i. the expression ^Cantab Shares to which the Merger Offer relates^ shall
be construed in accordance with sections 428 to 430F of the Companies
Act 1985, and
ii. Cantab Shares which have been unconditionally allotted but not issued
shall be deemed to carry the voting rights which they will carry upon
issue;
b. the passing at an extraordinary general meeting of Xenova (or any
adjournment thereof) of an ordinary resolution or ordinary resolutions to
approve, implement and effect the Merger Offer and the acquisition of any
Cantab Shares pursuant to the Merger Offer or otherwise;
c. the admission to the Official List of the New Xenova Shares (or such of
them as are due to be allotted at the time the Merger Offer becomes or is
declared unconditional in all other respects) becoming effective in
accordance with the Listing Rules and the admission of such shares to
trading on the London Stock Exchange`s market for listed securities
becoming effective or (if determined by Xenova and subject to the consent
of the Panel) the UKLA agreeing to admit such shares to the Official List
and the London Stock Exchange agreeing to admit such shares to trading
subject only to (i) the allotment of such shares and/or (ii) the Merger
Offer becoming or being declared unconditional in all respects;
d. no Third Party having intervened in any way and there not continuing to be
outstanding any statute, regulation, order or decision of any Third Party
in each case which would or might be reasonably likely (in any case to an
extent which is material in the context of the Xenova Group or the Cantab
Group, as the case may be, taken as a whole) to:
i. make the Merger Offer, its implementation or the acquisition or
proposed acquisition by Xenova of any shares or other securities in,
or control of, Cantab or any member of the Cantab Group void, illegal
or unenforceable in any jurisdiction, or otherwise directly or
indirectly restrain, prevent, prohibit, restrict or delay the same or
impose additional conditions or obligations with respect to the Merger
Offer or such acquisition, or otherwise materially challenge or
interfere with the Merger Offer or such acquisition, or require
material amendment to the terms of the Merger Offer or the acquisition
or proposed acquisition of any Cantab Shares or of control by Xenova
of Cantab or any member of the Cantab Group;
ii. require or prevent the divestiture by Xenova of any shares or other
securities in any member of the Cantab Group;
iii. require, prevent or delay the divestiture or alter the terms
envisaged for any proposed divestiture by any member of the Xenova
Group or by any member of the Cantab Group of all or any material
portion of their respective businesses, assets or properties or impose
any material limitation on the ability of any of them to conduct any
of their respective businesses or to own or control any of their
respective assets or properties or any material part thereof;
iv. require any member of the Xenova Group or of the Cantab Group to
acquire, or to offer to acquire, any shares or other securities (or
the equivalent) in any member of either group owned by any third
party;
v. impose any material limitation on the ability of any member of the
Xenova Group or of the Cantab Group to conduct or integrate or
co-ordinate its business, or any part of it, with the businesses or
any part of the businesses of any other member of the Xenova Group or
of the Cantab Group;
vi. result in any member of the Cantab Group or the Xenova Group ceasing
to be able to carry on business under any name under which it
presently does so; or
vii. otherwise adversely affect the business, assets, profits, financial
or trading position or prospects of any member of the Cantab Group or
of the Xenova Group,
and all applicable waiting and other time periods during which any Third
Party could have intervened under the laws of any jurisdiction having
expired, lapsed or been terminated;
e. the Office of Fair Trading or any relevant institute in the United Kingdom
not having indicated that it is the intention of the Secretary of State
for Trade and Industry to refer the proposed acquisition of Cantab by
Xenova to the Competition Commission;
f. in any case to an extent which is material in the context of the Xenova
Group or the Cantab Group, as the case may be, as a whole, all
notifications and filings which are necessary having been made, all
appropriate waiting and other time periods (including any extensions of
such waiting and other time periods) under any applicable legislation or
regulation of any jurisdiction having expired, lapsed or been terminated
(as appropriate) and all statutory or regulatory obligations in any
jurisdiction having been complied with in each case in connection with the
Merger Offer, the Merger, or the acquisition or proposed acquisition of
any shares or other securities in, Cantab or the control of Cantab or any
other member of the Cantab Group by Xenova or the carrying on by any
member of the Cantab Group of its business;
g. all Authorisations which are necessary or are reasonably considered
necessary or appropriate by Xenova in any jurisdiction for or in respect
of the Merger Offer, the Merger or the acquisition or proposed acquisition
of any shares or other securities in Cantab, or the acquisition of control
of any member of the Cantab Group by, Xenova or the carrying on by any
member of the Cantab Group of its business having been obtained, in terms
and in a form satisfactory to Xenova, from all appropriate Third Parties
or from any persons or bodies with whom any member of the Cantab Group has
entered into contractual arrangements, in each case where the absence of
such Authorisation would have a material adverse effect on the Cantab
Group taken as a whole, and all such Authorisations remaining in full
force and effect and there being no notice or intimation of any intention
to revoke, suspend, restrict, modify or not to renew any of the same;
h. except as disclosed in Cantab`s annual report and accounts for the year
ended 31 December 1999 or in Cantab`s preliminary results for the year
ended 31 December, 2000 as announced on 19 February 2001 or as otherwise
publicly announced by Cantab (by the delivery of an announcement to the
Company Announcements Office of the London Stock Exchange) prior to 16
February 2001 or as fairly disclosed to Xenova by or on behalf of Cantab
prior to 16 February 2001, there being no provision of any arrangement,
agreement, licence, permit, franchise or other instrument to which any
member of the Cantab Group is a party, or by or to which any such member
or any of its assets is or are or may be bound, entitled or subject or any
circumstance, which, in each case as a consequence of the Merger Offer,
the Merger or the acquisition or proposed acquisition of any shares or
other securities in, Cantab or the acquisition of control of any member of
the Cantab Group by Xenova or otherwise, or could or might reasonably be
expected to result in, (in any case to an extent which is material in the
context of the Cantab Group taken as a whole):
i. any monies borrowed by or any other indebtedness or liabilities (actual
or contingent) of, or any grant available to, any member of the Cantab
Group being or becoming repayable or capable of being declared
repayable immediately or prior to its stated repayment date or the
ability of any member of the Cantab Group to borrow monies or incur
any indebtedness being withdrawn or inhibited or becoming capable of
being withdrawn;
ii. the creation or enforcement of any mortgage, charge or other security
interest over the whole or any part of the business, property, assets
or interests of any member of the Cantab Group or any such mortgage,
charge or other security interest (wherever created, arising or having
arisen) becoming enforceable;
iii. any such arrangement, agreement, licence, permit, franchise or
instrument, or the rights, liabilities, obligations or interests of
any member of the Cantab Group thereunder, being, or becoming capable
of being, terminated or materially and adversely modified or affected
or any adverse action being taken or any onerous obligation or
liability arising thereunder;
iv. any asset or interest of any member of the Cantab Group being or
falling to be disposed of or ceasing to be available to any member of
the Cantab Group or any right arising under which any such asset or
interest could be required to be disposed of or could cease to be
available to any member of the Cantab Group otherwise than in the
ordinary course of business;
v. any member of the Cantab Group ceasing to be able to carry on business
under any name under which it presently does so;
vi. the rights, liabilities, obligations or interests of any member of the
Cantab Group under any such arrangement, agreement, licence, permit,
franchise or other instrument or the interests or business of any such
member in or with any other person, firm, company or body (or any
arrangement or arrangements relating to any such interests or
business) being terminated, or materially and adversely modified or
affected; or
vii. the financial or trading position or the prospects or the value of
any member of the Cantab Group being prejudiced or adversely affected,
and no event having occurred which, under any provision of any such
arrangement, agreement, licence, permit or other instrument, could result
in any of the events or circumstances which are referred to in paragraphs
(i) to (vii) of this condition (h) in any case to an extent which is or
would be material in the context of the Cantab Group taken as a whole;
i. since 31 December 1999 and except as disclosed in Cantab`s annual report
and accounts for the year then ended or in Cantab`s preliminary results
for the year ended 31 December, 2000 as announced on 19 February, 2001 or
as otherwise publicly announced by Cantab (by the delivery of an
announcement to the Company Announcements Office of the London Stock
Exchange) prior to 16 February, 2001 or as otherwise fairly disclosed to
Xenova by or on behalf of Cantab prior to 16 February, 2001 no member of
the Cantab Group having:
i. issued or agreed to issue, or authorised the issue of, additional
shares of any class, or securities convertible into or exchangeable
for, or rights, warrants or options to subscribe for or acquire, any
such shares or convertible securities other than as between Cantab and
wholly-owned subsidiaries of Cantab and other than any options granted
under any of the Cantab Share Option Schemes prior to 16 February,
2001 or any shares issued upon the exercise of any options granted
under any of the Cantab Share Option Schemes;
ii. purchased or redeemed or repaid any of its own shares or other
securities or reduced or made any other change to any part of its
share capital;
iii. recommended, declared, paid or made any bonus, dividend or other
distribution whether payable in cash or otherwise (other than to
Cantab or a wholly-owned subsidiary of Cantab);
iv. made or authorised or announced its intention to propose any change in
its loan capital;
v. (other than any acquisition or disposal in the ordinary course of
business or a transaction between Cantab and a wholly-owned subsidiary
of Cantab) merged with, demerged or acquired any body corporate,
partnership or business or acquired or disposed of or transferred,
mortgaged or charged or created any security interest over any assets
or any right, title or interest in any assets (including shares in any
undertaking and trade investments) or authorised, proposed or
announced its intention to do the same (which in any case is material
in the context of the Cantab Group taken as a whole);
vi. issued or authorised the issue of, or made any change in or to, any
debentures or (except in the ordinary course of business) incurred or
increased any indebtedness or liability (actual or contingent) which
in any case is material in the context of the Cantab Group taken as a
whole;
vii. entered into, varied, or authorised any agreement, transaction,
arrangement or commitment (whether in respect of capital expenditure
or otherwise) which:
A. is of a long term, onerous or unusual nature or magnitude or which
is or might reasonably be expected to involve an obligation of
such nature or magnitude; or
B. could materially restrict the business of any member of the Cantab
Group; or
C. is other than in the ordinary course of business,
and which in any case is material in the context of the Cantab Group
taken as a whole;
viii. entered into, implemented, effected or authorised any merger,
demerger, reconstruction, amalgamation, scheme, commitment or other
transaction or arrangement in respect of itself or another member of
the Cantab Group otherwise than in the ordinary course of business
which in any case is material in the context of the Cantab Group;
ix. entered into or varied the terms of, any contract, agreement or
arrangement with any of the directors of Cantab or, to an extent which
is material in the context of the Cantab Group taken as a whole, the
directors or senior executives of any member of the Cantab Group;
x. taken any corporate action or had any legal proceedings instituted or
threatened against it or order made for its winding-up (voluntarily or
otherwise), dissolution or reorganisation or for the appointment of a
receiver, administrator, administrative receiver, trustee or similar
officer of all or any part of its assets and revenues or any analogous
proceedings in any jurisdiction or appointed any analogous person in
any jurisdiction which in any case is material in the context of the
Cantab Group taken as a whole;
xi. been unable, or admitted in writing that it is unable, to pay its
debts or having stopped or suspended (or threatened to stop or
suspend) payment of its debts generally or ceased or threatened to
cease carrying on all or a substantial part of its business;
xii. waived or compromised any claim which is material in the context of
the Cantab Group taken as a whole;
xiii. made any alteration to its memorandum or articles of association
which is material in the context of the Merger Offer;
xiv. made or agreed or consented to any significant change to the terms of
the trust deeds constituting the pension schemes established for its
directors and/or employees and/or their dependants or to the benefits
which accrue, or the pensions which are payable thereunder, or to the
basis on which qualification for or accrual or entitlement to such
benefits or pensions are calculated or determined, or to the basis
upon which such liabilities (including pensions) of such pensions
schemes are funded or made, or agreed or consented to, any change to
the trustees, in each case which is material;
xv. entered into any agreement, commitment or arrangement or passed any
resolution or made any offer (which remains open for acceptance) or
announced any intention with respect to any of the transactions,
matters or events referred to in this condition (h) which is material
in the context of the Cantab Group taken as a whole;
j. since 31 December 1999 and except as disclosed in Cantab`s annual report
and accounts for the year then ended or in Cantab`s preliminary results
for the year ended 31 December, 2000 as announced on 19 February, 2001 or
as otherwise publicly announced by Cantab (by the delivery of an
announcement to the Company Announcements Office of the London Stock
Exchange) prior to 16 February, 2001 or as otherwise fairly disclosed to
Xenova by or on behalf of Cantab prior to 16 February, 2001:
i. there having been no adverse change or deterioration in the business,
assets, financial or trading positions or profit or prospects of any
member of the Cantab Group which in any case is material in the
context of the Cantab Group taken as a whole;
ii. no contingent or other liability of any member of the Cantab Group
having arisen or become apparent or increased which in any case is
material in the context of the Cantab Group taken as a whole;
iii. no litigation, arbitration proceedings, prosecution or other legal
proceedings (including patent proceedings and US patent interference
proceedings) to which any member of the Cantab Group is or may become
a party (whether as plaintiff, defendant or otherwise) having been
threatened, announced, implemented or instituted by or against or
remaining outstanding against or in respect of any member of the
Cantab Group which in any case is material in the context of the
Cantab Group taken as a whole; and
iv. (other than as a result of the Merger Offer) no enquiry or
investigation by, or complaint or reference to, any Third Party having
been threatened, announced, implemented, instituted by or against or
remaining outstanding against or in respect of any member of the
Cantab Group which in any case is material in the context of the
Cantab Group taken as a whole;
v. no circumstances having arisen which would entitle a third party to
take patent infringement proceedings against a member of the Cantab
Group which would be material in the context of the Cantab Group taken
as a whole;
vi. no material agreement to which any member of the Cantab Group is a
party and which would be material in the context of the Cantab Group
taken as a whole having been terminated by any other party to any such
agreement; or
k. Xenova not having discovered:
i. that any financial or business or other information concerning the
Cantab Group disclosed at any time (A) by or on behalf of any member
of the Cantab Group, whether publicly or in writing (including without
limitation information transmitted by facsimile, telex or e-mail) to
any member of the Xenova Group or its advisers or (B) in respect of
information relating to intellectual property, by or on behalf of any
member of the Cantab Group or its advisers, whether publicly or in
writing (including without limitation information transmitted by
facsimile, telex or e-mail) to any member of the Xenova Group or its
advisers or orally by telephone during a conference telephone call
convened at 4 p.m. on Monday 12 February, 2001 between Xenova and
certain of its professional advisers and Cantab and certain of its
professional advisers, is materially misleading or contains any
misrepresentation of fact or omits to state a fact necessary to make
any information contained therein not misleading and which was not
subsequently corrected before 16 February, 2001 by disclosure either
publicly or otherwise to Xenova, to an extent which in any case is
material in the context of the Merger Offer; or
ii. that any member of the Cantab Group is subject to any liability
(actual or contingent) except as disclosed in Cantab`s annual report
and accounts for the financial year ended 31 December 1999 or in
Cantab`s preliminary results for the year ended 31 December 2000 as
announced on 19 February 2001 or as otherwise publicly announced by
Cantab (by the delivery of an announcement to the Company Accountants
office of the London Stock Exchange prior to 16 February 2001) or
otherwise as fairly disclosed by or on behalf of, Cantab prior to 16
February, 2001 and which in any case is material in the context of the
Cantab Group taken as a whole;
l. Xenova not having discovered:
i. that save as fairly disclosed to Xenova by or on behalf of the Cantab
prior to 16 February, 2001 any past or present member of the Cantab
Group has not complied with any applicable legislation or regulations
of any jurisdiction with regard to the use, treatment, handling,
storage, transport, release, disposal, discharge, spillage, leak or
emission of any waste or hazardous substance or any substance likely
to impair the environment or harm human health, or otherwise relating
to environmental matters or the health and safety of any person, or
that there has otherwise been any such use, treatment, handling,
storage, transport, release, disposal, discharge, spillage, leak or
emission (whether or not this constituted a non-compliance by any
person with any legislation or regulations and wherever the same may
have taken place) which, in any case, would be likely to give rise to
any liability (whether actual or contingent) or cost on the part of
any member of the Cantab Group which in any case is material in the
context of the Cantab Group taken as a whole;
ii. that save as fairly disclosed to Xenova by or on behalf of Cantab
prior to 16 February, 2001 there is, or is likely to be, any
liability, whether actual or contingent, to make good, repair,
reinstate or clean up any property now or previously owned, occupied
or made use of by any past or present member of the Cantab Group or
any other property or any controlled waters under any environmental
legislation, regulation, notice, circular, order or other lawful
requirement of any relevant authority or third party or otherwise
which in any case is material in the context of the Cantab Group taken
as a whole; or
iii. save as fairly disclosed to Xenova by or on behalf of Cantab prior to
16 February, 2001 that circumstances exist whereby a person or class
of persons would be likely to have a claim in respect of any product
or process of manufacture or materials used therein now or previously
manufactured, sold or carried out by any past or present member of the
Cantab Group which is or would be material in the context of the
Cantab Group taken as a whole.
For the purpose of these conditions:
a. ^Third Party^ means any government, government department or governmental,
quasi-governmental, supranational, statutory, regulatory or investigative
body, authority (including any national anti-trust or merger control
authority), court, trade agency, association, institution or professional
or environmental body or any other person or body whatsoever in any
jurisdiction;
b. a Third Party shall be regarded as having
Part 1
CANTAB PHARMACEUTICALS PLC XENOVA GROUP PLC
Under Embargo - not to be released until 0700 19 February 2001
Not for release, distribution or publication in or into the United States,
Canada, Australia or Japan
Recommended Merger of Xenova Group plc with Cantab Pharmaceuticals plc
The Boards of Xenova and Cantab today announce that they have agreed terms for
a recommended merger of their businesses.
Transaction Highlights
The Merger:
* Creates an Enlarged Group with one of the largest clinical development
pipelines within the European biopharmaceutical sector, with four product
candidates in Phase II and three in Phase I.
* Broadens and enhances the product portfolio with a key area of focus on
cancer, where both companies have substantial expertise and exciting
product opportunities.
* Brings together the complementary drug discovery and development skills
of the two companies with which to develop current and future drug
candidates.
* Establishes an Enlarged Group with a number of valuable partnerships
with major pharmaceutical companies and with the potential for more
partnerships to follow.
* Strengthens and broadens the experience of the management team.
* Values the Enlarged Group at #123.7 million based on the Closing Price
of Xenova Shares on 16 February 2001 on the assumption that the Merger
Offer is accepted in full.
Details of the Merger Offer
The Merger will be achieved through a recommended all share offer to be made
by Nomura, on behalf of Xenova, for all of the issued (and to be issued) share
capital of Cantab.
* The Merger Offer will be made on the basis of 11 New Xenova Shares for
every 7 Cantab Shares.
* The Merger Offer values each Cantab Share at approximately 140 pence and
the entire existing issued share capital of Cantab at #62.1 million
(before taking account of the exercise of any options under the Cantab
Share Option Schemes) based on the Closing Price of 89 pence per Xenova
Share on 16 February 2001, the business day immediately prior to the date
of this announcement.
* The Merger Offer represents a premium of 16.5 per cent. to the Closing
Price of 120 pence per Cantab Share on 16 February 2001 based on the
Closing Price of Xenova Shares on the same date.
* The Cantab Directors, who have been so advised by their financial
advisers, Credit Suisse First Boston, consider the terms of the Merger
Offer to be fair and reasonable. In providing its advice to the Cantab
Directors, Credit Suisse First Boston has taken into account the
commercial assessment of the Cantab Directors. Accordingly, the Cantab
Directors will be unanimously recommending Cantab Shareholders to accept
the Merger Offer, as they have undertaken to do in respect of their own
aggregate holdings of 196,006 Cantab Shares, representing approximately
0.44 per cent. of Cantab`s existing issued share capital.
* In view of its size, the Merger Offer is conditional, inter alia, on the
approval of Xenova Shareholders. The Xenova Directors, who have received
financial advice from Nomura in relation to the Merger Offer, consider the
Merger Offer to be in the best interests of the Xenova Shareholders as a
whole. In providing its advice to the Xenova Directors, Nomura has taken
into account the Xenova Directors` commercial assessment of the Merger.
Accordingly, the Xenova Directors will be unanimously recommending Xenova
Shareholders to vote in favour of the Merger Offer as they have undertaken
to do in respect of their own beneficial holdings of, in aggregate,
314,916 Xenova Shares, representing approximately 0.45 per cent. of
Xenova`s existing issued share capital.
Management
Following the Merger Offer becoming or being declared unconditional in all
respects, the executive directors of the Enlarged Group will be:
Name Position
David A Oxlade Chief Executive Officer
Nicholas L Hart* Commercial Director
Daniel Abrams Chief Financial Officer
Stephen C Inglis* Research Director
Michael Moore Chief Scientific Officer
John St Clair Roberts* Medical Director
John Waterfall Development Director
* Current Cantab Directors
John Jackson, Chairman of Xenova, will continue in his role as non-executive
Chairman. Simon Duffy, Chairman of Cantab, will join as non-executive Deputy
Chairman and Gerard Fairtlough will join as non-executive director from the
Cantab Board. Upon completion of the Merger, Paul Bevan will resign as a
non-executive director from the Xenova Board and Jeremy Curnock Cook and
Michael Redmond will resign as non-executive directors from the Cantab Board.
Commenting on the Merger, David Oxlade, Chief Executive Officer of Xenova,
said:
^The merger of our two companies creates a larger, stronger biotechnology
group with a broad pipeline of products in development and a number of
valuable partnerships with major pharmaceutical companies. Shareholders will
benefit from the improved risk-reward profile that comes through a broadening
and deepening of the product pipeline.^
Simon Duffy, Chairman of Cantab, commented:
^In announcing a strategic review in October 2000, we recognised the need for
consolidation in the industry. We believe that the merger with Xenova
represents good value for our shareholders and provides a foundation for the
further development of our pipeline, technologies and expertise.^
Nick Hart, Acting Chief Executive Officer of Cantab, added:
^The enlarged group brings together two companies with a joint focus on cancer
and complementary technologies in drug discovery, providing a foundation for
the continued development of innovative medicines with high commercial
potential.^
THIS SUMMARY SHOULD BE READ IN CONJUNCTION WITH THE FULL TEXT OF THE FOLLOWING
ANNOUNCEMENT ABOUT THE MERGER OFFER
A presentation for analysts will be held at the offices of Financial Dynamics,
Holborn Gate, 26 Southampton Buildings, London WC2A 1PB, at 9.30am today, 19
February 2001. Coffee will be available from 9.15am.
Please call Mo Noonan for further details on 020 7269 7116.
Enquiries:
Xenova David Oxlade Tel: 01753 706 600
Daniel Abrams Tel: 020 7831 3113 (Financial
Dynamics)
Hilary
Reid-Evans
Nomura David Porter Tel: 020 7521 2000
Cantab Nick Hart Tel: 01223 423 413
Andy Burrows Tel: 020 7831 3113 (Financial
Dynamics)
Tel: 01223 436 503
Credit Suisse First Chris Lloyd Tel: 020 7888 1000
Boston Stephanie
Leouzon
Asim Mullick
Financial Dynamics David Yates Tel: 020 7831 3113
Nomura, which is regulated in the United Kingdom by The Securities and Futures
Authority Limited, is acting for Xenova and no one else in connection with the
Merger Offer and will not be responsible to anyone other than Xenova for
providing the protections afforded to customers of Nomura, or for providing
advice in relation to the Merger Offer or the New Xenova Shares.
Credit Suisse First Boston, which is regulated in the United Kingdom by The
Securities and Futures Authority Limited, is acting for Cantab and no one else
in connection with the Merger Offer and will not be responsible to anyone
other than Cantab for providing the protections afforded to customers of
Credit Suisse First Boston, or for providing advice in relation to the Merger
Offer.
This announcement does not constitute an offer or an invitation to purchase
any securities.
This announcement does not constitute an offer of securities for sale in the
United States and the New Xenova Shares have not been, and will not be,
registered under the United States Securities Act of 1933, as amended, nor
under any laws of any state of the United States, and the relevant clearances
have not been and will not be obtained from the relevant authorities in
Canada, Australia or Japan. Accordingly, New Xenova Shares may not be offered,
sold or delivered, directly or indirectly, in or into the United States,
Canada, Australia or Japan except pursuant to exemptions from applicable
requirements of such jurisdictions.
The Merger Offer will not be made, directly or indirectly, in or into, by use
of mails or any means of instrumentality (including, without limitation,
facsimile transmissions, telex, telephone or e-mail) of interstate or foreign
commerce of, or any facilities of a securities exchange of, the United States
nor is it being made in or into Canada, Australia, or Japan and the Merger
Offer will not be capable of acceptance by any such use, means,
instrumentality or facilities or from or within the United States, Canada,
Australia or Japan. Accordingly, copies of this press announcement are not
being, and must not be, mailed or otherwise distributed or sent in, into or
from the United States, Canada, Australia or Japan and persons receiving this
press announcement (including custodians, nominees and trustees) must not
distribute or send it in, into or from the United States, Canada, Australia or
Japan.
Appendix 3 contains the definitions and a glossary of terms used in this
announcement.
Not for release, distribution or publication in or into the United States,
Canada, Australia or Japan
Recommended Merger of Xenova Group plc with Cantab Pharmaceuticals plc
1. Introduction
The Boards of Xenova and Cantab today announce that they have agreed terms for
a proposed merger of their businesses. The Merger will be achieved through a
recommended all share offer to be made by Nomura, on behalf of Xenova, for all
of the issued (and to be issued) share capital of Cantab.
The Merger Offer will be made on the basis of 11 New Xenova Shares for every 7
Cantab Shares and so in proportion for any other number of Cantab Shares held.
The Merger Offer will value each Cantab Share at approximately 140 pence and
the entire existing issued share capital of Cantab at #62.1 million (based on
the Closing Price of 89 pence per Xenova Share on 16 February 2001 (the
business day immediately prior to this announcement)).
2. Recommendation and undertakings
The Cantab Directors, who have been so advised by their financial
advisers, Credit Suisse First Boston, consider the terms of the Merger
Offer to be fair and reasonable. In providing its advice to the Cantab
Directors, Credit Suisse First Boston has taken into account the
commercial assessment of the Cantab Directors.
Accordingly, the Cantab Directors will be unanimously recommending Cantab
Shareholders to accept the Merger Offer, as they have undertaken to do in
respect of their own aggregate holdings of 196,006 Cantab Shares,
representing approximately 0.44 per cent. of Cantab`s existing issued
share capital.
The Xenova Directors, who have received financial advice from Nomura in
relation to the Merger Offer, consider the Merger Offer to be in the best
interests of Xenova Shareholders as a whole. In providing its advice to
the Xenova Directors, Nomura has taken into account the Xenova Directors`
commercial assessment of the Merger.
Given its size, the Merger Offer is conditional, inter alia, upon the
approval of Xenova Shareholders.
The Xenova Directors will be unanimously recommending Xenova Shareholders
to vote in favour of the resolutions necessary to effect the Merger Offer
as they have undertaken to do in respect of their own beneficial holdings
of, in aggregate, 314,916 Xenova Shares, representing approximately 0.45
per cent. of Xenova`s existing issued share capital.
3. Merger Offer
On behalf of Xenova, Nomura will offer to acquire, subject to the
conditions and further terms set out in Appendix 1 of this announcement
and to be set out in the Offer Document and Form of Acceptance, all the
Cantab Shares on the following basis:
For every 7 Cantab Shares 11 New Xenova Shares
and so in proportion for any other number of Cantab Shares held.
On the basis of the Closing Price of 89 pence per Xenova Share on 16
February 2001 (the business day immediately prior to the date of this
announcement), the Merger Offer values each Cantab Share at approximately
140 pence and the entire existing issued share capital of Cantab at #62.1
million. Based on the Closing Price of Xenova Shares on that date, the
Merger Offer represents a premium of 16.5 per cent. over the Closing Price
of 120 pence per Cantab Share on the same date and a premium of 52.0 per
cent. over the Closing Price of 92 pence per Cantab Share on 31 October
2000, the day before Cantab announced it had received a number of
approaches that might or might not lead to the sale or merger of Cantab.
Full acceptance of the Merger Offer (without taking into account the
exercise of any options under the Cantab Share Option Schemes) would
result in the issue of 69.8 million New Xenova Shares to Cantab
Shareholders, representing 50.2 per cent. of the enlarged issued ordinary
share capital of Xenova.
The Merger Offer will extend to all Cantab Shares unconditionally allotted
or issued as at the date on which the Merger Offer is made and any further
Cantab Shares unconditionally allotted or issued while the Merger Offer
remains open for acceptance.
The Cantab Shares that are the subject of the Merger Offer will be
acquired by Xenova fully paid and free from all liens, charges,
encumbrances, rights of pre-emption and any other third party rights of
any nature whatsoever and together with all rights attaching thereto,
including the right to receive all dividends and other distributions (if
any), declared, made or paid after the date of this announcement. The
Cantab Board has not declared or recommended any dividends since
incorporation.
The New Xenova Shares to be issued pursuant to the Merger Offer will be
issued credited as fully paid and will rank pari passu in all respects
with the existing Xenova Shares.
4. Reasons for and benefits of the Merger
Both the Xenova Directors and the Cantab Directors believe that the Enlarged
Group created by the Merger will have enhanced prospects of introducing
commercially important new drugs to the healthcare market. Key features of the
Enlarged Group will include: a significant portfolio of potential
first-in-class and innovative products, including seven products in clinical
development; valuable partnerships with major pharmaceutical companies
including Celltech, Eli Lilly, GlaxoSmithKline and Pfizer, with the potential
for further collaborations in the current year; strong drug discovery and
development capabilities in both the biopharmaceutical and medicinal chemistry
fields; and a significantly strengthened proprietary technology base.
The Enlarged Group will have the benefit of an internationally experienced
management team to drive the focus and development of the extended portfolio
of programmes. The proposed combined management team has a proven track record
in identifying, developing and partnering innovative products and
technologies.
The Xenova Directors and the Cantab Directors believe that the expanded
product pipeline and broader technology platform of the Enlarged Group will
increase the chances of successfully bringing new products to market and
reduce the overall risk profile, thereby increasing the potential to unlock
inherent values within Xenova and Cantab. Furthermore, the Merger will create
a broader shareholder base that should ensure greater liquidity and therefore
promote a broader level of interest in the equity of the Enlarged Group.
A broad range of potential first-in-class and innovative products
The principal therapeutic areas of focus for the Enlarged Group will be
cancer, infectious diseases and addiction, with both companies combining their
expertise in the area of cancer where each company has a number of exciting
product opportunities. The Enlarged Group will have one of the largest
clinical pipelines among public companies within the European
biopharmaceutical sector, with four product candidates in Phase II and three
in Phase I, and a further five in pre-clinical development. Of particular
importance is the potential for the Enlarged Group to bring product candidates
into Phase III registration clinical trials through the involvement of
corporate partners for late stage development and commercialisation. Details
of the Enlarged Group`s product candidates are outlined in paragraph 5 below.
Strong drug discovery and development capabilities
The Xenova Directors and the Cantab Directors consider that the two companies
have highly complementary research and development skill sets. Xenova has
significant expertise in the discovery and clinical development of small
molecule drug candidates and has capabilities in the areas of bioinformatics,
medicinal chemistry and computer modelling. Cantab has strengths in the areas
of virology, immunology and gene therapy. The Enlarged Group will therefore
have an enhanced range of technologies with which to develop its current and
future products. It will also benefit from important relationships established
by both companies with leading academic centres and institutions in their
respective fields, providing access to expertise, new intellectual property
and new product opportunities.
Research and development for the Enlarged Group`s programmes will be located
within state-of-the-art facilities in Slough and Cambridge, with 163 employees
involved in areas including research and development, medical, quality
assurance, quality control and manufacturing.
Corporate partnerships
The Enlarged Group intends to continue the corporate collaborations of each of
Xenova and Cantab with their existing partners, Celltech, Eli Lilly,
GlaxoSmithKline and Pfizer. The Xenova Directors and the Cantab Directors
expect that the Enlarged Group has the potential to enter into further
partnerships with these and other pharmaceutical companies for the further
development and commercialisation of products that each company is currently
developing.
Financial position
Xenova and Cantab on a combined basis had cash and liquid investments of #27.5
million as at 31 December 2000 (before taking into account any merger costs).
In addition, Cantab received #5.75 million in January 2001 from
GlaxoSmithKline arising from the regulatory requirement by the US Federal
Trade Commission for GlaxoSmithKline to return the prophylactic rights to the
DISC-PRO programme following the merger of GlaxoWellcome plc with SmithKline
Beecham plc. The financial position of the Enlarged Group may also benefit
during 2001 from the exercise of the Xenova Warrants (exercisable at 85 pence
per Xenova Share) which, if fully exercised, would raise additional funds of #
9.8 million during the period to 31 October 2001. It may also benefit from any
upfront payments from the licensing of existing programmes.
As an additional benefit of the Merger, the Xenova Directors and the Cantab
Directors anticipate cost efficiencies by eliminating duplication from the
combined infrastructure.
5. Enlarged Group`s products
The Enlarged Group will focus on the therapeutic areas of cancer, infectious
diseases and addiction. The principal clinical development programmes,
including those expected to enter clinical trials during 2001, in each of
these therapeutic areas are described below:
Cancer
* XR9576 (P-gp MDR inhibitor) is potentially a first-in-class drug to
combat multi-drug resistance in cancer. The Xenova Directors expect that a
corporate partnership agreement to fund Phase III clinical trials as well
as the marketing of this product will be entered into during 2001.
* TA-HPV (Vaccinia vector HPV 16/18 vaccine) is an immunotherapeutic
vaccine, consisting of a live recombinant vaccinia virus, designed to
prevent the recurrence of cervical cancer. This vaccine is currently in
Phase II clinical trials.
* TA-CIN (HPV16 fusion protein vaccine) is a recombinant fusion protein,
derived from the HPV16 protein, designed as a treatment for women with
cervical dysplasia. Phase I clinical trials have been completed.
* DISC-GMCSF (DISC vectored GMCSF immunotherapeutic) is an
immunotherapeutic vaccine comprising a DISC-HSV vector expressing human
GMCSF. It is designed as a treatment for a broad range of solid tumours
and is currently in Phase I clinical trials.
* XR 11576 (Dual topoisomerase I/II inhibitor) a second generation
intravenous and oral cytotoxic drug candidate and XR5944 (Dual
topoisomerase I/II inhibitor), a second generation intravenous drug
candidate, one of which is expected to enter Phase I/II clinical trials
during 2001. This replaces the first generation candidate, XR5000, which
failed to demonstrate competitive efficacy in an initial Phase II clinical
trial. No further work on XR5000 is planned.
Infectious diseases
* TA-HSV (Herpes simplex therapeutic vaccine) is a vaccine designed for
the treatment of recurrent genital herpes and is in Phase II clinical
trials with partner GlaxoSmithKline.
* DISC-PRO (Herpes simplex prophylactic vaccine) is a prophylactic vaccine
designed to prevent genital and oro-labial herpes. Phase I clinical trials
are complete and preparations are under way for a clinical immunogenicity
study and Phase III registration studies for which the Xenova Directors
and the Proposed Directors intend to identify a corporate partner.
Addiction
* TA-CD (Cocaine conjugate vaccine) is a vaccine for the treatment of
cocaine addiction for which a Phase IIa clinical trial, supported by NIDA,
has been completed. Results from recently completed toxicology and
clinical studies are due to be submitted to the FDA in the near future and
further Phase II studies are expected to commence later in the current
year.
* TA-NIC (Nicotine conjugate vaccine) is a vaccine designed as a treatment
for nicotine dependence. Phase I clinical trials are scheduled to begin in
2001.
Other programmes
The Enlarged Group will also have a strong pipeline of earlier stage product
programmes and technologies to progress to clinical development or with which
to form corporate partnerships. These include:
* OX40/OX40L - a platform for the creation of multiple product candidates
targeting cancer and autoimmune disease. A partnership has already been
established with Celltech to develop an antibody-based product against
OX40 for treatment of autoimmune disease.
* DISC Vaccine technology - applicable to multiple disease targets. A
product candidate for prevention of bovine herpes (DISC-BHV) is in
development in partnership with Pfizer.
* PAI-1 inhibitor technology - a platform for the development of drugs
targeting cancer and cardiovascular disease. Research in the
cardiovascular area is being carried out in collaboration with Eli Lilly.
* VP22 technology - a novel technology for enhancing delivery of
gene-based therapeutics, being developed under a joint venture, Phogen
Limited, with Marie Curie Cancer Care.
6. Information on Xenova
Xenova is a biopharmaceutical company based in Slough with approximately
60 employees, specialising in the discovery and development of novel drugs
in which it creates and retains ownership of the intellectual property.
Xenova`s key area of focus is the development of novel cancer drugs that
address clear unmet clinical needs and offer attractive commercial
opportunities. Xenova currently has one key product in clinical
development, which is designed to address the problems of multi-drug
resistance in cancer. Xenova is currently in discussions with a number of
potential corporate partners with the intention of funding the product
candidate through Phase III clinical trials and into sales and marketing.
Xenova has a further five products at the preclinical and research stages
involving cancer projects targeting MRP-related multi-drug resistance,
topoisomerase inhibitors, telomerase and PAI-1, as well as a drug
development agreement with Eli Lilly, based on small molecule inhibitors
of PAI-1, to develop novel antithrombotic drugs for chronic use. Xenova
has a total of 54 granted patents and a further 100 individual patent
applications.
Xenova has the ability to access new targets for drug screening and lead
identification research through collaborations with various academic
research centres and by utilising its own diverse synthetic small molecule
library.
Xenova seeks to commercialise its development products through partnering
with major pharmaceutical companies. It considers the optimal timing for
partnering on a project by project basis following an assessment of the
scientific and commercial risks and returns for each individual project.
However, in general, a licensing partner will be sought to assist with the
Phase III trials and to take on the marketing and distribution.
Xenova announces its unaudited preliminary results for the year ended 31
December 2000 today. For the year ended 31 December 2000, Xenova incurred
a loss on ordinary activities before taxation and R&D tax credits of #10.0
million (1999: #10.1 million) and as at that date had net assets of #11.9
million (1999: #11.6 million) and cash and liquid investments of #12.2
million (1999: #10.1 million).
7. Information on Cantab
Cantab is a biotechnology company based in Cambridge with over 130
employees, focused on the development of novel human biopharmaceuticals
using its innovative expertise in vaccines, immunotherapy and gene
delivery.
Cantab currently has six products in clinical development and a further
seven at the preclinical and research stages. These products fall into the
categories of vaccines (prophylactic and therapeutic), immunotherapeutics
and gene therapeutics. Cantab`s product portfolio addresses areas of high
unmet clinical need and significant commercial potential, such as
infectious disease, cancer and drug addiction. In addition, Cantab has
developed novel proprietary platform technologies for vaccine construction
and gene therapy and through Phogen Limited, its joint venture with Marie
Curie Cancer Care, for enhanced gene and drug delivery. This product and
technology pipeline is supported by a strong intellectual property
portfolio with 66 patents granted and a further 134 individual patent
applications.
Cantab also operates a pilot plant for manufacture of clinical grade
material that has capacity available for contract manufacturing for other
biotechnology companies without such facilities.
Cantab announces its unaudited preliminary results for the year ended 31
December 2000 today. For the year ended 31 December 2000, Cantab incurred
a loss on ordinary activities before taxation and R&D tax credits of #5.1
million (1999: #8.7 million) and as at that date had net assets of #28.4
million (1999: #31.7 million) and cash and liquid investments of #15.3
million (1999: #26.1 million).
8. Directors, management and employees
Following the Merger Offer becoming or being declared unconditional in all
respects, the board of the Enlarged Group will be:
Non-executives
John BH Jackson Chairman
Simon P Duffy* Deputy Chairman
Gerard H Fairtlough* Non-executive Director
Peter L Gillett Non-executive Director
Adrian L Harris Non-executive Director
T Ronald Irwin Non-executive Director
Howard S Wachtler Non-executive Director
Executives
David A Oxlade Chief Executive Officer
Nicholas L Hart* Commercial Director
Daniel Abrams Chief Financial Officer
Stephen C Inglis* Research Director
Michael Moore Chief Scientific Officer
John St Clair Roberts* Medical Director
John Waterfall Development Director
*Proposed Directors who will join the Xenova Board from Cantab upon the
Merger Offer becoming or being declared wholly unconditional in all
respects
Upon the Merger Offer becoming or being declared unconditional in all
respects, Paul Bevan will resign as a non-executive director from the
Xenova Board and Jeremy Curnock Cook and Michael Redmond will resign as
non-executive directors from the Cantab Board.
The Proposed Directors will join the Xenova Board upon the Merger Offer
becoming or being declared wholly unconditional in all respects. It is
currently anticipated that shortly after Nicholas Hart, Stephen Inglis and
John St Clair Roberts are appointed to the Xenova Board, their respective
basic annual salaries will be adjusted to #140,000, #120,000 and #115,000
respectively, and that each will be entitled to a bonus of up to 40 per
cent. of his basic salary. Otherwise it is intended that the current terms
of service of the Proposed Directors will not be changed significantly
upon their appointment to the Xenova Board, although these arrangements
will be reviewed after such appointment and where appropriate salary and
benefits arrangements may be altered to integrate them appropriately into
the Xenova Board structure.
The Xenova Directors and the Proposed Directors have confirmed that the
existing employment rights, including the pension rights, of all
management and employees of Cantab will be fully safeguarded following
completion of the Merger.
9. Cantab Share Option Schemes
All options under the Cantab Share Option Schemes will become exercisable
once the Merger Offer becomes or is declared unconditional in all
respects.
Optionholders who decide to exercise their options will be able to accept
the Merger Offer (while it remains open for acceptance) in respect of the
Cantab Shares they receive on exercise. However, it may not be in the
interests of all Cantab optionholders to exercise their options, depending
on the relevant option exercise price and the value of the Xenova Shares.
Xenova will write to Cantab optionholders in more detail on this subject
in due course.
10. Settlement, listing and dealing
Application will be made for the New Xenova Shares to be admitted to the
Official List and to be admitted to trading on the London Stock Exchange`s
market for listed securities. It is expected that listing will become
effective and that dealings, for normal settlement, will begin on the
first business day following the day on which the Merger Offer becomes or
is declared unconditional in all respects (save for any condition relating
to admission to the Official List).
After the Merger Offer becomes or is declared unconditional in all
respects, Xenova intends to procure the making of an application by Cantab
to delist the Cantab Shares from the Official List. It is anticipated that
such cancellation will take effect no earlier than 20 business days after
the Merger Offer becomes or is declared unconditional in all respects.
If Xenova receives acceptances under the Merger Offer in respect of, and/
or otherwise acquires, 90 per cent. or more of the Cantab Shares to which
the Merger Offer relates, Xenova will exercise its rights pursuant to the
provisions of sections 428 to 430F of the Companies Act 1985 to acquire
compulsorily the remaining Cantab Shares to which the Merger Offer
relates.
Certificates for New Xenova Shares to be issued to Cantab Shareholders and
cheques in respect of fractional entitlements will be despatched no later
than 14 days after the Merger Offer becomes or is declared unconditional
in all respects. No certificates for New Xenova Shares will be issued in
respect of the entitlements of those Cantab Shareholders who hold their
shares in uncertificated form in CREST, settlement for which will be made
through the applicable CREST procedure (unless Xenova decides otherwise).
Further details on settlement, listing and dealing will be included in the
formal documents to be sent to Cantab Shareholders and Xenova Shareholders
in due course.
11. Overseas shareholders
The availability of the Merger Offer to persons not resident in the UK may
be affected by the laws of the relevant jurisdictions. In particular, the
Merger Offer will not be made, directly or indirectly, in or into the
United States, Canada, Australia or Japan. Cantab Shareholders who are not
resident in the UK should inform themselves about and observe any
applicable requirements.
Further details in relation to overseas shareholders will be contained in
the Offer Document.
12. General
Save for the irrevocable undertakings obtained from Cantab Directors referred
to in paragraph 2 above of this announcement, neither Xenova, nor any of its
directors, nor, so far as Xenova is aware, any person deemed to be acting in
concert with it, owns or controls any Cantab Shares or has any option to
acquire any Cantab Shares, or has entered into any derivative referenced to
securities of Cantab which remains outstanding. However, it has not been
possible to ascertain holdings of certain parties who may be deemed to be
acting in concert with Xenova for the purposes of the Merger Offer in respect
of Cantab Shares. Any such holdings would be included in the Offer Document.
The formal Offer Document, setting out full details of the Merger Offer,
together with Listing Particulars and a Form of Acceptance, will be posted to
Cantab Shareholders as soon as practicable. The Offer Document and the Listing
Particulars will also be despatched to Cantab optionholders for information
only. A circular containing a notice convening an Extraordinary General
Meeting of Xenova Shareholders to approve the Merger, together with the
Listing Particulars (and the Offer Document for information only), will be
despatched at the same time to Xenova Shareholders and to Xenova optionholders
and warrantholders for information only.
Enquiries:
Xenova David Oxlade Tel: 01753 706 600
Daniel Abrams Tel: 020 7831 3113 (Financial
Dynamics)
Hilary
Reid-Evans
Nomura David Porter Tel: 020 7521 2000
Cantab Nick Hart Tel: 01223 423 413
Andy Burrows Tel: 020 7831 3113 (Financial
Dynamics)
Tel: 01223 436 503
Credit Suisse First Chris Lloyd Tel: 020 7888 1000
Boston
Stephanie
Leouzon
Asim Mullick
Financial Dynamics David Yates Tel: 020 7831 3113
Nomura, which is regulated in the United Kingdom by The Securities and Futures
Authority Limited, is acting for Xenova and no one else in connection with the
Merger Offer and will not be responsible to anyone other than Xenova for
providing the protections afforded to customers of Nomura, nor for providing
advice in relation to the Merger Offer or the New Xenova Shares.
Credit Suisse First Boston, which is regulated in the United Kingdom by The
Securities and Futures Authority Limited, is acting for Cantab and no one else
in connection with the Merger Offer and will not be responsible to anyone
other than Cantab for providing the protections afforded to customers of
Credit Suisse First Boston, or for providing advice in relation to the Merger
Offer.
This announcement does not constitute an offer or an invitation to purchase
any securities.
This announcement does not constitute an offer of securities for sale in the
United States and the New Xenova Shares have not been, and will not be,
registered under the United States Securities Act of 1933, as amended, nor
under any laws of any state of the United States, and the relevant clearances
have not been and will not be obtained from the relevant authorities in
Canada, Australia or Japan. Accordingly, New Xenova Shares may not be offered,
sold or delivered, directly or indirectly, in or into the United States,
Canada, Australia or Japan except pursuant to exemptions from applicable
requirements of such jurisdictions.
The Merger Offer will not be made, directly or indirectly, in or into, by use
of mails or any means of instrumentality (including, without limitation,
facsimile transmissions, telex, telephone or e-mail) of interstate or foreign
commerce of, or any facilities of a securities exchange of, the United States
nor is it being made in or into Canada, Australia, or Japan and the Merger
Offer will not be capable of acceptance by any such use, means,
instrumentality or facilities or from or within the United States, Canada,
Australia or Japan. Accordingly, copies of this press announcement are not
being, and must not be, mailed or otherwise distributed or sent in, into or
from the United States, Canada, Australia or Japan and persons receiving the
press announcement (including custodians, nominees and trustees) must not
distribute or send it in, into or from the United States, Canada, Australia or
Japan.
Appendix 3 contains the definitions and glossary of terms used in the
announcement.
Part 2
APPENDIX 1
CONDITIONS OF THE MERGER OFFER
The Merger Offer will comply with the rules and regulations of the City Code,
the UKLA and the London Stock Exchange and will be subject to the following
conditions:
a. valid acceptances being received (and not, where permitted, withdrawn) by
not later than 3.00 p.m. (London time) on the first closing date of the
Merger Offer (or such later time(s) and/or date(s) as Xenova may, subject
to the rules of the City Code, decide) in respect of not less than 90 per
cent. (or such lower percentage as Xenova may decide) in nominal value of
the Cantab Shares to which the Merger Offer relates, provided that this
condition will not be satisfied unless Xenova and/or its wholly owned
subsidiaries shall have acquired or agreed to acquire (whether pursuant to
the Merger Offer or otherwise) Cantab Shares carrying in aggregate more
than 50 per cent. of the voting rights then normally exercisable at a
general meeting of Cantab, including for this purpose (except to the
extent otherwise agreed by the Panel) any such voting rights attaching to
any Cantab Shares that are unconditionally allotted or issued before the
Merger Offer becomes or is declared unconditional as to acceptances,
whether pursuant to the exercise of any outstanding subscription or
conversion rights or otherwise; and for this purpose:
i. the expression ^Cantab Shares to which the Merger Offer relates^ shall
be construed in accordance with sections 428 to 430F of the Companies
Act 1985, and
ii. Cantab Shares which have been unconditionally allotted but not issued
shall be deemed to carry the voting rights which they will carry upon
issue;
b. the passing at an extraordinary general meeting of Xenova (or any
adjournment thereof) of an ordinary resolution or ordinary resolutions to
approve, implement and effect the Merger Offer and the acquisition of any
Cantab Shares pursuant to the Merger Offer or otherwise;
c. the admission to the Official List of the New Xenova Shares (or such of
them as are due to be allotted at the time the Merger Offer becomes or is
declared unconditional in all other respects) becoming effective in
accordance with the Listing Rules and the admission of such shares to
trading on the London Stock Exchange`s market for listed securities
becoming effective or (if determined by Xenova and subject to the consent
of the Panel) the UKLA agreeing to admit such shares to the Official List
and the London Stock Exchange agreeing to admit such shares to trading
subject only to (i) the allotment of such shares and/or (ii) the Merger
Offer becoming or being declared unconditional in all respects;
d. no Third Party having intervened in any way and there not continuing to be
outstanding any statute, regulation, order or decision of any Third Party
in each case which would or might be reasonably likely (in any case to an
extent which is material in the context of the Xenova Group or the Cantab
Group, as the case may be, taken as a whole) to:
i. make the Merger Offer, its implementation or the acquisition or
proposed acquisition by Xenova of any shares or other securities in,
or control of, Cantab or any member of the Cantab Group void, illegal
or unenforceable in any jurisdiction, or otherwise directly or
indirectly restrain, prevent, prohibit, restrict or delay the same or
impose additional conditions or obligations with respect to the Merger
Offer or such acquisition, or otherwise materially challenge or
interfere with the Merger Offer or such acquisition, or require
material amendment to the terms of the Merger Offer or the acquisition
or proposed acquisition of any Cantab Shares or of control by Xenova
of Cantab or any member of the Cantab Group;
ii. require or prevent the divestiture by Xenova of any shares or other
securities in any member of the Cantab Group;
iii. require, prevent or delay the divestiture or alter the terms
envisaged for any proposed divestiture by any member of the Xenova
Group or by any member of the Cantab Group of all or any material
portion of their respective businesses, assets or properties or impose
any material limitation on the ability of any of them to conduct any
of their respective businesses or to own or control any of their
respective assets or properties or any material part thereof;
iv. require any member of the Xenova Group or of the Cantab Group to
acquire, or to offer to acquire, any shares or other securities (or
the equivalent) in any member of either group owned by any third
party;
v. impose any material limitation on the ability of any member of the
Xenova Group or of the Cantab Group to conduct or integrate or
co-ordinate its business, or any part of it, with the businesses or
any part of the businesses of any other member of the Xenova Group or
of the Cantab Group;
vi. result in any member of the Cantab Group or the Xenova Group ceasing
to be able to carry on business under any name under which it
presently does so; or
vii. otherwise adversely affect the business, assets, profits, financial
or trading position or prospects of any member of the Cantab Group or
of the Xenova Group,
and all applicable waiting and other time periods during which any Third
Party could have intervened under the laws of any jurisdiction having
expired, lapsed or been terminated;
e. the Office of Fair Trading or any relevant institute in the United Kingdom
not having indicated that it is the intention of the Secretary of State
for Trade and Industry to refer the proposed acquisition of Cantab by
Xenova to the Competition Commission;
f. in any case to an extent which is material in the context of the Xenova
Group or the Cantab Group, as the case may be, as a whole, all
notifications and filings which are necessary having been made, all
appropriate waiting and other time periods (including any extensions of
such waiting and other time periods) under any applicable legislation or
regulation of any jurisdiction having expired, lapsed or been terminated
(as appropriate) and all statutory or regulatory obligations in any
jurisdiction having been complied with in each case in connection with the
Merger Offer, the Merger, or the acquisition or proposed acquisition of
any shares or other securities in, Cantab or the control of Cantab or any
other member of the Cantab Group by Xenova or the carrying on by any
member of the Cantab Group of its business;
g. all Authorisations which are necessary or are reasonably considered
necessary or appropriate by Xenova in any jurisdiction for or in respect
of the Merger Offer, the Merger or the acquisition or proposed acquisition
of any shares or other securities in Cantab, or the acquisition of control
of any member of the Cantab Group by, Xenova or the carrying on by any
member of the Cantab Group of its business having been obtained, in terms
and in a form satisfactory to Xenova, from all appropriate Third Parties
or from any persons or bodies with whom any member of the Cantab Group has
entered into contractual arrangements, in each case where the absence of
such Authorisation would have a material adverse effect on the Cantab
Group taken as a whole, and all such Authorisations remaining in full
force and effect and there being no notice or intimation of any intention
to revoke, suspend, restrict, modify or not to renew any of the same;
h. except as disclosed in Cantab`s annual report and accounts for the year
ended 31 December 1999 or in Cantab`s preliminary results for the year
ended 31 December, 2000 as announced on 19 February 2001 or as otherwise
publicly announced by Cantab (by the delivery of an announcement to the
Company Announcements Office of the London Stock Exchange) prior to 16
February 2001 or as fairly disclosed to Xenova by or on behalf of Cantab
prior to 16 February 2001, there being no provision of any arrangement,
agreement, licence, permit, franchise or other instrument to which any
member of the Cantab Group is a party, or by or to which any such member
or any of its assets is or are or may be bound, entitled or subject or any
circumstance, which, in each case as a consequence of the Merger Offer,
the Merger or the acquisition or proposed acquisition of any shares or
other securities in, Cantab or the acquisition of control of any member of
the Cantab Group by Xenova or otherwise, or could or might reasonably be
expected to result in, (in any case to an extent which is material in the
context of the Cantab Group taken as a whole):
i. any monies borrowed by or any other indebtedness or liabilities (actual
or contingent) of, or any grant available to, any member of the Cantab
Group being or becoming repayable or capable of being declared
repayable immediately or prior to its stated repayment date or the
ability of any member of the Cantab Group to borrow monies or incur
any indebtedness being withdrawn or inhibited or becoming capable of
being withdrawn;
ii. the creation or enforcement of any mortgage, charge or other security
interest over the whole or any part of the business, property, assets
or interests of any member of the Cantab Group or any such mortgage,
charge or other security interest (wherever created, arising or having
arisen) becoming enforceable;
iii. any such arrangement, agreement, licence, permit, franchise or
instrument, or the rights, liabilities, obligations or interests of
any member of the Cantab Group thereunder, being, or becoming capable
of being, terminated or materially and adversely modified or affected
or any adverse action being taken or any onerous obligation or
liability arising thereunder;
iv. any asset or interest of any member of the Cantab Group being or
falling to be disposed of or ceasing to be available to any member of
the Cantab Group or any right arising under which any such asset or
interest could be required to be disposed of or could cease to be
available to any member of the Cantab Group otherwise than in the
ordinary course of business;
v. any member of the Cantab Group ceasing to be able to carry on business
under any name under which it presently does so;
vi. the rights, liabilities, obligations or interests of any member of the
Cantab Group under any such arrangement, agreement, licence, permit,
franchise or other instrument or the interests or business of any such
member in or with any other person, firm, company or body (or any
arrangement or arrangements relating to any such interests or
business) being terminated, or materially and adversely modified or
affected; or
vii. the financial or trading position or the prospects or the value of
any member of the Cantab Group being prejudiced or adversely affected,
and no event having occurred which, under any provision of any such
arrangement, agreement, licence, permit or other instrument, could result
in any of the events or circumstances which are referred to in paragraphs
(i) to (vii) of this condition (h) in any case to an extent which is or
would be material in the context of the Cantab Group taken as a whole;
i. since 31 December 1999 and except as disclosed in Cantab`s annual report
and accounts for the year then ended or in Cantab`s preliminary results
for the year ended 31 December, 2000 as announced on 19 February, 2001 or
as otherwise publicly announced by Cantab (by the delivery of an
announcement to the Company Announcements Office of the London Stock
Exchange) prior to 16 February, 2001 or as otherwise fairly disclosed to
Xenova by or on behalf of Cantab prior to 16 February, 2001 no member of
the Cantab Group having:
i. issued or agreed to issue, or authorised the issue of, additional
shares of any class, or securities convertible into or exchangeable
for, or rights, warrants or options to subscribe for or acquire, any
such shares or convertible securities other than as between Cantab and
wholly-owned subsidiaries of Cantab and other than any options granted
under any of the Cantab Share Option Schemes prior to 16 February,
2001 or any shares issued upon the exercise of any options granted
under any of the Cantab Share Option Schemes;
ii. purchased or redeemed or repaid any of its own shares or other
securities or reduced or made any other change to any part of its
share capital;
iii. recommended, declared, paid or made any bonus, dividend or other
distribution whether payable in cash or otherwise (other than to
Cantab or a wholly-owned subsidiary of Cantab);
iv. made or authorised or announced its intention to propose any change in
its loan capital;
v. (other than any acquisition or disposal in the ordinary course of
business or a transaction between Cantab and a wholly-owned subsidiary
of Cantab) merged with, demerged or acquired any body corporate,
partnership or business or acquired or disposed of or transferred,
mortgaged or charged or created any security interest over any assets
or any right, title or interest in any assets (including shares in any
undertaking and trade investments) or authorised, proposed or
announced its intention to do the same (which in any case is material
in the context of the Cantab Group taken as a whole);
vi. issued or authorised the issue of, or made any change in or to, any
debentures or (except in the ordinary course of business) incurred or
increased any indebtedness or liability (actual or contingent) which
in any case is material in the context of the Cantab Group taken as a
whole;
vii. entered into, varied, or authorised any agreement, transaction,
arrangement or commitment (whether in respect of capital expenditure
or otherwise) which:
A. is of a long term, onerous or unusual nature or magnitude or which
is or might reasonably be expected to involve an obligation of
such nature or magnitude; or
B. could materially restrict the business of any member of the Cantab
Group; or
C. is other than in the ordinary course of business,
and which in any case is material in the context of the Cantab Group
taken as a whole;
viii. entered into, implemented, effected or authorised any merger,
demerger, reconstruction, amalgamation, scheme, commitment or other
transaction or arrangement in respect of itself or another member of
the Cantab Group otherwise than in the ordinary course of business
which in any case is material in the context of the Cantab Group;
ix. entered into or varied the terms of, any contract, agreement or
arrangement with any of the directors of Cantab or, to an extent which
is material in the context of the Cantab Group taken as a whole, the
directors or senior executives of any member of the Cantab Group;
x. taken any corporate action or had any legal proceedings instituted or
threatened against it or order made for its winding-up (voluntarily or
otherwise), dissolution or reorganisation or for the appointment of a
receiver, administrator, administrative receiver, trustee or similar
officer of all or any part of its assets and revenues or any analogous
proceedings in any jurisdiction or appointed any analogous person in
any jurisdiction which in any case is material in the context of the
Cantab Group taken as a whole;
xi. been unable, or admitted in writing that it is unable, to pay its
debts or having stopped or suspended (or threatened to stop or
suspend) payment of its debts generally or ceased or threatened to
cease carrying on all or a substantial part of its business;
xii. waived or compromised any claim which is material in the context of
the Cantab Group taken as a whole;
xiii. made any alteration to its memorandum or articles of association
which is material in the context of the Merger Offer;
xiv. made or agreed or consented to any significant change to the terms of
the trust deeds constituting the pension schemes established for its
directors and/or employees and/or their dependants or to the benefits
which accrue, or the pensions which are payable thereunder, or to the
basis on which qualification for or accrual or entitlement to such
benefits or pensions are calculated or determined, or to the basis
upon which such liabilities (including pensions) of such pensions
schemes are funded or made, or agreed or consented to, any change to
the trustees, in each case which is material;
xv. entered into any agreement, commitment or arrangement or passed any
resolution or made any offer (which remains open for acceptance) or
announced any intention with respect to any of the transactions,
matters or events referred to in this condition (h) which is material
in the context of the Cantab Group taken as a whole;
j. since 31 December 1999 and except as disclosed in Cantab`s annual report
and accounts for the year then ended or in Cantab`s preliminary results
for the year ended 31 December, 2000 as announced on 19 February, 2001 or
as otherwise publicly announced by Cantab (by the delivery of an
announcement to the Company Announcements Office of the London Stock
Exchange) prior to 16 February, 2001 or as otherwise fairly disclosed to
Xenova by or on behalf of Cantab prior to 16 February, 2001:
i. there having been no adverse change or deterioration in the business,
assets, financial or trading positions or profit or prospects of any
member of the Cantab Group which in any case is material in the
context of the Cantab Group taken as a whole;
ii. no contingent or other liability of any member of the Cantab Group
having arisen or become apparent or increased which in any case is
material in the context of the Cantab Group taken as a whole;
iii. no litigation, arbitration proceedings, prosecution or other legal
proceedings (including patent proceedings and US patent interference
proceedings) to which any member of the Cantab Group is or may become
a party (whether as plaintiff, defendant or otherwise) having been
threatened, announced, implemented or instituted by or against or
remaining outstanding against or in respect of any member of the
Cantab Group which in any case is material in the context of the
Cantab Group taken as a whole; and
iv. (other than as a result of the Merger Offer) no enquiry or
investigation by, or complaint or reference to, any Third Party having
been threatened, announced, implemented, instituted by or against or
remaining outstanding against or in respect of any member of the
Cantab Group which in any case is material in the context of the
Cantab Group taken as a whole;
v. no circumstances having arisen which would entitle a third party to
take patent infringement proceedings against a member of the Cantab
Group which would be material in the context of the Cantab Group taken
as a whole;
vi. no material agreement to which any member of the Cantab Group is a
party and which would be material in the context of the Cantab Group
taken as a whole having been terminated by any other party to any such
agreement; or
k. Xenova not having discovered:
i. that any financial or business or other information concerning the
Cantab Group disclosed at any time (A) by or on behalf of any member
of the Cantab Group, whether publicly or in writing (including without
limitation information transmitted by facsimile, telex or e-mail) to
any member of the Xenova Group or its advisers or (B) in respect of
information relating to intellectual property, by or on behalf of any
member of the Cantab Group or its advisers, whether publicly or in
writing (including without limitation information transmitted by
facsimile, telex or e-mail) to any member of the Xenova Group or its
advisers or orally by telephone during a conference telephone call
convened at 4 p.m. on Monday 12 February, 2001 between Xenova and
certain of its professional advisers and Cantab and certain of its
professional advisers, is materially misleading or contains any
misrepresentation of fact or omits to state a fact necessary to make
any information contained therein not misleading and which was not
subsequently corrected before 16 February, 2001 by disclosure either
publicly or otherwise to Xenova, to an extent which in any case is
material in the context of the Merger Offer; or
ii. that any member of the Cantab Group is subject to any liability
(actual or contingent) except as disclosed in Cantab`s annual report
and accounts for the financial year ended 31 December 1999 or in
Cantab`s preliminary results for the year ended 31 December 2000 as
announced on 19 February 2001 or as otherwise publicly announced by
Cantab (by the delivery of an announcement to the Company Accountants
office of the London Stock Exchange prior to 16 February 2001) or
otherwise as fairly disclosed by or on behalf of, Cantab prior to 16
February, 2001 and which in any case is material in the context of the
Cantab Group taken as a whole;
l. Xenova not having discovered:
i. that save as fairly disclosed to Xenova by or on behalf of the Cantab
prior to 16 February, 2001 any past or present member of the Cantab
Group has not complied with any applicable legislation or regulations
of any jurisdiction with regard to the use, treatment, handling,
storage, transport, release, disposal, discharge, spillage, leak or
emission of any waste or hazardous substance or any substance likely
to impair the environment or harm human health, or otherwise relating
to environmental matters or the health and safety of any person, or
that there has otherwise been any such use, treatment, handling,
storage, transport, release, disposal, discharge, spillage, leak or
emission (whether or not this constituted a non-compliance by any
person with any legislation or regulations and wherever the same may
have taken place) which, in any case, would be likely to give rise to
any liability (whether actual or contingent) or cost on the part of
any member of the Cantab Group which in any case is material in the
context of the Cantab Group taken as a whole;
ii. that save as fairly disclosed to Xenova by or on behalf of Cantab
prior to 16 February, 2001 there is, or is likely to be, any
liability, whether actual or contingent, to make good, repair,
reinstate or clean up any property now or previously owned, occupied
or made use of by any past or present member of the Cantab Group or
any other property or any controlled waters under any environmental
legislation, regulation, notice, circular, order or other lawful
requirement of any relevant authority or third party or otherwise
which in any case is material in the context of the Cantab Group taken
as a whole; or
iii. save as fairly disclosed to Xenova by or on behalf of Cantab prior to
16 February, 2001 that circumstances exist whereby a person or class
of persons would be likely to have a claim in respect of any product
or process of manufacture or materials used therein now or previously
manufactured, sold or carried out by any past or present member of the
Cantab Group which is or would be material in the context of the
Cantab Group taken as a whole.
For the purpose of these conditions:
a. ^Third Party^ means any government, government department or governmental,
quasi-governmental, supranational, statutory, regulatory or investigative
body, authority (including any national anti-trust or merger control
authority), court, trade agency, association, institution or professional
or environmental body or any other person or body whatsoever in any
jurisdiction;
b. a Third Party shall be regarded as having
Erste Reaktionen auf die Fusion:
Im Blickpunkt des Anlegerinteresses am TechMark steht die Fusion des Pharmaunternehmens Xenova Group mit dem Branchenkollegen Cantab Pharmaceuticals, die Xenova einen Kurseinbruch von 12,9 Prozent auf 79,75 Euro beschert. Grund dafür sind die am Morgen veröffentlichten Details zum Geschäft. Cantab wird demnach mit einer Summe von 62,1 Millionen Pfund bewertet. Die Übernahme der Biotechgruppe wird über einen Aktientausch von jeweils 11 neu ausgegebenen Xenova-Aktien für 7 Cantab-Aktien (140 Pence) erfolgen. Cantab hat der Öffentlichkeit am Montagmorgen schrumpfende Verluste von 8,7 Millionen Pfund in 1999 auf 5,1 Millionen Pfund im vergangenen Jahr präsentiert. Das gemeinsame Unternehmen wird einen Wert von rund 124 Millionen Pfund haben. Die Cantab-Anteile geben um 1,7 Prozent auf 119 Pence nach.
(nachzulesen unter http://www.instock.de/topstory/artikel/index.jsp?153234
Im Blickpunkt des Anlegerinteresses am TechMark steht die Fusion des Pharmaunternehmens Xenova Group mit dem Branchenkollegen Cantab Pharmaceuticals, die Xenova einen Kurseinbruch von 12,9 Prozent auf 79,75 Euro beschert. Grund dafür sind die am Morgen veröffentlichten Details zum Geschäft. Cantab wird demnach mit einer Summe von 62,1 Millionen Pfund bewertet. Die Übernahme der Biotechgruppe wird über einen Aktientausch von jeweils 11 neu ausgegebenen Xenova-Aktien für 7 Cantab-Aktien (140 Pence) erfolgen. Cantab hat der Öffentlichkeit am Montagmorgen schrumpfende Verluste von 8,7 Millionen Pfund in 1999 auf 5,1 Millionen Pfund im vergangenen Jahr präsentiert. Das gemeinsame Unternehmen wird einen Wert von rund 124 Millionen Pfund haben. Die Cantab-Anteile geben um 1,7 Prozent auf 119 Pence nach.
(nachzulesen unter http://www.instock.de/topstory/artikel/index.jsp?153234
[/b]Kaufempfehlung am 28.03.2001 durch "The Times":[/b]
"It is quite conceivable that the new group will also deliver some juicy titbits of news in the coming months. A big licensing deal is expected soon for Xenova’s treatment, which helps to fight resistance to repeat chemotherapy. Results are also expected by the summer for Cantab’s treatment for herpes and a licensing partner could come forward to help the group with a vaccine for the same ailment. Trials of nicotine and cocaine addiction medicaments might also resume. Given the potential, Xenova’s shares look cheap. Buy."
Nachzulesen unter http://www.thetimes.co.uk/article/0,,38-105944,00.html
Weiter steht geschrieben:
Xenova/Cantab
XENOVA took the market by surprise when it said that it wanted to merge with Cantab Pharmaceuticals. However, the move does make sense. (Obwohl diese Fusion alle als absurd abgestempelt hatten)
Admittedly, the deal gets both companies out of holes. Xenova looked suspiciously like a one-product firm and was acutely vulnerable to testing failure. Cantab lost its way after product setbacks and loss of management. But the deal that unites them is more than opportunistic.
It creates a group with more size, and this, especially at this smaller end of the market, is important. It also gathers three approaches to cancer treatment under one roof. Alongside Xenova’s chemicals are Cantab’s antibodies and gene therapies. The combined group will have a pipeline of nine products in clinical trials, including five in cancer and two in infectious diseases.
The breadth of the portfolio helps to cut product risk and amalgamation of the balance sheets will pool resources, which totalled almost £28 million at the end of December.
"It is quite conceivable that the new group will also deliver some juicy titbits of news in the coming months. A big licensing deal is expected soon for Xenova’s treatment, which helps to fight resistance to repeat chemotherapy. Results are also expected by the summer for Cantab’s treatment for herpes and a licensing partner could come forward to help the group with a vaccine for the same ailment. Trials of nicotine and cocaine addiction medicaments might also resume. Given the potential, Xenova’s shares look cheap. Buy."
Nachzulesen unter http://www.thetimes.co.uk/article/0,,38-105944,00.html
Weiter steht geschrieben:
Xenova/Cantab
XENOVA took the market by surprise when it said that it wanted to merge with Cantab Pharmaceuticals. However, the move does make sense. (Obwohl diese Fusion alle als absurd abgestempelt hatten)
Admittedly, the deal gets both companies out of holes. Xenova looked suspiciously like a one-product firm and was acutely vulnerable to testing failure. Cantab lost its way after product setbacks and loss of management. But the deal that unites them is more than opportunistic.
It creates a group with more size, and this, especially at this smaller end of the market, is important. It also gathers three approaches to cancer treatment under one roof. Alongside Xenova’s chemicals are Cantab’s antibodies and gene therapies. The combined group will have a pipeline of nine products in clinical trials, including five in cancer and two in infectious diseases.
The breadth of the portfolio helps to cut product risk and amalgamation of the balance sheets will pool resources, which totalled almost £28 million at the end of December.
Xenova buy of Cantab declared wholly unconditional; claims 72.91 pct of Cantab
LONDON (AFX) - Xenova Group PLC said its recommended merger offer for Cantab Pharmaceuticals PLC has been declared unconditional in all respects.
Xenova said by April 5 it had received valid acceptances in respect of 32.4 mln Cantab shares, representing 72.91 pct of the share capital.
The offer will remain open for acceptance until further notice.
Gruß Bogo!
LONDON (AFX) - Xenova Group PLC said its recommended merger offer for Cantab Pharmaceuticals PLC has been declared unconditional in all respects.
Xenova said by April 5 it had received valid acceptances in respect of 32.4 mln Cantab shares, representing 72.91 pct of the share capital.
The offer will remain open for acceptance until further notice.
Gruß Bogo!
@Bogo:
Soll das nun heißen, daß der Deal nicht zustande kommen wird? Wieviel Prozent von Cantab müssen zustimmen?
Wenn der Deal in die Hosen gehen sollte, dann müßte eigentlich XENOVA rasant an Boden gewinnen!
Grüße
Panospana
Soll das nun heißen, daß der Deal nicht zustande kommen wird? Wieviel Prozent von Cantab müssen zustimmen?
Wenn der Deal in die Hosen gehen sollte, dann müßte eigentlich XENOVA rasant an Boden gewinnen!
Grüße
Panospana
Xenova is pleased to announce that, all of the conditions of the Merger Offer having been satisfied or waived, the Merger Offer is now declared unconditional in all respects (subject only to the New Xenova Shares being admitted to listing on the Official List of the UK Listing Authority and to trading on the London Stock Exchange’s market for listed securities, which is expected to commence at 8.00 a.m. on 9 April 2001).
By 3.00 p.m. on 5 April 2001, valid acceptances of the Merger Offer had been received in respect of 32,382,836 Cantab Shares, representing approximately 72.91 per cent. of the existing issued share capital of Cantab. The total number of acceptances includes acceptances in respect of 196,006 Cantab Shares (representing approximately 0.44 per cent. of the existing issued share capital of Cantab) which were the subject of irrevocable undertakings to accept the Merger Offer from Cantab Directors.
Settlement of the consideration to which Cantab Shareholders are entitled will be effected by 20 April 2001 in the case of valid acceptances already received, and within 14 days of receipt in the case of valid acceptances received after today’s date and while the Merger Offer remains open for acceptance.
The Merger Offer will remain open for acceptance until further notice. At least 14 days’ notice will be given before the Merger Offer is closed.
As stated in the Offer Document, Xenova will procure the cancellation of the listing of the Cantab Shares on the Official List and of trading in Cantab Shares on the London Stock Exchange’s market for listed securities. Such cancellation of listing and trading will take place on 9 May 2001.
As and when Xenova receives acceptances in respect of 90 per cent. in value of the Cantab Shares to which the Merger Offer relates, Xenova will seek to acquire compulsorily any outstanding Cantab Shares to which the Merger Offer relates pursuant to sections 428 to 430F of the Companies Act 1985.
Save as disclosed below, neither Xenova nor any person deemed to be acting in concert with it held any Cantab Shares or rights over Cantab Shares on 31 October 2000, the date immediately prior to the commencement of the Merger Offer Period. Save as disclosed herein, neither Xenova nor any person deemed to be acting in concert with it has acquired or agreed to acquire any Cantab Shares or rights over Cantab Shares since the Merger Offer Period commenced.
As at 31 October 2000, the last business day immediately prior to the commencement of the Merger Offer Period, Nomura, which is deemed to be acting in concert with Xenova, held 5,715 Cantab Shares (representing approximately 0.013 per cent. of the existing issued share capital of Cantab).
Simon Duffy, Gerard Fairtlough, Nicholas Hart, Stephen Inglis and John St Clair Roberts currently directors of Cantab, have today been appointed directors of Xenova. The resignation of Paul Bevan as a non-executive director of Xenova has also been accepted today.
Application has been made to the UK Listing Authority for up to 69,947,963 New Xenova Shares to be admitted to the Official List. Application has also been made to the London Stock Exchange for up to 69,947,963 New Xenova Shares to be admitted to trading on the London Stock Exchange’s market for listed securities. Admission of the New Xenova Shares to listing on the Official List and to trading on the London Stock Exchange’s market for listed securities is expected to become effective and dealings for normal settlement in New Xenova Shares are expected to commence at 8.00 a.m. on 9 April 2001.
Terms defined in the Offer Document dated 1 March 2001 have the same meaning in this announcement.
Tja, wer hilft da mal weiter? Wenn ich alles richtig verstanden habe sind 90 % angestrebt, wobei die Fusion allerdings eine sichere Sache zu sein scheint (Sorry, aber Börsenkenntnis und Englisch reichen nicht aus, um eine definitive Aussage meinerseits zu machen) .
Gruß Bogo!
By 3.00 p.m. on 5 April 2001, valid acceptances of the Merger Offer had been received in respect of 32,382,836 Cantab Shares, representing approximately 72.91 per cent. of the existing issued share capital of Cantab. The total number of acceptances includes acceptances in respect of 196,006 Cantab Shares (representing approximately 0.44 per cent. of the existing issued share capital of Cantab) which were the subject of irrevocable undertakings to accept the Merger Offer from Cantab Directors.
Settlement of the consideration to which Cantab Shareholders are entitled will be effected by 20 April 2001 in the case of valid acceptances already received, and within 14 days of receipt in the case of valid acceptances received after today’s date and while the Merger Offer remains open for acceptance.
The Merger Offer will remain open for acceptance until further notice. At least 14 days’ notice will be given before the Merger Offer is closed.
As stated in the Offer Document, Xenova will procure the cancellation of the listing of the Cantab Shares on the Official List and of trading in Cantab Shares on the London Stock Exchange’s market for listed securities. Such cancellation of listing and trading will take place on 9 May 2001.
As and when Xenova receives acceptances in respect of 90 per cent. in value of the Cantab Shares to which the Merger Offer relates, Xenova will seek to acquire compulsorily any outstanding Cantab Shares to which the Merger Offer relates pursuant to sections 428 to 430F of the Companies Act 1985.
Save as disclosed below, neither Xenova nor any person deemed to be acting in concert with it held any Cantab Shares or rights over Cantab Shares on 31 October 2000, the date immediately prior to the commencement of the Merger Offer Period. Save as disclosed herein, neither Xenova nor any person deemed to be acting in concert with it has acquired or agreed to acquire any Cantab Shares or rights over Cantab Shares since the Merger Offer Period commenced.
As at 31 October 2000, the last business day immediately prior to the commencement of the Merger Offer Period, Nomura, which is deemed to be acting in concert with Xenova, held 5,715 Cantab Shares (representing approximately 0.013 per cent. of the existing issued share capital of Cantab).
Simon Duffy, Gerard Fairtlough, Nicholas Hart, Stephen Inglis and John St Clair Roberts currently directors of Cantab, have today been appointed directors of Xenova. The resignation of Paul Bevan as a non-executive director of Xenova has also been accepted today.
Application has been made to the UK Listing Authority for up to 69,947,963 New Xenova Shares to be admitted to the Official List. Application has also been made to the London Stock Exchange for up to 69,947,963 New Xenova Shares to be admitted to trading on the London Stock Exchange’s market for listed securities. Admission of the New Xenova Shares to listing on the Official List and to trading on the London Stock Exchange’s market for listed securities is expected to become effective and dealings for normal settlement in New Xenova Shares are expected to commence at 8.00 a.m. on 9 April 2001.
Terms defined in the Offer Document dated 1 March 2001 have the same meaning in this announcement.
Tja, wer hilft da mal weiter? Wenn ich alles richtig verstanden habe sind 90 % angestrebt, wobei die Fusion allerdings eine sichere Sache zu sein scheint (Sorry, aber Börsenkenntnis und Englisch reichen nicht aus, um eine definitive Aussage meinerseits zu machen) .
Gruß Bogo!
@All:
Der Informationsthread läßt sich wieder laden!
Der Informationsthread läßt sich wieder laden!
RNS Number:9981C
Xenova Group PLC
2 May 2001
LETTER TO: XENOVA GROUP PLC
DATED: 30 April 2001
Companies Act 1985 (as amended):
Disclosure of Interests in Shares
In accordance with Part VI of the Companies Act 1985 (as amended) (the ^Act^),
we write to inform you that Prudential plc and certain of its subsidiary
companies have a notifiable interest in the issued share capital of your company
as detailed below.
For the purposes of S210 of the Act, the address for those companies identified
in the below schedule is Laurence Pountney Hill London EC4R 0HH.
LETTER FROM: Tom Dowler
for and on behalf of Prudential plc
Notifiable Position Report for XENOVA GROUP ORD GBP0.10
as at 27 April 2001
Percentage holdings are calculated using an issued share capital of 139,190,000
ORD GBP0.10 shares
Registered Holder Holding % Total Notifiable
Interest
Prudential plc 5,810,245 4.17
PRUCLT HSBC GIS NOM (UK) PAC AC 4,345,284
PRUCLT HSBC GIS NOM (UK) PPL AC 1,464,961
The Prudential Assurance Company Limited 5,810,245 4.17
PRUCLT HSBC GIS NOM (UK) PAC AC 4,345,284
PRUCLT HSBC GIS NOM (UK) PPL AC 1,464,961
END
Xenova Group PLC
2 May 2001
LETTER TO: XENOVA GROUP PLC
DATED: 30 April 2001
Companies Act 1985 (as amended):
Disclosure of Interests in Shares
In accordance with Part VI of the Companies Act 1985 (as amended) (the ^Act^),
we write to inform you that Prudential plc and certain of its subsidiary
companies have a notifiable interest in the issued share capital of your company
as detailed below.
For the purposes of S210 of the Act, the address for those companies identified
in the below schedule is Laurence Pountney Hill London EC4R 0HH.
LETTER FROM: Tom Dowler
for and on behalf of Prudential plc
Notifiable Position Report for XENOVA GROUP ORD GBP0.10
as at 27 April 2001
Percentage holdings are calculated using an issued share capital of 139,190,000
ORD GBP0.10 shares
Registered Holder Holding % Total Notifiable
Interest
Prudential plc 5,810,245 4.17
PRUCLT HSBC GIS NOM (UK) PAC AC 4,345,284
PRUCLT HSBC GIS NOM (UK) PPL AC 1,464,961
The Prudential Assurance Company Limited 5,810,245 4.17
PRUCLT HSBC GIS NOM (UK) PAC AC 4,345,284
PRUCLT HSBC GIS NOM (UK) PPL AC 1,464,961
END
LONDON (AFX) - Xenova Group PLC said integration with Cantab Pharmaceuticals is proceeding well, as it announced results for the three months to March 31, 2001.
Commenting, chief executive officer David Oxlade, said: "The merger with Cantab Pharmaceuticals provides us with a significantly enlarged clinical pipeline, which includes seven programmes in clinical trials and a major area of focus on cancer."
The merger was took place in early 2001. Proforma cash and investments of the combined group as at March 31 were 25 mln stg.
Xenova reported a first-quarter operating loss of 2.35 mln stg, up from 1.92 mln in the previous year, while the pretax loss rose to 2.4 mln stg from 1.77 mln.
R&D costs increased to 1.87 mln stg from 1.55 mln mainly due to the continued activity in the clinical development of XR9576 and the pre-clinical development of the second generation topoisomerase programme in this first quarter.
The company does not recommend a dividend.
Commenting in its product pipeline, Xenova said it is in licensing talks with a number of potential marketing partners for XR9576, a P-gP pump inhibitor designed to combat multi-drug resistance in cancer.
The company reported positive interim data from the third and final Phase IIa pharmacokinetic (PK) interaction study for XR9576 in February.
Gruß Bogo!
Commenting, chief executive officer David Oxlade, said: "The merger with Cantab Pharmaceuticals provides us with a significantly enlarged clinical pipeline, which includes seven programmes in clinical trials and a major area of focus on cancer."
The merger was took place in early 2001. Proforma cash and investments of the combined group as at March 31 were 25 mln stg.
Xenova reported a first-quarter operating loss of 2.35 mln stg, up from 1.92 mln in the previous year, while the pretax loss rose to 2.4 mln stg from 1.77 mln.
R&D costs increased to 1.87 mln stg from 1.55 mln mainly due to the continued activity in the clinical development of XR9576 and the pre-clinical development of the second generation topoisomerase programme in this first quarter.
The company does not recommend a dividend.
Commenting in its product pipeline, Xenova said it is in licensing talks with a number of potential marketing partners for XR9576, a P-gP pump inhibitor designed to combat multi-drug resistance in cancer.
The company reported positive interim data from the third and final Phase IIa pharmacokinetic (PK) interaction study for XR9576 in February.
Gruß Bogo!
Xenova Group plc Reports Positive Data from 2 Phase IIa Clinical Studies of P-glycoprotein inhibitor XR9576
SLOUGH, England, May 14 /PRNewswire/ -- Xenova Group plc (Nasdaq: XNVA) (London Stock Exchange: XEN) today presented results from two Phase IIa pharmacokinetic studies of the drug development candidate XR9576 at the annual meeting of the American Society of Clinical Oncology in San Francisco, California on May 12, 2001. Up to 90 per cent of cancer patients may develop resistance to current anti-cancer drugs and P-glycoprotein related multi-drug resistance is the most common form of this phenomenon. XR9576 is a potent small-molecule inhibitor of the P-glycoprotein pump and is the product of Xenova`s in-house research and development. It is being developed to restore the sensitivity of multi-drug resistant cancer cells to specific anti-cancer drugs.
In an open label Phase IIa study, the pharmacokinetic and pharmacodynamic interactions of a 150mg fixed single dose of XR9576, 175mg/m(2) of the cytotoxic drug paclitaxel and the combination of the two were evaluated in twelve patients with recurring ovarian cancer. XR9576 was given as a 30 minute infusion and paclitaxel as a 3 hour infusion, starting one and a half hours after the end of the XR9576 infusion. Patients received up to a total of five cycles of XR9576 and paclitaxel at three weekly intervals in combination with carboplatin.
The study showed that the combination treatment was well tolerated and that the combination of XR9576, paclitaxel and carboplatin gave responses in five out of the twelve patients, as assessed by independent review of CT scans and that seven out of the twelve patients received symptomatic benefit. Two of these patients obtained a complete remission of six and ten months post treatment respectively. Two patients obtained a partial remission and three had disease stabilization. The study was conducted in conjunction with the Royal Surrey County Hospital, Guildford, UK.
The results of a further open label Phase IIa study for XR9576, conducted in conjunction with the National Cancer Institute, Washington, DC, were also presented at the same meeting. The twenty five patient study was established to determine the safety of XR9576 when given in combination with the cytotoxic drug vinorelbine and to determine the extent, if any, of a pharmacokinetic interaction. The study concluded that a vinorelbine dose of 20mg/m(2) can be safely administered in combination with a single 150mg dose of XR9576 and that a single dose of XR9576 did not significantly affect the pharmacokinetics of vinorelbine. The study additionally showed that a single 150mg dose of XR9576 inhibits P-glycoprotein-mediated rhodamine efflux from circulating CD56+ cells for at least 48 hours and that this dose also inhibited the clearance of 99mTc-Sestamibi (an imaging agent pumped by P-gp) by the liver and some tumours. This demonstrated the presence of P-glycoprotein expression in these tumours, and allowed the visualization of a number of metastases. The study concluded that XR9576 is a potent P-glycoprotein antagonist, without significant side effects, and with less pharmacokinetic interference than other antagonists used previously.
Dr. Tito Fojo of the National Cancer Institute, and Principal Investigator for the vinorelbine trial, commented:
"The ideal multi-drug resistance modulator should allow cytotoxic drugs to be administered at or as close as possible to their normal dose. XR9576 itself is non-toxic and leaves cytotoxic drug levels largely unaffected. Assays have indicated that a single dose of XR9576 is sufficient to block the action of the P-gp pump for in excess of 24 hours and imaging studies have also indicated that XR9576 can effectively block the P-gp mediated efflux from tumours. Additionally, it is encouraging to see a number of positive responses amongst patients taking part in this study."
The studies form part of a series of three Phase IIa pharmacokinetic studies which have been successfully carried out by Xenova and in which XR9576 has been given in combination with the cytotoxics paclitaxel, vinorelbine and doxorubicin respectively.
The study series has confirmed that at the dose levels studied, no clinically significant pharmacokinetic interaction was observed and that the administration of XR9576 with paclitaxel, vinorelbine and doxorubicin was well tolerated. The cytotoxics can be used in combination with XR9576 at or close to their normal clinical dose. The positive responses noted in several of the patients in the studies have provided anecdotal evidence of efficacy.
Xenova has been in discussions with the FDA in the US and with a number of regulatory agencies in Europe with respect to the further development of this compound and the establishment of pivotal Phase III registration studies in these countries. Licensing discussions in relation to XR9576 are underway with a number of potential marketing partners. Notes
Following the merger with Cantab, Xenova Group plc`s product pipeline focuses principally on the therapeutic areas of cancer, infectious diseases and addiction. The Group has a well-established track record in the identification, development and partnering of innovative products and technologies. Currently, major products under development include: Cancer
XR9576 (Phase IIa clinical trials complete) -- a P-gp pump inhibitor which is designed to combat multi-drug resistance in cancer.
TA-HPV (Phase II clinical trials) -- an immunotherapeutic vaccine, designed to prevent the recurrence of cervical cancer.
TA-CIN (Phase I clinical trials) -- a recombinant fusion protein, designed as a treatment for women with cervical dysplasia.
DISC-GMCSF (Phase I clinical trials) -- an immunotherapeutic vaccine designed as a treatment for a broad range of solid tumours.
XR11576 -- (Pre-clinical development) -- a dual topoisomerase I and II inhibitor, designed as an orally administrable cytotoxic. Infectious Diseases
TA-HSV (Phase II clinical trials) -- a vaccine designed for the treatment of recurrent genital herpes, partnered with GlaxoSmithKline.
DISC-PRO ((Phase I clinical trials complete) -- a prophylactic vaccine designed for the prevention of genital and oro-labial herpes. Addiction
TA-CD (Phase IIa clinical trials complete) -- a vaccine for the treatment of cocaine addiction.
TA-NIC (Pre-clinical development) -- a vaccine designed as a treatment for nicotine dependence.
The Group has partnerships with a number of major pharmaceutical companies including Glaxo SmithKline, Lilly, Pfizer and Celltech.
For further information about Xenova and its products please visit the Xenova website at www.xenova.co.uk .
/CONTACT: David Oxlade, Chief Executive Officer, or Hilary Reid Evans, Corporate Communications, both of Xenova Group, +44-1753-706600; or David Yate or Fiona Noblet, both of Financial Dynamics, +44-207-831-3113, for Xenova Group/
SLOUGH, England, May 14 /PRNewswire/ -- Xenova Group plc (Nasdaq: XNVA) (London Stock Exchange: XEN) today presented results from two Phase IIa pharmacokinetic studies of the drug development candidate XR9576 at the annual meeting of the American Society of Clinical Oncology in San Francisco, California on May 12, 2001. Up to 90 per cent of cancer patients may develop resistance to current anti-cancer drugs and P-glycoprotein related multi-drug resistance is the most common form of this phenomenon. XR9576 is a potent small-molecule inhibitor of the P-glycoprotein pump and is the product of Xenova`s in-house research and development. It is being developed to restore the sensitivity of multi-drug resistant cancer cells to specific anti-cancer drugs.
In an open label Phase IIa study, the pharmacokinetic and pharmacodynamic interactions of a 150mg fixed single dose of XR9576, 175mg/m(2) of the cytotoxic drug paclitaxel and the combination of the two were evaluated in twelve patients with recurring ovarian cancer. XR9576 was given as a 30 minute infusion and paclitaxel as a 3 hour infusion, starting one and a half hours after the end of the XR9576 infusion. Patients received up to a total of five cycles of XR9576 and paclitaxel at three weekly intervals in combination with carboplatin.
The study showed that the combination treatment was well tolerated and that the combination of XR9576, paclitaxel and carboplatin gave responses in five out of the twelve patients, as assessed by independent review of CT scans and that seven out of the twelve patients received symptomatic benefit. Two of these patients obtained a complete remission of six and ten months post treatment respectively. Two patients obtained a partial remission and three had disease stabilization. The study was conducted in conjunction with the Royal Surrey County Hospital, Guildford, UK.
The results of a further open label Phase IIa study for XR9576, conducted in conjunction with the National Cancer Institute, Washington, DC, were also presented at the same meeting. The twenty five patient study was established to determine the safety of XR9576 when given in combination with the cytotoxic drug vinorelbine and to determine the extent, if any, of a pharmacokinetic interaction. The study concluded that a vinorelbine dose of 20mg/m(2) can be safely administered in combination with a single 150mg dose of XR9576 and that a single dose of XR9576 did not significantly affect the pharmacokinetics of vinorelbine. The study additionally showed that a single 150mg dose of XR9576 inhibits P-glycoprotein-mediated rhodamine efflux from circulating CD56+ cells for at least 48 hours and that this dose also inhibited the clearance of 99mTc-Sestamibi (an imaging agent pumped by P-gp) by the liver and some tumours. This demonstrated the presence of P-glycoprotein expression in these tumours, and allowed the visualization of a number of metastases. The study concluded that XR9576 is a potent P-glycoprotein antagonist, without significant side effects, and with less pharmacokinetic interference than other antagonists used previously.
Dr. Tito Fojo of the National Cancer Institute, and Principal Investigator for the vinorelbine trial, commented:
"The ideal multi-drug resistance modulator should allow cytotoxic drugs to be administered at or as close as possible to their normal dose. XR9576 itself is non-toxic and leaves cytotoxic drug levels largely unaffected. Assays have indicated that a single dose of XR9576 is sufficient to block the action of the P-gp pump for in excess of 24 hours and imaging studies have also indicated that XR9576 can effectively block the P-gp mediated efflux from tumours. Additionally, it is encouraging to see a number of positive responses amongst patients taking part in this study."
The studies form part of a series of three Phase IIa pharmacokinetic studies which have been successfully carried out by Xenova and in which XR9576 has been given in combination with the cytotoxics paclitaxel, vinorelbine and doxorubicin respectively.
The study series has confirmed that at the dose levels studied, no clinically significant pharmacokinetic interaction was observed and that the administration of XR9576 with paclitaxel, vinorelbine and doxorubicin was well tolerated. The cytotoxics can be used in combination with XR9576 at or close to their normal clinical dose. The positive responses noted in several of the patients in the studies have provided anecdotal evidence of efficacy.
Xenova has been in discussions with the FDA in the US and with a number of regulatory agencies in Europe with respect to the further development of this compound and the establishment of pivotal Phase III registration studies in these countries. Licensing discussions in relation to XR9576 are underway with a number of potential marketing partners. Notes
Following the merger with Cantab, Xenova Group plc`s product pipeline focuses principally on the therapeutic areas of cancer, infectious diseases and addiction. The Group has a well-established track record in the identification, development and partnering of innovative products and technologies. Currently, major products under development include: Cancer
XR9576 (Phase IIa clinical trials complete) -- a P-gp pump inhibitor which is designed to combat multi-drug resistance in cancer.
TA-HPV (Phase II clinical trials) -- an immunotherapeutic vaccine, designed to prevent the recurrence of cervical cancer.
TA-CIN (Phase I clinical trials) -- a recombinant fusion protein, designed as a treatment for women with cervical dysplasia.
DISC-GMCSF (Phase I clinical trials) -- an immunotherapeutic vaccine designed as a treatment for a broad range of solid tumours.
XR11576 -- (Pre-clinical development) -- a dual topoisomerase I and II inhibitor, designed as an orally administrable cytotoxic. Infectious Diseases
TA-HSV (Phase II clinical trials) -- a vaccine designed for the treatment of recurrent genital herpes, partnered with GlaxoSmithKline.
DISC-PRO ((Phase I clinical trials complete) -- a prophylactic vaccine designed for the prevention of genital and oro-labial herpes. Addiction
TA-CD (Phase IIa clinical trials complete) -- a vaccine for the treatment of cocaine addiction.
TA-NIC (Pre-clinical development) -- a vaccine designed as a treatment for nicotine dependence.
The Group has partnerships with a number of major pharmaceutical companies including Glaxo SmithKline, Lilly, Pfizer and Celltech.
For further information about Xenova and its products please visit the Xenova website at www.xenova.co.uk .
/CONTACT: David Oxlade, Chief Executive Officer, or Hilary Reid Evans, Corporate Communications, both of Xenova Group, +44-1753-706600; or David Yate or Fiona Noblet, both of Financial Dynamics, +44-207-831-3113, for Xenova Group/
Hallo Leute, besonders grüsse ich Panospana, kenne dich vom Rambusboard,
hier mal etwas auf Deutsch, damit jeder es verstehen kann. Habe es heute früh in boerse- online gelesen und bin mal bescheiden mit 1ooo Stück eingestiegen.
Unter den europäischen Werten befindet sich das Papier der englischen Biotechnologieschmiede Xenova mit einem Gewinn von acht Prozent in der Spitze heute ganz oben auf dem Siegertreppchen. Das Unternehmen berichtet von guten Ergebnissen eines Krebsmedikamentes, XR9576, in einer klinischen Studie der Phase IIa.
Das Medikament soll Resistenzen gegen herkömmliche Krebsmedikamente durchbrechen, die bei bis zu 90 Prozent der Krebspatienten eine effiziente Behandlung verhindern. Da XR9576 kein Konkurrenzprodukt zu Krebsmedikamenten wie Taxol, Vinorelbine oder Doxorubicin darstellt, sondern diese ergänzt, ist das Umsatzpotenzial gewaltig.
Ein Pluspunkt bei dem Unternehmen, das bislang von der deutschen Öffentlichkeit unbeachtet geblieben ist: Bislang führt Xenova alle klinischen Tests eigenständig durch, muss also Erfolge (noch) nicht mit einem großen Pharmapartner teilen.
Wie hoch die Umsätze für wirksame Krebsmedikamente sein können, beweist das Beispiel MabThera. Das Präparat von Roche, das gemeinsam von Genentech und IDEC unter dem Namen Rituxan entwickelt wurde, ist mit 586 Millionen Euro der viertgrösste Umsatzbringer des Konzerns. Bereits im ersten Jahr nach der Zulassung hatte das Präparat 185 Millionen Euro und im zweiten Jahr 319 Millionen Euro eingespielt.
Roche hat heute einen erweiterten Zulassungsantrag für das Medikament bei der europäischen Arzneimittelbehörde eingereicht. Demnach soll MabThera nicht nur bei normalem Lymphdrüsenkrebs, sondern auch bei einer besonders aggressiven Form der Krankheit als Kombinationstherapie mit einem Standardpräparat eingesetzt werden.
Erhält der Wirkstoff die Zulassung, so wird der Umsatz durch die erweiterten Anwendungsmöglichkeiten stark steigen. Rituxan wurde von den US-Biotechnologiefirmen IDEC und Genentech gemeinsam entwickelt und war eines der ersten Medikamente aus menschlichen Antikörpern.
Am Montag und Dienstag findetin San Francisco ein internationaler Kongress statt, auf dem die Unternehmen die Ergebnisse der klinischen Studien ihrer Krebsmedikamente diskutieren werden. Diese Nachrichten könnten einen starken Einfluss auf die Kurse in der Branche haben. Außer Roche werden der Pharmakonzern Novartis und die spanische Zeltia mit neuen Daten veröffentlichen.
Ich weiß nicht, ob man bei euch auch Geheimfavoriten eintraden kann, wenn ja, sagt mir bescheid.Halte mich natürlich an eure Spielregeln.
Gruß
Jethor
hier mal etwas auf Deutsch, damit jeder es verstehen kann. Habe es heute früh in boerse- online gelesen und bin mal bescheiden mit 1ooo Stück eingestiegen.
Unter den europäischen Werten befindet sich das Papier der englischen Biotechnologieschmiede Xenova mit einem Gewinn von acht Prozent in der Spitze heute ganz oben auf dem Siegertreppchen. Das Unternehmen berichtet von guten Ergebnissen eines Krebsmedikamentes, XR9576, in einer klinischen Studie der Phase IIa.
Das Medikament soll Resistenzen gegen herkömmliche Krebsmedikamente durchbrechen, die bei bis zu 90 Prozent der Krebspatienten eine effiziente Behandlung verhindern. Da XR9576 kein Konkurrenzprodukt zu Krebsmedikamenten wie Taxol, Vinorelbine oder Doxorubicin darstellt, sondern diese ergänzt, ist das Umsatzpotenzial gewaltig.
Ein Pluspunkt bei dem Unternehmen, das bislang von der deutschen Öffentlichkeit unbeachtet geblieben ist: Bislang führt Xenova alle klinischen Tests eigenständig durch, muss also Erfolge (noch) nicht mit einem großen Pharmapartner teilen.
Wie hoch die Umsätze für wirksame Krebsmedikamente sein können, beweist das Beispiel MabThera. Das Präparat von Roche, das gemeinsam von Genentech und IDEC unter dem Namen Rituxan entwickelt wurde, ist mit 586 Millionen Euro der viertgrösste Umsatzbringer des Konzerns. Bereits im ersten Jahr nach der Zulassung hatte das Präparat 185 Millionen Euro und im zweiten Jahr 319 Millionen Euro eingespielt.
Roche hat heute einen erweiterten Zulassungsantrag für das Medikament bei der europäischen Arzneimittelbehörde eingereicht. Demnach soll MabThera nicht nur bei normalem Lymphdrüsenkrebs, sondern auch bei einer besonders aggressiven Form der Krankheit als Kombinationstherapie mit einem Standardpräparat eingesetzt werden.
Erhält der Wirkstoff die Zulassung, so wird der Umsatz durch die erweiterten Anwendungsmöglichkeiten stark steigen. Rituxan wurde von den US-Biotechnologiefirmen IDEC und Genentech gemeinsam entwickelt und war eines der ersten Medikamente aus menschlichen Antikörpern.
Am Montag und Dienstag findetin San Francisco ein internationaler Kongress statt, auf dem die Unternehmen die Ergebnisse der klinischen Studien ihrer Krebsmedikamente diskutieren werden. Diese Nachrichten könnten einen starken Einfluss auf die Kurse in der Branche haben. Außer Roche werden der Pharmakonzern Novartis und die spanische Zeltia mit neuen Daten veröffentlichen.
Ich weiß nicht, ob man bei euch auch Geheimfavoriten eintraden kann, wenn ja, sagt mir bescheid.Halte mich natürlich an eure Spielregeln.
Gruß
Jethor
25.05.2001
Xenova kaufenswert
Biotech-Report Online
Die Analysten von Biotech-Report Online halten die Aktien von Xenova (WKN 890281) für kaufenswert.
Das Unternehmen erforsche und entwickle kleine Wirkstoffmoleküle, wobei sich Xenova hier vor allem auf die Resistenz von Krebszellen gegen Medikamente konzentriere, auf die sogenannte Multidrug-Resistenz. Die Gesellschaft habe einen Wirkstoff namens XR9576 entwickelt, der die Aufhebung von Mulitdrug-Resistance-Proteinen bewirke. Die klinische Phase II habe mit Erfolg beendet werden können. Die Analysten würden mit einem riesigen Umsatzpotenzial rechnen, da XR9576 bei allen resistenten Tumoren Einsatz finde und keine Konkurrenz zu anderen Medikamenten sei. Da die Gesellschaft alle Studien eigenständig durchführe, würden sämtliche Gewinne innerhalb des Hauses bleiben. Das Unternehmen habe noch weitere erfolgversprechende Produkte in der klinischen Entwicklung.
Für die Börsenkenner von Biotech-Report-Online ist die Xenova-Aktie somit ein Kauf, wobei dazu geraten wird, den Wert nur an der Heimatbörse zu ordern
Gruß Bogo!
Xenova kaufenswert
Biotech-Report Online
Die Analysten von Biotech-Report Online halten die Aktien von Xenova (WKN 890281) für kaufenswert.
Das Unternehmen erforsche und entwickle kleine Wirkstoffmoleküle, wobei sich Xenova hier vor allem auf die Resistenz von Krebszellen gegen Medikamente konzentriere, auf die sogenannte Multidrug-Resistenz. Die Gesellschaft habe einen Wirkstoff namens XR9576 entwickelt, der die Aufhebung von Mulitdrug-Resistance-Proteinen bewirke. Die klinische Phase II habe mit Erfolg beendet werden können. Die Analysten würden mit einem riesigen Umsatzpotenzial rechnen, da XR9576 bei allen resistenten Tumoren Einsatz finde und keine Konkurrenz zu anderen Medikamenten sei. Da die Gesellschaft alle Studien eigenständig durchführe, würden sämtliche Gewinne innerhalb des Hauses bleiben. Das Unternehmen habe noch weitere erfolgversprechende Produkte in der klinischen Entwicklung.
Für die Börsenkenner von Biotech-Report-Online ist die Xenova-Aktie somit ein Kauf, wobei dazu geraten wird, den Wert nur an der Heimatbörse zu ordern
Gruß Bogo!
LONDON, ON and SLOUGH, U.K., Jun 12, 2001 (Canada NewsWire via COMTEX) -- Viron Therapeutics Inc., a privately held Canadian biotechnology company developing viral proteins as novel anti-inflammatory therapeutics, announced today the license of an undisclosed novel anti-inflammatory protein to Xenova Group PLC, a public U.K. pharmaceutical company (Nasdaq NM: XNVA; London Stock Exchange: XEN). While the terms and conditions of this license remain confidential, Xenova will be progressing with the research & development of the licensed anti-inflammatory protein in a variety of inflammatory disease conditions. Under the terms of this agreement, Xenova receives exclusive sublicense to commercialize the intellectual property held by Viron with regard to the novel protein and its therapeutic uses. In addition, Viron and Xenova will collaborate to test the efficacy of this protein in a variety of disease models.
"This collaboration with Xenova continues Viron`s mission to develop our viral protein platform. We anticipate a productive long-term relationship with Xenova", remarked William A. McGinnis, Vice-Chair, Viron Therapeutics Inc.
Nick Hart, Commercial Director, Xenova Group plc commented, "We see this protein therapeutic having broad clinical applications, making this an exciting and a potentially substantial opportunity for Xenova and Viron."
Inflammatory diseases include a variety of clinical indications associated with imbalance of the human inflammatory response. Inflammation is a highly regulated cascade designed to respond to tissue injury or infection. This process is controlled by various different factors within the bloodstream that maintain a balance between pro- and anti-inflammatory environments. Ideally, this regulation constrains the human inflammatory response to a localized site for the short duration required to clear infection or injury. However, when this regulation becomes unbalanced, human inflammatory responses can occur at inappropriate tissue sites or can become excessive in extent or duration. In these cases, the inflammatory cascade may cause harmful infiltration and loss of function among various critical human tissues. These inflammatory diseases include: immune-mediated disorders (including multiple sclerosis, rheumatoid arthritis, acute transplant rejection), cardiovascular disorders (including angioplasty restenosis, by-pass graft occlusion, transplant vasculopathy) and other disorders (including asthma, inflammatory bowel disease, chronic transplant rejection).
Viron Therapeutics Inc.
-----------------------
As a spin-off of The John P. Robarts Research Institute (London, Ontario) in 1997, Viron Therapeutics Inc. became one of the first biotechnology companies to exploit the discovery that viral proteins can be used to inhibit the immune system. The Company is focused upon the commercialization of novel anti-inflammatory therapeutics and is currently developing several therapeutic proteins identified from viral sources to treat a range of inflammatory and immune-based disorders. The emphasis upon viral proteins emphasizes the emergence of a novel drug development approach that is unique in the current biotechnology industry. Integrating numerous core competencies within the Company to expedite the development of these viral anti-inflammatory proteins Viron has established a sustainable and rich product pipeline. Viron`s current product development pipeline consists of: Serine Proteinase Inhibitors (VT-100 Series), Chemokine Binding Proteins (VT-200) and Cytokine Binding Proteins (VT- 300 Series). For further information regarding Viron, please visit www.vironinc.com.
Xenova Group plc
----------------
Following the merger with Cantab, Xenova Group plc`s product pipeline focuses principally on the therapeutic areas of cancer, infectious diseases and addiction. The Group has a well-established track record in the identification, development and partnering of innovative products and technologies. Currently, major products under development include:
Cancer
------
- XR9576 (Phase IIa clinical trials complete) -- a P-gp pump inhibitor
that is designed to combat multi-drug resistance in cancer.
- TA-HPV (Phase II clinical trials) -- an immunotherapeutic vaccine,
designed to prevent the recurrence of cervical cancer.
- TA-CIN (Phase I clinical trials) -- a recombinant fusion protein,
designed as a treatment for women with cervical dysplasia.
- DISC-GMCSF (Phase I clinical trials) -- an immunotherapeutic vaccine
designed as a treatment for a broad range of solid tumours.
- XR11576 -- (Pre-clinical development) -- a dual topoisomerase I and II
inhibitor, designed as an orally administrable cytotoxic.
Infectious Diseases
-------------------
- TA-HSV (Phase II clinical trials) -- a vaccine designed for the
treatment of recurrent genital herpes, partnered with GlaxoSmithKline.
- DISC-PRO ((Phase I clinical trials complete) -- a prophylactic vaccine
designed for the prevention of genital and oro-labial herpes.
Addiction
---------
- TA-CD (Phase IIa clinical trials complete) -- a vaccine for the
treatment of cocaine addiction.
- TA-NIC (Pre-clinical development) -- a vaccine designed as a treatment
for nicotine dependence.
- The Group has partnerships with a number of major pharmaceutical
companies including Glaxo SmithKline, Lilly, Pfizer and Celltech.
For further information about Xenova and its products please visit the Xenova website at www.xenova.co.uk
Safe Harbor Statement under the US Private Securities Litigation Reform Act of 1995: Some or all of the statements in this document that relate to future plans, expectations, events, performances and the like are forward- looking statements, as defined in the US Private Securities Litigation Reform Act of 1995. Actual results of events could differ materially from those described in the forward-looking statements due to a variety of factors, including those set forth in the Company`s filings with the US Securities and Exchange Commission.
CONTACT: For further information: Viron Therapeutics Inc., Tel: 519-858-5109,
William A. McGinnis: Vice-Chair; Xenova Group plc, Tel: +44 (0) 1753 706600,
Hilary Reid Evans: Corporate Communications
Gruß Bogo!
"This collaboration with Xenova continues Viron`s mission to develop our viral protein platform. We anticipate a productive long-term relationship with Xenova", remarked William A. McGinnis, Vice-Chair, Viron Therapeutics Inc.
Nick Hart, Commercial Director, Xenova Group plc commented, "We see this protein therapeutic having broad clinical applications, making this an exciting and a potentially substantial opportunity for Xenova and Viron."
Inflammatory diseases include a variety of clinical indications associated with imbalance of the human inflammatory response. Inflammation is a highly regulated cascade designed to respond to tissue injury or infection. This process is controlled by various different factors within the bloodstream that maintain a balance between pro- and anti-inflammatory environments. Ideally, this regulation constrains the human inflammatory response to a localized site for the short duration required to clear infection or injury. However, when this regulation becomes unbalanced, human inflammatory responses can occur at inappropriate tissue sites or can become excessive in extent or duration. In these cases, the inflammatory cascade may cause harmful infiltration and loss of function among various critical human tissues. These inflammatory diseases include: immune-mediated disorders (including multiple sclerosis, rheumatoid arthritis, acute transplant rejection), cardiovascular disorders (including angioplasty restenosis, by-pass graft occlusion, transplant vasculopathy) and other disorders (including asthma, inflammatory bowel disease, chronic transplant rejection).
Viron Therapeutics Inc.
-----------------------
As a spin-off of The John P. Robarts Research Institute (London, Ontario) in 1997, Viron Therapeutics Inc. became one of the first biotechnology companies to exploit the discovery that viral proteins can be used to inhibit the immune system. The Company is focused upon the commercialization of novel anti-inflammatory therapeutics and is currently developing several therapeutic proteins identified from viral sources to treat a range of inflammatory and immune-based disorders. The emphasis upon viral proteins emphasizes the emergence of a novel drug development approach that is unique in the current biotechnology industry. Integrating numerous core competencies within the Company to expedite the development of these viral anti-inflammatory proteins Viron has established a sustainable and rich product pipeline. Viron`s current product development pipeline consists of: Serine Proteinase Inhibitors (VT-100 Series), Chemokine Binding Proteins (VT-200) and Cytokine Binding Proteins (VT- 300 Series). For further information regarding Viron, please visit www.vironinc.com.
Xenova Group plc
----------------
Following the merger with Cantab, Xenova Group plc`s product pipeline focuses principally on the therapeutic areas of cancer, infectious diseases and addiction. The Group has a well-established track record in the identification, development and partnering of innovative products and technologies. Currently, major products under development include:
Cancer
------
- XR9576 (Phase IIa clinical trials complete) -- a P-gp pump inhibitor
that is designed to combat multi-drug resistance in cancer.
- TA-HPV (Phase II clinical trials) -- an immunotherapeutic vaccine,
designed to prevent the recurrence of cervical cancer.
- TA-CIN (Phase I clinical trials) -- a recombinant fusion protein,
designed as a treatment for women with cervical dysplasia.
- DISC-GMCSF (Phase I clinical trials) -- an immunotherapeutic vaccine
designed as a treatment for a broad range of solid tumours.
- XR11576 -- (Pre-clinical development) -- a dual topoisomerase I and II
inhibitor, designed as an orally administrable cytotoxic.
Infectious Diseases
-------------------
- TA-HSV (Phase II clinical trials) -- a vaccine designed for the
treatment of recurrent genital herpes, partnered with GlaxoSmithKline.
- DISC-PRO ((Phase I clinical trials complete) -- a prophylactic vaccine
designed for the prevention of genital and oro-labial herpes.
Addiction
---------
- TA-CD (Phase IIa clinical trials complete) -- a vaccine for the
treatment of cocaine addiction.
- TA-NIC (Pre-clinical development) -- a vaccine designed as a treatment
for nicotine dependence.
- The Group has partnerships with a number of major pharmaceutical
companies including Glaxo SmithKline, Lilly, Pfizer and Celltech.
For further information about Xenova and its products please visit the Xenova website at www.xenova.co.uk
Safe Harbor Statement under the US Private Securities Litigation Reform Act of 1995: Some or all of the statements in this document that relate to future plans, expectations, events, performances and the like are forward- looking statements, as defined in the US Private Securities Litigation Reform Act of 1995. Actual results of events could differ materially from those described in the forward-looking statements due to a variety of factors, including those set forth in the Company`s filings with the US Securities and Exchange Commission.
CONTACT: For further information: Viron Therapeutics Inc., Tel: 519-858-5109,
William A. McGinnis: Vice-Chair; Xenova Group plc, Tel: +44 (0) 1753 706600,
Hilary Reid Evans: Corporate Communications
Gruß Bogo!
US authorities allow Xenova to resume trials of cocaine addiction vaccine
Jul 16, 2001 (M2 EUROPHARMA via COMTEX) -- The US Food and Drug Administration (FDA) has given the UK biotechnology company Xenova Group Plc permission to resume clinical tests of what is said to be the world`s first vaccine to treat cocaine addiction.
The FDA suspended Xenova`s tests of the TA-CD vaccine last August, after the company`s related nicotine vaccine caused eye irritation in rabbits during preclinical trials. However, further tests on animals, including primates, have shown no problems with either vaccine so toxicologists concluded the irritation affected only rabbits.
TA-CD was developed by US-based ImmuLogic and sold to Britain`s Cantab Pharmaceuticals Plc in 1998 which in turn was acquired by Xenova this year. The vaccine is designed to work by preventing cocaine from crossing into the brain through the bloodstream, blocking the normal `high` cocaine generates. Xenova now plans to conduct a trial in New York. The patients will be given cocaine under controlled conditions before and after vaccination, and their behaviour and blood chemistry will be monitored. The vaccine will probably not be available commercially for several years.
Jul 16, 2001 (M2 EUROPHARMA via COMTEX) -- The US Food and Drug Administration (FDA) has given the UK biotechnology company Xenova Group Plc permission to resume clinical tests of what is said to be the world`s first vaccine to treat cocaine addiction.
The FDA suspended Xenova`s tests of the TA-CD vaccine last August, after the company`s related nicotine vaccine caused eye irritation in rabbits during preclinical trials. However, further tests on animals, including primates, have shown no problems with either vaccine so toxicologists concluded the irritation affected only rabbits.
TA-CD was developed by US-based ImmuLogic and sold to Britain`s Cantab Pharmaceuticals Plc in 1998 which in turn was acquired by Xenova this year. The vaccine is designed to work by preventing cocaine from crossing into the brain through the bloodstream, blocking the normal `high` cocaine generates. Xenova now plans to conduct a trial in New York. The patients will be given cocaine under controlled conditions before and after vaccination, and their behaviour and blood chemistry will be monitored. The vaccine will probably not be available commercially for several years.
VANCOUVER, Aug 13, 2001 (Canada NewsWire via COMTEX) -- QLT Inc. (NASDAQ:QLTI; TSE:QLT) today announced that it has entered into an exclusive development and license agreement for XR9576, a Phase II P-gp inhibitor for multi-drug resistance (MDR) in oncology with Xenova Group plc (NASDAQ:XNVA; London Stock Exchange:XEN), a publicly traded biotechnology company based in the UK. Under the agreement QLT will assume responsibility for the continued development of XR9576 and marketing rights for North America. Xenova will retain marketing rights in Europe and the rest of world.
One of the major barriers to successful cancer treatment is the development of resistance by cancer cells to several drugs used in chemotherapy, known as multi-drug resistance (MDR). XR9576 targets the most common form of this drug resistance through the inhibition of P-glycoprotein, a membrane based "pump" that acts to expel the chemotherapy drug from the tumor cell, thereby reducing its efficacy. XR9576 has completed a series of three separate Phase IIa trials, in which the product was administered together with three of the world`s most commonly used chemotherapy agents (paclitaxel, doxorubicin, vinorelbine), each of which is known to be affected by this resistance mechanism.
"We have proven our drug development capabilities with the commercialization of Visudyne(TM) and Photofrin(R) and look forward to applying our expertise to the development of XR9576 in an area with such a high unmet medical need," said Dr. Julia Levy, President and Chief Executive Officer of QLT. "This collaboration underlines QLT`s commitment to expand beyond photodynamic therapy and supports our longer term plan to become a fully integrated biopharmaceutical company with a North American sales force."
Dr. Levy added, "Our internal evaluation of this product confirms that XR9576 is the leading MDR inhibitor in development based on its potency, selectivity and stage of development."
"The studies done to date suggest that XR9576 could offer significant advantages over previous generations of MDR inhibitors," said David Oxlade, Chief Executive Officer of Xenova Group plc. "We are very pleased to be pursuing the development of this compound with QLT given their proven track record in drug development and expertise in oncology."
Financial Terms
Under the terms of the agreement, QLT will pay Xenova an initial licensing fee of US$10 million and milestone payments up to a maximum of US$50 million, in addition to paying future development costs for the product. Upon commercialization, QLT will pay a royalty to Xenova in the range of 15 to 22 per cent depending on the level of North American sales.
Clinical Development Plan
Xenova has received clearance from the U.S. Food and Drug Administration (FDA) to proceed to Phase III development. QLT expects to initiate the Phase III program in the first half of 2002 once the clinical study protocol is finalized. An interim analysis is planned for mid-2003 in order to mitigate the financial risk of the program. Upon successful completion of the Phase III program, it is anticipated that QLT will initially file for approval of XR9576 in the U.S. for use in combination with first line chemotherapy in advanced non-small cell lung cancer (NSCLC) in 2005. NSCLC is the first of several indications for which XR9576 will be investigated.
XR9576 and Multi-drug Resistance
Multi-drug resistance (MDR) is a problem for many of the most common cancers and involves some of the most widely administered chemotherapeutic agents. In 1999, these drugs accounted for over 1.45 million office-based administrations by medical oncologists in the U.S.
The successful outcome of the XR9576 trials was announced in late 2000/early 2001. The trials demonstrated that the combination of XR9576 with a chemotherapy agent was safe and well tolerated. Further, no clinically significant pharmacokinetic interaction was found between XR9576 and the chemotherapy drug, a problem encountered by previous generation MDR inhibitors. This benefit allows the chemotherapy agent to be administered at its full normal clinical dose for optimal efficacy.
Background on QLT and Xenova
QLT Inc. (NASDAQ:QLTI; TSE:QLT) is a world leader in photodynamic therapy, a field of medicine utilizing light-activated drugs in the treatment of disease. QLT`s innovative science has led to the development and commercialization of breakthrough treatments utilizing this technology for applications in ophthalmology and oncology. QLT is exploring the potential of photodynamic therapy in other diseases. For more information, you are invited to visit QLT`s web site at www.qltinc.com.
Xenova Group plc`s product pipeline focuses principally on the therapeutic areas of cancer, infectious diseases and addiction. The Group has a well-established track record in the identification, development and partnering of innovative products and technologies. The Group has partnerships with a number of major pharmaceutical companies including Glaxo SmithKline, Lilly, Pfizer and Celltech. For further information about Xenova and its products please visit the Xenova website at www.xenova.co.uk
QLT Inc. will hold an analyst and institutional investor conference call to discuss the agreement with Xenova Group plc today, Monday, August 13, at 5:00 p.m. EST (2:00 p.m. PST). The call will be broadcast live via the Internet at www.qltinc.com. A replay of the call will be available via the Internet and also via telephone at 416-626-4100, access code 19529023.
Visudyne(TM) is a trademark of Novartis AG
PHOTOFRIN(R) is a registered trademark of Axcan Pharma
Certain statements in this press release constitute "forward-looking statements" of QLT within the meaning of the Private Securities Litigation Reform Act of 1995, which involve known and unknown risks, uncertainties and other factors that may cause our actual results to be materially different from any future results, performance or achievements expressed or implied by such statements. Forward-looking statements include, but are not limited to, those with respect to anticipated timing of clinical trials, regulatory submissions and regulatory approval for XR9576. These statements are only predictions and actual events or results may differ materially. Factors that could cause such actual events or results expressed or implied by such forward- looking statements to differ materially from any future results expressed or implied by such statements include, but are not limited to: we may experience inadequate patient enrolment for future clinical trials; results from future clinical trials for XR9576 are uncertain and may be unfavorable; our XR9576 product development efforts may not yield marketable products; we are dependent on third parties to develop and commercialize product candidates; currency fluctuations in our primary markets may impact our financial results; and other factors described in detail in QLT`s Annual Information Form on Form 10-K, forthcoming quarterly reports on Form 10-Q and other filings with the U.S. Securities and Exchange Commission. Forward-looking statements are based on our current expectations and QLT is not obligated to update such information to reflect later events or developments.
Gruß Bogo!
One of the major barriers to successful cancer treatment is the development of resistance by cancer cells to several drugs used in chemotherapy, known as multi-drug resistance (MDR). XR9576 targets the most common form of this drug resistance through the inhibition of P-glycoprotein, a membrane based "pump" that acts to expel the chemotherapy drug from the tumor cell, thereby reducing its efficacy. XR9576 has completed a series of three separate Phase IIa trials, in which the product was administered together with three of the world`s most commonly used chemotherapy agents (paclitaxel, doxorubicin, vinorelbine), each of which is known to be affected by this resistance mechanism.
"We have proven our drug development capabilities with the commercialization of Visudyne(TM) and Photofrin(R) and look forward to applying our expertise to the development of XR9576 in an area with such a high unmet medical need," said Dr. Julia Levy, President and Chief Executive Officer of QLT. "This collaboration underlines QLT`s commitment to expand beyond photodynamic therapy and supports our longer term plan to become a fully integrated biopharmaceutical company with a North American sales force."
Dr. Levy added, "Our internal evaluation of this product confirms that XR9576 is the leading MDR inhibitor in development based on its potency, selectivity and stage of development."
"The studies done to date suggest that XR9576 could offer significant advantages over previous generations of MDR inhibitors," said David Oxlade, Chief Executive Officer of Xenova Group plc. "We are very pleased to be pursuing the development of this compound with QLT given their proven track record in drug development and expertise in oncology."
Financial Terms
Under the terms of the agreement, QLT will pay Xenova an initial licensing fee of US$10 million and milestone payments up to a maximum of US$50 million, in addition to paying future development costs for the product. Upon commercialization, QLT will pay a royalty to Xenova in the range of 15 to 22 per cent depending on the level of North American sales.
Clinical Development Plan
Xenova has received clearance from the U.S. Food and Drug Administration (FDA) to proceed to Phase III development. QLT expects to initiate the Phase III program in the first half of 2002 once the clinical study protocol is finalized. An interim analysis is planned for mid-2003 in order to mitigate the financial risk of the program. Upon successful completion of the Phase III program, it is anticipated that QLT will initially file for approval of XR9576 in the U.S. for use in combination with first line chemotherapy in advanced non-small cell lung cancer (NSCLC) in 2005. NSCLC is the first of several indications for which XR9576 will be investigated.
XR9576 and Multi-drug Resistance
Multi-drug resistance (MDR) is a problem for many of the most common cancers and involves some of the most widely administered chemotherapeutic agents. In 1999, these drugs accounted for over 1.45 million office-based administrations by medical oncologists in the U.S.
The successful outcome of the XR9576 trials was announced in late 2000/early 2001. The trials demonstrated that the combination of XR9576 with a chemotherapy agent was safe and well tolerated. Further, no clinically significant pharmacokinetic interaction was found between XR9576 and the chemotherapy drug, a problem encountered by previous generation MDR inhibitors. This benefit allows the chemotherapy agent to be administered at its full normal clinical dose for optimal efficacy.
Background on QLT and Xenova
QLT Inc. (NASDAQ:QLTI; TSE:QLT) is a world leader in photodynamic therapy, a field of medicine utilizing light-activated drugs in the treatment of disease. QLT`s innovative science has led to the development and commercialization of breakthrough treatments utilizing this technology for applications in ophthalmology and oncology. QLT is exploring the potential of photodynamic therapy in other diseases. For more information, you are invited to visit QLT`s web site at www.qltinc.com.
Xenova Group plc`s product pipeline focuses principally on the therapeutic areas of cancer, infectious diseases and addiction. The Group has a well-established track record in the identification, development and partnering of innovative products and technologies. The Group has partnerships with a number of major pharmaceutical companies including Glaxo SmithKline, Lilly, Pfizer and Celltech. For further information about Xenova and its products please visit the Xenova website at www.xenova.co.uk
QLT Inc. will hold an analyst and institutional investor conference call to discuss the agreement with Xenova Group plc today, Monday, August 13, at 5:00 p.m. EST (2:00 p.m. PST). The call will be broadcast live via the Internet at www.qltinc.com. A replay of the call will be available via the Internet and also via telephone at 416-626-4100, access code 19529023.
Visudyne(TM) is a trademark of Novartis AG
PHOTOFRIN(R) is a registered trademark of Axcan Pharma
Certain statements in this press release constitute "forward-looking statements" of QLT within the meaning of the Private Securities Litigation Reform Act of 1995, which involve known and unknown risks, uncertainties and other factors that may cause our actual results to be materially different from any future results, performance or achievements expressed or implied by such statements. Forward-looking statements include, but are not limited to, those with respect to anticipated timing of clinical trials, regulatory submissions and regulatory approval for XR9576. These statements are only predictions and actual events or results may differ materially. Factors that could cause such actual events or results expressed or implied by such forward- looking statements to differ materially from any future results expressed or implied by such statements include, but are not limited to: we may experience inadequate patient enrolment for future clinical trials; results from future clinical trials for XR9576 are uncertain and may be unfavorable; our XR9576 product development efforts may not yield marketable products; we are dependent on third parties to develop and commercialize product candidates; currency fluctuations in our primary markets may impact our financial results; and other factors described in detail in QLT`s Annual Information Form on Form 10-K, forthcoming quarterly reports on Form 10-Q and other filings with the U.S. Securities and Exchange Commission. Forward-looking statements are based on our current expectations and QLT is not obligated to update such information to reflect later events or developments.
Gruß Bogo!
Noch eine weitere strategische Partnerschaft von XENOVA, welche ebenfalls heute bekanntgegeben wurde:
Xenova Group plc: Phogen Signs 15m Pound ($21m) Licensing Collaboration with Genencor for VP22 Technology
SLOUGH, England, Aug. 13 /PRNewswire/ -- Xenova Group plc (Nasdaq: XNVA; London Stock Exchange: XEN) today announces that its joint venture company, Phogen, has signed an exclusive worldwide license agreement with Palo Alto, California based Genencor International, Inc (Nasdaq: GCOR - news) for the application of Phogen`s VP22 technology to the development of a limited number of therapeutic vaccines for certain infectious viral diseases.
Phogen`s VP22 technology enables the spreading of peptides and proteins from one cell directly into neighboring cells, increasing the delivery efficiency of DNA-based vaccines. This may overcome one of the major challenges in the field of gene therapy and molecular medicine, namely the delivery of the desired genes or proteins to a sufficient number of target cells to elicit a therapeutic response. Vaccines may also be formulated using vectosome technology, in which DNA-based constructs are encapsulated using VP22 protein to increase intracellular uptake and hence potential clinical benefit.
Phogen`s VP22 technology has broad applications in a number of areas in addition to therapeutic vaccines, such as gene therapy, diagnostics, target validation and genomics and plant technology. Data relating to VP22 was published in the 4 May issue of the Journal of Biological Chemistry, which highlighted the light-activated properties of the technology. This property is of particular interest for cell-based screens and assays and for photodynamic therapy, allowing the delivery of test molecules to specific cells and/or tissues.
Genencor will initially evaluate Phogen`s proprietary VP22 technology for vaccines to treat diseases including hepatitis C (HCV), hepatitis B (HBV) and human papilloma virus (HPV). Genencor has also licensed an opt-in provision, which potentially provides Genencor with expanded access to the technology for application to additional therapeutic vaccine products in the field of infectious viral diseases and cancer.
Under the terms of the agreement, Phogen will receive up front license fees, research and development funding and annual license maintenance fees, as well as further payments on the attainment of clinical and regulatory milestones, plus royalties. The license agreement with Genencor will potentially provide Phogen with revenues of over 15m pounds sterling (pounds) ($21m), including 1.2m pounds ($1.7m) in the first year in license, option and contract research payments, plus undisclosed royalties following product launches.
David Oxlade, Chief Executive of Xenova, commented:
"The commercial potential in this collaboration is highly significant,
yet represents only a small area within the scope of opportunities
offered by Phogen`s VP22 technology. This relationship with Genencor
represents an important foundation for Phogen as it begins to unlock the
considerable potential of its wide-ranging drug delivery technology."
Debby Jo Blank, Genencor`s Chief Business Officer, said:
"We believe the Phogen technology is very strong. Adding this to our
existing in-house portfolio gives us the ability to optimise our lead
vaccine product candidates."
Notes to Editors
Phogen is a UK-based biopharmaceutical company established to develop and commercialize technology based on the protein VP22 for enhancing drug and gene delivery. The company is a joint venture between Xenova Group plc and Marie Curie Cancer Care (MCCC) the UK`s most comprehensive cancer care organization. VP22 technology has wide potential applications both for the enhancement of gene delivery efficiency and for light-activated intracellular delivery of oligonucleotides, proteins and peptides.
Xenova Group plc`s product pipeline focuses principally on the therapeutic area of cancer, with a secondary focus on infectious, autoimmune and cardiovascular diseases. The Group has a well-established track record in the identification, development and partnering of innovative products and technologies and has partnerships with a number of major pharmaceutical companies including GlaxoSmithKline, Lilly, Pfizer and Celltech.
For further information about Xenova and its products please visit the Xenova website at http://www.xenova.co.uk.
Genencor is a diversified biotechnology company that develops and delivers innovative products and services into the health care, agriculture, industrial and consumer markets. Using an integrated set of technology platforms, Genencor`s products deliver innovative and sustainable solutions to many of the problems of everyday life.
Genencor was established in 1982 as a joint venture between Genentech Inc. and Corning Incorporated. Since its founding, Genencor has grown to become a leading biotechnology company, with over $315 million in year 2000 revenues, more than 250 biotechnology products in commerce, and over 3,400 owned and licensed patents and applications. Genencor, with more than 1,500 employees worldwide, has principal offices in Palo Alto, California; Rochester, New York, and Leiden, the Netherlands.
Safe Harbor Statement under the US Private Securities Litigation Reform Act of 1995: Some or all of the statements in this document that relate to future plans, expectations, events, performances and the like are forward- looking statements, as defined in the US Private Securities Litigation Reform Act of 1995. Actual results of events could differ materially from those described in the forward-looking statements due to a variety of factors, including those set forth in the Company`s filings with the US Securities and Exchange Commission.
SOURCE: Xenova Group plc
Xenova Group plc: Phogen Signs 15m Pound ($21m) Licensing Collaboration with Genencor for VP22 Technology
SLOUGH, England, Aug. 13 /PRNewswire/ -- Xenova Group plc (Nasdaq: XNVA; London Stock Exchange: XEN) today announces that its joint venture company, Phogen, has signed an exclusive worldwide license agreement with Palo Alto, California based Genencor International, Inc (Nasdaq: GCOR - news) for the application of Phogen`s VP22 technology to the development of a limited number of therapeutic vaccines for certain infectious viral diseases.
Phogen`s VP22 technology enables the spreading of peptides and proteins from one cell directly into neighboring cells, increasing the delivery efficiency of DNA-based vaccines. This may overcome one of the major challenges in the field of gene therapy and molecular medicine, namely the delivery of the desired genes or proteins to a sufficient number of target cells to elicit a therapeutic response. Vaccines may also be formulated using vectosome technology, in which DNA-based constructs are encapsulated using VP22 protein to increase intracellular uptake and hence potential clinical benefit.
Phogen`s VP22 technology has broad applications in a number of areas in addition to therapeutic vaccines, such as gene therapy, diagnostics, target validation and genomics and plant technology. Data relating to VP22 was published in the 4 May issue of the Journal of Biological Chemistry, which highlighted the light-activated properties of the technology. This property is of particular interest for cell-based screens and assays and for photodynamic therapy, allowing the delivery of test molecules to specific cells and/or tissues.
Genencor will initially evaluate Phogen`s proprietary VP22 technology for vaccines to treat diseases including hepatitis C (HCV), hepatitis B (HBV) and human papilloma virus (HPV). Genencor has also licensed an opt-in provision, which potentially provides Genencor with expanded access to the technology for application to additional therapeutic vaccine products in the field of infectious viral diseases and cancer.
Under the terms of the agreement, Phogen will receive up front license fees, research and development funding and annual license maintenance fees, as well as further payments on the attainment of clinical and regulatory milestones, plus royalties. The license agreement with Genencor will potentially provide Phogen with revenues of over 15m pounds sterling (pounds) ($21m), including 1.2m pounds ($1.7m) in the first year in license, option and contract research payments, plus undisclosed royalties following product launches.
David Oxlade, Chief Executive of Xenova, commented:
"The commercial potential in this collaboration is highly significant,
yet represents only a small area within the scope of opportunities
offered by Phogen`s VP22 technology. This relationship with Genencor
represents an important foundation for Phogen as it begins to unlock the
considerable potential of its wide-ranging drug delivery technology."
Debby Jo Blank, Genencor`s Chief Business Officer, said:
"We believe the Phogen technology is very strong. Adding this to our
existing in-house portfolio gives us the ability to optimise our lead
vaccine product candidates."
Notes to Editors
Phogen is a UK-based biopharmaceutical company established to develop and commercialize technology based on the protein VP22 for enhancing drug and gene delivery. The company is a joint venture between Xenova Group plc and Marie Curie Cancer Care (MCCC) the UK`s most comprehensive cancer care organization. VP22 technology has wide potential applications both for the enhancement of gene delivery efficiency and for light-activated intracellular delivery of oligonucleotides, proteins and peptides.
Xenova Group plc`s product pipeline focuses principally on the therapeutic area of cancer, with a secondary focus on infectious, autoimmune and cardiovascular diseases. The Group has a well-established track record in the identification, development and partnering of innovative products and technologies and has partnerships with a number of major pharmaceutical companies including GlaxoSmithKline, Lilly, Pfizer and Celltech.
For further information about Xenova and its products please visit the Xenova website at http://www.xenova.co.uk.
Genencor is a diversified biotechnology company that develops and delivers innovative products and services into the health care, agriculture, industrial and consumer markets. Using an integrated set of technology platforms, Genencor`s products deliver innovative and sustainable solutions to many of the problems of everyday life.
Genencor was established in 1982 as a joint venture between Genentech Inc. and Corning Incorporated. Since its founding, Genencor has grown to become a leading biotechnology company, with over $315 million in year 2000 revenues, more than 250 biotechnology products in commerce, and over 3,400 owned and licensed patents and applications. Genencor, with more than 1,500 employees worldwide, has principal offices in Palo Alto, California; Rochester, New York, and Leiden, the Netherlands.
Safe Harbor Statement under the US Private Securities Litigation Reform Act of 1995: Some or all of the statements in this document that relate to future plans, expectations, events, performances and the like are forward- looking statements, as defined in the US Private Securities Litigation Reform Act of 1995. Actual results of events could differ materially from those described in the forward-looking statements due to a variety of factors, including those set forth in the Company`s filings with the US Securities and Exchange Commission.
SOURCE: Xenova Group plc
Xenova Group plc: US$105m (75m Pounds) North American Collaboration With QLT Inc for Multi-Drug Resistance Modulator XR9576
SLOUGH, England, Aug 13, 2001 /PRNewswire via COMTEX/ -- Xenova Group plc (Nasdaq: XNVA; London Stock Exchange: XEN) today announces that it has signed an exclusive licence agreement with Vancouver-based QLT Inc (Nasdaq: QLTI; TSE: QLT) for the development and for the marketing in the United States, Canada and Mexico of Xenova`s multi-drug resistance (MDR) modulator, XR9576, for the treatment of MDR in cancer.
In selecting the most suitable development and commercialization partner for XR9576 and in line with its goal of maximizing the product`s potential in the market, Xenova`s objective was to find a partner that has a commitment with respect to oncology, possesses strong clinical development expertise, the financial resources to fully support the program and, most importantly, does not have a vested interest in a particular chemotherapeutic agent which might present it with a conflict in terms of maximally exploiting XR9576`s potential.
QLT is a world leader in photodynamic therapy (PDT) using light-activated drugs to treat eye disease and various cancers. Based in Vancouver, Canada, and founded in 1981, QLT discovered and developed Photofrin(R), the world`s first PDT drug used in cancer, and Visudyne(TM), a PDT drug for the treatment of wet, age related macular degeneration which is partnered with Novartis AG and approved in almost 50 countries around the world. QLT has stated its objective is to build an integrated biopharmaceutical company and will use this opportunity to establish an oncology franchise.
Under the terms of the agreement, QLT will assume responsibility for the further development of XR9576, including Phase III trials, all regulatory filings and the manufacture and sale of XR9576 within those territories covered by the agreement. QLT will make an immediate upfront license payment of US$10m (7.1m pounds sterling) to Xenova and will provide up to US$45m (32.0m pounds) in funding for all development activities related to Phase III clinical studies for XR9576 in North America and Europe. Milestones of up to US$50m (35.6m pounds) and royalties in the range of 15 to 22 per cent depending on the level of North American sales are also receivable by Xenova.
Xenova retains all rights to XR9576 outside the United States, Canada and Mexico, including European and Rest of World marketing rights.
Xenova has obtained US FDA agreement to proceed with Phase III development for XR9576. QLT will adopt and refine the clinical plan and the Phase III program is expected to begin in the first half of 2002 once the clinical study protocol is finalized. It is anticipated that QLT will file for marketing approval of XR9576 in first line treatment in combination with chemotherapy in advanced non-small cell lung cancer (NSCLC) in 2005.
NSCLC is the first of several indications in which XR9576 will be investigated. Other potential cancer indications include breast, ovarian, acute myeloid leukemia, sarcoma and colorectal.
David Oxlade, Chief Executive of Xenova, commented:
"This deal with QLT allows us to proceed as planned with pivotal studies in Europe and the US, and gives us a strong development partner with a commitment to establishing a dedicated oncology marketing and infrastructure in the US.
"Importantly, this deal retains for Xenova all rights to XR9576 in Europe and the Rest of the World and, as we move towards obtaining marketing approvals, we shall be establishing further commercial partnerships to maximize the value of this important new therapeutic approach."
Julia Levy, President and CEO of QLT, said:
"This collaboration underlines QLT`s commitment to oncology and to expand beyond photodynamic therapy and supports our longer term plan to become a fully integrated biopharmaceutical company with a North American sales force.
"Our internal evaluation of this product confirms that XR9576 is the leading MDR inhibitor in development based on its potency, selectivity and stage of development. We have proven our drug development capabilities with the commercialization of Visudyne(TM) and Photofrin(R) and look forward to applying our expertise to the development of XR9576 in an area with such a high unmet clinical need."
Notes to Editors
Xenova Group plc`s product pipeline focuses principally on the therapeutic areas of cancer, with a secondary focus on infectious, autoimmune and cardiovascular diseases. The Group has a well-established track record in the identification, development and partnering of innovative products and technologies and has partnerships with a number of major pharmaceutical companies including GlaxoSmithKline, Lilly, Pfizer and Celltech.
XR9576
One of the major barriers to successful cancer chemotherapy is the development by cancer cells of resistance to those drugs being used for treatment. XR9576 targets this drug resistance mechanism through the inhibition of P-glycoprotein, a membrane based "pump" that acts to expel the cytotoxic drug from the tumour cell, preventing the cytotoxic drug from being fully effective. XR9576 has completed a series of three separate Phase IIa trials, in which XR9576 was administered together with three of the world`s best-selling cytotoxic drugs, each of which is known to be affected by the resistance mechanism. The successful outcome of these trials was announced in late 2000/early 2001. The trials demonstrated that the combination of XR9576 with the cytotoxic drug was safe and well tolerated and that no clinically significant pharmacokinetic interaction occurred between XR9576 and the cytotoxic drug. This allows the cytotoxic drug to be administered at or close to its full normal clinical dose, which is of potentially significant therapeutic benefit. A number of complete and partial responses (elimination or shrinkage of the tumor) were observed to occur during these open label and uncontrolled studies.
For further information about Xenova and its products please visit the Xenova website at http://www.xenova.co.uk.
QLT Inc is a world leader in photodynamic therapy, a field of medicine utilizing light-activated drugs in the treatment of disease. QLT`s innovative science has led to the development and commercialization of breakthrough treatments utilizing this technology for applications in ophthalmology and oncology and is exploring the potential in other diseases. For more information you are invited to visit QLT`s website at http://www.qltinc.com.
Visudyne(TM) is a trademark of Novartis AG
PHOTOFRIN(R) is a registered trademark of Axcan Pharma
Safe Harbor Statement under the US Private Securities Litigation Reform Act of 1995: Some or all of the statements in this document that relate to future plans, expectations, events, performances and the like are forward-looking statements, as defined in the US Private Securities Litigation Reform Act of 1995. Actual results of events could differ materially from those described in the forward-looking statements due to a variety of factors, including those set forth in the Company`s filings with the US Securities and Exchange Commission.
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SLOUGH, England, Aug 13, 2001 /PRNewswire via COMTEX/ -- Xenova Group plc (Nasdaq: XNVA; London Stock Exchange: XEN) today announces that it has signed an exclusive licence agreement with Vancouver-based QLT Inc (Nasdaq: QLTI; TSE: QLT) for the development and for the marketing in the United States, Canada and Mexico of Xenova`s multi-drug resistance (MDR) modulator, XR9576, for the treatment of MDR in cancer.
In selecting the most suitable development and commercialization partner for XR9576 and in line with its goal of maximizing the product`s potential in the market, Xenova`s objective was to find a partner that has a commitment with respect to oncology, possesses strong clinical development expertise, the financial resources to fully support the program and, most importantly, does not have a vested interest in a particular chemotherapeutic agent which might present it with a conflict in terms of maximally exploiting XR9576`s potential.
QLT is a world leader in photodynamic therapy (PDT) using light-activated drugs to treat eye disease and various cancers. Based in Vancouver, Canada, and founded in 1981, QLT discovered and developed Photofrin(R), the world`s first PDT drug used in cancer, and Visudyne(TM), a PDT drug for the treatment of wet, age related macular degeneration which is partnered with Novartis AG and approved in almost 50 countries around the world. QLT has stated its objective is to build an integrated biopharmaceutical company and will use this opportunity to establish an oncology franchise.
Under the terms of the agreement, QLT will assume responsibility for the further development of XR9576, including Phase III trials, all regulatory filings and the manufacture and sale of XR9576 within those territories covered by the agreement. QLT will make an immediate upfront license payment of US$10m (7.1m pounds sterling) to Xenova and will provide up to US$45m (32.0m pounds) in funding for all development activities related to Phase III clinical studies for XR9576 in North America and Europe. Milestones of up to US$50m (35.6m pounds) and royalties in the range of 15 to 22 per cent depending on the level of North American sales are also receivable by Xenova.
Xenova retains all rights to XR9576 outside the United States, Canada and Mexico, including European and Rest of World marketing rights.
Xenova has obtained US FDA agreement to proceed with Phase III development for XR9576. QLT will adopt and refine the clinical plan and the Phase III program is expected to begin in the first half of 2002 once the clinical study protocol is finalized. It is anticipated that QLT will file for marketing approval of XR9576 in first line treatment in combination with chemotherapy in advanced non-small cell lung cancer (NSCLC) in 2005.
NSCLC is the first of several indications in which XR9576 will be investigated. Other potential cancer indications include breast, ovarian, acute myeloid leukemia, sarcoma and colorectal.
David Oxlade, Chief Executive of Xenova, commented:
"This deal with QLT allows us to proceed as planned with pivotal studies in Europe and the US, and gives us a strong development partner with a commitment to establishing a dedicated oncology marketing and infrastructure in the US.
"Importantly, this deal retains for Xenova all rights to XR9576 in Europe and the Rest of the World and, as we move towards obtaining marketing approvals, we shall be establishing further commercial partnerships to maximize the value of this important new therapeutic approach."
Julia Levy, President and CEO of QLT, said:
"This collaboration underlines QLT`s commitment to oncology and to expand beyond photodynamic therapy and supports our longer term plan to become a fully integrated biopharmaceutical company with a North American sales force.
"Our internal evaluation of this product confirms that XR9576 is the leading MDR inhibitor in development based on its potency, selectivity and stage of development. We have proven our drug development capabilities with the commercialization of Visudyne(TM) and Photofrin(R) and look forward to applying our expertise to the development of XR9576 in an area with such a high unmet clinical need."
Notes to Editors
Xenova Group plc`s product pipeline focuses principally on the therapeutic areas of cancer, with a secondary focus on infectious, autoimmune and cardiovascular diseases. The Group has a well-established track record in the identification, development and partnering of innovative products and technologies and has partnerships with a number of major pharmaceutical companies including GlaxoSmithKline, Lilly, Pfizer and Celltech.
XR9576
One of the major barriers to successful cancer chemotherapy is the development by cancer cells of resistance to those drugs being used for treatment. XR9576 targets this drug resistance mechanism through the inhibition of P-glycoprotein, a membrane based "pump" that acts to expel the cytotoxic drug from the tumour cell, preventing the cytotoxic drug from being fully effective. XR9576 has completed a series of three separate Phase IIa trials, in which XR9576 was administered together with three of the world`s best-selling cytotoxic drugs, each of which is known to be affected by the resistance mechanism. The successful outcome of these trials was announced in late 2000/early 2001. The trials demonstrated that the combination of XR9576 with the cytotoxic drug was safe and well tolerated and that no clinically significant pharmacokinetic interaction occurred between XR9576 and the cytotoxic drug. This allows the cytotoxic drug to be administered at or close to its full normal clinical dose, which is of potentially significant therapeutic benefit. A number of complete and partial responses (elimination or shrinkage of the tumor) were observed to occur during these open label and uncontrolled studies.
For further information about Xenova and its products please visit the Xenova website at http://www.xenova.co.uk.
QLT Inc is a world leader in photodynamic therapy, a field of medicine utilizing light-activated drugs in the treatment of disease. QLT`s innovative science has led to the development and commercialization of breakthrough treatments utilizing this technology for applications in ophthalmology and oncology and is exploring the potential in other diseases. For more information you are invited to visit QLT`s website at http://www.qltinc.com.
Visudyne(TM) is a trademark of Novartis AG
PHOTOFRIN(R) is a registered trademark of Axcan Pharma
Safe Harbor Statement under the US Private Securities Litigation Reform Act of 1995: Some or all of the statements in this document that relate to future plans, expectations, events, performances and the like are forward-looking statements, as defined in the US Private Securities Litigation Reform Act of 1995. Actual results of events could differ materially from those described in the forward-looking statements due to a variety of factors, including those set forth in the Company`s filings with the US Securities and Exchange Commission.
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Xenova: Interim Results Announcement 2001
SLOUGH, England, Aug 13, 2001 /PRNewswire via COMTEX/ -- Xenova Group plc`s announced today:
* Multi-drug resistance program - US$105m (75m pounds) North American
collaboration with QLT Inc for multi-drug resistance modulator XR9576
- See separate press announcement
* US$21m (15m pounds) license and collaboration agreement signed between
Phogen (Xenova`s Joint Venture with Marie Curie Cancer Care) with
Genencor International Inc
- See separate press announcement
* Product pipeline - strategic review and update
Half Year Highlights:
* Completion of merger with Cantab Pharmaceuticals plc
* Cancer: Multi-drug resistance program
- Positive data from Phase IIa Vinorelbine study
* Addiction: Cocaine program
- Positive Phase IIa study results
* Cash and liquid resources as at 30 June 2001 18.1m pounds (US$25.4m)
Commenting, Chief Executive Officer, David Oxlade said:
"The XR9576 deal announced today with QLT allows us to proceed as planned with pivotal studies in Europe and the US, and gives us a strong development partner with a commitment to establishing a dedicated oncology marketing and sales infrastructure in the US.
"In addition, we are very pleased to be able to announce the Phogen relationship with Genencor, which represents an important step in realizing the potential of Phogen`s drug delivery enhancing technology.
"Our recent strategic review, which followed our merger with Cantab, has resulted in a company with a focused pipeline and an emphasis on cancer. We are most encouraged by the progress made by our products in the year to date. With four products in or having completed Phase II trials and a further four in or having completed Phase I, our product pipeline is progressing as planned."
Notes to Editors
Xenova Group plc`s product pipeline focuses principally on the therapeutic area of cancer, with a secondary focus on infectious, autoimmune and cardiovascular diseases. The Group has a well-established track record in the identification, development and partnering of innovative products and technologies and has partnerships with a number of major pharmaceutical companies including Glaxo SmithKline, Lilly, Pfizer and Celltech.
For further information about Xenova and its products please visit the Xenova website at http://www.xenova.co.uk.
Safe Harbor Statement under the US Private Securities Litigation Reform Act of 1995: Some or all of the statements in this document that relate to future plans, expectations, events, performances and the like are forward- looking statements, as defined in the US Private Securities Litigation Reform Act of 1995. Actual results of events could differ materially from those described in the forward-looking statements due to a variety of factors, including those set forth in the Company`s filings with the US Securities and Exchange Commission.
Chairman`s Statement
During the first six months of 2001 Xenova has made considerable progress. We have broadened our pipeline through our merger with Cantab Pharmaceuticals plc (`Cantab`), seen the positive development of a number of products through the clinic, rationalized our cost base and we have today signed two important collaborations, which we believe will produce significant value for our shareholders.
Following completion of the merger with Cantab, we have undertaken a wide-ranging strategic review. Our primary product focus remains oncology, with a secondary focus on infectious, autoimmune and cardiovascular diseases. For each program we have a specific commercial and partnering strategy, based on an assessment of the program`s commercial value, risk profile and technological status. Further details of the R&D review can be found in the Product Pipeline Update section of this report and is summarized as follows:
Medium Term Value Realization Existing
R&D Focus Opportunities Corporate
Partnerships
Cancer: Development: QLT - XR9576
Multi Drug DISC-PRO Genencor - VP22
Resistance - MRP TA-HPV/TA-CIN (Phogen)
Cytoreduction - Dual (following Phase II GlaxoSmithKline
Topiosomerase prime/boost study) - TA-HSV
Inhibitors (XR11576) TA-NIC (with Phase I Lilly
Angiogenesis - PAI-1 data) - PAI-Cardiovascular
Immunostimulation Research: Celltech - OX40
- DISC-GMCSF, OX40L CTB-Men.B (Autoimmune Disease)
Other: Autoimmunity DISC-Neuro Pfizer - Bovine
- OX40, M3 DISC-CMV and Feline Herpes
Infectious Disease NIDA - TA-CD
- OX40L
The implementation of the strategic review, together with the elimination of duplicated activities and other efficiency improvements made since the merger with Cantab, will result in a significant reduction in overall cash burn. Net cost savings of up to 2m pounds ($2.8m) are anticipated in the second half of 2001, which on an annualized basis are of the order of 9m pounds ($12.7m).
Merger with Cantab Pharmaceuticals plc
It was announced on 19 February 2001 that we had agreed terms for a merger with Cantab and the merger was declared unconditional on 6 April. Cantab`s shares were delisted from the London Stock Exchange on 9 May and its ADRs were delisted from the Nasdaq exchange on 19 July. Following the merger, former Cantab directors Nick Hart, Stephen Inglis and John St Clair Roberts joined the Xenova board as Commercial Director, Executive Director (Research Collaborations) and Medical Director respectively. Former Cantab non-executive Director Gerard Fairtlough has also joined the Xenova Board in a non-executive capacity and heads Xenova`s Remuneration Committee.
Product Pipeline Update - Clinical Trials
Cancer:
XR9576 - XR9576, a potent small-molecule inhibitor of the P-glycoprotein pump, has completed a series of three Phase IIa open label studies. The studies showed that the combination of XR9576 with the cytotoxic drugs vinorelbine, doxorubicin and paclitaxel respectively was well tolerated. In the paclitaxel trial, which was conducted in twelve patients with recurring ovarian cancer, following independent assessment of responses, four patients were judged to have obtained a partial remission and one patient a complete disease remission. The twenty-five patient vinorelbine study concluded that XR9576 is a potent P-glycoprotein antagonist, without significant side effects, and without clinically significant pharmacokinetic (drug:drug) interference. The results of these two trials were presented at the 2001 annual meeting of the American Society of Clinical Oncology, in San Francisco, California, USA. Positive results of the XR9576/doxorubicin trial were announced in late 2000.
Xenova has been in discussions with the US FDA and with a number of regulatory agencies in Europe with respect to the further development of this compound and the establishment of pivotal Phase III registration studies in these countries.
As separately announced today, Xenova has entered into an agreement with QLT Inc for the development and North American marketing of XR9576. This agreement could be worth up to 75m pounds (US$105m) for Xenova in the form of license and milestone payments and research and development funding to gain product marketing approval. QLT Inc. will provide up to $45m (32m pounds) in funding for all development activities related to Phase III clinical studies for XR9576 in North America and Europe up to a total of 32m pounds (US$45m). Royalties in the range of 15 to 22 per cent, depending on the level of North American sales, are also payable to Xenova. Xenova retains the rights to commercialize XR9576 in Europe and the Rest of the World and intends to establish further collaborations to maximize the value of this potentially first-in-class drug.
DISC-GMCSF - Immunotherapy is a key area of Xenova`s research. DISC-GMCSF, an innovative immunotherapeutic vaccine, is designed as a treatment for a broad range of solid tumors. DISC-GMCSF delivers the gene for the expression of GM-CSF, a potent stimulator of anti-tumor immune responses, direct to the tumor site through the use of a disabled virus vector (DISC) and is administered using direct injection. DISC-GMCSF is currently undergoing a Phase I clinical trial at three centers in the UK, in patients with metastatic melanoma. In preclinical studies DISC-GMCSF was shown to be effective in models of breast and colorectal cancer. Results of the Phase I trial are expected in early 2002.
TA-HPV/TA-CIN - TA-HPV is an immunotherapeutic vaccine, designed to prevent the recurrence of cervical cancer. The product is being developed as a therapeutic vaccine to be used alongside standard treatments, such as surgery, for cervical cancer. TA-HPV is currently in two open label, physician sponsored Phase II clinical trials. TA-CIN is a recombinant fusion protein, designed as a treatment for women with cervical dysplasia. TA-CIN has completed a double blind, randomized, placebo-controlled and dose-escalating Phase I trial to assess the product`s safety and immunogenicity. TA-CIN was found to be very well tolerated with no serious adverse events reported during the trial. It was also found to be immunogenic.
Preclinical studies have suggested that use of these two products in combination results in a greatly enhanced immune response. A `prime-boost` study is planned to investigate this immunization regimen in the clinic. Open label, physician sponsored trials, targeting the treatment of HPV associated ano-genital neoplasias, are expected to begin in late 2001. We intend to seek a partner for the further development of this program.
Infectious Diseases:
DISC-PRO - A prophylactic vaccine designed to prevent genital and oro-labial herpes, DISC-PRO has completed Phase I trials. These Phase I trials demonstrated that DISC-PRO was well tolerated and immunogenic. We expect to secure a corporate partner ahead of Phase III clinical trials for the further development of this program.
TA-HSV - TA-HSV is a vaccine designed for the treatment of recurrent genital herpes. It is currently undergoing Phase II clinical trials with our partner, GlaxoSmithKline. Results are awaited, and we anticipate that these will be announced in November 2001, following review by GlaxoSmithKline.
Addiction:
TA-CD - TA-CD is a vaccine for the treatment of cocaine addiction for which a Phase IIa clinical trial, supported by the US National Institute on Drug Abuse (NIDA), has recently been completed. The successful results of this trial, which was designed to evaluate the safety and immunogenicity of the vaccine, were announced in July 2001. Attenuation of the usual euphoric effects of cocaine was reported amongst patients who relapsed during the study, providing anecdotal evidence of the benefit TA-CD may provide. A new Phase II `Challenge` study, funded by NIDA, is expected to begin towards the end of 2001. This study is designed to provide an assessment of the efficacy of TA-CD, as determined by quantitative behavioral and other measurements.
Product Pipeline Review and Update - Preclinical
Cancer:
XR11576 - XR11576, a novel, orally administrable dual topoisomerase inhibitor, is designed for the treatment of common solid tumors. XR11576, which was discovered and developed by Xenova in collaboration with the Auckland Cancer Research Laboratory, New Zealand, has a significantly improved biological profile when compared with first generation topoisomerase inhibitors, including oral bioavailability and a marked enhancement of potency. Topoisomerase inhibition remains the focus of Xenova`s cytoreductive approach to cancer. It is planned for this program to enter Phase I clinical trials in the latter part of 2001.
XR5944 - XR5944 is a further second generation intravenous dual topoisomerase I/II inhibitor drug candidate, which complements the XR11576 program. XR5944 has shown exceptionally high potency as a cytotoxic agent in preclinical studies with a number of tumor cell lines. It is structurally distinct from XR11576 and has been shown to be unaffected by atypical multi-drug resistance mechanisms.
PAI-Cancer - In collaboration with the Institute for Cancer Research, we are developing an active novel inhibitor of a protein released by platelets and the cells lining the blood vessels and known as PAI-1. PAI is targeted at the treatment and prevention of metastatic cancer. Lilly has an option to acquire exclusive rights to develop and commercialize PAI-1 inhibitors in the cancer field, which, if exercised, would realize an upfront and milestone payments of up to $16.5m, with additional royalties payable on commercialized products.
OX40L - We have demonstrated that a product candidate for OX40L (a ligand known to bind to the OX40 receptor) has anti-tumor activity in preclinical models and work is now underway to test the product in a broader range of disease models.
MRP - Multi-Drug Resistance Protein (MRP) acts as a pump which, like the p-glycoprotein pump, expels small molecules out of cells and thus can help protect tumor cells from certain chemotherapeutic agents. We are currently carrying out a lead optimization program for a compound for the inhibition of MRP to further strengthen our position in the field of multi-drug resistance.
Other:
TA-NIC - Designed as a treatment for nicotine dependence, TA-NIC is a nicotine conjugate vaccine which is administered through a course of intramuscular injections. The vaccine will prime the immune system to produce anti-nicotine antibodies and, on smoking a cigarette, the nicotine will bind to these antibodies, which are too large to cross the blood-brain barrier, thus reducing or removing the pleasurable stimulus which usually accompanies smoking. It is expected that TA-NIC will enter Phase I clinical trials towards the end of 2001. We intend to seek a partner for the further development of this program following the availability of data from the Phase I study.
OX40 - OX40 is a platform technology which is capable of producing multiple drug candidates primarily targeting cancer and autoimmune disease. A partnership has been established with Celltech Group plc to develop an antibody-based product against OX40 for the treatment of autoimmune disease.
M3 - M3 is a viral protein with the capacity to bind to a broad range of chemokines which have multiple biological functions, including mediation of inflammation and promotion of angiogenesis. Consequently, chemokine inhibition is a potential approach to treatment of a wide range of diseases. Work is in progress in several preclinical models to evaluate potential efficacy.
PAI-CV - In conjunction with our partner Lilly, we are carrying out a research and development program for the development of a new class of oral antithrombotic drugs suitable for chronic use. Research is focused on the development of small molecule inhibitors of PAI-1 that are designed to enhance the break-up of blood clots without the bleeding side-effects of other marketed antithrombotic drugs. Xenova and Lilly entered into this collaboration in 1998.
DISC-VET - DISC-VET is currently undergoing development for the treatment of multiple diseases in animals. A product candidate, DISC-BHV, for the treatment of bovine herpes virus induced respiratory disease in cattle, is in development in partnership with Pfizer.
Phogen:
An equal voting rights joint venture between Xenova and Marie Curie Cancer Care, Phogen Limited is developing a novel technology, known as VP22, for the enhanced delivery of gene-based therapeutics. It was announced today that Phogen has entered into a 15m pounds ($21m) licensing agreement with Genencor International Inc, for the utilization of Phogen`s VP22 technology in the area of therapeutic vaccines for certain infectious viral diseases. Phogen will receive 1.2m pounds ($1.7m) in the first year in license, option and contract research payments. In addition, Genencor has an opt-in provision for additional therapeutic vaccine products in the field of infectious viral diseases and cancer. Phogen intends to seek further partnering opportunities for its novel technologies.
Data relating to VP22 were published in the 4 May 2001 issue of the Journal of Biological Chemistry, and highlighted the light-activated properties of the technology. This property is of particular interest for cell-based screens and assays and for photodynamic therapy, allowing the targeted delivery of test molecules to specific cells and/or tissues.
Financial Summary
Acquisition of Cantab Pharmaceuticals plc
On 6 April 2001, the Group announced the successful completion of the merger with Cantab. The Xenova shares issued and to be issued as consideration to Cantab shareholders to enable Xenova to acquire 100% of Cantab were valued at 49p on 5 April 2001, valuing Cantab at 34.2m pounds ($48.1m). With 16.8m pounds ($23.7m) of cash and liquid resources, this effectively valued the technology and other assets in Cantab at 17.4m pounds ($24.5m).
In addition to acquiring Cantab and its UK trading company Cantab Pharmaceuticals Research Limited (now renamed Xenova Research Limited), the Group acquired as part of this transaction the 45% equity share in Phogen referred to elsewhere in this announcement.
Operating Performance
Consolidated into the Group`s results from 6 April 2001, the acquired Cantab business has contributed to a net loss per share of 6p, which compares with the net loss per share in the same period in 2000 of 7p.
In the 6 months to 30 June 2001 the Group`s revenue, arising from the acquired Cantab business, increased to 0.5m pounds ($0.7m) (2000: 0.1m pounds, $0.1m). With ongoing partnerships with GlaxoSmithKline, Lilly, Pfizer and Celltech, revenues in the period primarily reflect the continued Phase II clinical trial work with GlaxoSmithKline in respect of the TA-HSV program.
Total research and development (R&D) expenditure of 6.6m pounds ($9.3m) (2000: 3.2m pounds, $4.4m) relates to the preclinical development of the second-generation topoisomerase program and the completion of Phase II clinical development of XR9576 plus R&D expenditure in respect of the acquired Cantab business of 2.9m pounds ($4.0m). Cantab Research and Development expenditure reflects the ongoing pre-clinical and clinical developments, and includes the cost of the Group`s own clinical trial manufacturing facility.
Total administrative expenses of 2.3m pounds ($3.2m) have increased by 1.5m pounds ($2.1m) from the prior period partly due to the one-off costs of both integrating the Cantab business and relocating the Slough based operations to improved facilities. Included within administrative expenses are the exceptional costs, primarily severance pay of 0.7m pounds ($0.9m), in respect of the reorganization performed in the second quarter.
Amortization costs of 0.3m pounds ($0.4m) relate to the amortization of goodwill arising upon acquisition of the Cantab business of 11.7m pounds ($16.5m), which is being amortized over the 10 year estimated useful life of the business.
The increased net interest income reflects the increased cash and liquid resources balance held throughout the period. Following the rise since 31 December 2000 in the listed market price of the 88,668 Cubist Pharmaceuticals shares held by the Group, 0.7m pounds ($0.9m) has been written back to the profit and loss account to mark the shares held to their market price.
Subsequent Events
XR9576: On 13 August 2001 an agreement was signed with QLT Inc. to license XR9576. Under the terms of this agreement, Xenova could receive up to 42.7 million pounds (US$60m) in the form of upfront, license and milestone payments. In addition QLT Inc. will support development of Phase III trials up to a value of 32 million pounds (US$45m). Xenova will also receive royalties on future North American sales in the range of 15 to 22 per cent.
Phogen: On 13 August 2001 an agreement was signed between the Group`s 45% joint venture, Phogen, and Genencor International Inc. to license the VP22 technology. Under the terms of this agreement, Phogen could receive over 15 million pounds ($21 million) in the form of license, option and milestone payments plus research and development funding. In addition, Phogen will receive royalties on future sales.
Reorganization
Since April this year, the Group has made significant progress towards the integration of the Xenova and Cantab businesses. As part of this process, the Group has consolidated all head office functions and administrative services in order to maximize the costs savings achieved by the enlarged Group. Surplus building space will be sublet to minimize the Group`s ongoing commitments. In addition, the Group is currently reviewing opportunities to exploit excess manufacturing capacity.
As part of the strategic review of both the research and development pipeline and other activities, announced on 21 June 2001, 45 positions have been lost across both the head office and research and development functions. Included within the administrative expenses for this period is 0.7m pounds ($0.9m) in respect of the severance payments payable.
As a result of the product pipeline announcements and the integration measures already undertaken, the Group anticipates making up to 2m pounds ($2.8m) of net cost savings in the second half of this year, which on an annualized basis are of the order of up to 9m pounds ($12.7m).
Cash and liquid investments
Cash and liquid resources at 30 June 2001 totaled 18.1m pounds ($25.4m) (2000: 6.2m pounds ($8.7m)).
Cash of 15.7m pounds ($22.0m) and liquid resources of 2.4m pounds ($3.4m) at 30 June 2001 (2000: cash 6.2m pounds ($8.7m), liquid resources nil) remain despite both the exceptional facilities relocation expenditure of 2.2m pounds ($3.1m) and the Cantab related transaction costs paid to 30 June 2001 of 1.8m pounds ($2.5m). Transaction costs paid by both Cantab and Xenova total 3.5m pounds ($4.9m).
As a result of today`s collaboration announcement with QLT Inc., Xenova will receive 7.2m pounds ($10m) during 2001.
Based upon the expected monthly cash burn rate for the second half of the year, the cash and liquid resources are sufficient to fund current operations for in excess of a year.
Revenue recognition policy
In accordance with emerging best practice on revenue recognition, the Group has adopted a modified accounting policy from 1 January 2001. This policy states that license fees and milestone payments will be spread over the life of the relevant agreement in proportion to the work performed by the Group, but be limited to the non refundable amounts actually received.
Share capital
The number of shares in issue and to be issued rose to 139.0 million as at 30 June 2001, from 69.2 million at 31 December 2000, due principally to the 69.8 million shares provided in consideration for the Cantab business acquired.
As at 30 June 2001, 11.5 million warrants from the July 2000 Placing and Open Offer were outstanding, exercisable at 85p up to 31 October 2001. The Group could potentially raise a further 9.8m pounds upon the exercise of these warrants.
Die Zahlen veröffentlich ich hier nicht, denn W:0 kann diese nicht automatisch in Spaltenform erscheinen lassen. Würde somit viel zu unübersichtlich werden. Die Zahlen werden sicherlich auch unter der Xenova-website ersichtlich sein.
These unaudited interim statements, which do not constitute statutory accounts within the meaning of Section 240 of the Companies Act 1985, have been prepared using the accounting policies set out in the Group`s 2000 Annual Report and Accounts except as set out below. The 2000 Annual Report and Accounts received an unqualified auditor`s report and have been delivered to the Registrar of Companies.
These consolidated financial statements have been prepared to include the revenues, costs and cash flows of the Cantab Pharmaceuticals Plc (`Cantab`) group from 6 April 2001, using acquisition accounting principles (Note 2).
Following the acquisition of Cantab the Group has adopted the following accounting policy in respect of intangible fixed assets. Goodwill arising from the purchase of subsidiary undertakings, representing the difference between the fair value of the purchase consideration and the fair value of the net assets acquired, is capitalized as an intangible asset and amortized on a straight line basis over its estimated useful economic life. Goodwill similarly arising on the acquisition of associates or joint ventures is recorded as part of the related investment.
Other intangible fixed assets, including acquired intellectual property, are capitalized at cost and amortized on a straight line basis over the estimated useful economic life of the asset, having taken into account the risk factors associated with developing a pharmaceutical product.
In accordance with emerging best practice on revenue recognition, the Group has adopted a modified accounting policy from 1 January 2001. This policy states that license fees and milestone payments are spread over the life of the relevant agreement in proportion to the work performed by the Group, but is limited to the non refundable amounts received. The revenue recognized in 2000, under the former policy of recognizing such payments on receipt, would not have been materially different under the revised accounting policy adopted from 2001.
There have been no other changes to the Group`s accounting policies in 2001.
Notes to the Interim Statement (continued)
(2) Acquisition of Cantab Pharmaceuticals plc
On 6 April 2001 the Group announced the successful merger with Cantab. Under the terms of the offer made to Cantab shareholders, 11 shares in Xenova Group plc were issued in exchange for 7 shares held in Cantab. On this basis Cantab was valued on 5 April 2001 at #34.2m based upon a closing Xenova Group plc share price of 49p.
Details of the book value and provisional fair value of the assets and liabilities of Cantab as at 6 April 2001 are set out below:
Hier fehlt wieder eine kleine Tabelle, wie oben
There have been no accounting policy adjustments made to the balance sheet values stated at 6 April 2001. Intangible assets acquired comprised license fees which have not been capitalized separately from goodwill. In addition to the 768,000 pounds of acquisition expenses paid, share issue costs of 864,000 pounds were incurred.
In accordance with the accounting policy set out in the basis of preparation note, the goodwill arising on the acquisition has been capitalized and amortized over the 10 year estimated useful life of the acquired business.
In addition to the planned acquisition of 100% of Cantab Pharmaceuticals plc and the UK trading company Cantab Research Limited (now renamed Xenova Research Limited), the Group acquires as part of this transaction, a 45% share in Phogen, a joint venture with Marie Curie Cancer Care.
As part of the strategic review of both the research and development pipeline and other activities, announced on 21 June 2001, 45 positions have been lost across both the head office and research and development functions. Included within the administrative expenses for this period is 0.7m pounds ($0.9m) in respect of the severance payments payable.
The audited consolidated results of the Cantab Pharmaceuticals plc group for the year ended 31 December 2000, including the Group`s share of Phogen, included revenues of 8,403,000 pounds, an operating loss of 6,452,000 pounds and a net loss of 3,913,000 pounds. Consolidated net assets of the Cantab group at 31 December 2000 stood at 28,374,000 pounds of which 15,257,000 pounds comprised cash and liquid resources.
Notes to the Interim Statement (continued)
(3) Amounts written back on investments
The 675,000 pounds written back on investments reflects the unrealized gain on the Group`s holding of 88,668 Cubist Pharmaceutical shares following a rise in the listed market price since 31 December 2000.
(4) Taxation
Following the changes introduced as part of the Finance Act 2000 in respect of Scientific Research Allowances (now renamed `Research and Development Allowances`), the Group has recognized the R&D tax credit in respect of the first half of the year that will be received in 2002.
Hier fehlt wieder eine kleine Tabelle, wie oben
XR9576
On 13 August 2001 an agreement was signed with QLT Inc. to license the XR9576 product. Under the terms of this agreement, Xenova could receive up to 42.7 million pounds in the form of license and milestone payments. In addition QLT Inc. will support development of Phase III trials up to a value of 32 million pounds. Xenova will receive royalties on future sales.
Phogen
On 13 August 2001 an agreement was signed between the Group`s 45% joint venture Phogen and Genencor International Inc. to license the VP22 technology. Under the terms of this agreement, Phogen could receive up to 15.3 million pounds in the form of license, option and milestone payments plus research and development funding. In addition Phogen will receive royalties on future sales.
(8) Going concern
The Group is an emerging pharmaceutical business and as such expects to absorb cash until products are commercialized. The Directors have a reasonable expectation that the Group has, or can reasonably expect to obtain, adequate cash resources to enable it to continue in operational existence for the foreseeable future, and have therefore prepared the financial statements on the going concern basis.
Independent review report to Xenova Group plc
Introduction
We have been instructed by the company to review the financial information which comprises the consolidated profit and loss account, consolidated statement of total recognized gains and losses, consolidated balance sheet, consolidated cash flow statement, reconciliation of net cash flow to movement in net funds and notes 1 to 8 thereto. We have read the other information contained in the interim report and considered whether it contains any apparent misstatements or material inconsistencies with the financial information.
Directors` responsibilities
The interim report, including the financial information contained therein, is the responsibility of, and has been approved by the directors. The directors are responsible for preparing the interim report in accordance with the Listing Rules of the Financial Services Authority which require that the accounting policies and presentation applied to the interim figures should be consistent with those applied in preparing the preceding annual accounts except where any changes, and the reasons for them, are disclosed.
Review work performed
We conducted our review in accordance with guidance contained in Bulletin 1999/4 issued by the Auditing Practices Board for use in the United Kingdom. A review consists principally of making enquiries of Xenova Group plc management and applying analytical procedures to the financial information and underlying financial data and, based thereon, assessing whether the accounting policies and presentation have been consistently applied unless otherwise disclosed. A review excludes audit procedures such as tests of controls and verification of assets, liabilities and transactions. It is substantially less in scope than an audit performed in accordance with United Kingdom Auditing Standards and therefore provides a lower level of assurance than an audit. Accordingly we do not express an audit opinion on the financial information.
Review conclusion
On the basis of our review we are not aware of any material modifications that should be made to the financial information as presented for the six months ended 30 June 2001.
PricewaterhouseCoopers
Chartered Accountants
Uxbridge
13 August 2001
MAKE YOUR OPINION COUNT - Click Here
http://tbutton.prnewswire.com/prn/11690X82742158
SLOUGH, England, Aug 13, 2001 /PRNewswire via COMTEX/ -- Xenova Group plc`s announced today:
* Multi-drug resistance program - US$105m (75m pounds) North American
collaboration with QLT Inc for multi-drug resistance modulator XR9576
- See separate press announcement
* US$21m (15m pounds) license and collaboration agreement signed between
Phogen (Xenova`s Joint Venture with Marie Curie Cancer Care) with
Genencor International Inc
- See separate press announcement
* Product pipeline - strategic review and update
Half Year Highlights:
* Completion of merger with Cantab Pharmaceuticals plc
* Cancer: Multi-drug resistance program
- Positive data from Phase IIa Vinorelbine study
* Addiction: Cocaine program
- Positive Phase IIa study results
* Cash and liquid resources as at 30 June 2001 18.1m pounds (US$25.4m)
Commenting, Chief Executive Officer, David Oxlade said:
"The XR9576 deal announced today with QLT allows us to proceed as planned with pivotal studies in Europe and the US, and gives us a strong development partner with a commitment to establishing a dedicated oncology marketing and sales infrastructure in the US.
"In addition, we are very pleased to be able to announce the Phogen relationship with Genencor, which represents an important step in realizing the potential of Phogen`s drug delivery enhancing technology.
"Our recent strategic review, which followed our merger with Cantab, has resulted in a company with a focused pipeline and an emphasis on cancer. We are most encouraged by the progress made by our products in the year to date. With four products in or having completed Phase II trials and a further four in or having completed Phase I, our product pipeline is progressing as planned."
Notes to Editors
Xenova Group plc`s product pipeline focuses principally on the therapeutic area of cancer, with a secondary focus on infectious, autoimmune and cardiovascular diseases. The Group has a well-established track record in the identification, development and partnering of innovative products and technologies and has partnerships with a number of major pharmaceutical companies including Glaxo SmithKline, Lilly, Pfizer and Celltech.
For further information about Xenova and its products please visit the Xenova website at http://www.xenova.co.uk.
Safe Harbor Statement under the US Private Securities Litigation Reform Act of 1995: Some or all of the statements in this document that relate to future plans, expectations, events, performances and the like are forward- looking statements, as defined in the US Private Securities Litigation Reform Act of 1995. Actual results of events could differ materially from those described in the forward-looking statements due to a variety of factors, including those set forth in the Company`s filings with the US Securities and Exchange Commission.
Chairman`s Statement
During the first six months of 2001 Xenova has made considerable progress. We have broadened our pipeline through our merger with Cantab Pharmaceuticals plc (`Cantab`), seen the positive development of a number of products through the clinic, rationalized our cost base and we have today signed two important collaborations, which we believe will produce significant value for our shareholders.
Following completion of the merger with Cantab, we have undertaken a wide-ranging strategic review. Our primary product focus remains oncology, with a secondary focus on infectious, autoimmune and cardiovascular diseases. For each program we have a specific commercial and partnering strategy, based on an assessment of the program`s commercial value, risk profile and technological status. Further details of the R&D review can be found in the Product Pipeline Update section of this report and is summarized as follows:
Medium Term Value Realization Existing
R&D Focus Opportunities Corporate
Partnerships
Cancer: Development: QLT - XR9576
Multi Drug DISC-PRO Genencor - VP22
Resistance - MRP TA-HPV/TA-CIN (Phogen)
Cytoreduction - Dual (following Phase II GlaxoSmithKline
Topiosomerase prime/boost study) - TA-HSV
Inhibitors (XR11576) TA-NIC (with Phase I Lilly
Angiogenesis - PAI-1 data) - PAI-Cardiovascular
Immunostimulation Research: Celltech - OX40
- DISC-GMCSF, OX40L CTB-Men.B (Autoimmune Disease)
Other: Autoimmunity DISC-Neuro Pfizer - Bovine
- OX40, M3 DISC-CMV and Feline Herpes
Infectious Disease NIDA - TA-CD
- OX40L
The implementation of the strategic review, together with the elimination of duplicated activities and other efficiency improvements made since the merger with Cantab, will result in a significant reduction in overall cash burn. Net cost savings of up to 2m pounds ($2.8m) are anticipated in the second half of 2001, which on an annualized basis are of the order of 9m pounds ($12.7m).
Merger with Cantab Pharmaceuticals plc
It was announced on 19 February 2001 that we had agreed terms for a merger with Cantab and the merger was declared unconditional on 6 April. Cantab`s shares were delisted from the London Stock Exchange on 9 May and its ADRs were delisted from the Nasdaq exchange on 19 July. Following the merger, former Cantab directors Nick Hart, Stephen Inglis and John St Clair Roberts joined the Xenova board as Commercial Director, Executive Director (Research Collaborations) and Medical Director respectively. Former Cantab non-executive Director Gerard Fairtlough has also joined the Xenova Board in a non-executive capacity and heads Xenova`s Remuneration Committee.
Product Pipeline Update - Clinical Trials
Cancer:
XR9576 - XR9576, a potent small-molecule inhibitor of the P-glycoprotein pump, has completed a series of three Phase IIa open label studies. The studies showed that the combination of XR9576 with the cytotoxic drugs vinorelbine, doxorubicin and paclitaxel respectively was well tolerated. In the paclitaxel trial, which was conducted in twelve patients with recurring ovarian cancer, following independent assessment of responses, four patients were judged to have obtained a partial remission and one patient a complete disease remission. The twenty-five patient vinorelbine study concluded that XR9576 is a potent P-glycoprotein antagonist, without significant side effects, and without clinically significant pharmacokinetic (drug:drug) interference. The results of these two trials were presented at the 2001 annual meeting of the American Society of Clinical Oncology, in San Francisco, California, USA. Positive results of the XR9576/doxorubicin trial were announced in late 2000.
Xenova has been in discussions with the US FDA and with a number of regulatory agencies in Europe with respect to the further development of this compound and the establishment of pivotal Phase III registration studies in these countries.
As separately announced today, Xenova has entered into an agreement with QLT Inc for the development and North American marketing of XR9576. This agreement could be worth up to 75m pounds (US$105m) for Xenova in the form of license and milestone payments and research and development funding to gain product marketing approval. QLT Inc. will provide up to $45m (32m pounds) in funding for all development activities related to Phase III clinical studies for XR9576 in North America and Europe up to a total of 32m pounds (US$45m). Royalties in the range of 15 to 22 per cent, depending on the level of North American sales, are also payable to Xenova. Xenova retains the rights to commercialize XR9576 in Europe and the Rest of the World and intends to establish further collaborations to maximize the value of this potentially first-in-class drug.
DISC-GMCSF - Immunotherapy is a key area of Xenova`s research. DISC-GMCSF, an innovative immunotherapeutic vaccine, is designed as a treatment for a broad range of solid tumors. DISC-GMCSF delivers the gene for the expression of GM-CSF, a potent stimulator of anti-tumor immune responses, direct to the tumor site through the use of a disabled virus vector (DISC) and is administered using direct injection. DISC-GMCSF is currently undergoing a Phase I clinical trial at three centers in the UK, in patients with metastatic melanoma. In preclinical studies DISC-GMCSF was shown to be effective in models of breast and colorectal cancer. Results of the Phase I trial are expected in early 2002.
TA-HPV/TA-CIN - TA-HPV is an immunotherapeutic vaccine, designed to prevent the recurrence of cervical cancer. The product is being developed as a therapeutic vaccine to be used alongside standard treatments, such as surgery, for cervical cancer. TA-HPV is currently in two open label, physician sponsored Phase II clinical trials. TA-CIN is a recombinant fusion protein, designed as a treatment for women with cervical dysplasia. TA-CIN has completed a double blind, randomized, placebo-controlled and dose-escalating Phase I trial to assess the product`s safety and immunogenicity. TA-CIN was found to be very well tolerated with no serious adverse events reported during the trial. It was also found to be immunogenic.
Preclinical studies have suggested that use of these two products in combination results in a greatly enhanced immune response. A `prime-boost` study is planned to investigate this immunization regimen in the clinic. Open label, physician sponsored trials, targeting the treatment of HPV associated ano-genital neoplasias, are expected to begin in late 2001. We intend to seek a partner for the further development of this program.
Infectious Diseases:
DISC-PRO - A prophylactic vaccine designed to prevent genital and oro-labial herpes, DISC-PRO has completed Phase I trials. These Phase I trials demonstrated that DISC-PRO was well tolerated and immunogenic. We expect to secure a corporate partner ahead of Phase III clinical trials for the further development of this program.
TA-HSV - TA-HSV is a vaccine designed for the treatment of recurrent genital herpes. It is currently undergoing Phase II clinical trials with our partner, GlaxoSmithKline. Results are awaited, and we anticipate that these will be announced in November 2001, following review by GlaxoSmithKline.
Addiction:
TA-CD - TA-CD is a vaccine for the treatment of cocaine addiction for which a Phase IIa clinical trial, supported by the US National Institute on Drug Abuse (NIDA), has recently been completed. The successful results of this trial, which was designed to evaluate the safety and immunogenicity of the vaccine, were announced in July 2001. Attenuation of the usual euphoric effects of cocaine was reported amongst patients who relapsed during the study, providing anecdotal evidence of the benefit TA-CD may provide. A new Phase II `Challenge` study, funded by NIDA, is expected to begin towards the end of 2001. This study is designed to provide an assessment of the efficacy of TA-CD, as determined by quantitative behavioral and other measurements.
Product Pipeline Review and Update - Preclinical
Cancer:
XR11576 - XR11576, a novel, orally administrable dual topoisomerase inhibitor, is designed for the treatment of common solid tumors. XR11576, which was discovered and developed by Xenova in collaboration with the Auckland Cancer Research Laboratory, New Zealand, has a significantly improved biological profile when compared with first generation topoisomerase inhibitors, including oral bioavailability and a marked enhancement of potency. Topoisomerase inhibition remains the focus of Xenova`s cytoreductive approach to cancer. It is planned for this program to enter Phase I clinical trials in the latter part of 2001.
XR5944 - XR5944 is a further second generation intravenous dual topoisomerase I/II inhibitor drug candidate, which complements the XR11576 program. XR5944 has shown exceptionally high potency as a cytotoxic agent in preclinical studies with a number of tumor cell lines. It is structurally distinct from XR11576 and has been shown to be unaffected by atypical multi-drug resistance mechanisms.
PAI-Cancer - In collaboration with the Institute for Cancer Research, we are developing an active novel inhibitor of a protein released by platelets and the cells lining the blood vessels and known as PAI-1. PAI is targeted at the treatment and prevention of metastatic cancer. Lilly has an option to acquire exclusive rights to develop and commercialize PAI-1 inhibitors in the cancer field, which, if exercised, would realize an upfront and milestone payments of up to $16.5m, with additional royalties payable on commercialized products.
OX40L - We have demonstrated that a product candidate for OX40L (a ligand known to bind to the OX40 receptor) has anti-tumor activity in preclinical models and work is now underway to test the product in a broader range of disease models.
MRP - Multi-Drug Resistance Protein (MRP) acts as a pump which, like the p-glycoprotein pump, expels small molecules out of cells and thus can help protect tumor cells from certain chemotherapeutic agents. We are currently carrying out a lead optimization program for a compound for the inhibition of MRP to further strengthen our position in the field of multi-drug resistance.
Other:
TA-NIC - Designed as a treatment for nicotine dependence, TA-NIC is a nicotine conjugate vaccine which is administered through a course of intramuscular injections. The vaccine will prime the immune system to produce anti-nicotine antibodies and, on smoking a cigarette, the nicotine will bind to these antibodies, which are too large to cross the blood-brain barrier, thus reducing or removing the pleasurable stimulus which usually accompanies smoking. It is expected that TA-NIC will enter Phase I clinical trials towards the end of 2001. We intend to seek a partner for the further development of this program following the availability of data from the Phase I study.
OX40 - OX40 is a platform technology which is capable of producing multiple drug candidates primarily targeting cancer and autoimmune disease. A partnership has been established with Celltech Group plc to develop an antibody-based product against OX40 for the treatment of autoimmune disease.
M3 - M3 is a viral protein with the capacity to bind to a broad range of chemokines which have multiple biological functions, including mediation of inflammation and promotion of angiogenesis. Consequently, chemokine inhibition is a potential approach to treatment of a wide range of diseases. Work is in progress in several preclinical models to evaluate potential efficacy.
PAI-CV - In conjunction with our partner Lilly, we are carrying out a research and development program for the development of a new class of oral antithrombotic drugs suitable for chronic use. Research is focused on the development of small molecule inhibitors of PAI-1 that are designed to enhance the break-up of blood clots without the bleeding side-effects of other marketed antithrombotic drugs. Xenova and Lilly entered into this collaboration in 1998.
DISC-VET - DISC-VET is currently undergoing development for the treatment of multiple diseases in animals. A product candidate, DISC-BHV, for the treatment of bovine herpes virus induced respiratory disease in cattle, is in development in partnership with Pfizer.
Phogen:
An equal voting rights joint venture between Xenova and Marie Curie Cancer Care, Phogen Limited is developing a novel technology, known as VP22, for the enhanced delivery of gene-based therapeutics. It was announced today that Phogen has entered into a 15m pounds ($21m) licensing agreement with Genencor International Inc, for the utilization of Phogen`s VP22 technology in the area of therapeutic vaccines for certain infectious viral diseases. Phogen will receive 1.2m pounds ($1.7m) in the first year in license, option and contract research payments. In addition, Genencor has an opt-in provision for additional therapeutic vaccine products in the field of infectious viral diseases and cancer. Phogen intends to seek further partnering opportunities for its novel technologies.
Data relating to VP22 were published in the 4 May 2001 issue of the Journal of Biological Chemistry, and highlighted the light-activated properties of the technology. This property is of particular interest for cell-based screens and assays and for photodynamic therapy, allowing the targeted delivery of test molecules to specific cells and/or tissues.
Financial Summary
Acquisition of Cantab Pharmaceuticals plc
On 6 April 2001, the Group announced the successful completion of the merger with Cantab. The Xenova shares issued and to be issued as consideration to Cantab shareholders to enable Xenova to acquire 100% of Cantab were valued at 49p on 5 April 2001, valuing Cantab at 34.2m pounds ($48.1m). With 16.8m pounds ($23.7m) of cash and liquid resources, this effectively valued the technology and other assets in Cantab at 17.4m pounds ($24.5m).
In addition to acquiring Cantab and its UK trading company Cantab Pharmaceuticals Research Limited (now renamed Xenova Research Limited), the Group acquired as part of this transaction the 45% equity share in Phogen referred to elsewhere in this announcement.
Operating Performance
Consolidated into the Group`s results from 6 April 2001, the acquired Cantab business has contributed to a net loss per share of 6p, which compares with the net loss per share in the same period in 2000 of 7p.
In the 6 months to 30 June 2001 the Group`s revenue, arising from the acquired Cantab business, increased to 0.5m pounds ($0.7m) (2000: 0.1m pounds, $0.1m). With ongoing partnerships with GlaxoSmithKline, Lilly, Pfizer and Celltech, revenues in the period primarily reflect the continued Phase II clinical trial work with GlaxoSmithKline in respect of the TA-HSV program.
Total research and development (R&D) expenditure of 6.6m pounds ($9.3m) (2000: 3.2m pounds, $4.4m) relates to the preclinical development of the second-generation topoisomerase program and the completion of Phase II clinical development of XR9576 plus R&D expenditure in respect of the acquired Cantab business of 2.9m pounds ($4.0m). Cantab Research and Development expenditure reflects the ongoing pre-clinical and clinical developments, and includes the cost of the Group`s own clinical trial manufacturing facility.
Total administrative expenses of 2.3m pounds ($3.2m) have increased by 1.5m pounds ($2.1m) from the prior period partly due to the one-off costs of both integrating the Cantab business and relocating the Slough based operations to improved facilities. Included within administrative expenses are the exceptional costs, primarily severance pay of 0.7m pounds ($0.9m), in respect of the reorganization performed in the second quarter.
Amortization costs of 0.3m pounds ($0.4m) relate to the amortization of goodwill arising upon acquisition of the Cantab business of 11.7m pounds ($16.5m), which is being amortized over the 10 year estimated useful life of the business.
The increased net interest income reflects the increased cash and liquid resources balance held throughout the period. Following the rise since 31 December 2000 in the listed market price of the 88,668 Cubist Pharmaceuticals shares held by the Group, 0.7m pounds ($0.9m) has been written back to the profit and loss account to mark the shares held to their market price.
Subsequent Events
XR9576: On 13 August 2001 an agreement was signed with QLT Inc. to license XR9576. Under the terms of this agreement, Xenova could receive up to 42.7 million pounds (US$60m) in the form of upfront, license and milestone payments. In addition QLT Inc. will support development of Phase III trials up to a value of 32 million pounds (US$45m). Xenova will also receive royalties on future North American sales in the range of 15 to 22 per cent.
Phogen: On 13 August 2001 an agreement was signed between the Group`s 45% joint venture, Phogen, and Genencor International Inc. to license the VP22 technology. Under the terms of this agreement, Phogen could receive over 15 million pounds ($21 million) in the form of license, option and milestone payments plus research and development funding. In addition, Phogen will receive royalties on future sales.
Reorganization
Since April this year, the Group has made significant progress towards the integration of the Xenova and Cantab businesses. As part of this process, the Group has consolidated all head office functions and administrative services in order to maximize the costs savings achieved by the enlarged Group. Surplus building space will be sublet to minimize the Group`s ongoing commitments. In addition, the Group is currently reviewing opportunities to exploit excess manufacturing capacity.
As part of the strategic review of both the research and development pipeline and other activities, announced on 21 June 2001, 45 positions have been lost across both the head office and research and development functions. Included within the administrative expenses for this period is 0.7m pounds ($0.9m) in respect of the severance payments payable.
As a result of the product pipeline announcements and the integration measures already undertaken, the Group anticipates making up to 2m pounds ($2.8m) of net cost savings in the second half of this year, which on an annualized basis are of the order of up to 9m pounds ($12.7m).
Cash and liquid investments
Cash and liquid resources at 30 June 2001 totaled 18.1m pounds ($25.4m) (2000: 6.2m pounds ($8.7m)).
Cash of 15.7m pounds ($22.0m) and liquid resources of 2.4m pounds ($3.4m) at 30 June 2001 (2000: cash 6.2m pounds ($8.7m), liquid resources nil) remain despite both the exceptional facilities relocation expenditure of 2.2m pounds ($3.1m) and the Cantab related transaction costs paid to 30 June 2001 of 1.8m pounds ($2.5m). Transaction costs paid by both Cantab and Xenova total 3.5m pounds ($4.9m).
As a result of today`s collaboration announcement with QLT Inc., Xenova will receive 7.2m pounds ($10m) during 2001.
Based upon the expected monthly cash burn rate for the second half of the year, the cash and liquid resources are sufficient to fund current operations for in excess of a year.
Revenue recognition policy
In accordance with emerging best practice on revenue recognition, the Group has adopted a modified accounting policy from 1 January 2001. This policy states that license fees and milestone payments will be spread over the life of the relevant agreement in proportion to the work performed by the Group, but be limited to the non refundable amounts actually received.
Share capital
The number of shares in issue and to be issued rose to 139.0 million as at 30 June 2001, from 69.2 million at 31 December 2000, due principally to the 69.8 million shares provided in consideration for the Cantab business acquired.
As at 30 June 2001, 11.5 million warrants from the July 2000 Placing and Open Offer were outstanding, exercisable at 85p up to 31 October 2001. The Group could potentially raise a further 9.8m pounds upon the exercise of these warrants.
Die Zahlen veröffentlich ich hier nicht, denn W:0 kann diese nicht automatisch in Spaltenform erscheinen lassen. Würde somit viel zu unübersichtlich werden. Die Zahlen werden sicherlich auch unter der Xenova-website ersichtlich sein.
These unaudited interim statements, which do not constitute statutory accounts within the meaning of Section 240 of the Companies Act 1985, have been prepared using the accounting policies set out in the Group`s 2000 Annual Report and Accounts except as set out below. The 2000 Annual Report and Accounts received an unqualified auditor`s report and have been delivered to the Registrar of Companies.
These consolidated financial statements have been prepared to include the revenues, costs and cash flows of the Cantab Pharmaceuticals Plc (`Cantab`) group from 6 April 2001, using acquisition accounting principles (Note 2).
Following the acquisition of Cantab the Group has adopted the following accounting policy in respect of intangible fixed assets. Goodwill arising from the purchase of subsidiary undertakings, representing the difference between the fair value of the purchase consideration and the fair value of the net assets acquired, is capitalized as an intangible asset and amortized on a straight line basis over its estimated useful economic life. Goodwill similarly arising on the acquisition of associates or joint ventures is recorded as part of the related investment.
Other intangible fixed assets, including acquired intellectual property, are capitalized at cost and amortized on a straight line basis over the estimated useful economic life of the asset, having taken into account the risk factors associated with developing a pharmaceutical product.
In accordance with emerging best practice on revenue recognition, the Group has adopted a modified accounting policy from 1 January 2001. This policy states that license fees and milestone payments are spread over the life of the relevant agreement in proportion to the work performed by the Group, but is limited to the non refundable amounts received. The revenue recognized in 2000, under the former policy of recognizing such payments on receipt, would not have been materially different under the revised accounting policy adopted from 2001.
There have been no other changes to the Group`s accounting policies in 2001.
Notes to the Interim Statement (continued)
(2) Acquisition of Cantab Pharmaceuticals plc
On 6 April 2001 the Group announced the successful merger with Cantab. Under the terms of the offer made to Cantab shareholders, 11 shares in Xenova Group plc were issued in exchange for 7 shares held in Cantab. On this basis Cantab was valued on 5 April 2001 at #34.2m based upon a closing Xenova Group plc share price of 49p.
Details of the book value and provisional fair value of the assets and liabilities of Cantab as at 6 April 2001 are set out below:
Hier fehlt wieder eine kleine Tabelle, wie oben
There have been no accounting policy adjustments made to the balance sheet values stated at 6 April 2001. Intangible assets acquired comprised license fees which have not been capitalized separately from goodwill. In addition to the 768,000 pounds of acquisition expenses paid, share issue costs of 864,000 pounds were incurred.
In accordance with the accounting policy set out in the basis of preparation note, the goodwill arising on the acquisition has been capitalized and amortized over the 10 year estimated useful life of the acquired business.
In addition to the planned acquisition of 100% of Cantab Pharmaceuticals plc and the UK trading company Cantab Research Limited (now renamed Xenova Research Limited), the Group acquires as part of this transaction, a 45% share in Phogen, a joint venture with Marie Curie Cancer Care.
As part of the strategic review of both the research and development pipeline and other activities, announced on 21 June 2001, 45 positions have been lost across both the head office and research and development functions. Included within the administrative expenses for this period is 0.7m pounds ($0.9m) in respect of the severance payments payable.
The audited consolidated results of the Cantab Pharmaceuticals plc group for the year ended 31 December 2000, including the Group`s share of Phogen, included revenues of 8,403,000 pounds, an operating loss of 6,452,000 pounds and a net loss of 3,913,000 pounds. Consolidated net assets of the Cantab group at 31 December 2000 stood at 28,374,000 pounds of which 15,257,000 pounds comprised cash and liquid resources.
Notes to the Interim Statement (continued)
(3) Amounts written back on investments
The 675,000 pounds written back on investments reflects the unrealized gain on the Group`s holding of 88,668 Cubist Pharmaceutical shares following a rise in the listed market price since 31 December 2000.
(4) Taxation
Following the changes introduced as part of the Finance Act 2000 in respect of Scientific Research Allowances (now renamed `Research and Development Allowances`), the Group has recognized the R&D tax credit in respect of the first half of the year that will be received in 2002.
Hier fehlt wieder eine kleine Tabelle, wie oben
XR9576
On 13 August 2001 an agreement was signed with QLT Inc. to license the XR9576 product. Under the terms of this agreement, Xenova could receive up to 42.7 million pounds in the form of license and milestone payments. In addition QLT Inc. will support development of Phase III trials up to a value of 32 million pounds. Xenova will receive royalties on future sales.
Phogen
On 13 August 2001 an agreement was signed between the Group`s 45% joint venture Phogen and Genencor International Inc. to license the VP22 technology. Under the terms of this agreement, Phogen could receive up to 15.3 million pounds in the form of license, option and milestone payments plus research and development funding. In addition Phogen will receive royalties on future sales.
(8) Going concern
The Group is an emerging pharmaceutical business and as such expects to absorb cash until products are commercialized. The Directors have a reasonable expectation that the Group has, or can reasonably expect to obtain, adequate cash resources to enable it to continue in operational existence for the foreseeable future, and have therefore prepared the financial statements on the going concern basis.
Independent review report to Xenova Group plc
Introduction
We have been instructed by the company to review the financial information which comprises the consolidated profit and loss account, consolidated statement of total recognized gains and losses, consolidated balance sheet, consolidated cash flow statement, reconciliation of net cash flow to movement in net funds and notes 1 to 8 thereto. We have read the other information contained in the interim report and considered whether it contains any apparent misstatements or material inconsistencies with the financial information.
Directors` responsibilities
The interim report, including the financial information contained therein, is the responsibility of, and has been approved by the directors. The directors are responsible for preparing the interim report in accordance with the Listing Rules of the Financial Services Authority which require that the accounting policies and presentation applied to the interim figures should be consistent with those applied in preparing the preceding annual accounts except where any changes, and the reasons for them, are disclosed.
Review work performed
We conducted our review in accordance with guidance contained in Bulletin 1999/4 issued by the Auditing Practices Board for use in the United Kingdom. A review consists principally of making enquiries of Xenova Group plc management and applying analytical procedures to the financial information and underlying financial data and, based thereon, assessing whether the accounting policies and presentation have been consistently applied unless otherwise disclosed. A review excludes audit procedures such as tests of controls and verification of assets, liabilities and transactions. It is substantially less in scope than an audit performed in accordance with United Kingdom Auditing Standards and therefore provides a lower level of assurance than an audit. Accordingly we do not express an audit opinion on the financial information.
Review conclusion
On the basis of our review we are not aware of any material modifications that should be made to the financial information as presented for the six months ended 30 June 2001.
PricewaterhouseCoopers
Chartered Accountants
Uxbridge
13 August 2001
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Dienstag 14. August 2001, 17:47 Uhr
Genencor erweitert seine therapeutische Impfstoff-Plattform durch exklusives Lizenzabkommen mit Phogen
Die beiden Unternehmen vereinbarten außerdem eine Zusammenarbeit zur Entwicklung eine neuen Methode zur Zellversorgung von DNA-basierten Impfstoffen
Palo Alto, California, USA, und Cambridge, England - Das Unternehmen Genencor International Inc. (Nasdaq: GCOR) gab heute bekannt, dass es dem Aufbau einer hervorragenden Impfstoff-Plattform durch die Erteilung einer exklusiven weltweiten Konzession an die VP22-Technologie von Phogen zur Entwicklung therapeutischer Impfstoffe der zweiten Generation zur Behandlung infektiöser Viruserkrankungen einen Schritt näher gekommen sei. Zunächst wird Genencor die V22-Gentechnologie von Phogen für Impfungen gegen Krankheiten wie Hepatitis C (HCV), Hepatitis B (HBV) und humanes Papillomavirus (HPV) prüfen. Genencor wird die Exklusivrechte für die Vermarktung dieser Ziele mit der Option auf den Erwerb der Rechte zur Verwendung der Technologie für zusätzliche Impfstoffe im Bereich infektiöse Viruserkrankungen und Krebs haben. Außerdem arbeiten Genencor und Phogen zusammen an der Entwicklung der Vektorapplikation von VP22 zur Verbesserung von DNA-basierten Impfungen.
Phogen wird eine Lizenzgebühr als Sofortzahlung sowie F+E-Finanzierung, jährliche Lizenzunterhaltungsgebühren und Prämien bei der Realisierung klinischer Ziele erhalten. Insgesamt wird der Lizenzvertrag mit Genencor Phogen voraussichtliche Erträge von über 21 Millionen US-Dollar einbringen, zusätzlich zu Tantiemen bei der Markteinführung von Produkten.
Die VP22-Technologie von Phogen erlaubt den direkten Übergang von Peptiden und Proteinen von einer Zelle in eine benachbarte, womit die Wirkstoff-Versorgung von DNA-basierten Impfstoffen verbessert wird. Damit kann eventuell eine der derzeit größten Herausforderungen im Bereich Gen- und Molekularmedizin, nämlich die Versorgung einer ausreichenden Anzahl von Zellen mit dem gewünschten Gen oder Protein zur Realisierung einer therapeutischen Antwort, gelöst werden. Zusätzlich zur intrazellulären Versorgung können DNA-basierte Impfstoffe auch mit Aggregaten oder Vektoren kombiniert werden, wobei das Protein VP22 zur Verkapselung des Vakzine-Konstrukts verwendet wird. Diese Formel bietet potenzielle klinische Vorteile.
"Wir waren von den präklinischen Daten von Phogen sehr beeindruckt und unabhängige Laboratorien überzeugten uns von der Wichtigkeit der Integration des VP22-Gens in ein Vakzine-Konstrukt. Im Vergleich zu anderen intrazellulären Versorgungsstrategien, die in Tests mit Mäusen untersucht wurden, ist Phogens Technologie unserer Meinung nach sehr vielversprechend", sagte Dr. Debby Jo Blank, Chief Business Officer of Health Care bei Genencor. "Die Beifügung dieser neuen Technologie zu unserem eigenen Immunologie- und Proteintechnologie-Portfolio gibt uns die Möglichkeit, die Wirksamkeit unserer führenden Vakzine-Produktkandidaten zu optimieren."
Dr. Elizabeth Rollinson, Commercial Director bei Phogen, sagte: "Wir glauben, dass der Zugang zur VP22-Technologie für Genencor einen wichtigen Vorteil bei der Entwicklung seiner ausgewählten therapeutischen Impfstoffe bedeutet. Das kommerzielle Potential dieses Abkommens ist erheblich und stellt dennoch nur einen kleinen Teil der gesamten Bandbreite von Möglichkeiten dar, die die VP22-Technologie bietet. Diese Vereinbarung stellt für uns also eine wichtige Basis für die Weiterentwicklung des großen Potentials der Drug-Delivery-Technologie bei Phogen dar."
Als Teil seiner Tätigkeit im Bereich Gesundheitsvorsorge entwickelt Genencor derzeit eine therapeutische State-of-the-Art-Impfstoff-Plattform. Im Juli gab das Unternehmen seine Zusammenarbeit mit Epimmune zur Entwicklung von Impfstoffen gegen HCV, HBV und HPV bekannt. Die Beifügung der VP22-Technologie von Phogen stellt ein weiteres Schlüsselelement in der Entwicklung dieser Plattform dar. Dr. Blank sagte: "Die Entwicklung therapeutischer Impfstoffe bietet noch unerschlossenes Marktpotential und wir glauben, dass wir durch unser Fachwissen in den Bereichen Immunologie und Protein-Technologie sowie durch Abkommen zur Zusammenarbeit wie dem Vorliegenden und möglichen weiteren einen großen Marktvorteil erlangen können.
Über Phogen
Phogen ist ein 1997 gegründetes Biopharmazieunternehmen mit Sitz in Großbritannien, das auf dem Protein VP22 basierende Technologie zur Verbesserung der Drug- und Gen-Delivery entwickelt und vermarktet. Das Unternehmen ist ein Joint Venture aus der Xenova Group plc (Nasdaq: XNVA; LSE: XEN) und Marie Curie Cancer Care (MCCC), der größten Organisation zur Krebsbekämpfung in Großbritannien. Die VP22-Technologie bietet ein großes Anwendungspotential für die Verbesserung sowohl einer wirksamen Gen-Delivery als auch für die lichtaktivierte intrazelluläre Delivery von Oligonukleotiden, Proteinen und Peptiden.
Über Genencor
Genencor International ist ein diversifiziertes Biotechnologie-Unternehmen, das innovative Produkte für den Gesundheits-, Landwirtschafts- und Industriechemikalienmarkt entwickelt. Unter Einsatz einer integrierten Palette von technologischen Plattformen erzeugt Genencor Produkte, die innovative und umweltfreundliche Lösungen für viele Probleme des täglichen Lebens bieten.
Genencor wurde 1982 als Joint Venture von Genentech Inc. und Corning Incorporated gegründet. Inzwischen hat sich Genencor zu einem führenden biotechnologischen Unternehmen entwickelt, mit Jahreseinnahmen von mehr als 315 Millionen Dollar, einem derzeitigen Handelsangebot vom über 250 biotechnologischen Produkten sowie mehr als 3.400 eigenen und lizenzierten Patenten und Anwendungen. Das Unternehmen beschäftigt weltweit über 1.500 Mitarbeiter und betreibt Geschäftszentralen im kalifornischen Palo Alto, in Rochester, New York, und im niederländischen Leiden.
Abgesehen von den in dieser Pressemitteilung enthaltenen historischen Informationen kann sie auch in die Zukunft gerichtete Aussagen umfassen, die Risiken und Unwägbarkeiten unterliegen, die im Zusammenhang stehen mit erheblichen Schwankungen der Produktleistung durch die Abhängigkeit von Dritten, neuen und unsicheren, von Genencor verwendeten Technologien und deren unsichere Anwendung auf neue Geschäftsbereiche, dem Versäumnis, Produkte für den Gesundheitsmarkt zu entwickeln, der Unfähigkeit, bestimmte Transaktionen durchzuführen oder das Ausbleiben erwarteter Gewinne aus Akquisitionen, der Abhängigkeit von intellektuellen Eigentumsrechten, der Tatsache, dass Genencor gegen andere Wettbewerber seines Industriezweigs zu bestehen hat und den in Zusammenhang mit dem Veralten bestimmter Technologien stehenden Risiken. Die tatsächlichen Ergebnisse können erheblich von den angekündigten abweichen. Die in die Zukunft gerichteten Aussagen entsprechen den Einschätzungen von Genencor zum Zeitpunkt der Veröffentlichung dieser Pressemitteilung. Genencor lehnt jedoch jede Verantwortung oder Verpflichtung für die Aktualisierung der in die Zukunft gerichteten Aussagen ab.
Internet: http://www.genencor.com
Gruß Bogo!
Genencor erweitert seine therapeutische Impfstoff-Plattform durch exklusives Lizenzabkommen mit Phogen
Die beiden Unternehmen vereinbarten außerdem eine Zusammenarbeit zur Entwicklung eine neuen Methode zur Zellversorgung von DNA-basierten Impfstoffen
Palo Alto, California, USA, und Cambridge, England - Das Unternehmen Genencor International Inc. (Nasdaq: GCOR) gab heute bekannt, dass es dem Aufbau einer hervorragenden Impfstoff-Plattform durch die Erteilung einer exklusiven weltweiten Konzession an die VP22-Technologie von Phogen zur Entwicklung therapeutischer Impfstoffe der zweiten Generation zur Behandlung infektiöser Viruserkrankungen einen Schritt näher gekommen sei. Zunächst wird Genencor die V22-Gentechnologie von Phogen für Impfungen gegen Krankheiten wie Hepatitis C (HCV), Hepatitis B (HBV) und humanes Papillomavirus (HPV) prüfen. Genencor wird die Exklusivrechte für die Vermarktung dieser Ziele mit der Option auf den Erwerb der Rechte zur Verwendung der Technologie für zusätzliche Impfstoffe im Bereich infektiöse Viruserkrankungen und Krebs haben. Außerdem arbeiten Genencor und Phogen zusammen an der Entwicklung der Vektorapplikation von VP22 zur Verbesserung von DNA-basierten Impfungen.
Phogen wird eine Lizenzgebühr als Sofortzahlung sowie F+E-Finanzierung, jährliche Lizenzunterhaltungsgebühren und Prämien bei der Realisierung klinischer Ziele erhalten. Insgesamt wird der Lizenzvertrag mit Genencor Phogen voraussichtliche Erträge von über 21 Millionen US-Dollar einbringen, zusätzlich zu Tantiemen bei der Markteinführung von Produkten.
Die VP22-Technologie von Phogen erlaubt den direkten Übergang von Peptiden und Proteinen von einer Zelle in eine benachbarte, womit die Wirkstoff-Versorgung von DNA-basierten Impfstoffen verbessert wird. Damit kann eventuell eine der derzeit größten Herausforderungen im Bereich Gen- und Molekularmedizin, nämlich die Versorgung einer ausreichenden Anzahl von Zellen mit dem gewünschten Gen oder Protein zur Realisierung einer therapeutischen Antwort, gelöst werden. Zusätzlich zur intrazellulären Versorgung können DNA-basierte Impfstoffe auch mit Aggregaten oder Vektoren kombiniert werden, wobei das Protein VP22 zur Verkapselung des Vakzine-Konstrukts verwendet wird. Diese Formel bietet potenzielle klinische Vorteile.
"Wir waren von den präklinischen Daten von Phogen sehr beeindruckt und unabhängige Laboratorien überzeugten uns von der Wichtigkeit der Integration des VP22-Gens in ein Vakzine-Konstrukt. Im Vergleich zu anderen intrazellulären Versorgungsstrategien, die in Tests mit Mäusen untersucht wurden, ist Phogens Technologie unserer Meinung nach sehr vielversprechend", sagte Dr. Debby Jo Blank, Chief Business Officer of Health Care bei Genencor. "Die Beifügung dieser neuen Technologie zu unserem eigenen Immunologie- und Proteintechnologie-Portfolio gibt uns die Möglichkeit, die Wirksamkeit unserer führenden Vakzine-Produktkandidaten zu optimieren."
Dr. Elizabeth Rollinson, Commercial Director bei Phogen, sagte: "Wir glauben, dass der Zugang zur VP22-Technologie für Genencor einen wichtigen Vorteil bei der Entwicklung seiner ausgewählten therapeutischen Impfstoffe bedeutet. Das kommerzielle Potential dieses Abkommens ist erheblich und stellt dennoch nur einen kleinen Teil der gesamten Bandbreite von Möglichkeiten dar, die die VP22-Technologie bietet. Diese Vereinbarung stellt für uns also eine wichtige Basis für die Weiterentwicklung des großen Potentials der Drug-Delivery-Technologie bei Phogen dar."
Als Teil seiner Tätigkeit im Bereich Gesundheitsvorsorge entwickelt Genencor derzeit eine therapeutische State-of-the-Art-Impfstoff-Plattform. Im Juli gab das Unternehmen seine Zusammenarbeit mit Epimmune zur Entwicklung von Impfstoffen gegen HCV, HBV und HPV bekannt. Die Beifügung der VP22-Technologie von Phogen stellt ein weiteres Schlüsselelement in der Entwicklung dieser Plattform dar. Dr. Blank sagte: "Die Entwicklung therapeutischer Impfstoffe bietet noch unerschlossenes Marktpotential und wir glauben, dass wir durch unser Fachwissen in den Bereichen Immunologie und Protein-Technologie sowie durch Abkommen zur Zusammenarbeit wie dem Vorliegenden und möglichen weiteren einen großen Marktvorteil erlangen können.
Über Phogen
Phogen ist ein 1997 gegründetes Biopharmazieunternehmen mit Sitz in Großbritannien, das auf dem Protein VP22 basierende Technologie zur Verbesserung der Drug- und Gen-Delivery entwickelt und vermarktet. Das Unternehmen ist ein Joint Venture aus der Xenova Group plc (Nasdaq: XNVA; LSE: XEN) und Marie Curie Cancer Care (MCCC), der größten Organisation zur Krebsbekämpfung in Großbritannien. Die VP22-Technologie bietet ein großes Anwendungspotential für die Verbesserung sowohl einer wirksamen Gen-Delivery als auch für die lichtaktivierte intrazelluläre Delivery von Oligonukleotiden, Proteinen und Peptiden.
Über Genencor
Genencor International ist ein diversifiziertes Biotechnologie-Unternehmen, das innovative Produkte für den Gesundheits-, Landwirtschafts- und Industriechemikalienmarkt entwickelt. Unter Einsatz einer integrierten Palette von technologischen Plattformen erzeugt Genencor Produkte, die innovative und umweltfreundliche Lösungen für viele Probleme des täglichen Lebens bieten.
Genencor wurde 1982 als Joint Venture von Genentech Inc. und Corning Incorporated gegründet. Inzwischen hat sich Genencor zu einem führenden biotechnologischen Unternehmen entwickelt, mit Jahreseinnahmen von mehr als 315 Millionen Dollar, einem derzeitigen Handelsangebot vom über 250 biotechnologischen Produkten sowie mehr als 3.400 eigenen und lizenzierten Patenten und Anwendungen. Das Unternehmen beschäftigt weltweit über 1.500 Mitarbeiter und betreibt Geschäftszentralen im kalifornischen Palo Alto, in Rochester, New York, und im niederländischen Leiden.
Abgesehen von den in dieser Pressemitteilung enthaltenen historischen Informationen kann sie auch in die Zukunft gerichtete Aussagen umfassen, die Risiken und Unwägbarkeiten unterliegen, die im Zusammenhang stehen mit erheblichen Schwankungen der Produktleistung durch die Abhängigkeit von Dritten, neuen und unsicheren, von Genencor verwendeten Technologien und deren unsichere Anwendung auf neue Geschäftsbereiche, dem Versäumnis, Produkte für den Gesundheitsmarkt zu entwickeln, der Unfähigkeit, bestimmte Transaktionen durchzuführen oder das Ausbleiben erwarteter Gewinne aus Akquisitionen, der Abhängigkeit von intellektuellen Eigentumsrechten, der Tatsache, dass Genencor gegen andere Wettbewerber seines Industriezweigs zu bestehen hat und den in Zusammenhang mit dem Veralten bestimmter Technologien stehenden Risiken. Die tatsächlichen Ergebnisse können erheblich von den angekündigten abweichen. Die in die Zukunft gerichteten Aussagen entsprechen den Einschätzungen von Genencor zum Zeitpunkt der Veröffentlichung dieser Pressemitteilung. Genencor lehnt jedoch jede Verantwortung oder Verpflichtung für die Aktualisierung der in die Zukunft gerichteten Aussagen ab.
Internet: http://www.genencor.com
Gruß Bogo!
Dienstag 14. August 2001, 11:57 Uhr
Xenova trifft Lizenzvereinbarung mit QLT
Das britische Biotechnologie-Unternehmen Xenova Group Plc. schloss mit der kanadischen QLT Inc (Frankfurt: 877927.F - Nachrichten). einen Lizenzvertrag für Nordamerika hinsichtlich seines Krebs-Medikaments XR 9576. Die Vereinbarung hat ein Volumen von 105,0 Mio. Dollar.
Tumore sind gegen eine Vielzahl von Medikamenten resistent, weil die Krebs-Zellmembrane ein Protein produziert, welches die Medikamente aus den Zellen spült. XR 9576 unterdrückt diese Resistenz.
Das Präparat soll in der ersten Jahreshälfte 2002 mit der klinischen Testphase III starten. Die Marktzulassung könnte dann 2005 beantragt werden.
Die Aktien von Xenova stiegen bisher um 20,25 Prozent und notieren aktuell in London bei 47,50 Pence.
Gruß Bogo!
Xenova trifft Lizenzvereinbarung mit QLT
Das britische Biotechnologie-Unternehmen Xenova Group Plc. schloss mit der kanadischen QLT Inc (Frankfurt: 877927.F - Nachrichten). einen Lizenzvertrag für Nordamerika hinsichtlich seines Krebs-Medikaments XR 9576. Die Vereinbarung hat ein Volumen von 105,0 Mio. Dollar.
Tumore sind gegen eine Vielzahl von Medikamenten resistent, weil die Krebs-Zellmembrane ein Protein produziert, welches die Medikamente aus den Zellen spült. XR 9576 unterdrückt diese Resistenz.
Das Präparat soll in der ersten Jahreshälfte 2002 mit der klinischen Testphase III starten. Die Marktzulassung könnte dann 2005 beantragt werden.
Die Aktien von Xenova stiegen bisher um 20,25 Prozent und notieren aktuell in London bei 47,50 Pence.
Gruß Bogo!
British Press
"The shares(of Xenova) have risen 22 per cent to 48p on today’s news. But that still begs the question, why, at £72m, the merged entity is still worth significantly less than the sum of the two constituents prior to the alliance?"
Full article:
http://investorschronicle.ft.com/cgi-bin/gx.cgi/FTContentSer…
Analysis
--------------------------------------------------------------------------------
Xenova finds devlopement partner for lead drug
Tuesday 14 Aug 2001
The UK biotech also clears up its strategic direction in the wake of its unpopular merger with Cantab.
--------------------------------------------------------------------------------
Deal signed worth £75m to take lead product through Phase III trials
Strategic review should save costs of £2m in second half
Despite a strengthened portfolio, Xenova is still undervalued
In a deal worth up to £75m, Xenova has signed a development partner for XR9576, its drug for modulating the resistance of cancer patients to chemotherapy. A series of Phase II trials were completed at the end of 2000, but progress into Phase III was put on hold until a partner could be found to fund it. Under the terms of the deal, QLT will pay £32m to finance the Phase III trials in Europe and America in return for the marketing rights in North America. Xenova will receive a 15 to 22 per cent cut of sales, depending on how well they do, in addition to extra payments once certain milestones are met. Analysts predict sales could reach $500-600m.
The announcement comes alongside Xenova’s interim results – the first reported figures since its unpopular merger with Cantab earlier this year. The decision to fit a vaccines designer (Cantab) with a company developing small molecule drugs against cancer (Xenova) was not met with universal acclaim.
In a move to address the issue of incompatibility, management has announced the results of a strategic review that will also cut costs by £2m in the second half. On an annualised basis that equates to £9m from annual costs on a pro-forma figure of £24m. The aim now is to focus on the treatment of cancer.
As such, management has indicated its intention to license out its DISC-PRO vaccine (designed to prevent the herpes) ahead of Phase III trials as well as its anti-addiction vaccine, which is hoped will help cocaine addicts kick the habit. Positive results from a Phase II a study were released in July. With £18m-worth of cash, plus an extra £7m due this year from signing the deal with QLT, Xenova needn’t rush these projects out the door, allowing management time to negotiate the best possible terms.
After the failure of Xenova’s second lead product in clinical trials earlier on this year, shareholders would have been pinning their hopes to the success of XR9576 as this was the only product left in the pipeline in clinical trials. However, Xenova now has four products in or having completed Phase II trials and a further four in or having completed Phase I. The shares have risen 22 per cent to 48p on today’s news. But that still begs the question, why, at £72m, the merged entity is still worth significantly less than the sum of the two constituents prior to the alliance?
"The shares(of Xenova) have risen 22 per cent to 48p on today’s news. But that still begs the question, why, at £72m, the merged entity is still worth significantly less than the sum of the two constituents prior to the alliance?"
Full article:
http://investorschronicle.ft.com/cgi-bin/gx.cgi/FTContentSer…
Analysis
--------------------------------------------------------------------------------
Xenova finds devlopement partner for lead drug
Tuesday 14 Aug 2001
The UK biotech also clears up its strategic direction in the wake of its unpopular merger with Cantab.
--------------------------------------------------------------------------------
Deal signed worth £75m to take lead product through Phase III trials
Strategic review should save costs of £2m in second half
Despite a strengthened portfolio, Xenova is still undervalued
In a deal worth up to £75m, Xenova has signed a development partner for XR9576, its drug for modulating the resistance of cancer patients to chemotherapy. A series of Phase II trials were completed at the end of 2000, but progress into Phase III was put on hold until a partner could be found to fund it. Under the terms of the deal, QLT will pay £32m to finance the Phase III trials in Europe and America in return for the marketing rights in North America. Xenova will receive a 15 to 22 per cent cut of sales, depending on how well they do, in addition to extra payments once certain milestones are met. Analysts predict sales could reach $500-600m.
The announcement comes alongside Xenova’s interim results – the first reported figures since its unpopular merger with Cantab earlier this year. The decision to fit a vaccines designer (Cantab) with a company developing small molecule drugs against cancer (Xenova) was not met with universal acclaim.
In a move to address the issue of incompatibility, management has announced the results of a strategic review that will also cut costs by £2m in the second half. On an annualised basis that equates to £9m from annual costs on a pro-forma figure of £24m. The aim now is to focus on the treatment of cancer.
As such, management has indicated its intention to license out its DISC-PRO vaccine (designed to prevent the herpes) ahead of Phase III trials as well as its anti-addiction vaccine, which is hoped will help cocaine addicts kick the habit. Positive results from a Phase II a study were released in July. With £18m-worth of cash, plus an extra £7m due this year from signing the deal with QLT, Xenova needn’t rush these projects out the door, allowing management time to negotiate the best possible terms.
After the failure of Xenova’s second lead product in clinical trials earlier on this year, shareholders would have been pinning their hopes to the success of XR9576 as this was the only product left in the pipeline in clinical trials. However, Xenova now has four products in or having completed Phase II trials and a further four in or having completed Phase I. The shares have risen 22 per cent to 48p on today’s news. But that still begs the question, why, at £72m, the merged entity is still worth significantly less than the sum of the two constituents prior to the alliance?
Unter http://ukinvest.uk-wire.com/cgi-bin/index?company=XEN gibt es eine komplette Übersicht, über alle Neuigkeiten zu XENOVA, nach Datum sortiert.
Kommentare zu XENOVA:
Nachzulesen unter http://money.telegraph.co.uk/money/main.jhtml?xml=/money/200…
Xenova cheap and risky
WHEN Xenova bought rival biotechnology company Cantab Pharmaceuticals last February, the market reacted like it had come down with a dose of the genital warts that Cantab`s lead drug failed to treat effectively.
The two companies were not an obvious fit, and Cantab was not a particularly attractive proposition. The only justification for the all-paper deal - that both companies were focused on cancer drugs, did not wash with investors.
Xenova shares, which hit highs of 431p at the top of the biotechnology boom, slid down to 42.5p. Yesterday they stood at 47p, down 1 as the market continued to evaluate six-month figures, and two licensing deals announced earlier this week.
The figures were much as expected, with pre-tax losses widening to £7.39m from £3.59m on sales up from £78,000 to £504,000. The licensing deals were much better news, although many people`s attitude seemed to be `about time too`.
The company has signed a deal with Canadian group QLT for its lead drug, snappily named XR9576. This will give Xenova a £7.1m upfront payment as part of a total of £42.7m if the drug is developed as planned.
XR9576 treats the problem of chemotherapy patients being resistant to the drugs that treat them if they have to undergo the course a second time round. The deal gives Xenova more cash to play with, and makes a trip to the market less likely in the near future.
The second deal, between Genencor and Xenova`s 50pc joint venture Phogen, could be worth over £15m. This gives Xenova enough cash to last for about 18 months. It has eight products in the pipeline, but only one in late-stage development. Even that is unlikely to be marketed until 2006 - but at least Xenova has managed to offload the development risk onto QLT.
The shares may be cheap, but Xenova is still too risky.
Nachzulesen unter http://money.telegraph.co.uk/money/main.jhtml?xml=/money/200…
Xenova cheap and risky
WHEN Xenova bought rival biotechnology company Cantab Pharmaceuticals last February, the market reacted like it had come down with a dose of the genital warts that Cantab`s lead drug failed to treat effectively.
The two companies were not an obvious fit, and Cantab was not a particularly attractive proposition. The only justification for the all-paper deal - that both companies were focused on cancer drugs, did not wash with investors.
Xenova shares, which hit highs of 431p at the top of the biotechnology boom, slid down to 42.5p. Yesterday they stood at 47p, down 1 as the market continued to evaluate six-month figures, and two licensing deals announced earlier this week.
The figures were much as expected, with pre-tax losses widening to £7.39m from £3.59m on sales up from £78,000 to £504,000. The licensing deals were much better news, although many people`s attitude seemed to be `about time too`.
The company has signed a deal with Canadian group QLT for its lead drug, snappily named XR9576. This will give Xenova a £7.1m upfront payment as part of a total of £42.7m if the drug is developed as planned.
XR9576 treats the problem of chemotherapy patients being resistant to the drugs that treat them if they have to undergo the course a second time round. The deal gives Xenova more cash to play with, and makes a trip to the market less likely in the near future.
The second deal, between Genencor and Xenova`s 50pc joint venture Phogen, could be worth over £15m. This gives Xenova enough cash to last for about 18 months. It has eight products in the pipeline, but only one in late-stage development. Even that is unlikely to be marketed until 2006 - but at least Xenova has managed to offload the development risk onto QLT.
The shares may be cheap, but Xenova is still too risky.
RNS Number:1340J
Xenova Group PLC
29 August 2001
Letter to Xenova PLC
Biotechnology Venture Fund S.A.
In accordance with the provisions of Section 198 of the Companies Act 1985, we
wish to advise you that on 23 August 2001 the above fund sold a total of 400,000
shares of Xenova PLC at a price of 45p per share.
We understand that the holding has now been reduced to under 3% of the equity.
Letter from Abingworth Management Limited.
END
Xenova Group PLC
29 August 2001
Letter to Xenova PLC
Biotechnology Venture Fund S.A.
In accordance with the provisions of Section 198 of the Companies Act 1985, we
wish to advise you that on 23 August 2001 the above fund sold a total of 400,000
shares of Xenova PLC at a price of 45p per share.
We understand that the holding has now been reduced to under 3% of the equity.
Letter from Abingworth Management Limited.
END
Xenova Group plc: Anti-Nicotine Addiction Vaccine TA-NIC Enters Phase I Trials
SLOUGH, England, Sep 10, 2001 /PRNewswire via COMTEX/ -- Xenova Group plc (Nasdaq: XNVA) (London Stock Exchange: XEN) today announces that its novel therapeutic vaccine, TA-NIC, which is being developed for the treatment of nicotine addiction, has entered Phase I clinical trials.
The Phase I study is a double-blind, randomised, placebo-controlled study to assess the safety, tolerability and immunogenicity of the TA-NIC vaccine in both smokers and non-smokers. The vaccine is administered by intra-muscular injection. In the first instance, two different dose levels are to be investigated in a variety of dosing regimens.
TA-NIC is believed to be the first anti-nicotine addiction vaccine to enter clinical testing. TA-NIC uses a novel mode of action whereby it seeks to prevent nicotine from entering the brain. Currently available therapies for nicotine addiction include nicotine replacement therapy, delivered via skin patches, chewing gum or inhalers or treatment with the nicotine-free drug bupropion.
Over 1 billion people worldwide smoke tobacco products (World Health Organisation), resulting in approximately 3 million deaths annually (American Cancer Society, 1996) from smoking-related disease. Despite the known health risks, many people who want to give up smoking cigarettes (or other tobacco products) find it very difficult to do so, due to the addictive properties of nicotine and the unpleasant withdrawal symptoms. Approximately 17 million smokers in the US alone attempt to quit each year (Center for Disease Control and Prevention).
TA-NIC is Xenova`s second anti-addiction drug candidate to enter clinical trials. An anti-cocaine addiction vaccine, TA-CD, is currently in Phase II clinical development in the US. Other Xenova products currently undergoing clinical trials target the treatment of cancer and infectious diseases.
David Oxlade, Xenova`s Chief Executive, said: "Most people who want to stop smoking find it very hard to do so, even though they may be aware of the risks involved. Although at an early stage of development, if TA-NIC can be of assistance it could have an important contribution to make in reducing the burdens that smoking imposes."
Notes:
Xenova Group plc`s product pipeline focuses principally on the therapeutic area of cancer, with a secondary focus on infectious, autoimmune and cardiovascular diseases. The Group has a well-established track record in the identification, development and partnering of innovative products and technologies and has partnerships with a number of major pharmaceutical companies including Glaxo SmithKline, Lilly, Pfizer, QLT Inc and Celltech.
SLOUGH, England, Sep 10, 2001 /PRNewswire via COMTEX/ -- Xenova Group plc (Nasdaq: XNVA) (London Stock Exchange: XEN) today announces that its novel therapeutic vaccine, TA-NIC, which is being developed for the treatment of nicotine addiction, has entered Phase I clinical trials.
The Phase I study is a double-blind, randomised, placebo-controlled study to assess the safety, tolerability and immunogenicity of the TA-NIC vaccine in both smokers and non-smokers. The vaccine is administered by intra-muscular injection. In the first instance, two different dose levels are to be investigated in a variety of dosing regimens.
TA-NIC is believed to be the first anti-nicotine addiction vaccine to enter clinical testing. TA-NIC uses a novel mode of action whereby it seeks to prevent nicotine from entering the brain. Currently available therapies for nicotine addiction include nicotine replacement therapy, delivered via skin patches, chewing gum or inhalers or treatment with the nicotine-free drug bupropion.
Over 1 billion people worldwide smoke tobacco products (World Health Organisation), resulting in approximately 3 million deaths annually (American Cancer Society, 1996) from smoking-related disease. Despite the known health risks, many people who want to give up smoking cigarettes (or other tobacco products) find it very difficult to do so, due to the addictive properties of nicotine and the unpleasant withdrawal symptoms. Approximately 17 million smokers in the US alone attempt to quit each year (Center for Disease Control and Prevention).
TA-NIC is Xenova`s second anti-addiction drug candidate to enter clinical trials. An anti-cocaine addiction vaccine, TA-CD, is currently in Phase II clinical development in the US. Other Xenova products currently undergoing clinical trials target the treatment of cancer and infectious diseases.
David Oxlade, Xenova`s Chief Executive, said: "Most people who want to stop smoking find it very hard to do so, even though they may be aware of the risks involved. Although at an early stage of development, if TA-NIC can be of assistance it could have an important contribution to make in reducing the burdens that smoking imposes."
Notes:
Xenova Group plc`s product pipeline focuses principally on the therapeutic area of cancer, with a secondary focus on infectious, autoimmune and cardiovascular diseases. The Group has a well-established track record in the identification, development and partnering of innovative products and technologies and has partnerships with a number of major pharmaceutical companies including Glaxo SmithKline, Lilly, Pfizer, QLT Inc and Celltech.
Handelsblatt vom 14.09.2001 bezüglich TA-NIC
Impfung erleichtert Rauchern das Aufhören
Der Pharmakonzern Xenova hat einen Impfstoff entwickelt, der Rauchern das Aufhören erleichtern soll. Die Antinikotin-Impfung verhindert laut dem medizinischen Direktor des Unternehmens John Roberts, dass Nikotin ins Gehirn eindringt. Das Nikotin wird am passieren der Blut-Hirn-Schranke gehindert. Die derzeit angebotenen Hilfen zielen dagegen darauf, die Entzugserscheinungen durch Kaugummis und Pflaster zu reduzieren. Erste Versuche starten demnächst mit 60 Freiwilligen in Belgien. Erweisen sich die Ergebnisse als positiv, soll der Impfstoff in 5 Jahren auf den Markt kommen, so ein Bericht des Fachmagazins NEW Scientist.
Gruß Bogo!
Impfung erleichtert Rauchern das Aufhören
Der Pharmakonzern Xenova hat einen Impfstoff entwickelt, der Rauchern das Aufhören erleichtern soll. Die Antinikotin-Impfung verhindert laut dem medizinischen Direktor des Unternehmens John Roberts, dass Nikotin ins Gehirn eindringt. Das Nikotin wird am passieren der Blut-Hirn-Schranke gehindert. Die derzeit angebotenen Hilfen zielen dagegen darauf, die Entzugserscheinungen durch Kaugummis und Pflaster zu reduzieren. Erste Versuche starten demnächst mit 60 Freiwilligen in Belgien. Erweisen sich die Ergebnisse als positiv, soll der Impfstoff in 5 Jahren auf den Markt kommen, so ein Bericht des Fachmagazins NEW Scientist.
Gruß Bogo!
Cantab-Deal mit Nebenwirkung:
Xenova Group plc Results of TA-HSV Phase II Trial For the Treatment of Genital Herpes
SLOUGH, England, Oct. 10 /PRNewswire/ -- Xenova Group plc (Nasdaq: XNVA; London Stock Exchange: XEN), today announced results from the Phase II clinical efficacy trial conducted in collaboration with its partner, GlaxoSmithKline (GSK), with TA-HSV (a therapeutic vaccine designed for the treatment of genital herpes). Analysis has shown that the trial has not met its clinical endpoints.
The multi-centre, placebo controlled study was conducted amongst 483 HSV-2 seropositive patients with symptomatic recurrent genital herpes. No significant difference was seen between the treatment arm and the control group with respect to time to first recurrence, the total number of recurrences or other clinical outcomes assessed during the course of the study. Further development by GSK of the therapeutic vaccine TA-HSV is not planned and the TA-HSV development agreement between the two companies will be terminated effective January 2002. Xenova to continue development of prophylactic herpes vaccine, DISC-PRO
Xenova will continue to develop DISC-PRO, a prophylactic vaccine designed to prevent genital and oro-labial herpes. Xenova holds all rights to DISC-PRO.
Phase I results using DISC-PRO among seronegative subjects (people who have not been previously exposed to the herpes virus) have demonstrated excellent safety and immunogenicity responses. The immunogenicity responses have reached levels which are believed to be appropriate for the prevention of both genital and oro-labial herpes. In addition, preclinical studies have shown that vaccination using DISC-PRO is capable of preventing herpes disease with greater than 90% efficacy following viral challenge. The work conducted to date for the development of TA-HSV, especially that relating to manufacturing and scale-up, provides significant support for the further development of DISC-PRO.
The company believes, on the basis of available preclinical and clinical trial results, that prevention of genital and oro-labial herpes by vaccination remains an achievable and highly desirable goal and intends to seek a corporate partner in due course to support late stage clinical trials. Notes to Editors
Xenova`s product pipeline focuses principally on the therapeutic areas of cancer, infectious, autoimmune and cardiovascular diseases. The Group has a well-established track record in the identification, development and partnering of innovative products and technologies. Xenova has partnerships with a number of major pharmaceutical companies including Lilly, Pfizer, Celltech and QLT Inc.
Gruß Bogo!
Xenova Group plc Results of TA-HSV Phase II Trial For the Treatment of Genital Herpes
SLOUGH, England, Oct. 10 /PRNewswire/ -- Xenova Group plc (Nasdaq: XNVA; London Stock Exchange: XEN), today announced results from the Phase II clinical efficacy trial conducted in collaboration with its partner, GlaxoSmithKline (GSK), with TA-HSV (a therapeutic vaccine designed for the treatment of genital herpes). Analysis has shown that the trial has not met its clinical endpoints.
The multi-centre, placebo controlled study was conducted amongst 483 HSV-2 seropositive patients with symptomatic recurrent genital herpes. No significant difference was seen between the treatment arm and the control group with respect to time to first recurrence, the total number of recurrences or other clinical outcomes assessed during the course of the study. Further development by GSK of the therapeutic vaccine TA-HSV is not planned and the TA-HSV development agreement between the two companies will be terminated effective January 2002. Xenova to continue development of prophylactic herpes vaccine, DISC-PRO
Xenova will continue to develop DISC-PRO, a prophylactic vaccine designed to prevent genital and oro-labial herpes. Xenova holds all rights to DISC-PRO.
Phase I results using DISC-PRO among seronegative subjects (people who have not been previously exposed to the herpes virus) have demonstrated excellent safety and immunogenicity responses. The immunogenicity responses have reached levels which are believed to be appropriate for the prevention of both genital and oro-labial herpes. In addition, preclinical studies have shown that vaccination using DISC-PRO is capable of preventing herpes disease with greater than 90% efficacy following viral challenge. The work conducted to date for the development of TA-HSV, especially that relating to manufacturing and scale-up, provides significant support for the further development of DISC-PRO.
The company believes, on the basis of available preclinical and clinical trial results, that prevention of genital and oro-labial herpes by vaccination remains an achievable and highly desirable goal and intends to seek a corporate partner in due course to support late stage clinical trials. Notes to Editors
Xenova`s product pipeline focuses principally on the therapeutic areas of cancer, infectious, autoimmune and cardiovascular diseases. The Group has a well-established track record in the identification, development and partnering of innovative products and technologies. Xenova has partnerships with a number of major pharmaceutical companies including Lilly, Pfizer, Celltech and QLT Inc.
Gruß Bogo!
Xenova
Biotech stock is inexpensive - keep buying (Sunday Telegraph)
Biotech stock is inexpensive - keep buying (Sunday Telegraph)
Xenova Group PLC - Directors` Purchase of Shares
RNS Number:7826L
Xenova Group PLC
18 October 2001
18 October 2001: Xenova Group plc: Directors` Purchases of Shares
Xenova Group plc (the "Company")
The Company was notified on 17 October 2001 that the directors listed below
acquired the following numbers of ordinary shares of 10 pence each of the
Company on 17 October 2001 at a price of 25.5 pence per share.
Director Number of shares Total holding of Total holding as
purchased ordinary shares percentage of
following issued share
purchase capital
John Jackson 35,000 130,445 0.09
David Oxlade 38,920 133,365 0.10
Daniel Abrams 19,460 58,054 0.04
Michael Moore 38,920 71,097 0.05
John St Clair Roberts 77,850 83,742 0.06
Stephen Inglis 31,140 182,006 0.13
Gerard Fairtlough 19,460 147,138 0.11
Nick Hart 38,920 54,634 0.04
All of the above holdings are beneficial holdings of the relevant director and
are registered in the name of the relevant director, except in the case of Mr
Inglis. Of the shares purchased by Mr Inglis 7,785 shares were acquired by
his wife (Moira Inglis) and each of his children (James Devear Inglis, David
John MacArthur Inglis and Alison Juliet Inglis) also acquired 7,785 shares
each.
In addition, the Company was notified on 16 October 2001 that Peter Gillett
beneficially acquired 5,000 ordinary shares of 10 pence each of the Company on
16 October 2001 at a price of 26.6 pence per share. Following this purchase,
Mr Gillett holds 10,000 ordinary shares of the Company, representing 0.01% of
the Company`s issued share capital.
END
RNS Number:7826L
Xenova Group PLC
18 October 2001
18 October 2001: Xenova Group plc: Directors` Purchases of Shares
Xenova Group plc (the "Company")
The Company was notified on 17 October 2001 that the directors listed below
acquired the following numbers of ordinary shares of 10 pence each of the
Company on 17 October 2001 at a price of 25.5 pence per share.
Director Number of shares Total holding of Total holding as
purchased ordinary shares percentage of
following issued share
purchase capital
John Jackson 35,000 130,445 0.09
David Oxlade 38,920 133,365 0.10
Daniel Abrams 19,460 58,054 0.04
Michael Moore 38,920 71,097 0.05
John St Clair Roberts 77,850 83,742 0.06
Stephen Inglis 31,140 182,006 0.13
Gerard Fairtlough 19,460 147,138 0.11
Nick Hart 38,920 54,634 0.04
All of the above holdings are beneficial holdings of the relevant director and
are registered in the name of the relevant director, except in the case of Mr
Inglis. Of the shares purchased by Mr Inglis 7,785 shares were acquired by
his wife (Moira Inglis) and each of his children (James Devear Inglis, David
John MacArthur Inglis and Alison Juliet Inglis) also acquired 7,785 shares
each.
In addition, the Company was notified on 16 October 2001 that Peter Gillett
beneficially acquired 5,000 ordinary shares of 10 pence each of the Company on
16 October 2001 at a price of 26.6 pence per share. Following this purchase,
Mr Gillett holds 10,000 ordinary shares of the Company, representing 0.01% of
the Company`s issued share capital.
END
Xenova Group plc: Successful Results of Phase IIa and Phase I HPV-Related Clinical Trials and Start of Combined `Prime-Boost` Phase II Trial
SLOUGH, England, Oct 26, 2001 /PRNewswire via COMTEX/ -- Xenova Group plc (Nasdaq: XNVA; London Stock Exchange: XEN) today announced the successful results of clinical trials for two of its vaccines for the treatment of human papillomavirus (HPV) associated diseases. HPV infection is a recognized risk factor in both anal and genital cancers.
Successful Results of Phase IIa trial of TA-HPV
Results from a physician-initiated Phase IIa trial of Xenova`s TA-HPV vaccine in women with high grade vulval intra-epithelial neoplasia (VIN 3), part of a group of conditions known collectively as ano-genital intraepithelial neoplasia (AGIN), were presented at the 19th International Human Papillomavirus Conference (September 2001).
The 18-patient study, which was conducted by researchers at St Mary`s Hospital, Manchester and the Paterson Institute for Cancer Research, Manchester, showed that the vaccine was safe and well tolerated. Forty-four per cent of patients demonstrated an objective clinical response at six months and a further twenty-two per cent showed significant symptom relief. A further Phase IIa AGIN study is ongoing at Addenbrooke`s Hospital, Cambridge, UK and is due to be completed in the near future.
VIN 3 is a high-risk human papillomavirus (HPV) associated condition. The incidence of VIN has increased over the last 20 years, particularly in younger women. VIN 3 is difficult to treat, has a high recurrence rate and is a condition that can progress to cancerous disease.
Successful Results of Phase I trial of TA-CIN
The successful results of a Phase I safety and immunogenicity study for TA-CIN, a Xenova vaccine which is being developed for the treatment of cervical intraepithelial neoplasia (CIN), a further AGIN condition, were also presented at the recent Human Papillomavirus Conference. In this placebo-controlled, dose-escalating study, the vaccine was administered by intramuscular injection to 40 healthy volunteers. TA-CIN was found to be very well tolerated. No serious adverse events were reported during the study. The vaccine was also found to be immunogenic. TA-CIN specific antibody responses, and positive T cell responses were seen in all of the cohorts receiving active vaccine.
Phase II `Prime Boost` Clinical Trial Begins
Preclinical studies, conducted by Xenova in conjunction with scientists at the Leiden University Medical Center, The Netherlands, have demonstrated that a combination of TA-HPV and TA-CIN results in an immune response that is significantly stronger than that observed with either product alone. Using this `prime-boost` immunization regimen, the CD8+ T cell response, which is believed to be important in controlling HPV infection, is increased 5-10 fold. The results of this preclinical study were published in the June 1st 2001 issue of `Vaccine.`
Based on the positive results of the TA-HPV and TA-CIN clinical studies to date and on the significant preclinical combination study, a `prime-boost` Phase II clinical trial, in which TA-HPV is given in combination with TA-CIN, has now begun at 3 centers in the UK, Cambridge, Cardiff and Manchester. The studies are being conducted in up to 30 women with HPV associated AGIN conditions, excluding CIN. This will allow evaluation over a six-month period of the effect of the combined vaccination regime on disease progression.
David Oxlade, Chief Executive Officer of Xenova, commented:
"HPV has been linked to both AGIN and to ano-genital cancers. AGIN conditions are highly recurrent, difficult to treat and have debilitating effects for sufferers. The Prime-Boost study is designed to prime, focus and boost the immune response against HPV infection in AGIN, using two vaccines in combination. If successful, this approach will play a significant role in the treatment of AGIN and prevention of related ano-genital cancers."
SLOUGH, England, Oct 26, 2001 /PRNewswire via COMTEX/ -- Xenova Group plc (Nasdaq: XNVA; London Stock Exchange: XEN) today announced the successful results of clinical trials for two of its vaccines for the treatment of human papillomavirus (HPV) associated diseases. HPV infection is a recognized risk factor in both anal and genital cancers.
Successful Results of Phase IIa trial of TA-HPV
Results from a physician-initiated Phase IIa trial of Xenova`s TA-HPV vaccine in women with high grade vulval intra-epithelial neoplasia (VIN 3), part of a group of conditions known collectively as ano-genital intraepithelial neoplasia (AGIN), were presented at the 19th International Human Papillomavirus Conference (September 2001).
The 18-patient study, which was conducted by researchers at St Mary`s Hospital, Manchester and the Paterson Institute for Cancer Research, Manchester, showed that the vaccine was safe and well tolerated. Forty-four per cent of patients demonstrated an objective clinical response at six months and a further twenty-two per cent showed significant symptom relief. A further Phase IIa AGIN study is ongoing at Addenbrooke`s Hospital, Cambridge, UK and is due to be completed in the near future.
VIN 3 is a high-risk human papillomavirus (HPV) associated condition. The incidence of VIN has increased over the last 20 years, particularly in younger women. VIN 3 is difficult to treat, has a high recurrence rate and is a condition that can progress to cancerous disease.
Successful Results of Phase I trial of TA-CIN
The successful results of a Phase I safety and immunogenicity study for TA-CIN, a Xenova vaccine which is being developed for the treatment of cervical intraepithelial neoplasia (CIN), a further AGIN condition, were also presented at the recent Human Papillomavirus Conference. In this placebo-controlled, dose-escalating study, the vaccine was administered by intramuscular injection to 40 healthy volunteers. TA-CIN was found to be very well tolerated. No serious adverse events were reported during the study. The vaccine was also found to be immunogenic. TA-CIN specific antibody responses, and positive T cell responses were seen in all of the cohorts receiving active vaccine.
Phase II `Prime Boost` Clinical Trial Begins
Preclinical studies, conducted by Xenova in conjunction with scientists at the Leiden University Medical Center, The Netherlands, have demonstrated that a combination of TA-HPV and TA-CIN results in an immune response that is significantly stronger than that observed with either product alone. Using this `prime-boost` immunization regimen, the CD8+ T cell response, which is believed to be important in controlling HPV infection, is increased 5-10 fold. The results of this preclinical study were published in the June 1st 2001 issue of `Vaccine.`
Based on the positive results of the TA-HPV and TA-CIN clinical studies to date and on the significant preclinical combination study, a `prime-boost` Phase II clinical trial, in which TA-HPV is given in combination with TA-CIN, has now begun at 3 centers in the UK, Cambridge, Cardiff and Manchester. The studies are being conducted in up to 30 women with HPV associated AGIN conditions, excluding CIN. This will allow evaluation over a six-month period of the effect of the combined vaccination regime on disease progression.
David Oxlade, Chief Executive Officer of Xenova, commented:
"HPV has been linked to both AGIN and to ano-genital cancers. AGIN conditions are highly recurrent, difficult to treat and have debilitating effects for sufferers. The Prime-Boost study is designed to prime, focus and boost the immune response against HPV infection in AGIN, using two vaccines in combination. If successful, this approach will play a significant role in the treatment of AGIN and prevention of related ano-genital cancers."
Xenova
Tepid reception for trials (Guardian); running low on cash (Express)
Tepid reception for trials (Guardian); running low on cash (Express)
Trails fail to impress
The Guardian - United Kingdom; Oct 27, 2001
Biotech group Xenova has announced the successful completion of key clinical trials of two vaccines for anal and genital cancer, prompting shares to climb 4.75p to 36p.
The news comes only weeks after shares fell 5p following Xenova`s defeat in its efforts to develop a vaccine for genital herpes.
Yesterday it said it was to start a trial of the two cancer vaccines in tandem after tests on animals showed an increase in immune response had ranged between five and tenfold.
Some analysts, however, suggested yesterday`s announcement was not a major step for the vaccines which are at a relatively early stage of development.
One analyst said the firm will have to produce more significant evidence of progress if it is to win round investors unimpressed with the decision to take over Cantab Pharmaceuticals in February.
The Guardian - United Kingdom; Oct 27, 2001
Biotech group Xenova has announced the successful completion of key clinical trials of two vaccines for anal and genital cancer, prompting shares to climb 4.75p to 36p.
The news comes only weeks after shares fell 5p following Xenova`s defeat in its efforts to develop a vaccine for genital herpes.
Yesterday it said it was to start a trial of the two cancer vaccines in tandem after tests on animals showed an increase in immune response had ranged between five and tenfold.
Some analysts, however, suggested yesterday`s announcement was not a major step for the vaccines which are at a relatively early stage of development.
One analyst said the firm will have to produce more significant evidence of progress if it is to win round investors unimpressed with the decision to take over Cantab Pharmaceuticals in February.
COMPANIES & FINANCE UK: Xenova drugs may combat smallpox
Financial Times; Oct 27, 2001
By DAVID FIRN
Two cancer vaccines being developed by Xenova, the biotechnology company, could be used to protect the population against a smallpox attack, the company claimed yesterday.
The vaccines, which Xenova acquired when it purchased its UK rival Cantab last year, are intended to protect against human papillomavirus, which causes cervical cancer. However, they are made by attaching parts of HPV to smallpox. The result is immunity to both viruses.
David Oxlade, chief executive, played down the significance of the smallpox link, saying it was chosen because it was the safest and best understood virus for producing vaccines.
However, he said Xenova could produce a smallpox vaccine if a government requested it. "Technically . . . we`ve got the expertise," he said.
Xenova shares rose 15 per cent, by 4 3/4p to 36p, after the company said it was starting new clinical trials of the vaccines following encouraging results in recent studies.
Xenova is to test the two vaccines, known as TA-HPV and TA-CIN, against human papillomavirus together, to see whether the combination can prevent a range of sexually transmitted cancers caused by HPV.
Mr Oxlade said animal experiments showed that using the two vaccines together boosted the immune response five to 10 times more than either vaccine alone.
Three weeks ago, the company`s shares fell sharply after the failure of TA-HSV, another of its vaccines for HPV, resulted in the termination of a development collaboration with GlaxoSmithKline.
Yesterday, Xenova said TA-HPV successfully relieved the symptoms of vulval intra-epithelial neoplasia, a pre-cancerous condition caused by HPV.
TA-CIN was shown to be safe in a separate clinical trial in patients with cervical intraepithelial neoplasia, which can also lead to cancer.
About half a million women develop cervical cancer each year worldwide. The current treatment is surgery or laser ablation of the abnormal cells. Mr Oxlade said the market for the vaccines could be worth "several hundred million dollars".
The trial will evaluate the combination treatment in women with pre-cancerous cells.
Financial Times; Oct 27, 2001
By DAVID FIRN
Two cancer vaccines being developed by Xenova, the biotechnology company, could be used to protect the population against a smallpox attack, the company claimed yesterday.
The vaccines, which Xenova acquired when it purchased its UK rival Cantab last year, are intended to protect against human papillomavirus, which causes cervical cancer. However, they are made by attaching parts of HPV to smallpox. The result is immunity to both viruses.
David Oxlade, chief executive, played down the significance of the smallpox link, saying it was chosen because it was the safest and best understood virus for producing vaccines.
However, he said Xenova could produce a smallpox vaccine if a government requested it. "Technically . . . we`ve got the expertise," he said.
Xenova shares rose 15 per cent, by 4 3/4p to 36p, after the company said it was starting new clinical trials of the vaccines following encouraging results in recent studies.
Xenova is to test the two vaccines, known as TA-HPV and TA-CIN, against human papillomavirus together, to see whether the combination can prevent a range of sexually transmitted cancers caused by HPV.
Mr Oxlade said animal experiments showed that using the two vaccines together boosted the immune response five to 10 times more than either vaccine alone.
Three weeks ago, the company`s shares fell sharply after the failure of TA-HSV, another of its vaccines for HPV, resulted in the termination of a development collaboration with GlaxoSmithKline.
Yesterday, Xenova said TA-HPV successfully relieved the symptoms of vulval intra-epithelial neoplasia, a pre-cancerous condition caused by HPV.
TA-CIN was shown to be safe in a separate clinical trial in patients with cervical intraepithelial neoplasia, which can also lead to cancer.
About half a million women develop cervical cancer each year worldwide. The current treatment is surgery or laser ablation of the abnormal cells. Mr Oxlade said the market for the vaccines could be worth "several hundred million dollars".
The trial will evaluate the combination treatment in women with pre-cancerous cells.
Xenova
Rich pipeline points to a buy (Sunday Times)
Rich pipeline points to a buy (Sunday Times)
Xenova
BIOTECHNOLOGY group Xenova has had something of a volatile month.
Just over two weeks ago, its stock plunged to all-time lows, hitting 23p per share, after pharmaceuticals giant GlaxoSmithKline pulled out of a partnership to develop a vaccine treatment for genital herpes, following the drugs failure in Phase II clinical trials.
On Friday, after Xenova announced that results of early clinical trials on two other vaccines for anal and genital pre-cancerous conditions had been successful, the stock bounced 13 per cent to 35.5p.
In the meantime, directors of the group have made some money by spending a few thousand pounds each buying the shares at about 25p.
So are they right to be bullish, or were the stock purchases just for show?
If directors don`t know their own company, nobody does.
Xenova has had one high-profile drugs failure, and significantly it was the key drug acquired with its purchase of rival Cantab Pharmaceuticals last year, for what seemed a cheap Pounds 53 million.
However, it has several high potential drugs in its pipeline, one of which is the XR9576 product to treat multi-drug resistant cancer, now being developed in partnership with QLT of Canada, which is paying up-front fees of Pounds 7 million, with potentially much more to come.
Final Phase III trials get under way next year, and this now looks to be Xenova`s most promising product.
Doubts remain over QLT, a leader in photodynamic therapy development, but with little experience in anti-cancer drugs. Nevertheless, ING Barings Charterhouse reckon XR9576`s sales could hit Pounds 300 million.
The treatment for anal and genital pre-cancerous conditions, at the centre of yesterday`s announcement, are also interesting. The TA-HPV vaccine did well in Phase II clinical trials, while TA-CIN performed encouragingly in early Phase I trials.
Clearly, Xenova is a risky proposition. But it could be potentially rewarding for those who fancy a gamble.
BIOTECHNOLOGY group Xenova has had something of a volatile month.
Just over two weeks ago, its stock plunged to all-time lows, hitting 23p per share, after pharmaceuticals giant GlaxoSmithKline pulled out of a partnership to develop a vaccine treatment for genital herpes, following the drugs failure in Phase II clinical trials.
On Friday, after Xenova announced that results of early clinical trials on two other vaccines for anal and genital pre-cancerous conditions had been successful, the stock bounced 13 per cent to 35.5p.
In the meantime, directors of the group have made some money by spending a few thousand pounds each buying the shares at about 25p.
So are they right to be bullish, or were the stock purchases just for show?
If directors don`t know their own company, nobody does.
Xenova has had one high-profile drugs failure, and significantly it was the key drug acquired with its purchase of rival Cantab Pharmaceuticals last year, for what seemed a cheap Pounds 53 million.
However, it has several high potential drugs in its pipeline, one of which is the XR9576 product to treat multi-drug resistant cancer, now being developed in partnership with QLT of Canada, which is paying up-front fees of Pounds 7 million, with potentially much more to come.
Final Phase III trials get under way next year, and this now looks to be Xenova`s most promising product.
Doubts remain over QLT, a leader in photodynamic therapy development, but with little experience in anti-cancer drugs. Nevertheless, ING Barings Charterhouse reckon XR9576`s sales could hit Pounds 300 million.
The treatment for anal and genital pre-cancerous conditions, at the centre of yesterday`s announcement, are also interesting. The TA-HPV vaccine did well in Phase II clinical trials, while TA-CIN performed encouragingly in early Phase I trials.
Clearly, Xenova is a risky proposition. But it could be potentially rewarding for those who fancy a gamble.
Xenova Group plc Board Changes and Appointment of New Commercial Director
SLOUGH, England, Oct 30, 2001 /PRNewswire via COMTEX/ -- Xenova Group plc (Nasdaq: XNVA; London Stock Exchange: XEN) today announced that Commercial Director Mr. Nick Hart will resign from the Board effective 31 December 2001. He will remain with Xenova on a part time basis for a short period after 31 December. Mr. Hart will be joining UK-based Bioscience Managers Limited, a corporate and investment advisory firm specializing in the life science sector. He joined Xenova following the merger with Cantab Pharmaceuticals plc (Cantab) in April 2001. Mr. Hart joined Cantab as Finance Director in 1990 and was acting Chief Executive of Cantab during the period immediately prior to the Xenova/Cantab merger.
Dr Joy Barton will join Xenova on 5 November 2001 as Commercial Director, based at Slough, UK and will become a member of the senior management team. Dr Barton joins Xenova from Accenture, (formerly Andersen Consulting), where she has specialized in providing consultancy to the pharmaceutical industry on the commercialization of key products resulting from research & development.
Dr Stephen Inglis will also resign from the Board effective 31 December 2001 in order to take up an appointment as Director of the National Institute of Biological Standards and Control (NIBSC). Dr Inglis joined Xenova as Research Director, Biologics, following the merger with Cantab in April 2001. He was previously Research Director, Cantab. Before joining Cantab in 1989 as Head of Molecular Sciences, he was a lecturer in Virology in the Department of Pathology at Cambridge University.
David Oxlade, Xenova`s Chief Executive Officer, commented:
"Nick and Stephen have made a considerable contribution to the successful merger completed earlier this year, and will be missed. We wish them every success in their new roles and thank them both for their significant contributions to both Cantab and more recently Xenova. I also welcome Joy to Xenova; her specialist commercial experience in the pharmaceutical field will be of great value to our team."
Notes to Editors
Xenova`s product pipeline focuses principally on the therapeutic areas of cancer, infectious, autoimmune and cardiovascular diseases. The Group has a well-established track record in the identification, development and partnering of innovative products and technologies. Xenova has partnerships with a number of major pharmaceutical companies including Lilly, Pfizer, Celltech and QLT Inc.
For further information about Xenova and its products please visit the Xenova website at http://www.xenova.co.uk.
SLOUGH, England, Oct 30, 2001 /PRNewswire via COMTEX/ -- Xenova Group plc (Nasdaq: XNVA; London Stock Exchange: XEN) today announced that Commercial Director Mr. Nick Hart will resign from the Board effective 31 December 2001. He will remain with Xenova on a part time basis for a short period after 31 December. Mr. Hart will be joining UK-based Bioscience Managers Limited, a corporate and investment advisory firm specializing in the life science sector. He joined Xenova following the merger with Cantab Pharmaceuticals plc (Cantab) in April 2001. Mr. Hart joined Cantab as Finance Director in 1990 and was acting Chief Executive of Cantab during the period immediately prior to the Xenova/Cantab merger.
Dr Joy Barton will join Xenova on 5 November 2001 as Commercial Director, based at Slough, UK and will become a member of the senior management team. Dr Barton joins Xenova from Accenture, (formerly Andersen Consulting), where she has specialized in providing consultancy to the pharmaceutical industry on the commercialization of key products resulting from research & development.
Dr Stephen Inglis will also resign from the Board effective 31 December 2001 in order to take up an appointment as Director of the National Institute of Biological Standards and Control (NIBSC). Dr Inglis joined Xenova as Research Director, Biologics, following the merger with Cantab in April 2001. He was previously Research Director, Cantab. Before joining Cantab in 1989 as Head of Molecular Sciences, he was a lecturer in Virology in the Department of Pathology at Cambridge University.
David Oxlade, Xenova`s Chief Executive Officer, commented:
"Nick and Stephen have made a considerable contribution to the successful merger completed earlier this year, and will be missed. We wish them every success in their new roles and thank them both for their significant contributions to both Cantab and more recently Xenova. I also welcome Joy to Xenova; her specialist commercial experience in the pharmaceutical field will be of great value to our team."
Notes to Editors
Xenova`s product pipeline focuses principally on the therapeutic areas of cancer, infectious, autoimmune and cardiovascular diseases. The Group has a well-established track record in the identification, development and partnering of innovative products and technologies. Xenova has partnerships with a number of major pharmaceutical companies including Lilly, Pfizer, Celltech and QLT Inc.
For further information about Xenova and its products please visit the Xenova website at http://www.xenova.co.uk.
Xenova Group plc - Cancer Research Update at EORTC/NCI AACR Symposium
SLOUGH, England, Oct 31, 2001 /PRNewswire via COMTEX/ -- Xenova Group plc (Nasdaq: XNVA; London Stock Exchange: XEN) today announced the publication of new research data at the EORTC/NCI AACR Symposium on Molecular Targets & Cancer Therapeutics, currently being held in Miami Beach, Florida.
Xenova has presented data at the Symposium on recent progress made in Xenova`s anti-angiogenesis and cytotoxic drug research program. Data presented included progress made with Xenova`s second generation topoisomerase inhibitors and a research update for Xenova`s plasminogen activator-1 (PAI-1) inhibition program. Details of an earlier Phase IIa trial for Xenova`s lead multi-drug resistance modulator candidate, XR9576, were also presented.
Topoisomerase Inhibition
Poster: Ex vivo activity of two novel dual topoisomerase I and II inhibitors XR5944 and XR11576 against solid tumors
The preclinical studies, carried out in conjunction with Professor Ian Cree of Queen Alexandra Hospital, Portsmouth and UCL, London, UK, were conducted with biopsy samples taken from 24 ovarian and 27 cutaneous melanoma patients. Cutaneous melanoma is a tumor generally regarded as resistant to chemotherapy.
The data presented demonstrated a more than 20-fold enhancement of potency for XR11576 and XR5944, two of Xenova`s second-generation topoisomerase inhibitors, relative to a first generation inhibitor (XR5000). XR11576 and XR5944 have both been developed by Xenova`s in-house research function. The topoisomerase program has been developed from Xenova`s collaboration with the Auckland Cancer Research Centre. It is anticipated that XR11576 will enter Phase I/II clinical trials before the end of 2001.
Poster: XR11612, a novel dual inhibitor of topoisomerase I and II with potent antitumor activity
Preclinical data comparing the in vitro efficacy of XR11612, a further novel, next generation topoisomerase inhibitor, with a number of widely used cytotoxic drugs have also been presented.
These preclinical studies compared the in vitro efficacy of XR11612 and the cytotoxic drugs and assessed the degree to which they are affected by the various types of drug resistance mechanism frequently found in cancer patients. XR11612 was shown to be unaffected by P-glycoprotein, MRP (multi-drug resistance protein) or atypical drug resistance mechanisms. XR11612 also showed significant antitumor efficacy against murine and human carcinoma models after IV and oral administration. In this study the activity profile of XR11612 was observed to be equal to or better than a number of widely used anticancer drugs including doxorubicin and topotecan and also TAS 103, a drug candidate under development by Bristol-Myers Squibb.
Topoisomerase inhibitors comprise a major class of cytotoxic anti-cancer agent that is widely used to treat cancer patients. Topoisomerases are enzymes which are critically involved in the replication of DNA during the process of cell division and which therefore play a key role in the proliferation of cancer cells.
Anti-angiogenesis program
Poster: Low molecular weight inhibitors of PAI-1 suppress tumor cell invasion and angiogenesis in vitro and reduce tumor cell growth in vivo
Evidence has been presented supporting the critical role of PAI-1 in cancer progression and metastasis, as well as the ability of antibodies and a small molecule PAI-1 inhibitor (XR5967) to significantly inhibit cell invasion and migration.
In related studies, a second small molecule PAI-1 inhibitor (XR5118) has also been shown to significantly inhibit tumor growth in a metastatic lung carcinoma model.
Xenova is developing its PAI-1 inhibitors as novel inhibitors of angiogenesis. Angiogenesis is believed to be important in the process of tumor cell invasion, migration and metastasis. Angiogenesis inhibitors have shown promise in preclinical studies in inhibiting tumor cell migration, invasion and metastasis.
Xenova has a collaboration with Lilly for the development of Xenova`s PAI-1 inhibitors for use in cardiovascular disease. Lilly also has an option to acquire rights to Xenova`s PAI-1 inhibitors for use in cancer.
Multi-drug resistance modulation program
Poster: The novel P-glycoprotein (P-gp) antagonist, XR9576, in combination with vinorelbine, has no effect on the pharmacokinetics of the cytotoxic drug
Results from a previously reported Phase IIa study multi-drug resistance modulator XR9576 (tariquidar) were additionally presented. XR9576 was given in combination with vinorelbine in a study conducted by the National Cancer Institute (USA). The study found that a 150 mg dose of XR9576 (tariquidar) did not significantly affect the pharmacokinetic parameters of vinorelbine when given at up to 22.5 mg/m2 and demonstrated that a vinorelbine dose of 20 mg/m2 can be safely administered in combination with a single 150 mg dose of XR9576 (tariquidar) in a heavily pre-treated group of patients. XR9576 has also successfully completed further Phase IIa combination studies with the cytotoxic drugs doxorubicin and paclitaxel.
Xenova signed an agreement for the development and North American marketing of XR9576 with QLT Inc in August 2001. It is anticipated that XR9576 will enter Phase III clinical trials in the first half of 2002.
SLOUGH, England, Oct 31, 2001 /PRNewswire via COMTEX/ -- Xenova Group plc (Nasdaq: XNVA; London Stock Exchange: XEN) today announced the publication of new research data at the EORTC/NCI AACR Symposium on Molecular Targets & Cancer Therapeutics, currently being held in Miami Beach, Florida.
Xenova has presented data at the Symposium on recent progress made in Xenova`s anti-angiogenesis and cytotoxic drug research program. Data presented included progress made with Xenova`s second generation topoisomerase inhibitors and a research update for Xenova`s plasminogen activator-1 (PAI-1) inhibition program. Details of an earlier Phase IIa trial for Xenova`s lead multi-drug resistance modulator candidate, XR9576, were also presented.
Topoisomerase Inhibition
Poster: Ex vivo activity of two novel dual topoisomerase I and II inhibitors XR5944 and XR11576 against solid tumors
The preclinical studies, carried out in conjunction with Professor Ian Cree of Queen Alexandra Hospital, Portsmouth and UCL, London, UK, were conducted with biopsy samples taken from 24 ovarian and 27 cutaneous melanoma patients. Cutaneous melanoma is a tumor generally regarded as resistant to chemotherapy.
The data presented demonstrated a more than 20-fold enhancement of potency for XR11576 and XR5944, two of Xenova`s second-generation topoisomerase inhibitors, relative to a first generation inhibitor (XR5000). XR11576 and XR5944 have both been developed by Xenova`s in-house research function. The topoisomerase program has been developed from Xenova`s collaboration with the Auckland Cancer Research Centre. It is anticipated that XR11576 will enter Phase I/II clinical trials before the end of 2001.
Poster: XR11612, a novel dual inhibitor of topoisomerase I and II with potent antitumor activity
Preclinical data comparing the in vitro efficacy of XR11612, a further novel, next generation topoisomerase inhibitor, with a number of widely used cytotoxic drugs have also been presented.
These preclinical studies compared the in vitro efficacy of XR11612 and the cytotoxic drugs and assessed the degree to which they are affected by the various types of drug resistance mechanism frequently found in cancer patients. XR11612 was shown to be unaffected by P-glycoprotein, MRP (multi-drug resistance protein) or atypical drug resistance mechanisms. XR11612 also showed significant antitumor efficacy against murine and human carcinoma models after IV and oral administration. In this study the activity profile of XR11612 was observed to be equal to or better than a number of widely used anticancer drugs including doxorubicin and topotecan and also TAS 103, a drug candidate under development by Bristol-Myers Squibb.
Topoisomerase inhibitors comprise a major class of cytotoxic anti-cancer agent that is widely used to treat cancer patients. Topoisomerases are enzymes which are critically involved in the replication of DNA during the process of cell division and which therefore play a key role in the proliferation of cancer cells.
Anti-angiogenesis program
Poster: Low molecular weight inhibitors of PAI-1 suppress tumor cell invasion and angiogenesis in vitro and reduce tumor cell growth in vivo
Evidence has been presented supporting the critical role of PAI-1 in cancer progression and metastasis, as well as the ability of antibodies and a small molecule PAI-1 inhibitor (XR5967) to significantly inhibit cell invasion and migration.
In related studies, a second small molecule PAI-1 inhibitor (XR5118) has also been shown to significantly inhibit tumor growth in a metastatic lung carcinoma model.
Xenova is developing its PAI-1 inhibitors as novel inhibitors of angiogenesis. Angiogenesis is believed to be important in the process of tumor cell invasion, migration and metastasis. Angiogenesis inhibitors have shown promise in preclinical studies in inhibiting tumor cell migration, invasion and metastasis.
Xenova has a collaboration with Lilly for the development of Xenova`s PAI-1 inhibitors for use in cardiovascular disease. Lilly also has an option to acquire rights to Xenova`s PAI-1 inhibitors for use in cancer.
Multi-drug resistance modulation program
Poster: The novel P-glycoprotein (P-gp) antagonist, XR9576, in combination with vinorelbine, has no effect on the pharmacokinetics of the cytotoxic drug
Results from a previously reported Phase IIa study multi-drug resistance modulator XR9576 (tariquidar) were additionally presented. XR9576 was given in combination with vinorelbine in a study conducted by the National Cancer Institute (USA). The study found that a 150 mg dose of XR9576 (tariquidar) did not significantly affect the pharmacokinetic parameters of vinorelbine when given at up to 22.5 mg/m2 and demonstrated that a vinorelbine dose of 20 mg/m2 can be safely administered in combination with a single 150 mg dose of XR9576 (tariquidar) in a heavily pre-treated group of patients. XR9576 has also successfully completed further Phase IIa combination studies with the cytotoxic drugs doxorubicin and paclitaxel.
Xenova signed an agreement for the development and North American marketing of XR9576 with QLT Inc in August 2001. It is anticipated that XR9576 will enter Phase III clinical trials in the first half of 2002.
Klingt doch gar nicht so schlecht, oder?
XENOVA sees XR11576 cancer treatment Phase I/II clinical trials before yr-end
AFX Europe; Oct 31, 2001
LONDON (AFX) - Xenova Group PLC said it expects its XR11576 cancer treatment, a second generation topoisomerase inhibitor, to enter Phase I/II clinical trials before the end of the year.
The group has presented data on progress of its anti-angiogenesis and cytotoxic drug research programmes at the EORTC/NCI AACR Symposium on Molecular Targets & Cancer Therapeutics, currently being held in Miami Beach, Florida.
It said it also received positive results from studies of XR11612, a novel dual inhibitor of topoisomerase I and II with potent antitumour activity
XR11612 was shown to be unaffected by P-glycoprotein, MRP (multi-drug resistance protein) or atypical drug resistance mechanisms. XR11612 also showed significant antitumour efficacy against murine and human carcinoma models after iv and oral administration.
Xenova said that, in this study, the activity profile of XR11612 was observed to be equal to or better than a number of widely used anticancer drugs including doxorubicin and topotecan and also TAS 103, a drug candidate under development by Bristol-Myers Squibb.
Evidence was also presented supporting the critical role of Xenova`s plasminogen activator-1 (PAI-1) in cancer progression and metastasis, as well as the ability of antibodies and a small molecule PAI-1 inhibitor (XR5967) to significantly inhibit cell invasion and migration.
AFX Europe; Oct 31, 2001
LONDON (AFX) - Xenova Group PLC said it expects its XR11576 cancer treatment, a second generation topoisomerase inhibitor, to enter Phase I/II clinical trials before the end of the year.
The group has presented data on progress of its anti-angiogenesis and cytotoxic drug research programmes at the EORTC/NCI AACR Symposium on Molecular Targets & Cancer Therapeutics, currently being held in Miami Beach, Florida.
It said it also received positive results from studies of XR11612, a novel dual inhibitor of topoisomerase I and II with potent antitumour activity
XR11612 was shown to be unaffected by P-glycoprotein, MRP (multi-drug resistance protein) or atypical drug resistance mechanisms. XR11612 also showed significant antitumour efficacy against murine and human carcinoma models after iv and oral administration.
Xenova said that, in this study, the activity profile of XR11612 was observed to be equal to or better than a number of widely used anticancer drugs including doxorubicin and topotecan and also TAS 103, a drug candidate under development by Bristol-Myers Squibb.
Evidence was also presented supporting the critical role of Xenova`s plasminogen activator-1 (PAI-1) in cancer progression and metastasis, as well as the ability of antibodies and a small molecule PAI-1 inhibitor (XR5967) to significantly inhibit cell invasion and migration.
Xenova completes initial clinical trials of two vaccines
Nov 05, 2001 (M2 EUROPHARMA via COMTEX) -- The UK-based biotech company Xenova Group Plc reports that the initial clinical trials of two of its drugs - TA-HPV and TA-CIN - have been completed successfully.
Both the drugs are vaccines, designed to prevent the development of diseases associated with human papillomavirus (HPV) - a recognised risk factor in both anal and genital cancers.
According to Xenova the phase IIa trial of TA-HPV, involving 18 patients, showed that the product was safe and well tolerated. TA-CIN, meanwhile, has been tested in a phase I study with 40 healthy volunteers. Xenova says the vaccine was found to be very well tolerated and also immunogenic. The company has now begun a phase II clinical trial in which TA-HPV is given in combination with TA-CIN.
Xenova is currently developing both vaccines alone but hopes to find a commercial partner if further trials are successful.
Nov 05, 2001 (M2 EUROPHARMA via COMTEX) -- The UK-based biotech company Xenova Group Plc reports that the initial clinical trials of two of its drugs - TA-HPV and TA-CIN - have been completed successfully.
Both the drugs are vaccines, designed to prevent the development of diseases associated with human papillomavirus (HPV) - a recognised risk factor in both anal and genital cancers.
According to Xenova the phase IIa trial of TA-HPV, involving 18 patients, showed that the product was safe and well tolerated. TA-CIN, meanwhile, has been tested in a phase I study with 40 healthy volunteers. Xenova says the vaccine was found to be very well tolerated and also immunogenic. The company has now begun a phase II clinical trial in which TA-HPV is given in combination with TA-CIN.
Xenova is currently developing both vaccines alone but hopes to find a commercial partner if further trials are successful.
Xenova Group plc - Cancer Research Update at EORTC/NCI AACR Symposium
SLOUGH, England, Oct. 31 /PRNewswire/ -- Xenova Group plc (Nasdaq: XNVA; London Stock Exchange: XEN) today announced the publication of new research data at the EORTC/NCI AACR Symposium on Molecular Targets & Cancer Therapeutics, currently being held in Miami Beach, Florida.
Xenova has presented data at the Symposium on recent progress made in Xenova`s anti-angiogenesis and cytotoxic drug research program. Data presented included progress made with Xenova`s second generation topoisomerase inhibitors and a research update for Xenova`s plasminogen activator-1 (PAI-1) inhibition program. Details of an earlier Phase IIa trial for Xenova`s lead multi-drug resistance modulator candidate, XR9576, were also presented. Topoisomerase Inhibition
Poster: Ex vivo activity of two novel dual topoisomerase I and II inhibitors XR5944 and XR11576 against solid tumors
The preclinical studies, carried out in conjunction with Professor Ian Cree of Queen Alexandra Hospital, Portsmouth and UCL, London, UK, were conducted with biopsy samples taken from 24 ovarian and 27 cutaneous melanoma patients. Cutaneous melanoma is a tumor generally regarded as resistant to chemotherapy.
The data presented demonstrated a more than 20-fold enhancement of potency for XR11576 and XR5944, two of Xenova`s second-generation topoisomerase inhibitors, relative to a first generation inhibitor (XR5000). XR11576 and XR5944 have both been developed by Xenova`s in-house research function. The topoisomerase program has been developed from Xenova`s collaboration with the Auckland Cancer Research Centre. It is anticipated that XR11576 will enter Phase I/II clinical trials before the end of 2001.
Poster: XR11612, a novel dual inhibitor of topoisomerase I and II with potent antitumor activity
Preclinical data comparing the in vitro efficacy of XR11612, a further novel, next generation topoisomerase inhibitor, with a number of widely used cytotoxic drugs have also been presented.
These preclinical studies compared the in vitro efficacy of XR11612 and the cytotoxic drugs and assessed the degree to which they are affected by the various types of drug resistance mechanism frequently found in cancer patients. XR11612 was shown to be unaffected by P-glycoprotein, MRP (multi-drug resistance protein) or atypical drug resistance mechanisms. XR11612 also showed significant antitumor efficacy against murine and human carcinoma models after IV and oral administration. In this study the activity profile of XR11612 was observed to be equal to or better than a number of widely used anticancer drugs including doxorubicin and topotecan and also TAS 103, a drug candidate under development by Bristol-Myers Squibb.
Topoisomerase inhibitors comprise a major class of cytotoxic anti-cancer agent that is widely used to treat cancer patients. Topoisomerases are enzymes which are critically involved in the replication of DNA during the process of cell division and which therefore play a key role in the proliferation of cancer cells. Anti-angiogenesis program
Poster: Low molecular weight inhibitors of PAI-1 suppress tumor cell invasion and angiogenesis in vitro and reduce tumor cell growth in vivo
Evidence has been presented supporting the critical role of PAI-1 in cancer progression and metastasis, as well as the ability of antibodies and a small molecule PAI-1 inhibitor (XR5967) to significantly inhibit cell invasion and migration.
In related studies, a second small molecule PAI-1 inhibitor (XR5118) has also been shown to significantly inhibit tumor growth in a metastatic lung carcinoma model.
Xenova is developing its PAI-1 inhibitors as novel inhibitors of angiogenesis. Angiogenesis is believed to be important in the process of tumor cell invasion, migration and metastasis. Angiogenesis inhibitors have shown promise in preclinical studies in inhibiting tumor cell migration, invasion and metastasis.
Xenova has a collaboration with Lilly for the development of Xenova`s PAI-1 inhibitors for use in cardiovascular disease. Lilly also has an option to acquire rights to Xenova`s PAI-1 inhibitors for use in cancer. Multi-drug resistance modulation program
Poster: The novel P-glycoprotein (P-gp) antagonist, XR9576, in combination with vinorelbine, has no effect on the pharmacokinetics of the cytotoxic drug
Results from a previously reported Phase IIa study multi-drug resistance modulator XR9576 (tariquidar) were additionally presented. XR9576 was given in combination with vinorelbine in a study conducted by the National Cancer Institute (USA). The study found that a 150 mg dose of XR9576 (tariquidar) did not significantly affect the pharmacokinetic parameters of vinorelbine when given at up to 22.5 mg/m2 and demonstrated that a vinorelbine dose of 20 mg/m2 can be safely administered in combination with a single 150 mg dose of XR9576 (tariquidar) in a heavily pre-treated group of patients. XR9576 has also successfully completed further Phase IIa combination studies with the cytotoxic drugs doxorubicin and paclitaxel.
Xenova signed an agreement for the development and North American marketing of XR9576 with QLT Inc in August 2001. It is anticipated that XR9576 will enter Phase III clinical trials in the first half of 2002. Notes to Editors
Xenova`s product pipeline focuses principally on the therapeutic areas of cancer, infectious, autoimmune and cardiovascular diseases. The Group has a well-established track record in the identification, development and partnering of innovative products and technologies. Xenova has partnerships with a number of major pharmaceutical companies including Lilly, Pfizer, Celltech and QLT Inc.
For further information about Xenova and its products please visit the Xenova website at http://www.xenova.co.uk.
Safe Harbor Statement under the US Private Securities Litigation Reform Act of 1995: Some or all of the statements in this document that relate to future plans, expectations, events, performances and the like are forward-looking statements, as defined in the US Private Securities Litigation Reform Act of 1995. Actual results of events could differ materially from those described in the forward-looking statements due to a variety of factors, including those set forth in the Company`s filings with the US Securities and Exchange Commission.
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/CONTACT: UK - David Oxlade, Chief Executive Officer, Daniel Abrams, Finance Director, or Hilary Reid Evans, Corporate Communications, all of Xenova Group plc, +44-0-1753-706600; David Yates or Fiona Noblet, both of Financial Dynamics, +44-0-207-831-3113; or US - Brad Miles, +1-212-477-9007, ext. 17, or Lauren Tortorete, +1-212-477-9007, ext. 20, both of BMC Communications for Xenova Group plc/
SLOUGH, England, Oct. 31 /PRNewswire/ -- Xenova Group plc (Nasdaq: XNVA; London Stock Exchange: XEN) today announced the publication of new research data at the EORTC/NCI AACR Symposium on Molecular Targets & Cancer Therapeutics, currently being held in Miami Beach, Florida.
Xenova has presented data at the Symposium on recent progress made in Xenova`s anti-angiogenesis and cytotoxic drug research program. Data presented included progress made with Xenova`s second generation topoisomerase inhibitors and a research update for Xenova`s plasminogen activator-1 (PAI-1) inhibition program. Details of an earlier Phase IIa trial for Xenova`s lead multi-drug resistance modulator candidate, XR9576, were also presented. Topoisomerase Inhibition
Poster: Ex vivo activity of two novel dual topoisomerase I and II inhibitors XR5944 and XR11576 against solid tumors
The preclinical studies, carried out in conjunction with Professor Ian Cree of Queen Alexandra Hospital, Portsmouth and UCL, London, UK, were conducted with biopsy samples taken from 24 ovarian and 27 cutaneous melanoma patients. Cutaneous melanoma is a tumor generally regarded as resistant to chemotherapy.
The data presented demonstrated a more than 20-fold enhancement of potency for XR11576 and XR5944, two of Xenova`s second-generation topoisomerase inhibitors, relative to a first generation inhibitor (XR5000). XR11576 and XR5944 have both been developed by Xenova`s in-house research function. The topoisomerase program has been developed from Xenova`s collaboration with the Auckland Cancer Research Centre. It is anticipated that XR11576 will enter Phase I/II clinical trials before the end of 2001.
Poster: XR11612, a novel dual inhibitor of topoisomerase I and II with potent antitumor activity
Preclinical data comparing the in vitro efficacy of XR11612, a further novel, next generation topoisomerase inhibitor, with a number of widely used cytotoxic drugs have also been presented.
These preclinical studies compared the in vitro efficacy of XR11612 and the cytotoxic drugs and assessed the degree to which they are affected by the various types of drug resistance mechanism frequently found in cancer patients. XR11612 was shown to be unaffected by P-glycoprotein, MRP (multi-drug resistance protein) or atypical drug resistance mechanisms. XR11612 also showed significant antitumor efficacy against murine and human carcinoma models after IV and oral administration. In this study the activity profile of XR11612 was observed to be equal to or better than a number of widely used anticancer drugs including doxorubicin and topotecan and also TAS 103, a drug candidate under development by Bristol-Myers Squibb.
Topoisomerase inhibitors comprise a major class of cytotoxic anti-cancer agent that is widely used to treat cancer patients. Topoisomerases are enzymes which are critically involved in the replication of DNA during the process of cell division and which therefore play a key role in the proliferation of cancer cells. Anti-angiogenesis program
Poster: Low molecular weight inhibitors of PAI-1 suppress tumor cell invasion and angiogenesis in vitro and reduce tumor cell growth in vivo
Evidence has been presented supporting the critical role of PAI-1 in cancer progression and metastasis, as well as the ability of antibodies and a small molecule PAI-1 inhibitor (XR5967) to significantly inhibit cell invasion and migration.
In related studies, a second small molecule PAI-1 inhibitor (XR5118) has also been shown to significantly inhibit tumor growth in a metastatic lung carcinoma model.
Xenova is developing its PAI-1 inhibitors as novel inhibitors of angiogenesis. Angiogenesis is believed to be important in the process of tumor cell invasion, migration and metastasis. Angiogenesis inhibitors have shown promise in preclinical studies in inhibiting tumor cell migration, invasion and metastasis.
Xenova has a collaboration with Lilly for the development of Xenova`s PAI-1 inhibitors for use in cardiovascular disease. Lilly also has an option to acquire rights to Xenova`s PAI-1 inhibitors for use in cancer. Multi-drug resistance modulation program
Poster: The novel P-glycoprotein (P-gp) antagonist, XR9576, in combination with vinorelbine, has no effect on the pharmacokinetics of the cytotoxic drug
Results from a previously reported Phase IIa study multi-drug resistance modulator XR9576 (tariquidar) were additionally presented. XR9576 was given in combination with vinorelbine in a study conducted by the National Cancer Institute (USA). The study found that a 150 mg dose of XR9576 (tariquidar) did not significantly affect the pharmacokinetic parameters of vinorelbine when given at up to 22.5 mg/m2 and demonstrated that a vinorelbine dose of 20 mg/m2 can be safely administered in combination with a single 150 mg dose of XR9576 (tariquidar) in a heavily pre-treated group of patients. XR9576 has also successfully completed further Phase IIa combination studies with the cytotoxic drugs doxorubicin and paclitaxel.
Xenova signed an agreement for the development and North American marketing of XR9576 with QLT Inc in August 2001. It is anticipated that XR9576 will enter Phase III clinical trials in the first half of 2002. Notes to Editors
Xenova`s product pipeline focuses principally on the therapeutic areas of cancer, infectious, autoimmune and cardiovascular diseases. The Group has a well-established track record in the identification, development and partnering of innovative products and technologies. Xenova has partnerships with a number of major pharmaceutical companies including Lilly, Pfizer, Celltech and QLT Inc.
For further information about Xenova and its products please visit the Xenova website at http://www.xenova.co.uk.
Safe Harbor Statement under the US Private Securities Litigation Reform Act of 1995: Some or all of the statements in this document that relate to future plans, expectations, events, performances and the like are forward-looking statements, as defined in the US Private Securities Litigation Reform Act of 1995. Actual results of events could differ materially from those described in the forward-looking statements due to a variety of factors, including those set forth in the Company`s filings with the US Securities and Exchange Commission.
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/CONTACT: UK - David Oxlade, Chief Executive Officer, Daniel Abrams, Finance Director, or Hilary Reid Evans, Corporate Communications, all of Xenova Group plc, +44-0-1753-706600; David Yates or Fiona Noblet, both of Financial Dynamics, +44-0-207-831-3113; or US - Brad Miles, +1-212-477-9007, ext. 17, or Lauren Tortorete, +1-212-477-9007, ext. 20, both of BMC Communications for Xenova Group plc/
UK public companies have 130 products in development, compared to nearest rival Denmark with 30, while Celltech Group (LSE: CCH.L - news) and Xenova Group (LSE: XEN.L - news) struck two of Europe`s largest biotech licensing deals for their experimental drugs.
British firms have also taken a leading role in consolidation in the sector -- a trend which analysts expect to gather pace in the years ahead -- with acquisitions this year from Xenova, Celltech, KS Biomedix (LSE: KSB.L - news) Holdings Plc, PowderJect Pharmaceuticals and BioFocus (LSE: BIO.L - news) .
British firms have also taken a leading role in consolidation in the sector -- a trend which analysts expect to gather pace in the years ahead -- with acquisitions this year from Xenova, Celltech, KS Biomedix (LSE: KSB.L - news) Holdings Plc, PowderJect Pharmaceuticals and BioFocus (LSE: BIO.L - news) .
Xenova Group plc - Third Quarter Results Announcement
SLOUGH, England, Nov 20, 2001 /PRNewswire via COMTEX/ -- Xenova Group plc (Nasdaq: XNVA; London Stock Exchange: XEN), today announced its results for the three-month period to 30 September 2001.
Operating Highlights: Three Months to 30 September 2001
* Cancer: 71.4m pounds (US$105m) North American collaboration
with QLT Inc for multi-drug resistance modulator XR9576 (tariquidar)
* Phogen Joint Venture: 14.3m pounds (US$21m) license and collaboration
agreement with Genencor International
* Addiction: Positive Phase IIa study results for cocaine program
-- Anti-nicotine vaccine enters Phase I clinical trials
* Cash and liquid resources as at 30 September 2001 17.5m pounds
(US$25.7m)
Subsequent Events
* Cancer: Successful results announced for TA-HPV Phase IIa clinical
trials and for TA-CIN Phase I clinical trials
-- Start of Phase II `prime/boost` trial for TA-HPV and TA-CIN
* Infectious Diseases: Termination of TA-HSV study
* Phogen Joint Venture: Research collaboration with Cell Genesys
* Cancer program research update presented at Symposium on Molecular
Targets and Cancer Therapeutics
* Board Changes
Commenting, Chief Executive Officer David Oxlade said:
"Following the merger with Cantab, Xenova is a stronger company with a broad pipeline of high value opportunities. The last quarter in particular has been one of accelerated progress, including the partnering of our lead drug candidate with QLT for the North American market, the entry of our anti-nicotine vaccine to Phase I clinical trials and the positive study results from the Phase IIa trial for our anti-cocaine addiction vaccine."
Progress Update - Clinical Product Pipeline
XR9576 (tariquidar) -- Following the successful conclusion of a series of three Phase IIa clinical trials for Xenova`s multi-drug resistance (MDR) modulator, XR9576 (which now has the generic name tariquidar), an exclusive license agreement was signed in August 2001 with Vancouver-based QLT Inc for the development and North American marketing of XR9576 for the treatment of MDR in cancer.
QLT has assumed responsibility within North America for the further development of XR9576, including Phase III trials, all regulatory filings and the manufacture and sale of XR9576. QLT made an immediate upfront license payment to Xenova of US$10m (6.9m pounds) and will provide up to US$45m (30.6m pounds) in funding for development activities related to Phase III clinical studies for XR9576 in North America and Europe. Milestones of up to US$50m (34.0m pounds) and royalties in the range of 15 to 22 per cent depending on the level of North American sales are also receivable by Xenova. A Phase III clinical trial program is expected to begin in the first half of 2002.
Xenova retains commercialization rights and substantially all revenue rights to XR9576 outside the United States, Canada and Mexico.
Data from a previously reported Phase IIa study for XR9576 were presented at the Symposium on Molecular Targets and Cancer Therapeutics held in October 2001 in Miami, Florida, USA. Results presented demonstrated that a dose of 20mg/m2 of vinorelbine (a widely used cytotoxic drug) can be safely administered in combination with a single 150mg dose of XR9576 in a heavily pre-treated group of patients. No pharmacokinetic interaction was detected.
TA-HPV and TA-CIN -- TA-HPV and TA-CIN are vaccines which target the treatment of human papillomavirus (HPV) associated diseases. HPV infection has been linked to a group of conditions known collectively as ano-genital intraepithelial neoplasia (AGIN) and to ano-genital cancers. The successful conclusion of a Phase IIa trial for TA-HPV, of a Phase I trial for TA-CIN and the commencement of a Phase II trial to investigate a `prime-boost` regimen, which combines both products, were announced in October 2001. Preclinical studies have demonstrated that a combination of TA-HPV and TA-CIN results in an immune response that is significantly stronger than that observed with either product alone.
A further Phase IIa AGIN study for TA-HPV is ongoing and is due to be completed in the near future. AGIN conditions are highly recurrent, difficult to treat and have debilitating effects for sufferers.
TA-HSV -- Results of the Phase II clinical efficacy trial for TA-HSV, a therapeutic vaccine designed for the treatment of genital herpes, were announced in early October. The trial was conducted in collaboration with Xenova`s partner, GlaxoSmithKline (GSK). Analysis showed that the trial did not meet its clinical endpoints and further development of the vaccine is not planned. The TA-HSV agreement between Xenova and GSK will be terminated, effective January 2002.
TA-CD -- an anti-cocaine vaccine, TA-CD was released from clinical hold in July 2001. TA-CD had been placed on precautionary hold in late 2000 following the observation that a related product caused eye irritation in preclinical studies. Extensive further testing of the related product showed no safety implications.
The successful results of a Phase IIa trial for TA-CD were also announced in July 2001. TA-CD was shown to be well tolerated systemically and locally and was able to generate higher and earlier antibody titres than those seen in a Phase I trial, potentially benefiting the patient by establishing a more rapid therapeutic effect.
Xenova expects to begin a Phase II cocaine challenge study in the US in 2002. The purpose of this study is to provide an assessment of the efficacy of TA-CD, as determined by quantitative behavioral and other measurements.
TA-NIC -- it was announced in September 2001 that TA-NIC, a novel therapeutic vaccine which is being developed for the treatment of nicotine addiction, has entered Phase I clinical trials. It is believed to be the first anti-nicotine addiction vaccine to enter clinical testing. TA-NIC uses a novel mode of action whereby it seeks to prevent nicotine from entering the brain, thus reducing or removing the pleasurable stimulus which usually accompanies smoking.
Progress Update -- Preclinical Product Pipeline
XR11576 -- A novel dual topoisomerase inhibitor, XR11576 is designed for the treatment of common solid tumors. XR11576 has a significantly improved biological profile when compared with first generation topoisomerase inhibitors, including oral bioavailability and a marked enhancement of potency. It is planned that XR11576 will enter Phase I clinical trials before the end of 2001.
XR5944 -- along with XR11576, XR5944 is part of the second generation of intravenous dual topoisomerase I/II inhibitor program. XR5944 has shown unusually high potency as a cytotoxic agent in preclinical studies with a number of tumor cells.
Data relating to the efficacy of XR11576 and XR5944 were presented at the October EORTC/AACR/NCI Symposium on Molecular Targets and Cancer Therapeutics and demonstrated a more than 20-fold enhancement of potency for these compounds relative to a first generation topoisomerase inhibitor. XR11576 and XR5944 have both been developed by Xenova`s in-house research function. Data was also presented on a further topoisomerase inhibitor, XR11612, showing that the activity profile of XR11612 was equal to or better than a number of widely used anti-cancer drugs.
PAI-1 Cancer -- Xenova is developing its PAI-1 inhibitors as novel inhibitors of angiogenesis. Data relating to this program were presented at the October Symposium on Molecular Targets and Cancer Therapeutics, supporting the critical role of PAI-1 in cancer progression and metastasis, as well as the ability of antibodies to PAI-1 and a small molecule PAI-1 inhibitor (XR5967) to significantly inhibit cell invasion and migration. In related studies a second small molecule PAI-1 inhibitor (XR5118) was also shown to significantly inhibit cell invasion and migration.
Phogen
A joint venture between Xenova and Marie Curie Cancer Care, Phogen Limited is developing a novel technology, known as VP22, for the enhanced delivery of gene-based therapeutics.
Data relating to VP22 were published in the 4 May 2001 issue of the "Journal of Biological Chemistry," which highlighted the light-activated properties of the technology.
In August 2001, it was announced that Phogen has entered into a 14.3m pounds (US$21m) licensing agreement with Genencor International Inc for the utilization of VP22 technology in the area of therapeutic vaccines for certain infectious viral diseases.
In October 2001, Phogen entered into a research collaboration with Cell Genesys Inc in the field of gene therapy, for the development of products for cancer and cardiovascular disease.
Board Changes
On 30th October 2001 it was announced that Commercial Director Nick Hart and Executive Director (Commercial Collaborations) Stephen Inglis are to leave the Board at the end of December 2001. Both have made significant contributions to the development of firstly Cantab Pharmaceuticals and more recently Xenova Group plc. Nick Hart will remain with Xenova on a part time basis for a short period after 31 December in order to affect a handover to Commercial Director, Dr Joy Barton, who joined the company in early November and who is a member of the senior management team.
Financial Summary
Operating Performance
In the 3 months to 30 September 2001, the Group`s revenue from licensing deals, strategic partnerships and manufacturing outsourcing rose to 0.7m pounds ($1.1m) (2000 nil pounds ($nil)).
In accordance with the Group`s revenue recognition policy, of the 6.9m pounds ($10m) received from QLT as part of the XR9576 partnership deal, 0.4m pounds ($0.5m) was included in the quarter to 30 September 2001. Of the 0.8m pounds ($1.1m) received from Genencor by Phogen, the Group`s 45% shareholding joint venture, 0.1m pounds ($0.1m) was recognized by the Group in the nine months to 30 September 2001. Other revenue included 0.2m pounds ($0.3m) from GlaxoSmithKline in respect of the TA-HSV partnership which will cease at the year-end and 0.1m pounds ($0.1m) of contract manufacturing revenue from new contracts. Revenue in the 9-month period to 30 September 2001 of 1.2m pounds ($1.8m) excludes 0.9m pounds ($1.4m) of pre-acquisition revenue generated in the first quarter of the year.
As a result of the implementation of the strategic review performed following the merger of Xenova and Cantab, as announced in the interim statement in August 2001, total operating expenses, excluding exceptional items, have reduced from 5.9m pounds ($8.7m) in the second quarter by 7.4% to 5.5m pounds ($8.1m) in the third quarter of 2001.
Due to savings made on non-priority programs, research expenditure was reduced in the quarter from 4.8m pounds ($7.0m) by 7.3% to 4.4m pounds ($6.5m) compared to the second quarter. Compared to the second quarter of 1.2m pounds ($1.7m), continued reductions in administrative expenses (excluding exceptional items) contributed to a fall in expenses of 7.9% in the quarter to 1.1m pounds ($1.6m).
Of the total administrative expenses for the 9 months to 30 September 2001 amounting to 3.4m pounds ($4.9m), 0.7m pounds ($1.0m) relates to exceptional reorganization costs and 0.6m pounds ($0.9m) to the amortization over a 10-year period of the goodwill in respect of the acquisition of Cantab.
The increased net interest income reflects the increased cash and liquid resources balance held throughout the nine months to 30 September 2001. Following revaluation to the listed market price of the 88,668 Cubist Pharmaceuticals shares held by the Group, 0.4m pounds ($0.6m) has been written off in the quarter to mark the shares to their market price, reducing the overall gain in 9 months in 2001 to 0.3m pounds ($0.4m).
The net loss per share this quarter of 3p (second quarter 3p) reflects the Group`s achievement in obtaining valuable strategic partnerships and developing the product pipeline, whilst minimizing operating expenses.
Cash and liquid investments
Cash and liquid resources at 30 September 2001 total 17.5m pounds ($25.7m) (2000: #13.3m $19.5m).
Cash of 15.5m pounds ($22.8m) and liquid resources of 2.0m pounds ($2.9m) at 30 September 2001 (2000: cash 13.3m pounds ($19.5m), liquid resources nil), excludes the receipt of 1.9m pounds ($2.8m) in respect of the year 2000 R&D tax credit successfully recovered in October.
Share capital
The number of shares in issue and to be issued stood at 139.0 million as at 30 September 2001.
The Directors do not currently propose a dividend for 2001 (2000: nil).
Notes to Editors
Xenova`s product pipeline focuses principally on the therapeutic areas of cancer, infectious, autoimmune and cardiovascular diseases. The Group has a well-established track record in the identification, development and partnering of innovative products and technologies. Xenova has partnerships with a number of major pharmaceutical companies including Lilly, Pfizer, Celltech and QLT Inc.
For further information about Xenova and its products please visit the Xenova website at http://www.xenova.co.uk.
Safe Harbor Statement under the US Private Securities Litigation Reform Act of 1995: Some or all of the statements in this document that relate to future plans, expectations, events, performances and the like are forward-looking statements, as defined in the US Private Securities Litigation Reform Act of 1995. Actual results of events could differ materially from those described in the forward-looking statements due to a variety of factors, including those set forth in the Company`s filings with the US Securities and Exchange Commission.
Consolidated Profit and Loss Account (unaudited)
Three months ended Nine months ended
30 30 30 30 30 30
Sept Sept Sept Sept Sept Sept
2001 2001 2000 2001 2001 2000
$000 000 000 $000 000 000
pounds pounds pounds pounds
Turnover (including share of joint venture)
Continuing
operations 544 370 -- 544 370 78
Acquisitions 593 404 -- 1,334 908 --
Less: share of
joint venture
revenue (69) (47) -- (73) (50) --
Turnover 1,068 727 -- 1,805 1,228 78
Operating expenses
Research and development costs
Continuing
operations (2,943) (2,002) (2,121) (8,498) (5,781) (5,283)
Acquisitions (3,555) (2,419) -- (7,765) (5,283) --
(6,498) (4,421) (2,121) (16,263) (11,064) (5,283)
Administrative expenses
Continuing
operations (801) (545) (412) (2,396) (1,630) (1,208)
Continuing
operations:
exceptional
reorganization
costs -- -- -- (91) (62) --
(801) (545) (412) (2,487) (1,692) (1,208)
Acquisitions (335) (228) -- (717) (488) --
Acquisitions:
exceptional
reorganization
costs -- -- -- (876) (596) --
Acquisitions:
amortization
of goodwill (431) (293) -- (862) (586) --
(766) (521) -- (2,455) (1,670) --
Total administrative
expenses (1,567) (1,066) (412) (4,942) (3,362) (1,208)
Total operating
expenses (8,065) (5,487) (2,533) (21,205) (14,426) (6,491)
Group operating loss
Continuing
operations (3,200) (2,177) (2,533) (10,441) (7,103) (6,413)
Acquisitions (3,797) (2,583) -- (8,959) (6,095) --
(6,997) (4,760) (2,533) (19,400) (13,198) (6,413)
Acquisitions:
share of
operating profit
of joint venture 49 33 -- 6 4 --
Total operating loss:
Group and share of
joint venture (6,948) (4,727) (2,533) (19,394) (13,194) (6,413)
Interest (net) 273 186 188 861 586 478
Amounts written (off)/
back on
investments (622) (423) -- 371 252 --
Loss on ordinary
activities before
taxation (7,297) (4,964) (2,345) (18,162) (12,356) (5,935)
Tax on loss on
ordinary
activities 753 512 -- 2,086 1,419 --
Loss on ordinary
activities after
taxation attributable
to members of
Xenova Group
plc (6,544) (4,452) (2,345) (16,076) (10,937) (5,935)
Loss per share
(basic and
diluted) (5c) (3p) (4p) (14c) (9p) (10p)
Shares used in
computing net
loss per share
(thousands) 139,044 139,044 62,971 115,780 115,780 57,525
US Dollar amounts have been translated at the closing rate on
30 September 2001 (1.00 pounds: $1.4699) solely for information.
Condensed Consolidated Balance Sheet (unaudited)
Unaudited Unaudited Audited
As at As at As at
30 Sept 30 Sept 31 Dec
2001 2001 2000
$000 000 000
pounds pounds
Cash and investments 25,697 17,482 12,233
Other current assets 8,784 5,976 1,510
Fixed assets (including
goodwill) 30,565 20,794 543
Total assets 65,046 44,252 14,286
Current liabilities (including
provisions & deferred
income) (14,686) (9,991) (2,410)
Shareholders` equity (50,360) (34,261) (11,876)
Total liabilities and
shareholders` equity (65,046) (44,252) (14,286)
US Dollar amounts have been translated at the closing rate on
30 September 2001 (1.00 pounds: $1.4699) solely for information.
Notes to the Statement
Basis of preparation
These unaudited statements, which do not constitute statutory accounts within the meaning of Section 240 of the Companies Act 1985, have been prepared using the accounting policies set out in the Group`s 2000 Annual Report and Accounts except as set out below. The 2000 Annual Report and Accounts received an unqualified auditor`s report and have been delivered to the Registrar of Companies.
These consolidated financial statements have been prepared to include the revenues, costs and cash flows of the Cantab Pharmaceuticals Plc (`Cantab`) group from 6 April 2001, using acquisition accounting principles as set out in the interim statement.
Following the acquisition of Cantab the Group has adopted the following accounting policy in respect of intangible fixed assets. Goodwill arising from the purchase of subsidiary undertakings, representing the difference between the fair value of the purchase consideration and the fair value of the net assets acquired, is capitalized as an intangible asset and amortized on a straight line basis over its estimated useful economic life. Goodwill similarly arising on the acquisition of associates or joint ventures is recorded as part of the related investment.
Other intangible fixed assets, including acquired intellectual property, are capitalized at cost and amortized on a straight line basis over the estimated useful economic life of the asset, having taken into account the risk factors associated with developing a pharmaceutical product.
In accordance with emerging best practice on revenue recognition, the Group has adopted a modified accounting policy from 1 January 2001. This policy states that license fees and milestone payments are spread over the life of the relevant agreement in proportion to the work performed by the Group, but is limited to the non-refundable amounts received or receivable. The revenue recognized in 2000, under the former policy of recognizing such payments on receipt, would not have been materially different under the revised accounting policy adopted from 2001.
There have been no other changes to the Group`s accounting policies in 2001.
Going concern
The Group is an emerging pharmaceutical business and as such expects to absorb cash until products are commercialized. The Directors have a reasonable expectation that the Group has, or can reasonably expect to obtain, adequate cash resources to enable it to continue in operational existence for the foreseeable future, and have therefore prepared the financial statements on the going concern basis.
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SOURCE Xenova Group plc
CONTACT: UK - David Oxlade, Chief Executive Officer, Daniel Abrams,
Finance Director, or Hilary Reid Evans, Corporate Communications, all of
Xenova Group plc +44-0-1753-706600; or David Yates or Fiona Noblet, both of
Financial Dynamics, +44-0-207-831-3113, for Xenova Group plc; or US - Brad
Miles, +1-212-477-9007, ext. 17, or Lauren Tortorete, +1-212-477-9007,
ext. 20, both of BMC Communications for Xenova Group plc
URL: http://www.xenova.co.uk
http://www.prnewswire.com
Copyright (C) 2001 PR Newswire. All rights reserved.
SLOUGH, England, Nov 20, 2001 /PRNewswire via COMTEX/ -- Xenova Group plc (Nasdaq: XNVA; London Stock Exchange: XEN), today announced its results for the three-month period to 30 September 2001.
Operating Highlights: Three Months to 30 September 2001
* Cancer: 71.4m pounds (US$105m) North American collaboration
with QLT Inc for multi-drug resistance modulator XR9576 (tariquidar)
* Phogen Joint Venture: 14.3m pounds (US$21m) license and collaboration
agreement with Genencor International
* Addiction: Positive Phase IIa study results for cocaine program
-- Anti-nicotine vaccine enters Phase I clinical trials
* Cash and liquid resources as at 30 September 2001 17.5m pounds
(US$25.7m)
Subsequent Events
* Cancer: Successful results announced for TA-HPV Phase IIa clinical
trials and for TA-CIN Phase I clinical trials
-- Start of Phase II `prime/boost` trial for TA-HPV and TA-CIN
* Infectious Diseases: Termination of TA-HSV study
* Phogen Joint Venture: Research collaboration with Cell Genesys
* Cancer program research update presented at Symposium on Molecular
Targets and Cancer Therapeutics
* Board Changes
Commenting, Chief Executive Officer David Oxlade said:
"Following the merger with Cantab, Xenova is a stronger company with a broad pipeline of high value opportunities. The last quarter in particular has been one of accelerated progress, including the partnering of our lead drug candidate with QLT for the North American market, the entry of our anti-nicotine vaccine to Phase I clinical trials and the positive study results from the Phase IIa trial for our anti-cocaine addiction vaccine."
Progress Update - Clinical Product Pipeline
XR9576 (tariquidar) -- Following the successful conclusion of a series of three Phase IIa clinical trials for Xenova`s multi-drug resistance (MDR) modulator, XR9576 (which now has the generic name tariquidar), an exclusive license agreement was signed in August 2001 with Vancouver-based QLT Inc for the development and North American marketing of XR9576 for the treatment of MDR in cancer.
QLT has assumed responsibility within North America for the further development of XR9576, including Phase III trials, all regulatory filings and the manufacture and sale of XR9576. QLT made an immediate upfront license payment to Xenova of US$10m (6.9m pounds) and will provide up to US$45m (30.6m pounds) in funding for development activities related to Phase III clinical studies for XR9576 in North America and Europe. Milestones of up to US$50m (34.0m pounds) and royalties in the range of 15 to 22 per cent depending on the level of North American sales are also receivable by Xenova. A Phase III clinical trial program is expected to begin in the first half of 2002.
Xenova retains commercialization rights and substantially all revenue rights to XR9576 outside the United States, Canada and Mexico.
Data from a previously reported Phase IIa study for XR9576 were presented at the Symposium on Molecular Targets and Cancer Therapeutics held in October 2001 in Miami, Florida, USA. Results presented demonstrated that a dose of 20mg/m2 of vinorelbine (a widely used cytotoxic drug) can be safely administered in combination with a single 150mg dose of XR9576 in a heavily pre-treated group of patients. No pharmacokinetic interaction was detected.
TA-HPV and TA-CIN -- TA-HPV and TA-CIN are vaccines which target the treatment of human papillomavirus (HPV) associated diseases. HPV infection has been linked to a group of conditions known collectively as ano-genital intraepithelial neoplasia (AGIN) and to ano-genital cancers. The successful conclusion of a Phase IIa trial for TA-HPV, of a Phase I trial for TA-CIN and the commencement of a Phase II trial to investigate a `prime-boost` regimen, which combines both products, were announced in October 2001. Preclinical studies have demonstrated that a combination of TA-HPV and TA-CIN results in an immune response that is significantly stronger than that observed with either product alone.
A further Phase IIa AGIN study for TA-HPV is ongoing and is due to be completed in the near future. AGIN conditions are highly recurrent, difficult to treat and have debilitating effects for sufferers.
TA-HSV -- Results of the Phase II clinical efficacy trial for TA-HSV, a therapeutic vaccine designed for the treatment of genital herpes, were announced in early October. The trial was conducted in collaboration with Xenova`s partner, GlaxoSmithKline (GSK). Analysis showed that the trial did not meet its clinical endpoints and further development of the vaccine is not planned. The TA-HSV agreement between Xenova and GSK will be terminated, effective January 2002.
TA-CD -- an anti-cocaine vaccine, TA-CD was released from clinical hold in July 2001. TA-CD had been placed on precautionary hold in late 2000 following the observation that a related product caused eye irritation in preclinical studies. Extensive further testing of the related product showed no safety implications.
The successful results of a Phase IIa trial for TA-CD were also announced in July 2001. TA-CD was shown to be well tolerated systemically and locally and was able to generate higher and earlier antibody titres than those seen in a Phase I trial, potentially benefiting the patient by establishing a more rapid therapeutic effect.
Xenova expects to begin a Phase II cocaine challenge study in the US in 2002. The purpose of this study is to provide an assessment of the efficacy of TA-CD, as determined by quantitative behavioral and other measurements.
TA-NIC -- it was announced in September 2001 that TA-NIC, a novel therapeutic vaccine which is being developed for the treatment of nicotine addiction, has entered Phase I clinical trials. It is believed to be the first anti-nicotine addiction vaccine to enter clinical testing. TA-NIC uses a novel mode of action whereby it seeks to prevent nicotine from entering the brain, thus reducing or removing the pleasurable stimulus which usually accompanies smoking.
Progress Update -- Preclinical Product Pipeline
XR11576 -- A novel dual topoisomerase inhibitor, XR11576 is designed for the treatment of common solid tumors. XR11576 has a significantly improved biological profile when compared with first generation topoisomerase inhibitors, including oral bioavailability and a marked enhancement of potency. It is planned that XR11576 will enter Phase I clinical trials before the end of 2001.
XR5944 -- along with XR11576, XR5944 is part of the second generation of intravenous dual topoisomerase I/II inhibitor program. XR5944 has shown unusually high potency as a cytotoxic agent in preclinical studies with a number of tumor cells.
Data relating to the efficacy of XR11576 and XR5944 were presented at the October EORTC/AACR/NCI Symposium on Molecular Targets and Cancer Therapeutics and demonstrated a more than 20-fold enhancement of potency for these compounds relative to a first generation topoisomerase inhibitor. XR11576 and XR5944 have both been developed by Xenova`s in-house research function. Data was also presented on a further topoisomerase inhibitor, XR11612, showing that the activity profile of XR11612 was equal to or better than a number of widely used anti-cancer drugs.
PAI-1 Cancer -- Xenova is developing its PAI-1 inhibitors as novel inhibitors of angiogenesis. Data relating to this program were presented at the October Symposium on Molecular Targets and Cancer Therapeutics, supporting the critical role of PAI-1 in cancer progression and metastasis, as well as the ability of antibodies to PAI-1 and a small molecule PAI-1 inhibitor (XR5967) to significantly inhibit cell invasion and migration. In related studies a second small molecule PAI-1 inhibitor (XR5118) was also shown to significantly inhibit cell invasion and migration.
Phogen
A joint venture between Xenova and Marie Curie Cancer Care, Phogen Limited is developing a novel technology, known as VP22, for the enhanced delivery of gene-based therapeutics.
Data relating to VP22 were published in the 4 May 2001 issue of the "Journal of Biological Chemistry," which highlighted the light-activated properties of the technology.
In August 2001, it was announced that Phogen has entered into a 14.3m pounds (US$21m) licensing agreement with Genencor International Inc for the utilization of VP22 technology in the area of therapeutic vaccines for certain infectious viral diseases.
In October 2001, Phogen entered into a research collaboration with Cell Genesys Inc in the field of gene therapy, for the development of products for cancer and cardiovascular disease.
Board Changes
On 30th October 2001 it was announced that Commercial Director Nick Hart and Executive Director (Commercial Collaborations) Stephen Inglis are to leave the Board at the end of December 2001. Both have made significant contributions to the development of firstly Cantab Pharmaceuticals and more recently Xenova Group plc. Nick Hart will remain with Xenova on a part time basis for a short period after 31 December in order to affect a handover to Commercial Director, Dr Joy Barton, who joined the company in early November and who is a member of the senior management team.
Financial Summary
Operating Performance
In the 3 months to 30 September 2001, the Group`s revenue from licensing deals, strategic partnerships and manufacturing outsourcing rose to 0.7m pounds ($1.1m) (2000 nil pounds ($nil)).
In accordance with the Group`s revenue recognition policy, of the 6.9m pounds ($10m) received from QLT as part of the XR9576 partnership deal, 0.4m pounds ($0.5m) was included in the quarter to 30 September 2001. Of the 0.8m pounds ($1.1m) received from Genencor by Phogen, the Group`s 45% shareholding joint venture, 0.1m pounds ($0.1m) was recognized by the Group in the nine months to 30 September 2001. Other revenue included 0.2m pounds ($0.3m) from GlaxoSmithKline in respect of the TA-HSV partnership which will cease at the year-end and 0.1m pounds ($0.1m) of contract manufacturing revenue from new contracts. Revenue in the 9-month period to 30 September 2001 of 1.2m pounds ($1.8m) excludes 0.9m pounds ($1.4m) of pre-acquisition revenue generated in the first quarter of the year.
As a result of the implementation of the strategic review performed following the merger of Xenova and Cantab, as announced in the interim statement in August 2001, total operating expenses, excluding exceptional items, have reduced from 5.9m pounds ($8.7m) in the second quarter by 7.4% to 5.5m pounds ($8.1m) in the third quarter of 2001.
Due to savings made on non-priority programs, research expenditure was reduced in the quarter from 4.8m pounds ($7.0m) by 7.3% to 4.4m pounds ($6.5m) compared to the second quarter. Compared to the second quarter of 1.2m pounds ($1.7m), continued reductions in administrative expenses (excluding exceptional items) contributed to a fall in expenses of 7.9% in the quarter to 1.1m pounds ($1.6m).
Of the total administrative expenses for the 9 months to 30 September 2001 amounting to 3.4m pounds ($4.9m), 0.7m pounds ($1.0m) relates to exceptional reorganization costs and 0.6m pounds ($0.9m) to the amortization over a 10-year period of the goodwill in respect of the acquisition of Cantab.
The increased net interest income reflects the increased cash and liquid resources balance held throughout the nine months to 30 September 2001. Following revaluation to the listed market price of the 88,668 Cubist Pharmaceuticals shares held by the Group, 0.4m pounds ($0.6m) has been written off in the quarter to mark the shares to their market price, reducing the overall gain in 9 months in 2001 to 0.3m pounds ($0.4m).
The net loss per share this quarter of 3p (second quarter 3p) reflects the Group`s achievement in obtaining valuable strategic partnerships and developing the product pipeline, whilst minimizing operating expenses.
Cash and liquid investments
Cash and liquid resources at 30 September 2001 total 17.5m pounds ($25.7m) (2000: #13.3m $19.5m).
Cash of 15.5m pounds ($22.8m) and liquid resources of 2.0m pounds ($2.9m) at 30 September 2001 (2000: cash 13.3m pounds ($19.5m), liquid resources nil), excludes the receipt of 1.9m pounds ($2.8m) in respect of the year 2000 R&D tax credit successfully recovered in October.
Share capital
The number of shares in issue and to be issued stood at 139.0 million as at 30 September 2001.
The Directors do not currently propose a dividend for 2001 (2000: nil).
Notes to Editors
Xenova`s product pipeline focuses principally on the therapeutic areas of cancer, infectious, autoimmune and cardiovascular diseases. The Group has a well-established track record in the identification, development and partnering of innovative products and technologies. Xenova has partnerships with a number of major pharmaceutical companies including Lilly, Pfizer, Celltech and QLT Inc.
For further information about Xenova and its products please visit the Xenova website at http://www.xenova.co.uk.
Safe Harbor Statement under the US Private Securities Litigation Reform Act of 1995: Some or all of the statements in this document that relate to future plans, expectations, events, performances and the like are forward-looking statements, as defined in the US Private Securities Litigation Reform Act of 1995. Actual results of events could differ materially from those described in the forward-looking statements due to a variety of factors, including those set forth in the Company`s filings with the US Securities and Exchange Commission.
Consolidated Profit and Loss Account (unaudited)
Three months ended Nine months ended
30 30 30 30 30 30
Sept Sept Sept Sept Sept Sept
2001 2001 2000 2001 2001 2000
$000 000 000 $000 000 000
pounds pounds pounds pounds
Turnover (including share of joint venture)
Continuing
operations 544 370 -- 544 370 78
Acquisitions 593 404 -- 1,334 908 --
Less: share of
joint venture
revenue (69) (47) -- (73) (50) --
Turnover 1,068 727 -- 1,805 1,228 78
Operating expenses
Research and development costs
Continuing
operations (2,943) (2,002) (2,121) (8,498) (5,781) (5,283)
Acquisitions (3,555) (2,419) -- (7,765) (5,283) --
(6,498) (4,421) (2,121) (16,263) (11,064) (5,283)
Administrative expenses
Continuing
operations (801) (545) (412) (2,396) (1,630) (1,208)
Continuing
operations:
exceptional
reorganization
costs -- -- -- (91) (62) --
(801) (545) (412) (2,487) (1,692) (1,208)
Acquisitions (335) (228) -- (717) (488) --
Acquisitions:
exceptional
reorganization
costs -- -- -- (876) (596) --
Acquisitions:
amortization
of goodwill (431) (293) -- (862) (586) --
(766) (521) -- (2,455) (1,670) --
Total administrative
expenses (1,567) (1,066) (412) (4,942) (3,362) (1,208)
Total operating
expenses (8,065) (5,487) (2,533) (21,205) (14,426) (6,491)
Group operating loss
Continuing
operations (3,200) (2,177) (2,533) (10,441) (7,103) (6,413)
Acquisitions (3,797) (2,583) -- (8,959) (6,095) --
(6,997) (4,760) (2,533) (19,400) (13,198) (6,413)
Acquisitions:
share of
operating profit
of joint venture 49 33 -- 6 4 --
Total operating loss:
Group and share of
joint venture (6,948) (4,727) (2,533) (19,394) (13,194) (6,413)
Interest (net) 273 186 188 861 586 478
Amounts written (off)/
back on
investments (622) (423) -- 371 252 --
Loss on ordinary
activities before
taxation (7,297) (4,964) (2,345) (18,162) (12,356) (5,935)
Tax on loss on
ordinary
activities 753 512 -- 2,086 1,419 --
Loss on ordinary
activities after
taxation attributable
to members of
Xenova Group
plc (6,544) (4,452) (2,345) (16,076) (10,937) (5,935)
Loss per share
(basic and
diluted) (5c) (3p) (4p) (14c) (9p) (10p)
Shares used in
computing net
loss per share
(thousands) 139,044 139,044 62,971 115,780 115,780 57,525
US Dollar amounts have been translated at the closing rate on
30 September 2001 (1.00 pounds: $1.4699) solely for information.
Condensed Consolidated Balance Sheet (unaudited)
Unaudited Unaudited Audited
As at As at As at
30 Sept 30 Sept 31 Dec
2001 2001 2000
$000 000 000
pounds pounds
Cash and investments 25,697 17,482 12,233
Other current assets 8,784 5,976 1,510
Fixed assets (including
goodwill) 30,565 20,794 543
Total assets 65,046 44,252 14,286
Current liabilities (including
provisions & deferred
income) (14,686) (9,991) (2,410)
Shareholders` equity (50,360) (34,261) (11,876)
Total liabilities and
shareholders` equity (65,046) (44,252) (14,286)
US Dollar amounts have been translated at the closing rate on
30 September 2001 (1.00 pounds: $1.4699) solely for information.
Notes to the Statement
Basis of preparation
These unaudited statements, which do not constitute statutory accounts within the meaning of Section 240 of the Companies Act 1985, have been prepared using the accounting policies set out in the Group`s 2000 Annual Report and Accounts except as set out below. The 2000 Annual Report and Accounts received an unqualified auditor`s report and have been delivered to the Registrar of Companies.
These consolidated financial statements have been prepared to include the revenues, costs and cash flows of the Cantab Pharmaceuticals Plc (`Cantab`) group from 6 April 2001, using acquisition accounting principles as set out in the interim statement.
Following the acquisition of Cantab the Group has adopted the following accounting policy in respect of intangible fixed assets. Goodwill arising from the purchase of subsidiary undertakings, representing the difference between the fair value of the purchase consideration and the fair value of the net assets acquired, is capitalized as an intangible asset and amortized on a straight line basis over its estimated useful economic life. Goodwill similarly arising on the acquisition of associates or joint ventures is recorded as part of the related investment.
Other intangible fixed assets, including acquired intellectual property, are capitalized at cost and amortized on a straight line basis over the estimated useful economic life of the asset, having taken into account the risk factors associated with developing a pharmaceutical product.
In accordance with emerging best practice on revenue recognition, the Group has adopted a modified accounting policy from 1 January 2001. This policy states that license fees and milestone payments are spread over the life of the relevant agreement in proportion to the work performed by the Group, but is limited to the non-refundable amounts received or receivable. The revenue recognized in 2000, under the former policy of recognizing such payments on receipt, would not have been materially different under the revised accounting policy adopted from 2001.
There have been no other changes to the Group`s accounting policies in 2001.
Going concern
The Group is an emerging pharmaceutical business and as such expects to absorb cash until products are commercialized. The Directors have a reasonable expectation that the Group has, or can reasonably expect to obtain, adequate cash resources to enable it to continue in operational existence for the foreseeable future, and have therefore prepared the financial statements on the going concern basis.
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SOURCE Xenova Group plc
CONTACT: UK - David Oxlade, Chief Executive Officer, Daniel Abrams,
Finance Director, or Hilary Reid Evans, Corporate Communications, all of
Xenova Group plc +44-0-1753-706600; or David Yates or Fiona Noblet, both of
Financial Dynamics, +44-0-207-831-3113, for Xenova Group plc; or US - Brad
Miles, +1-212-477-9007, ext. 17, or Lauren Tortorete, +1-212-477-9007,
ext. 20, both of BMC Communications for Xenova Group plc
URL: http://www.xenova.co.uk
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Monday December 17, 7:02 am Eastern Time
Press Release
SOURCE: Millennium Pharmaceuticals, Inc.
Millennium In-Licenses Novel Oncology Program From Xenova
- Addition of Three Novel Molecules Complement Company`s Portfolio of Cancer Product Candidates -
CAMBRIDGE, Mass., and SLOUGH, U.K., Dec. 17 /PRNewswire/ -- Millennium Pharmaceuticals, Inc. (Nasdaq: MLNM - news) and Xenova Group, plc (Nasdaq: XNVA; London Stock Exchange: XEN), today announced that the companies have signed a license agreement for the development and North American commercialization of Xenova`s novel compounds, which have a unique mechanism of action including dual inhibition of topoisomerases I and II, for the treatment of solid tumors in cancer. The program includes three molecules; XR11576, XR5944, and XR11612. XR11576 is an oral agent that has entered Phase I clinical development with the first patients screened for study entry. The two additional compounds are in preclinical development.
(Photo: http://www.newscom.com/cgi-bin/prnh/19991220/MLNMLOGO )
Under the terms of the agreement, Millennium will acquire development and exclusive marketing rights to the topoisomerase program in North America in exchange for an upfront payment of US$11.5m (7.8m pounds) as well as future milestone payments and royalties following the achievement of specific development and sales goals. Xenova retains commercialization rights for all products arising from this topoisomerase collaboration outside the United States, Canada and Mexico, including marketing in Europe and the rest of the world. Xenova will retain responsibility for performing development activities associated with the program, which will be funded by Millennium commencing in 2003, to the end of Phase II clinical trials. Thereafter, Millennium will assume responsibility for subsequent development activities in North America and Xenova will retain development activity responsibility for the rest of the world. Additionally, Millennium has the right to market in North America any improvements or additional products based on the same topoisomerase inhibitor technology, in which case Xenova will receive further milestones and royalties on the sales of such products. Additional terms of the agreement were not disclosed.
``We have been impressed by the potential of Xenova`s compounds and believe this is a novel and exciting mechanism of action that falls into a proven class of therapies, but more importantly, as suggested by the dramatic activity in in vivo models, may have additional undiscovered mechanisms that are synergistic with cellular pathways that are part of Millennium`s ongoing research effort,`` said John Maraganore, Ph.D., senior vice president, strategic product development at Millennium. ``Millennium continues to build a significant portfolio of cutting-edge cancer therapeutics through a combination of internally-derived, in-licensed and acquired products and capabilities. We believe this latest collaboration has the potential to complement our lead oncology program, LDP-341, and we plan to move these molecules forward aggressively.``
``We are delighted to announce this collaboration with Millennium, a strong North American partner with both a commitment to pursuing oncology as a core franchise area and a deep existing oncology pipeline,`` said David Oxlade, Chief Executive Officer of Xenova. ``Today`s agreement gives us an excellent development and marketing partner, potentially provides us with future milestone payments and royalties which are significant for our business and allows us to retain substantial rights to the program outside North America.``
Topoisomerases are enzymes that are critically involved in the replication of DNA during the process of cell division and that play a key role in the proliferation of cancer cells. Topoisomerase inhibitors comprise a major and established class of cytotoxic anti-cancer agent that is widely used to treat cancer patients. Topoisomerase inhibitors that inhibit either topoisomerase I or II are used to treat a number of different tumor types: camptothecins (topoisomerase I inhibitors) for colorectal cancer; anthracyclines (topoisomerase II inhibitors) for breast, ovarian, bladder cancer and Non Hodgkin`s Lymphoma; etoposide (topoisomerase II inhibitor) for lung cancer. Given the differing roles and expression of the two types of enzymes within the cell cycle, inhibitors of both topoisomerase I and topoisomerase II (dual inhibitors) are expected to have potentially significant therapeutic advantage over agents targeting one type of topoisomerase alone. In addition, dual inhibitors may circumvent mechanisms of drug resistance and may also have a broader spectrum of activity as expression levels of the two enzymes are variable between different types of cancers, as suggested by Xenova`s preclinical data of the three molecules.
Dual Inhibitor of Topoisomerase I and II
Topoisomerases I and II are well-characterized enzymes that are responsible for DNA topology and are essential for DNA replication. Inhibition of these enzymes blocks cell division and leads to apoptosis, or cell death. Several widely used anticancer agents target topoisomerases, including irinotecan, topotecan, doxorubicin, and etoposide.
In preclinical studies XR11576 has shown a significantly improved biological profile when compared with first generation dual topoisomerase I and II inhibitors, including oral bioavailability and a marked enhancement of potency. In preclinical studies XR5944 has demonstrated exceptional activity against human and murine tumor cell lines. XR5944 has been shown to induce tumor regression in the majority of cases in a model considered to be relatively unresponsive to chemotherapy. In a further preclinical model, low doses of XR5944 induced complete tumor regression in the majority of cases and was more effective in this respect than certain currently marketed topoisomerase inhibitors. In preclinical studies XR11612 was shown to have significant antitumor efficacy against certain cancer disease models.
The three dual topoisomerase inhibitors are thought to result in DNA damage in cells, activating the pathways that lead to apoptotic cell death in tumor cells. Millennium is investigating LDP-341, which also works to interrupt the apoptotic pathways, allowing for potential synergies between the two oncology programs.
Millennium`s Oncology Franchise
Millennium has committed to pursuing oncology as a core franchise area, dedicating significant resources and capabilities in the areas of technology, scientific expertise and strategic business development. To this end, Millennium has already produced a deep oncology pipeline that ranges from multiple novel targets to commercialized therapeutic and diagnostic products. Among the most advanced clinical compounds is LDP-341, a proteasome inhibitor that is currently is in phase II trials for multiple myeloma and chronic lymphocytic leukemia, and in phase I trials for a variety of solid tumors including colon, breast, pancreatic and prostate cancers. Millennium`s oncology pipeline also includes an anti-PSMA antibody currently in phase I clinical trials for advanced prostate cancer, and guanylyl cyclase C (GC-C), a protein uniquely expressed on the cell surface of colorectal tumors, and its related ST ligand. The CAMPATH® (alemtuzumab) monoclonal antibody, a therapeutic developed from a joint venture of Millennium, is on the market in both the United States and a number of European countries. A Millennium alliance partner and licensee is in the process of developing and commercializing Melastatin(TM), a melastatin detection product developed through our predictive medicine efforts.
Millennium Pharmaceuticals, Inc.
Millennium, a leading biopharmaceutical company, applies its comprehensive and integrated science and technology platform for the discovery and development of breakthrough therapeutic and predictive medicine products, with a goal of delivering personalized medicine. Through the industrialization of this gene-to-patient platform, Millennium is also striving to accelerate the process of drug discovery and development. Headquartered in Cambridge, Massachusetts, Millennium currently employs more than 1,500 people.
Xenova Group, plc
Xenova Group plc`s product pipeline focuses principally on the therapeutic areas of cancer, infectious and autoimmune diseases. Xenova currently has a broad pipeline of eight products in clinical development. Xenova`s lead program is a P-glycoprotein antagonist for the treatment of multi-drug resistance in cancer, known as tariquidar or XR9576. Tariquidar has completed a successful series of three Phase IIa clinical trials and is expected to enter Phase III clinical development in the first half of 2002. Tariquidar was partnered for the North American market with QLT Inc in August 2001. The Group has a well-established track record in the identification, development and partnering of innovative products and technologies and has partnerships with other major pharmaceutical companies including Lilly, Pfizer and Celltech.
For Millennium: This press release contains ``forward-looking statements,`` including statements about our growth and future operating results, discovery and development of products, potential acquisitions, strategic alliances and intellectual property. Various risks may cause Millennium`s actual results to differ materially, including: adverse results in our drug discovery and clinical development processes; failure to obtain patent protection for our discoveries; commercial limitations imposed by patents owned or controlled by third parties; our dependence upon strategic alliance partners to develop and commercialize products and services based on our work; difficulties or delays in obtaining regulatory approvals to market products and services resulting from our development efforts; and the requirement for substantial funding to conduct research and development and to expand commercialization activities. For a further list and description of the risks and uncertainties we face, see the reports we have filed with the Securities and Exchange Commission. We disclaim any intention or obligation to update or revise any forward-looking statements, whether as a result of new information, future events or otherwise.
For Xenova Disclaimer to take advantage of the ``Safe Harbor`` provisions of the US Private Securities Litigation Reform Act of 1995. This press release contains ``forward-looking statements,`` including statements about the discovery, development and commercialization of products. Various risks may cause Xenova`s actual results to differ materially from those expressed or implied by the forward looking statements, including: adverse results in our drug discovery and clinical development programs; failure to obtain patent protection for our discoveries; commercial limitations imposed by patents owned or controlled by third parties; our dependence upon strategic alliance partners to develop and commercialize products and services; difficulties or delays in obtaining regulatory approvals to market products and services resulting from our development efforts; the requirement for substantial funding to conduct research and development and to expand commercialization activities; and product initiatives by competitors. For a further list and description of the risks and uncertainties we face, see the reports we have filed with the Securities and Exchange Commission. We disclaim any intention or obligation to update or revise any forward-looking statements, whether as a result of new information, future events or otherwise.
Editor`s Note: This release is available on Millennium`s website at www.millennium.com.
For further information about Xenova please visit the Xenova website at www.xenova.co.uk
Contacts:
Gina Brazier (investor)
(617) 551-3611
Adriana Jenkins (media)
(617) 761-6996
Millennium Pharmaceuticals, Inc.
David Oxlade: Chief Executive Officer
Daniel Abrams: Finance Director
Hilary Reid-Evans: Corporate Communications
Tel: +44 (0) 1753 706600
Xenova Group plc
Brad Miles(Ext 17)/Lauren Tortorete (Ext 20)
Tel 212 477 9007
BMC Communications
SOURCE: Millennium Pharmaceuticals, Inc.
Press Release
SOURCE: Millennium Pharmaceuticals, Inc.
Millennium In-Licenses Novel Oncology Program From Xenova
- Addition of Three Novel Molecules Complement Company`s Portfolio of Cancer Product Candidates -
CAMBRIDGE, Mass., and SLOUGH, U.K., Dec. 17 /PRNewswire/ -- Millennium Pharmaceuticals, Inc. (Nasdaq: MLNM - news) and Xenova Group, plc (Nasdaq: XNVA; London Stock Exchange: XEN), today announced that the companies have signed a license agreement for the development and North American commercialization of Xenova`s novel compounds, which have a unique mechanism of action including dual inhibition of topoisomerases I and II, for the treatment of solid tumors in cancer. The program includes three molecules; XR11576, XR5944, and XR11612. XR11576 is an oral agent that has entered Phase I clinical development with the first patients screened for study entry. The two additional compounds are in preclinical development.
(Photo: http://www.newscom.com/cgi-bin/prnh/19991220/MLNMLOGO )
Under the terms of the agreement, Millennium will acquire development and exclusive marketing rights to the topoisomerase program in North America in exchange for an upfront payment of US$11.5m (7.8m pounds) as well as future milestone payments and royalties following the achievement of specific development and sales goals. Xenova retains commercialization rights for all products arising from this topoisomerase collaboration outside the United States, Canada and Mexico, including marketing in Europe and the rest of the world. Xenova will retain responsibility for performing development activities associated with the program, which will be funded by Millennium commencing in 2003, to the end of Phase II clinical trials. Thereafter, Millennium will assume responsibility for subsequent development activities in North America and Xenova will retain development activity responsibility for the rest of the world. Additionally, Millennium has the right to market in North America any improvements or additional products based on the same topoisomerase inhibitor technology, in which case Xenova will receive further milestones and royalties on the sales of such products. Additional terms of the agreement were not disclosed.
``We have been impressed by the potential of Xenova`s compounds and believe this is a novel and exciting mechanism of action that falls into a proven class of therapies, but more importantly, as suggested by the dramatic activity in in vivo models, may have additional undiscovered mechanisms that are synergistic with cellular pathways that are part of Millennium`s ongoing research effort,`` said John Maraganore, Ph.D., senior vice president, strategic product development at Millennium. ``Millennium continues to build a significant portfolio of cutting-edge cancer therapeutics through a combination of internally-derived, in-licensed and acquired products and capabilities. We believe this latest collaboration has the potential to complement our lead oncology program, LDP-341, and we plan to move these molecules forward aggressively.``
``We are delighted to announce this collaboration with Millennium, a strong North American partner with both a commitment to pursuing oncology as a core franchise area and a deep existing oncology pipeline,`` said David Oxlade, Chief Executive Officer of Xenova. ``Today`s agreement gives us an excellent development and marketing partner, potentially provides us with future milestone payments and royalties which are significant for our business and allows us to retain substantial rights to the program outside North America.``
Topoisomerases are enzymes that are critically involved in the replication of DNA during the process of cell division and that play a key role in the proliferation of cancer cells. Topoisomerase inhibitors comprise a major and established class of cytotoxic anti-cancer agent that is widely used to treat cancer patients. Topoisomerase inhibitors that inhibit either topoisomerase I or II are used to treat a number of different tumor types: camptothecins (topoisomerase I inhibitors) for colorectal cancer; anthracyclines (topoisomerase II inhibitors) for breast, ovarian, bladder cancer and Non Hodgkin`s Lymphoma; etoposide (topoisomerase II inhibitor) for lung cancer. Given the differing roles and expression of the two types of enzymes within the cell cycle, inhibitors of both topoisomerase I and topoisomerase II (dual inhibitors) are expected to have potentially significant therapeutic advantage over agents targeting one type of topoisomerase alone. In addition, dual inhibitors may circumvent mechanisms of drug resistance and may also have a broader spectrum of activity as expression levels of the two enzymes are variable between different types of cancers, as suggested by Xenova`s preclinical data of the three molecules.
Dual Inhibitor of Topoisomerase I and II
Topoisomerases I and II are well-characterized enzymes that are responsible for DNA topology and are essential for DNA replication. Inhibition of these enzymes blocks cell division and leads to apoptosis, or cell death. Several widely used anticancer agents target topoisomerases, including irinotecan, topotecan, doxorubicin, and etoposide.
In preclinical studies XR11576 has shown a significantly improved biological profile when compared with first generation dual topoisomerase I and II inhibitors, including oral bioavailability and a marked enhancement of potency. In preclinical studies XR5944 has demonstrated exceptional activity against human and murine tumor cell lines. XR5944 has been shown to induce tumor regression in the majority of cases in a model considered to be relatively unresponsive to chemotherapy. In a further preclinical model, low doses of XR5944 induced complete tumor regression in the majority of cases and was more effective in this respect than certain currently marketed topoisomerase inhibitors. In preclinical studies XR11612 was shown to have significant antitumor efficacy against certain cancer disease models.
The three dual topoisomerase inhibitors are thought to result in DNA damage in cells, activating the pathways that lead to apoptotic cell death in tumor cells. Millennium is investigating LDP-341, which also works to interrupt the apoptotic pathways, allowing for potential synergies between the two oncology programs.
Millennium`s Oncology Franchise
Millennium has committed to pursuing oncology as a core franchise area, dedicating significant resources and capabilities in the areas of technology, scientific expertise and strategic business development. To this end, Millennium has already produced a deep oncology pipeline that ranges from multiple novel targets to commercialized therapeutic and diagnostic products. Among the most advanced clinical compounds is LDP-341, a proteasome inhibitor that is currently is in phase II trials for multiple myeloma and chronic lymphocytic leukemia, and in phase I trials for a variety of solid tumors including colon, breast, pancreatic and prostate cancers. Millennium`s oncology pipeline also includes an anti-PSMA antibody currently in phase I clinical trials for advanced prostate cancer, and guanylyl cyclase C (GC-C), a protein uniquely expressed on the cell surface of colorectal tumors, and its related ST ligand. The CAMPATH® (alemtuzumab) monoclonal antibody, a therapeutic developed from a joint venture of Millennium, is on the market in both the United States and a number of European countries. A Millennium alliance partner and licensee is in the process of developing and commercializing Melastatin(TM), a melastatin detection product developed through our predictive medicine efforts.
Millennium Pharmaceuticals, Inc.
Millennium, a leading biopharmaceutical company, applies its comprehensive and integrated science and technology platform for the discovery and development of breakthrough therapeutic and predictive medicine products, with a goal of delivering personalized medicine. Through the industrialization of this gene-to-patient platform, Millennium is also striving to accelerate the process of drug discovery and development. Headquartered in Cambridge, Massachusetts, Millennium currently employs more than 1,500 people.
Xenova Group, plc
Xenova Group plc`s product pipeline focuses principally on the therapeutic areas of cancer, infectious and autoimmune diseases. Xenova currently has a broad pipeline of eight products in clinical development. Xenova`s lead program is a P-glycoprotein antagonist for the treatment of multi-drug resistance in cancer, known as tariquidar or XR9576. Tariquidar has completed a successful series of three Phase IIa clinical trials and is expected to enter Phase III clinical development in the first half of 2002. Tariquidar was partnered for the North American market with QLT Inc in August 2001. The Group has a well-established track record in the identification, development and partnering of innovative products and technologies and has partnerships with other major pharmaceutical companies including Lilly, Pfizer and Celltech.
For Millennium: This press release contains ``forward-looking statements,`` including statements about our growth and future operating results, discovery and development of products, potential acquisitions, strategic alliances and intellectual property. Various risks may cause Millennium`s actual results to differ materially, including: adverse results in our drug discovery and clinical development processes; failure to obtain patent protection for our discoveries; commercial limitations imposed by patents owned or controlled by third parties; our dependence upon strategic alliance partners to develop and commercialize products and services based on our work; difficulties or delays in obtaining regulatory approvals to market products and services resulting from our development efforts; and the requirement for substantial funding to conduct research and development and to expand commercialization activities. For a further list and description of the risks and uncertainties we face, see the reports we have filed with the Securities and Exchange Commission. We disclaim any intention or obligation to update or revise any forward-looking statements, whether as a result of new information, future events or otherwise.
For Xenova Disclaimer to take advantage of the ``Safe Harbor`` provisions of the US Private Securities Litigation Reform Act of 1995. This press release contains ``forward-looking statements,`` including statements about the discovery, development and commercialization of products. Various risks may cause Xenova`s actual results to differ materially from those expressed or implied by the forward looking statements, including: adverse results in our drug discovery and clinical development programs; failure to obtain patent protection for our discoveries; commercial limitations imposed by patents owned or controlled by third parties; our dependence upon strategic alliance partners to develop and commercialize products and services; difficulties or delays in obtaining regulatory approvals to market products and services resulting from our development efforts; the requirement for substantial funding to conduct research and development and to expand commercialization activities; and product initiatives by competitors. For a further list and description of the risks and uncertainties we face, see the reports we have filed with the Securities and Exchange Commission. We disclaim any intention or obligation to update or revise any forward-looking statements, whether as a result of new information, future events or otherwise.
Editor`s Note: This release is available on Millennium`s website at www.millennium.com.
For further information about Xenova please visit the Xenova website at www.xenova.co.uk
Contacts:
Gina Brazier (investor)
(617) 551-3611
Adriana Jenkins (media)
(617) 761-6996
Millennium Pharmaceuticals, Inc.
David Oxlade: Chief Executive Officer
Daniel Abrams: Finance Director
Hilary Reid-Evans: Corporate Communications
Tel: +44 (0) 1753 706600
Xenova Group plc
Brad Miles(Ext 17)/Lauren Tortorete (Ext 20)
Tel 212 477 9007
BMC Communications
SOURCE: Millennium Pharmaceuticals, Inc.
A. Ein Bericht zu XENOVA:
====> nachzulesen als Auszug (ganz unten im Bericht) unter http://www.signalsmag.com/signalsmag.nsf/0/CD71A97CFE9AB43E8…
Meanwhile, a much smaller British company, Xenova Group plc, employing means that couldn`t have been more contrary to the New Paradigm -- messy, slow screening of microbes against a membrane-associated protein with no crystal-structure determination, and slow, painful lead optimization -- may have come up with a superior MDR drug called XR9576. "A computational approach may well have missed this one," says Xenova CSO Michael Moore.
Xenova began life in 1987 as a natural-products company. In the early 1990s, via the ultra-laborious cell-based screening of a library composed of bacteria and fungi, Xenova scientists eventually isolated the prototype for a compound that`s just now beginning to pay off. It was grueling, because after getting a bacterial hit, it was then necessary to separate out the actually active substance from the bug.
Going from a hit to a characterized chemical took about six months. At the time, Xenova employed no more than a dozen medicinal chemists. Then came the optimization stage. That was a lot of work, too. "The molecule itself would have never made a drug without a great deal of modification," says Moore, "although the nucleus is still apparent in XR9576."
More than a dozen approved chemo compounds are pumped by P-gp, making a successful pump inhibitor potentially useful across a broad market. Phase IIa trials of XR9576 taken along with three such drugs suggest that XR9576 is not only extremely potent but also highly selective, soluble, orally available, nontoxic and metabolized slowly enough so that it may be dosed once a day -- less frequently than competing candidates. Also, XR9576 doesn`t significantly increase the toxicity of chemo drugs to non-cancerous cells, as have Vertex`s VX710 and Novartis` candidate PSC833 (also known as Amdray), which failed in Phase III. These two drugs were "second generation" compounds, based on a template that had been around for a while, that were mere competitive substrates for P-gp. Third-generation inhibitors such as Xenova`s de novo drug and those of its two main competitors, Eli Lilly and Co. (LY335979) and Ontogen Corp. (OC144-093), bind allosterically to P-gp, disfiguring it.
Xenova`s dogged perseverance – and, Moore modestly acknowledges, no small measure of good luck -- has paid off. In August the company signed a $105 million deal ($55 million in non-contingent payments) for late-stage development and marketing of XR9576 with QLT Inc. a Canadian company that specializes in photodynamic therapy. Staying focused helped, too. "My feeling," says Moore, "is that there`s quite a skill in recognizing the value of what you`ve got. In a bigger company, it may be that the challenge of the sort of compound we discovered gets overlooked."
B. UPGRADES:
ING: auf Buy von Hold! Kursziel: 114 pence
UBS Warburg: `Buy`
CFSB: `Outperform` from `Hold`
====> nachzulesen als Auszug (ganz unten im Bericht) unter http://www.signalsmag.com/signalsmag.nsf/0/CD71A97CFE9AB43E8…
Meanwhile, a much smaller British company, Xenova Group plc, employing means that couldn`t have been more contrary to the New Paradigm -- messy, slow screening of microbes against a membrane-associated protein with no crystal-structure determination, and slow, painful lead optimization -- may have come up with a superior MDR drug called XR9576. "A computational approach may well have missed this one," says Xenova CSO Michael Moore.
Xenova began life in 1987 as a natural-products company. In the early 1990s, via the ultra-laborious cell-based screening of a library composed of bacteria and fungi, Xenova scientists eventually isolated the prototype for a compound that`s just now beginning to pay off. It was grueling, because after getting a bacterial hit, it was then necessary to separate out the actually active substance from the bug.
Going from a hit to a characterized chemical took about six months. At the time, Xenova employed no more than a dozen medicinal chemists. Then came the optimization stage. That was a lot of work, too. "The molecule itself would have never made a drug without a great deal of modification," says Moore, "although the nucleus is still apparent in XR9576."
More than a dozen approved chemo compounds are pumped by P-gp, making a successful pump inhibitor potentially useful across a broad market. Phase IIa trials of XR9576 taken along with three such drugs suggest that XR9576 is not only extremely potent but also highly selective, soluble, orally available, nontoxic and metabolized slowly enough so that it may be dosed once a day -- less frequently than competing candidates. Also, XR9576 doesn`t significantly increase the toxicity of chemo drugs to non-cancerous cells, as have Vertex`s VX710 and Novartis` candidate PSC833 (also known as Amdray), which failed in Phase III. These two drugs were "second generation" compounds, based on a template that had been around for a while, that were mere competitive substrates for P-gp. Third-generation inhibitors such as Xenova`s de novo drug and those of its two main competitors, Eli Lilly and Co. (LY335979) and Ontogen Corp. (OC144-093), bind allosterically to P-gp, disfiguring it.
Xenova`s dogged perseverance – and, Moore modestly acknowledges, no small measure of good luck -- has paid off. In August the company signed a $105 million deal ($55 million in non-contingent payments) for late-stage development and marketing of XR9576 with QLT Inc. a Canadian company that specializes in photodynamic therapy. Staying focused helped, too. "My feeling," says Moore, "is that there`s quite a skill in recognizing the value of what you`ve got. In a bigger company, it may be that the challenge of the sort of compound we discovered gets overlooked."
B. UPGRADES:
ING: auf Buy von Hold! Kursziel: 114 pence
UBS Warburg: `Buy`
CFSB: `Outperform` from `Hold`
Nachrichten aus dem US-Yahoo-Board:
1.) Kaufempfehlung (Computererrechnet!) http://quotes.barchart.com/texpert.asp?sym=xnva&code=XDAILY
2.) TELEGRAPH 29.12.2001 - Xenova for brave hearts
XENOVA may sound like one of the female cast of a science fiction novel, but it`s actually a cancer-focused biotech group. The shares hit highs of 431p at the height of the biotechnology boom. However, that`s a long time in the past now, and the company still hasn`t recovered from buying rival Cantab in an all-paper deal last February.
Cantab was struggling after the failure of its genital warts drug. Xenova bought it, warts and all, and that sent the shares spiralling down to 42.5p. They haven`t recovered since. Investors questioned Xenova`s strategy, and the compatibility of the two companies.
It wasn`t an immediately obvious deal, by any means, as the two companies had very different strategies. However, recent newsflow makes Xenova look more attractive. Before Christmas, the company announced two deals, with Millennium and QLT, which have improved the funding position. These go some way towards validating Xenova`s technology as both are top-tier.
The company now has enough cash to continue operations until mid-2003. Like most biotechnology groups, it is still loss-making, and is expected to be £15m in the red at the year-end.
However, it has a very strong pipeline, with eight products in clinical development. The lead product is in Phase III, but the others are still some way off.
Xenova is undeniably risky, and questions remain over strategy. However, these two deals make the company look attractive and further newsflow should have a positive effect on price.
The shares, at 58 this week, are now a buy for the brave.
1.) Kaufempfehlung (Computererrechnet!) http://quotes.barchart.com/texpert.asp?sym=xnva&code=XDAILY
2.) TELEGRAPH 29.12.2001 - Xenova for brave hearts
XENOVA may sound like one of the female cast of a science fiction novel, but it`s actually a cancer-focused biotech group. The shares hit highs of 431p at the height of the biotechnology boom. However, that`s a long time in the past now, and the company still hasn`t recovered from buying rival Cantab in an all-paper deal last February.
Cantab was struggling after the failure of its genital warts drug. Xenova bought it, warts and all, and that sent the shares spiralling down to 42.5p. They haven`t recovered since. Investors questioned Xenova`s strategy, and the compatibility of the two companies.
It wasn`t an immediately obvious deal, by any means, as the two companies had very different strategies. However, recent newsflow makes Xenova look more attractive. Before Christmas, the company announced two deals, with Millennium and QLT, which have improved the funding position. These go some way towards validating Xenova`s technology as both are top-tier.
The company now has enough cash to continue operations until mid-2003. Like most biotechnology groups, it is still loss-making, and is expected to be £15m in the red at the year-end.
However, it has a very strong pipeline, with eight products in clinical development. The lead product is in Phase III, but the others are still some way off.
Xenova is undeniably risky, and questions remain over strategy. However, these two deals make the company look attractive and further newsflow should have a positive effect on price.
The shares, at 58 this week, are now a buy for the brave.
XENOVA steht als TOP-Tip für 2002 in England:
Guardian Top 10 Tips for 2002: Universal Salvage; Budgens; Screen; Amersham; Marconi; Business Post; Xenova; Yule Catto; BSkyB
Schlagzeile vom 02.01.2002:
Xenova
Merger trouble should not deter (Guardian)
...weiteres wird sicherlich noch folgen!
Guardian Top 10 Tips for 2002: Universal Salvage; Budgens; Screen; Amersham; Marconi; Business Post; Xenova; Yule Catto; BSkyB
Schlagzeile vom 02.01.2002:
Xenova
Merger trouble should not deter (Guardian)
...weiteres wird sicherlich noch folgen!
Xenova nachzulesen unter http://www.guardian.co.uk/Archive/Article/0,4273,4327726,00.… vom 02.01.2002
A poorly received merger with struggling vaccines group Cantab Pharmaceuticals in the spring left Xenova shares in the doldrums for much of last year but the Slough biotech company has signed two significant deals in the past six months.
Xenova has found partners willing to bank-roll elements of its development pipeline in return for the right to develop and sell drugs based on its research in certain parts of the world. In both cases so far Xenova has licensed rights to the compounds in the north American market, leaving the company free to sign more deals in Europe and Asia.
Xenova`s first such deal, signed with Vancouver-based QLT in August, involved the development of a drug to treat the problem of multi-drug resistance in cancer.
The second deal, announced in September, will see US drug company Millennium Pharmaceuticals pay Xenova to develop at least two of three compounds it has discovered which play a crucial role in halting the replication of cancer cells.
Both deals will see Xenova get up-front payments as well as milestone payments during the phase two trials and royalties from any final drugs.
British investor interest since the Cantab deal has been subdued with loss-making Xenova currently valued at just under £90m - or barely four times the cash it has in the bank. For an investor looking to get involved in biotech stocks, Xenova at 76.25p has few equals.
A poorly received merger with struggling vaccines group Cantab Pharmaceuticals in the spring left Xenova shares in the doldrums for much of last year but the Slough biotech company has signed two significant deals in the past six months.
Xenova has found partners willing to bank-roll elements of its development pipeline in return for the right to develop and sell drugs based on its research in certain parts of the world. In both cases so far Xenova has licensed rights to the compounds in the north American market, leaving the company free to sign more deals in Europe and Asia.
Xenova`s first such deal, signed with Vancouver-based QLT in August, involved the development of a drug to treat the problem of multi-drug resistance in cancer.
The second deal, announced in September, will see US drug company Millennium Pharmaceuticals pay Xenova to develop at least two of three compounds it has discovered which play a crucial role in halting the replication of cancer cells.
Both deals will see Xenova get up-front payments as well as milestone payments during the phase two trials and royalties from any final drugs.
British investor interest since the Cantab deal has been subdued with loss-making Xenova currently valued at just under £90m - or barely four times the cash it has in the bank. For an investor looking to get involved in biotech stocks, Xenova at 76.25p has few equals.
LETTER TO: XENOVA GROUP PLC
Section 198 Companies Act
In accordance with S198 of the Companies Act we hereby notify you that RAB
Capital Ltd, acting as investment manager for a number of commingled funds, has
acquired, through purchases on 31 December 2001, a further 60,000 ordinary
shares in Xenova Group plc.
RAB Capital Ltd`s notifiable interest is thereby increased to 4,909,552 shares
representing 3.53% of the issued share capital.
RAB Capital does not act as custodian for its clients and therefore the shares
are held in the nominee name or the custodian of our clients, which is Morstan
Nominees Ltd.
LETTER FROM: RAB CAPITAL LTD
Section 198 Companies Act
In accordance with S198 of the Companies Act we hereby notify you that RAB
Capital Ltd, acting as investment manager for a number of commingled funds, has
acquired, through purchases on 31 December 2001, a further 60,000 ordinary
shares in Xenova Group plc.
RAB Capital Ltd`s notifiable interest is thereby increased to 4,909,552 shares
representing 3.53% of the issued share capital.
RAB Capital does not act as custodian for its clients and therefore the shares
are held in the nominee name or the custodian of our clients, which is Morstan
Nominees Ltd.
LETTER FROM: RAB CAPITAL LTD
Undervalued biotechs ripe for re-rating
By Peter Rees
Wed 9 Jan 2002,
nachzulesen unter http://www.sharecast.com/news/scnews1.asp?StoryID=38336
LONDON (SHARECAST) - A disastrous year for biotechs in 2001 has left many shares undervalued and liable to rise sharply on good news, according to Lehman Brothers.
In a quarterly review of the sector, the broker cites recent rises in the shares of PPL Therapeutics, Vernalis and Xenova as evidence of a good-news effect that was absent for most of last year.
In 2001, risk-averse investors spurned companies with valuable technology, so-called platform companies such as Cambridge Antibody Technology, but distant profitability for those with products already on the market. Hence Europe`s larger biotechs, including Celltech, NovoNordisk and Serono, outperformed the sector.
Now as investors shift from defensives to cyclical and technology shares, biotechs are a natural home for cash rotating out of defensive healthcare companies, Lehman Brothers says.
And because their Nasdaq-traded counterparts were more resilient to anti-tech sentiment, the gap in valuations between US and European platform companies has widened.
UK companies that are most likely to benefit from a re-rating include proteomics firm Oxford Glycosciences and antibody specialist CAT, Lehman said.
The broker also recommends Celltech shares, despite their recovery in the last quarter of 2001. In late September they dipped below 550p but now trade above 900p. The broker`s price target is 3,000p.
LONDON, Jan 9 (Reuters) - Shares in British biotechnology firm Xenova Plc bounced nine percent early on Wednesday as investors stocked up anticipating a fresh announcement on its product pipeline, analysts and market makers said.
By 0947 GMT Xenova shares were up five pence to 62-1/2p, well up from recent lows of 35p in December, but down from a peak of 77p last week.
One market maker said volume of 790,000 shares by midmorning was about average for Xenova.
Andrew Forsyth, analyst at Williams de Broe said sentiment on the stock was changing, and further gains could be in prospect following recent deals.
"Talking to institutions, some are interested in the stock because of deals they`ve done last year, and the merger with Cantab seems to have worked, and we haven`t had any problems with integration," he said.
"It`s had a run of good news, and we`re probably expecting more of the same from them. Speculation is generally on product advancement. We could maybe expect further alliances, maybe more from the vaccine side of the pipeline," he added.
A market maker said speculation had been circulating since the New Year that Xenova might be set to announce a new deal.
A Xenova spokeswoman declined to comment on Wednesday.
Xenova shares were boosted recently by news in December of a licensing deal for three of its experimental cancer drugs with U.S. biotechnology firm Millennium Pharmaceuticals .
Market watchers also pointed to a run of positive media and analyst comment on the shares.
"I can see the chart going onto around 90p to a pound on a six-month basis. Interest is being regenerated in the stock," said Forsyth.
By Peter Rees
Wed 9 Jan 2002,
nachzulesen unter http://www.sharecast.com/news/scnews1.asp?StoryID=38336
LONDON (SHARECAST) - A disastrous year for biotechs in 2001 has left many shares undervalued and liable to rise sharply on good news, according to Lehman Brothers.
In a quarterly review of the sector, the broker cites recent rises in the shares of PPL Therapeutics, Vernalis and Xenova as evidence of a good-news effect that was absent for most of last year.
In 2001, risk-averse investors spurned companies with valuable technology, so-called platform companies such as Cambridge Antibody Technology, but distant profitability for those with products already on the market. Hence Europe`s larger biotechs, including Celltech, NovoNordisk and Serono, outperformed the sector.
Now as investors shift from defensives to cyclical and technology shares, biotechs are a natural home for cash rotating out of defensive healthcare companies, Lehman Brothers says.
And because their Nasdaq-traded counterparts were more resilient to anti-tech sentiment, the gap in valuations between US and European platform companies has widened.
UK companies that are most likely to benefit from a re-rating include proteomics firm Oxford Glycosciences and antibody specialist CAT, Lehman said.
The broker also recommends Celltech shares, despite their recovery in the last quarter of 2001. In late September they dipped below 550p but now trade above 900p. The broker`s price target is 3,000p.
LONDON, Jan 9 (Reuters) - Shares in British biotechnology firm Xenova Plc bounced nine percent early on Wednesday as investors stocked up anticipating a fresh announcement on its product pipeline, analysts and market makers said.
By 0947 GMT Xenova shares were up five pence to 62-1/2p, well up from recent lows of 35p in December, but down from a peak of 77p last week.
One market maker said volume of 790,000 shares by midmorning was about average for Xenova.
Andrew Forsyth, analyst at Williams de Broe said sentiment on the stock was changing, and further gains could be in prospect following recent deals.
"Talking to institutions, some are interested in the stock because of deals they`ve done last year, and the merger with Cantab seems to have worked, and we haven`t had any problems with integration," he said.
"It`s had a run of good news, and we`re probably expecting more of the same from them. Speculation is generally on product advancement. We could maybe expect further alliances, maybe more from the vaccine side of the pipeline," he added.
A market maker said speculation had been circulating since the New Year that Xenova might be set to announce a new deal.
A Xenova spokeswoman declined to comment on Wednesday.
Xenova shares were boosted recently by news in December of a licensing deal for three of its experimental cancer drugs with U.S. biotechnology firm Millennium Pharmaceuticals .
Market watchers also pointed to a run of positive media and analyst comment on the shares.
"I can see the chart going onto around 90p to a pound on a six-month basis. Interest is being regenerated in the stock," said Forsyth.
Undervalued biotechs ripe for re-rating
By Peter Rees
Wed 9 Jan 2002,
nachzulesen unter http://www.sharecast.com/news/scnews1.asp?StoryID=38336
LONDON (SHARECAST) - A disastrous year for biotechs in 2001 has left many shares undervalued and liable to rise sharply on good news, according to Lehman Brothers.
In a quarterly review of the sector, the broker cites recent rises in the shares of PPL Therapeutics, Vernalis and Xenova as evidence of a good-news effect that was absent for most of last year.
In 2001, risk-averse investors spurned companies with valuable technology, so-called platform companies such as Cambridge Antibody Technology, but distant profitability for those with products already on the market. Hence Europe`s larger biotechs, including Celltech, NovoNordisk and Serono, outperformed the sector.
Now as investors shift from defensives to cyclical and technology shares, biotechs are a natural home for cash rotating out of defensive healthcare companies, Lehman Brothers says.
And because their Nasdaq-traded counterparts were more resilient to anti-tech sentiment, the gap in valuations between US and European platform companies has widened.
UK companies that are most likely to benefit from a re-rating include proteomics firm Oxford Glycosciences and antibody specialist CAT, Lehman said.
The broker also recommends Celltech shares, despite their recovery in the last quarter of 2001. In late September they dipped below 550p but now trade above 900p. The broker`s price target is 3,000p.
LONDON, Jan 9 (Reuters) - Shares in British biotechnology firm Xenova Plc bounced nine percent early on Wednesday as investors stocked up anticipating a fresh announcement on its product pipeline, analysts and market makers said.
By 0947 GMT Xenova shares were up five pence to 62-1/2p, well up from recent lows of 35p in December, but down from a peak of 77p last week.
One market maker said volume of 790,000 shares by midmorning was about average for Xenova.
Andrew Forsyth, analyst at Williams de Broe said sentiment on the stock was changing, and further gains could be in prospect following recent deals.
"Talking to institutions, some are interested in the stock because of deals they`ve done last year, and the merger with Cantab seems to have worked, and we haven`t had any problems with integration," he said.
"It`s had a run of good news, and we`re probably expecting more of the same from them. Speculation is generally on product advancement. We could maybe expect further alliances, maybe more from the vaccine side of the pipeline," he added.
A market maker said speculation had been circulating since the New Year that Xenova might be set to announce a new deal.
A Xenova spokeswoman declined to comment on Wednesday.
Xenova shares were boosted recently by news in December of a licensing deal for three of its experimental cancer drugs with U.S. biotechnology firm Millennium Pharmaceuticals .
Market watchers also pointed to a run of positive media and analyst comment on the shares.
"I can see the chart going onto around 90p to a pound on a six-month basis. Interest is being regenerated in the stock," said Forsyth.
By Peter Rees
Wed 9 Jan 2002,
nachzulesen unter http://www.sharecast.com/news/scnews1.asp?StoryID=38336
LONDON (SHARECAST) - A disastrous year for biotechs in 2001 has left many shares undervalued and liable to rise sharply on good news, according to Lehman Brothers.
In a quarterly review of the sector, the broker cites recent rises in the shares of PPL Therapeutics, Vernalis and Xenova as evidence of a good-news effect that was absent for most of last year.
In 2001, risk-averse investors spurned companies with valuable technology, so-called platform companies such as Cambridge Antibody Technology, but distant profitability for those with products already on the market. Hence Europe`s larger biotechs, including Celltech, NovoNordisk and Serono, outperformed the sector.
Now as investors shift from defensives to cyclical and technology shares, biotechs are a natural home for cash rotating out of defensive healthcare companies, Lehman Brothers says.
And because their Nasdaq-traded counterparts were more resilient to anti-tech sentiment, the gap in valuations between US and European platform companies has widened.
UK companies that are most likely to benefit from a re-rating include proteomics firm Oxford Glycosciences and antibody specialist CAT, Lehman said.
The broker also recommends Celltech shares, despite their recovery in the last quarter of 2001. In late September they dipped below 550p but now trade above 900p. The broker`s price target is 3,000p.
LONDON, Jan 9 (Reuters) - Shares in British biotechnology firm Xenova Plc bounced nine percent early on Wednesday as investors stocked up anticipating a fresh announcement on its product pipeline, analysts and market makers said.
By 0947 GMT Xenova shares were up five pence to 62-1/2p, well up from recent lows of 35p in December, but down from a peak of 77p last week.
One market maker said volume of 790,000 shares by midmorning was about average for Xenova.
Andrew Forsyth, analyst at Williams de Broe said sentiment on the stock was changing, and further gains could be in prospect following recent deals.
"Talking to institutions, some are interested in the stock because of deals they`ve done last year, and the merger with Cantab seems to have worked, and we haven`t had any problems with integration," he said.
"It`s had a run of good news, and we`re probably expecting more of the same from them. Speculation is generally on product advancement. We could maybe expect further alliances, maybe more from the vaccine side of the pipeline," he added.
A market maker said speculation had been circulating since the New Year that Xenova might be set to announce a new deal.
A Xenova spokeswoman declined to comment on Wednesday.
Xenova shares were boosted recently by news in December of a licensing deal for three of its experimental cancer drugs with U.S. biotechnology firm Millennium Pharmaceuticals .
Market watchers also pointed to a run of positive media and analyst comment on the shares.
"I can see the chart going onto around 90p to a pound on a six-month basis. Interest is being regenerated in the stock," said Forsyth.
Undervalued biotechs ripe for re-rating
By Peter Rees
Wed 9 Jan 2002,
nachzulesen unter http://www.sharecast.com/news/scnews1.asp?StoryID=38336
LONDON (SHARECAST) - A disastrous year for biotechs in 2001 has left many shares undervalued and liable to rise sharply on good news, according to Lehman Brothers.
In a quarterly review of the sector, the broker cites recent rises in the shares of PPL Therapeutics, Vernalis and Xenova as evidence of a good-news effect that was absent for most of last year.
In 2001, risk-averse investors spurned companies with valuable technology, so-called platform companies such as Cambridge Antibody Technology, but distant profitability for those with products already on the market. Hence Europe`s larger biotechs, including Celltech, NovoNordisk and Serono, outperformed the sector.
Now as investors shift from defensives to cyclical and technology shares, biotechs are a natural home for cash rotating out of defensive healthcare companies, Lehman Brothers says.
And because their Nasdaq-traded counterparts were more resilient to anti-tech sentiment, the gap in valuations between US and European platform companies has widened.
UK companies that are most likely to benefit from a re-rating include proteomics firm Oxford Glycosciences and antibody specialist CAT, Lehman said.
The broker also recommends Celltech shares, despite their recovery in the last quarter of 2001. In late September they dipped below 550p but now trade above 900p. The broker`s price target is 3,000p.
LONDON, Jan 9 (Reuters) - Shares in British biotechnology firm Xenova Plc bounced nine percent early on Wednesday as investors stocked up anticipating a fresh announcement on its product pipeline, analysts and market makers said.
By 0947 GMT Xenova shares were up five pence to 62-1/2p, well up from recent lows of 35p in December, but down from a peak of 77p last week.
One market maker said volume of 790,000 shares by midmorning was about average for Xenova.
Andrew Forsyth, analyst at Williams de Broe said sentiment on the stock was changing, and further gains could be in prospect following recent deals.
"Talking to institutions, some are interested in the stock because of deals they`ve done last year, and the merger with Cantab seems to have worked, and we haven`t had any problems with integration," he said.
"It`s had a run of good news, and we`re probably expecting more of the same from them. Speculation is generally on product advancement. We could maybe expect further alliances, maybe more from the vaccine side of the pipeline," he added.
A market maker said speculation had been circulating since the New Year that Xenova might be set to announce a new deal.
A Xenova spokeswoman declined to comment on Wednesday.
Xenova shares were boosted recently by news in December of a licensing deal for three of its experimental cancer drugs with U.S. biotechnology firm Millennium Pharmaceuticals .
Market watchers also pointed to a run of positive media and analyst comment on the shares.
"I can see the chart going onto around 90p to a pound on a six-month basis. Interest is being regenerated in the stock," said Forsyth.
By Peter Rees
Wed 9 Jan 2002,
nachzulesen unter http://www.sharecast.com/news/scnews1.asp?StoryID=38336
LONDON (SHARECAST) - A disastrous year for biotechs in 2001 has left many shares undervalued and liable to rise sharply on good news, according to Lehman Brothers.
In a quarterly review of the sector, the broker cites recent rises in the shares of PPL Therapeutics, Vernalis and Xenova as evidence of a good-news effect that was absent for most of last year.
In 2001, risk-averse investors spurned companies with valuable technology, so-called platform companies such as Cambridge Antibody Technology, but distant profitability for those with products already on the market. Hence Europe`s larger biotechs, including Celltech, NovoNordisk and Serono, outperformed the sector.
Now as investors shift from defensives to cyclical and technology shares, biotechs are a natural home for cash rotating out of defensive healthcare companies, Lehman Brothers says.
And because their Nasdaq-traded counterparts were more resilient to anti-tech sentiment, the gap in valuations between US and European platform companies has widened.
UK companies that are most likely to benefit from a re-rating include proteomics firm Oxford Glycosciences and antibody specialist CAT, Lehman said.
The broker also recommends Celltech shares, despite their recovery in the last quarter of 2001. In late September they dipped below 550p but now trade above 900p. The broker`s price target is 3,000p.
LONDON, Jan 9 (Reuters) - Shares in British biotechnology firm Xenova Plc bounced nine percent early on Wednesday as investors stocked up anticipating a fresh announcement on its product pipeline, analysts and market makers said.
By 0947 GMT Xenova shares were up five pence to 62-1/2p, well up from recent lows of 35p in December, but down from a peak of 77p last week.
One market maker said volume of 790,000 shares by midmorning was about average for Xenova.
Andrew Forsyth, analyst at Williams de Broe said sentiment on the stock was changing, and further gains could be in prospect following recent deals.
"Talking to institutions, some are interested in the stock because of deals they`ve done last year, and the merger with Cantab seems to have worked, and we haven`t had any problems with integration," he said.
"It`s had a run of good news, and we`re probably expecting more of the same from them. Speculation is generally on product advancement. We could maybe expect further alliances, maybe more from the vaccine side of the pipeline," he added.
A market maker said speculation had been circulating since the New Year that Xenova might be set to announce a new deal.
A Xenova spokeswoman declined to comment on Wednesday.
Xenova shares were boosted recently by news in December of a licensing deal for three of its experimental cancer drugs with U.S. biotechnology firm Millennium Pharmaceuticals .
Market watchers also pointed to a run of positive media and analyst comment on the shares.
"I can see the chart going onto around 90p to a pound on a six-month basis. Interest is being regenerated in the stock," said Forsyth.
Undervalued biotechs ripe for re-rating
By Peter Rees
Wed 9 Jan 2002,
nachzulesen unter http://www.sharecast.com/news/scnews1.asp?StoryID=38336
LONDON (SHARECAST) - A disastrous year for biotechs in 2001 has left many shares undervalued and liable to rise sharply on good news, according to Lehman Brothers.
In a quarterly review of the sector, the broker cites recent rises in the shares of PPL Therapeutics, Vernalis and Xenova as evidence of a good-news effect that was absent for most of last year.
In 2001, risk-averse investors spurned companies with valuable technology, so-called platform companies such as Cambridge Antibody Technology, but distant profitability for those with products already on the market. Hence Europe`s larger biotechs, including Celltech, NovoNordisk and Serono, outperformed the sector.
Now as investors shift from defensives to cyclical and technology shares, biotechs are a natural home for cash rotating out of defensive healthcare companies, Lehman Brothers says.
And because their Nasdaq-traded counterparts were more resilient to anti-tech sentiment, the gap in valuations between US and European platform companies has widened.
UK companies that are most likely to benefit from a re-rating include proteomics firm Oxford Glycosciences and antibody specialist CAT, Lehman said.
The broker also recommends Celltech shares, despite their recovery in the last quarter of 2001. In late September they dipped below 550p but now trade above 900p. The broker`s price target is 3,000p.
LONDON, Jan 9 (Reuters) - Shares in British biotechnology firm Xenova Plc bounced nine percent early on Wednesday as investors stocked up anticipating a fresh announcement on its product pipeline, analysts and market makers said.
By 0947 GMT Xenova shares were up five pence to 62-1/2p, well up from recent lows of 35p in December, but down from a peak of 77p last week.
One market maker said volume of 790,000 shares by midmorning was about average for Xenova.
Andrew Forsyth, analyst at Williams de Broe said sentiment on the stock was changing, and further gains could be in prospect following recent deals.
"Talking to institutions, some are interested in the stock because of deals they`ve done last year, and the merger with Cantab seems to have worked, and we haven`t had any problems with integration," he said.
"It`s had a run of good news, and we`re probably expecting more of the same from them. Speculation is generally on product advancement. We could maybe expect further alliances, maybe more from the vaccine side of the pipeline," he added.
A market maker said speculation had been circulating since the New Year that Xenova might be set to announce a new deal.
A Xenova spokeswoman declined to comment on Wednesday.
Xenova shares were boosted recently by news in December of a licensing deal for three of its experimental cancer drugs with U.S. biotechnology firm Millennium Pharmaceuticals .
Market watchers also pointed to a run of positive media and analyst comment on the shares.
"I can see the chart going onto around 90p to a pound on a six-month basis. Interest is being regenerated in the stock," said Forsyth.
By Peter Rees
Wed 9 Jan 2002,
nachzulesen unter http://www.sharecast.com/news/scnews1.asp?StoryID=38336
LONDON (SHARECAST) - A disastrous year for biotechs in 2001 has left many shares undervalued and liable to rise sharply on good news, according to Lehman Brothers.
In a quarterly review of the sector, the broker cites recent rises in the shares of PPL Therapeutics, Vernalis and Xenova as evidence of a good-news effect that was absent for most of last year.
In 2001, risk-averse investors spurned companies with valuable technology, so-called platform companies such as Cambridge Antibody Technology, but distant profitability for those with products already on the market. Hence Europe`s larger biotechs, including Celltech, NovoNordisk and Serono, outperformed the sector.
Now as investors shift from defensives to cyclical and technology shares, biotechs are a natural home for cash rotating out of defensive healthcare companies, Lehman Brothers says.
And because their Nasdaq-traded counterparts were more resilient to anti-tech sentiment, the gap in valuations between US and European platform companies has widened.
UK companies that are most likely to benefit from a re-rating include proteomics firm Oxford Glycosciences and antibody specialist CAT, Lehman said.
The broker also recommends Celltech shares, despite their recovery in the last quarter of 2001. In late September they dipped below 550p but now trade above 900p. The broker`s price target is 3,000p.
LONDON, Jan 9 (Reuters) - Shares in British biotechnology firm Xenova Plc bounced nine percent early on Wednesday as investors stocked up anticipating a fresh announcement on its product pipeline, analysts and market makers said.
By 0947 GMT Xenova shares were up five pence to 62-1/2p, well up from recent lows of 35p in December, but down from a peak of 77p last week.
One market maker said volume of 790,000 shares by midmorning was about average for Xenova.
Andrew Forsyth, analyst at Williams de Broe said sentiment on the stock was changing, and further gains could be in prospect following recent deals.
"Talking to institutions, some are interested in the stock because of deals they`ve done last year, and the merger with Cantab seems to have worked, and we haven`t had any problems with integration," he said.
"It`s had a run of good news, and we`re probably expecting more of the same from them. Speculation is generally on product advancement. We could maybe expect further alliances, maybe more from the vaccine side of the pipeline," he added.
A market maker said speculation had been circulating since the New Year that Xenova might be set to announce a new deal.
A Xenova spokeswoman declined to comment on Wednesday.
Xenova shares were boosted recently by news in December of a licensing deal for three of its experimental cancer drugs with U.S. biotechnology firm Millennium Pharmaceuticals .
Market watchers also pointed to a run of positive media and analyst comment on the shares.
"I can see the chart going onto around 90p to a pound on a six-month basis. Interest is being regenerated in the stock," said Forsyth.
Undervalued biotechs ripe for re-rating
By Peter Rees
Wed 9 Jan 2002,
nachzulesen unter http://www.sharecast.com/news/scnews1.asp?StoryID=38336
LONDON (SHARECAST) - A disastrous year for biotechs in 2001 has left many shares undervalued and liable to rise sharply on good news, according to Lehman Brothers.
In a quarterly review of the sector, the broker cites recent rises in the shares of PPL Therapeutics, Vernalis and Xenova as evidence of a good-news effect that was absent for most of last year.
In 2001, risk-averse investors spurned companies with valuable technology, so-called platform companies such as Cambridge Antibody Technology, but distant profitability for those with products already on the market. Hence Europe`s larger biotechs, including Celltech, NovoNordisk and Serono, outperformed the sector.
Now as investors shift from defensives to cyclical and technology shares, biotechs are a natural home for cash rotating out of defensive healthcare companies, Lehman Brothers says.
And because their Nasdaq-traded counterparts were more resilient to anti-tech sentiment, the gap in valuations between US and European platform companies has widened.
UK companies that are most likely to benefit from a re-rating include proteomics firm Oxford Glycosciences and antibody specialist CAT, Lehman said.
The broker also recommends Celltech shares, despite their recovery in the last quarter of 2001. In late September they dipped below 550p but now trade above 900p. The broker`s price target is 3,000p.
LONDON, Jan 9 (Reuters) - Shares in British biotechnology firm Xenova Plc bounced nine percent early on Wednesday as investors stocked up anticipating a fresh announcement on its product pipeline, analysts and market makers said.
By 0947 GMT Xenova shares were up five pence to 62-1/2p, well up from recent lows of 35p in December, but down from a peak of 77p last week.
One market maker said volume of 790,000 shares by midmorning was about average for Xenova.
Andrew Forsyth, analyst at Williams de Broe said sentiment on the stock was changing, and further gains could be in prospect following recent deals.
"Talking to institutions, some are interested in the stock because of deals they`ve done last year, and the merger with Cantab seems to have worked, and we haven`t had any problems with integration," he said.
"It`s had a run of good news, and we`re probably expecting more of the same from them. Speculation is generally on product advancement. We could maybe expect further alliances, maybe more from the vaccine side of the pipeline," he added.
A market maker said speculation had been circulating since the New Year that Xenova might be set to announce a new deal.
A Xenova spokeswoman declined to comment on Wednesday.
Xenova shares were boosted recently by news in December of a licensing deal for three of its experimental cancer drugs with U.S. biotechnology firm Millennium Pharmaceuticals .
Market watchers also pointed to a run of positive media and analyst comment on the shares.
"I can see the chart going onto around 90p to a pound on a six-month basis. Interest is being regenerated in the stock," said Forsyth.
By Peter Rees
Wed 9 Jan 2002,
nachzulesen unter http://www.sharecast.com/news/scnews1.asp?StoryID=38336
LONDON (SHARECAST) - A disastrous year for biotechs in 2001 has left many shares undervalued and liable to rise sharply on good news, according to Lehman Brothers.
In a quarterly review of the sector, the broker cites recent rises in the shares of PPL Therapeutics, Vernalis and Xenova as evidence of a good-news effect that was absent for most of last year.
In 2001, risk-averse investors spurned companies with valuable technology, so-called platform companies such as Cambridge Antibody Technology, but distant profitability for those with products already on the market. Hence Europe`s larger biotechs, including Celltech, NovoNordisk and Serono, outperformed the sector.
Now as investors shift from defensives to cyclical and technology shares, biotechs are a natural home for cash rotating out of defensive healthcare companies, Lehman Brothers says.
And because their Nasdaq-traded counterparts were more resilient to anti-tech sentiment, the gap in valuations between US and European platform companies has widened.
UK companies that are most likely to benefit from a re-rating include proteomics firm Oxford Glycosciences and antibody specialist CAT, Lehman said.
The broker also recommends Celltech shares, despite their recovery in the last quarter of 2001. In late September they dipped below 550p but now trade above 900p. The broker`s price target is 3,000p.
LONDON, Jan 9 (Reuters) - Shares in British biotechnology firm Xenova Plc bounced nine percent early on Wednesday as investors stocked up anticipating a fresh announcement on its product pipeline, analysts and market makers said.
By 0947 GMT Xenova shares were up five pence to 62-1/2p, well up from recent lows of 35p in December, but down from a peak of 77p last week.
One market maker said volume of 790,000 shares by midmorning was about average for Xenova.
Andrew Forsyth, analyst at Williams de Broe said sentiment on the stock was changing, and further gains could be in prospect following recent deals.
"Talking to institutions, some are interested in the stock because of deals they`ve done last year, and the merger with Cantab seems to have worked, and we haven`t had any problems with integration," he said.
"It`s had a run of good news, and we`re probably expecting more of the same from them. Speculation is generally on product advancement. We could maybe expect further alliances, maybe more from the vaccine side of the pipeline," he added.
A market maker said speculation had been circulating since the New Year that Xenova might be set to announce a new deal.
A Xenova spokeswoman declined to comment on Wednesday.
Xenova shares were boosted recently by news in December of a licensing deal for three of its experimental cancer drugs with U.S. biotechnology firm Millennium Pharmaceuticals .
Market watchers also pointed to a run of positive media and analyst comment on the shares.
"I can see the chart going onto around 90p to a pound on a six-month basis. Interest is being regenerated in the stock," said Forsyth.
Undervalued biotechs ripe for re-rating
By Peter Rees
Wed 9 Jan 2002,
nachzulesen unter http://www.sharecast.com/news/scnews1.asp?StoryID=38336
LONDON (SHARECAST) - A disastrous year for biotechs in 2001 has left many shares undervalued and liable to rise sharply on good news, according to Lehman Brothers.
In a quarterly review of the sector, the broker cites recent rises in the shares of PPL Therapeutics, Vernalis and Xenova as evidence of a good-news effect that was absent for most of last year.
In 2001, risk-averse investors spurned companies with valuable technology, so-called platform companies such as Cambridge Antibody Technology, but distant profitability for those with products already on the market. Hence Europe`s larger biotechs, including Celltech, NovoNordisk and Serono, outperformed the sector.
Now as investors shift from defensives to cyclical and technology shares, biotechs are a natural home for cash rotating out of defensive healthcare companies, Lehman Brothers says.
And because their Nasdaq-traded counterparts were more resilient to anti-tech sentiment, the gap in valuations between US and European platform companies has widened.
UK companies that are most likely to benefit from a re-rating include proteomics firm Oxford Glycosciences and antibody specialist CAT, Lehman said.
The broker also recommends Celltech shares, despite their recovery in the last quarter of 2001. In late September they dipped below 550p but now trade above 900p. The broker`s price target is 3,000p.
LONDON, Jan 9 (Reuters) - Shares in British biotechnology firm Xenova Plc bounced nine percent early on Wednesday as investors stocked up anticipating a fresh announcement on its product pipeline, analysts and market makers said.
By 0947 GMT Xenova shares were up five pence to 62-1/2p, well up from recent lows of 35p in December, but down from a peak of 77p last week.
One market maker said volume of 790,000 shares by midmorning was about average for Xenova.
Andrew Forsyth, analyst at Williams de Broe said sentiment on the stock was changing, and further gains could be in prospect following recent deals.
"Talking to institutions, some are interested in the stock because of deals they`ve done last year, and the merger with Cantab seems to have worked, and we haven`t had any problems with integration," he said.
"It`s had a run of good news, and we`re probably expecting more of the same from them. Speculation is generally on product advancement. We could maybe expect further alliances, maybe more from the vaccine side of the pipeline," he added.
A market maker said speculation had been circulating since the New Year that Xenova might be set to announce a new deal.
A Xenova spokeswoman declined to comment on Wednesday.
Xenova shares were boosted recently by news in December of a licensing deal for three of its experimental cancer drugs with U.S. biotechnology firm Millennium Pharmaceuticals .
Market watchers also pointed to a run of positive media and analyst comment on the shares.
"I can see the chart going onto around 90p to a pound on a six-month basis. Interest is being regenerated in the stock," said Forsyth.
By Peter Rees
Wed 9 Jan 2002,
nachzulesen unter http://www.sharecast.com/news/scnews1.asp?StoryID=38336
LONDON (SHARECAST) - A disastrous year for biotechs in 2001 has left many shares undervalued and liable to rise sharply on good news, according to Lehman Brothers.
In a quarterly review of the sector, the broker cites recent rises in the shares of PPL Therapeutics, Vernalis and Xenova as evidence of a good-news effect that was absent for most of last year.
In 2001, risk-averse investors spurned companies with valuable technology, so-called platform companies such as Cambridge Antibody Technology, but distant profitability for those with products already on the market. Hence Europe`s larger biotechs, including Celltech, NovoNordisk and Serono, outperformed the sector.
Now as investors shift from defensives to cyclical and technology shares, biotechs are a natural home for cash rotating out of defensive healthcare companies, Lehman Brothers says.
And because their Nasdaq-traded counterparts were more resilient to anti-tech sentiment, the gap in valuations between US and European platform companies has widened.
UK companies that are most likely to benefit from a re-rating include proteomics firm Oxford Glycosciences and antibody specialist CAT, Lehman said.
The broker also recommends Celltech shares, despite their recovery in the last quarter of 2001. In late September they dipped below 550p but now trade above 900p. The broker`s price target is 3,000p.
LONDON, Jan 9 (Reuters) - Shares in British biotechnology firm Xenova Plc bounced nine percent early on Wednesday as investors stocked up anticipating a fresh announcement on its product pipeline, analysts and market makers said.
By 0947 GMT Xenova shares were up five pence to 62-1/2p, well up from recent lows of 35p in December, but down from a peak of 77p last week.
One market maker said volume of 790,000 shares by midmorning was about average for Xenova.
Andrew Forsyth, analyst at Williams de Broe said sentiment on the stock was changing, and further gains could be in prospect following recent deals.
"Talking to institutions, some are interested in the stock because of deals they`ve done last year, and the merger with Cantab seems to have worked, and we haven`t had any problems with integration," he said.
"It`s had a run of good news, and we`re probably expecting more of the same from them. Speculation is generally on product advancement. We could maybe expect further alliances, maybe more from the vaccine side of the pipeline," he added.
A market maker said speculation had been circulating since the New Year that Xenova might be set to announce a new deal.
A Xenova spokeswoman declined to comment on Wednesday.
Xenova shares were boosted recently by news in December of a licensing deal for three of its experimental cancer drugs with U.S. biotechnology firm Millennium Pharmaceuticals .
Market watchers also pointed to a run of positive media and analyst comment on the shares.
"I can see the chart going onto around 90p to a pound on a six-month basis. Interest is being regenerated in the stock," said Forsyth.
LONDON, Jan 9 (Reuters) - Shares in British biotechnology firm Xenova Plc bounced nine percent early on Wednesday as investors stocked up anticipating a fresh announcement on its product pipeline, analysts and market makers said.
By 0947 GMT Xenova shares were up five pence to 62-1/2p, well up from recent lows of 35p in December, but down from a peak of 77p last week.
One market maker said volume of 790,000 shares by midmorning was about average for Xenova.
Andrew Forsyth, analyst at Williams de Broe said sentiment on the stock was changing, and further gains could be in prospect following recent deals.
"Talking to institutions, some are interested in the stock because of deals they`ve done last year, and the merger with Cantab seems to have worked, and we haven`t had any problems with integration," he said.
"It`s had a run of good news, and we`re probably expecting more of the same from them. Speculation is generally on product advancement. We could maybe expect further alliances, maybe more from the vaccine side of the pipeline," he added.
A market maker said speculation had been circulating since the New Year that Xenova might be set to announce a new deal.
A Xenova spokeswoman declined to comment on Wednesday.
Xenova shares were boosted recently by news in December of a licensing deal for three of its experimental cancer drugs with U.S. biotechnology firm Millennium Pharmaceuticals .
Market watchers also pointed to a run of positive media and analyst comment on the shares.
"I can see the chart going onto around 90p to a pound on a six-month basis. Interest is being regenerated in the stock," said Forsyth.
By 0947 GMT Xenova shares were up five pence to 62-1/2p, well up from recent lows of 35p in December, but down from a peak of 77p last week.
One market maker said volume of 790,000 shares by midmorning was about average for Xenova.
Andrew Forsyth, analyst at Williams de Broe said sentiment on the stock was changing, and further gains could be in prospect following recent deals.
"Talking to institutions, some are interested in the stock because of deals they`ve done last year, and the merger with Cantab seems to have worked, and we haven`t had any problems with integration," he said.
"It`s had a run of good news, and we`re probably expecting more of the same from them. Speculation is generally on product advancement. We could maybe expect further alliances, maybe more from the vaccine side of the pipeline," he added.
A market maker said speculation had been circulating since the New Year that Xenova might be set to announce a new deal.
A Xenova spokeswoman declined to comment on Wednesday.
Xenova shares were boosted recently by news in December of a licensing deal for three of its experimental cancer drugs with U.S. biotechnology firm Millennium Pharmaceuticals .
Market watchers also pointed to a run of positive media and analyst comment on the shares.
"I can see the chart going onto around 90p to a pound on a six-month basis. Interest is being regenerated in the stock," said Forsyth.
@Panospana
was hat dich denn letzte Nacht "geärgert" -sind doch gute news
Schönen Sonntag noch
Wunram
was hat dich denn letzte Nacht "geärgert" -sind doch gute news
Schönen Sonntag noch
Wunram
Xenova Group plc Anti-Cancer Compound XR11576 Enters Clinical Trials
SLOUGH, England, Feb 5, 2002 /PRNewswire-FirstCall via COMTEX/ -- Xenova Group plc (Nasdaq: XNVA; London Stock Exchange: XEN) today announced that patient dosing has begun at the University Hospital of Rotterdam, Rotterdam Cancer Institute with XR11576 (MLN576), a novel anti-cancer agent.
This open label, Phase I trial is being carried out at centres in the UK and the Netherlands and comprises multiple ascending oral doses in patients with solid tumors. Patients will be monitored for safety, tolerability, pharmacokinetics and anti-tumor activity.
XR11576 (MLN576) is one of a program of compounds for the treatment of solid tumors. Along with compounds XR5944 (MLN944) and XR11612 (MLN612), XR11576 (MLN576) is the subject of a license agreement with Millennium Pharmaceuticals Inc, which was announced in December 2001 for the development and exclusive North American commercialization rights to this program. The compounds are believed to be novel DNA targeting agents that affect the DNA replication process through a mechanism of action which involves the dual inhibition of topoisomerases I and II. Xenova retains responsibility for performing development activities associated with the program, which will be funded by Millennium commencing in 2003, to the end of Phase II clinical trials.
David Oxlade, Xenova`s Chief Executive, said: "XR11576 has shown considerable promise in preclinical studies including good oral bioavailability. These compounds have a novel and exciting mechanism of action and have shown considerable evidence of activity in in vivo xenograft models. There remains a clear need in the marketplace for new cytotoxics in order to improve the quality of treatment and outcomes for a large number of cancer patients."
Notes to Editors
Xenova Group plc`s product pipeline focuses principally on cancer and immunotherapy. Xenova currently has a broad pipeline of products in clinical development. The multi-drug resistance modulator tariquidar/XR9576, North American rights for which were licensed to QLT Inc in August 2001, is expected to enter Phase III clinical trials during the first half of 2002. Two immunotherapeutic vaccines, TA-HPV and TA-CIN, are undergoing Phase II `Prime-Boost` clinical trials in combination for the treatment of ano-genital dysplasia and a third vaccine, DISC-GMCSF, is being evaluated for the treatment of malignant melanoma. In non-cancer related therapy areas, TA-CD, a vaccine for the treatment of cocaine addiction, is currently undergoing Phase II trials and a vaccine for the treatment of nicotine addiction, TA-NIC, is in Phase I clinical trials. DISC-PRO, a vaccine for the prevention of herpes, has completed Phase I trials. In addition, a product candidate for the prevention of bovine herpes, DISC-BHV, was entered into development by Xenova`s global partner, Pfizer Animal Health, in January 2001.
The Group has a well-established track record in the identification, development and partnering of innovative products and technologies and has partnerships with major pharmaceutical companies including Lilly, Pfizer, Celltech, QLT and Millennium.
For further information about Xenova and its products please visit the Xenova website at http://www.xenova.co.uk
SLOUGH, England, Feb 5, 2002 /PRNewswire-FirstCall via COMTEX/ -- Xenova Group plc (Nasdaq: XNVA; London Stock Exchange: XEN) today announced that patient dosing has begun at the University Hospital of Rotterdam, Rotterdam Cancer Institute with XR11576 (MLN576), a novel anti-cancer agent.
This open label, Phase I trial is being carried out at centres in the UK and the Netherlands and comprises multiple ascending oral doses in patients with solid tumors. Patients will be monitored for safety, tolerability, pharmacokinetics and anti-tumor activity.
XR11576 (MLN576) is one of a program of compounds for the treatment of solid tumors. Along with compounds XR5944 (MLN944) and XR11612 (MLN612), XR11576 (MLN576) is the subject of a license agreement with Millennium Pharmaceuticals Inc, which was announced in December 2001 for the development and exclusive North American commercialization rights to this program. The compounds are believed to be novel DNA targeting agents that affect the DNA replication process through a mechanism of action which involves the dual inhibition of topoisomerases I and II. Xenova retains responsibility for performing development activities associated with the program, which will be funded by Millennium commencing in 2003, to the end of Phase II clinical trials.
David Oxlade, Xenova`s Chief Executive, said: "XR11576 has shown considerable promise in preclinical studies including good oral bioavailability. These compounds have a novel and exciting mechanism of action and have shown considerable evidence of activity in in vivo xenograft models. There remains a clear need in the marketplace for new cytotoxics in order to improve the quality of treatment and outcomes for a large number of cancer patients."
Notes to Editors
Xenova Group plc`s product pipeline focuses principally on cancer and immunotherapy. Xenova currently has a broad pipeline of products in clinical development. The multi-drug resistance modulator tariquidar/XR9576, North American rights for which were licensed to QLT Inc in August 2001, is expected to enter Phase III clinical trials during the first half of 2002. Two immunotherapeutic vaccines, TA-HPV and TA-CIN, are undergoing Phase II `Prime-Boost` clinical trials in combination for the treatment of ano-genital dysplasia and a third vaccine, DISC-GMCSF, is being evaluated for the treatment of malignant melanoma. In non-cancer related therapy areas, TA-CD, a vaccine for the treatment of cocaine addiction, is currently undergoing Phase II trials and a vaccine for the treatment of nicotine addiction, TA-NIC, is in Phase I clinical trials. DISC-PRO, a vaccine for the prevention of herpes, has completed Phase I trials. In addition, a product candidate for the prevention of bovine herpes, DISC-BHV, was entered into development by Xenova`s global partner, Pfizer Animal Health, in January 2001.
The Group has a well-established track record in the identification, development and partnering of innovative products and technologies and has partnerships with major pharmaceutical companies including Lilly, Pfizer, Celltech, QLT and Millennium.
For further information about Xenova and its products please visit the Xenova website at http://www.xenova.co.uk
Au weia...was ist denn jetzt passiert???
-12% ????????????????
-12% ????????????????
LONDON (AFX) - Fulcrum Pharma PLC, the independent drug development company, said it has extended its development agreement with Xenova Group PLC after successfully completing the first milestone of the multi-year agreement between the two companies.
Clinical trials of their next generation oncology product can now commence and the next milestone target is to take the product through to proof of concept, said Fulcrum.
slm/ For more information and to contact AFX: www.afxnews.com and www.afxpress.com Copyright 2002 AFX News Ltd.
Gruß Bogo!
Clinical trials of their next generation oncology product can now commence and the next milestone target is to take the product through to proof of concept, said Fulcrum.
slm/ For more information and to contact AFX: www.afxnews.com and www.afxpress.com Copyright 2002 AFX News Ltd.
Gruß Bogo!
RNS Number:4069R
Xenova Group PLC
13 February 2002
Section 198 Companies Act
In accordance with S198 of the Companies Act we hereby notify you that RAB
Capital Ltd, acting as investment manager for a number of commingled funds, has
acquired, through purchases on 12 February 2002, a further 480,000 ordinary
shares in Xenova Group plc. RAB Capital Ltd`s notifiable interest is thereby
increased to 5,389,552 shares representing 3.88% of the issued share capital.
RAB Capital does not act as custodian for its clients and therefore the shares
are held in the nominee name of the custodian of our clients, which is Morstan
Nominees Ltd.
Xenova Group PLC
13 February 2002
Section 198 Companies Act
In accordance with S198 of the Companies Act we hereby notify you that RAB
Capital Ltd, acting as investment manager for a number of commingled funds, has
acquired, through purchases on 12 February 2002, a further 480,000 ordinary
shares in Xenova Group plc. RAB Capital Ltd`s notifiable interest is thereby
increased to 5,389,552 shares representing 3.88% of the issued share capital.
RAB Capital does not act as custodian for its clients and therefore the shares
are held in the nominee name of the custodian of our clients, which is Morstan
Nominees Ltd.
RNS Number:6130R
Xenova Group PLC
18 February 2002
Letter to Xenova Group plc
Section 198 Companies Act
In accordance with S198 of the Companies Act we hereby notify you that RAB
Capital Ltd, acting as investment manager for a number of commingled funds, has
acquired, through purchases on 14 and 15 February 2002, a further 250,000
ordinary shares in Xenova Group plc. RAB Capital Ltd`s notifiable interest is
thereby increased to 5,639,552 shares representing 4.06% of the issued share
capital.
RAB Capital does not act as custodian for its clients and therefore the shares
are held in the nominee name of the custodian of our clients, which is Morstan
Nominees Ltd.
From RAB Capital Ltd
Xenova Group PLC
18 February 2002
Letter to Xenova Group plc
Section 198 Companies Act
In accordance with S198 of the Companies Act we hereby notify you that RAB
Capital Ltd, acting as investment manager for a number of commingled funds, has
acquired, through purchases on 14 and 15 February 2002, a further 250,000
ordinary shares in Xenova Group plc. RAB Capital Ltd`s notifiable interest is
thereby increased to 5,639,552 shares representing 4.06% of the issued share
capital.
RAB Capital does not act as custodian for its clients and therefore the shares
are held in the nominee name of the custodian of our clients, which is Morstan
Nominees Ltd.
From RAB Capital Ltd
Xenova Group plc Preliminary Results for the Year Ended 31 December 2001
SLOUGH, England, Feb. 19 /PRNewswire-FirstCall/ -- Xenova Group plc (Nasdaq: XNVA; London Stock Exchange: XEN) today announces its results for the year to 31 December 2001.
Highlights
* North American collaboration with QLT Inc for P-gp inhibitor XR9576
(tariquidar) worth 71.9m pounds sterling (pounds) (US$105m) including
milestones, excluding royalties
* 7.9m pounds (US$11.5m) upfront payment plus milestones and royalties
from North American licensing deal with Millennium Pharmaceuticals,
Inc for novel DNA targeting agent program
* Collaborations by joint venture Phogen with Genencor (up to
15m pounds (US$21m)) and Cell Genesys (undisclosed) for VP22
technology
* Start of combined `Prime-Boost` Phase II trials for cancer program
vaccines TA-CIN and TA-HPV
* Anti-nicotine addiction vaccine TA-NIC entry to Phase I
clinical trials
* Merger with Cantab completed April 2001
Financial Highlights
* Cash and liquid resources at 31 December 2001 24.0m pounds
(2000: 12.2m pounds)
* Cash received of 14.8m pounds from new licensing deals
* Significant cost savings post Cantab merger
Commenting, David Oxlade, Chief Executive Officer of Xenova Group plc said: "2001 was a year of major change and substantial progress for Xenova. The integration of Cantab with Xenova was successfully accomplished and has resulted in a company with a broad cancer-focused pipeline of early to late stage products, a streamlined cost base and a strong list of collaborative partners, to which we were delighted to add QLT and Millennium during the course of the year. Xenova enters 2002 soundly financed, broadly based and confident of further good progress during the year."
Chief Executive`s Review
Following the merger with Cantab, Xenova has focused its resources on the discovery and development of commercially attractive, novel small molecule and biologic drug candidates, primarily in the therapeutic areas of cancer and immune disease.
Product Development
Drug Candidates
XR9576 (tariquidar) -- Xenova`s P-glycoprotein modulator, which targets
the reversal of multi-drug resistance in cancer, completed a series of three
open label Phase IIa clinical trials in early 2001. The successful results
of a trial in which XR9576 was given with doxorubicin were reported in late
2000. The results of two other Phase IIa trials, in which XR9576 was given
with paclitaxel or vinorelbine (two widely used cytotoxic drugs), were
reported in May at the annual meeting of the American Society of Clinical
Oncology and showed that XR9576 was well tolerated and that it is a potent
P-glycoprotein antagonist. These trials also confirmed that, at the dose
levels studied, no clinically significant pharmacokinetic interaction was
observed, that the administration of XR5976 with paclitaxel, vinorelbine and
doxorubicin was well tolerated and that the cytotoxics can be used in
combination with XR9576 at, or close to their normal clinical dose. Positive
responses, which were noted in several of the patients in the studies,
provided anecdotal evidence of efficacy.
In August Xenova announced the signing of an exclusive license agreement with QLT Inc for the development and marketing of XR9576 in the United States, Canada and Mexico. Under the terms of this agreement, QLT has assumed responsibility for the further development of XR9576, including Phase III trials, all regulatory filings and the manufacture and sale of XR9576 within those territories covered by the agreement. QLT made an immediate upfront license payment to Xenova of US$10m (6.9m pounds) and will provide up to $45m (30.8m pounds) in funding for development activities related to Phase III clinical studies for XR9576 in North America and Europe. Milestones of up to US$50m (34.2m pounds) and royalties in the range of 15 to 22 per cent depending on the level of North American sales are also receivable by Xenova.
Xenova retains substantially all rights to XR9576 outside the United States, Canada and Mexico, including European and Rest of World marketing rights.
FDA permission has been obtained to proceed with Phase III clinical trials and it is anticipated that these trials will begin in mid 2002.
XR11576 (MLN576) -- Along with compounds XR5944 and XR11612, XR11576 forms part of Xenova`s program of novel DNA targeting agents, whose method of action involves dual inhibition of topoisomerases I and II. The program is being developed for the treatment of solid tumours in cancer. XR11576 is an oral agent, which completed pharmacological and toxicity testing during 2001 prior to entry into Phase I clinical development. Patient dosing for an open label, Phase I trial, which is being carried out at centres in the UK and the Netherlands, began in February 2002. Like XR11576, XR11612 is orally bioavailable and has shown increased potency in preclinical trials. It is being developed as a back-up compound to XR11576. XR5944 has shown exceptionally high potency as a cytotoxic in preclinical studies with a number of cell lines and xenograft models. XR5944 is an intravenous agent which is structurally distinct from XR11576, and has been shown to be unaffected by atypical multi-drug resistance. All three compounds are the product of Xenova`s in-house research and development.
It was announced in December 2001 that Xenova has entered into a license agreement with Millennium Pharmaceuticals Inc for the development and North American commercialization of these novel compounds. Under the terms of the agreement, Millennium has acquired development and exclusive marketing rights to the program in North America, in exchange for an upfront payment of US$11.5m (7.9m pounds) as well as future milestone payments and royalties following the achievement of specific development and sales goals. Xenova continues to have responsibility for performing development activities associated with the program to the end of Phase II trials, which will be funded by Millennium from 2003. Following completion of Phase II trials, Millennium will assume responsibility for the program`s further development and commercialization in North America, while Xenova has responsibility for its further development and commercialization rights in Europe and the Rest of the World.
TA-HPV and TA-CIN -- TA-HPV is a vaccinia viral vector, carrying human papillomavirus genes, which is being developed to treat cervical cancer. A series of Phase II trials is currently underway and the results of one of these were reported in September 2001. In this trial forty-four per cent of patients were judged to show an objective clinical response at six months and a further twenty-two per cent showed significant symptom relief.
TA-CIN is a therapeutic vaccine which is being developed for the treatment of cervical intraepithelial neoplasia. The successful results of a Phase I safety and immunogenicity study were reported in October 2001.
Preclinical studies have demonstrated that a combination of TA-HPV and TA-CIN results in an immune response that is significantly stronger than that observed in either product alone. The start of a Phase II combined `Prime- Boost` trial was announced in October 2001. In this open-label, physician- sponsored trial, primer followed by a booster dose are being given to up to 30 women with human papillomavirus associated conditions at 3 centres in the UK. Results of these trials are expected in the second half of 2002.
TA-CD -- TA-CD is a therapeutic vaccine which is under development for the treatment of cocaine addiction. The successful results of a four-dose Phase IIa trial for TA-CD were announced in July 2001, and showed TA-CD to be well tolerated and able to generate higher and earlier antibody titres than those seen in an earlier three-dose Phase I trial, potentially benefiting the patient by establishing a more rapid therapeutic effect. An attenuation of the usual euphoric effects of cocaine was reported amongst patients who admitted using cocaine during the study, providing anecdotal evidence of the benefit TA-CD may provide. It is expected that TA-CD will enter a new Phase II dose escalation study and a Phase II cocaine administration study, funded by the US National Institute on Drug Abuse, both of which are anticipated to begin in mid 2002.
TA-NIC -- TA-NIC is a therapeutic vaccine which is under development for the treatment of nicotine addiction. TA-NIC entered a Phase I study to assess the vaccine`s safety, tolerability and immunogenicity in September 2001. It is anticipated that preliminary results from this study will be available in the second half of 2002.
TA-HSV -- TA-HSV was under development for the treatment of genital herpes and utilized Xenova`s proprietary DISC technology. This technology involves disabling a herpes virus by removing a gene, allowing a single cycle of replication but preventing replicated viruses from spreading to other cells. The results of a Phase II clinical efficacy trial for the therapeutic vaccine, TA-HSV, which was conducted in collaboration with Xenova`s program partner, GlaxoSmithKline, were announced in October 2001. Analysis of the results showed that the trial did not meet its clinical endpoints. Further development of TA-HSV is not planned.
DISC-PRO -- DISC-PRO is a prophylactic vaccine which is in development for the prevention of oro-facial and genital herpes. During the course of a Phase I study, DISC-PRO was found to be well-tolerated and immunogenic. It is intended to seek a corporate partner for this program ahead of entering Phase III clinical trials.
DISC-GMCSF -- DISC-GMCSF is a gene therapy product which is being developed to enhance the immune response to tumours. Preclinical data relating to DISC-GMCSF were published in September 2001 and showed DISC-GMCSF to be safe with no adverse reactions reported. DISC-GMCSF is currently in a Phase I trial for patients with metastatic melanoma. Results of this trial are expected in the second half of 2002.
DISC-VET -- DISC-VET is a program to develop Xenova`s DISC technology for the treatment of animal disease and is applicable to multiple disease targets. DISC-BHV is a vaccine which is designed for the prevention of infectious bovine rhinotracheitis, an upper respiratory tract infection in cattle, caused by the bovine herpes virus. DISC-BHV has been shown to be safe and to offer protection against disease symptoms. Xenova`s partner, Pfizer Animal Health, entered DISC-BHV into development in January 2001.
Early Development Programs
PAI-1 Inhibitors (Anti-Thrombotic) -- Research continued throughout 2001 on this program, which is based on compounds from Xenova`s in-house research. These compounds are active in both venous and arterial models of thrombosis and are orally absorbed. A paper by Xenova, detailing the successful synthesis and biological activities of a series of inhibitors of PAI-1, based on a Xenova compound known as XR5118, was published in 2001 in the journal Biorganic and Medicinal Letters (2001; 11: 2589-2592). Xenova established a partnership with Lilly for this preclinical research area in February 1998.
PAI-1 Inhibitors (Anti-Cancer) -- Research is also continuing on this program in which Xenova is collaborating with the Institute of Cancer Research. PAI-1 has been shown to play a role in the spread of cancer. Papers published by Xenova in 2001 have shown that antibodies to PAI-1 alter the invasive and migratory properties of human cancer cells in vitro (Clinical and Experimental Metastasis, (2001; 18: 445-453)) and that low molecular weight inhibitors of PAI -1 suppress tumour cell invasion and angiogenesis in vitro and reduce tumour growth in vivo (Clinical Cancer Research (2001; 7 (Suppl): 3670)).
Multi-Drug Resistance Protein (MRP) -- Research continued during 2001 and Xenova has developed the assays needed to find a drug candidate for this program. It is expected that compounds will enter preclinical development during 2002. Like P-gp, MRP acts as a pump and expels small molecules such as cytotoxics from cells. Xenova is also exploring the potential application of MRP inhibitors in asthma.
OX40/OX40L -- OX40 and OX40L are a pair of interacting cell-surface proteins. A product candidate, OX40L, has shown efficacy in several disease models including cancer. Xenova`s partner, Celltech, is developing an antibody based product against OX40 for the treatment of autoimmune disease. A paper relating to the successful development of an immunoassay for OX40 was published by Xenova in 2001.
M3 -- Work is currently in progress with several preclinical models to evaluate the potential efficacy of M3, a virally-derived, broad-spectrum chemokine binding protein which has potential application in many disease areas, including cancer and immune-inflammatory disease.
MEN.B -- In collaboration with the Institute for Infections and Immunity at Nottingham University (UK), Xenova is developing a vaccine for the prevention of disease caused by infection with meningitis group B. The program is currently at the lead product evaluation stage.
VP22 -- VP22 is a transport protein which transports genes, proteins and certain classes of therapeutic small molecules, such as antisense drugs, into cells and which targets the delivery to the nucleus of cells. Xenova is currently investigating the potential of VP22 in drug delivery and gene therapy through Phogen, a 50/50 funded joint venture with Marie Curie Cancer Care.
In August 2001 Phogen signed a licensing agreement, potentially worth up to 15m pounds ($21m) in license, option and research payments, plus undisclosed royalties, with Genencor International, Inc for the application of VP22 technology to the development of a limited number of therapeutic vaccines for certain infectious viral diseases. In October 2001, Phogen signed a research collaboration agreement with Cell Genesys, Inc in the field of gene therapy and relating to products for cancer and cardiovascular disease. Management
As announced in October 2001, Commercial Director Nick Hart and Dr Stephen Inglis, Research Director, Biologics both resigned from the Board effective 31 December 2001. The Board thanks both Nick Hart and Stephen Inglis for their considerable contribution to the successful integration of Cantab with Xenova and wishes them well in their future careers. Patents
Xenova has received notification from the US Patent and Trademark Office Board of Patent Appeals and Interferences of the Board`s final decision in relation to an interference proceeding concerning two of Xenova`s granted US patents covering DISC virus vaccines. The Board`s final decision terminates the interference proceedings and leaves Xenova`s patents in force.
Financial Summary
Acquisition of Cantab Pharmaceuticals plc
On 6 April 2001, the Group announced the successful completion of the merger with Cantab. Xenova shares, issued as consideration to Cantab shareholders to acquire 100% of Cantab, were valued at 49p on 5 April 2001, valuing Cantab at 34.2m pounds ($49.9m). With 16.8m pounds ($24.5m) of cash and liquid resources, this effectively valued the technology and other assets in Cantab at 17.4m pounds ($25.4m).
In addition to acquiring Cantab Pharmaceuticals plc and its UK trading company Cantab Pharmaceuticals Research Limited, (now renamed Xenova Research Limited), the Group acquired as part of this transaction a 45% share in Phogen Limited, a joint venture company with Marie Curie Cancer Care. Operating Performance
The acquired Cantab business was consolidated into the Group`s results from 6 April 2001, and has contributed to a net loss per share of 13p, which compares with a net loss per share for 2000 of 15p.
In the year to 31 December 2001 the Group`s revenue, including that from the acquired Cantab business, increased to 1.8m pounds ($2.6m) (2000: 0.1m pounds, $0.1m). Revenues in the year include revenues derived from the new license agreement on XR9576/tariquidar with QLT (0.6m pounds ($0.9m)) and the completion of Phase II clinical trial work with GlaxoSmithKline in respect of the TA-HSV program (0.7m pounds ($1.1m)), which was terminated in December 2001. In accordance with the revenue recognition policy set out in Note 1, a further 6.3m pounds ($9.3m) of upfront license fees received from QLT in August 2001 and all of the 7.9m pounds ($11.5m) of upfront license fees received from Millennium in December 2001 have been deferred. The upfront license fees from QLT and Millennium are non-refundable.
Total research and development (R&D) expenditure of 15.4m pounds ($22.4m) (2000: 7.4m pounds, $10.8m) includes the preclinical development of the novel DNA-targeting agent program, which has been licensed to Millennium, the completion of Phase II clinical development of tariquidar, which has now been licensed to QLT and the expenditure in respect of the acquired Cantab business of 7.0m pounds ($10.2m).
Total administrative expenses of 4.9m pounds ($7.1m) have increased by 2.8m pounds ($4.1m) from the prior year primarily due to the remaining administrative costs associated with the acquired Cantab business of 1.0m pounds ($1.5m), exceptional reorganization costs of 1.0m pounds ($1.4m) and amortization costs of 0.9m pounds ($1.3m). These amortization costs relate to the amortization of goodwill arising upon acquisition of the Cantab business of 11.7m pounds ($17.1m), which is being amortized over the 10 year estimated useful life of the business.
Total net operating expenses for the second half of the year increased to 11.2m pounds ($16.3m), up from 8.9m pounds ($13.1m) in the first half year, following the inclusion of Cantab for the whole period and the impact of a reorganization and strategic review announced in June 2001.
The increased net interest income reflects the increased cash and liquid resources balance held throughout the period. Following the rise since 31 December 2000 in the listed market price of the 88,668 Cubist Pharmaceuticals shares held by the Group, 0.5m pounds ($0.7m) has been written back to the profit and loss account to recognize their year end market price. Reorganization
Since April 2001, the Group has consolidated all head office functions and administrative services in order to maximize the cost savings for the enlarged Group. Surplus building space has been and will continue to be sublet to minimize the Group`s ongoing commitments.
As part of the strategic review of both the research and development pipeline and other activities, announced on 21 June 2001, approximately 25% or 47 positions have been lost across both the head office and research and development functions. Included within the exceptional reorganization costs for the year is 1.0m pounds ($1.4m) comprising severance payments.
As a result of both integration measures already undertaken, excluding exceptional items and goodwill amortization, and cost reductions resulting from product partnering activities, the Group has made an estimated 6.2m pounds ($9.1m) in cost savings this year when compared to the costs of the separate Xenova and Cantab businesses in 2000. Cash and liquid resources
Cash and liquid resources at 31 December 2001 totaled 24.0m pounds ($35.0m) (2000: 12.2m pounds $17.9m). The Group had cash of 21.8m pounds ($31.9m) and liquid resources of 2.2m pounds ($3.2m) at 31 December 2001 (2000: cash 10.5m pounds ($15.3m), liquid resources 1.7m pounds ($2.5m)) following both exceptional facilities relocation expenditure of 2.7m pounds ($3.9m) and Cantab-related transaction costs paid of 1.8m pounds ($2.6m). Transaction costs paid by both Cantab and Xenova totaled 3.5m pounds ($5.1m)).
Included in liquid resources is an investment in Cubist which subsequent to the year end fell in value, following an announcement by Cubist of clinical trial data, such that at 17 January 2002 the share price was $17 valuing the investment held at 1.0m pounds, representing a decline from the valuation at 31 December 2001 of 1.2m pounds. Revenue recognition policy
In accordance with emerging best practice on revenue recognition, the Group has adopted a modified accounting policy from 1 January 2001, as set out in Note 1. This policy states that license fees and milestone payments will be spread over the life of the relevant agreement in proportion to the work performed by the Group, but be limited to the non refundable amounts actually received. Share capital
The number of shares in issue rose to 139.0 million as at 31 December 2001 from 69.2 million at 31 December 2000, due principally to the issue of 69.8 million shares in consideration for the Cantab business acquired.
A total of 11.8 million warrants, resulting from the July 2000 Placing and Open Offer, and exercisable at 85p up to 31 October 2001, were not exercised and so lapsed at that date.
The Directors do not propose a dividend for 2001 (2000: nil).
Notes to Editors
Xenova Group plc`s product pipeline focuses principally on the therapeutic areas of cancer and immune system disorders. Xenova currently has a broad pipeline of eight products in clinical development. Xenova`s lead program is a P-glycoprotein antagonist for the treatment of multi-drug resistance in cancer, known as tariquidar or XR9576. Tariquidar has completed a successful series of three Phase IIa clinical trials and is expected to enter Phase III clinical development in the first half of 2002. Tariquidar was partnered for the North American market with QLT Inc in August 2001. The Group has a well-established track record in the identification, development and partnering of innovative products and technologies and has partnerships with other major pharmaceutical companies including Lilly, Pfizer, Celltech and Millennium Pharmaceuticals.
For further information about Xenova and its products please visit the Xenova website at http://www.xenova.co.uk
For Xenova: Disclaimer to take advantage of the "Safe Harbor" provisions of the US Private Securities Litigation Reform Act of 1995. This press release contains "forward-looking statements," including statements about the discovery, development and commercialization of products. Various risks may cause Xenova`s actual results to differ materially from those expressed or implied by the forward looking statements, including: adverse results in our drug discovery and clinical development programs; failure to obtain patent protection for our discoveries; commercial limitations imposed by patents owned or controlled by third parties; our dependence upon strategic alliance partners to develop and commercialize products and services; difficulties or delays in obtaining regulatory approvals to market products and services resulting from our development efforts; the requirement for substantial funding to conduct research and development and to expand commercialization activities; and product initiatives by competitors. For a further list and description of the risks and uncertainties we face, see the reports we have filed with the Securities and Exchange Commission. We disclaim any intention or obligation to update or revise any forward-looking statements, whether as a result of new information, future events or otherwise.
Consolidated Profit and Loss Account (unaudited)
Unaudited Unaudited Unaudited Audited
Year Year Six months Year
Ended Ended Ended Ended
31 December 31 December 31 December 31 December
2001 2001 2001 2000
Notes $000 000 pounds 000 pounds 000 pounds
Turnover (including
share of joint
venture)
Continuing operations 1 842 577 577 78
Acquisitions 1,898 1,300 796
Less: share of joint
venture revenue (138) (95) (92) --
Turnover 2,602 1,782 1,281 78
Operating expenses
Research and
development costs
Continuing operations (12,264) (8,400) (4,621) (7,422)
Acquisitions (10,182) (6,974) (4,110) --
(22,446) (15,374) (8,731) (7,422)
Administrative expenses
Continuing operations (2,860) (1,959) (874) (2,033)
Continuing operations:
exceptional
reorganization costs (91) (62) -- --
(2,951) (2,021) (874) (2,033)
Acquisitions (1,463) (1,002) (742) --
Acquisitions:
exceptional
reorganization
costs 2 (1,421) (973) (377) --
Acquisitions: amortization
of goodwill 2 (1,283) (879) (586) --
(4,167) (2,854) (1,705) --
Total administrative
expenses (7,118) (4,875) (2,579) (2,033)
Other operating income -
acquisitions 168 115 115 --
Total net operating
expenses (29,396) (20,134) (11,195) (9,455)
Group operating loss
Continuing operations (14,372) (9,844) (4,918) (9,377)
Acquisitions (12,422) (8,508) (4,996) --
(26,794) (18,352) (9,914) (9,377)
Acquisitions: share
of operating loss of
joint venture (48) (33) (4) --
Total operating loss:
Group and share of (26,842) (18,385) (9,918) (9,377)
joint venture
Loss on sale of businesses:
Adjustment to consideration -- -- -- (1,279)
Loss on ordinary activities
before interest (26,842) (18,385) (9,918) (10,656)
Interest (net) 1,101 754 354 661
Amounts written back on/
(from) investments 3 676 463 (212) --
Loss on ordinary
activities
before taxation (25,065) (17,168) (9,776) (9,995)
Tax on loss on ordinary
activities 4 2,623 1,797 890 690
Loss on ordinary
activities after
taxation
attributable to
members of Xenova
Group plc (22,442) (15,371) (8,886) (9,305)
Loss per share (basic
and diluted) (18c) (13p) (6p) (15p)
Shares used in
computing net loss
per share
(thousands) 121,596 121,596 139,045 60,486
Statement of Total Recognized Gains and Losses (unaudited)
Unaudited Unaudited Unaudited Audited
Year Year Six Months Year
Ended Ended Ended Ended
31 December 31 December 31 December 31 December
2001 2001 2001 2000
$000 000 pounds 000 pounds 000 pounds
Loss attributable to
Xenova Group plc (22,398) (15,341) (8,885) (9,305)
Loss attributable to
joint venture (44) (30) (1) --
Total loss attributable
to members of Xenova
Group plc (22,442) (15,371) (8,886) (9,305)
Translation difference -- -- (2) 54
Total recognized gains
and losses in the
period attributable to
members of Xenova
Group plc (22,442) (15,371) (8,888) (9,251)
US Dollar amounts have been translated at the closing rate on 31 December 2001 (1.00 pounds: $1.46) solely for information.
Consolidated Balance Sheet (unaudited)
Unaudited Unaudited Unaudited Audited
As at As at As at As at
31 December 31 December 30 June 31 December
2001 2001 2001 2000
Notes $000 000 pounds 000 pounds 000 pounds
Fixed assets
Intangible assets 2 15,765 10,798 11,379 --
Tangible assets 13,996 9,586 9,880 543
29,761 20,384 21,259 543
Current assets
Debtors:
Due within one year 6,037 4,135 5,552 1,510
6,037 4,135 5,552 1,510
Investments 3 3,189 2,184 2,396 1,721
Cash at bank and
in hand 31,851 21,816 15,676 10,512
41,077 28,135 23,624 13,743
Creditors: amounts
falling due within
one year 7 (26,893) (18,420) (5,703) (2,390)
Net current assets 14,184 9,715 17,921 11,353
Total assets less
current liabilities 43,945 30,099 39,180 11,896
Creditors: amounts
falling due after
more than (323) (221) (367) --
one year
Provisions for
liabilities and
charges (15) (10) (25) (20)
Investment in joint venture:
Share of gross assets 639 438 40 --
Share of gross
liabilities (730) (500) (101) --
Goodwill arising on
acquisition 44 30 32 --
(47) (32) (29) --
Total net assets 43,560 29,836 38,759 11,876
Capital and reserves
Called up share capital 20,300 13,904 13,062 6,924
Shares to be issued -- -- 4,127 --
Share premium account 107,850 73,870 73,925 74,781
Merger reserve 39,738 27,218 23,933 --
Other reserves 26,137 17,902 17,902 17,902
Profit and loss
account (150,465) (103,058) (94,190) (87,731)
Shareholders` funds -
equity interests 5 43,560 29,836 38,759 11,876
US Dollar amounts have been translated at the closing rate on 31 December 2001 (1.00 pounds: $1.46) solely for information.
Consolidated Cash Flow Statement (unaudited)
Unaudited Unaudited Unaudited Audited
Year Year Six months Year
Ended Ended Ended Ended
31 December 31 December 31 December 31 December
2001 2001 2001 2000
Notes $000 000 pounds 000 pounds 000 pounds
Net cash outflow/
(inflow) from
operating 6 (5,600) (3,836) 4,308 (9,354)
Activities
Returns on investments
and servicing of
Finance
Interest received 1,494 1,023 647 606
Interest element of
finance lease rental
payments (22) (15) (10) --
Net cash inflow from
returns on
investments and servicing
of finance 1,472 1,008 637 606
Taxation 2,730 1,870 1,870 --
Capital expenditure
and financial
investment
Purchase of tangible
fixed assets (4,084) (2,797) (573) (303)
Net cash outflow from
capital expenditure
and financial
investment (4,084) (2,797) (573) (303)
Acquisitions and disposals
Purchase of subsidiary
undertakings (1,121) (768) -- --
Cash at bank and in
hand acquired with
subsidiary 24,560 16,822 -- --
Net cash inflow for
acquisitions 23,439 16,054 -- --
Management of liquid resources
Net sale of Investments -- -- -- 514
Net cash inflow/(outflow)
before financing 17,957 12,299 6,242 (8,537)
Financing
Issue of ordinary
share capital 13 9 -- 10,252
Expenses on issue of
shares (1,342) (919) (55) (772)
Capital element of
finance lease rental
payments (127) (87) (47) --
Net cash (outflow)/inflow
from financing (1,456) (997) (102) 9,480
Increase in cash during
the period 16,501 11,302 6,140 943
US Dollar amounts have been translated at the closing rate on 31 December 2001 (1.00 pounds: $1.46) solely for information.
Reconciliation of Net Cash Flow to Movement in Net Funds (unaudited)
Unaudited Unaudited Unaudited Audited
Year Year Six Months Year
Ended Ended Ended Ended
31 December 31 December 31 December 31 December
2001 2001 2001 2000
$000 000 pounds 000 pounds 000 pounds
Increase in cash
during the period 16,501 11,302 6,140 943
Capital element of
finance lease
payments 127 87 47 --
Change in liquid
resources -- -- -- (514)
Change in net funds
resulting from
cash flows 16,628 11,389 6,187 429
Finance leases acquired
with subsidiary
operations (148) (101) -- --
Movement in value of
liquid investments 676 463 (212) 1,721
Translation difference 3 2 -- 2
Change in net funds 17,159 11,753 5,975 2,152
Net funds at
1 January/30 June 17,860 12,233 18,011 10,081
Net funds at
31 December 35,019 23,986 23,986 12,233
US Dollar amounts have been translated at the closing rate on 31 December 2001 (1.00 pounds: $1.46) solely for information.
Notes to the Preliminary Announcement
1 Basis of preparation
These unaudited statements, which do not constitute statutory accounts
within the meaning of Section 240 of the Companies Act 1985, have been
prepared using the accounting policies set out in the Group`s 2000 Annual
Report and Accounts except as set out below. The 2000 Annual Report and
Accounts received an unqualified auditor`s report and have been delivered to
the Registrar of Companies.
Following the introduction of Financial Reporting Standard 18 -- `Accounting policies` (FRS18), a review of the Group`s accounting policies has been performed and will continue to be performed on a regular basis. As a result of this review, other than as noted below, there have been no changes to the Group`s accounting policies in 2001.
These consolidated financial statements have been prepared to include the revenues, costs and cash flows of the Cantab Pharmaceuticals Plc (`Cantab`) group from 6 April 2001, using acquisition accounting principles (Note 2).
Following the acquisition of Cantab the Group has adopted the following accounting policy in respect of intangible fixed assets. Goodwill arising from the purchase of subsidiary undertakings, representing the difference between the fair value of the purchase consideration and the fair value of the net assets acquired, is capitalized as an intangible asset and amortized on a straight line basis over its estimated useful economic life. Goodwill similarly arising on the acquisition of associates or joint ventures is recorded as part of the related investment.
Other intangible fixed assets, including acquired intellectual property, are capitalized at cost and amortized on a straight line basis over the estimated useful economic life of the asset, having taken into account the risk factors associated with developing a pharmaceutical product.
In accordance with emerging best practice on revenue recognition, the Group has adopted a modified accounting policy from 1 January 2001. This policy states that license fees and milestone payments are spread over the life of the relevant agreement in proportion to the work performed by the Group, but is limited to the non refundable amounts received. The estimation techniques used to spread the revenue reflect both the scientific and commercial risks of individual contracts. Ordinarily, revenue is spread using a technique, which first adjusts the total contract revenue based upon the estimated probability of receipt given the commercial nature and scientific stage of development of the program. In limited cases, revenue in respect of contracts deemed to be of higher scientific or commercial risk is spread using a contingency adjusted technique to reflect the increased uncertainty of future receipts. The revenue recognized in 2000, under the former policy of recognizing such payments in full on receipt, would not have been materially different under the revised accounting policy adopted from 2001.
2 Acquisition of Cantab Pharmaceuticals plc group
On 6 April 2001 the Group announced the merger with Cantab. Under the
terms of the offer made to Cantab shareholders, 11 shares in Xenova Group plc
have been issued in exchange for 7 shares held in Cantab, valuing Cantab on 5
April 2001 at 34.2m pounds based upon a closing Xenova Group Plc share price
of 49p.
Details of the book value and provisional fair value of the assets and liabilities of Cantab as at 6 April 2001 are set out below:
Book values Adjustments Fair values
000 pounds 000 pounds 000 pounds
Fixed assets
Tangible 7,463 -- 7,463
Intangible 1,415 (1,415) --
Debtors 3,686 -- 3,686
Cash and liquid investments 16,822 -- 16,822
Creditors falling due
within one year (4,243) -- (4,243)
Creditors falling due after
more than one year (438) -- (438)
Investment in joint venture -
share of gross liabilities (32) -- (32)
Net assets acquired 24,673 (1,415) 23,258
Satisfied by:
Shares issued and to be issued 34,197
Expenses of acquisition 768
Total consideration 34,965
Goodwill arising on acquisition 11,707
There have been no accounting policy adjustments made to the balance sheet values stated at 6 April 2001. Intangible assets acquired comprised license fees which have not been capitalized separately from goodwill. In addition to the 768,000 pounds of acquisition expenses paid, share issue costs of 919,000 pounds were incurred. In accordance with the accounting policy set out in the basis of preparation note, the goodwill arising on the acquisition has been capitalized and amortized over the 10 year estimated useful life of the acquired business.
In addition to acquiring 100% of Cantab Pharmaceuticals plc and the UK trading company Cantab Research Limited (now renamed Xenova Research Limited), the Group acquired as part of this transaction, a 45% share in Phogen, a joint venture with Marie Curie Cancer Cure.
As part of the strategic review of both the research and development pipeline and other activities, announced on 21 June 2001, approximately 25% or 47 positions have been lost across both the head office and research and development functions. Included within the administrative expenses is 1.0m pounds in respect of the severance payments.
The audited consolidated results of the Cantab Pharmaceuticals plc group for the year ended 31 December 2000, including the Group`s share of Phogen, included revenues of 8,403,000 pounds, an operating loss of 6,452,000 pounds and a net loss of 3,913,000 pounds. Consolidated net assets of the Cantab group at 31 December 2000 stood at 28,374,000 pounds of which 15,257,000 pounds comprised cash and liquid resources.
3 Amounts written back on investments
The 463,000 pounds written back on investments reflects the unrealized
gain on the Group`s holding of 88,668 Cubist Pharmaceutical shares following
a rise in the listed market price since 31 December 2000 (Note 9).
4 Taxation
Following the changes introduced as part of the Finance Act 2000 in
respect of Scientific Research Allowances (now renamed `Research and
Development Allowances`), the Group has recognized an R&D tax credit of
2,292,000 pounds in respect of the year that will be received in 2002 (2001:
1,879,000 pounds).
5 Reconciliation of movement in shareholders` funds
Unaudited Unaudited Audited
Year Six Months Year
Ended Ended Ended
31 December 31 December 31 December
2001 2001 2000
000 pounds 000 pounds 000 pounds
At start of period 11,876 38,759 11,620
Allotments of shares
in the period 9 -- 10,252
Issue of shares in respect
of acquisition 34,197 4,127 --
Shares to be issued -- (4,127) --
Expenses on issue of shares (919) (55) (772)
Shares to be issued under
long term incentive
Scheme 44 20 27
Retained loss for
the period (15,371) (8,886) (9,305)
Exchange movement -- (2) 54
At end of period 29,836 29,836 11,876
6 Reconciliation of operating loss to net cash outflow from
operating activities
Unaudited Unaudited Audited
Year Six Months Year
Ended Ended Ended
31 December 31 December 31 December
2001 2001 2000
000 pounds 000 pounds 000 pounds
Group operating loss (18,352) (9,914) (9,377)
Depreciation and amortization 2,080 1,278 212
Provision for liabilities
and charges (10) (15) 20
Loss on disposal of tangible
fixed assets 16 16 --
Decrease / (increase) in debtors 734 154 (253)
(Decrease)/Increase in
creditors (excluding
deferred income) (2,573) (1,456) 17
Increase in deferred income 14,225 14,225 --
Charge for long term
incentive scheme 44 20 27
Net cash outflow from
operating activities (3,836) 4,308 (9,354)
Cash outflow in respect of exceptional reorganization costs was 1,035,000 pounds (2000: Nil)
7 Creditors
Included within creditors is 14.2m pounds (2000: Nil) in respect of
deferred revenue.
8 Going concern
The Group is an emerging pharmaceutical business and as such expects to
absorb cash until products are commercialized. The Directors have a
reasonable expectation that the Group has, or can reasonably expect to
obtain, adequate cash resources to enable it to continue in operational
existence for the foreseeable future, and have therefore prepared the
financial statements on the going concern basis.
9 Subsequent events
Included in liquid resources is an investment in Cubist which subsequent
to the year end fell in value, following an announcement by Cubist of
clinical trial data, such that at 17 January 2002 the share price was $17
valuing the investment held at 1.0m pounds, representing a decline from the
valuation at 31 December 2001 of 1.2m pounds.
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/CONTACT: UK: David A Oxlade, Chief Executive Officer, or Daniel Abrams, Group Finance Director, or Hilary Reid Evans, Corporate Communications, all of Xenova Group plc, +44-1753-706600; or David Yates or Fiona Noblet, both of Financial Dynamics, +44-207-831-3113; or US: Media - Brad Miles, ext. 17 or Lauren Tortorete, ext. 20, or Investors - Jonathan Fassberg, ext. 16, or Lee Stern, ext. 22, all of Trout Group-BMC Communications, +1-212-477-9007, for Xenova plc/
SLOUGH, England, Feb. 19 /PRNewswire-FirstCall/ -- Xenova Group plc (Nasdaq: XNVA; London Stock Exchange: XEN) today announces its results for the year to 31 December 2001.
Highlights
* North American collaboration with QLT Inc for P-gp inhibitor XR9576
(tariquidar) worth 71.9m pounds sterling (pounds) (US$105m) including
milestones, excluding royalties
* 7.9m pounds (US$11.5m) upfront payment plus milestones and royalties
from North American licensing deal with Millennium Pharmaceuticals,
Inc for novel DNA targeting agent program
* Collaborations by joint venture Phogen with Genencor (up to
15m pounds (US$21m)) and Cell Genesys (undisclosed) for VP22
technology
* Start of combined `Prime-Boost` Phase II trials for cancer program
vaccines TA-CIN and TA-HPV
* Anti-nicotine addiction vaccine TA-NIC entry to Phase I
clinical trials
* Merger with Cantab completed April 2001
Financial Highlights
* Cash and liquid resources at 31 December 2001 24.0m pounds
(2000: 12.2m pounds)
* Cash received of 14.8m pounds from new licensing deals
* Significant cost savings post Cantab merger
Commenting, David Oxlade, Chief Executive Officer of Xenova Group plc said: "2001 was a year of major change and substantial progress for Xenova. The integration of Cantab with Xenova was successfully accomplished and has resulted in a company with a broad cancer-focused pipeline of early to late stage products, a streamlined cost base and a strong list of collaborative partners, to which we were delighted to add QLT and Millennium during the course of the year. Xenova enters 2002 soundly financed, broadly based and confident of further good progress during the year."
Chief Executive`s Review
Following the merger with Cantab, Xenova has focused its resources on the discovery and development of commercially attractive, novel small molecule and biologic drug candidates, primarily in the therapeutic areas of cancer and immune disease.
Product Development
Drug Candidates
XR9576 (tariquidar) -- Xenova`s P-glycoprotein modulator, which targets
the reversal of multi-drug resistance in cancer, completed a series of three
open label Phase IIa clinical trials in early 2001. The successful results
of a trial in which XR9576 was given with doxorubicin were reported in late
2000. The results of two other Phase IIa trials, in which XR9576 was given
with paclitaxel or vinorelbine (two widely used cytotoxic drugs), were
reported in May at the annual meeting of the American Society of Clinical
Oncology and showed that XR9576 was well tolerated and that it is a potent
P-glycoprotein antagonist. These trials also confirmed that, at the dose
levels studied, no clinically significant pharmacokinetic interaction was
observed, that the administration of XR5976 with paclitaxel, vinorelbine and
doxorubicin was well tolerated and that the cytotoxics can be used in
combination with XR9576 at, or close to their normal clinical dose. Positive
responses, which were noted in several of the patients in the studies,
provided anecdotal evidence of efficacy.
In August Xenova announced the signing of an exclusive license agreement with QLT Inc for the development and marketing of XR9576 in the United States, Canada and Mexico. Under the terms of this agreement, QLT has assumed responsibility for the further development of XR9576, including Phase III trials, all regulatory filings and the manufacture and sale of XR9576 within those territories covered by the agreement. QLT made an immediate upfront license payment to Xenova of US$10m (6.9m pounds) and will provide up to $45m (30.8m pounds) in funding for development activities related to Phase III clinical studies for XR9576 in North America and Europe. Milestones of up to US$50m (34.2m pounds) and royalties in the range of 15 to 22 per cent depending on the level of North American sales are also receivable by Xenova.
Xenova retains substantially all rights to XR9576 outside the United States, Canada and Mexico, including European and Rest of World marketing rights.
FDA permission has been obtained to proceed with Phase III clinical trials and it is anticipated that these trials will begin in mid 2002.
XR11576 (MLN576) -- Along with compounds XR5944 and XR11612, XR11576 forms part of Xenova`s program of novel DNA targeting agents, whose method of action involves dual inhibition of topoisomerases I and II. The program is being developed for the treatment of solid tumours in cancer. XR11576 is an oral agent, which completed pharmacological and toxicity testing during 2001 prior to entry into Phase I clinical development. Patient dosing for an open label, Phase I trial, which is being carried out at centres in the UK and the Netherlands, began in February 2002. Like XR11576, XR11612 is orally bioavailable and has shown increased potency in preclinical trials. It is being developed as a back-up compound to XR11576. XR5944 has shown exceptionally high potency as a cytotoxic in preclinical studies with a number of cell lines and xenograft models. XR5944 is an intravenous agent which is structurally distinct from XR11576, and has been shown to be unaffected by atypical multi-drug resistance. All three compounds are the product of Xenova`s in-house research and development.
It was announced in December 2001 that Xenova has entered into a license agreement with Millennium Pharmaceuticals Inc for the development and North American commercialization of these novel compounds. Under the terms of the agreement, Millennium has acquired development and exclusive marketing rights to the program in North America, in exchange for an upfront payment of US$11.5m (7.9m pounds) as well as future milestone payments and royalties following the achievement of specific development and sales goals. Xenova continues to have responsibility for performing development activities associated with the program to the end of Phase II trials, which will be funded by Millennium from 2003. Following completion of Phase II trials, Millennium will assume responsibility for the program`s further development and commercialization in North America, while Xenova has responsibility for its further development and commercialization rights in Europe and the Rest of the World.
TA-HPV and TA-CIN -- TA-HPV is a vaccinia viral vector, carrying human papillomavirus genes, which is being developed to treat cervical cancer. A series of Phase II trials is currently underway and the results of one of these were reported in September 2001. In this trial forty-four per cent of patients were judged to show an objective clinical response at six months and a further twenty-two per cent showed significant symptom relief.
TA-CIN is a therapeutic vaccine which is being developed for the treatment of cervical intraepithelial neoplasia. The successful results of a Phase I safety and immunogenicity study were reported in October 2001.
Preclinical studies have demonstrated that a combination of TA-HPV and TA-CIN results in an immune response that is significantly stronger than that observed in either product alone. The start of a Phase II combined `Prime- Boost` trial was announced in October 2001. In this open-label, physician- sponsored trial, primer followed by a booster dose are being given to up to 30 women with human papillomavirus associated conditions at 3 centres in the UK. Results of these trials are expected in the second half of 2002.
TA-CD -- TA-CD is a therapeutic vaccine which is under development for the treatment of cocaine addiction. The successful results of a four-dose Phase IIa trial for TA-CD were announced in July 2001, and showed TA-CD to be well tolerated and able to generate higher and earlier antibody titres than those seen in an earlier three-dose Phase I trial, potentially benefiting the patient by establishing a more rapid therapeutic effect. An attenuation of the usual euphoric effects of cocaine was reported amongst patients who admitted using cocaine during the study, providing anecdotal evidence of the benefit TA-CD may provide. It is expected that TA-CD will enter a new Phase II dose escalation study and a Phase II cocaine administration study, funded by the US National Institute on Drug Abuse, both of which are anticipated to begin in mid 2002.
TA-NIC -- TA-NIC is a therapeutic vaccine which is under development for the treatment of nicotine addiction. TA-NIC entered a Phase I study to assess the vaccine`s safety, tolerability and immunogenicity in September 2001. It is anticipated that preliminary results from this study will be available in the second half of 2002.
TA-HSV -- TA-HSV was under development for the treatment of genital herpes and utilized Xenova`s proprietary DISC technology. This technology involves disabling a herpes virus by removing a gene, allowing a single cycle of replication but preventing replicated viruses from spreading to other cells. The results of a Phase II clinical efficacy trial for the therapeutic vaccine, TA-HSV, which was conducted in collaboration with Xenova`s program partner, GlaxoSmithKline, were announced in October 2001. Analysis of the results showed that the trial did not meet its clinical endpoints. Further development of TA-HSV is not planned.
DISC-PRO -- DISC-PRO is a prophylactic vaccine which is in development for the prevention of oro-facial and genital herpes. During the course of a Phase I study, DISC-PRO was found to be well-tolerated and immunogenic. It is intended to seek a corporate partner for this program ahead of entering Phase III clinical trials.
DISC-GMCSF -- DISC-GMCSF is a gene therapy product which is being developed to enhance the immune response to tumours. Preclinical data relating to DISC-GMCSF were published in September 2001 and showed DISC-GMCSF to be safe with no adverse reactions reported. DISC-GMCSF is currently in a Phase I trial for patients with metastatic melanoma. Results of this trial are expected in the second half of 2002.
DISC-VET -- DISC-VET is a program to develop Xenova`s DISC technology for the treatment of animal disease and is applicable to multiple disease targets. DISC-BHV is a vaccine which is designed for the prevention of infectious bovine rhinotracheitis, an upper respiratory tract infection in cattle, caused by the bovine herpes virus. DISC-BHV has been shown to be safe and to offer protection against disease symptoms. Xenova`s partner, Pfizer Animal Health, entered DISC-BHV into development in January 2001.
Early Development Programs
PAI-1 Inhibitors (Anti-Thrombotic) -- Research continued throughout 2001 on this program, which is based on compounds from Xenova`s in-house research. These compounds are active in both venous and arterial models of thrombosis and are orally absorbed. A paper by Xenova, detailing the successful synthesis and biological activities of a series of inhibitors of PAI-1, based on a Xenova compound known as XR5118, was published in 2001 in the journal Biorganic and Medicinal Letters (2001; 11: 2589-2592). Xenova established a partnership with Lilly for this preclinical research area in February 1998.
PAI-1 Inhibitors (Anti-Cancer) -- Research is also continuing on this program in which Xenova is collaborating with the Institute of Cancer Research. PAI-1 has been shown to play a role in the spread of cancer. Papers published by Xenova in 2001 have shown that antibodies to PAI-1 alter the invasive and migratory properties of human cancer cells in vitro (Clinical and Experimental Metastasis, (2001; 18: 445-453)) and that low molecular weight inhibitors of PAI -1 suppress tumour cell invasion and angiogenesis in vitro and reduce tumour growth in vivo (Clinical Cancer Research (2001; 7 (Suppl): 3670)).
Multi-Drug Resistance Protein (MRP) -- Research continued during 2001 and Xenova has developed the assays needed to find a drug candidate for this program. It is expected that compounds will enter preclinical development during 2002. Like P-gp, MRP acts as a pump and expels small molecules such as cytotoxics from cells. Xenova is also exploring the potential application of MRP inhibitors in asthma.
OX40/OX40L -- OX40 and OX40L are a pair of interacting cell-surface proteins. A product candidate, OX40L, has shown efficacy in several disease models including cancer. Xenova`s partner, Celltech, is developing an antibody based product against OX40 for the treatment of autoimmune disease. A paper relating to the successful development of an immunoassay for OX40 was published by Xenova in 2001.
M3 -- Work is currently in progress with several preclinical models to evaluate the potential efficacy of M3, a virally-derived, broad-spectrum chemokine binding protein which has potential application in many disease areas, including cancer and immune-inflammatory disease.
MEN.B -- In collaboration with the Institute for Infections and Immunity at Nottingham University (UK), Xenova is developing a vaccine for the prevention of disease caused by infection with meningitis group B. The program is currently at the lead product evaluation stage.
VP22 -- VP22 is a transport protein which transports genes, proteins and certain classes of therapeutic small molecules, such as antisense drugs, into cells and which targets the delivery to the nucleus of cells. Xenova is currently investigating the potential of VP22 in drug delivery and gene therapy through Phogen, a 50/50 funded joint venture with Marie Curie Cancer Care.
In August 2001 Phogen signed a licensing agreement, potentially worth up to 15m pounds ($21m) in license, option and research payments, plus undisclosed royalties, with Genencor International, Inc for the application of VP22 technology to the development of a limited number of therapeutic vaccines for certain infectious viral diseases. In October 2001, Phogen signed a research collaboration agreement with Cell Genesys, Inc in the field of gene therapy and relating to products for cancer and cardiovascular disease. Management
As announced in October 2001, Commercial Director Nick Hart and Dr Stephen Inglis, Research Director, Biologics both resigned from the Board effective 31 December 2001. The Board thanks both Nick Hart and Stephen Inglis for their considerable contribution to the successful integration of Cantab with Xenova and wishes them well in their future careers. Patents
Xenova has received notification from the US Patent and Trademark Office Board of Patent Appeals and Interferences of the Board`s final decision in relation to an interference proceeding concerning two of Xenova`s granted US patents covering DISC virus vaccines. The Board`s final decision terminates the interference proceedings and leaves Xenova`s patents in force.
Financial Summary
Acquisition of Cantab Pharmaceuticals plc
On 6 April 2001, the Group announced the successful completion of the merger with Cantab. Xenova shares, issued as consideration to Cantab shareholders to acquire 100% of Cantab, were valued at 49p on 5 April 2001, valuing Cantab at 34.2m pounds ($49.9m). With 16.8m pounds ($24.5m) of cash and liquid resources, this effectively valued the technology and other assets in Cantab at 17.4m pounds ($25.4m).
In addition to acquiring Cantab Pharmaceuticals plc and its UK trading company Cantab Pharmaceuticals Research Limited, (now renamed Xenova Research Limited), the Group acquired as part of this transaction a 45% share in Phogen Limited, a joint venture company with Marie Curie Cancer Care. Operating Performance
The acquired Cantab business was consolidated into the Group`s results from 6 April 2001, and has contributed to a net loss per share of 13p, which compares with a net loss per share for 2000 of 15p.
In the year to 31 December 2001 the Group`s revenue, including that from the acquired Cantab business, increased to 1.8m pounds ($2.6m) (2000: 0.1m pounds, $0.1m). Revenues in the year include revenues derived from the new license agreement on XR9576/tariquidar with QLT (0.6m pounds ($0.9m)) and the completion of Phase II clinical trial work with GlaxoSmithKline in respect of the TA-HSV program (0.7m pounds ($1.1m)), which was terminated in December 2001. In accordance with the revenue recognition policy set out in Note 1, a further 6.3m pounds ($9.3m) of upfront license fees received from QLT in August 2001 and all of the 7.9m pounds ($11.5m) of upfront license fees received from Millennium in December 2001 have been deferred. The upfront license fees from QLT and Millennium are non-refundable.
Total research and development (R&D) expenditure of 15.4m pounds ($22.4m) (2000: 7.4m pounds, $10.8m) includes the preclinical development of the novel DNA-targeting agent program, which has been licensed to Millennium, the completion of Phase II clinical development of tariquidar, which has now been licensed to QLT and the expenditure in respect of the acquired Cantab business of 7.0m pounds ($10.2m).
Total administrative expenses of 4.9m pounds ($7.1m) have increased by 2.8m pounds ($4.1m) from the prior year primarily due to the remaining administrative costs associated with the acquired Cantab business of 1.0m pounds ($1.5m), exceptional reorganization costs of 1.0m pounds ($1.4m) and amortization costs of 0.9m pounds ($1.3m). These amortization costs relate to the amortization of goodwill arising upon acquisition of the Cantab business of 11.7m pounds ($17.1m), which is being amortized over the 10 year estimated useful life of the business.
Total net operating expenses for the second half of the year increased to 11.2m pounds ($16.3m), up from 8.9m pounds ($13.1m) in the first half year, following the inclusion of Cantab for the whole period and the impact of a reorganization and strategic review announced in June 2001.
The increased net interest income reflects the increased cash and liquid resources balance held throughout the period. Following the rise since 31 December 2000 in the listed market price of the 88,668 Cubist Pharmaceuticals shares held by the Group, 0.5m pounds ($0.7m) has been written back to the profit and loss account to recognize their year end market price. Reorganization
Since April 2001, the Group has consolidated all head office functions and administrative services in order to maximize the cost savings for the enlarged Group. Surplus building space has been and will continue to be sublet to minimize the Group`s ongoing commitments.
As part of the strategic review of both the research and development pipeline and other activities, announced on 21 June 2001, approximately 25% or 47 positions have been lost across both the head office and research and development functions. Included within the exceptional reorganization costs for the year is 1.0m pounds ($1.4m) comprising severance payments.
As a result of both integration measures already undertaken, excluding exceptional items and goodwill amortization, and cost reductions resulting from product partnering activities, the Group has made an estimated 6.2m pounds ($9.1m) in cost savings this year when compared to the costs of the separate Xenova and Cantab businesses in 2000. Cash and liquid resources
Cash and liquid resources at 31 December 2001 totaled 24.0m pounds ($35.0m) (2000: 12.2m pounds $17.9m). The Group had cash of 21.8m pounds ($31.9m) and liquid resources of 2.2m pounds ($3.2m) at 31 December 2001 (2000: cash 10.5m pounds ($15.3m), liquid resources 1.7m pounds ($2.5m)) following both exceptional facilities relocation expenditure of 2.7m pounds ($3.9m) and Cantab-related transaction costs paid of 1.8m pounds ($2.6m). Transaction costs paid by both Cantab and Xenova totaled 3.5m pounds ($5.1m)).
Included in liquid resources is an investment in Cubist which subsequent to the year end fell in value, following an announcement by Cubist of clinical trial data, such that at 17 January 2002 the share price was $17 valuing the investment held at 1.0m pounds, representing a decline from the valuation at 31 December 2001 of 1.2m pounds. Revenue recognition policy
In accordance with emerging best practice on revenue recognition, the Group has adopted a modified accounting policy from 1 January 2001, as set out in Note 1. This policy states that license fees and milestone payments will be spread over the life of the relevant agreement in proportion to the work performed by the Group, but be limited to the non refundable amounts actually received. Share capital
The number of shares in issue rose to 139.0 million as at 31 December 2001 from 69.2 million at 31 December 2000, due principally to the issue of 69.8 million shares in consideration for the Cantab business acquired.
A total of 11.8 million warrants, resulting from the July 2000 Placing and Open Offer, and exercisable at 85p up to 31 October 2001, were not exercised and so lapsed at that date.
The Directors do not propose a dividend for 2001 (2000: nil).
Notes to Editors
Xenova Group plc`s product pipeline focuses principally on the therapeutic areas of cancer and immune system disorders. Xenova currently has a broad pipeline of eight products in clinical development. Xenova`s lead program is a P-glycoprotein antagonist for the treatment of multi-drug resistance in cancer, known as tariquidar or XR9576. Tariquidar has completed a successful series of three Phase IIa clinical trials and is expected to enter Phase III clinical development in the first half of 2002. Tariquidar was partnered for the North American market with QLT Inc in August 2001. The Group has a well-established track record in the identification, development and partnering of innovative products and technologies and has partnerships with other major pharmaceutical companies including Lilly, Pfizer, Celltech and Millennium Pharmaceuticals.
For further information about Xenova and its products please visit the Xenova website at http://www.xenova.co.uk
For Xenova: Disclaimer to take advantage of the "Safe Harbor" provisions of the US Private Securities Litigation Reform Act of 1995. This press release contains "forward-looking statements," including statements about the discovery, development and commercialization of products. Various risks may cause Xenova`s actual results to differ materially from those expressed or implied by the forward looking statements, including: adverse results in our drug discovery and clinical development programs; failure to obtain patent protection for our discoveries; commercial limitations imposed by patents owned or controlled by third parties; our dependence upon strategic alliance partners to develop and commercialize products and services; difficulties or delays in obtaining regulatory approvals to market products and services resulting from our development efforts; the requirement for substantial funding to conduct research and development and to expand commercialization activities; and product initiatives by competitors. For a further list and description of the risks and uncertainties we face, see the reports we have filed with the Securities and Exchange Commission. We disclaim any intention or obligation to update or revise any forward-looking statements, whether as a result of new information, future events or otherwise.
Consolidated Profit and Loss Account (unaudited)
Unaudited Unaudited Unaudited Audited
Year Year Six months Year
Ended Ended Ended Ended
31 December 31 December 31 December 31 December
2001 2001 2001 2000
Notes $000 000 pounds 000 pounds 000 pounds
Turnover (including
share of joint
venture)
Continuing operations 1 842 577 577 78
Acquisitions 1,898 1,300 796
Less: share of joint
venture revenue (138) (95) (92) --
Turnover 2,602 1,782 1,281 78
Operating expenses
Research and
development costs
Continuing operations (12,264) (8,400) (4,621) (7,422)
Acquisitions (10,182) (6,974) (4,110) --
(22,446) (15,374) (8,731) (7,422)
Administrative expenses
Continuing operations (2,860) (1,959) (874) (2,033)
Continuing operations:
exceptional
reorganization costs (91) (62) -- --
(2,951) (2,021) (874) (2,033)
Acquisitions (1,463) (1,002) (742) --
Acquisitions:
exceptional
reorganization
costs 2 (1,421) (973) (377) --
Acquisitions: amortization
of goodwill 2 (1,283) (879) (586) --
(4,167) (2,854) (1,705) --
Total administrative
expenses (7,118) (4,875) (2,579) (2,033)
Other operating income -
acquisitions 168 115 115 --
Total net operating
expenses (29,396) (20,134) (11,195) (9,455)
Group operating loss
Continuing operations (14,372) (9,844) (4,918) (9,377)
Acquisitions (12,422) (8,508) (4,996) --
(26,794) (18,352) (9,914) (9,377)
Acquisitions: share
of operating loss of
joint venture (48) (33) (4) --
Total operating loss:
Group and share of (26,842) (18,385) (9,918) (9,377)
joint venture
Loss on sale of businesses:
Adjustment to consideration -- -- -- (1,279)
Loss on ordinary activities
before interest (26,842) (18,385) (9,918) (10,656)
Interest (net) 1,101 754 354 661
Amounts written back on/
(from) investments 3 676 463 (212) --
Loss on ordinary
activities
before taxation (25,065) (17,168) (9,776) (9,995)
Tax on loss on ordinary
activities 4 2,623 1,797 890 690
Loss on ordinary
activities after
taxation
attributable to
members of Xenova
Group plc (22,442) (15,371) (8,886) (9,305)
Loss per share (basic
and diluted) (18c) (13p) (6p) (15p)
Shares used in
computing net loss
per share
(thousands) 121,596 121,596 139,045 60,486
Statement of Total Recognized Gains and Losses (unaudited)
Unaudited Unaudited Unaudited Audited
Year Year Six Months Year
Ended Ended Ended Ended
31 December 31 December 31 December 31 December
2001 2001 2001 2000
$000 000 pounds 000 pounds 000 pounds
Loss attributable to
Xenova Group plc (22,398) (15,341) (8,885) (9,305)
Loss attributable to
joint venture (44) (30) (1) --
Total loss attributable
to members of Xenova
Group plc (22,442) (15,371) (8,886) (9,305)
Translation difference -- -- (2) 54
Total recognized gains
and losses in the
period attributable to
members of Xenova
Group plc (22,442) (15,371) (8,888) (9,251)
US Dollar amounts have been translated at the closing rate on 31 December 2001 (1.00 pounds: $1.46) solely for information.
Consolidated Balance Sheet (unaudited)
Unaudited Unaudited Unaudited Audited
As at As at As at As at
31 December 31 December 30 June 31 December
2001 2001 2001 2000
Notes $000 000 pounds 000 pounds 000 pounds
Fixed assets
Intangible assets 2 15,765 10,798 11,379 --
Tangible assets 13,996 9,586 9,880 543
29,761 20,384 21,259 543
Current assets
Debtors:
Due within one year 6,037 4,135 5,552 1,510
6,037 4,135 5,552 1,510
Investments 3 3,189 2,184 2,396 1,721
Cash at bank and
in hand 31,851 21,816 15,676 10,512
41,077 28,135 23,624 13,743
Creditors: amounts
falling due within
one year 7 (26,893) (18,420) (5,703) (2,390)
Net current assets 14,184 9,715 17,921 11,353
Total assets less
current liabilities 43,945 30,099 39,180 11,896
Creditors: amounts
falling due after
more than (323) (221) (367) --
one year
Provisions for
liabilities and
charges (15) (10) (25) (20)
Investment in joint venture:
Share of gross assets 639 438 40 --
Share of gross
liabilities (730) (500) (101) --
Goodwill arising on
acquisition 44 30 32 --
(47) (32) (29) --
Total net assets 43,560 29,836 38,759 11,876
Capital and reserves
Called up share capital 20,300 13,904 13,062 6,924
Shares to be issued -- -- 4,127 --
Share premium account 107,850 73,870 73,925 74,781
Merger reserve 39,738 27,218 23,933 --
Other reserves 26,137 17,902 17,902 17,902
Profit and loss
account (150,465) (103,058) (94,190) (87,731)
Shareholders` funds -
equity interests 5 43,560 29,836 38,759 11,876
US Dollar amounts have been translated at the closing rate on 31 December 2001 (1.00 pounds: $1.46) solely for information.
Consolidated Cash Flow Statement (unaudited)
Unaudited Unaudited Unaudited Audited
Year Year Six months Year
Ended Ended Ended Ended
31 December 31 December 31 December 31 December
2001 2001 2001 2000
Notes $000 000 pounds 000 pounds 000 pounds
Net cash outflow/
(inflow) from
operating 6 (5,600) (3,836) 4,308 (9,354)
Activities
Returns on investments
and servicing of
Finance
Interest received 1,494 1,023 647 606
Interest element of
finance lease rental
payments (22) (15) (10) --
Net cash inflow from
returns on
investments and servicing
of finance 1,472 1,008 637 606
Taxation 2,730 1,870 1,870 --
Capital expenditure
and financial
investment
Purchase of tangible
fixed assets (4,084) (2,797) (573) (303)
Net cash outflow from
capital expenditure
and financial
investment (4,084) (2,797) (573) (303)
Acquisitions and disposals
Purchase of subsidiary
undertakings (1,121) (768) -- --
Cash at bank and in
hand acquired with
subsidiary 24,560 16,822 -- --
Net cash inflow for
acquisitions 23,439 16,054 -- --
Management of liquid resources
Net sale of Investments -- -- -- 514
Net cash inflow/(outflow)
before financing 17,957 12,299 6,242 (8,537)
Financing
Issue of ordinary
share capital 13 9 -- 10,252
Expenses on issue of
shares (1,342) (919) (55) (772)
Capital element of
finance lease rental
payments (127) (87) (47) --
Net cash (outflow)/inflow
from financing (1,456) (997) (102) 9,480
Increase in cash during
the period 16,501 11,302 6,140 943
US Dollar amounts have been translated at the closing rate on 31 December 2001 (1.00 pounds: $1.46) solely for information.
Reconciliation of Net Cash Flow to Movement in Net Funds (unaudited)
Unaudited Unaudited Unaudited Audited
Year Year Six Months Year
Ended Ended Ended Ended
31 December 31 December 31 December 31 December
2001 2001 2001 2000
$000 000 pounds 000 pounds 000 pounds
Increase in cash
during the period 16,501 11,302 6,140 943
Capital element of
finance lease
payments 127 87 47 --
Change in liquid
resources -- -- -- (514)
Change in net funds
resulting from
cash flows 16,628 11,389 6,187 429
Finance leases acquired
with subsidiary
operations (148) (101) -- --
Movement in value of
liquid investments 676 463 (212) 1,721
Translation difference 3 2 -- 2
Change in net funds 17,159 11,753 5,975 2,152
Net funds at
1 January/30 June 17,860 12,233 18,011 10,081
Net funds at
31 December 35,019 23,986 23,986 12,233
US Dollar amounts have been translated at the closing rate on 31 December 2001 (1.00 pounds: $1.46) solely for information.
Notes to the Preliminary Announcement
1 Basis of preparation
These unaudited statements, which do not constitute statutory accounts
within the meaning of Section 240 of the Companies Act 1985, have been
prepared using the accounting policies set out in the Group`s 2000 Annual
Report and Accounts except as set out below. The 2000 Annual Report and
Accounts received an unqualified auditor`s report and have been delivered to
the Registrar of Companies.
Following the introduction of Financial Reporting Standard 18 -- `Accounting policies` (FRS18), a review of the Group`s accounting policies has been performed and will continue to be performed on a regular basis. As a result of this review, other than as noted below, there have been no changes to the Group`s accounting policies in 2001.
These consolidated financial statements have been prepared to include the revenues, costs and cash flows of the Cantab Pharmaceuticals Plc (`Cantab`) group from 6 April 2001, using acquisition accounting principles (Note 2).
Following the acquisition of Cantab the Group has adopted the following accounting policy in respect of intangible fixed assets. Goodwill arising from the purchase of subsidiary undertakings, representing the difference between the fair value of the purchase consideration and the fair value of the net assets acquired, is capitalized as an intangible asset and amortized on a straight line basis over its estimated useful economic life. Goodwill similarly arising on the acquisition of associates or joint ventures is recorded as part of the related investment.
Other intangible fixed assets, including acquired intellectual property, are capitalized at cost and amortized on a straight line basis over the estimated useful economic life of the asset, having taken into account the risk factors associated with developing a pharmaceutical product.
In accordance with emerging best practice on revenue recognition, the Group has adopted a modified accounting policy from 1 January 2001. This policy states that license fees and milestone payments are spread over the life of the relevant agreement in proportion to the work performed by the Group, but is limited to the non refundable amounts received. The estimation techniques used to spread the revenue reflect both the scientific and commercial risks of individual contracts. Ordinarily, revenue is spread using a technique, which first adjusts the total contract revenue based upon the estimated probability of receipt given the commercial nature and scientific stage of development of the program. In limited cases, revenue in respect of contracts deemed to be of higher scientific or commercial risk is spread using a contingency adjusted technique to reflect the increased uncertainty of future receipts. The revenue recognized in 2000, under the former policy of recognizing such payments in full on receipt, would not have been materially different under the revised accounting policy adopted from 2001.
2 Acquisition of Cantab Pharmaceuticals plc group
On 6 April 2001 the Group announced the merger with Cantab. Under the
terms of the offer made to Cantab shareholders, 11 shares in Xenova Group plc
have been issued in exchange for 7 shares held in Cantab, valuing Cantab on 5
April 2001 at 34.2m pounds based upon a closing Xenova Group Plc share price
of 49p.
Details of the book value and provisional fair value of the assets and liabilities of Cantab as at 6 April 2001 are set out below:
Book values Adjustments Fair values
000 pounds 000 pounds 000 pounds
Fixed assets
Tangible 7,463 -- 7,463
Intangible 1,415 (1,415) --
Debtors 3,686 -- 3,686
Cash and liquid investments 16,822 -- 16,822
Creditors falling due
within one year (4,243) -- (4,243)
Creditors falling due after
more than one year (438) -- (438)
Investment in joint venture -
share of gross liabilities (32) -- (32)
Net assets acquired 24,673 (1,415) 23,258
Satisfied by:
Shares issued and to be issued 34,197
Expenses of acquisition 768
Total consideration 34,965
Goodwill arising on acquisition 11,707
There have been no accounting policy adjustments made to the balance sheet values stated at 6 April 2001. Intangible assets acquired comprised license fees which have not been capitalized separately from goodwill. In addition to the 768,000 pounds of acquisition expenses paid, share issue costs of 919,000 pounds were incurred. In accordance with the accounting policy set out in the basis of preparation note, the goodwill arising on the acquisition has been capitalized and amortized over the 10 year estimated useful life of the acquired business.
In addition to acquiring 100% of Cantab Pharmaceuticals plc and the UK trading company Cantab Research Limited (now renamed Xenova Research Limited), the Group acquired as part of this transaction, a 45% share in Phogen, a joint venture with Marie Curie Cancer Cure.
As part of the strategic review of both the research and development pipeline and other activities, announced on 21 June 2001, approximately 25% or 47 positions have been lost across both the head office and research and development functions. Included within the administrative expenses is 1.0m pounds in respect of the severance payments.
The audited consolidated results of the Cantab Pharmaceuticals plc group for the year ended 31 December 2000, including the Group`s share of Phogen, included revenues of 8,403,000 pounds, an operating loss of 6,452,000 pounds and a net loss of 3,913,000 pounds. Consolidated net assets of the Cantab group at 31 December 2000 stood at 28,374,000 pounds of which 15,257,000 pounds comprised cash and liquid resources.
3 Amounts written back on investments
The 463,000 pounds written back on investments reflects the unrealized
gain on the Group`s holding of 88,668 Cubist Pharmaceutical shares following
a rise in the listed market price since 31 December 2000 (Note 9).
4 Taxation
Following the changes introduced as part of the Finance Act 2000 in
respect of Scientific Research Allowances (now renamed `Research and
Development Allowances`), the Group has recognized an R&D tax credit of
2,292,000 pounds in respect of the year that will be received in 2002 (2001:
1,879,000 pounds).
5 Reconciliation of movement in shareholders` funds
Unaudited Unaudited Audited
Year Six Months Year
Ended Ended Ended
31 December 31 December 31 December
2001 2001 2000
000 pounds 000 pounds 000 pounds
At start of period 11,876 38,759 11,620
Allotments of shares
in the period 9 -- 10,252
Issue of shares in respect
of acquisition 34,197 4,127 --
Shares to be issued -- (4,127) --
Expenses on issue of shares (919) (55) (772)
Shares to be issued under
long term incentive
Scheme 44 20 27
Retained loss for
the period (15,371) (8,886) (9,305)
Exchange movement -- (2) 54
At end of period 29,836 29,836 11,876
6 Reconciliation of operating loss to net cash outflow from
operating activities
Unaudited Unaudited Audited
Year Six Months Year
Ended Ended Ended
31 December 31 December 31 December
2001 2001 2000
000 pounds 000 pounds 000 pounds
Group operating loss (18,352) (9,914) (9,377)
Depreciation and amortization 2,080 1,278 212
Provision for liabilities
and charges (10) (15) 20
Loss on disposal of tangible
fixed assets 16 16 --
Decrease / (increase) in debtors 734 154 (253)
(Decrease)/Increase in
creditors (excluding
deferred income) (2,573) (1,456) 17
Increase in deferred income 14,225 14,225 --
Charge for long term
incentive scheme 44 20 27
Net cash outflow from
operating activities (3,836) 4,308 (9,354)
Cash outflow in respect of exceptional reorganization costs was 1,035,000 pounds (2000: Nil)
7 Creditors
Included within creditors is 14.2m pounds (2000: Nil) in respect of
deferred revenue.
8 Going concern
The Group is an emerging pharmaceutical business and as such expects to
absorb cash until products are commercialized. The Directors have a
reasonable expectation that the Group has, or can reasonably expect to
obtain, adequate cash resources to enable it to continue in operational
existence for the foreseeable future, and have therefore prepared the
financial statements on the going concern basis.
9 Subsequent events
Included in liquid resources is an investment in Cubist which subsequent
to the year end fell in value, following an announcement by Cubist of
clinical trial data, such that at 17 January 2002 the share price was $17
valuing the investment held at 1.0m pounds, representing a decline from the
valuation at 31 December 2001 of 1.2m pounds.
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/CONTACT: UK: David A Oxlade, Chief Executive Officer, or Daniel Abrams, Group Finance Director, or Hilary Reid Evans, Corporate Communications, all of Xenova Group plc, +44-1753-706600; or David Yates or Fiona Noblet, both of Financial Dynamics, +44-207-831-3113; or US: Media - Brad Miles, ext. 17 or Lauren Tortorete, ext. 20, or Investors - Jonathan Fassberg, ext. 16, or Lee Stern, ext. 22, all of Trout Group-BMC Communications, +1-212-477-9007, for Xenova plc/
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Xenova Group PLC
28 February 2002
Letter to Xenova Group PLC
Section 198 Companies Act
In accordance with S198 of the Companies Act we hereby notify you that RAB
Capital Ltd, acting as investment manager for a number of commingled funds, has
acquired, through purchases on 26 February 2002, a further 200,000 ordinary
shares in Xenova Group plc. RAB Capital Ltd`s notifiable interest is thereby
increased to 5,839,552 shares representing 4.20% of the issued share capital.
RAB Capital does not act as custodian for its clients and therefore the shares
are held in the nominee name of the custodian of our clients, which is Morstan
Nominees Ltd.
Please contact me on 020 7389 7015 if you have any queries on the above.
Letter From RAB Capital , Neil Warrender, Compliance & Accounts Manager
Gruß Bogo!
Xenova Group PLC
28 February 2002
Letter to Xenova Group PLC
Section 198 Companies Act
In accordance with S198 of the Companies Act we hereby notify you that RAB
Capital Ltd, acting as investment manager for a number of commingled funds, has
acquired, through purchases on 26 February 2002, a further 200,000 ordinary
shares in Xenova Group plc. RAB Capital Ltd`s notifiable interest is thereby
increased to 5,839,552 shares representing 4.20% of the issued share capital.
RAB Capital does not act as custodian for its clients and therefore the shares
are held in the nominee name of the custodian of our clients, which is Morstan
Nominees Ltd.
Please contact me on 020 7389 7015 if you have any queries on the above.
Letter From RAB Capital , Neil Warrender, Compliance & Accounts Manager
Gruß Bogo!
Xenova Group plc Successful Results of Phase IIa Trial For Therapeutic Vaccine TA-HPV
SLOUGH, England, March 27 /PRNewswire-FirstCall/ -- Xenova Group plc (Nasdaq: XNVA; London Stock Exchange: XEN) announces the publication of results from a physician-initiated Phase IIa trial of Xenova`s TA-HPV therapeutic vaccine at the meeting of the British Society of Investigative Dermatology, held this week in Norwich, UK.
Results of the trial, which was carried out by researchers at Addenbrooke`s Hospital, Cambridge, UK, in a total of 12 women with high grade human papillomavirus (HPV) positive ano-genital intraepithelial neoplasia (AGIN) of up to 15 years` duration, showed the vaccine to be safe and well tolerated. Five (42%) of the patients showed at least a 50% reduction in total lesion diameter over 24 weeks, of whom one patient showed complete regression of her lesion. Overall, there was an average decrease in lesion size of 40% with 83% of women showing some improvement. Results of the study indicate that this vaccine may have an effect on HPV-positive AGIN and suggest that further studies are warranted. These results are consistent with data announced in October 2001 from a similar Phase IIa study involving 18 patients conducted at St Mary`s Hospital, Manchester, UK.
AGIN is a chronic disorder associated with high risk genital HPVs and is frequently multifocal, with recurrence common after surgical excision. There is a high risk of progression to invasive malignancy in the form of ano-genital cancers, such as vulval cancer.
TA-HPV is a vaccine containing certain disease-associated HPV genes inserted into a carrier vaccinia virus vector. TA-HPV is currently undergoing an open-label, physician-sponsored Phase II `Prime-Boost` clinical trial in conjunction with a further Xenova vaccine, TA-CIN. Results of this `Prime-Boost` trial, which is being carried out in up to 30 women at 3 centres in the UK, are expected in the second half of 2002.
David Oxlade, Chief Executive Officer of Xenova, commented: "The results of this study are highly encouraging, and support the results of a previous Phase IIa study announced last year, which showed complete or partial response in a similar percentage of patients. AGIN conditions are highly recurrent, difficult to treat and have debilitating effects for sufferers. The results of the `Prime-Boost` trial will provide us with an indication of the best development route for both our TA-HPV and TA-CIN vaccines." Notes to Editors
Gruß Bogo!
SLOUGH, England, March 27 /PRNewswire-FirstCall/ -- Xenova Group plc (Nasdaq: XNVA; London Stock Exchange: XEN) announces the publication of results from a physician-initiated Phase IIa trial of Xenova`s TA-HPV therapeutic vaccine at the meeting of the British Society of Investigative Dermatology, held this week in Norwich, UK.
Results of the trial, which was carried out by researchers at Addenbrooke`s Hospital, Cambridge, UK, in a total of 12 women with high grade human papillomavirus (HPV) positive ano-genital intraepithelial neoplasia (AGIN) of up to 15 years` duration, showed the vaccine to be safe and well tolerated. Five (42%) of the patients showed at least a 50% reduction in total lesion diameter over 24 weeks, of whom one patient showed complete regression of her lesion. Overall, there was an average decrease in lesion size of 40% with 83% of women showing some improvement. Results of the study indicate that this vaccine may have an effect on HPV-positive AGIN and suggest that further studies are warranted. These results are consistent with data announced in October 2001 from a similar Phase IIa study involving 18 patients conducted at St Mary`s Hospital, Manchester, UK.
AGIN is a chronic disorder associated with high risk genital HPVs and is frequently multifocal, with recurrence common after surgical excision. There is a high risk of progression to invasive malignancy in the form of ano-genital cancers, such as vulval cancer.
TA-HPV is a vaccine containing certain disease-associated HPV genes inserted into a carrier vaccinia virus vector. TA-HPV is currently undergoing an open-label, physician-sponsored Phase II `Prime-Boost` clinical trial in conjunction with a further Xenova vaccine, TA-CIN. Results of this `Prime-Boost` trial, which is being carried out in up to 30 women at 3 centres in the UK, are expected in the second half of 2002.
David Oxlade, Chief Executive Officer of Xenova, commented: "The results of this study are highly encouraging, and support the results of a previous Phase IIa study announced last year, which showed complete or partial response in a similar percentage of patients. AGIN conditions are highly recurrent, difficult to treat and have debilitating effects for sufferers. The results of the `Prime-Boost` trial will provide us with an indication of the best development route for both our TA-HPV and TA-CIN vaccines." Notes to Editors
Gruß Bogo!
Tuesday April 2, 2:00 am Eastern Time
Press Release
SOURCE: Xenova Group plc
Xenova Group plc Patient Dosing Begins in Phase IIa Dose Escalation Trial for Anti-Cocaine Addiction Vaccine TA-CD
SLOUGH, England, April 2 /PRNewswire-FirstCall/ -- Xenova Group plc (Nasdaq: XNVA; London Stock Exchange: XEN) today announces that patient dosing has begun in a Phase IIa dose escalation trial for Xenova`s therapeutic vaccine TA-CD, which is under development for the treatment of cocaine addiction. The open label trial is being conducted by Dr Thomas Kosten, Professor of Psychiatry, Yale University School of Medicine and is designed to evaluate the safety and immunogenicity of TA-CD using a 4 or 5 dose vaccination schedule.
This study is being funded in part by the US National Institute on Drug Abuse (NIDA). NIDA have also supported earlier clinical work as part of this programme.
The results of an earlier four-dose Phase IIa dose escalation study, which were reported in July 2001, found that TA-CD was well tolerated both systemically and locally, and was able to generate higher and earlier antibody titres than those seen in a Phase I trial using a three-dose vaccination schedule. Cocaine specific antibodies were found to persist throughout the 12 weeks of the study and an attenuation of the usual euphoric effects of cocaine was reported amongst five of the six patients who relapsed during the study, providing anecdotal evidence of the benefit TA-CD may provide.
The euphoria associated with cocaine abuse is believed to be due to blockade of dopamine uptake in the brain. TA-CD is designed to work by generating antibodies in the bloodstream, thus preventing cocaine from crossing from the bloodstream into the brain. Patients may therefore be expected to benefit from the support offered by TA-CD during sustained relapse prevention therapy that should continue for 6 to 18 months after stopping cocaine.
David Oxlade, Chief Executive Officer of Xenova, commented:
``TA-CD has shown considerable promise to date. With more than a million cocaine users in the US alone, there is a real need for an effective therapy to help habitual cocaine users to overcome their problems of drug abuse and addiction.``
Notes to Editors
Xenova Group plc`s product pipeline focuses principally on the therapeutic areas of cancer and immune system disorders. Xenova currently has a broad pipeline of eight products in clinical development. Xenova`s lead programme is a P-glycoprotein antagonist for the treatment of multi-drug resistance in cancer, known as tariquidar or XR9576. Tariquidar has completed a successful series of three Phase IIa clinical trials and is expected to enter Phase III clinical development in the first half of 2002. Tariquidar was partnered for the North American market with QLT Inc in August 2001. The Group has a well-established track record in the identification, development and partnering of innovative products and technologies and has partnerships with other major pharmaceutical companies including Lilly, Pfizer, Celltech and Millennium Pharmaceuticals.
For further information about Xenova and its products please visit the Xenova website at http://www.xenova.co.uk
For Xenova: Disclaimer to take advantage of the ``Safe Harbor`` provisions of the US Private Securities Litigation Reform Act of 1995. This press release contains ``forward-looking statements,`` including statements about the discovery, development and commercialisation of products. Various risks may cause Xenova`s actual results to differ materially from those expressed or implied by the forward looking statements, including: adverse results in our drug discovery and clinical development programs; failure to obtain patent protection for our discoveries; commercial limitations imposed by patents owned or controlled by third parties; our dependence upon strategic alliance partners to develop and commercialise products and services; difficulties or delays in obtaining regulatory approvals to market products and services resulting from our development efforts; the requirement for substantial funding to conduct research and development and to expand commercialisation activities; and product initiatives by competitors. For a further list and description of the risks and uncertainties we face, see the reports we have filed with the Securities and Exchange Commission. We disclaim any intention or obligation to update or revise any forward-looking statements, whether as a result of new information, future events or otherwise.
SOURCE: Xenova Group plc
Press Release
SOURCE: Xenova Group plc
Xenova Group plc Patient Dosing Begins in Phase IIa Dose Escalation Trial for Anti-Cocaine Addiction Vaccine TA-CD
SLOUGH, England, April 2 /PRNewswire-FirstCall/ -- Xenova Group plc (Nasdaq: XNVA; London Stock Exchange: XEN) today announces that patient dosing has begun in a Phase IIa dose escalation trial for Xenova`s therapeutic vaccine TA-CD, which is under development for the treatment of cocaine addiction. The open label trial is being conducted by Dr Thomas Kosten, Professor of Psychiatry, Yale University School of Medicine and is designed to evaluate the safety and immunogenicity of TA-CD using a 4 or 5 dose vaccination schedule.
This study is being funded in part by the US National Institute on Drug Abuse (NIDA). NIDA have also supported earlier clinical work as part of this programme.
The results of an earlier four-dose Phase IIa dose escalation study, which were reported in July 2001, found that TA-CD was well tolerated both systemically and locally, and was able to generate higher and earlier antibody titres than those seen in a Phase I trial using a three-dose vaccination schedule. Cocaine specific antibodies were found to persist throughout the 12 weeks of the study and an attenuation of the usual euphoric effects of cocaine was reported amongst five of the six patients who relapsed during the study, providing anecdotal evidence of the benefit TA-CD may provide.
The euphoria associated with cocaine abuse is believed to be due to blockade of dopamine uptake in the brain. TA-CD is designed to work by generating antibodies in the bloodstream, thus preventing cocaine from crossing from the bloodstream into the brain. Patients may therefore be expected to benefit from the support offered by TA-CD during sustained relapse prevention therapy that should continue for 6 to 18 months after stopping cocaine.
David Oxlade, Chief Executive Officer of Xenova, commented:
``TA-CD has shown considerable promise to date. With more than a million cocaine users in the US alone, there is a real need for an effective therapy to help habitual cocaine users to overcome their problems of drug abuse and addiction.``
Notes to Editors
Xenova Group plc`s product pipeline focuses principally on the therapeutic areas of cancer and immune system disorders. Xenova currently has a broad pipeline of eight products in clinical development. Xenova`s lead programme is a P-glycoprotein antagonist for the treatment of multi-drug resistance in cancer, known as tariquidar or XR9576. Tariquidar has completed a successful series of three Phase IIa clinical trials and is expected to enter Phase III clinical development in the first half of 2002. Tariquidar was partnered for the North American market with QLT Inc in August 2001. The Group has a well-established track record in the identification, development and partnering of innovative products and technologies and has partnerships with other major pharmaceutical companies including Lilly, Pfizer, Celltech and Millennium Pharmaceuticals.
For further information about Xenova and its products please visit the Xenova website at http://www.xenova.co.uk
For Xenova: Disclaimer to take advantage of the ``Safe Harbor`` provisions of the US Private Securities Litigation Reform Act of 1995. This press release contains ``forward-looking statements,`` including statements about the discovery, development and commercialisation of products. Various risks may cause Xenova`s actual results to differ materially from those expressed or implied by the forward looking statements, including: adverse results in our drug discovery and clinical development programs; failure to obtain patent protection for our discoveries; commercial limitations imposed by patents owned or controlled by third parties; our dependence upon strategic alliance partners to develop and commercialise products and services; difficulties or delays in obtaining regulatory approvals to market products and services resulting from our development efforts; the requirement for substantial funding to conduct research and development and to expand commercialisation activities; and product initiatives by competitors. For a further list and description of the risks and uncertainties we face, see the reports we have filed with the Securities and Exchange Commission. We disclaim any intention or obligation to update or revise any forward-looking statements, whether as a result of new information, future events or otherwise.
SOURCE: Xenova Group plc
Xenova begins cocaine vaccine trial
Apr 09, 2002 (M2 EUROPHARMA via COMTEX) -- The UK-based biotechnology company Xenova Group Plc has begun patient dosing in a phase IIa dose escalation trial of TA-CD, its new vaccine being developed for the treatment of cocaine addiction.
The study, which is conducted by Dr. Thomas Kosten at the Yale University School of Medicine, is designed to evaluate the safety and efficacy of the drug and to find the best dose pattern. The US National Institute on Drug Abuse is funding part of the project.
The euphoria associated with cocaine abuse is believed to be due to a blockade of dopamine uptake in the brain. TA-CD is intended to work by generating antibodies in the bloodstream to prevent cocaine molecules from crossing from the bloodstream into the brain.
(Daily Telegraph, 03 Apr 2002; Statement by Xenova Group, 02 Apr 2002.) M2 Europharma includes paraphrased and abstracted material with the source, which is deemed to be reliable and duly identified. M2E is unable to provide full-text copies of these original documents.
Apr 09, 2002 (M2 EUROPHARMA via COMTEX) -- The UK-based biotechnology company Xenova Group Plc has begun patient dosing in a phase IIa dose escalation trial of TA-CD, its new vaccine being developed for the treatment of cocaine addiction.
The study, which is conducted by Dr. Thomas Kosten at the Yale University School of Medicine, is designed to evaluate the safety and efficacy of the drug and to find the best dose pattern. The US National Institute on Drug Abuse is funding part of the project.
The euphoria associated with cocaine abuse is believed to be due to a blockade of dopamine uptake in the brain. TA-CD is intended to work by generating antibodies in the bloodstream to prevent cocaine molecules from crossing from the bloodstream into the brain.
(Daily Telegraph, 03 Apr 2002; Statement by Xenova Group, 02 Apr 2002.) M2 Europharma includes paraphrased and abstracted material with the source, which is deemed to be reliable and duly identified. M2E is unable to provide full-text copies of these original documents.
Xenova Group plc: Potential US$63m (£43.2m) Development and Licence Agreement with Genentech Inc for Novel Drugs in Immune Inflammatory Disease
Slough, UK, 23 April, 2002 - Xenova Group plc (Nasdaq NM: XNVA; London Stock Exchange: XEN) today announces that it has signed an exclusive development and licence agreement with South San Francisco-based Genentech Inc (NYSE: DNA) worth up to US$63m plus royalties. The agreement provides Genentech with worldwide rights to develop and market products primarily targeting disorders of the immune system based on Xenova`s OX40 receptor protein and anti-OX40 Ligand antibody programmes.
Genentech will pay Xenova licence fees of up to US$5m (£3.4m) over the first year of the collaboration. In addition, Genentech will pay Xenova up to US$58m (£39.7m) in milestones assuming successful development and commercialisation of a product. Significant tiered royalties, depending on the level of sales, are also receivable by Xenova.
Genentech has also acquired an option, but not an obligation, to develop a second product. Should a second product be developed and commercialised, further milestone payments and royalties would apply.
Xenova will transfer to Genentech responsibility for the further development of the relevant programmes, including preclinical and clinical trials, all regulatory filings and the manufacture and sale of any products arising from the agreement worldwide. Genentech will fund all future development activities within the scope of the agreement.
Xenova retains for its proprietary development and commercialisation in oncology and other applications all rights to OX40 Ligand and stimulatory anti-OX40 antibodies. Xenova`s OX40 platform technology is part of the portfolio of pre-clinical research programmes acquired through its merger with Cantab Pharmaceuticals plc in 2001.
OX40 is a platform technology capable of producing several therapeutic solutions. OX40 and OX40 Ligand are a pair of interacting cell-surface proteins which are important for the induction and regulation of immunity. The therapeutic potential of these cell-surface proteins lies in their ability to modulate the immune system. Modulation of the immune system has the potential to be of benefit in a wide range of diseases including inflammatory and autoimmune disease, infectious diseases and cancer. Xenova is the holder of exclusive licences to several patents relating to the OX40 platform.
David Oxlade, Chief Executive of Xenova, commented:
"We are delighted with this new agreement with Genentech, our third major partnership in the last 8 months. Genentech has a remarkable track record in successfully bringing innovative therapeutic solutions to market in this field. The OX40 mechanism has been shown to be a key component of the body`s immune system and is an important new therapeutic target. This agreement highlights the enhanced commercial potential in Xenova`s research portfolio since the merger with Cantab and realises both immediate and long term value for the company. It also clearly illustrates our strategy of seeking partnerships with major players who are capable of exploiting our science in applications which lie outside our main focus on cancer and immunotherapy."
Slough, UK, 23 April, 2002 - Xenova Group plc (Nasdaq NM: XNVA; London Stock Exchange: XEN) today announces that it has signed an exclusive development and licence agreement with South San Francisco-based Genentech Inc (NYSE: DNA) worth up to US$63m plus royalties. The agreement provides Genentech with worldwide rights to develop and market products primarily targeting disorders of the immune system based on Xenova`s OX40 receptor protein and anti-OX40 Ligand antibody programmes.
Genentech will pay Xenova licence fees of up to US$5m (£3.4m) over the first year of the collaboration. In addition, Genentech will pay Xenova up to US$58m (£39.7m) in milestones assuming successful development and commercialisation of a product. Significant tiered royalties, depending on the level of sales, are also receivable by Xenova.
Genentech has also acquired an option, but not an obligation, to develop a second product. Should a second product be developed and commercialised, further milestone payments and royalties would apply.
Xenova will transfer to Genentech responsibility for the further development of the relevant programmes, including preclinical and clinical trials, all regulatory filings and the manufacture and sale of any products arising from the agreement worldwide. Genentech will fund all future development activities within the scope of the agreement.
Xenova retains for its proprietary development and commercialisation in oncology and other applications all rights to OX40 Ligand and stimulatory anti-OX40 antibodies. Xenova`s OX40 platform technology is part of the portfolio of pre-clinical research programmes acquired through its merger with Cantab Pharmaceuticals plc in 2001.
OX40 is a platform technology capable of producing several therapeutic solutions. OX40 and OX40 Ligand are a pair of interacting cell-surface proteins which are important for the induction and regulation of immunity. The therapeutic potential of these cell-surface proteins lies in their ability to modulate the immune system. Modulation of the immune system has the potential to be of benefit in a wide range of diseases including inflammatory and autoimmune disease, infectious diseases and cancer. Xenova is the holder of exclusive licences to several patents relating to the OX40 platform.
David Oxlade, Chief Executive of Xenova, commented:
"We are delighted with this new agreement with Genentech, our third major partnership in the last 8 months. Genentech has a remarkable track record in successfully bringing innovative therapeutic solutions to market in this field. The OX40 mechanism has been shown to be a key component of the body`s immune system and is an important new therapeutic target. This agreement highlights the enhanced commercial potential in Xenova`s research portfolio since the merger with Cantab and realises both immediate and long term value for the company. It also clearly illustrates our strategy of seeking partnerships with major players who are capable of exploiting our science in applications which lie outside our main focus on cancer and immunotherapy."
Reuters Business
Xenova rises on immune system disorder deal
(Adds CEO interview, analysts, detail, background, shares)
By Mark Potter
LONDON, April 23 (Reuters) - Shares in Xenova Plc rallied on Tuesday after the British biotechnology firm said it had agreed to license out early-stage technology to treat immune system disorders, an asset which most analysts had disregarded.
Xenova said the deal, with U.S. biotech giant Genentech Inc. (NYSENA - news) and worth up to $63 million plus royalties, covered technology it had inherited from its merger with Cantab Pharmaceuticals last year and would allow it to focus on its specialist fields of cancer and infectious diseases.
Few analysts had seen much potential in the merger with Cantab, but Xenova has now signed three deals in eight months worth more than $300 million, silencing many critics.
``There`s a lot of contingencies in the deal (with Genentech). But to be honest, I don`t think many analysts had this in their models, so it`s a great bonus,`` said Sam Fazeli, analyst at Altium Capital, who rates Xenova a ``strong buy``.
Xenova`s shares climbed as much as nine percent in early trade. At 0815 GMT they were four pence or 6.7 percent higher at 64p, valuing the business at 89 million pounds ($129 million).
``For a programme that`s not yet in the clinic, this is a very significant achievement,`` Xenova Chief Executive David Oxlade told Reuters. ``And it`s not even the whole programme.``
REGULATING IMMUNE RESPONSES
Under the deal, Genentech will have access to Xenova`s OX40 receptor protein and anti-OX40 Ligand antibody programmes to formulate a treatment for immune system disorders.
OX40 and OX40 Ligand are a pair of cell-surface proteins which are able to regulate the immune system.
Oxlade said the deal with Genentech covered only the technology`s potential to dampen immune responses, and that Xenova was retaining control of its role in stimulating them.
Genentech will pay Xenova licence fees of up to $5 million over the first year of the collaboration, and will pay up to $58 million in milestone payments, assuming successful development and commercialisation of a product.
Xenova will also receive significant tiered royalties depending on the level of sales of any product.
Genentech also has the option to develop and commercialise a second product, which would trigger further milestone payments and royalties.
Xenova had 24 million pounds, or around two years, of cash left at the end of last year, and Oxlade said the deal with Genentech would give it a little more breathing space.
He added the firm was on track to start final Phase III clinical trials of its lead product, cancer treatment tariquidar, in the middle of this year.
Gruß Bogo!
Xenova rises on immune system disorder deal
(Adds CEO interview, analysts, detail, background, shares)
By Mark Potter
LONDON, April 23 (Reuters) - Shares in Xenova Plc rallied on Tuesday after the British biotechnology firm said it had agreed to license out early-stage technology to treat immune system disorders, an asset which most analysts had disregarded.
Xenova said the deal, with U.S. biotech giant Genentech Inc. (NYSENA - news) and worth up to $63 million plus royalties, covered technology it had inherited from its merger with Cantab Pharmaceuticals last year and would allow it to focus on its specialist fields of cancer and infectious diseases.
Few analysts had seen much potential in the merger with Cantab, but Xenova has now signed three deals in eight months worth more than $300 million, silencing many critics.
``There`s a lot of contingencies in the deal (with Genentech). But to be honest, I don`t think many analysts had this in their models, so it`s a great bonus,`` said Sam Fazeli, analyst at Altium Capital, who rates Xenova a ``strong buy``.
Xenova`s shares climbed as much as nine percent in early trade. At 0815 GMT they were four pence or 6.7 percent higher at 64p, valuing the business at 89 million pounds ($129 million).
``For a programme that`s not yet in the clinic, this is a very significant achievement,`` Xenova Chief Executive David Oxlade told Reuters. ``And it`s not even the whole programme.``
REGULATING IMMUNE RESPONSES
Under the deal, Genentech will have access to Xenova`s OX40 receptor protein and anti-OX40 Ligand antibody programmes to formulate a treatment for immune system disorders.
OX40 and OX40 Ligand are a pair of cell-surface proteins which are able to regulate the immune system.
Oxlade said the deal with Genentech covered only the technology`s potential to dampen immune responses, and that Xenova was retaining control of its role in stimulating them.
Genentech will pay Xenova licence fees of up to $5 million over the first year of the collaboration, and will pay up to $58 million in milestone payments, assuming successful development and commercialisation of a product.
Xenova will also receive significant tiered royalties depending on the level of sales of any product.
Genentech also has the option to develop and commercialise a second product, which would trigger further milestone payments and royalties.
Xenova had 24 million pounds, or around two years, of cash left at the end of last year, and Oxlade said the deal with Genentech would give it a little more breathing space.
He added the firm was on track to start final Phase III clinical trials of its lead product, cancer treatment tariquidar, in the middle of this year.
Gruß Bogo!
Xenova Group plc First Quarter Results 2002
SLOUGH, England, May 9 /PRNewswire-FirstCall/ -- Xenova Group plc (Nasdaq: XNVA; London: XEN) today announces its results for the quarter ended 31 March 2002.
Year to Date Highlights
* Anti-cancer compound XR11576 enters Phase I clinical trials
* Successful results of Phase IIa trial for therapeutic vaccine TA-HPV
* Patient dosing begins in Phase IIa trial for anti-cocaine addiction
vaccine TA-CD
* 44.2m pounds Sterling ($63m) development and licence agreement with
Genentech Inc for novel drugs in immune inflammatory disease
* Revenue recognised in quarter of 2.8m pounds ($3.9m) (2001 nil pounds
($nil))
* Cash and liquid resources 17.1m pounds ($24.3m) at 31 March 2002
(2001: 8.1m pounds ($11.5m)), excluding 3.5m pounds ($5m) licence
payment from Genentech agreement
Commenting, Chief Executive Officer David Oxlade said: "Xenova has made substantial progress both clinically and commercially, as exemplified by the new collaborations we have entered into recently. There is every indication that this momentum will continue, with, for example, the anticipated entry of our lead compound, Tariquidar, to Phase III clinical trials around the middle of this year."
Notes to Editors
Xenova Group plc`s product pipeline focuses principally on the therapeutic areas of cancer and immune system disorders. Xenova currently has a broad pipeline of eight products in clinical development. Xenova`s lead programme is a P-glycoprotein antagonist for the treatment of multi-drug resistance in cancer, known as tariquidar or XR9576. Tariquidar has completed a successful series of three Phase IIa clinical trials and is expected to enter Phase III clinical development in mid 2002. Tariquidar is partnered for the North American market with QLT Inc. The Group has a well-established track record in the identification, development and partnering of innovative products and technologies and has partnerships with other major pharmaceutical companies including Lilly, Pfizer, Celltech, Millennium Pharmaceuticals and Genentech.
For further information about Xenova and its products please visit the Xenova website at http://www.xenova.co.uk .
For Xenova: Disclaimer to take advantage of the "Safe Harbor" provisions of the US Private Securities Litigation Reform Act of 1995. This press release contains "forward-looking statements," including statements about the discovery, development and commercialisation of products. Various risks may cause Xenova`s actual results to differ materially from those expressed or implied by the forward looking statements, including: adverse results in our drug discovery and clinical development programs; failure to obtain patent protection for our discoveries; commercial limitations imposed by patents owned or controlled by third parties; our dependence upon strategic alliance partners to develop and commercialise products and services; difficulties or delays in obtaining regulatory approvals to market products and services resulting from our development efforts; the requirement for substantial funding to conduct research and development and to expand commercialisation activities; and product initiatives by competitors. For a further list and description of the risks and uncertainties we face, see the reports we have filed with the Securities and Exchange Commission. We disclaim any intention or obligation to update or revise any forward-looking statements, whether as a result of new information, future events or otherwise.
Quarterly Review
Product Pipeline Update
Multi-drug resistance programme: A 73.7m pounds ($105m) collaboration
with QLT Inc for the development and North American marketing of Tariquidar
(the P-gp pump inhibitor formerly known as XR9576) was announced in August
2001. Since then, good progress has been made towards the anticipated
commencement of Phase III clinical trials in mid-2002. Initiation of trial
centres is continuing on schedule and all necessary FDA approvals are now in
place.
Tariquidar is being developed to address the large, frequently occurring problem of multidrug resistance faced by cancer patients whose tumours do not respond to chemotherapy.
Data were presented at the American Association for Cancer Research (AACR) meeting in April 2002 relating to the pharmacokinetic (PK) interaction between Tariquidar and the cytotoxic drugs paclitaxel, doxorubicin and vinorelbine and demonstrating that no significant interaction occurred. Further data also presented at the AACR conference related to in vitro studies for Tariquidar and demonstrated that clinically significant interaction is unlikely between Tariquidar and chemotherapy agents.
An abstract has been accepted for the May 2002 meeting of the American Society of Clinical Oncology (ASCO), which demonstrates that Tariquidar has minimal effects on the PK interaction of paclitaxel, doxorubicin and vinorelbine and can be administered with full-dose chemotherapy in patients with cancer.
Novel mechanism of action anti-cancer programme: Following the December 2001 announcement that Xenova had entered into a North American licensing agreement with Millennium Pharmaceuticals Inc (Millennium) for its compounds XR11576, XR5944 and XR11612, it was announced in February 2002 that patient dosing began in an open-label Phase I trial for the oral compound, XR11576. Preclinical studies continue for compounds XR5944 and XR11612. These compounds comprise a programme for the treatment of solid tumours. The compounds are believed to be novel DNA targeting agents that affect the DNA replication process through a mechanism of action which involves the dual inhibition of topoisomerases I and II. Sales of the two leading single topoisomerase inhibitor compounds alone are estimated to have been in excess of $800m in 2000. There are no currently marketed dual topoisomerase inhibitors.
TA-HPV: As announced in March 2002, successful results of a physician- initiated Phase IIa trial of Xenova`s therapeutic vaccine, TA-HPV were published at the meeting of the British Society of Investigative Dermatology. Researchers at Addenbrooke`s Hospital, Cambridge, UK showed the vaccine to be safe and well tolerated in a study of 12 women with high grade human papillomavirus positive ano-genital intraepithelial neoplasia. TA-HPV is currently undergoing an open-label, physician-sponsored Phase IIa `prime- boost` trial in conjunction with a further Xenova vaccine, TA-CIN, the results of which are anticipated in the second half of 2002.
TA-CD: It was announced in April 2002 that patient dosing had begun in a Phase IIa dose escalation trial for Xenova`s anti-cocaine addiction vaccine, TA-CD. The trial is being conducted by Dr Thomas Kosten of Yale University School of Medicine and is designed to evaluate the safety and immunogenicity of TA-CD using a 4 or 5 dose vaccination schedule. The study is being funded in part by the US National Institute on Drug Abuse.
OX40: It was also announced in April 2002 that Xenova has signed an exclusive development and licence agreement with Genentech Inc, worth up to 44.2m pounds ($63m), granting Genentech worldwide rights to develop and market products primarily targeting disorders of the immune system based on Xenova`s OX40 receptor protein and anti-OX40 ligand antibody programmes. Xenova retains all rights to OX40 ligand and stimulatory anti-OX40 antibodies for its proprietary development and commercialisation in oncology and other applications.
Other Programmes: Research and development continued throughout the first quarter for the Group`s other programmes, and includes a Phase I trial in melanoma for the vaccine DISC-GMCSF and a Phase I trial for the anti-nicotine vaccine, TA-NIC. Xenova`s research pipeline includes programmes such as those for PAI-1 inhibition in the treatment of cancer and cardiovascular disease, and multi-drug resistance protein (MRP) inhibition in the treatment of cancer. An update will be provided for all of Xenova`s product development programmes at the time of the interim (Quarter 2) results in August this year.
Financial Summary
Operating Performance
In the three months to 31 March 2002, the Group`s revenues from licensing
agreements, strategic partnerships and manufacturing outsourcing were 2.8m
pounds ($3.9m) (2001 nil pounds ($nil)).
In accordance with the Group`s revenue recognition policy, of the 6.9m pounds ($10m) received from QLT in 2001 as part of the Tariquidar licensing agreement, 0.6m pounds ($0.9m) was included in the quarter to 31 March 2002, with a further 5.7m pounds ($8.2m) being deferred to future periods. Of the #7.9m ($11.3m) received from Millennium 2.0m pounds ($2.8m) was recognised by the Group in the three months to 31 March 2002, with a further 5.9m pounds ($8.4m) being deferred to future periods. Other revenue included 0.2m pounds ($0.3m) in respect of ongoing contract vaccine manufacturing.
Total operating expenses have reduced from 5.7m pounds ($8.1m) in the fourth quarter 2001 by 2% to 5.6m pounds ($7.9m) in the first quarter of 2002. The first quarter operating expenses for 2001 of 2.4m pounds ($3.4m) preceded the acquisition of Cantab Pharmaceuticals plc (Cantab).
Research expenditure of 4.3m pounds ($6.1m) remained in line with the fourth quarter 2001 (4.3m pounds ($6.1m)). Research expenditure in the first quarter of 2001, prior to the acquisition of Cantab, was 1.9m pounds ($2.7m). There is not expected to be a significant impact to research expenditure following the licensing agreements with QLT and Millennium until 2003 when cost reimbursement commences under the latter agreement relating to a programme of novel DNA targeting agents. The cost reductions made in quarter four 2001 were maintained in quarter one 2002, with administration expenses (excluding the amortisation of goodwill) remaining at 1.5m pounds ($2.1m). The subletting of excess facilities reduced net operating expenses by 0.2m pounds ($0.3m) in quarter one (2001: nil).
Of the total administrative expenses for the three months to 31 March 2002 of 1.5m pounds ($2.1m), 0.3m pounds ($0.4m) relates to the amortisation over a 10-year period of the goodwill in respect of the acquisition of Cantab in 2001.
The increased net interest income reflects the increased cash and liquid resources balance held throughout the three months to 31 March 2002.
The net loss per share in quarter one was 2p (2001: 3p).
Cash and liquid investments
Cash and liquid resources at 31 March 2002 totalled 17.1m pounds ($24.3m) (2001: 8.1m pounds ($11.5m)). Cash of 15.9m pounds ($22.7m) and liquid resources of 1.2m pounds ($1.6m) at 31 March 2002 (2001: cash 8.1m pounds ($11.5m), liquid resources nil), excludes the receipt of 3.5m pounds ($5m) in respect of licence fees payable by Genentech in respect of the OX40 deal announced in April 2002.
Included in liquid resources is an investment in Cubist Pharmaceuticals Inc which subsequent to the 2001 year end fell in value, following an announcement by Cubist of clinical trial data, such that at the 31 March 2002 the share price was $18.48 valuing the investment held at 1.2m pounds ($1.6m), representing a decline of 1.0m pounds ($1.5m) from the valuation at 31 December 2001 of 2.2m pounds ($3.1m).
Share capital
The number of shares in issue stood at 139.1 million as at 31 March 2002.
The Directors do not currently propose a dividend for 2002 (2001: nil).
Consolidated Profit and Loss Account (unaudited)
Three Months Ended
Unaudited Unaudited Unaudited
31 March 31 March 31 March
2002 2002 2001
$000 000 pounds 000 pounds
Turnover (including share
of joint venture) 3,972 2,789 --
Less: share of joint
venture revenue (37) (26) --
Turnover 3,935 2,763 --
Operating expenses
Research and development costs (6,109) (4,290) (1,873)
Administrative expenses (2,081) (1,461) (480)
Total operating expenses (8,190) (5,751) (2,353)
Other operating income 262 184 --
Group operating loss (3,993) (2,804) (2,353)
Loss on sale of business:
Adjustment to
Discovery consideration -- -- (186)
Share of operating loss
of joint venture (46) (32) --
Total operating loss: Group
and share of joint
Venture (4,039) (2,836) (2,539)
Interest (net) 247 173 131
Amounts written off
investments (1,471) (1,033) --
Loss on ordinary activities
before taxation (5,263) (3,696) (2,408)
Tax on loss on ordinary
activities (R&D tax credit) 642 451 231
Loss on ordinary activities
after taxation attributable
to members of Xenova Group plc (4,621) (3,245) (2,177)
Loss per share (basic and diluted) (3c) (2p) (3p)
Shares used in computing net
loss per share (thousands) 139,057 139,057 69,251
US Dollar amounts have been translated at the closing rate on 31 March 2002 (1.00 pounds: $1.4241) solely for information.
Condensed Consolidated Balance Sheet (unaudited)
Unaudited Unaudited Unaudited
As at As at As at
31 March 31 March 31 March
2002 2002 2001
$000 000 pounds 000 pounds
Cash and liquid resources 24,326 17,082 8,105
Other current assets 6,347 4,457 1,292
Fixed assets (including goodwill) 28,182 19,789 1,957
Total assets 58,855 41,328 11,354
Current liabilities (including
provisions & deferred income) (20,953) (14,713) (1,636)
Shareholders` equity (37,902) (26,615) (9,718)
Total liabilities and
shareholders` equity (58,855) (41,328) (11,354)
US Dollar amounts have been translated at the closing rate on 31 March 2002 (1.00 pounds: $1.4241) solely for information.
Notes to the Statement
Basis of preparation
These unaudited statements, which do not constitute statutory accounts within the meaning of Section 240 of the Companies Act 1985, have been prepared using the accounting policies set out in the Group`s 2001 Annual Report and Accounts. The 2001 Annual Report and Accounts received an unqualified auditor`s report and will be delivered to the Registrar of Companies.
Going concern
The Group is an emerging pharmaceutical business and as such expects to absorb cash until products are commercialised. The Directors have a reasonable expectation that the Group has, or can reasonably expect to obtain, adequate cash resources to enable it to continue in operational existence for the foreseeable future, and have therefore prepared the financial statements on the going concern basis.
Gruß Bogo!
SLOUGH, England, May 9 /PRNewswire-FirstCall/ -- Xenova Group plc (Nasdaq: XNVA; London: XEN) today announces its results for the quarter ended 31 March 2002.
Year to Date Highlights
* Anti-cancer compound XR11576 enters Phase I clinical trials
* Successful results of Phase IIa trial for therapeutic vaccine TA-HPV
* Patient dosing begins in Phase IIa trial for anti-cocaine addiction
vaccine TA-CD
* 44.2m pounds Sterling ($63m) development and licence agreement with
Genentech Inc for novel drugs in immune inflammatory disease
* Revenue recognised in quarter of 2.8m pounds ($3.9m) (2001 nil pounds
($nil))
* Cash and liquid resources 17.1m pounds ($24.3m) at 31 March 2002
(2001: 8.1m pounds ($11.5m)), excluding 3.5m pounds ($5m) licence
payment from Genentech agreement
Commenting, Chief Executive Officer David Oxlade said: "Xenova has made substantial progress both clinically and commercially, as exemplified by the new collaborations we have entered into recently. There is every indication that this momentum will continue, with, for example, the anticipated entry of our lead compound, Tariquidar, to Phase III clinical trials around the middle of this year."
Notes to Editors
Xenova Group plc`s product pipeline focuses principally on the therapeutic areas of cancer and immune system disorders. Xenova currently has a broad pipeline of eight products in clinical development. Xenova`s lead programme is a P-glycoprotein antagonist for the treatment of multi-drug resistance in cancer, known as tariquidar or XR9576. Tariquidar has completed a successful series of three Phase IIa clinical trials and is expected to enter Phase III clinical development in mid 2002. Tariquidar is partnered for the North American market with QLT Inc. The Group has a well-established track record in the identification, development and partnering of innovative products and technologies and has partnerships with other major pharmaceutical companies including Lilly, Pfizer, Celltech, Millennium Pharmaceuticals and Genentech.
For further information about Xenova and its products please visit the Xenova website at http://www.xenova.co.uk .
For Xenova: Disclaimer to take advantage of the "Safe Harbor" provisions of the US Private Securities Litigation Reform Act of 1995. This press release contains "forward-looking statements," including statements about the discovery, development and commercialisation of products. Various risks may cause Xenova`s actual results to differ materially from those expressed or implied by the forward looking statements, including: adverse results in our drug discovery and clinical development programs; failure to obtain patent protection for our discoveries; commercial limitations imposed by patents owned or controlled by third parties; our dependence upon strategic alliance partners to develop and commercialise products and services; difficulties or delays in obtaining regulatory approvals to market products and services resulting from our development efforts; the requirement for substantial funding to conduct research and development and to expand commercialisation activities; and product initiatives by competitors. For a further list and description of the risks and uncertainties we face, see the reports we have filed with the Securities and Exchange Commission. We disclaim any intention or obligation to update or revise any forward-looking statements, whether as a result of new information, future events or otherwise.
Quarterly Review
Product Pipeline Update
Multi-drug resistance programme: A 73.7m pounds ($105m) collaboration
with QLT Inc for the development and North American marketing of Tariquidar
(the P-gp pump inhibitor formerly known as XR9576) was announced in August
2001. Since then, good progress has been made towards the anticipated
commencement of Phase III clinical trials in mid-2002. Initiation of trial
centres is continuing on schedule and all necessary FDA approvals are now in
place.
Tariquidar is being developed to address the large, frequently occurring problem of multidrug resistance faced by cancer patients whose tumours do not respond to chemotherapy.
Data were presented at the American Association for Cancer Research (AACR) meeting in April 2002 relating to the pharmacokinetic (PK) interaction between Tariquidar and the cytotoxic drugs paclitaxel, doxorubicin and vinorelbine and demonstrating that no significant interaction occurred. Further data also presented at the AACR conference related to in vitro studies for Tariquidar and demonstrated that clinically significant interaction is unlikely between Tariquidar and chemotherapy agents.
An abstract has been accepted for the May 2002 meeting of the American Society of Clinical Oncology (ASCO), which demonstrates that Tariquidar has minimal effects on the PK interaction of paclitaxel, doxorubicin and vinorelbine and can be administered with full-dose chemotherapy in patients with cancer.
Novel mechanism of action anti-cancer programme: Following the December 2001 announcement that Xenova had entered into a North American licensing agreement with Millennium Pharmaceuticals Inc (Millennium) for its compounds XR11576, XR5944 and XR11612, it was announced in February 2002 that patient dosing began in an open-label Phase I trial for the oral compound, XR11576. Preclinical studies continue for compounds XR5944 and XR11612. These compounds comprise a programme for the treatment of solid tumours. The compounds are believed to be novel DNA targeting agents that affect the DNA replication process through a mechanism of action which involves the dual inhibition of topoisomerases I and II. Sales of the two leading single topoisomerase inhibitor compounds alone are estimated to have been in excess of $800m in 2000. There are no currently marketed dual topoisomerase inhibitors.
TA-HPV: As announced in March 2002, successful results of a physician- initiated Phase IIa trial of Xenova`s therapeutic vaccine, TA-HPV were published at the meeting of the British Society of Investigative Dermatology. Researchers at Addenbrooke`s Hospital, Cambridge, UK showed the vaccine to be safe and well tolerated in a study of 12 women with high grade human papillomavirus positive ano-genital intraepithelial neoplasia. TA-HPV is currently undergoing an open-label, physician-sponsored Phase IIa `prime- boost` trial in conjunction with a further Xenova vaccine, TA-CIN, the results of which are anticipated in the second half of 2002.
TA-CD: It was announced in April 2002 that patient dosing had begun in a Phase IIa dose escalation trial for Xenova`s anti-cocaine addiction vaccine, TA-CD. The trial is being conducted by Dr Thomas Kosten of Yale University School of Medicine and is designed to evaluate the safety and immunogenicity of TA-CD using a 4 or 5 dose vaccination schedule. The study is being funded in part by the US National Institute on Drug Abuse.
OX40: It was also announced in April 2002 that Xenova has signed an exclusive development and licence agreement with Genentech Inc, worth up to 44.2m pounds ($63m), granting Genentech worldwide rights to develop and market products primarily targeting disorders of the immune system based on Xenova`s OX40 receptor protein and anti-OX40 ligand antibody programmes. Xenova retains all rights to OX40 ligand and stimulatory anti-OX40 antibodies for its proprietary development and commercialisation in oncology and other applications.
Other Programmes: Research and development continued throughout the first quarter for the Group`s other programmes, and includes a Phase I trial in melanoma for the vaccine DISC-GMCSF and a Phase I trial for the anti-nicotine vaccine, TA-NIC. Xenova`s research pipeline includes programmes such as those for PAI-1 inhibition in the treatment of cancer and cardiovascular disease, and multi-drug resistance protein (MRP) inhibition in the treatment of cancer. An update will be provided for all of Xenova`s product development programmes at the time of the interim (Quarter 2) results in August this year.
Financial Summary
Operating Performance
In the three months to 31 March 2002, the Group`s revenues from licensing
agreements, strategic partnerships and manufacturing outsourcing were 2.8m
pounds ($3.9m) (2001 nil pounds ($nil)).
In accordance with the Group`s revenue recognition policy, of the 6.9m pounds ($10m) received from QLT in 2001 as part of the Tariquidar licensing agreement, 0.6m pounds ($0.9m) was included in the quarter to 31 March 2002, with a further 5.7m pounds ($8.2m) being deferred to future periods. Of the #7.9m ($11.3m) received from Millennium 2.0m pounds ($2.8m) was recognised by the Group in the three months to 31 March 2002, with a further 5.9m pounds ($8.4m) being deferred to future periods. Other revenue included 0.2m pounds ($0.3m) in respect of ongoing contract vaccine manufacturing.
Total operating expenses have reduced from 5.7m pounds ($8.1m) in the fourth quarter 2001 by 2% to 5.6m pounds ($7.9m) in the first quarter of 2002. The first quarter operating expenses for 2001 of 2.4m pounds ($3.4m) preceded the acquisition of Cantab Pharmaceuticals plc (Cantab).
Research expenditure of 4.3m pounds ($6.1m) remained in line with the fourth quarter 2001 (4.3m pounds ($6.1m)). Research expenditure in the first quarter of 2001, prior to the acquisition of Cantab, was 1.9m pounds ($2.7m). There is not expected to be a significant impact to research expenditure following the licensing agreements with QLT and Millennium until 2003 when cost reimbursement commences under the latter agreement relating to a programme of novel DNA targeting agents. The cost reductions made in quarter four 2001 were maintained in quarter one 2002, with administration expenses (excluding the amortisation of goodwill) remaining at 1.5m pounds ($2.1m). The subletting of excess facilities reduced net operating expenses by 0.2m pounds ($0.3m) in quarter one (2001: nil).
Of the total administrative expenses for the three months to 31 March 2002 of 1.5m pounds ($2.1m), 0.3m pounds ($0.4m) relates to the amortisation over a 10-year period of the goodwill in respect of the acquisition of Cantab in 2001.
The increased net interest income reflects the increased cash and liquid resources balance held throughout the three months to 31 March 2002.
The net loss per share in quarter one was 2p (2001: 3p).
Cash and liquid investments
Cash and liquid resources at 31 March 2002 totalled 17.1m pounds ($24.3m) (2001: 8.1m pounds ($11.5m)). Cash of 15.9m pounds ($22.7m) and liquid resources of 1.2m pounds ($1.6m) at 31 March 2002 (2001: cash 8.1m pounds ($11.5m), liquid resources nil), excludes the receipt of 3.5m pounds ($5m) in respect of licence fees payable by Genentech in respect of the OX40 deal announced in April 2002.
Included in liquid resources is an investment in Cubist Pharmaceuticals Inc which subsequent to the 2001 year end fell in value, following an announcement by Cubist of clinical trial data, such that at the 31 March 2002 the share price was $18.48 valuing the investment held at 1.2m pounds ($1.6m), representing a decline of 1.0m pounds ($1.5m) from the valuation at 31 December 2001 of 2.2m pounds ($3.1m).
Share capital
The number of shares in issue stood at 139.1 million as at 31 March 2002.
The Directors do not currently propose a dividend for 2002 (2001: nil).
Consolidated Profit and Loss Account (unaudited)
Three Months Ended
Unaudited Unaudited Unaudited
31 March 31 March 31 March
2002 2002 2001
$000 000 pounds 000 pounds
Turnover (including share
of joint venture) 3,972 2,789 --
Less: share of joint
venture revenue (37) (26) --
Turnover 3,935 2,763 --
Operating expenses
Research and development costs (6,109) (4,290) (1,873)
Administrative expenses (2,081) (1,461) (480)
Total operating expenses (8,190) (5,751) (2,353)
Other operating income 262 184 --
Group operating loss (3,993) (2,804) (2,353)
Loss on sale of business:
Adjustment to
Discovery consideration -- -- (186)
Share of operating loss
of joint venture (46) (32) --
Total operating loss: Group
and share of joint
Venture (4,039) (2,836) (2,539)
Interest (net) 247 173 131
Amounts written off
investments (1,471) (1,033) --
Loss on ordinary activities
before taxation (5,263) (3,696) (2,408)
Tax on loss on ordinary
activities (R&D tax credit) 642 451 231
Loss on ordinary activities
after taxation attributable
to members of Xenova Group plc (4,621) (3,245) (2,177)
Loss per share (basic and diluted) (3c) (2p) (3p)
Shares used in computing net
loss per share (thousands) 139,057 139,057 69,251
US Dollar amounts have been translated at the closing rate on 31 March 2002 (1.00 pounds: $1.4241) solely for information.
Condensed Consolidated Balance Sheet (unaudited)
Unaudited Unaudited Unaudited
As at As at As at
31 March 31 March 31 March
2002 2002 2001
$000 000 pounds 000 pounds
Cash and liquid resources 24,326 17,082 8,105
Other current assets 6,347 4,457 1,292
Fixed assets (including goodwill) 28,182 19,789 1,957
Total assets 58,855 41,328 11,354
Current liabilities (including
provisions & deferred income) (20,953) (14,713) (1,636)
Shareholders` equity (37,902) (26,615) (9,718)
Total liabilities and
shareholders` equity (58,855) (41,328) (11,354)
US Dollar amounts have been translated at the closing rate on 31 March 2002 (1.00 pounds: $1.4241) solely for information.
Notes to the Statement
Basis of preparation
These unaudited statements, which do not constitute statutory accounts within the meaning of Section 240 of the Companies Act 1985, have been prepared using the accounting policies set out in the Group`s 2001 Annual Report and Accounts. The 2001 Annual Report and Accounts received an unqualified auditor`s report and will be delivered to the Registrar of Companies.
Going concern
The Group is an emerging pharmaceutical business and as such expects to absorb cash until products are commercialised. The Directors have a reasonable expectation that the Group has, or can reasonably expect to obtain, adequate cash resources to enable it to continue in operational existence for the foreseeable future, and have therefore prepared the financial statements on the going concern basis.
Gruß Bogo!
Xenova Group plc Successful Results of Phase I Trial for TA-NIC First Evaluation of Anti-Nicotine Vaccine in Man Disc-Gmcsf Found to Be Safe and Well Tolerated in Phase I Trial
SLOUGH, England, Jun 14, 2002 /PRNewswire-FirstCall via COMTEX/ -- Xenova Group plc (Nasdaq NM: XNVA; London Stock Exchange: XEN) today announces that analysis of safety and preliminary immunogenicity data from a Phase I trial for the anti-nicotine vaccine, TA-NIC, has shown the vaccine to be safe and well tolerated both systemically and locally and that the vaccine generated a specific anti-nicotine response.
This double-blind, randomised, placebo-controlled study was designed to assess the safety, tolerability and immunogenicity of the TA-NIC vaccine in both smokers and non-smokers. The vaccine was administered by intra-muscular injection and investigated at two different dose levels in a variety of dosing regimens.
TA-NIC is one of two Xenova anti-addiction product candidates undergoing clinical trials. An anti-cocaine vaccine, TA-CD, is currently in Phase II clinical development.
Speaking late yesterday at the 64th Annual Scientific Meeting of the College on Problems of Drug Dependence, in Quebec, Canada, Dr John St Clair Roberts, Medical Director of Xenova, commented:
"These preliminary results have shown that TA-NIC is both safe and well tolerated in the 60 smokers and non-smokers who took part in the trial, and that it is capable of generating antibodies which specifically bind to nicotine. We believe this is potentially important in preventing nicotine from reaching the brain, and therefore in addressing the problem of nicotine dependence. The results are extremely encouraging and will help format our future clinical development programme."
DISC-GMCSF
Xenova also announces today that its gene-therapy-based oncology product, DISC-GMCSF, has completed a Phase I trial. The dose-escalating safety study was carried out in a total of 9 patients with metastatic melanoma at three centres in the UK. DISC-GMCSF was injected directly into superficial lesions.
Following assessment of the trial results, DISC-GMCSF was found to be well tolerated, with no serious adverse events reported. The DISC vector was shown to be localised at the site of injection and had not spread beyond the required therapeutic area, as demonstrated by the lack of detectible DISC- GMCSF elsewhere in the body, a key objective of the study.
Preclinical data for DISC-GMCSF was published in July 2001 and showed DISC-GMCSF to be well tolerated. Preclinical models have also shown DISC- GMCSF to have efficacy in models of breast and colorectal cancer.
David Oxlade, Chief Executive of Xenova, commented:
"We are encouraged by the good safety profile shown by both of these products during their respective trials. This is the first time that a vaccine to treat nicotine dependence has been tested in man and we are particularly encouraged that TA-NIC has been shown to produce a specific anti-nicotine immune response."
Notes
Xenova Group plc`s product pipeline focuses principally on the therapeutic areas of cancer and immune system disorders. Xenova currently has a broad pipeline of eight programmes in clinical development. Xenova`s lead programme is a P-glycoprotein antagonist for the treatment of multi-drug resistance in cancer, known as tariquidar or XR9576. Tariquidar has completed a successful series of three Phase IIa clinical trials and is expected to enter Phase III clinical development in mid 2002. Tariquidar was partnered for the North American market with QLT Inc in late 2001. The Group has a well-established track record in the identification, development and partnering of innovative products and technologies and has partnerships with other major pharmaceutical companies including Lilly, Pfizer, Celltech, Genentech and Millennium Pharmaceuticals.
TA-NIC -- The active ingredient of the TA-NIC vaccine is a protein conjugate composed of a nicotine derivative coupled to recombinant cholera toxin B (rCTB). The protein conjugate is adsorbed onto aluminium hydroxide gel adjuvant. TA-NIC is intended as an aid to smoking cessation and has been designed to generate anti-nicotine antibodies. Nicotine present in the blood will encounter and bind to these antibodies, and the resulting nicotine-antibody complexes are too large to cross the blood-brain barrier, thus keeping nicotine out of the brain. The reinforcement of satisfying the craving will be absent or reduced, helping the smoker to break the habit.
DISC-GMCSF -- DISC-GMCSF is an oncology product that has been developed from Xenova`s proprietary DISC virus platform. It is based on Herpes Simples Virus type 2 (HSV-2) which has been modified by deleting the essential gH gene and replacing it with the gene for the cytokine Granulocyte Macrophage-Colony Stimulating Factor (GM-CSF).
DISC-GMCSF is designed to stimulate an immune response against antigens carried on host tumour cells. When DISC-GMCSF is delivered into a tumour it infects the surrounding cells and expresses GM-CSF, a potent stimulator of anti-tumour immune responses. DISC-GMCSF then completes a single cycle of replication that kills the tumour cells and releases tumour associated antigens for uptake by antigen presenting cells. It is hoped that the combination of GM-CSF expression and cell lysis will result in powerful anti tumour immune responses effective against both the injected tumour and distant metastases.
SLOUGH, England, Jun 14, 2002 /PRNewswire-FirstCall via COMTEX/ -- Xenova Group plc (Nasdaq NM: XNVA; London Stock Exchange: XEN) today announces that analysis of safety and preliminary immunogenicity data from a Phase I trial for the anti-nicotine vaccine, TA-NIC, has shown the vaccine to be safe and well tolerated both systemically and locally and that the vaccine generated a specific anti-nicotine response.
This double-blind, randomised, placebo-controlled study was designed to assess the safety, tolerability and immunogenicity of the TA-NIC vaccine in both smokers and non-smokers. The vaccine was administered by intra-muscular injection and investigated at two different dose levels in a variety of dosing regimens.
TA-NIC is one of two Xenova anti-addiction product candidates undergoing clinical trials. An anti-cocaine vaccine, TA-CD, is currently in Phase II clinical development.
Speaking late yesterday at the 64th Annual Scientific Meeting of the College on Problems of Drug Dependence, in Quebec, Canada, Dr John St Clair Roberts, Medical Director of Xenova, commented:
"These preliminary results have shown that TA-NIC is both safe and well tolerated in the 60 smokers and non-smokers who took part in the trial, and that it is capable of generating antibodies which specifically bind to nicotine. We believe this is potentially important in preventing nicotine from reaching the brain, and therefore in addressing the problem of nicotine dependence. The results are extremely encouraging and will help format our future clinical development programme."
DISC-GMCSF
Xenova also announces today that its gene-therapy-based oncology product, DISC-GMCSF, has completed a Phase I trial. The dose-escalating safety study was carried out in a total of 9 patients with metastatic melanoma at three centres in the UK. DISC-GMCSF was injected directly into superficial lesions.
Following assessment of the trial results, DISC-GMCSF was found to be well tolerated, with no serious adverse events reported. The DISC vector was shown to be localised at the site of injection and had not spread beyond the required therapeutic area, as demonstrated by the lack of detectible DISC- GMCSF elsewhere in the body, a key objective of the study.
Preclinical data for DISC-GMCSF was published in July 2001 and showed DISC-GMCSF to be well tolerated. Preclinical models have also shown DISC- GMCSF to have efficacy in models of breast and colorectal cancer.
David Oxlade, Chief Executive of Xenova, commented:
"We are encouraged by the good safety profile shown by both of these products during their respective trials. This is the first time that a vaccine to treat nicotine dependence has been tested in man and we are particularly encouraged that TA-NIC has been shown to produce a specific anti-nicotine immune response."
Notes
Xenova Group plc`s product pipeline focuses principally on the therapeutic areas of cancer and immune system disorders. Xenova currently has a broad pipeline of eight programmes in clinical development. Xenova`s lead programme is a P-glycoprotein antagonist for the treatment of multi-drug resistance in cancer, known as tariquidar or XR9576. Tariquidar has completed a successful series of three Phase IIa clinical trials and is expected to enter Phase III clinical development in mid 2002. Tariquidar was partnered for the North American market with QLT Inc in late 2001. The Group has a well-established track record in the identification, development and partnering of innovative products and technologies and has partnerships with other major pharmaceutical companies including Lilly, Pfizer, Celltech, Genentech and Millennium Pharmaceuticals.
TA-NIC -- The active ingredient of the TA-NIC vaccine is a protein conjugate composed of a nicotine derivative coupled to recombinant cholera toxin B (rCTB). The protein conjugate is adsorbed onto aluminium hydroxide gel adjuvant. TA-NIC is intended as an aid to smoking cessation and has been designed to generate anti-nicotine antibodies. Nicotine present in the blood will encounter and bind to these antibodies, and the resulting nicotine-antibody complexes are too large to cross the blood-brain barrier, thus keeping nicotine out of the brain. The reinforcement of satisfying the craving will be absent or reduced, helping the smoker to break the habit.
DISC-GMCSF -- DISC-GMCSF is an oncology product that has been developed from Xenova`s proprietary DISC virus platform. It is based on Herpes Simples Virus type 2 (HSV-2) which has been modified by deleting the essential gH gene and replacing it with the gene for the cytokine Granulocyte Macrophage-Colony Stimulating Factor (GM-CSF).
DISC-GMCSF is designed to stimulate an immune response against antigens carried on host tumour cells. When DISC-GMCSF is delivered into a tumour it infects the surrounding cells and expresses GM-CSF, a potent stimulator of anti-tumour immune responses. DISC-GMCSF then completes a single cycle of replication that kills the tumour cells and releases tumour associated antigens for uptake by antigen presenting cells. It is hoped that the combination of GM-CSF expression and cell lysis will result in powerful anti tumour immune responses effective against both the injected tumour and distant metastases.
Xenova Group plc Phase III Trials Begin for Tariquidar
SLOUGH, United Kingdom, Jun 28, 2002 /PRNewswire-FirstCall via COMTEX/ -- Xenova Group plc (Nasdaq: XNVA; London Stock Exchange: XEN) today announces that patient enrolment has begun in two pivotal Phase III clinical trials for tariquidar, in which tariquidar is being used as an adjunctive treatment in combination with first-line chemotherapy for non-small cell lung cancer (NSCLC) patients. Discovered by Xenova, tariquidar, a P-glycoprotein (P-gp) inhibitor, is being developed for the treatment of multidrug resistance (MDR) in cancer with QLT Inc. (Nasdaq: QLTI; TSE: QLT), Xenova`s partner for North America.
The two double-blind, randomised, placebo-controlled trials are being carried out in patients with stage IIIb/IV NSCLC at approximately 100 centres located throughout North America and Europe. Patients will receive as first-line therapy paclitaxel/carboplatin and either tariquidar or placebo in one trial and vinorelbine and either tariquidar or placebo in the second. Approximately 1,000 patients will be recruited in total. The trials are designed to demonstrate the ability of tariquidar to enhance the effectiveness of chemotherapeutic agents affected by MDR and the primary end-point of both trials is overall survival. An interim analysis is planned for mid-2003.
It is anticipated that, on successful completion of the Phase III programme, QLT will file for approval of tariquidar in North America for use in combination with first-line chemotherapy in advanced NSCLC by the end of 2005. NSCLC is the first of several indications for which tariquidar will be investigated. A Phase IIb trial with tariquidar in patients with refractory breast cancer is also underway at the University of Texas MD Anderson Cancer Center.
In August 2001, Xenova signed an exclusive licence agreement with Vancouver-based QLT Inc (Nasdaq MN: QLTI; TSE: QLT) for the development and marketing in the United States, Canada and Mexico of Xenova`s P-gp inhibitor, XR9576 (tariquidar) for the treatment of MDR in cancer. Under the terms of the agreement, QLT have assumed responsibility for the further development of tariquidar, including Phase III trials, all regulatory filings and the manufacture and sale of tariquidar within those territories covered by the agreement. QLT made an immediate upfront licence payment to Xenova of US$10m (7.1m pounds sterling) and will provide up to US$45m (32.0m pounds) in funding for all development activities related to Phase III clinical studies for tariquidar in North America and Europe. Milestones of up to US$50m (35.6m pounds) and royalties in the range of 15 to 22 per cent depending on the level of North American sales are also receivable by Xenova.
Xenova retains substantially all commercial rights to tariquidar outside the United States, Canada and Mexico, including European and Rest of World marketing rights.
David Oxlade, Chief Executive of Xenova, commented:
"There is increasing evidence of the rationale for this approach to the
treatment of non-small cell lung cancer. For example, in one independent
study, patients whose tumours were P-gp negative had a significantly
longer survival time than patients whose tumours were P-gp positive.
Together with our partner, QLT, good progress has been made in the 10
months since the signing of our licence agreement and we are pleased
that tariquidar has entered clinical registration studies on schedule."
Paul J. Hastings, President and CEO of QLT Inc, said:
"We are extremely pleased to begin the Phase III trials for tariquidar
on time and to have reached another critical milestone in our
development pipeline. We believe tariquidar has the potential to be
QLT`s next big success story."
Contacts:
UK: US:
Xenova Group plc Trout Group/BMC Communications
Tel: +44 (0)1753 706600 Tel: 001 212 477 9007
David A Oxlade, Chief Executive Officer Press: Brad Miles (Ext 17)
Daniel Abrams, Group Finance Director Lauren Tortorete (Ext 20)
Hilary Reid Evans, Corporate Investors: Jonathan Fassberg
Communications (Ext 16)
Lee Stern (Ext 22)
Financial Dynamics
Tel: +44 (0)207 831 3113
David Yates/Fiona Noblet
QLT Inc
Media: Tamara Hicks, Tel 001 604 707 7316
Investors: Therese Crozier or Tamara Hicks
Tel 001 604 707 7000
NOTES TO EDITORS: Xenova Group plc`s product pipeline focuses principally on the therapeutic areas of cancer and immune system disorders. Xenova currently has a broad pipeline of eight programmes in clinical development. The Group has a well-established track record in the identification, development and partnering of innovative products and technologies and has partnerships with major pharmaceutical companies including Lilly, Pfizer, Celltech, Genentech, QLT and Millennium Pharmaceuticals.
Tariquidar - One of the major barriers to successful cancer chemotherapy is the development by cancer cells of resistance to those drugs being used for treatment. Tariquidar targets this drug resistance mechanism through the inhibition of P-glycoprotein, a membrane based "pump" that acts to expel the cytotoxic drug from the tumour cell, preventing the cytotoxic drug from being fully effective. Tariquidar has completed a series of three separate Phase IIa trials, in which tariquidar was administered together with three of the world`s best-selling cytotoxic drugs, each of which is known to be affected by the resistance mechanism. The successful outcome of these trials was announced in late 2000/early 2001. The trials demonstrated that the combination of tariquidar with the cytotoxic drug was safe and well tolerated and that no clinically significant pharmacokinetic interaction occurred between tariquidar and the cytotoxic drug. This allows the cytotoxic drug to be administered at or close to its full normal clinical dose, which is of potentially significant therapeutic benefit. A number of complete and partial responses (elimination or shrinkage of the tumour) were observed to occur during these open label and uncontrolled studies.
For further information about Xenova and its products please visit the Xenova website at www.xenova.co.uk
Lung Cancer - In the United States, a total of 169,500 new cases of lung cancer were estimated for 2001, accounting for 13% of cancer diagnoses. Lung cancer is the leading cause of cancer-related death in the United States, accounting for over 30% of cancer deaths in men and 25% in women. NSCLC accounts for approximately 80% of all lung cancer cases.
QLT Inc is a global biopharmaceutical company dedicated to the discovery, development and commercialisation of innovative therapies to treat cancer, eye diseases and immune disorders. Combining expertise in opthalmopogy, oncology and photodynamic therapy, QLT has commercialised two products to date, including Visudyne(R) therapy which is the largest selling ophthalmology product ever launched. For more information you are invited to visit QLT`s website at www.qltinc.com.
For Xenova: Disclaimer to take advantage of the "Safe Harbor" provisions of the US Private Securities Litigation Reform Act of 1995. This press release contains "forward-looking statements," including statements about the discovery, development and commercialisation of products. Various risks may cause Xenova`s actual results to differ materially from those expressed or implied by the forward looking statements, including: adverse results in our drug discovery and clinical development programs; failure to obtain patent protection for our discoveries; commercial limitations imposed by patents owned or controlled by third parties; our dependence upon strategic alliance partners to develop and commercialise products and services; difficulties or delays in obtaining regulatory approvals to market products and services resulting from our development efforts; the requirement for substantial funding to conduct research and development and to expand commercialization activities; and product initiatives by competitors. For a further list and description of the risks and uncertainties we face, see the reports we have filed with the Securities and Exchange Commission. We disclaim any intention or obligation to update or revise any forward-looking statements, whether as a result of new information, future events or otherwise
SLOUGH, United Kingdom, Jun 28, 2002 /PRNewswire-FirstCall via COMTEX/ -- Xenova Group plc (Nasdaq: XNVA; London Stock Exchange: XEN) today announces that patient enrolment has begun in two pivotal Phase III clinical trials for tariquidar, in which tariquidar is being used as an adjunctive treatment in combination with first-line chemotherapy for non-small cell lung cancer (NSCLC) patients. Discovered by Xenova, tariquidar, a P-glycoprotein (P-gp) inhibitor, is being developed for the treatment of multidrug resistance (MDR) in cancer with QLT Inc. (Nasdaq: QLTI; TSE: QLT), Xenova`s partner for North America.
The two double-blind, randomised, placebo-controlled trials are being carried out in patients with stage IIIb/IV NSCLC at approximately 100 centres located throughout North America and Europe. Patients will receive as first-line therapy paclitaxel/carboplatin and either tariquidar or placebo in one trial and vinorelbine and either tariquidar or placebo in the second. Approximately 1,000 patients will be recruited in total. The trials are designed to demonstrate the ability of tariquidar to enhance the effectiveness of chemotherapeutic agents affected by MDR and the primary end-point of both trials is overall survival. An interim analysis is planned for mid-2003.
It is anticipated that, on successful completion of the Phase III programme, QLT will file for approval of tariquidar in North America for use in combination with first-line chemotherapy in advanced NSCLC by the end of 2005. NSCLC is the first of several indications for which tariquidar will be investigated. A Phase IIb trial with tariquidar in patients with refractory breast cancer is also underway at the University of Texas MD Anderson Cancer Center.
In August 2001, Xenova signed an exclusive licence agreement with Vancouver-based QLT Inc (Nasdaq MN: QLTI; TSE: QLT) for the development and marketing in the United States, Canada and Mexico of Xenova`s P-gp inhibitor, XR9576 (tariquidar) for the treatment of MDR in cancer. Under the terms of the agreement, QLT have assumed responsibility for the further development of tariquidar, including Phase III trials, all regulatory filings and the manufacture and sale of tariquidar within those territories covered by the agreement. QLT made an immediate upfront licence payment to Xenova of US$10m (7.1m pounds sterling) and will provide up to US$45m (32.0m pounds) in funding for all development activities related to Phase III clinical studies for tariquidar in North America and Europe. Milestones of up to US$50m (35.6m pounds) and royalties in the range of 15 to 22 per cent depending on the level of North American sales are also receivable by Xenova.
Xenova retains substantially all commercial rights to tariquidar outside the United States, Canada and Mexico, including European and Rest of World marketing rights.
David Oxlade, Chief Executive of Xenova, commented:
"There is increasing evidence of the rationale for this approach to the
treatment of non-small cell lung cancer. For example, in one independent
study, patients whose tumours were P-gp negative had a significantly
longer survival time than patients whose tumours were P-gp positive.
Together with our partner, QLT, good progress has been made in the 10
months since the signing of our licence agreement and we are pleased
that tariquidar has entered clinical registration studies on schedule."
Paul J. Hastings, President and CEO of QLT Inc, said:
"We are extremely pleased to begin the Phase III trials for tariquidar
on time and to have reached another critical milestone in our
development pipeline. We believe tariquidar has the potential to be
QLT`s next big success story."
Contacts:
UK: US:
Xenova Group plc Trout Group/BMC Communications
Tel: +44 (0)1753 706600 Tel: 001 212 477 9007
David A Oxlade, Chief Executive Officer Press: Brad Miles (Ext 17)
Daniel Abrams, Group Finance Director Lauren Tortorete (Ext 20)
Hilary Reid Evans, Corporate Investors: Jonathan Fassberg
Communications (Ext 16)
Lee Stern (Ext 22)
Financial Dynamics
Tel: +44 (0)207 831 3113
David Yates/Fiona Noblet
QLT Inc
Media: Tamara Hicks, Tel 001 604 707 7316
Investors: Therese Crozier or Tamara Hicks
Tel 001 604 707 7000
NOTES TO EDITORS: Xenova Group plc`s product pipeline focuses principally on the therapeutic areas of cancer and immune system disorders. Xenova currently has a broad pipeline of eight programmes in clinical development. The Group has a well-established track record in the identification, development and partnering of innovative products and technologies and has partnerships with major pharmaceutical companies including Lilly, Pfizer, Celltech, Genentech, QLT and Millennium Pharmaceuticals.
Tariquidar - One of the major barriers to successful cancer chemotherapy is the development by cancer cells of resistance to those drugs being used for treatment. Tariquidar targets this drug resistance mechanism through the inhibition of P-glycoprotein, a membrane based "pump" that acts to expel the cytotoxic drug from the tumour cell, preventing the cytotoxic drug from being fully effective. Tariquidar has completed a series of three separate Phase IIa trials, in which tariquidar was administered together with three of the world`s best-selling cytotoxic drugs, each of which is known to be affected by the resistance mechanism. The successful outcome of these trials was announced in late 2000/early 2001. The trials demonstrated that the combination of tariquidar with the cytotoxic drug was safe and well tolerated and that no clinically significant pharmacokinetic interaction occurred between tariquidar and the cytotoxic drug. This allows the cytotoxic drug to be administered at or close to its full normal clinical dose, which is of potentially significant therapeutic benefit. A number of complete and partial responses (elimination or shrinkage of the tumour) were observed to occur during these open label and uncontrolled studies.
For further information about Xenova and its products please visit the Xenova website at www.xenova.co.uk
Lung Cancer - In the United States, a total of 169,500 new cases of lung cancer were estimated for 2001, accounting for 13% of cancer diagnoses. Lung cancer is the leading cause of cancer-related death in the United States, accounting for over 30% of cancer deaths in men and 25% in women. NSCLC accounts for approximately 80% of all lung cancer cases.
QLT Inc is a global biopharmaceutical company dedicated to the discovery, development and commercialisation of innovative therapies to treat cancer, eye diseases and immune disorders. Combining expertise in opthalmopogy, oncology and photodynamic therapy, QLT has commercialised two products to date, including Visudyne(R) therapy which is the largest selling ophthalmology product ever launched. For more information you are invited to visit QLT`s website at www.qltinc.com.
For Xenova: Disclaimer to take advantage of the "Safe Harbor" provisions of the US Private Securities Litigation Reform Act of 1995. This press release contains "forward-looking statements," including statements about the discovery, development and commercialisation of products. Various risks may cause Xenova`s actual results to differ materially from those expressed or implied by the forward looking statements, including: adverse results in our drug discovery and clinical development programs; failure to obtain patent protection for our discoveries; commercial limitations imposed by patents owned or controlled by third parties; our dependence upon strategic alliance partners to develop and commercialise products and services; difficulties or delays in obtaining regulatory approvals to market products and services resulting from our development efforts; the requirement for substantial funding to conduct research and development and to expand commercialization activities; and product initiatives by competitors. For a further list and description of the risks and uncertainties we face, see the reports we have filed with the Securities and Exchange Commission. We disclaim any intention or obligation to update or revise any forward-looking statements, whether as a result of new information, future events or otherwise
Xenova Group plc will be announcing its results for the second quarter ending
30 June 2002 on Wednesday 14 August 2002.
30 June 2002 on Wednesday 14 August 2002.
Doch noch was Interessantes zu XENOVA und gefunden.
LONDON (AFX) - Several of Britain`s biggest biotechnology companies have been
holding secret talks in an attempt to forge a cancer company that could compete on a
global stage , the Financial Times reported citing bankers involved in the project.
The initiative, under discussion for several weeks, is understood to involve four
cancer specialists -- Xenova PLC, Antisoma PLC, British Biotech PLC and KS Biomedix
-- as well as cash-rich Oxford GlycoSciences PLC, the newspaper said.
"It`s about time we created UK Oncology plc," one banker involved in the project
is reported as saying.
Another squad of companies, including Oxford Biomedica PLC, which specialises in
gene discovery, and Protherics PLC, the vaccine company, are understood to be on the
sidelines of negotiations, the article continued. Bankers also cite Alizyme PLC,
Vernalis PLC and PPL Therapeutics PLC as potential participants, the newspaper
added.
In the 20 years since Britain`s biotech industry began, merger and acquisition
activity has been rare, with founder-managers across a fragmented sector reluctant to
let go of the reins.
The principal catalyst for the talks is believed to have been the interest of
proactive investors who are pushing for mergers in a bid to reverse share price
falls, the newspaper said.
Last month, it emerged that Amvescap, the Anglo-American fund manager, had taken
up leading shareholder positions at British Biotech, OGS and Xenova, some of the
sector`s cheapest stocks. It also has holdings in Oxford Biomedica and Antisoma.
"
LONDON (AFX) - Several of Britain`s biggest biotechnology companies have been
holding secret talks in an attempt to forge a cancer company that could compete on a
global stage , the Financial Times reported citing bankers involved in the project.
The initiative, under discussion for several weeks, is understood to involve four
cancer specialists -- Xenova PLC, Antisoma PLC, British Biotech PLC and KS Biomedix
-- as well as cash-rich Oxford GlycoSciences PLC, the newspaper said.
"It`s about time we created UK Oncology plc," one banker involved in the project
is reported as saying.
Another squad of companies, including Oxford Biomedica PLC, which specialises in
gene discovery, and Protherics PLC, the vaccine company, are understood to be on the
sidelines of negotiations, the article continued. Bankers also cite Alizyme PLC,
Vernalis PLC and PPL Therapeutics PLC as potential participants, the newspaper
added.
In the 20 years since Britain`s biotech industry began, merger and acquisition
activity has been rare, with founder-managers across a fragmented sector reluctant to
let go of the reins.
The principal catalyst for the talks is believed to have been the interest of
proactive investors who are pushing for mergers in a bid to reverse share price
falls, the newspaper said.
Last month, it emerged that Amvescap, the Anglo-American fund manager, had taken
up leading shareholder positions at British Biotech, OGS and Xenova, some of the
sector`s cheapest stocks. It also has holdings in Oxford Biomedica and Antisoma.
"
Ich habe die Zahlen aus einer UK-Website. Nichteinmal in der XENOVA-Website waren Sie um ca. 12 Uhr zu finden. Daher vielleicht die niegrigen Umsaetze heute in Londen.
Xenova Group PLC
14 August 2002
14 August 2002
Xenova: Interim Results Announcement 2002
Half Year Highlights:
• Phase III trials begin for multi-drug resistance modulator tariquidar
• Successful results of Phase IIa trial for therapeutic vaccine TA-HPV
• Patient dosing begins in Phase IIa study for anti-cocaine addiction
vaccine TA-CD
• First evaluation of anti-nicotine vaccine in man - positive Phase I
results for TA-NIC
• Positive Phase I results for immunotherapeutic anti-cancer vaccine
DISC-GMCSF
• Anti-cancer compound XR11576 enters Phase I clinical trials
• $63m (£43.2m) development and licence agreement with Genentech Inc for
novel drugs in immune inflammatory disease
• Cash and liquid resources as at 30 June £15.1m, ($23.0m)
Commenting, Chief Executive Officer, David Oxlade said:
`Xenova has made considerable progress in the first six months of 2002, both in
terms of advancing its clinical pipeline and in expanding its revenue-generating
collaborations.
`Tariquidar`s entry to Phase III studies in June was an important step forward
and highlights the maturity of our growing clinical product portfolio. The
licence agreement announced in April with Genentech, to develop novel therapies
for auto-immune disease, underlines the potential of our early stage product
pipeline.`
Contacts:
UK: US:
Xenova Group plc Trout Group/BMC Communications
Tel: +44 (0)1753 706600 Tel: 001 212 477 9007
David A Oxlade, Chief Executive Officer Press: Brad Miles (Ext 17) Lauren Tortorete (Ext 20)
Daniel Abrams, Group Finance Director Investors: Jonathan Fassberg (Ext 16) Lee Stern (Ext 22)
Hilary Reid Evans, Corporate Communications
Financial Dynamics
Tel: +44 (0)207 831 3113
Fiona Noblet / Jonathan Birt
Notes to Editors
Xenova Group plc`s product pipeline focuses principally on the therapeutic areas
of cancer and immune system disorders. Xenova currently has a broad pipeline of
eight programmes in clinical development. The Group has a well-established
track record in the identification, development and partnering of innovative
products and technologies and has partnerships with significant pharmaceutical
companies including Lilly, Pfizer, Celltech, Genentech, QLT and Millennium
Pharmaceuticals.
For further information about Xenova and its products please visit the Xenova
website at www.xenova.co.uk
For Xenova: Disclaimer to take advantage of the `Safe Harbor` provisions of the
US Private Securities Litigation Reform Act of 1995. This press release contains
`forward-looking statements,` including statements about the discovery,
development and commercialisation of products. Various risks may cause Xenova`s
actual results to differ materially from those expressed or implied by the
forward looking statements, including: adverse results in our drug discovery and
clinical development programs; failure to obtain patent protection for our
discoveries; commercial limitations imposed by patents owned or controlled by
third parties; our dependence upon strategic alliance partners to develop and
commercialise products and services; difficulties or delays in obtaining
regulatory approvals to market products and services resulting from our
development efforts; the requirement for substantial funding to conduct research
and development and to expand commercialisation activities; and product
initiatives by competitors. For a further list and description of the risks and
uncertainties we face, see the reports we have filed with the Securities and
Exchange Commission. We disclaim any intention or obligation to update or
revise any forward-looking statements, whether as a result of new information,
future events or otherwise.
Chairman`s Statement
During the first six months of 2002 we have made considerable progress in
advancing our clinical pipeline. Our clinical portfolio now includes one Phase
III, two Phase II and four Phase I drug candidates, plus an animal disease
product in the equivalent of Phase I trials. We believe we have established a
strong and well-balanced product pipeline, strengthened by a further eight
products in preclinical development.
We aim to create a robust, sustainable and revenue generating company in the
medium term and, with this objective in mind, we seek to optimise revenues from
upfront and milestone payments by entering into licensing agreements for our
products. To this end, we entered into a development and licence agreement with
Genentech Inc (Genentech), in April 2002, worth a potential $63m (Β£43.2m),
granting Genentech worldwide rights to develop and market products primarily
targeting disorders of the immune system based on Xenova`s OX40 receptor protein
and anti-OX40 Ligand antibody programmes. Good progress has also been made under
some of our existing partnership agreements during the first half of 2002,
evidenced by the progress into clinical trials of XR11576, with our partner
Millennium Pharmaceuticals Inc (Millennium), and the start of Phase III trials
for tariquidar, with our partner QLT Inc (QLT).
Our commercial strategy is to consider the optimal time for partnering of our
products on a project by project basis. You will find details of the progress
made by all our programmes, and of the agreements in place, in the Product
Pipeline Update section of this statement.
Revenues increased to Β£6.8m ($10.3m) from Β£0.5m ($0.8m), when compared with the
first six months of 2001, due primarily to revenues recorded in relation to the
three major partnerships outlined above. Total net operating expenses remained
constant at Β£11.0m ($16.8m) when compared with the last six months of 2001
(Β£11.2m ($17.1m)).
Based on our expected net monthly cash outflow, cash and liquid resources as at
the end of June were sufficient to fund our current operations for in excess of
one year.
Product Pipeline Update - Clinical Trials
Cancer:
XR9576 (tariquidar) - Discovered by Xenova, tariquidar, a potent small-molecule
inhibitor of the P-glycoprotein pump, is being developed for the treatment of
multidrug resistance (MDR) in cancer. In August 2001, Xenova signed an
exclusive licence agreement with QLT Inc for the development and marketing in
the United States, Canada and Mexico of tariquidar for the treatment of MDR in
cancer. Under the terms of the agreement, QLT has assumed responsibility for
the further development of tariquidar in those territories covered by the
agreement. QLT made an immediate upfront licence payment to Xenova of US$10m
(Β£7.1m) and will provide up to US$45m (Β£32m) in funding for all development
activities related to Phase III clinical studies for tariquidar in North America
and Europe. Milestones of up to US$50m (Β£35.6m) and royalties in the range of
15 to 22 per cent, depending on the level of North American sales, are also
receivable by Xenova. Xenova retains substantially all commercial rights to
tariquidar outside the United States, Canada and Mexico, including European and
Rest of World rights.
Tariquidar entered two pivotal Phase III clinical trials, in which tariquidar is
being used as an adjunctive treatment in combination with first-line
chemotherapy for non-small cell lung cancer (NSCLC) patients, in June 2002. The
two double-blind, randomised, placebo-controlled trials are being carried out in
patients with stage IIIb/IV NSCLC at approximately 100 centres located
throughout North America and Europe. An interim analysis is planned for
mid-2003 and it is anticipated that, on successful completion of the Phase III
programme, QLT will file for approval of tariquidar in North America for use in
combination with first-line chemotherapy in advanced NSCLC by the end of 2005
and Xenova will file for marketing approval in Europe.
DISC-GMCSF - DISC-GMCSF, an innovative immunotherapeutic vaccine, is designed as
a treatment for a broad range of solid tumours. DISC-GMCSF delivers the gene for
the expression of GM-CSF, a potent stimulator of anti-tumour immune responses,
direct to the tumour site through the use of a disabled virus vector (DISC) and
is administered using direct injection. In preclinical studies DISC-GMCSF was
shown to be effective in models of breast and colorectal cancer. As announced
in June 2002, DISC-GMCSF successfully completed a Phase I dose-escalating safety
study at three centres in the UK, in patients with metastatic melanoma.
DISC-GMCSF was found to be well tolerated, with no serious adverse events
reported. The DISC vector was shown to be localised at the site of injection
and had not spread beyond the required therapeutic area, a key objective of the
study.
TA-HPV/TA-CIN - TA-HPV is an immunotherapeutic vaccine, which is being developed
to prevent the recurrence of cervical cancer. The product is intended to be
used as a therapeutic vaccine alongside standard treatments, such as surgery,
for cervical cancer. The results of two physician-initiated Phase IIa trials,
in which TA-HPV was tested in patients with high-grade vulval intra-epithelial
neoplasia (VIN 3), have shown the vaccine to be safe and well tolerated, with a
complete or partial response being shown in over 40% of cases.
TA-CIN is a recombinant fusion protein, designed as a treatment for women with
cervical dysplasia. Preclinical studies have suggested that use of this product
together with TA-HPV results in a greatly enhanced immune response. An open
label, physician sponsored Phase II `prime-boost` study, targeting the treatment
of HPV associated ano-genital neoplasias, began in October 2001. Results of
this trial are anticipated by the end of the current year.
XR11576 (MLN576) - XR11576, XR5944 and XR11612 are novel DNA targeting agents,
whose method of action includes dual inhibition of topoisomerases I and II.
XR11576 is the subject of a licence agreement with Millennium Pharmaceuticals
Inc, announced in December 2001. The other compounds covered by this agreement,
XR5944 (MLN944) and XR11612 (MLN612), are currently in preclinical development.
XR11576 entered Phase I clinical trials in February 2002. The open label Phase
I trial is being carried out at centres in the UK and the Netherlands and
comprises multiple ascending oral doses in patients with solid tumours.
Patients are being monitored for safety, tolerability, pharmacokinetics and
anti-tumour activity. Xenova retains responsibility for performing development
activities associated with the programme to the end of Phase II clinical trials.
Millennium will provide funding for the programme commencing in 2003, up to
the agreed level of $20m.
Other:
DISC-PRO - A prophylactic vaccine designed to prevent genital and oro-labial
herpes, DISC-PRO has completed Phase I trials. These Phase I trials demonstrated
that DISC-PRO was well tolerated and immunogenic. We intend to secure a
corporate partner ahead of Phase III clinical trials for the further development
of this programme.
TA-NIC - Designed as a treatment for nicotine addiction, TA-NIC is a nicotine
conjugate vaccine which is administered through a course of intramuscular
injections. The vaccine is designed to prime the immune system to produce
anti-nicotine antibodies such that, on smoking a cigarette, the nicotine will
bind to these antibodies, which are too large to cross the blood-brain barrier,
thus reducing or removing the pleasurable stimulus which usually accompanies
smoking. The successful results of a Phase I trial for TA-NIC, reported in June
2002, showed the vaccine to be safe and well tolerated both systemically and
locally in the 60 smokers and non-smokers who took part in the trial, and that
the vaccine generated a specific anti-nicotine response. This is the first time
such a vaccine has been tested in man.
TA-CD - TA-CD is a therapeutic vaccine which is under development for the
treatment of cocaine addiction. It`s mechanism of action is similar to that of
TA-NIC. A Phase IIa dose escalation trial, supported by the US National
Institute on Drug Abuse (NIDA), began in April 2002. The results of an earlier
Phase IIa dose escalation study, which were reported in July 2001, showed TA-CD
to be well tolerated both systemically and locally. Cocaine specific antibodies
were found to persist throughout the 12 weeks of the study and an attenuation of
the usual euphoric effects of cocaine was reported amongst patients who relapsed
during the study, providing anecdotal evidence of the benefit TA-CD may provide.
DISC-VET - DISC-VET is currently undergoing development for the treatment of
multiple diseases in animals. A product candidate, DISC-BHV, for the treatment
of bovine herpes virus induced respiratory disease in cattle, is in the
equivalent of Phase I clinical development in partnership with Pfizer.
Product Pipeline Review and Update - Preclinical
Cancer:
XR5944 (MLN944) and XR11612 (MLN612) - XR5944 and XR11612 form, with XR11576,
the programme of novel anti-cancer agents which was partnered with Millennium in
December 2001. XR5944 has shown exceptionally high potency as a cytotoxic agent
in preclinical studies with a number of human tumour cell lines both in vitro
and in vivo. It is structurally distinct from XR11576 and has been shown to be
unaffected by atypical multi-drug resistance mechanisms. XR11612 is in
preclinical testing as a back-up to XR11576.
PAI-Cancer - In collaboration with the Institute for Cancer Research, we are
developing an active novel inhibitor of a protein released by platelets and the
cells lining the blood vessels known as PAI-1. PAI is an unfavourable
prognostic indicator in many human cancers and is strongly implicated in the
metastatic process. Lilly has an option to acquire exclusive rights to develop
and commercialise PAI-1 inhibitors in the cancer field, which, if exercised,
would realise upfront and milestone payments of up to $16.5m, with additional
royalties payable on commercialised products.
OX40L - OX40 is a platform technology which is capable of producing multiple
drug candidates primarily targeting cancer and autoimmune disease. We have
demonstrated that a product candidate for OX40L (the ligand which binds to the
OX40 receptor) elicits anti-tumour activity in preclinical models and work is
underway to test the product in a broader range of disease models, including
those for infectious diseases. A Β£43.2m development and licence agreement was
signed in April 2002 with Genentech for the worldwide rights to develop and
market products, primarily targeting disorders of the immune system, based on
Xenova`s OX40 receptor protein and anti-OX40 Ligand antibody programmes. Under
this agreement, Xenova retains all rights to the up-regulation of the immune
system using the OX40:OX40L interaction, including for use in oncology and
infectious disease therapy.
MRP - Multi-Drug Resistance Protein (MRP) acts as a pump which, like the
P-glycoprotein pump, expels small molecules out of cells and thus can help
protect tumour cells from certain chemotherapeutic agents. We are currently
carrying out a lead optimisation programme for a compound for the inhibition of
MRP to further strengthen our position in the field of multi-drug resistance.
Other:
OX40 - A partnership has been established with Celltech Group plc to develop an
antibody-based product against OX40 for the treatment of autoimmune disease.
Along with OX40L, OX40 is also the subject of a development and licence
agreement with Genentech (see above).
M3 - M3 is a viral protein with the capacity to bind to a broad range of
chemokines which have multiple biological functions, including mediation of
inflammation and promotion of angiogenesis. Consequently, chemokine inhibition
is a potential approach to treatment of a wide range of diseases. Work is in
progress in several preclinical models to evaluate potential efficacy.
PAI-CV - In conjunction with our partner Lilly, we are carrying out a research
and development programme for the development of a new class of oral
antithrombotic drugs suitable for chronic use. Research is focused on the
development of small molecule inhibitors of PAI-1 that are designed to enhance
the break-up of blood clots without the side-effects of bleeding associated with
other marketed antithrombotic drugs. Xenova and Lilly entered into this
collaboration in 1998.
MEN-B - Xenova is currently developing a vaccine for the prevention of
meningitis caused by meningococcal group B infections. This programme is being
carried out in collaboration with the Institute for Infections and Immunity,
based at Nottingham University. The aim is to construct a live attenuated
vaccine, which should give good protection against all group B strains. The
programme is currently at the lead product evaluation stage.
Phogen:
A joint venture between Xenova and Marie Curie Cancer Care, Phogen Limited is
developing a novel technology, known as VP22, for the enhanced delivery of
gene-based therapeutics. Phogen entered into a Β£15.0m ($21.0m) licensing
agreement with Genencor International Inc, for the utilisation of Phogen`s VP22
technology in the area of therapeutic vaccines for certain infectious viral
diseases, in August 2001. A further research collaboration was announced with
Cell Genesys in October 2001. Phogen intends to seek additional partnering
opportunities for its novel technologies.
Financial Summary
Operating Performance
In the six months to 30 June 2002, the Group`s revenues from licensing
agreements, strategic partnerships and manufacturing outsourcing were Β£6.8m
($10.3m) (2001 Β£0.5m ($0.8m)).
In accordance with the Group`s revenue recognition policy, of the Β£6.9m ($10.6m)
received from QLT in 2001 as part of the tariquidar licensing agreement, Β£1.2m
($1.8m) was included in the 6 months to 30 June 2002, with a further Β£5.2m
($7.9m) being deferred to future periods. Of the Β£7.9m ($12.0m) received from
Millennium, Β£4.9m ($7.4m) was recognised by the Group in the six months to 30
June 2002, with a further Β£3.0m ($4.6m) being deferred to future periods.
Following the successful completion of a further licensing deal in the period in
respect of the OX40 program with Genentech, Β£0.3m ($0.5m) of the upfront licence
fee of Β£2.7m ($4.2m) has been recognised in this half year. Other revenue
included Β£0.4m ($0.6m) in respect of ongoing contract vaccine manufacturing.
The net operating expenses for the six months to 30 June 2002 were Β£11.0m
($16.8m) (2001: Β£8.9m ($13.6m)). The total net operating expenses in the 6
months to 30 June 2002 of Β£11.0m ($16.8m) remained in line with the second half
of 2001 (Β£11.2m ($17.1m)) which reflected the ongoing savings resulting from the
2001 mid year strategic review following the acquisition of Cantab on 4 April
2001. Accordingly, the first half results in 2001 included only one quarter of
the Cantab results.
Total research expenditure for the six months to 30 June 2002 was Β£8.4m ($12.9m)
(2001: Β£6.6m ($10.1m)). Research expenditure included substantial preclinical
and clinical development of the programme of novel DNA targeting agents, one of
which (XR11576) entered Phase I clinical trials in February, and completion of
Phase I clinical development of TA-NIC. There is not expected to be a
significant impact to research expenditure following the licensing agreements
with QLT and Millennium until 2003, when cost reimbursement commences under the
latter agreement relating to the programme of novel DNA targeting agents.
Total administration expenditure for the six months to 30 June 2002 was Β£2.8m
($4.3m) (2001: Β£2.3m ($3.5m)). The cost reductions realised in quarter one 2002
were maintained in quarter two 2002, with administrative expenses (excluding the
amortisation of goodwill) falling slightly to Β£1.1m ($1.7m) (Q1 2002: Β£1.2m
($1.8m)). The subletting of excess facilities reduced net operating expenses by
Β£0.2m ($0.3m) in the first six months of 2002 (2001: nil).
Of the total administrative expenses for the six months to 30 June 2002 of Β£2.8m
($4.3m), Β£0.6m ($0.9m) relates to the amortisation, over a 10-year period, of
the goodwill in respect of the acquisition of Cantab in 2001.
Cash outflow before financing and acquisitions in the six months to 30 June 2002
of Β£7.3m ($11.1m) has been reduced from 2001 (Β£10.0m ($15.3m)). Cash received
from licensing activity during the six months ended 30 June 2002 was Β£2.7m
($4.2m) (2001: nil).
The Company continues to explore licensing opportunities to maximise value for
shareholders and reduce cash outflow.
The net loss per share in the six months to 30 June 2002 was 3.3p (2001: 6.2p).
Cash and liquid resources
Cash and liquid resources at 30 June 2002 totalled Β£15.1m ($23.0m) (2001: Β£18.1m
($27.6m)). Of this balance, cash was Β£14.5m ($22.2m) and liquid resources were
Β£0.5m ($0.8m) at 30 June 2002 (2001: cash Β£15.7m ($23.9m), liquid resources
Β£2.4m ($3.7m)).
Included in liquid resources is an investment in Cubist Pharmaceuticals Inc.,
which subsequent to the 2001 year end fell in value, following an announcement
by Cubist of clinical trial data, such that at 30 June 2002 the share price was
$9.41 valuing the investment held at Β£0.5m ($0.8m), representing a decline of
Β£1.7m ($2.6m) from the valuation at 31 December 2001 of Β£2.2m ($3.4m).
Based upon the expected net monthly cash outflow, the cash and liquid
investments are sufficient to fund current operations for in excess of one year.
Share capital
The number of shares in issue stood at 139.1 million as at 30 June 2002 (2001:
139.0 million).
The Directors do not propose to pay an interim dividend for 2002 (2001: nil).
Consolidated Profit and Loss Account (unaudited)
Unaudited Unaudited Unaudited Audited
Six Months Six Months Six Months Year
Ended Ended Ended Ended
30 June 30 June 30 June 31 December
Notes 2002 2002 2001 2001
$000 Β£000 Β£000 Β£000
Turnover (including share of joint venture) 10,549 6,914 504 1,877
Less: share of joint venture revenue (230) (151) (3) (95)
_____ _____ _____ _____
Turnover 10,319 6,763 501 1,782
Operating expenses
Research and development costs (12,853) (8,424) (6,643) (15,374)
_____ _____ _____ _____
(12,853) (8,424) (6,643) (15,374)
_____ _____ _____ _____
Administrative expenses (3,441) (2,255) (1,345) (2,961)
Administrative expenses: exceptional - - (658) (1,035)
reorganisation costs
Administrative expenses: amortisation of (894) (586) (293) (879)
goodwill
_____ _____ _____ _____
Total administrative expenses (4,335) (2,841) (2,296) (4,875)
Other operating income 417 273 - 115
Total net operating expenses (16,771) (10,992) (8,939) (20,134)
____ ____ ____ ____
Group operating loss (6,452) (4,229) (8,438) (18,352)
Share of operating profit/(loss) of joint 53 35 (29) (33)
venture
____ ____ ____ ____
Total operating loss: Group and share of joint (6,399) (4,194) (8,467) (18,385)
venture
Interest (net) 514 337 400 754
Amounts written (off) / back to investments 2 (2,498) (1,637) 675 463
____ ____ ____ ____
Loss on ordinary activities before taxation (8,383) (5,494) (7,392) (17,168)
Tax on loss on ordinary activities 3 1,329 871 907 1,797
____ ____ ____ ____
Loss on ordinary activities after taxation (7,054) (4,623) (6,485) (15,371)
attributable to members of Xenova Group plc
4 ____ ____ ____ ____
Loss per share (basic and diluted) (5.1c) (3.3p) (6.2p) (12.6p)
____ ____ ____ ____
Shares used in computing net loss per share 139,057 139,057 104,044 121,596
(thousands)
US Dollar amounts have been translated at the closing rate on 30 June 2002
(Β£1.00: $1.5258) solely for information.
Statement of Total Recognised Gains and Losses (unaudited)
Unaudited Unaudited Unaudited Audited
Six months Six months Six months Year
Ended Ended Ended Ended
30 June 30 June 30 June 31 December
2002 2002 2001 2001
Β£000 $000 Β£000 Β£000
Loss attributable to Xenova Group plc (7,115) (4,663) (6,456) (15,341)
Loss attributable to joint venture 61 40 (29) (30)
_____ _____ _____ _____
Total loss attributable to members of Xenova
Group plc (7,054) (4,623) (6,485) (15,371)
Translation difference (1) (1) 2 -
_____ _____ _____ _____
Total recognised gains and losses in the period (7,055) (4,624) (6,483) (15,371)
attributable to members of Xenova Group plc
_____ _____ _____ _____
US Dollar amounts have been translated at the closing rate on 30 June 2002
(Β£1.00: $1.5258) solely for information.
Consolidated Balance Sheet (unaudited)
Unaudited Unaudited Unaudited Audited
As at As at As at As at
30 June 30 June 30 June 31 December
2002 2002 2001 2001
Notes $000 Β£000 Β£000 Β£000
Fixed Assets
Intangible assets 15,585 10,214 11,379 10,798
Tangible assets 13,813 9,053 9,880 9,586
Investment in joint venture:
Share of gross assets 638 418 40 438
Share of gross liabilities (671) (440) (101) (500)
Goodwill arising on acquisition 42 28 32 30
_____ _____ _____ _____
9 6 (29) (32)
_____ _____ _____ _____
29,407 19,273 21,230 20,352
Current Assets
Debtors 6,875 4,506 5,552 4,135
Investments 2 834 547 2,396 2,184
Cash at bank and in hand 22,158 14,522 15,676 21,816
_____ _____ _____ _____
29,867 19,575 23,624 28,135
Creditors: amounts falling due within one 6 (20,424) (13,386) (5,703) (18,420)
year
_____ _____ _____ _____
Net current assets 9,443 6,189 17,921 9,715
Total assets less current liabilities 38,850 25,462 39,151 30,067
Creditors: amounts falling due after more (323) (212) (367) (221)
than one year
Provisions for liabilities and charges (20) (13) (25) (10)
_____ _____ _____ _____
Total net assets 38,507 25,237 38,759 29,836
_____ _____ _____ _____
Capital and reserves
Called up share capital 21,218 13,906 13,062 13,904
Shares to be issued - - 4,127 -
Share premium account 112,714 73,872 73,925 73,870
Merger reserve 41,529 27,218 23,933 27,218
Other reserves 27,315 17,902 17,902 17,902
Profit and loss account (164,269) (107,661) (94,190) (103,058)
_____ _____ _____ _____
Shareholders` funds - equity interests 4 38,507 25,237 38,759 29,836
_____ _____ _____ _____
US Dollar amounts have been translated at the closing rate on 30 June 2002
(Β£1.00: $1.5258) solely for information.
Consolidated Cash Flow Statement (unaudited)
Notes Unaudited Unaudited Unaudited Audited
Six months Six months Six months Year
Ended Ended Ended Ended
30 June 30 June 30 June 31 December
2002 2002 2001 2001
$000 Β£000 Β£000 Β£000
Net cash outflow from operating activities 5 (11,295) (7,403) (8,144) (3,836)
Returns on investments and servicing of
finance
Interest received 517 339 376 1,023
Interest element of finance lease rental (3) (2) (5) (15)
payments
_____ _____ _____ _____
Net cash inflow from returns on 514 337 371 1,008
investments and servicing of finance
Taxation 3 - - - 1,870
Capital expenditure and financial
investment
Purchase of tangible fixed assets (351) (230) (2,224) (2,797)
_____ _____ _____ _____
Net cash outflow from capital expenditure (351) (230) (2,224) (2,797)
and financial investment
Acquisitions and disposals
Purchase of subsidiary undertakings - - (768) (768)
Cash at bank and in hand acquired with - - 16,822 16,822
subsidiary
_____ _____ _____ _____
Net cash inflow from acquisitions - - 16,054 16,054
_____ _____ _____ _____
Net cash (outflow)/inflow before financing (11,132) (7,296) 6,057 12,299
Financing
Issue of ordinary share capital 6 4 9 9
Expenses on issue of shares - - (864) (919)
Capital element of finance lease rental (3) (2) (40) (87)
payments
_____ _____ _____ _____
Net cash inflow/(outflow) from financing 3 2 (895) (997)
_____ _____ _____ _____
(Decrease)/increase in cash during the (11,129) (7,294) 5,162 11,302
period
_____ _____ _____ _____
Reconciliation of Net Cash Flow to Movement in Net Funds (unaudited)
Unaudited Unaudited Unaudited Audited
Six Months Six Months Six Months Year
Ended Ended Ended Ended
30 June 30 June 30 June 31 December
2002 2002 2001 2001
$000 Β£000 Β£000 Β£000
(Decrease)/increase in cash during the period (11,129) (7,294) 5,162 11,302
Capital element of finance lease payments 3 2 40 87
_____ _____ _____ _____
Change in net funds resulting from cash flows (11,126) (7,292) 5,202 11,389
Finance leases acquired with subsidiary operations - (101) (101)
Change in value of liquid investments (2,498) (1,637) 675 463
Translation difference - - 2 2
_____ _____ _____ _____
Change in net funds (13,624) (8,929) 5,778 11,753
Net funds at 1 January 36,598 23,986 12,233 12,233
_____ _____ _____ _____
Net funds at 30 June / 31 December 22,974 15,057 18,011 23,986
_____ _____ _____ _____
US Dollar amounts have been translated at the closing rate on 30 June 2002
(Β£1.00: $1.5258) solely for information.
Notes to the Interim Statement
1 Basis of preparation
These unaudited interim statements, which do not constitute statutory accounts
within the meaning of Section 240 of the Companies Act 1985, have been prepared
using the accounting policies set out in the Group`s 2001 Annual Report and
Accounts except as set out below. The 2001 Annual Report and Accounts received
an unqualified auditor`s report and have been delivered to the Registrar of
Companies.
Following the issue of Financial Reporting Standard Number 19 - `Deferred tax`
the group has adopted the incremental liability approach (`Full` provision
basis) from 1 January 2002. The Group`s policy now states, `Deferred tax is
recognised in respect of timing differences that have originated but not
reversed by the balance sheet date, but only when transactions or events that
result in a right to pay less tax or an obligation to pay more tax in the future
have occurred at the balance sheet date. The likelihood of these rights or
obligations arising is based upon the estimated probabilities of future events
occurring, taking into account the relevant factors pertinent to the industry
sector in which the Group operates. Deferred tax is measured on a non-discounted
basis`. The deferred tax recognised in 2001 under the former policy (nil) would
not have been different under the revised policy adopted from 2002.
There have been no other changes to the Group`s accounting policies in 2002.
2 Amounts written back on investments
The Β£1,637,000 written off on investments reflects the unrealised loss on the
Group`s holding of 88,668 Cubist Pharmaceuticals Inc shares following a fall in
the listed market price since 31 December 2001.
3 Taxation
The Group has recognised the R&D tax credit in respect of the first half of the
year that will be received in 2003. The Group has not recognised any deferred
tax assets or liabilities in the period.
4 Reconciliation of movements in shareholders` funds
Unaudited Unaudited Audited
Six Months Six Months Year
Ended Ended Ended
30 June 30 June 31 December
2002 2001 2001
Β£000 Β£000 Β£000
At start of period 29,836 11,876 11,876
Allotments of shares in the period 4 9 9
Issue of shares in respect of acquisition - 30,070 34,197
Shares to be issued - 4,127 -
Expenses on issue of shares - (864) (919)
Shares to be issued under long term incentive scheme 21 24 44
Loss for the period (4,623) (6,485) (15,371)
Exchange movement (1) 2 -
_____ _____ _____
At end of period 25,237 38,759 29,836
_____ _____ _____
5 Reconciliation of operating loss to net cash outflow from operating
activities
Unaudited Unaudited Audited
Six Months Six Months Year
Ended Ended Ended
30 June 30 June 31 December
2002 2001 2001
Β£000 Β£000 Β£000
Group operating loss (4,229) (8,438) (18,352)
Depreciation 763 509 1,201
Amortisation 588 293 879
Provision for liabilities and charges 3 5 (10)
Net loss on disposal of tangible fixed assets - - 16
Decrease in debtors 500 580 734
Decrease in creditors (1,478) (1,117) (2,573)
Charge for long term incentive scheme 21 24 44
(Decrease)/increase in deferred income (3,571) - 14,225
_____ _____ _____
Net cash outflow from operating activities (7,403) (8,144) (3,836)
_____ _____ _____
6 Deferred income
Included in Creditors is Β£10,654,000 (30 June 2001: Β£nil, 31 December 2001:
Β£14,225,000) in respect of deferred income.
7 Going concern
The Group is an emerging pharmaceutical business and as such expects to absorb
cash until products are commercialised. The Directors have a reasonable
expectation that the Group has, or can reasonably expect to obtain, adequate
cash resources to enable it to continue in operational existence for the
foreseeable future, and have therefore prepared the financial statements on the
going concern basis.
Independent review report to Xenova Group plc
Introduction
We have been instructed by the company to review the financial information set
out on pages 9 to 15. We have read the other information contained in the
interim report and considered whether it contains any apparent misstatements or
material inconsistencies with the financial information.
Directors` responsibilities
The interim report, including the financial information contained therein, is
the responsibility of, and has been approved by the directors. The directors are
responsible for preparing the interim report in accordance with the Listing
Rules of the Financial Services Authority which require that the accounting
policies and presentation applied to the interim figures should be consistent
with those applied in preparing the preceding annual accounts except where any
changes, and the reasons for them, are disclosed.
Review work performed
We conducted our review in accordance with guidance contained in Bulletin 1999/4
issued by the Auditing Practices Board for use in the United Kingdom. A review
consists principally of making enquiries of Xenova Group plc management and
applying analytical procedures to the financial information and underlying
financial data and, based thereon, assessing whether the accounting policies and
presentation have been consistently applied unless otherwise disclosed. A review
excludes audit procedures such as tests of controls and verification of assets,
liabilities and transactions. It is substantially less in scope than an audit
performed in accordance with United Kingdom Auditing Standards and therefore
provides a lower level of assurance than an audit. Accordingly we do not express
an audit opinion on the financial information.
Review conclusion
On the basis of our review we are not aware of any material modifications that
should be made to the financial information as presented for the six months
ended 30 June 2002.
PricewaterhouseCoopers
Chartered Accountants
Uxbridge
14 August 2002
Notes:
(a) The maintenance and integrity of the Xenova Group plc website
is the responsibility of the directors; the work carried out by the auditors
does not involve consideration of these matters and, accordingly, the auditors
accept no responsibility for any changes that may have occurred to the interim
report since it was initially presented on the website.
(b) Legislation in the United Kingdom governing the preparation and
dissemination of financial information may differ from legislation in other
jurisdictions.
This information is provided by RNS
The company news service from the London Stock Exchange
Updated at 11:20 on Wed,14 Aug 2002. Data 15
Xenova Group PLC
14 August 2002
14 August 2002
Xenova: Interim Results Announcement 2002
Half Year Highlights:
• Phase III trials begin for multi-drug resistance modulator tariquidar
• Successful results of Phase IIa trial for therapeutic vaccine TA-HPV
• Patient dosing begins in Phase IIa study for anti-cocaine addiction
vaccine TA-CD
• First evaluation of anti-nicotine vaccine in man - positive Phase I
results for TA-NIC
• Positive Phase I results for immunotherapeutic anti-cancer vaccine
DISC-GMCSF
• Anti-cancer compound XR11576 enters Phase I clinical trials
• $63m (£43.2m) development and licence agreement with Genentech Inc for
novel drugs in immune inflammatory disease
• Cash and liquid resources as at 30 June £15.1m, ($23.0m)
Commenting, Chief Executive Officer, David Oxlade said:
`Xenova has made considerable progress in the first six months of 2002, both in
terms of advancing its clinical pipeline and in expanding its revenue-generating
collaborations.
`Tariquidar`s entry to Phase III studies in June was an important step forward
and highlights the maturity of our growing clinical product portfolio. The
licence agreement announced in April with Genentech, to develop novel therapies
for auto-immune disease, underlines the potential of our early stage product
pipeline.`
Contacts:
UK: US:
Xenova Group plc Trout Group/BMC Communications
Tel: +44 (0)1753 706600 Tel: 001 212 477 9007
David A Oxlade, Chief Executive Officer Press: Brad Miles (Ext 17) Lauren Tortorete (Ext 20)
Daniel Abrams, Group Finance Director Investors: Jonathan Fassberg (Ext 16) Lee Stern (Ext 22)
Hilary Reid Evans, Corporate Communications
Financial Dynamics
Tel: +44 (0)207 831 3113
Fiona Noblet / Jonathan Birt
Notes to Editors
Xenova Group plc`s product pipeline focuses principally on the therapeutic areas
of cancer and immune system disorders. Xenova currently has a broad pipeline of
eight programmes in clinical development. The Group has a well-established
track record in the identification, development and partnering of innovative
products and technologies and has partnerships with significant pharmaceutical
companies including Lilly, Pfizer, Celltech, Genentech, QLT and Millennium
Pharmaceuticals.
For further information about Xenova and its products please visit the Xenova
website at www.xenova.co.uk
For Xenova: Disclaimer to take advantage of the `Safe Harbor` provisions of the
US Private Securities Litigation Reform Act of 1995. This press release contains
`forward-looking statements,` including statements about the discovery,
development and commercialisation of products. Various risks may cause Xenova`s
actual results to differ materially from those expressed or implied by the
forward looking statements, including: adverse results in our drug discovery and
clinical development programs; failure to obtain patent protection for our
discoveries; commercial limitations imposed by patents owned or controlled by
third parties; our dependence upon strategic alliance partners to develop and
commercialise products and services; difficulties or delays in obtaining
regulatory approvals to market products and services resulting from our
development efforts; the requirement for substantial funding to conduct research
and development and to expand commercialisation activities; and product
initiatives by competitors. For a further list and description of the risks and
uncertainties we face, see the reports we have filed with the Securities and
Exchange Commission. We disclaim any intention or obligation to update or
revise any forward-looking statements, whether as a result of new information,
future events or otherwise.
Chairman`s Statement
During the first six months of 2002 we have made considerable progress in
advancing our clinical pipeline. Our clinical portfolio now includes one Phase
III, two Phase II and four Phase I drug candidates, plus an animal disease
product in the equivalent of Phase I trials. We believe we have established a
strong and well-balanced product pipeline, strengthened by a further eight
products in preclinical development.
We aim to create a robust, sustainable and revenue generating company in the
medium term and, with this objective in mind, we seek to optimise revenues from
upfront and milestone payments by entering into licensing agreements for our
products. To this end, we entered into a development and licence agreement with
Genentech Inc (Genentech), in April 2002, worth a potential $63m (Β£43.2m),
granting Genentech worldwide rights to develop and market products primarily
targeting disorders of the immune system based on Xenova`s OX40 receptor protein
and anti-OX40 Ligand antibody programmes. Good progress has also been made under
some of our existing partnership agreements during the first half of 2002,
evidenced by the progress into clinical trials of XR11576, with our partner
Millennium Pharmaceuticals Inc (Millennium), and the start of Phase III trials
for tariquidar, with our partner QLT Inc (QLT).
Our commercial strategy is to consider the optimal time for partnering of our
products on a project by project basis. You will find details of the progress
made by all our programmes, and of the agreements in place, in the Product
Pipeline Update section of this statement.
Revenues increased to Β£6.8m ($10.3m) from Β£0.5m ($0.8m), when compared with the
first six months of 2001, due primarily to revenues recorded in relation to the
three major partnerships outlined above. Total net operating expenses remained
constant at Β£11.0m ($16.8m) when compared with the last six months of 2001
(Β£11.2m ($17.1m)).
Based on our expected net monthly cash outflow, cash and liquid resources as at
the end of June were sufficient to fund our current operations for in excess of
one year.
Product Pipeline Update - Clinical Trials
Cancer:
XR9576 (tariquidar) - Discovered by Xenova, tariquidar, a potent small-molecule
inhibitor of the P-glycoprotein pump, is being developed for the treatment of
multidrug resistance (MDR) in cancer. In August 2001, Xenova signed an
exclusive licence agreement with QLT Inc for the development and marketing in
the United States, Canada and Mexico of tariquidar for the treatment of MDR in
cancer. Under the terms of the agreement, QLT has assumed responsibility for
the further development of tariquidar in those territories covered by the
agreement. QLT made an immediate upfront licence payment to Xenova of US$10m
(Β£7.1m) and will provide up to US$45m (Β£32m) in funding for all development
activities related to Phase III clinical studies for tariquidar in North America
and Europe. Milestones of up to US$50m (Β£35.6m) and royalties in the range of
15 to 22 per cent, depending on the level of North American sales, are also
receivable by Xenova. Xenova retains substantially all commercial rights to
tariquidar outside the United States, Canada and Mexico, including European and
Rest of World rights.
Tariquidar entered two pivotal Phase III clinical trials, in which tariquidar is
being used as an adjunctive treatment in combination with first-line
chemotherapy for non-small cell lung cancer (NSCLC) patients, in June 2002. The
two double-blind, randomised, placebo-controlled trials are being carried out in
patients with stage IIIb/IV NSCLC at approximately 100 centres located
throughout North America and Europe. An interim analysis is planned for
mid-2003 and it is anticipated that, on successful completion of the Phase III
programme, QLT will file for approval of tariquidar in North America for use in
combination with first-line chemotherapy in advanced NSCLC by the end of 2005
and Xenova will file for marketing approval in Europe.
DISC-GMCSF - DISC-GMCSF, an innovative immunotherapeutic vaccine, is designed as
a treatment for a broad range of solid tumours. DISC-GMCSF delivers the gene for
the expression of GM-CSF, a potent stimulator of anti-tumour immune responses,
direct to the tumour site through the use of a disabled virus vector (DISC) and
is administered using direct injection. In preclinical studies DISC-GMCSF was
shown to be effective in models of breast and colorectal cancer. As announced
in June 2002, DISC-GMCSF successfully completed a Phase I dose-escalating safety
study at three centres in the UK, in patients with metastatic melanoma.
DISC-GMCSF was found to be well tolerated, with no serious adverse events
reported. The DISC vector was shown to be localised at the site of injection
and had not spread beyond the required therapeutic area, a key objective of the
study.
TA-HPV/TA-CIN - TA-HPV is an immunotherapeutic vaccine, which is being developed
to prevent the recurrence of cervical cancer. The product is intended to be
used as a therapeutic vaccine alongside standard treatments, such as surgery,
for cervical cancer. The results of two physician-initiated Phase IIa trials,
in which TA-HPV was tested in patients with high-grade vulval intra-epithelial
neoplasia (VIN 3), have shown the vaccine to be safe and well tolerated, with a
complete or partial response being shown in over 40% of cases.
TA-CIN is a recombinant fusion protein, designed as a treatment for women with
cervical dysplasia. Preclinical studies have suggested that use of this product
together with TA-HPV results in a greatly enhanced immune response. An open
label, physician sponsored Phase II `prime-boost` study, targeting the treatment
of HPV associated ano-genital neoplasias, began in October 2001. Results of
this trial are anticipated by the end of the current year.
XR11576 (MLN576) - XR11576, XR5944 and XR11612 are novel DNA targeting agents,
whose method of action includes dual inhibition of topoisomerases I and II.
XR11576 is the subject of a licence agreement with Millennium Pharmaceuticals
Inc, announced in December 2001. The other compounds covered by this agreement,
XR5944 (MLN944) and XR11612 (MLN612), are currently in preclinical development.
XR11576 entered Phase I clinical trials in February 2002. The open label Phase
I trial is being carried out at centres in the UK and the Netherlands and
comprises multiple ascending oral doses in patients with solid tumours.
Patients are being monitored for safety, tolerability, pharmacokinetics and
anti-tumour activity. Xenova retains responsibility for performing development
activities associated with the programme to the end of Phase II clinical trials.
Millennium will provide funding for the programme commencing in 2003, up to
the agreed level of $20m.
Other:
DISC-PRO - A prophylactic vaccine designed to prevent genital and oro-labial
herpes, DISC-PRO has completed Phase I trials. These Phase I trials demonstrated
that DISC-PRO was well tolerated and immunogenic. We intend to secure a
corporate partner ahead of Phase III clinical trials for the further development
of this programme.
TA-NIC - Designed as a treatment for nicotine addiction, TA-NIC is a nicotine
conjugate vaccine which is administered through a course of intramuscular
injections. The vaccine is designed to prime the immune system to produce
anti-nicotine antibodies such that, on smoking a cigarette, the nicotine will
bind to these antibodies, which are too large to cross the blood-brain barrier,
thus reducing or removing the pleasurable stimulus which usually accompanies
smoking. The successful results of a Phase I trial for TA-NIC, reported in June
2002, showed the vaccine to be safe and well tolerated both systemically and
locally in the 60 smokers and non-smokers who took part in the trial, and that
the vaccine generated a specific anti-nicotine response. This is the first time
such a vaccine has been tested in man.
TA-CD - TA-CD is a therapeutic vaccine which is under development for the
treatment of cocaine addiction. It`s mechanism of action is similar to that of
TA-NIC. A Phase IIa dose escalation trial, supported by the US National
Institute on Drug Abuse (NIDA), began in April 2002. The results of an earlier
Phase IIa dose escalation study, which were reported in July 2001, showed TA-CD
to be well tolerated both systemically and locally. Cocaine specific antibodies
were found to persist throughout the 12 weeks of the study and an attenuation of
the usual euphoric effects of cocaine was reported amongst patients who relapsed
during the study, providing anecdotal evidence of the benefit TA-CD may provide.
DISC-VET - DISC-VET is currently undergoing development for the treatment of
multiple diseases in animals. A product candidate, DISC-BHV, for the treatment
of bovine herpes virus induced respiratory disease in cattle, is in the
equivalent of Phase I clinical development in partnership with Pfizer.
Product Pipeline Review and Update - Preclinical
Cancer:
XR5944 (MLN944) and XR11612 (MLN612) - XR5944 and XR11612 form, with XR11576,
the programme of novel anti-cancer agents which was partnered with Millennium in
December 2001. XR5944 has shown exceptionally high potency as a cytotoxic agent
in preclinical studies with a number of human tumour cell lines both in vitro
and in vivo. It is structurally distinct from XR11576 and has been shown to be
unaffected by atypical multi-drug resistance mechanisms. XR11612 is in
preclinical testing as a back-up to XR11576.
PAI-Cancer - In collaboration with the Institute for Cancer Research, we are
developing an active novel inhibitor of a protein released by platelets and the
cells lining the blood vessels known as PAI-1. PAI is an unfavourable
prognostic indicator in many human cancers and is strongly implicated in the
metastatic process. Lilly has an option to acquire exclusive rights to develop
and commercialise PAI-1 inhibitors in the cancer field, which, if exercised,
would realise upfront and milestone payments of up to $16.5m, with additional
royalties payable on commercialised products.
OX40L - OX40 is a platform technology which is capable of producing multiple
drug candidates primarily targeting cancer and autoimmune disease. We have
demonstrated that a product candidate for OX40L (the ligand which binds to the
OX40 receptor) elicits anti-tumour activity in preclinical models and work is
underway to test the product in a broader range of disease models, including
those for infectious diseases. A Β£43.2m development and licence agreement was
signed in April 2002 with Genentech for the worldwide rights to develop and
market products, primarily targeting disorders of the immune system, based on
Xenova`s OX40 receptor protein and anti-OX40 Ligand antibody programmes. Under
this agreement, Xenova retains all rights to the up-regulation of the immune
system using the OX40:OX40L interaction, including for use in oncology and
infectious disease therapy.
MRP - Multi-Drug Resistance Protein (MRP) acts as a pump which, like the
P-glycoprotein pump, expels small molecules out of cells and thus can help
protect tumour cells from certain chemotherapeutic agents. We are currently
carrying out a lead optimisation programme for a compound for the inhibition of
MRP to further strengthen our position in the field of multi-drug resistance.
Other:
OX40 - A partnership has been established with Celltech Group plc to develop an
antibody-based product against OX40 for the treatment of autoimmune disease.
Along with OX40L, OX40 is also the subject of a development and licence
agreement with Genentech (see above).
M3 - M3 is a viral protein with the capacity to bind to a broad range of
chemokines which have multiple biological functions, including mediation of
inflammation and promotion of angiogenesis. Consequently, chemokine inhibition
is a potential approach to treatment of a wide range of diseases. Work is in
progress in several preclinical models to evaluate potential efficacy.
PAI-CV - In conjunction with our partner Lilly, we are carrying out a research
and development programme for the development of a new class of oral
antithrombotic drugs suitable for chronic use. Research is focused on the
development of small molecule inhibitors of PAI-1 that are designed to enhance
the break-up of blood clots without the side-effects of bleeding associated with
other marketed antithrombotic drugs. Xenova and Lilly entered into this
collaboration in 1998.
MEN-B - Xenova is currently developing a vaccine for the prevention of
meningitis caused by meningococcal group B infections. This programme is being
carried out in collaboration with the Institute for Infections and Immunity,
based at Nottingham University. The aim is to construct a live attenuated
vaccine, which should give good protection against all group B strains. The
programme is currently at the lead product evaluation stage.
Phogen:
A joint venture between Xenova and Marie Curie Cancer Care, Phogen Limited is
developing a novel technology, known as VP22, for the enhanced delivery of
gene-based therapeutics. Phogen entered into a Β£15.0m ($21.0m) licensing
agreement with Genencor International Inc, for the utilisation of Phogen`s VP22
technology in the area of therapeutic vaccines for certain infectious viral
diseases, in August 2001. A further research collaboration was announced with
Cell Genesys in October 2001. Phogen intends to seek additional partnering
opportunities for its novel technologies.
Financial Summary
Operating Performance
In the six months to 30 June 2002, the Group`s revenues from licensing
agreements, strategic partnerships and manufacturing outsourcing were Β£6.8m
($10.3m) (2001 Β£0.5m ($0.8m)).
In accordance with the Group`s revenue recognition policy, of the Β£6.9m ($10.6m)
received from QLT in 2001 as part of the tariquidar licensing agreement, Β£1.2m
($1.8m) was included in the 6 months to 30 June 2002, with a further Β£5.2m
($7.9m) being deferred to future periods. Of the Β£7.9m ($12.0m) received from
Millennium, Β£4.9m ($7.4m) was recognised by the Group in the six months to 30
June 2002, with a further Β£3.0m ($4.6m) being deferred to future periods.
Following the successful completion of a further licensing deal in the period in
respect of the OX40 program with Genentech, Β£0.3m ($0.5m) of the upfront licence
fee of Β£2.7m ($4.2m) has been recognised in this half year. Other revenue
included Β£0.4m ($0.6m) in respect of ongoing contract vaccine manufacturing.
The net operating expenses for the six months to 30 June 2002 were Β£11.0m
($16.8m) (2001: Β£8.9m ($13.6m)). The total net operating expenses in the 6
months to 30 June 2002 of Β£11.0m ($16.8m) remained in line with the second half
of 2001 (Β£11.2m ($17.1m)) which reflected the ongoing savings resulting from the
2001 mid year strategic review following the acquisition of Cantab on 4 April
2001. Accordingly, the first half results in 2001 included only one quarter of
the Cantab results.
Total research expenditure for the six months to 30 June 2002 was Β£8.4m ($12.9m)
(2001: Β£6.6m ($10.1m)). Research expenditure included substantial preclinical
and clinical development of the programme of novel DNA targeting agents, one of
which (XR11576) entered Phase I clinical trials in February, and completion of
Phase I clinical development of TA-NIC. There is not expected to be a
significant impact to research expenditure following the licensing agreements
with QLT and Millennium until 2003, when cost reimbursement commences under the
latter agreement relating to the programme of novel DNA targeting agents.
Total administration expenditure for the six months to 30 June 2002 was Β£2.8m
($4.3m) (2001: Β£2.3m ($3.5m)). The cost reductions realised in quarter one 2002
were maintained in quarter two 2002, with administrative expenses (excluding the
amortisation of goodwill) falling slightly to Β£1.1m ($1.7m) (Q1 2002: Β£1.2m
($1.8m)). The subletting of excess facilities reduced net operating expenses by
Β£0.2m ($0.3m) in the first six months of 2002 (2001: nil).
Of the total administrative expenses for the six months to 30 June 2002 of Β£2.8m
($4.3m), Β£0.6m ($0.9m) relates to the amortisation, over a 10-year period, of
the goodwill in respect of the acquisition of Cantab in 2001.
Cash outflow before financing and acquisitions in the six months to 30 June 2002
of Β£7.3m ($11.1m) has been reduced from 2001 (Β£10.0m ($15.3m)). Cash received
from licensing activity during the six months ended 30 June 2002 was Β£2.7m
($4.2m) (2001: nil).
The Company continues to explore licensing opportunities to maximise value for
shareholders and reduce cash outflow.
The net loss per share in the six months to 30 June 2002 was 3.3p (2001: 6.2p).
Cash and liquid resources
Cash and liquid resources at 30 June 2002 totalled Β£15.1m ($23.0m) (2001: Β£18.1m
($27.6m)). Of this balance, cash was Β£14.5m ($22.2m) and liquid resources were
Β£0.5m ($0.8m) at 30 June 2002 (2001: cash Β£15.7m ($23.9m), liquid resources
Β£2.4m ($3.7m)).
Included in liquid resources is an investment in Cubist Pharmaceuticals Inc.,
which subsequent to the 2001 year end fell in value, following an announcement
by Cubist of clinical trial data, such that at 30 June 2002 the share price was
$9.41 valuing the investment held at Β£0.5m ($0.8m), representing a decline of
Β£1.7m ($2.6m) from the valuation at 31 December 2001 of Β£2.2m ($3.4m).
Based upon the expected net monthly cash outflow, the cash and liquid
investments are sufficient to fund current operations for in excess of one year.
Share capital
The number of shares in issue stood at 139.1 million as at 30 June 2002 (2001:
139.0 million).
The Directors do not propose to pay an interim dividend for 2002 (2001: nil).
Consolidated Profit and Loss Account (unaudited)
Unaudited Unaudited Unaudited Audited
Six Months Six Months Six Months Year
Ended Ended Ended Ended
30 June 30 June 30 June 31 December
Notes 2002 2002 2001 2001
$000 Β£000 Β£000 Β£000
Turnover (including share of joint venture) 10,549 6,914 504 1,877
Less: share of joint venture revenue (230) (151) (3) (95)
_____ _____ _____ _____
Turnover 10,319 6,763 501 1,782
Operating expenses
Research and development costs (12,853) (8,424) (6,643) (15,374)
_____ _____ _____ _____
(12,853) (8,424) (6,643) (15,374)
_____ _____ _____ _____
Administrative expenses (3,441) (2,255) (1,345) (2,961)
Administrative expenses: exceptional - - (658) (1,035)
reorganisation costs
Administrative expenses: amortisation of (894) (586) (293) (879)
goodwill
_____ _____ _____ _____
Total administrative expenses (4,335) (2,841) (2,296) (4,875)
Other operating income 417 273 - 115
Total net operating expenses (16,771) (10,992) (8,939) (20,134)
____ ____ ____ ____
Group operating loss (6,452) (4,229) (8,438) (18,352)
Share of operating profit/(loss) of joint 53 35 (29) (33)
venture
____ ____ ____ ____
Total operating loss: Group and share of joint (6,399) (4,194) (8,467) (18,385)
venture
Interest (net) 514 337 400 754
Amounts written (off) / back to investments 2 (2,498) (1,637) 675 463
____ ____ ____ ____
Loss on ordinary activities before taxation (8,383) (5,494) (7,392) (17,168)
Tax on loss on ordinary activities 3 1,329 871 907 1,797
____ ____ ____ ____
Loss on ordinary activities after taxation (7,054) (4,623) (6,485) (15,371)
attributable to members of Xenova Group plc
4 ____ ____ ____ ____
Loss per share (basic and diluted) (5.1c) (3.3p) (6.2p) (12.6p)
____ ____ ____ ____
Shares used in computing net loss per share 139,057 139,057 104,044 121,596
(thousands)
US Dollar amounts have been translated at the closing rate on 30 June 2002
(Β£1.00: $1.5258) solely for information.
Statement of Total Recognised Gains and Losses (unaudited)
Unaudited Unaudited Unaudited Audited
Six months Six months Six months Year
Ended Ended Ended Ended
30 June 30 June 30 June 31 December
2002 2002 2001 2001
Β£000 $000 Β£000 Β£000
Loss attributable to Xenova Group plc (7,115) (4,663) (6,456) (15,341)
Loss attributable to joint venture 61 40 (29) (30)
_____ _____ _____ _____
Total loss attributable to members of Xenova
Group plc (7,054) (4,623) (6,485) (15,371)
Translation difference (1) (1) 2 -
_____ _____ _____ _____
Total recognised gains and losses in the period (7,055) (4,624) (6,483) (15,371)
attributable to members of Xenova Group plc
_____ _____ _____ _____
US Dollar amounts have been translated at the closing rate on 30 June 2002
(Β£1.00: $1.5258) solely for information.
Consolidated Balance Sheet (unaudited)
Unaudited Unaudited Unaudited Audited
As at As at As at As at
30 June 30 June 30 June 31 December
2002 2002 2001 2001
Notes $000 Β£000 Β£000 Β£000
Fixed Assets
Intangible assets 15,585 10,214 11,379 10,798
Tangible assets 13,813 9,053 9,880 9,586
Investment in joint venture:
Share of gross assets 638 418 40 438
Share of gross liabilities (671) (440) (101) (500)
Goodwill arising on acquisition 42 28 32 30
_____ _____ _____ _____
9 6 (29) (32)
_____ _____ _____ _____
29,407 19,273 21,230 20,352
Current Assets
Debtors 6,875 4,506 5,552 4,135
Investments 2 834 547 2,396 2,184
Cash at bank and in hand 22,158 14,522 15,676 21,816
_____ _____ _____ _____
29,867 19,575 23,624 28,135
Creditors: amounts falling due within one 6 (20,424) (13,386) (5,703) (18,420)
year
_____ _____ _____ _____
Net current assets 9,443 6,189 17,921 9,715
Total assets less current liabilities 38,850 25,462 39,151 30,067
Creditors: amounts falling due after more (323) (212) (367) (221)
than one year
Provisions for liabilities and charges (20) (13) (25) (10)
_____ _____ _____ _____
Total net assets 38,507 25,237 38,759 29,836
_____ _____ _____ _____
Capital and reserves
Called up share capital 21,218 13,906 13,062 13,904
Shares to be issued - - 4,127 -
Share premium account 112,714 73,872 73,925 73,870
Merger reserve 41,529 27,218 23,933 27,218
Other reserves 27,315 17,902 17,902 17,902
Profit and loss account (164,269) (107,661) (94,190) (103,058)
_____ _____ _____ _____
Shareholders` funds - equity interests 4 38,507 25,237 38,759 29,836
_____ _____ _____ _____
US Dollar amounts have been translated at the closing rate on 30 June 2002
(Β£1.00: $1.5258) solely for information.
Consolidated Cash Flow Statement (unaudited)
Notes Unaudited Unaudited Unaudited Audited
Six months Six months Six months Year
Ended Ended Ended Ended
30 June 30 June 30 June 31 December
2002 2002 2001 2001
$000 Β£000 Β£000 Β£000
Net cash outflow from operating activities 5 (11,295) (7,403) (8,144) (3,836)
Returns on investments and servicing of
finance
Interest received 517 339 376 1,023
Interest element of finance lease rental (3) (2) (5) (15)
payments
_____ _____ _____ _____
Net cash inflow from returns on 514 337 371 1,008
investments and servicing of finance
Taxation 3 - - - 1,870
Capital expenditure and financial
investment
Purchase of tangible fixed assets (351) (230) (2,224) (2,797)
_____ _____ _____ _____
Net cash outflow from capital expenditure (351) (230) (2,224) (2,797)
and financial investment
Acquisitions and disposals
Purchase of subsidiary undertakings - - (768) (768)
Cash at bank and in hand acquired with - - 16,822 16,822
subsidiary
_____ _____ _____ _____
Net cash inflow from acquisitions - - 16,054 16,054
_____ _____ _____ _____
Net cash (outflow)/inflow before financing (11,132) (7,296) 6,057 12,299
Financing
Issue of ordinary share capital 6 4 9 9
Expenses on issue of shares - - (864) (919)
Capital element of finance lease rental (3) (2) (40) (87)
payments
_____ _____ _____ _____
Net cash inflow/(outflow) from financing 3 2 (895) (997)
_____ _____ _____ _____
(Decrease)/increase in cash during the (11,129) (7,294) 5,162 11,302
period
_____ _____ _____ _____
Reconciliation of Net Cash Flow to Movement in Net Funds (unaudited)
Unaudited Unaudited Unaudited Audited
Six Months Six Months Six Months Year
Ended Ended Ended Ended
30 June 30 June 30 June 31 December
2002 2002 2001 2001
$000 Β£000 Β£000 Β£000
(Decrease)/increase in cash during the period (11,129) (7,294) 5,162 11,302
Capital element of finance lease payments 3 2 40 87
_____ _____ _____ _____
Change in net funds resulting from cash flows (11,126) (7,292) 5,202 11,389
Finance leases acquired with subsidiary operations - (101) (101)
Change in value of liquid investments (2,498) (1,637) 675 463
Translation difference - - 2 2
_____ _____ _____ _____
Change in net funds (13,624) (8,929) 5,778 11,753
Net funds at 1 January 36,598 23,986 12,233 12,233
_____ _____ _____ _____
Net funds at 30 June / 31 December 22,974 15,057 18,011 23,986
_____ _____ _____ _____
US Dollar amounts have been translated at the closing rate on 30 June 2002
(Β£1.00: $1.5258) solely for information.
Notes to the Interim Statement
1 Basis of preparation
These unaudited interim statements, which do not constitute statutory accounts
within the meaning of Section 240 of the Companies Act 1985, have been prepared
using the accounting policies set out in the Group`s 2001 Annual Report and
Accounts except as set out below. The 2001 Annual Report and Accounts received
an unqualified auditor`s report and have been delivered to the Registrar of
Companies.
Following the issue of Financial Reporting Standard Number 19 - `Deferred tax`
the group has adopted the incremental liability approach (`Full` provision
basis) from 1 January 2002. The Group`s policy now states, `Deferred tax is
recognised in respect of timing differences that have originated but not
reversed by the balance sheet date, but only when transactions or events that
result in a right to pay less tax or an obligation to pay more tax in the future
have occurred at the balance sheet date. The likelihood of these rights or
obligations arising is based upon the estimated probabilities of future events
occurring, taking into account the relevant factors pertinent to the industry
sector in which the Group operates. Deferred tax is measured on a non-discounted
basis`. The deferred tax recognised in 2001 under the former policy (nil) would
not have been different under the revised policy adopted from 2002.
There have been no other changes to the Group`s accounting policies in 2002.
2 Amounts written back on investments
The Β£1,637,000 written off on investments reflects the unrealised loss on the
Group`s holding of 88,668 Cubist Pharmaceuticals Inc shares following a fall in
the listed market price since 31 December 2001.
3 Taxation
The Group has recognised the R&D tax credit in respect of the first half of the
year that will be received in 2003. The Group has not recognised any deferred
tax assets or liabilities in the period.
4 Reconciliation of movements in shareholders` funds
Unaudited Unaudited Audited
Six Months Six Months Year
Ended Ended Ended
30 June 30 June 31 December
2002 2001 2001
Β£000 Β£000 Β£000
At start of period 29,836 11,876 11,876
Allotments of shares in the period 4 9 9
Issue of shares in respect of acquisition - 30,070 34,197
Shares to be issued - 4,127 -
Expenses on issue of shares - (864) (919)
Shares to be issued under long term incentive scheme 21 24 44
Loss for the period (4,623) (6,485) (15,371)
Exchange movement (1) 2 -
_____ _____ _____
At end of period 25,237 38,759 29,836
_____ _____ _____
5 Reconciliation of operating loss to net cash outflow from operating
activities
Unaudited Unaudited Audited
Six Months Six Months Year
Ended Ended Ended
30 June 30 June 31 December
2002 2001 2001
Β£000 Β£000 Β£000
Group operating loss (4,229) (8,438) (18,352)
Depreciation 763 509 1,201
Amortisation 588 293 879
Provision for liabilities and charges 3 5 (10)
Net loss on disposal of tangible fixed assets - - 16
Decrease in debtors 500 580 734
Decrease in creditors (1,478) (1,117) (2,573)
Charge for long term incentive scheme 21 24 44
(Decrease)/increase in deferred income (3,571) - 14,225
_____ _____ _____
Net cash outflow from operating activities (7,403) (8,144) (3,836)
_____ _____ _____
6 Deferred income
Included in Creditors is Β£10,654,000 (30 June 2001: Β£nil, 31 December 2001:
Β£14,225,000) in respect of deferred income.
7 Going concern
The Group is an emerging pharmaceutical business and as such expects to absorb
cash until products are commercialised. The Directors have a reasonable
expectation that the Group has, or can reasonably expect to obtain, adequate
cash resources to enable it to continue in operational existence for the
foreseeable future, and have therefore prepared the financial statements on the
going concern basis.
Independent review report to Xenova Group plc
Introduction
We have been instructed by the company to review the financial information set
out on pages 9 to 15. We have read the other information contained in the
interim report and considered whether it contains any apparent misstatements or
material inconsistencies with the financial information.
Directors` responsibilities
The interim report, including the financial information contained therein, is
the responsibility of, and has been approved by the directors. The directors are
responsible for preparing the interim report in accordance with the Listing
Rules of the Financial Services Authority which require that the accounting
policies and presentation applied to the interim figures should be consistent
with those applied in preparing the preceding annual accounts except where any
changes, and the reasons for them, are disclosed.
Review work performed
We conducted our review in accordance with guidance contained in Bulletin 1999/4
issued by the Auditing Practices Board for use in the United Kingdom. A review
consists principally of making enquiries of Xenova Group plc management and
applying analytical procedures to the financial information and underlying
financial data and, based thereon, assessing whether the accounting policies and
presentation have been consistently applied unless otherwise disclosed. A review
excludes audit procedures such as tests of controls and verification of assets,
liabilities and transactions. It is substantially less in scope than an audit
performed in accordance with United Kingdom Auditing Standards and therefore
provides a lower level of assurance than an audit. Accordingly we do not express
an audit opinion on the financial information.
Review conclusion
On the basis of our review we are not aware of any material modifications that
should be made to the financial information as presented for the six months
ended 30 June 2002.
PricewaterhouseCoopers
Chartered Accountants
Uxbridge
14 August 2002
Notes:
(a) The maintenance and integrity of the Xenova Group plc website
is the responsibility of the directors; the work carried out by the auditors
does not involve consideration of these matters and, accordingly, the auditors
accept no responsibility for any changes that may have occurred to the interim
report since it was initially presented on the website.
(b) Legislation in the United Kingdom governing the preparation and
dissemination of financial information may differ from legislation in other
jurisdictions.
This information is provided by RNS
The company news service from the London Stock Exchange
Updated at 11:20 on Wed,14 Aug 2002. Data 15
Xenova chief asked to stay on board
By Patrick Jenkins
FT.com site; Aug 15, 2002
Xenova, the cancer drug specialist, has asked John Jackson, its heavyweight 73-year-old chairman, to stay in place to pilot plans for further mergers and acquisitions.
Mr Jackson said: "I`d like to stay for a further two years to help Xenova fulfil its potential as the core for another Celltech."
Xenova, which on Wednesday reported interim results in line with expectations, has an acquisitive record, most recently buying Cantab, the vaccines company, last year.
But it remains only a seventeenth fraction of the size of Celltech, Britain`s biggest and acquisitively built biotechnology company, of which Mr Jackson is also chairman.
It emerged last weekend that Xenova could be a ringleader in nascent plans by bankers to create a "UK Oncology Plc".
Early-stage talks have already taken place involving British Biotech, Antisoma and KS Biomedix, the UK`s other cancer companies, and Oxford GlycoSciences, the cash-rich technology group.
David Oxlade, Xenova`s chief executive, denied on Wednesday that five-way merger talks were taking place, but it is understood that discussions were ongoing.
Mr Jackson`s decision to stay in the driving seat will surprise the City. He is due to quit the chair at Celltech in the autumn after 20 years and has said he wants to ease himself out of a handful of other big directorships.
Xenova`s most urgent reason for seeking a merger with a well-capitalised rival would be to gain access to cash.
After burning ý7.3m ($11.5m) in the six months to the end of June, the company has just ý15.1m in the bank - "a little more than 12 months` money," according to Daniel Abrams, finance director.
The burn rate fell by more than a quarter, after a 25 per cent similar reduction in the staff numbers and the contribution of ý6.4m from licensing deals. with third parties.
That pushed turnover up to ý6.8m and helped cut pre-tax losses from ý7.39m to ý5.49m. A further ý10.5m already received from licence partners would be recognised in the profit and loss account by the end of next year, Mr Abrams said.
But Xenova is not expected to break into profit until 2006 at the earliest, when its lead product - cancer treatment tariquidar - is due to reach the market. It entered final-stage Phase III trials in June.
Further income would be generated by licensing other products, to partners, Mr Oxlade said. Candidates included the company`s treatments for herpes and cervical cancer and vaccines to combat nicotine and cocaine addiction. Genentech, the US biotech group, with which Xenova already has several licence agreements, is considered a likely partner for further cancer deals.
By Patrick Jenkins
FT.com site; Aug 15, 2002
Xenova, the cancer drug specialist, has asked John Jackson, its heavyweight 73-year-old chairman, to stay in place to pilot plans for further mergers and acquisitions.
Mr Jackson said: "I`d like to stay for a further two years to help Xenova fulfil its potential as the core for another Celltech."
Xenova, which on Wednesday reported interim results in line with expectations, has an acquisitive record, most recently buying Cantab, the vaccines company, last year.
But it remains only a seventeenth fraction of the size of Celltech, Britain`s biggest and acquisitively built biotechnology company, of which Mr Jackson is also chairman.
It emerged last weekend that Xenova could be a ringleader in nascent plans by bankers to create a "UK Oncology Plc".
Early-stage talks have already taken place involving British Biotech, Antisoma and KS Biomedix, the UK`s other cancer companies, and Oxford GlycoSciences, the cash-rich technology group.
David Oxlade, Xenova`s chief executive, denied on Wednesday that five-way merger talks were taking place, but it is understood that discussions were ongoing.
Mr Jackson`s decision to stay in the driving seat will surprise the City. He is due to quit the chair at Celltech in the autumn after 20 years and has said he wants to ease himself out of a handful of other big directorships.
Xenova`s most urgent reason for seeking a merger with a well-capitalised rival would be to gain access to cash.
After burning ý7.3m ($11.5m) in the six months to the end of June, the company has just ý15.1m in the bank - "a little more than 12 months` money," according to Daniel Abrams, finance director.
The burn rate fell by more than a quarter, after a 25 per cent similar reduction in the staff numbers and the contribution of ý6.4m from licensing deals. with third parties.
That pushed turnover up to ý6.8m and helped cut pre-tax losses from ý7.39m to ý5.49m. A further ý10.5m already received from licence partners would be recognised in the profit and loss account by the end of next year, Mr Abrams said.
But Xenova is not expected to break into profit until 2006 at the earliest, when its lead product - cancer treatment tariquidar - is due to reach the market. It entered final-stage Phase III trials in June.
Further income would be generated by licensing other products, to partners, Mr Oxlade said. Candidates included the company`s treatments for herpes and cervical cancer and vaccines to combat nicotine and cocaine addiction. Genentech, the US biotech group, with which Xenova already has several licence agreements, is considered a likely partner for further cancer deals.
Xenova`s partnerships lift H1 figures
Nerma Jelacic
FT.com site; Aug 15, 2002
LONDON (FT Investor) - Xenova, the UK cancer specialist group, on Wednesday said its recent licensing agreements helped it narrow its first-half losses while it managed to save enough cash to last for the next year.
In the six months to June 30, the group`s revenues from licensing agreements, strategic partnerships and manufacturing outsourcing were at ý6.8m, a leap from ý0.5m a year ago. Among its partners include Lilly, Pfizer and Celltech .
"Xenova has made considerable progress in the first six months of 2002, both in terms of advancing its clinical pipeline and in expanding its revenue-generating collaborations," said David Oxlade, the chief executive.
But shares in Xenova followed the sharply lower trend on the markets on Wednesday trading down 2.2 per cent at 46p. The group has lost about 30 per cent of its value from this year`s high of 70p.
Losses-before-tax in the six months to June 30 were at ý5.5m, an improvement on the ý7.4m losses at the same time last year. Cash and liquid resources stood at ý15.1m
"Based on our expected net monthly cash outflow, cash and liquid resources as at the end of June were sufficient to fund our current operations for in excess of one year," Mr Oxlade said.
In its statement, Xenova made no reference to a Financial Times report on Saturday that it, along with rivals Antisoma, British Biotech and KS Biomedix, were in talks about creating a cancer company to compete on a global stage. See more on Biotechs in secret talks over cancer group
See Xenova statement on real-time regulatory news
Nerma Jelacic
FT.com site; Aug 15, 2002
LONDON (FT Investor) - Xenova, the UK cancer specialist group, on Wednesday said its recent licensing agreements helped it narrow its first-half losses while it managed to save enough cash to last for the next year.
In the six months to June 30, the group`s revenues from licensing agreements, strategic partnerships and manufacturing outsourcing were at ý6.8m, a leap from ý0.5m a year ago. Among its partners include Lilly, Pfizer and Celltech .
"Xenova has made considerable progress in the first six months of 2002, both in terms of advancing its clinical pipeline and in expanding its revenue-generating collaborations," said David Oxlade, the chief executive.
But shares in Xenova followed the sharply lower trend on the markets on Wednesday trading down 2.2 per cent at 46p. The group has lost about 30 per cent of its value from this year`s high of 70p.
Losses-before-tax in the six months to June 30 were at ý5.5m, an improvement on the ý7.4m losses at the same time last year. Cash and liquid resources stood at ý15.1m
"Based on our expected net monthly cash outflow, cash and liquid resources as at the end of June were sufficient to fund our current operations for in excess of one year," Mr Oxlade said.
In its statement, Xenova made no reference to a Financial Times report on Saturday that it, along with rivals Antisoma, British Biotech and KS Biomedix, were in talks about creating a cancer company to compete on a global stage. See more on Biotechs in secret talks over cancer group
See Xenova statement on real-time regulatory news
XENOVA (XEN)
Investors Chronicle - United Kingdom; Aug 23, 2002
Xenova had a strong first half - But, judging by the share price performance, youýd never have guessed. In April, the company sold US biotech Genentech the rights to a biological control mechanism it had patented. The OX 40 cell surface receptors and the corresponding binding proteins help regulate the immune system. However, Genentech may only exploit the platform in the design of drugs that dampen the immune system - for example, in controlling auto-immune diseases like rheumatism. Xenova retains the rights for up-regulating the immune system. Aside from a $5m (GBP3.27m) fee up-front, Xenova could receive up to $58m from Genentech - provided the drug hits the requisite development milestones - plus a cut of future sales.
It wouldnýt be the first time management has demonstrated canny bargaining skills, since this represents the third big deal in nine months. In December, Xenova sold the rights to three anti-cancer compounds to another US biotech, Millennium Pharmaceuticals. The first of these drugs has already entered clinical trials; the second is expected to follow in 2003, triggering a $20m research and development commitment from Millennium.
Last August, Xenova partnered its lead product, tariquidar, with Canadian firm QLT. The drug aims to help patients overcome resistance to chemotherapy and entered two final-stage trials in June. QLT will pay $45m to fund its development, plus up to $50m in milestones, weighted towards the end of 2005-2006 when the drug completes these trials and is filed for approval.
Xenova reported just GBP6.4m of the up-front payments from these three deals - deferring GBP10.6m, in line with the conservative accounting practice of only counting payments from agreements once costs are incurred.
Elsewhere in the portfolio, data from early-stage trials in the worldýs first anti-smoking vaccine showed it to be both safe and effective in generating an anti-nicotine response. The antibodies produced bind to the nicotine, creating a molecule too large to pass through the blood-brain barrier thus quelling the pleasurable effects. A cocaine vaccine that uses the same mechanism began a dose-ranging study in April. A cervical cancer vaccine also proved safe, though the big hope is for its use in combination with another Xenova vaccine, which is expected to illicit a much greater immune response. The results of that trial are expected in the autumn.
With annualised cash-burn running at GBP14m, there is sufficient cash for a year. Given the wealth of licensing opportunities in the pipeline, though, that could prove to be conservative.
Ord price: 45p Market value: GBP63m
Touch: 44-46p 12-month High: 76p Low: 24p
Dividend yield: nil PE ratio: na
Net asset value: 18p* Net cash: GBP15.1m
*Includes intangibles of GBP10.2m, or 7.3p a share
Half-year Turnover Pre-tax Stated earnings Net div per
to 30 Jun (GBPm) profit (GBPm) per share (p) share (p)
2001 0.50 -7.39 -6.2 nil
2002 6.76 -5.49 -3.3 nil
% change +1,252 - - -
Last IC view: 20 Jun 2002, page 39
Investors Chronicle - United Kingdom; Aug 23, 2002
Xenova had a strong first half - But, judging by the share price performance, youýd never have guessed. In April, the company sold US biotech Genentech the rights to a biological control mechanism it had patented. The OX 40 cell surface receptors and the corresponding binding proteins help regulate the immune system. However, Genentech may only exploit the platform in the design of drugs that dampen the immune system - for example, in controlling auto-immune diseases like rheumatism. Xenova retains the rights for up-regulating the immune system. Aside from a $5m (GBP3.27m) fee up-front, Xenova could receive up to $58m from Genentech - provided the drug hits the requisite development milestones - plus a cut of future sales.
It wouldnýt be the first time management has demonstrated canny bargaining skills, since this represents the third big deal in nine months. In December, Xenova sold the rights to three anti-cancer compounds to another US biotech, Millennium Pharmaceuticals. The first of these drugs has already entered clinical trials; the second is expected to follow in 2003, triggering a $20m research and development commitment from Millennium.
Last August, Xenova partnered its lead product, tariquidar, with Canadian firm QLT. The drug aims to help patients overcome resistance to chemotherapy and entered two final-stage trials in June. QLT will pay $45m to fund its development, plus up to $50m in milestones, weighted towards the end of 2005-2006 when the drug completes these trials and is filed for approval.
Xenova reported just GBP6.4m of the up-front payments from these three deals - deferring GBP10.6m, in line with the conservative accounting practice of only counting payments from agreements once costs are incurred.
Elsewhere in the portfolio, data from early-stage trials in the worldýs first anti-smoking vaccine showed it to be both safe and effective in generating an anti-nicotine response. The antibodies produced bind to the nicotine, creating a molecule too large to pass through the blood-brain barrier thus quelling the pleasurable effects. A cocaine vaccine that uses the same mechanism began a dose-ranging study in April. A cervical cancer vaccine also proved safe, though the big hope is for its use in combination with another Xenova vaccine, which is expected to illicit a much greater immune response. The results of that trial are expected in the autumn.
With annualised cash-burn running at GBP14m, there is sufficient cash for a year. Given the wealth of licensing opportunities in the pipeline, though, that could prove to be conservative.
Ord price: 45p Market value: GBP63m
Touch: 44-46p 12-month High: 76p Low: 24p
Dividend yield: nil PE ratio: na
Net asset value: 18p* Net cash: GBP15.1m
*Includes intangibles of GBP10.2m, or 7.3p a share
Half-year Turnover Pre-tax Stated earnings Net div per
to 30 Jun (GBPm) profit (GBPm) per share (p) share (p)
2001 0.50 -7.39 -6.2 nil
2002 6.76 -5.49 -3.3 nil
% change +1,252 - - -
Last IC view: 20 Jun 2002, page 39
British Biotech in merger talks with Morphosys
By FT.com staff
FT.com site; Sep 09, 2002
Shares in British Biotech, the cancer specialist group, jumped more than 12 per cent on Monday after the it announced it was in early stage merger talks with Morphosys, the German biotech company.
A combination of British Biotech and Morphosys, the antibody specialist, could create a company with a market capitalisation of about ý75-ý100m. Confirmation of the talks followed weekend reports that the UK group was in discussions with its Neuer Markt listed rival. British Biotech has been on the acquisition trail for several years and has held talks fellow cancer specialists Xenova and Antisoma. This is believed to be the first time the UK group has made an announcement on a potential merger. On Monday, British Biotech advised its shareholders "to take no action" and said a further announcement would be made in due course.The shares rose 64p to reach 563p in early mornin trade in London.
By FT.com staff
FT.com site; Sep 09, 2002
Shares in British Biotech, the cancer specialist group, jumped more than 12 per cent on Monday after the it announced it was in early stage merger talks with Morphosys, the German biotech company.
A combination of British Biotech and Morphosys, the antibody specialist, could create a company with a market capitalisation of about ý75-ý100m. Confirmation of the talks followed weekend reports that the UK group was in discussions with its Neuer Markt listed rival. British Biotech has been on the acquisition trail for several years and has held talks fellow cancer specialists Xenova and Antisoma. This is believed to be the first time the UK group has made an announcement on a potential merger. On Monday, British Biotech advised its shareholders "to take no action" and said a further announcement would be made in due course.The shares rose 64p to reach 563p in early mornin trade in London.
Xenova shares dive on rights issue news
By FT.com staff in London
FT.com site; Sep 11, 2002
Shares in Xenova fell 12 per cent on Wednesday after the UK biotech announced details of a rights issues that it hopes will raise ý11m ($17.08m) to fund new drugs and research.
The 8-for-33 issue at 32.5p per share is an almost 25 per cent discount to Xenova`s closing price on Tuesday and is fully underwritten by Nomura. Net proceeds will be ý9.9m.
David Oxlade, chief executive of the acquisitive company which last year bought Cantab, said: "The funds raised will help Xenova to continue to develop and further strengthen its portfolio of innovative new drugs and to progress a number of new drug candidates towards or into clinical trials."
The company will use some of the money to move cancer treatment tariquidar, its lead product, through Phase III trials. Success of the drug is crucial for Xenova, which is not expected to break into profit until 2006 at the earliest when tariquidar reaches the market.
Xenova said if the issue was to fail it would be forced to out-license products and rights earlier than expected.
It emerged in August that Xenova could be a ringleader in nascent plans by bankers to create a "UK Oncology Plc". Early-stage talks have already taken place involving British Biotech, Antisoma and KS Biomedix, the UK`s other cancer companies, and Oxford GlycoSciences, the cash-rich technology group.
The company`s most urgent reason for seeking a merger with a well-capitalised rival would be to gain access to cash. After burning through ý7.3m in the six months to the end of June, Xenova has just ý15.1m in the bank, which is expected to last about 12 months.
The burn rate fell by more than a quarter, after a similar reduction in the staff numbers and the contribution of ý6.4m from licensing deals. That pushed turnover up to ý6.8m and helped cut pre-tax losses from ý7.39m to ý5.49m.
Xenova said on Wednesday that current trading was in line with expectations.
Xenova jumps 9% after Genentech deal
Friedel Rother
FT.com site; Sep 10, 2002
LONDON (FT Investor) - Xenova shares jumped on Tuesday after the UK biotech company said it had signed a deal worth as much as 43.2m, plus royalties, with US company Genentech.
The contract gives Genentech worldwide rights to develop and market products based on Xenova`s OX40 technology, particularly products used to target disorder of the immune system.
Under the terms of the agreement, Genentech will pay Xenova licence fees of as much as 3.4m over the first year of the deal, plus up to 39.7m in milestones.
Xenova could also receive "significant tiered royalties" depending on the level of sales, it said in a statement.
Shares rose 9.2 per cent to 65.5p in London trade. During the past year, the shares have hit a high of 77.9p and a low of 23p.
David Oxlade, chief executive of Xenova, said: "This agreement clearly illustrates our strategy of seeking partnerships with major players who are capable of exploiting our science in applications which lie outside our main focus on cancer and immunotherapy."
See Xenova statement on FT Investor real-time RNS
By FT.com staff in London
FT.com site; Sep 11, 2002
Shares in Xenova fell 12 per cent on Wednesday after the UK biotech announced details of a rights issues that it hopes will raise ý11m ($17.08m) to fund new drugs and research.
The 8-for-33 issue at 32.5p per share is an almost 25 per cent discount to Xenova`s closing price on Tuesday and is fully underwritten by Nomura. Net proceeds will be ý9.9m.
David Oxlade, chief executive of the acquisitive company which last year bought Cantab, said: "The funds raised will help Xenova to continue to develop and further strengthen its portfolio of innovative new drugs and to progress a number of new drug candidates towards or into clinical trials."
The company will use some of the money to move cancer treatment tariquidar, its lead product, through Phase III trials. Success of the drug is crucial for Xenova, which is not expected to break into profit until 2006 at the earliest when tariquidar reaches the market.
Xenova said if the issue was to fail it would be forced to out-license products and rights earlier than expected.
It emerged in August that Xenova could be a ringleader in nascent plans by bankers to create a "UK Oncology Plc". Early-stage talks have already taken place involving British Biotech, Antisoma and KS Biomedix, the UK`s other cancer companies, and Oxford GlycoSciences, the cash-rich technology group.
The company`s most urgent reason for seeking a merger with a well-capitalised rival would be to gain access to cash. After burning through ý7.3m in the six months to the end of June, Xenova has just ý15.1m in the bank, which is expected to last about 12 months.
The burn rate fell by more than a quarter, after a similar reduction in the staff numbers and the contribution of ý6.4m from licensing deals. That pushed turnover up to ý6.8m and helped cut pre-tax losses from ý7.39m to ý5.49m.
Xenova said on Wednesday that current trading was in line with expectations.
Xenova jumps 9% after Genentech deal
Friedel Rother
FT.com site; Sep 10, 2002
LONDON (FT Investor) - Xenova shares jumped on Tuesday after the UK biotech company said it had signed a deal worth as much as 43.2m, plus royalties, with US company Genentech.
The contract gives Genentech worldwide rights to develop and market products based on Xenova`s OX40 technology, particularly products used to target disorder of the immune system.
Under the terms of the agreement, Genentech will pay Xenova licence fees of as much as 3.4m over the first year of the deal, plus up to 39.7m in milestones.
Xenova could also receive "significant tiered royalties" depending on the level of sales, it said in a statement.
Shares rose 9.2 per cent to 65.5p in London trade. During the past year, the shares have hit a high of 77.9p and a low of 23p.
David Oxlade, chief executive of Xenova, said: "This agreement clearly illustrates our strategy of seeking partnerships with major players who are capable of exploiting our science in applications which lie outside our main focus on cancer and immunotherapy."
See Xenova statement on FT Investor real-time RNS
Not for release, distribution or publication in or into the United States,
Canada, Australia, the Republic of Ireland or Japan
Xenova Group plc
Announces a fully underwritten 8 for 33 rights issue to raise approximately £11
million
Slough, UK, 11 September, 2002 - Xenova Group plc (Nasdaq NM: XNVA; London Stock
Exchange: XEN), the UK-based bio-pharmaceuticals group, which focuses on the
therapeutic areas of cancer and immune system disorders, today announces that it
proposes to raise approximately £9.9 million (net of expenses) by means of a
rights issue.
The Rights Issue of approximately 33.7 million New Ordinary Shares at a price of
32.5 pence per New Ordinary Share is being made to Qualifying Shareholders by
way of an 8 for 33 rights issue. This represents a discount of 24.9 per cent.
to the closing middle market price of 43.25 pence per Ordinary Share on 10
September 2002, the last business day before this announcement. The Rights
Issue has been fully underwritten by Nomura (save to the extent of the
Directors` Undertakings).
A prospectus produced by the Company and containing details of the Rights Issue
is expected to be posted to Qualifying Shareholders today. It is expected that
Provisional Allotment Letters will be sent to Qualifying non-CREST Shareholders
following the Extraordinary General Meeting to be held on 4 October 2002 and
that Qualifying CREST Shareholders (who will not receive a Provisional Allotment
Letter) will receive a credit to their appropriate stock accounts in CREST in
respect of their Nil Paid Rights on 4 October 2002.
David Oxlade, Chief Executive Officer of Xenova, commented:
`We are pleased to be able to announce this fully underwritten rights issue at a
time of such volatile and difficult market conditions. The funds raised will
help Xenova to continue to develop and further strengthen its portfolio of
innovative new drugs and to progress a number of new drug candidates towards or
into clinical trials.`
Enquiries:
Xenova Group PLC Tel.: 01753 706 600
David Oxlade, Chief Executive Officer
Daniel Abrams, Chief Financial Officer
Hilary Reid Evans, Head of Corporate Communications
Nomura International PLC Tel.: 020 7521 2000
Charles Spicer
David Rasouly
Media Enquiries: Financial Dynamics Tel.: 020 7831 3113
Fiona Noblet
Jonathan Birt
Nomura, which is regulated in the United Kingdom by the Financial Services
Authority, is acting for Xenova and no one else in connection with the Rights
Issue and will not be responsible to anyone other than Xenova for providing the
protections afforded to clients of Nomura, nor for providing advice in relation
to the Rights Issue or the New Ordinary Shares.
The Directors of Xenova are the persons responsible for the information
contained in this announcement. To the best of the knowledge and belief of the
Directors (who have taken all reasonable care to ensure that such is the case)
the information contained in this announcement is in accordance with the facts
and does not omit anything likely to affect the import of such information.
This announcement does not constitute an offer to sell, or the solicitation of
an offer to subscribe for, the Nil Paid Rights, the Fully Paid Rights, or the
New Ordinary Shares in the United States or in any other jurisdiction in which
such offer or solicitation is unlawful. The Nil Paid Rights, the Fully Paid
Rights, the New Ordinary Shares and the Provisional Allotment Letters have not
been, and will not be, registered under the US Securities Act of 1933 (as
amended) or under the applicable securities laws of Canada, Australia, the
Republic of Ireland, or Japan. Accordingly, unless an exemption under any
applicable laws is available, the New Ordinary Shares or Provisional Allotment
Letters may not be offered, sold, transferred, taken up or delivered, directly
or indirectly, in the US, Canada, Australia, the Republic of Ireland or Japan or
any other country outside the United Kingdom where such distribution may
otherwise lead to a breach of any law or regulatory requirement.
XENOVA GROUP PLC
PROPOSED RIGHTS ISSUE TO RAISE APPROXIMATELY £11 MILLION
1. Introduction
Xenova announces today that it proposes to raise approximately £11.0 million
(approximately £9.9 million net of expenses) by way of an 8 for 33 Rights Issue
to Qualifying Shareholders of 33,710,703 New Ordinary Shares at a price of 32.5
pence per New Ordinary Share, representing a discount of 10.75 pence (24.9 per
cent.) to the closing middle market price of 43.25 pence for Ordinary Shares
trading on the London Stock Exchange on 10 September 2002 (the last practicable
date prior to the date of this announcement).
A prospectus produced by the Company and containing details of the Rights Issue
is expected to be posted to Qualifying Shareholders today. It is expected that
Provisional Allotment Letters will be sent to Qualifying non-CREST Shareholders
following the Extraordinary General Meeting to be held on 4 October 2002 and
Qualifying CREST Shareholders (who will not receive a Provisional Allotment
Letter) will receive a credit to their appropriate stock accounts in CREST in
respect of their Nil Paid Rights on 4 October 2002.
2. Background on Xenova
Xenova is an emerging bio-pharmaceutical company focusing on the therapeutic
areas of cancer and immune system disorders. The Group has a strong track record
in the discovery and development of novel drug candidates, in which it creates
and retains ownership of intellectual property. The Company merged with Cantab
in April 2001, and now employs approximately 140 people at its facilities in
Slough and Cambridge, in the United Kingdom.
The last eighteen months have been a significant period in the history of the
Company, during which the business was expanded through the successful
completion of the merger with Cantab, a number of clinical trials were
successfully completed and important and valuable commercial licensing
agreements were entered into, validating both the strategy and the research and
development activities of the Group. These significant events included:
• the merger with Cantab, which brought together complementary
competencies in the development of new cancer treatments and created a group
with one of the largest clinical development pipelines among listed European
bio-pharmaceuticals companies. Following the merger the Directors carried out a
strategic review of the enlarged group, which resulted in focusing the Group`s
activities and resources on key programmes and led to a substantial reduction in
the combined operating expenses of the Group. Integration of the two businesses
has now been successfully completed;
• the entry into Phase III clinical trials of the Group`s lead drug
candidate, tariquidar (XR9576), a P-glycoprotein inhibitor being developed for
the treatment of MDR in cancer patients;
• the entry into Phase I clinical trials of XR11576, one of the Group`s
novel DNA targeting agents for potential cancer therapy;
• a significant licensing agreement with QLT for the conduct and funding
by QLT of North American and European registration studies, and North American
marketing, of tariquidar (XR9576). Xenova retains substantially all marketing
rights to commercialise the product outside North America;
• a significant licensing agreement with Millennium for the development
and North American marketing of three of the Company`s early stage novel DNA
targeting agents (XR11576, XR5944 and XR11612) for potential cancer therapy.
Xenova retains substantially all marketing rights to commercialise any products
arising from this programme outside North America;
• a further important licensing agreement with Genentech for the
research, development, and worldwide marketing of products primarily targeting
disorders of the immune system based on the OX40 receptor protein and anti-OX40
Ligand antibody programmes. Xenova has retained the global rights to the
applications of the anti-OX40 antibodies and OX40 Ligand programmes relating to
cancer and infectious diseases; and
• two licensing agreements entered into by Phogen, a joint venture
between Xenova and Marie Curie Cancer Care, in respect of the application of
Phogen`s VP22 technology. The first of these collaborations, with Genencor,
relates to the application of VP22 technology to the development of therapeutic
vaccines for certain infectious viral diseases. The second, with Cell Genesys,
relates to the application of VP22 technology to the enhanced delivery of
certain proprietary Cell Genesys genes for the development of products for
cancer and cardiovascular disease.
As a result of these and other developments, the Directors believe that Xenova
now has a strong and well balanced portfolio of product candidates in
development, with 8 products in clinical trials and a further 8 in preclinical
development, and an experienced research and development team supported by a
range of technologies to drive the progress of its product portfolio. The Group
has established a number of commercial collaborations with major pharmaceutical
companies and, in addition to QLT, Millennium, Genentech, Genencor and Cell
Genesys referred to above, also has collaborations with Celltech, Lilly and
Pfizer.
3. Current Trading and Prospects
The Company published its interim results on 14 August 2002. As at 30 June 2002,
Xenova had £15.1 million in cash and liquid resources.
Since the date of the Company`s last published annual accounts, the Group has
continued to make progress, in line with Directors` expectations, with the
development of its drug candidates and early stage programmes.
The Directors continue to expect that the output of its research and development
activities will generate drug candidates that are capable of being partnered
with pharmaceutical or biotechnology companies for their further development and
eventual commercialisation in line with the Group`s commercial strategy. The
Group will continue to seek opportunities to license out compounds at an
appropriate stage of their development.
The Directors expect that losses and cash outflows will continue for a number of
years. However, the Directors believe that this fundraising will place the
Company in a stronger position to continue the development of the business. If
the Rights Issue does not proceed the Company would need to out-license further
products or rights to other territories at an earlier stage than otherwise
intended. The timing of further fundraising will depend on the timing and
magnitude of revenues, in particular milestones and other payments from
programmes licensed out.
4. Reasons for the Rights Issue and Use of Proceeds
Xenova will use the proceeds of the Rights Issue to continue to develop and
exploit its clinical products and to progress its promising early pipeline
towards or into clinical development. The Group is also seeking to expand this
pipeline through a focus on in-house drug discovery and on in-licensing of
products as and when the right opportunities arise. The Directors believe that
the additional financial strength resulting from the Rights Issue will put the
Group in a better position to negotiate favourable terms for its licensing
agreements or any other corporate transactions.
The specific areas to which the funds from the Rights Issue, as well as existing
funds, will be applied include the following:
• progressing tariquidar through Phase III clinical trials. While the
North American rights to this product candidate have been licensed to QLT,
Xenova intends to progress the development of tariquidar in Europe and the Rest
of the World, licensing it out in these other territories at the most
appropriate time;
• progressing one or more product candidates from the novel DNA
targeting agent programme (XR11576, XR11612 and XR5944) to late stage clinical
trials. While the North American rights of certain of these compounds have been
licensed to Millennium, Xenova is responsible for any additional development
costs in Europe and the Rest of the World;
• progressing the addiction vaccines, TA-NIC and TA-CD, through clinical
trials;
• progressing the DISC-PRO prophylactic vaccine and DISC-GMCSF
gene-therapy product through clinical trials to a stage when they can be
licensed out to a partner;
• in respect of the Group`s early stage research projects, seeking to
establish proof of concept of, amongst others, MRP, OX40L, MEN.B, PAI-1
inhibitors (for cancer) and M3, and to progress a product candidate from each of
these programmes towards or into clinical development; and
• in-licensing of new early stage programmes from other companies or
through collaborations with academic research centres and institutions as and
when the right opportunities arise.
The net proceeds of the Rights Issue are expected to be £9.9 million. The
Directors currently estimate that £6.6 million will be invested in the further
development of programmes currently in clinical development and £3.3 million
will be invested in the development of current research and early stage
pre-clinical programmes.
5. Details of the Rights Issue
The Company is proposing to raise approximately £9.9 million, net of expenses,
by way of the Rights Issue. Subject to the terms and conditions set out below,
it is proposed that 33,710,703 New Ordinary Shares will be provisionally
allotted by way of rights to Qualifying Shareholders at a price of 32.5 pence
per New Ordinary Share, payable in full on acceptance, on the following basis:
8 New Ordinary Shares for every 33 Ordinary Shares
held on the Record Date and so in proportion for any other number of Ordinary
Shares then held. Holdings of shares in certificated and uncertificated form
will be treated as separate holdings for the purposes of calculating
entitlements under the Rights Issue. Entitlements of Qualifying Shareholders
under the Rights Issue will be rounded down to the nearest whole number of New
Ordinary Shares. Fractions of New Ordinary Shares will not be allotted to
Qualifying Shareholders but will be aggregated and sold in the market, nil paid,
for the benefit of the Company. The allotment and issue of the New Ordinary
Shares will be made upon and subject to the terms and conditions set out in the
Prospectus, the Provisional Allotment Letters to Qualifying non-CREST
Shareholders and the Company`s memorandum and articles of association. The
offer of New Ordinary Shares to Qualifying CREST Shareholders will be made, on
the terms and conditions set out in the Prospectus and the memorandum and
articles of association, at the time when (such Qualifying CREST Shareholders`
stock accounts having been credited as described in sub-paragraph (a) below) Nil
Paid Rights are enabled for settlement as described in sub-paragraph (b) below.
The issue of the New Ordinary Shares has been underwritten in full by Nomura
(except to the extent of the Directors` Undertakings) pursuant to the
Underwriting Agreement.
Application has been made to the UKLA for the New Ordinary Shares to be admitted
to the Official List and application has been made for the New Ordinary Shares
to be admitted to trading on the market for listed securities of the London
Stock Exchange. It is expected that Admission will become effective and that
dealings in the New Ordinary Shares, nil paid, will commence at 8.00 a.m. on 7
October 2002. The New Ordinary Shares will, when issued and fully paid, rank
pari passu in all respects with the existing Ordinary Shares, including the
right to receive in full all dividends and other distributions hereafter paid,
made or declared on the Ordinary Shares.
The existing Ordinary Shares are already admitted to Crest. Applications will
be made for the Nil Paid Rights, Fully Paid Rights and the New Ordinary Shares
to be admitted to CREST. CRESTCo requires, amongst other things, the Company to
confirm to it that the New Ordinary Shares have been admitted to the Official
List before CRESTCo will admit any security to CREST. As soon as practicable
after Admission, the Company will confirm this to CRESTCo.
Subject to the passing of a special resolution, Resolution1, Provisional
Allotment Letters in respect of Nil Paid Rights will be despatched to Qualifying
non-CREST Shareholders at their own risk on 4 October 2002.
Subject, inter alia, to the conditions referred to below being satisfied, it is
intended that:
(a) Computershare Investor Services PLC will instruct CRESTCo to credit the
appropriate stock accounts of Qualifying CREST Shareholders with such
shareholders` entitlements to Nil Paid Rights on 4 October 2002; and
(b) the Nil Paid Rights and the Fully Paid Rights will be enabled for
settlement by CRESTCo by 8.00 a.m. on 7 October 2002, or, if later, as soon as
practicable after the Company has confirmed to CRESTCo that all the conditions
for admission of such rights to CREST have been satisfied.
The Rights Issue is conditional upon:
i. the passing of a special resolution, Resolution 1, to be proposed at the
Extraordinary General Meeting;
ii. the Underwriting Agreement not having terminated prior to the satisfaction
of the condition referred to in sub-paragraph iii. below; and
iii. Admission becoming effective by no later than 8.00 a.m. on 7 October 2002
(or such later time and/or date as Nomura may decide, being not later than 8.00
a.m. on 15 October 2002).
If, for any reason, the Provisional Allotment Letters are posted otherwise than
on the day of the Extraordinary General Meeting or the Extraordinary General
Meeting does not take place on 4 October 2002, or share accounts of Qualifying
CREST Shareholders cannot be credited, or the Nil Paid Rights cannot be enabled,
by 8.00 a.m. on 7 October 2002, the times and dates referred to in this
announcement may be revised and the times and dates so revised will be contained
in the Provisional Allotment Letters and will be notified by the Company to the
UKLA, a Regulatory Information Service and, where appropriate, to Qualifying
Shareholders.
The latest time and date for acceptance and payment in full in respect of the
Rights Issue is expected to be 9.30 a.m. on 28 October 2002.
The full terms and conditions of the Rights Issue, including the procedure for
acceptance and payment and the procedure in respect of rights not taken up, will
be included in the Prospectus and, in case of Qualifying non-CREST Shareholders,
the Provisional Allotment Letter.
6. Extraordinary General Meeting
An Extraordinary General Meeting is to be held at 10.00 a.m. on 4 October 2002
at Nomura House, 1 St. Martin`s-le-Grand, London EC1A 4NP at which a special
resolution, Resolution 1, necessary to implement the Rights Issue will be
proposed.
A further ordinary resolution, Resolution 2, will also be proposed to amend some
of the Share Option Schemes in order to delete the prescriptive flow rates and
dilution limits that are hindering the operation of the Share Option Schemes.
The overriding 10% in ten years` dilution limit will remain.
7. Further Information
Enquiries:
Xenova Group PLC Tel.: 01753 706 600
David Oxlade, Chief Executive Officer
Daniel Abrams, Chief Financial Officer
Hilary Reid Evans, Head of Corporate Communications
Nomura International PLC Tel.: 020 7521 2000
Charles Spicer
David Rasouly
Media enquiries: Financial Dynamics Tel.: 020 7831 3113
Fiona Noblet
Jonathan Birt
Nomura, which is regulated in the United Kingdom by the Financial Services
Authority, is acting for Xenova and no one else in connection with the Rights
Issue and will not be responsible to anyone other than Xenova for providing the
protections afforded to clients of Nomura, nor for providing advice in relation
to the Rights Issue or the New Ordinary Shares.
This announcement does not constitute an offer to sell, or the solicitation of
an offer to subscribe for, the Nil Paid Rights, the Fully Paid Rights the New
Ordinary Shares in any jurisdiction in which such offer or solicitation is
unlawful. The Nil Paid Rights, the Fully Paid Rights, the New Ordinary Shares
and the Provisional Allotment Letters have not been, and will not be, registered
under the US Securities Act of 1933 (as amended) or under the applicable
securities laws of Canada, Australia, the Republic of Ireland, or Japan.
Accordingly, unless an exemption under any applicable laws is available, the New
Ordinary Shares or Provisional Allotment Letters may not be offered, sold,
transferred, taken up or delivered, directly or indirectly, in the US, Canada,
Australia, the Republic of Ireland or Japan or any other country outside the
United Kingdom where such distribution may otherwise lead to a breach of any law
or regulatory requirement.
This press release is not an offer of securities for sale in the United States.
The Nil Paid Rights, the Fully Paid Rights and the New Ordinary Shares may not
be offered or sold in the United States.
Appendix 1 - Expected timetable of Principal Events
It is currently anticipated that the Rights Issue will proceed in accordance
with the following timetable:
Record date for the Rights Issue close of business on 2 October
2002
Latest time and date for receipt of Forms of Proxy 10.00 a.m. on 2 October 2002
Extraordinary General Meeting 10.00 a.m. on 4 October 2002
Provisional Allotment Letters despatched to Qualifying non-CREST Shareholders 4 October 2002
Admission, dealings in New Ordinary Shares to commence, nil paid 8.00 a.m. on 7 October 2002
Nil Paid Rights and Fully Paid Rights enabled in CREST 8.00 a.m. on 7 October 2002
Recommended latest time for requesting withdrawal of Nil Paid Rights from 9.30 a.m. on 22 October 2002
CREST
Latest time for depositing renounced Provisional Allotment Letters (nil paid 3.00 p.m. on 23 October 2002
or fully paid) into CREST or for dematerialising Nil Paid Rights into a CREST
stock account
Latest time and date for splitting Provisional Allotment Letters, nil paid or 3.00 p.m. on 24 October 2002
fully paid
Latest time and date for acceptance and payment in full and for registration 9.30 a.m. on 28 October 2002
of renunciation
Dealings in New Ordinary Shares to commence, fully paid 8.00 a.m. on 29 October 2002
CREST Stock Accounts credited for New Ordinary Shares in uncertificated form 29 October 2002
Definitive share certificates for New Ordinary Shares despatched by 4 November 2002
Appendix 2 - Definitions
`Admission` admission of the New Ordinary Shares (nil paid) to the Official List
and to trading on the market for listed securities of the London Stock
Exchange
`Cantab` Cantab Pharmaceuticals plc
`Celltech` Celltech Group plc
`Cell Genesys` Cell Genesys, Inc.
`certificated form` a share or other security which is not in uncertificated form
`CREST` The relevant system (as defined in the Regulations) in respect of
which CRESTCo Limited is the Operator (as defined in the Regulations)
`CREST stock account` a CREST stock account
`Directors` The directors of Xenova
`Directors` Undertakings` the irrevocable undertaking of certain Directors to take up all or
part of their entitlement as Qualifying Shareholders pursuant to the
Rights Issue
`Extraordinary General Meeting` or `EGM` The extraordinary general meeting of the Company to be held at 10.00
a.m. on 4 October 2002, notice of which will be set out in the
Prospectus
`Form of Proxy` means the form of proxy for use at the EGM, which will accompany the
Prospectus
`Fully Paid Rights` The rights to acquire New Ordinary Shares, fully paid
`Genencor` Genencor International, Inc.
`Genentech` Genentech, Inc.
`GSK` GlaxoSmithKline PLC
`Lilly` Eli Lilly & Company of Indianapolis, USA
`London Stock Exchange` London Stock Exchange PLC
`Millennium` Millennium Pharmaceuticals, Inc.
`New Ordinary Shares` Ordinary Shares to be issued pursuant to the Rights Issue
`Nil Paid Rights` The New Ordinary Shares, in nil paid form, provisionally allotted to
Qualifying Shareholders pursuant to the Rights Issue
`Nomura` Nomura International plc
`Official List` the Official List of the UKLA
`Ordinary Shares` ordinary shares of 10 pence each in the share capital of the Company
`Overseas Shareholders` Shareholders with registered addresses outside the United Kingdom or
who are citizens or residents of countries outside the United Kingdom
`Pfizer` Pfizer Animal Health, Inc.
`Phogen` Phogen Ltd
`Prospectus` the prospectus relating to the proposed rights issue
`Provisional Allotment Letter` or `PAL` the renounceable provisional allotment letter to be sent to Qualifying
non-CREST Shareholders in respect of the New Ordinary Shares to be
provisionally allotted to them pursuant to the Rights Issue
`QLT` QLT, Inc.
`Qualifying CREST Shareholders` Qualifying Shareholders who hold Ordinary Shares on the relevant
register of members of the Company at the close of business on the
Record Date in uncertificated form
`Qualifying non-CREST Shareholders` Qualifying Shareholders who hold Ordinary Shares on the relevant
register of members of the Company at the close of business on the
Record Date in certificated form
`Qualifying Shareholders` holders of Ordinary Shares on the register of members of the Company
as at the close of business on the Record Date, except as described in
Part 3 of the Prospectus in respect of certain Overseas Shareholders
`Record Date` 2 October 2002
`Regulations` the Uncertificated Securities Regulations 2001 (SI/3755)
`Resolutions` the special resolution (``Resolution 1``) and the ordinary resolution
(``Resolution 2``) to be proposed at the EGM
`Rights Issue` the offer of 33,710,703 New Ordinary Shares by way of rights to
Qualifying Shareholders on the basis set out in the Prospectus and,
for Qualifying non-CREST Holders only, the Provisional Allotment
Letter
`Shareholder` a holder of Ordinary Shares
`Share Option Schemes` the Xenova Limited 1988 Share Option Scheme, the Xenova Group 1992
Share Option Scheme, the Xenova Group 1996 Share Option Scheme, the
Xenova Group 1996 Savings-Related Share Option Plan and the Xenova
Deferred Share Bonus Plan
`stock account` an account within a member account in CREST to which a holding of a
particular share or other security in CREST is credited
`UKLA` or `UK Listing Authority` the UK Listing Authority, being the Financial Services Authority
acting as the competent authority for the purposes of Part VI of the
Financial Services and Markets Act 2000
`uncertificated form` a share or security which is for the time being recorded on the
relevant register of members as being held in uncertificated form in
CREST, and title to which, by virtue of the Regulations, may be
transferred by means of CREST
`Underwriting Agreement` the conditional underwriting agreement dated 11 September 2002 between
the Company and Nomura in relation to the Rights Issue
`US`, `USA` or `United States` the United States of America, its territories and possessions and any
state of the United States of America and the District of Columbia
`Xenova Group` or the `Group` Xenova and its subsidiary undertakings from time to time
`Xenova` or the `Company` Xenova Group plc and/or where applicable any of its subsidiaries
This information is provided by RNS
The company news service from the London Stock Exchange
Canada, Australia, the Republic of Ireland or Japan
Xenova Group plc
Announces a fully underwritten 8 for 33 rights issue to raise approximately £11
million
Slough, UK, 11 September, 2002 - Xenova Group plc (Nasdaq NM: XNVA; London Stock
Exchange: XEN), the UK-based bio-pharmaceuticals group, which focuses on the
therapeutic areas of cancer and immune system disorders, today announces that it
proposes to raise approximately £9.9 million (net of expenses) by means of a
rights issue.
The Rights Issue of approximately 33.7 million New Ordinary Shares at a price of
32.5 pence per New Ordinary Share is being made to Qualifying Shareholders by
way of an 8 for 33 rights issue. This represents a discount of 24.9 per cent.
to the closing middle market price of 43.25 pence per Ordinary Share on 10
September 2002, the last business day before this announcement. The Rights
Issue has been fully underwritten by Nomura (save to the extent of the
Directors` Undertakings).
A prospectus produced by the Company and containing details of the Rights Issue
is expected to be posted to Qualifying Shareholders today. It is expected that
Provisional Allotment Letters will be sent to Qualifying non-CREST Shareholders
following the Extraordinary General Meeting to be held on 4 October 2002 and
that Qualifying CREST Shareholders (who will not receive a Provisional Allotment
Letter) will receive a credit to their appropriate stock accounts in CREST in
respect of their Nil Paid Rights on 4 October 2002.
David Oxlade, Chief Executive Officer of Xenova, commented:
`We are pleased to be able to announce this fully underwritten rights issue at a
time of such volatile and difficult market conditions. The funds raised will
help Xenova to continue to develop and further strengthen its portfolio of
innovative new drugs and to progress a number of new drug candidates towards or
into clinical trials.`
Enquiries:
Xenova Group PLC Tel.: 01753 706 600
David Oxlade, Chief Executive Officer
Daniel Abrams, Chief Financial Officer
Hilary Reid Evans, Head of Corporate Communications
Nomura International PLC Tel.: 020 7521 2000
Charles Spicer
David Rasouly
Media Enquiries: Financial Dynamics Tel.: 020 7831 3113
Fiona Noblet
Jonathan Birt
Nomura, which is regulated in the United Kingdom by the Financial Services
Authority, is acting for Xenova and no one else in connection with the Rights
Issue and will not be responsible to anyone other than Xenova for providing the
protections afforded to clients of Nomura, nor for providing advice in relation
to the Rights Issue or the New Ordinary Shares.
The Directors of Xenova are the persons responsible for the information
contained in this announcement. To the best of the knowledge and belief of the
Directors (who have taken all reasonable care to ensure that such is the case)
the information contained in this announcement is in accordance with the facts
and does not omit anything likely to affect the import of such information.
This announcement does not constitute an offer to sell, or the solicitation of
an offer to subscribe for, the Nil Paid Rights, the Fully Paid Rights, or the
New Ordinary Shares in the United States or in any other jurisdiction in which
such offer or solicitation is unlawful. The Nil Paid Rights, the Fully Paid
Rights, the New Ordinary Shares and the Provisional Allotment Letters have not
been, and will not be, registered under the US Securities Act of 1933 (as
amended) or under the applicable securities laws of Canada, Australia, the
Republic of Ireland, or Japan. Accordingly, unless an exemption under any
applicable laws is available, the New Ordinary Shares or Provisional Allotment
Letters may not be offered, sold, transferred, taken up or delivered, directly
or indirectly, in the US, Canada, Australia, the Republic of Ireland or Japan or
any other country outside the United Kingdom where such distribution may
otherwise lead to a breach of any law or regulatory requirement.
XENOVA GROUP PLC
PROPOSED RIGHTS ISSUE TO RAISE APPROXIMATELY £11 MILLION
1. Introduction
Xenova announces today that it proposes to raise approximately £11.0 million
(approximately £9.9 million net of expenses) by way of an 8 for 33 Rights Issue
to Qualifying Shareholders of 33,710,703 New Ordinary Shares at a price of 32.5
pence per New Ordinary Share, representing a discount of 10.75 pence (24.9 per
cent.) to the closing middle market price of 43.25 pence for Ordinary Shares
trading on the London Stock Exchange on 10 September 2002 (the last practicable
date prior to the date of this announcement).
A prospectus produced by the Company and containing details of the Rights Issue
is expected to be posted to Qualifying Shareholders today. It is expected that
Provisional Allotment Letters will be sent to Qualifying non-CREST Shareholders
following the Extraordinary General Meeting to be held on 4 October 2002 and
Qualifying CREST Shareholders (who will not receive a Provisional Allotment
Letter) will receive a credit to their appropriate stock accounts in CREST in
respect of their Nil Paid Rights on 4 October 2002.
2. Background on Xenova
Xenova is an emerging bio-pharmaceutical company focusing on the therapeutic
areas of cancer and immune system disorders. The Group has a strong track record
in the discovery and development of novel drug candidates, in which it creates
and retains ownership of intellectual property. The Company merged with Cantab
in April 2001, and now employs approximately 140 people at its facilities in
Slough and Cambridge, in the United Kingdom.
The last eighteen months have been a significant period in the history of the
Company, during which the business was expanded through the successful
completion of the merger with Cantab, a number of clinical trials were
successfully completed and important and valuable commercial licensing
agreements were entered into, validating both the strategy and the research and
development activities of the Group. These significant events included:
• the merger with Cantab, which brought together complementary
competencies in the development of new cancer treatments and created a group
with one of the largest clinical development pipelines among listed European
bio-pharmaceuticals companies. Following the merger the Directors carried out a
strategic review of the enlarged group, which resulted in focusing the Group`s
activities and resources on key programmes and led to a substantial reduction in
the combined operating expenses of the Group. Integration of the two businesses
has now been successfully completed;
• the entry into Phase III clinical trials of the Group`s lead drug
candidate, tariquidar (XR9576), a P-glycoprotein inhibitor being developed for
the treatment of MDR in cancer patients;
• the entry into Phase I clinical trials of XR11576, one of the Group`s
novel DNA targeting agents for potential cancer therapy;
• a significant licensing agreement with QLT for the conduct and funding
by QLT of North American and European registration studies, and North American
marketing, of tariquidar (XR9576). Xenova retains substantially all marketing
rights to commercialise the product outside North America;
• a significant licensing agreement with Millennium for the development
and North American marketing of three of the Company`s early stage novel DNA
targeting agents (XR11576, XR5944 and XR11612) for potential cancer therapy.
Xenova retains substantially all marketing rights to commercialise any products
arising from this programme outside North America;
• a further important licensing agreement with Genentech for the
research, development, and worldwide marketing of products primarily targeting
disorders of the immune system based on the OX40 receptor protein and anti-OX40
Ligand antibody programmes. Xenova has retained the global rights to the
applications of the anti-OX40 antibodies and OX40 Ligand programmes relating to
cancer and infectious diseases; and
• two licensing agreements entered into by Phogen, a joint venture
between Xenova and Marie Curie Cancer Care, in respect of the application of
Phogen`s VP22 technology. The first of these collaborations, with Genencor,
relates to the application of VP22 technology to the development of therapeutic
vaccines for certain infectious viral diseases. The second, with Cell Genesys,
relates to the application of VP22 technology to the enhanced delivery of
certain proprietary Cell Genesys genes for the development of products for
cancer and cardiovascular disease.
As a result of these and other developments, the Directors believe that Xenova
now has a strong and well balanced portfolio of product candidates in
development, with 8 products in clinical trials and a further 8 in preclinical
development, and an experienced research and development team supported by a
range of technologies to drive the progress of its product portfolio. The Group
has established a number of commercial collaborations with major pharmaceutical
companies and, in addition to QLT, Millennium, Genentech, Genencor and Cell
Genesys referred to above, also has collaborations with Celltech, Lilly and
Pfizer.
3. Current Trading and Prospects
The Company published its interim results on 14 August 2002. As at 30 June 2002,
Xenova had £15.1 million in cash and liquid resources.
Since the date of the Company`s last published annual accounts, the Group has
continued to make progress, in line with Directors` expectations, with the
development of its drug candidates and early stage programmes.
The Directors continue to expect that the output of its research and development
activities will generate drug candidates that are capable of being partnered
with pharmaceutical or biotechnology companies for their further development and
eventual commercialisation in line with the Group`s commercial strategy. The
Group will continue to seek opportunities to license out compounds at an
appropriate stage of their development.
The Directors expect that losses and cash outflows will continue for a number of
years. However, the Directors believe that this fundraising will place the
Company in a stronger position to continue the development of the business. If
the Rights Issue does not proceed the Company would need to out-license further
products or rights to other territories at an earlier stage than otherwise
intended. The timing of further fundraising will depend on the timing and
magnitude of revenues, in particular milestones and other payments from
programmes licensed out.
4. Reasons for the Rights Issue and Use of Proceeds
Xenova will use the proceeds of the Rights Issue to continue to develop and
exploit its clinical products and to progress its promising early pipeline
towards or into clinical development. The Group is also seeking to expand this
pipeline through a focus on in-house drug discovery and on in-licensing of
products as and when the right opportunities arise. The Directors believe that
the additional financial strength resulting from the Rights Issue will put the
Group in a better position to negotiate favourable terms for its licensing
agreements or any other corporate transactions.
The specific areas to which the funds from the Rights Issue, as well as existing
funds, will be applied include the following:
• progressing tariquidar through Phase III clinical trials. While the
North American rights to this product candidate have been licensed to QLT,
Xenova intends to progress the development of tariquidar in Europe and the Rest
of the World, licensing it out in these other territories at the most
appropriate time;
• progressing one or more product candidates from the novel DNA
targeting agent programme (XR11576, XR11612 and XR5944) to late stage clinical
trials. While the North American rights of certain of these compounds have been
licensed to Millennium, Xenova is responsible for any additional development
costs in Europe and the Rest of the World;
• progressing the addiction vaccines, TA-NIC and TA-CD, through clinical
trials;
• progressing the DISC-PRO prophylactic vaccine and DISC-GMCSF
gene-therapy product through clinical trials to a stage when they can be
licensed out to a partner;
• in respect of the Group`s early stage research projects, seeking to
establish proof of concept of, amongst others, MRP, OX40L, MEN.B, PAI-1
inhibitors (for cancer) and M3, and to progress a product candidate from each of
these programmes towards or into clinical development; and
• in-licensing of new early stage programmes from other companies or
through collaborations with academic research centres and institutions as and
when the right opportunities arise.
The net proceeds of the Rights Issue are expected to be £9.9 million. The
Directors currently estimate that £6.6 million will be invested in the further
development of programmes currently in clinical development and £3.3 million
will be invested in the development of current research and early stage
pre-clinical programmes.
5. Details of the Rights Issue
The Company is proposing to raise approximately £9.9 million, net of expenses,
by way of the Rights Issue. Subject to the terms and conditions set out below,
it is proposed that 33,710,703 New Ordinary Shares will be provisionally
allotted by way of rights to Qualifying Shareholders at a price of 32.5 pence
per New Ordinary Share, payable in full on acceptance, on the following basis:
8 New Ordinary Shares for every 33 Ordinary Shares
held on the Record Date and so in proportion for any other number of Ordinary
Shares then held. Holdings of shares in certificated and uncertificated form
will be treated as separate holdings for the purposes of calculating
entitlements under the Rights Issue. Entitlements of Qualifying Shareholders
under the Rights Issue will be rounded down to the nearest whole number of New
Ordinary Shares. Fractions of New Ordinary Shares will not be allotted to
Qualifying Shareholders but will be aggregated and sold in the market, nil paid,
for the benefit of the Company. The allotment and issue of the New Ordinary
Shares will be made upon and subject to the terms and conditions set out in the
Prospectus, the Provisional Allotment Letters to Qualifying non-CREST
Shareholders and the Company`s memorandum and articles of association. The
offer of New Ordinary Shares to Qualifying CREST Shareholders will be made, on
the terms and conditions set out in the Prospectus and the memorandum and
articles of association, at the time when (such Qualifying CREST Shareholders`
stock accounts having been credited as described in sub-paragraph (a) below) Nil
Paid Rights are enabled for settlement as described in sub-paragraph (b) below.
The issue of the New Ordinary Shares has been underwritten in full by Nomura
(except to the extent of the Directors` Undertakings) pursuant to the
Underwriting Agreement.
Application has been made to the UKLA for the New Ordinary Shares to be admitted
to the Official List and application has been made for the New Ordinary Shares
to be admitted to trading on the market for listed securities of the London
Stock Exchange. It is expected that Admission will become effective and that
dealings in the New Ordinary Shares, nil paid, will commence at 8.00 a.m. on 7
October 2002. The New Ordinary Shares will, when issued and fully paid, rank
pari passu in all respects with the existing Ordinary Shares, including the
right to receive in full all dividends and other distributions hereafter paid,
made or declared on the Ordinary Shares.
The existing Ordinary Shares are already admitted to Crest. Applications will
be made for the Nil Paid Rights, Fully Paid Rights and the New Ordinary Shares
to be admitted to CREST. CRESTCo requires, amongst other things, the Company to
confirm to it that the New Ordinary Shares have been admitted to the Official
List before CRESTCo will admit any security to CREST. As soon as practicable
after Admission, the Company will confirm this to CRESTCo.
Subject to the passing of a special resolution, Resolution1, Provisional
Allotment Letters in respect of Nil Paid Rights will be despatched to Qualifying
non-CREST Shareholders at their own risk on 4 October 2002.
Subject, inter alia, to the conditions referred to below being satisfied, it is
intended that:
(a) Computershare Investor Services PLC will instruct CRESTCo to credit the
appropriate stock accounts of Qualifying CREST Shareholders with such
shareholders` entitlements to Nil Paid Rights on 4 October 2002; and
(b) the Nil Paid Rights and the Fully Paid Rights will be enabled for
settlement by CRESTCo by 8.00 a.m. on 7 October 2002, or, if later, as soon as
practicable after the Company has confirmed to CRESTCo that all the conditions
for admission of such rights to CREST have been satisfied.
The Rights Issue is conditional upon:
i. the passing of a special resolution, Resolution 1, to be proposed at the
Extraordinary General Meeting;
ii. the Underwriting Agreement not having terminated prior to the satisfaction
of the condition referred to in sub-paragraph iii. below; and
iii. Admission becoming effective by no later than 8.00 a.m. on 7 October 2002
(or such later time and/or date as Nomura may decide, being not later than 8.00
a.m. on 15 October 2002).
If, for any reason, the Provisional Allotment Letters are posted otherwise than
on the day of the Extraordinary General Meeting or the Extraordinary General
Meeting does not take place on 4 October 2002, or share accounts of Qualifying
CREST Shareholders cannot be credited, or the Nil Paid Rights cannot be enabled,
by 8.00 a.m. on 7 October 2002, the times and dates referred to in this
announcement may be revised and the times and dates so revised will be contained
in the Provisional Allotment Letters and will be notified by the Company to the
UKLA, a Regulatory Information Service and, where appropriate, to Qualifying
Shareholders.
The latest time and date for acceptance and payment in full in respect of the
Rights Issue is expected to be 9.30 a.m. on 28 October 2002.
The full terms and conditions of the Rights Issue, including the procedure for
acceptance and payment and the procedure in respect of rights not taken up, will
be included in the Prospectus and, in case of Qualifying non-CREST Shareholders,
the Provisional Allotment Letter.
6. Extraordinary General Meeting
An Extraordinary General Meeting is to be held at 10.00 a.m. on 4 October 2002
at Nomura House, 1 St. Martin`s-le-Grand, London EC1A 4NP at which a special
resolution, Resolution 1, necessary to implement the Rights Issue will be
proposed.
A further ordinary resolution, Resolution 2, will also be proposed to amend some
of the Share Option Schemes in order to delete the prescriptive flow rates and
dilution limits that are hindering the operation of the Share Option Schemes.
The overriding 10% in ten years` dilution limit will remain.
7. Further Information
Enquiries:
Xenova Group PLC Tel.: 01753 706 600
David Oxlade, Chief Executive Officer
Daniel Abrams, Chief Financial Officer
Hilary Reid Evans, Head of Corporate Communications
Nomura International PLC Tel.: 020 7521 2000
Charles Spicer
David Rasouly
Media enquiries: Financial Dynamics Tel.: 020 7831 3113
Fiona Noblet
Jonathan Birt
Nomura, which is regulated in the United Kingdom by the Financial Services
Authority, is acting for Xenova and no one else in connection with the Rights
Issue and will not be responsible to anyone other than Xenova for providing the
protections afforded to clients of Nomura, nor for providing advice in relation
to the Rights Issue or the New Ordinary Shares.
This announcement does not constitute an offer to sell, or the solicitation of
an offer to subscribe for, the Nil Paid Rights, the Fully Paid Rights the New
Ordinary Shares in any jurisdiction in which such offer or solicitation is
unlawful. The Nil Paid Rights, the Fully Paid Rights, the New Ordinary Shares
and the Provisional Allotment Letters have not been, and will not be, registered
under the US Securities Act of 1933 (as amended) or under the applicable
securities laws of Canada, Australia, the Republic of Ireland, or Japan.
Accordingly, unless an exemption under any applicable laws is available, the New
Ordinary Shares or Provisional Allotment Letters may not be offered, sold,
transferred, taken up or delivered, directly or indirectly, in the US, Canada,
Australia, the Republic of Ireland or Japan or any other country outside the
United Kingdom where such distribution may otherwise lead to a breach of any law
or regulatory requirement.
This press release is not an offer of securities for sale in the United States.
The Nil Paid Rights, the Fully Paid Rights and the New Ordinary Shares may not
be offered or sold in the United States.
Appendix 1 - Expected timetable of Principal Events
It is currently anticipated that the Rights Issue will proceed in accordance
with the following timetable:
Record date for the Rights Issue close of business on 2 October
2002
Latest time and date for receipt of Forms of Proxy 10.00 a.m. on 2 October 2002
Extraordinary General Meeting 10.00 a.m. on 4 October 2002
Provisional Allotment Letters despatched to Qualifying non-CREST Shareholders 4 October 2002
Admission, dealings in New Ordinary Shares to commence, nil paid 8.00 a.m. on 7 October 2002
Nil Paid Rights and Fully Paid Rights enabled in CREST 8.00 a.m. on 7 October 2002
Recommended latest time for requesting withdrawal of Nil Paid Rights from 9.30 a.m. on 22 October 2002
CREST
Latest time for depositing renounced Provisional Allotment Letters (nil paid 3.00 p.m. on 23 October 2002
or fully paid) into CREST or for dematerialising Nil Paid Rights into a CREST
stock account
Latest time and date for splitting Provisional Allotment Letters, nil paid or 3.00 p.m. on 24 October 2002
fully paid
Latest time and date for acceptance and payment in full and for registration 9.30 a.m. on 28 October 2002
of renunciation
Dealings in New Ordinary Shares to commence, fully paid 8.00 a.m. on 29 October 2002
CREST Stock Accounts credited for New Ordinary Shares in uncertificated form 29 October 2002
Definitive share certificates for New Ordinary Shares despatched by 4 November 2002
Appendix 2 - Definitions
`Admission` admission of the New Ordinary Shares (nil paid) to the Official List
and to trading on the market for listed securities of the London Stock
Exchange
`Cantab` Cantab Pharmaceuticals plc
`Celltech` Celltech Group plc
`Cell Genesys` Cell Genesys, Inc.
`certificated form` a share or other security which is not in uncertificated form
`CREST` The relevant system (as defined in the Regulations) in respect of
which CRESTCo Limited is the Operator (as defined in the Regulations)
`CREST stock account` a CREST stock account
`Directors` The directors of Xenova
`Directors` Undertakings` the irrevocable undertaking of certain Directors to take up all or
part of their entitlement as Qualifying Shareholders pursuant to the
Rights Issue
`Extraordinary General Meeting` or `EGM` The extraordinary general meeting of the Company to be held at 10.00
a.m. on 4 October 2002, notice of which will be set out in the
Prospectus
`Form of Proxy` means the form of proxy for use at the EGM, which will accompany the
Prospectus
`Fully Paid Rights` The rights to acquire New Ordinary Shares, fully paid
`Genencor` Genencor International, Inc.
`Genentech` Genentech, Inc.
`GSK` GlaxoSmithKline PLC
`Lilly` Eli Lilly & Company of Indianapolis, USA
`London Stock Exchange` London Stock Exchange PLC
`Millennium` Millennium Pharmaceuticals, Inc.
`New Ordinary Shares` Ordinary Shares to be issued pursuant to the Rights Issue
`Nil Paid Rights` The New Ordinary Shares, in nil paid form, provisionally allotted to
Qualifying Shareholders pursuant to the Rights Issue
`Nomura` Nomura International plc
`Official List` the Official List of the UKLA
`Ordinary Shares` ordinary shares of 10 pence each in the share capital of the Company
`Overseas Shareholders` Shareholders with registered addresses outside the United Kingdom or
who are citizens or residents of countries outside the United Kingdom
`Pfizer` Pfizer Animal Health, Inc.
`Phogen` Phogen Ltd
`Prospectus` the prospectus relating to the proposed rights issue
`Provisional Allotment Letter` or `PAL` the renounceable provisional allotment letter to be sent to Qualifying
non-CREST Shareholders in respect of the New Ordinary Shares to be
provisionally allotted to them pursuant to the Rights Issue
`QLT` QLT, Inc.
`Qualifying CREST Shareholders` Qualifying Shareholders who hold Ordinary Shares on the relevant
register of members of the Company at the close of business on the
Record Date in uncertificated form
`Qualifying non-CREST Shareholders` Qualifying Shareholders who hold Ordinary Shares on the relevant
register of members of the Company at the close of business on the
Record Date in certificated form
`Qualifying Shareholders` holders of Ordinary Shares on the register of members of the Company
as at the close of business on the Record Date, except as described in
Part 3 of the Prospectus in respect of certain Overseas Shareholders
`Record Date` 2 October 2002
`Regulations` the Uncertificated Securities Regulations 2001 (SI/3755)
`Resolutions` the special resolution (``Resolution 1``) and the ordinary resolution
(``Resolution 2``) to be proposed at the EGM
`Rights Issue` the offer of 33,710,703 New Ordinary Shares by way of rights to
Qualifying Shareholders on the basis set out in the Prospectus and,
for Qualifying non-CREST Holders only, the Provisional Allotment
Letter
`Shareholder` a holder of Ordinary Shares
`Share Option Schemes` the Xenova Limited 1988 Share Option Scheme, the Xenova Group 1992
Share Option Scheme, the Xenova Group 1996 Share Option Scheme, the
Xenova Group 1996 Savings-Related Share Option Plan and the Xenova
Deferred Share Bonus Plan
`stock account` an account within a member account in CREST to which a holding of a
particular share or other security in CREST is credited
`UKLA` or `UK Listing Authority` the UK Listing Authority, being the Financial Services Authority
acting as the competent authority for the purposes of Part VI of the
Financial Services and Markets Act 2000
`uncertificated form` a share or security which is for the time being recorded on the
relevant register of members as being held in uncertificated form in
CREST, and title to which, by virtue of the Regulations, may be
transferred by means of CREST
`Underwriting Agreement` the conditional underwriting agreement dated 11 September 2002 between
the Company and Nomura in relation to the Rights Issue
`US`, `USA` or `United States` the United States of America, its territories and possessions and any
state of the United States of America and the District of Columbia
`Xenova Group` or the `Group` Xenova and its subsidiary undertakings from time to time
`Xenova` or the `Company` Xenova Group plc and/or where applicable any of its subsidiaries
This information is provided by RNS
The company news service from the London Stock Exchange
COMPANIES & FINANCE UK & IRELAND: Xenova rights issue improves mood in sector
By Patrick Jenkins
Financial Times; Sep 12, 2002
Xenova, the cancer and vaccines specialist, yesterday announced a ý10m rights issue, in a move that analysts said could improve sentiment in the depressed biotechnology sector.
The issue, fully underwritten by Nomura, is the first in the industry for six months. It extends Xenova`s funding by about nine months to the spring of 2004.
Xenova had suggested in recent months that it wanted to resolve its cash shortage by merging with a well funded rival.
Over the summer, it initiated discussions with Oxford GlycoSciences, the cash-rich, product-poor group, with a view to creating an entity that other cancer companies could be folded into.
David Oxlade, chief executive, said yesterday that the rights issue did not change its strategic interest in merger and acquisitions. "Being better funded strengthens our hand in any discussions," he said.
Analysts questioned why the company had not raised more.
But Daniel Abrams, finance director, said that would have entailed courting new institutional investors. "Given the current state of the market and the biotechnology sector, we felt there was no merit in approaching new investors."
Nevertheless, Sally Bennett, biotech analyst at ING Barings, said: "It is very positive for the sector that shareholders are still willing to support a company that has proved itself."
She said it was evidence that the sector as a whole might be emerging from the doldrums, with a split emerging between the winners and losers.
Xenova`s eight-for-33 rights issue is priced at 32?p, a 25 per cent discount to Tuesday`s closing price. It will raise ý11m gross, and ý9.9m net.
An extraordinary meeting will be held on October 4 to approve the operation.
The company will maintain its current programme of research and development spending, putting two-thirds of the money into clinical development and a third into earlier-stage research.
The shares fell 5?p yesterday to 38p.
By Patrick Jenkins
Financial Times; Sep 12, 2002
Xenova, the cancer and vaccines specialist, yesterday announced a ý10m rights issue, in a move that analysts said could improve sentiment in the depressed biotechnology sector.
The issue, fully underwritten by Nomura, is the first in the industry for six months. It extends Xenova`s funding by about nine months to the spring of 2004.
Xenova had suggested in recent months that it wanted to resolve its cash shortage by merging with a well funded rival.
Over the summer, it initiated discussions with Oxford GlycoSciences, the cash-rich, product-poor group, with a view to creating an entity that other cancer companies could be folded into.
David Oxlade, chief executive, said yesterday that the rights issue did not change its strategic interest in merger and acquisitions. "Being better funded strengthens our hand in any discussions," he said.
Analysts questioned why the company had not raised more.
But Daniel Abrams, finance director, said that would have entailed courting new institutional investors. "Given the current state of the market and the biotechnology sector, we felt there was no merit in approaching new investors."
Nevertheless, Sally Bennett, biotech analyst at ING Barings, said: "It is very positive for the sector that shareholders are still willing to support a company that has proved itself."
She said it was evidence that the sector as a whole might be emerging from the doldrums, with a split emerging between the winners and losers.
Xenova`s eight-for-33 rights issue is priced at 32?p, a 25 per cent discount to Tuesday`s closing price. It will raise ý11m gross, and ý9.9m net.
An extraordinary meeting will be held on October 4 to approve the operation.
The company will maintain its current programme of research and development spending, putting two-thirds of the money into clinical development and a third into earlier-stage research.
The shares fell 5?p yesterday to 38p.
Anscheinen scheint eine Firma Interesse zu haben, XENOVA zu kaufen ?!?!
Allerdings weiß ich noch nicht, was ich davon halten soll. Offensichtlich nur ein Wunschgedanken, denn lt. den Expansionsplänen von David Oxlade dürfte das wohl etwas in Konflikt geraten. Er will ja XENOVA zu einer zweiten CELLTECH machen, also das größte Biounternehmen Englands.
Möglich wäre eine feindliche Übernahme. Dazu müßte man prüfen, wieviele Aktien in Streubesitz sich befinden und ob so etwas theoretisch überhaupt möglich wäre.
Aus der bevorstehende Kapitalerhöhung allerdings kann man erkennen, daß XENOVA es überhaupt nicht will, daß "Fremde" sich in XENOVA einkaufen sondern die langfristig orientierte Anleger (wie wir) dazu nutzen will, XENOVA`s Stellung im Markt zu sichern und auszubauen.
Naja, anbei der ziemlich lange Bericht:
LONDON -(Dow Jones)- Cash-rich biotechnology company Oxford GlycoSciences PLC (OGSI, news) Thursday said it is restructuring its business into three separate units and is in acquisition talks.
OGS, along with a growing number of European biotechs, has seen its share price fall by more than 90% since its early 2000 peak, leaving its market capitalization languishing below its cash levels, while it`s yet to get a drug to market.
"It`s an honest review. I`m not happy with the financial numbers, which is why together with the management team I`ve taken a number of steps," Chief Executive David Ebsworth, who took over the helm just ninety days ago, told Dow Jones Newswires. The weak market cap versus cash is "very frustrating," he said.
Ebsworth said he`s in talks with a number of companies with to merge or buy a company focused on cancer, or to buy in cancer products. There seems to be more opportunities for M&A in oncology than elsewhere, he said.
OGS is to be split into three separate divisions: oncology; inherited storage disorders, which aims for profitability in 2005 and includes the company`s most advanced drug Vevesca, for Gaucher`s disease; and a proteomics division, aiming for profit in 2003, to leverage OGS` expertise in studying the role of proteins in disease. Each division will report its own profit and loss account from 2003.
In addition, recent job cuts in the U.K., the closure of an office in New Jersey, the restructuring of research and technology alliances and the hand-over in July of European marketing for Vevesca to Actelion Ltd. (Z.ATL, news), should together cut the company`s spending by around GBP10 million a year going forward, said Ebsworth.
Shares were down 2.5 pence, or 1.6%, at 150 pence at 0753 GMT. This values the company at GBP85 million, while its net cash position at June 30 was GBP153 million.
"With the second largest cash pile in U.K. biotech, OGS is well-touted as one of the key potential consolidators in a sector that appears ripe for synergistic M&A," said Adrian Howd, analyst at ABN Amro.
"The segmentation of the business announced today is in our view a `clearing of the decks` in preparation for larger oncology-focused product acquisitions or M&A," said Howd.
"The restructuring is significant. Ebsworth has taken a pragmatic approach," said Sam Fazeli at Nomura.
As a result, transparency across the business will increase, while future divestment of any one of the three new divisions will be easier, said Fazeli. He said that the proteomics business may eventually be sold, and speculated that Xenova Group PLC (XNVA, news) is one of OGS` potential acquisition targets.
The company met U.S. regulators at the Food and Drug Administration Tuesday to discuss the progress of Vevesca, and now awaits the FDA`s response, said Ebsworth. The FDA said in June that the drug wasn`t approvable, but OGS hopes for a review of the decision.
Vevesca, for genetic disorder Gaucher`s disease, is by far the most advanced of OGS`s drugs, and is on the threshold of being approved in Europe after the Committee for Proprietary Medicinal Products recommended that the European Union approve it for sale. The company plans to submit it by year-end for marketing approval in Israel, where a large number of sufferers live.
Also Thursday, the company reported first-half earnings in line with analysts` forecasts, and announced the appointment of Denis Mulhall as Chief Financial Officer. Mulhall was previously CFO at Metzeler Automotive Profile Systems.
Revenues in the six months were GBP5.8 million, down from GBP8.7 million in the first half of 2001 and bang in line with the market consensus. Loss per share at 35.1 pence was wider than the 13.3 pence loss in the first half of 2001, but roughly in line with forecasts of 31 pence.
Allerdings weiß ich noch nicht, was ich davon halten soll. Offensichtlich nur ein Wunschgedanken, denn lt. den Expansionsplänen von David Oxlade dürfte das wohl etwas in Konflikt geraten. Er will ja XENOVA zu einer zweiten CELLTECH machen, also das größte Biounternehmen Englands.
Möglich wäre eine feindliche Übernahme. Dazu müßte man prüfen, wieviele Aktien in Streubesitz sich befinden und ob so etwas theoretisch überhaupt möglich wäre.
Aus der bevorstehende Kapitalerhöhung allerdings kann man erkennen, daß XENOVA es überhaupt nicht will, daß "Fremde" sich in XENOVA einkaufen sondern die langfristig orientierte Anleger (wie wir) dazu nutzen will, XENOVA`s Stellung im Markt zu sichern und auszubauen.
Naja, anbei der ziemlich lange Bericht:
LONDON -(Dow Jones)- Cash-rich biotechnology company Oxford GlycoSciences PLC (OGSI, news) Thursday said it is restructuring its business into three separate units and is in acquisition talks.
OGS, along with a growing number of European biotechs, has seen its share price fall by more than 90% since its early 2000 peak, leaving its market capitalization languishing below its cash levels, while it`s yet to get a drug to market.
"It`s an honest review. I`m not happy with the financial numbers, which is why together with the management team I`ve taken a number of steps," Chief Executive David Ebsworth, who took over the helm just ninety days ago, told Dow Jones Newswires. The weak market cap versus cash is "very frustrating," he said.
Ebsworth said he`s in talks with a number of companies with to merge or buy a company focused on cancer, or to buy in cancer products. There seems to be more opportunities for M&A in oncology than elsewhere, he said.
OGS is to be split into three separate divisions: oncology; inherited storage disorders, which aims for profitability in 2005 and includes the company`s most advanced drug Vevesca, for Gaucher`s disease; and a proteomics division, aiming for profit in 2003, to leverage OGS` expertise in studying the role of proteins in disease. Each division will report its own profit and loss account from 2003.
In addition, recent job cuts in the U.K., the closure of an office in New Jersey, the restructuring of research and technology alliances and the hand-over in July of European marketing for Vevesca to Actelion Ltd. (Z.ATL, news), should together cut the company`s spending by around GBP10 million a year going forward, said Ebsworth.
Shares were down 2.5 pence, or 1.6%, at 150 pence at 0753 GMT. This values the company at GBP85 million, while its net cash position at June 30 was GBP153 million.
"With the second largest cash pile in U.K. biotech, OGS is well-touted as one of the key potential consolidators in a sector that appears ripe for synergistic M&A," said Adrian Howd, analyst at ABN Amro.
"The segmentation of the business announced today is in our view a `clearing of the decks` in preparation for larger oncology-focused product acquisitions or M&A," said Howd.
"The restructuring is significant. Ebsworth has taken a pragmatic approach," said Sam Fazeli at Nomura.
As a result, transparency across the business will increase, while future divestment of any one of the three new divisions will be easier, said Fazeli. He said that the proteomics business may eventually be sold, and speculated that Xenova Group PLC (XNVA, news) is one of OGS` potential acquisition targets.
The company met U.S. regulators at the Food and Drug Administration Tuesday to discuss the progress of Vevesca, and now awaits the FDA`s response, said Ebsworth. The FDA said in June that the drug wasn`t approvable, but OGS hopes for a review of the decision.
Vevesca, for genetic disorder Gaucher`s disease, is by far the most advanced of OGS`s drugs, and is on the threshold of being approved in Europe after the Committee for Proprietary Medicinal Products recommended that the European Union approve it for sale. The company plans to submit it by year-end for marketing approval in Israel, where a large number of sufferers live.
Also Thursday, the company reported first-half earnings in line with analysts` forecasts, and announced the appointment of Denis Mulhall as Chief Financial Officer. Mulhall was previously CFO at Metzeler Automotive Profile Systems.
Revenues in the six months were GBP5.8 million, down from GBP8.7 million in the first half of 2001 and bang in line with the market consensus. Loss per share at 35.1 pence was wider than the 13.3 pence loss in the first half of 2001, but roughly in line with forecasts of 31 pence.
Xenova`s Tariquidar Granted FDA Fast Track Status
3 Oct 2002, 02:00am ET
/FROM PR NEWSWIRE NEW YORK 800-776-8090/
SLOUGH, England, Oct. 3 /PRNewswire-FirstCall/ -- Xenova Group plc (NASDAQ:XNVA; London Stock Exchange: XEN) today announces that the US Food and Drug Administration (FDA) has granted fast track review status to tariquidar for the treatment of multi-drug resistance in first-line treatment
of non-small cell lung cancer (NSCLC) patients.
Under the FDA Modernization Act of 1997, designation as a Fast Track Product means that the FDA will facilitate the development and expedite the review of a new drug that is intended for the treatment of a serious or a life-threatening condition, if it demonstrates the potential to address unmet clinical needs for such a condition.
Xenova and its North American partner, QLT Inc.NASDAQ:QLTI; TSE:QLT),are currently evaluating tariquidar in two pivotal Phase III clinical trials as an adjunctive treatment in combination with first-line chemotherapy for NSCLC patients.
David Oxlade, Chief Executive of Xenova, commented:
"We are delighted with the FDA`s decision to grant fast track designation to tariquidar. Non-small cell lung cancer is a leading cause of cancer deaths and our current trials are designed to demonstrate that the use of tariquidar will improve survival of patients with this condition."
Current clinical trial programme: In June 2002 it was announced that patient enrolment has begun in two pivotal Phase III trials for tariquidar. The two double-blind, randomised, placebo-controlled trials are being carried
out on approximately 1,000 patients at approximately 100 centres located throughout North America and Europe. The primary end-point of both trials is overall survival. An interim safety analysis is planned for mid-2003.
It is anticipated that, on successful completion of the Phase III programme, QLT will file for approval of tariquidar in North America for use in combination with first-line chemotherapy in advanced NSCLC by the end of
2005.
Partnership with QLT Inc: As announced In August 2001, Xenova has entered into an agreement with QLT for the development and North American marketing of tariquidar. This agreement will provide Xenova with funding, in
the form of licence and milestone payments and research and development funding, to gain product marketing approval. QLT paid an upfront licence fee of US$10m (7.1m pounds) and will provide up to US$45m (28.9m pounds) in funding for development activities related to Phase III clinical studies for tariquidar in North America and Europe. In addition, milestones of up to US$50m (32.2m pounds) and royalties in the range of 15 to 22 per cent depending on the level of North American sales are also payable to Xenova.
Xenova retains substantially all rights to commercialise tariquidar in Europe and the Rest of the World and Xenova`s directors intend to establish further collaborations to maximise the value of this potentially first-in-class drug.
Notes to Editors
Xenova Group plc is an emerging bio-pharmaceutical company focusing on the therapeutic areas of cancer and immune system disorders. Xenova`s directors believe that it has a strong and well balanced portfolio of product candidates in development, with 8 products in clinical trials and a further 8 in preclinical development. The Group has a strong track record in the discovery and development of novel drug candidates and has established partnerships with major pharmaceutical companies including Lilly, Pfizer,
Celltech, Genentech, QLT and Millennium Pharmaceuticals.
Tariquidar -- There is a substantial market opportunity for a drug that overcomes multi-drug resistance (MDR). It is estimated that, depending on the type of cancer, between 30 and 80 per cent of solid tumours develop resistance to anti-cancer drugs. In 1999 the total cancer drugs market was
around $23 billion per annum, of which over 30 per cent was made up of cytotoxics. A drug resistance modulator such as tariquidar would be used in combination with these cytotoxics, such as the taxanes, anthracyclines and
vinca alkaloids. The most common known form of MDR is the result of over-production of a membrane protein, known as P-gp, which pumps anti-cancer drugs out of cells. Tariquidar is a drug candidate which is being developed to restore the sensitivity of MDR cancer cells to specific cytotoxic drugs by blocking the P-gp pump, thus preventing the export of cytotoxic drugs from cancer cells. A series of three Phase IIa trials for tariquidar have been carried out to study the pharmacokinetic behaviour of tariquidar when given
with a range of marketed cytotoxic agents, namely vinorelbine, doxorubicin and paclitaxel, comprising some of the world`s best-selling cytotoxic drugs.
The results of the tariquidar/paclitaxel study were announced in March 2000,the tariquidar/doxorubicin trial in March 2001 and the tariquidar/vinorelbine trial in May 2001. The results of these three studies demonstrated that
tariquidar is a potent P-gp inhibitor, without significant side effects and with less pharmacokinetic interaction than other inhibitors used previously.
The trial investigator reported that 7 patients received symptomatic benefit out of a 12 patient sample receiving paclitaxel, carboplatin and tariquidar.
However, interpretation of these results should take into account the relatively small number of patients in the trial.
For further information about Xenova and its products please visit the Xenova website at http://www.xenova.co.uk
QLT Inc is a global biopharmaceutical company dedicated to the discovery, development and commercialisation of innovative therapies to treat cancer, eye diseases and immune disorders. Combining expertise in opthalmopogy,
oncology and photodynamic therapy, QLT has commercialised two products to date, including Visudyne(R) therapy which is the largest selling ophthalmology product ever launched. For more information you are invited to
visit QLT`s website at http://www.qltinc.com.
For Xenova: Disclaimer to take advantage of the "Safe Harbor" provisions of the US Private Securities Litigation Reform Act of 1995......
http://tbutton.prnewswire.com/prn/11690X01487886
SOURCE Xenova Group plc.
-0- 10/03/2002
/CONTACT: (UK) David A Oxlade, Chief Executive Officer, or Daniel Abrams, Group Finance Director, or Hilary Reid Evans, Corporate Communications, all of Xenova Group, +44-1753-706600; or (US) Press, Brad Miles (Ext 17), Lauren Tortorete (Ext 20), Investors: Jonathan Fassberg
(Ext 16) Lee Stern (Ext 22) all of Trout Group/BMC Communications, +1-212-477-9007; or Fiona Noblet of Financial Dynamics, +44-207-831-3113; or Media: Tamara Hicks, +1-604-707-7316, or Investors: Therese Crozier, or
Tamara Hicks, +1-604-707-7000, both of QLT Inc./
3 Oct 2002, 02:00am ET
/FROM PR NEWSWIRE NEW YORK 800-776-8090/
SLOUGH, England, Oct. 3 /PRNewswire-FirstCall/ -- Xenova Group plc (NASDAQ:XNVA; London Stock Exchange: XEN) today announces that the US Food and Drug Administration (FDA) has granted fast track review status to tariquidar for the treatment of multi-drug resistance in first-line treatment
of non-small cell lung cancer (NSCLC) patients.
Under the FDA Modernization Act of 1997, designation as a Fast Track Product means that the FDA will facilitate the development and expedite the review of a new drug that is intended for the treatment of a serious or a life-threatening condition, if it demonstrates the potential to address unmet clinical needs for such a condition.
Xenova and its North American partner, QLT Inc.NASDAQ:QLTI; TSE:QLT),are currently evaluating tariquidar in two pivotal Phase III clinical trials as an adjunctive treatment in combination with first-line chemotherapy for NSCLC patients.
David Oxlade, Chief Executive of Xenova, commented:
"We are delighted with the FDA`s decision to grant fast track designation to tariquidar. Non-small cell lung cancer is a leading cause of cancer deaths and our current trials are designed to demonstrate that the use of tariquidar will improve survival of patients with this condition."
Current clinical trial programme: In June 2002 it was announced that patient enrolment has begun in two pivotal Phase III trials for tariquidar. The two double-blind, randomised, placebo-controlled trials are being carried
out on approximately 1,000 patients at approximately 100 centres located throughout North America and Europe. The primary end-point of both trials is overall survival. An interim safety analysis is planned for mid-2003.
It is anticipated that, on successful completion of the Phase III programme, QLT will file for approval of tariquidar in North America for use in combination with first-line chemotherapy in advanced NSCLC by the end of
2005.
Partnership with QLT Inc: As announced In August 2001, Xenova has entered into an agreement with QLT for the development and North American marketing of tariquidar. This agreement will provide Xenova with funding, in
the form of licence and milestone payments and research and development funding, to gain product marketing approval. QLT paid an upfront licence fee of US$10m (7.1m pounds) and will provide up to US$45m (28.9m pounds) in funding for development activities related to Phase III clinical studies for tariquidar in North America and Europe. In addition, milestones of up to US$50m (32.2m pounds) and royalties in the range of 15 to 22 per cent depending on the level of North American sales are also payable to Xenova.
Xenova retains substantially all rights to commercialise tariquidar in Europe and the Rest of the World and Xenova`s directors intend to establish further collaborations to maximise the value of this potentially first-in-class drug.
Notes to Editors
Xenova Group plc is an emerging bio-pharmaceutical company focusing on the therapeutic areas of cancer and immune system disorders. Xenova`s directors believe that it has a strong and well balanced portfolio of product candidates in development, with 8 products in clinical trials and a further 8 in preclinical development. The Group has a strong track record in the discovery and development of novel drug candidates and has established partnerships with major pharmaceutical companies including Lilly, Pfizer,
Celltech, Genentech, QLT and Millennium Pharmaceuticals.
Tariquidar -- There is a substantial market opportunity for a drug that overcomes multi-drug resistance (MDR). It is estimated that, depending on the type of cancer, between 30 and 80 per cent of solid tumours develop resistance to anti-cancer drugs. In 1999 the total cancer drugs market was
around $23 billion per annum, of which over 30 per cent was made up of cytotoxics. A drug resistance modulator such as tariquidar would be used in combination with these cytotoxics, such as the taxanes, anthracyclines and
vinca alkaloids. The most common known form of MDR is the result of over-production of a membrane protein, known as P-gp, which pumps anti-cancer drugs out of cells. Tariquidar is a drug candidate which is being developed to restore the sensitivity of MDR cancer cells to specific cytotoxic drugs by blocking the P-gp pump, thus preventing the export of cytotoxic drugs from cancer cells. A series of three Phase IIa trials for tariquidar have been carried out to study the pharmacokinetic behaviour of tariquidar when given
with a range of marketed cytotoxic agents, namely vinorelbine, doxorubicin and paclitaxel, comprising some of the world`s best-selling cytotoxic drugs.
The results of the tariquidar/paclitaxel study were announced in March 2000,the tariquidar/doxorubicin trial in March 2001 and the tariquidar/vinorelbine trial in May 2001. The results of these three studies demonstrated that
tariquidar is a potent P-gp inhibitor, without significant side effects and with less pharmacokinetic interaction than other inhibitors used previously.
The trial investigator reported that 7 patients received symptomatic benefit out of a 12 patient sample receiving paclitaxel, carboplatin and tariquidar.
However, interpretation of these results should take into account the relatively small number of patients in the trial.
For further information about Xenova and its products please visit the Xenova website at http://www.xenova.co.uk
QLT Inc is a global biopharmaceutical company dedicated to the discovery, development and commercialisation of innovative therapies to treat cancer, eye diseases and immune disorders. Combining expertise in opthalmopogy,
oncology and photodynamic therapy, QLT has commercialised two products to date, including Visudyne(R) therapy which is the largest selling ophthalmology product ever launched. For more information you are invited to
visit QLT`s website at http://www.qltinc.com.
For Xenova: Disclaimer to take advantage of the "Safe Harbor" provisions of the US Private Securities Litigation Reform Act of 1995......
http://tbutton.prnewswire.com/prn/11690X01487886
SOURCE Xenova Group plc.
-0- 10/03/2002
/CONTACT: (UK) David A Oxlade, Chief Executive Officer, or Daniel Abrams, Group Finance Director, or Hilary Reid Evans, Corporate Communications, all of Xenova Group, +44-1753-706600; or (US) Press, Brad Miles (Ext 17), Lauren Tortorete (Ext 20), Investors: Jonathan Fassberg
(Ext 16) Lee Stern (Ext 22) all of Trout Group/BMC Communications, +1-212-477-9007; or Fiona Noblet of Financial Dynamics, +44-207-831-3113; or Media: Tamara Hicks, +1-604-707-7316, or Investors: Therese Crozier, or
Tamara Hicks, +1-604-707-7000, both of QLT Inc./
Xenova Group plc
EGM Results
Slough, UK, 4 October 2002 - The Board of Xenova Group plc (Nasdaq NM: XNVA;
London Stock Exchange: XEN), today announces that at the Extraordinary General
Meeting of the Company held earlier today, the special resolution proposed to
increase the Company`s authorised share capital, grant the Directors authority
to allot shares and disapply statutory pre-emption rights in order to implement
the Rights Issue was duly passed. The ordinary resolution proposed to remove
the prescriptive flow rates and dilution limits from certain of the Company`s
Share Option Schemes was also passed.
The Rights Issue of approximately 33.7 million New Ordinary Shares at a price of
32.5 pence per New Ordinary Share is being made to Qualifying Shareholders by
way of an 8 for 33 rights issue. Xenova proposes to raise approximately £9.9
million (net of expenses) pursuant to the Rights Issue. The Rights Issue has
been fully underwritten by Nomura International plc (except to the extent of the
undertakings given by certain directors to take up all or part of their
entitlements under the Rights Issue).
Provisional Allotment Letters in respect of entitlements to New Ordinary Shares
under the Rights Issue will be posted to Qualifying non-CREST Shareholders later
today. The Nil Paid Rights will be credited to the stock accounts of Qualifying
CREST Shareholders later today and enabled in CREST on 7 October 2002.
It is expected that Admission will become effective and that dealings in the New
Ordinary Shares, nil paid, will commence at 8.00 a.m. on 7 October 2002. The
latest time for acceptance and payment under the Rights Issue is 9.30 a.m on 28
October 2002.
Defined terms used in this announcement have the same meanings as set out in the
Company`s prospectus dated 11 September 2002 in connection with the Rights
Issue.
EGM Results
Slough, UK, 4 October 2002 - The Board of Xenova Group plc (Nasdaq NM: XNVA;
London Stock Exchange: XEN), today announces that at the Extraordinary General
Meeting of the Company held earlier today, the special resolution proposed to
increase the Company`s authorised share capital, grant the Directors authority
to allot shares and disapply statutory pre-emption rights in order to implement
the Rights Issue was duly passed. The ordinary resolution proposed to remove
the prescriptive flow rates and dilution limits from certain of the Company`s
Share Option Schemes was also passed.
The Rights Issue of approximately 33.7 million New Ordinary Shares at a price of
32.5 pence per New Ordinary Share is being made to Qualifying Shareholders by
way of an 8 for 33 rights issue. Xenova proposes to raise approximately £9.9
million (net of expenses) pursuant to the Rights Issue. The Rights Issue has
been fully underwritten by Nomura International plc (except to the extent of the
undertakings given by certain directors to take up all or part of their
entitlements under the Rights Issue).
Provisional Allotment Letters in respect of entitlements to New Ordinary Shares
under the Rights Issue will be posted to Qualifying non-CREST Shareholders later
today. The Nil Paid Rights will be credited to the stock accounts of Qualifying
CREST Shareholders later today and enabled in CREST on 7 October 2002.
It is expected that Admission will become effective and that dealings in the New
Ordinary Shares, nil paid, will commence at 8.00 a.m. on 7 October 2002. The
latest time for acceptance and payment under the Rights Issue is 9.30 a.m on 28
October 2002.
Defined terms used in this announcement have the same meanings as set out in the
Company`s prospectus dated 11 September 2002 in connection with the Rights
Issue.
Xenova wins FDA fast track status for lung cancer drug
Oct 10, 2002 (M2 EUROPHARMA via COMTEX) -- UK-based biotechnology company Xenova Group Plc has been granted fast track review status by the US Food and Drug Administration (FDA).
The decision applies to tariquidar, Xenova`s multi-drug resistant treatment for non-small cell lung cancer. Fast track status means that the FDA will facilitate the development and expedite the review of the new drug.
Tariquidar is reportedly the only product being developed that could be used to treat lung cancer patients who do not respond to chemotherapy.
The drug is currently in phase III trials and Xenova, with its partner QLT Inc, expects to file for approval of tariquidar in North America by the end of 2005.
(Evening Standard, 03 Oct 2002; FT Investor, 03 Oct 2002; Xenova Group Plc statement, 03 Oct 2002.) M2 Europharma includes paraphrased and abstracted material with the source, which is deemed to be reliable and duly identified. M2E is unable to provide full-text copies of these original documents.
Oct 10, 2002 (M2 EUROPHARMA via COMTEX) -- UK-based biotechnology company Xenova Group Plc has been granted fast track review status by the US Food and Drug Administration (FDA).
The decision applies to tariquidar, Xenova`s multi-drug resistant treatment for non-small cell lung cancer. Fast track status means that the FDA will facilitate the development and expedite the review of the new drug.
Tariquidar is reportedly the only product being developed that could be used to treat lung cancer patients who do not respond to chemotherapy.
The drug is currently in phase III trials and Xenova, with its partner QLT Inc, expects to file for approval of tariquidar in North America by the end of 2005.
(Evening Standard, 03 Oct 2002; FT Investor, 03 Oct 2002; Xenova Group Plc statement, 03 Oct 2002.) M2 Europharma includes paraphrased and abstracted material with the source, which is deemed to be reliable and duly identified. M2E is unable to provide full-text copies of these original documents.
Results of Rights Issue
Slough, UK, 29 October 2002 - The Board of Xenova Group plc (Nasdaq NM: XNVA;
London Stock Exchange: XEN) announces that the fully underwritten 8 for 33
Rights Issue of 33,710,703 New Ordinary Shares, at a price of 32.5 pence per New
Ordinary Share, closed at 9.30 a.m on 28 October 2002. Xenova will raise
approximately £9.9 million (net of expenses) pursuant to the Rights Issue.
Xenova received valid acceptances in respect of 5,516,146 New Ordinary Shares
from Qualifying Shareholders, which represents an aggregate take up of 16.36 per
cent. This includes 135,852 New Ordinary Shares taken up by Directors pursuant
to irrevocable undertakings or otherwise. The balance of the New Ordinary
Shares not taken up or subscribed for, being 28,194,557 New Ordinary Shares, has
been fully underwritten by Nomura International plc, which will notify
sub-underwriters of their allocations later today. The sub-underwriting of the
Rights Issue was strongly supported by existing shareholders, with eighteen of
the Company`s institutional shareholders acting as sub-underwriters.
It has not been possible to procure, and Nomura, as underwriter, does not
consider that it will be possible to procure, subscribers for the New Ordinary
Shares that have not been validly taken up at a price (net of expenses) in
excess of the Rights Issue Price. Accordingly, there will be no net proceeds
available for distribution to Qualifying Shareholders who did not take up their
entitlements or to Overseas Shareholders in accordance with the terms of the
Rights Issue. It is expected that definitive share certificates in respect of
the New Ordinary Shares will be dispatched to shareholders by 4 November 2002.
Crest stock accounts for New Ordinary Shares in uncertificated form were
credited earlier today.
At the time of arranging the underwriting of the Rights Issue, the Board was
mindful of the recommendations of the Competition Commission with regard to the
competitive tendering of sub-underwriting commissions. However, after careful
consideration at the time, the Directors did not believe that by virtue of the
size of the Rights Issue such a process would have resulted in lower commissions
than they have agreed in respect of the Rights Issue.
Defined terms used in this announcement have the same meanings as set out in the
Company`s prospectus dated 11 September 2002 in connection with the Rights
Issue.
Enquiries:
Xenova Group PLC Tel.: 01753 706 600
David Oxlade, Chief Executive Officer
Daniel Abrams, Chief Financial Officer
Hilary Reid Evans, Head of Corporate Communications
Nomura International PLC Tel.: 020 7521 2000
Charles Spicer
David Rasouly
Media Enquiries: Financial Dynamics Tel.: 020 7831 3113
Fiona Noblet
Jonathan Birt
Nomura, which is regulated in the United Kingdom by the Financial Services
Authority, is acting for Xenova and no one else in connection with the Rights
Issue and will not be responsible to anyone other than Xenova for providing the
protections afforded to clients of Nomura, nor for providing advice in relation
to the Rights Issue or the New Ordinary Shares.
This announcement does not constitute an offer to sell, or the solicitation of
an offer to subscribe for, any securities in the United States or in any other
jurisdiction in which such offer or solicitation is unlawful. The New Ordinary
Shares have not been, and will not be, registered under the US Securities Act of
1933 (as amended) or under the applicable securities laws of Canada, Australia,
the Republic of Ireland, or Japan. Accordingly, unless an exemption under any
applicable laws is available, the New Ordinary Shares may not be offered, sold,
transferred, taken up or delivered, directly or indirectly, in the US, Canada,
Australia, the Republic of Ireland or Japan or any other country outside the
United Kingdom where such distribution may otherwise lead to a breach of any law
or regulatory requirement.
Slough, UK, 29 October 2002 - The Board of Xenova Group plc (Nasdaq NM: XNVA;
London Stock Exchange: XEN) announces that the fully underwritten 8 for 33
Rights Issue of 33,710,703 New Ordinary Shares, at a price of 32.5 pence per New
Ordinary Share, closed at 9.30 a.m on 28 October 2002. Xenova will raise
approximately £9.9 million (net of expenses) pursuant to the Rights Issue.
Xenova received valid acceptances in respect of 5,516,146 New Ordinary Shares
from Qualifying Shareholders, which represents an aggregate take up of 16.36 per
cent. This includes 135,852 New Ordinary Shares taken up by Directors pursuant
to irrevocable undertakings or otherwise. The balance of the New Ordinary
Shares not taken up or subscribed for, being 28,194,557 New Ordinary Shares, has
been fully underwritten by Nomura International plc, which will notify
sub-underwriters of their allocations later today. The sub-underwriting of the
Rights Issue was strongly supported by existing shareholders, with eighteen of
the Company`s institutional shareholders acting as sub-underwriters.
It has not been possible to procure, and Nomura, as underwriter, does not
consider that it will be possible to procure, subscribers for the New Ordinary
Shares that have not been validly taken up at a price (net of expenses) in
excess of the Rights Issue Price. Accordingly, there will be no net proceeds
available for distribution to Qualifying Shareholders who did not take up their
entitlements or to Overseas Shareholders in accordance with the terms of the
Rights Issue. It is expected that definitive share certificates in respect of
the New Ordinary Shares will be dispatched to shareholders by 4 November 2002.
Crest stock accounts for New Ordinary Shares in uncertificated form were
credited earlier today.
At the time of arranging the underwriting of the Rights Issue, the Board was
mindful of the recommendations of the Competition Commission with regard to the
competitive tendering of sub-underwriting commissions. However, after careful
consideration at the time, the Directors did not believe that by virtue of the
size of the Rights Issue such a process would have resulted in lower commissions
than they have agreed in respect of the Rights Issue.
Defined terms used in this announcement have the same meanings as set out in the
Company`s prospectus dated 11 September 2002 in connection with the Rights
Issue.
Enquiries:
Xenova Group PLC Tel.: 01753 706 600
David Oxlade, Chief Executive Officer
Daniel Abrams, Chief Financial Officer
Hilary Reid Evans, Head of Corporate Communications
Nomura International PLC Tel.: 020 7521 2000
Charles Spicer
David Rasouly
Media Enquiries: Financial Dynamics Tel.: 020 7831 3113
Fiona Noblet
Jonathan Birt
Nomura, which is regulated in the United Kingdom by the Financial Services
Authority, is acting for Xenova and no one else in connection with the Rights
Issue and will not be responsible to anyone other than Xenova for providing the
protections afforded to clients of Nomura, nor for providing advice in relation
to the Rights Issue or the New Ordinary Shares.
This announcement does not constitute an offer to sell, or the solicitation of
an offer to subscribe for, any securities in the United States or in any other
jurisdiction in which such offer or solicitation is unlawful. The New Ordinary
Shares have not been, and will not be, registered under the US Securities Act of
1933 (as amended) or under the applicable securities laws of Canada, Australia,
the Republic of Ireland, or Japan. Accordingly, unless an exemption under any
applicable laws is available, the New Ordinary Shares may not be offered, sold,
transferred, taken up or delivered, directly or indirectly, in the US, Canada,
Australia, the Republic of Ireland or Japan or any other country outside the
United Kingdom where such distribution may otherwise lead to a breach of any law
or regulatory requirement.
Prudential hält ja knapp 9 % an Gesamt-XENOVA. :-)
und wollen zu 32,5 pence Ihre neue Anteile sichern!
LETTER TO XENOVA GROUP PLC
Companies Act 1985 (as amended):
Disclosure of Interests in Shares
In accordance with Part VI of the Companies Act 1985 (as amended) (the `Act`),
we write to inform you that Prudential plc and certain of its subsidiary
companies have a notifiable interest in the issued share capital of your company
as detailed in the schedule below.
FOR AND ON BEHALF OF PRUDENTIAL PLC
Notifiable Position Report for XENOVA GROUP ORD GBP0.10
as at 29 October 2002
Percentage holdings are calculated using an issued share capital of 172,767,353
ORD GBP0.10 shares
Registered Holder Holding %
Prudential Plc 7,556,607 4.37 Total Notifiable Interest
PRUCLT HSBC GIS NOM(UK) PAC AC 6,701,596
PRUCLT HSBC GIS NOM(UK) PPL AC 855,011
The Prudential Assurance Company Limited 7,556,607 4.37
PRUCLT HSBC GIS NOM(UK) PAC AC 6,701,596
PRUCLT HSBC GIS NOM(UK) PPL AC 855,011
Ob die nun in den bereits 16,36 % enthalten sind, welche bereits zu 32,5 pence gekauft haben, weiß ich nicht. Allerdings könnte ich mir vorstellen, daß gewisse Interessenten in diesen Zeiten bis zur letzten Minute warten und pokern, so wie wir auch, in der Hoffnung, etwas billiger zu kaufen. Diese Denkweise allerdings wird sehr rasche Kurssprünge nach oben bewirken.
Viele Grüße
Panospana
und wollen zu 32,5 pence Ihre neue Anteile sichern!
LETTER TO XENOVA GROUP PLC
Companies Act 1985 (as amended):
Disclosure of Interests in Shares
In accordance with Part VI of the Companies Act 1985 (as amended) (the `Act`),
we write to inform you that Prudential plc and certain of its subsidiary
companies have a notifiable interest in the issued share capital of your company
as detailed in the schedule below.
FOR AND ON BEHALF OF PRUDENTIAL PLC
Notifiable Position Report for XENOVA GROUP ORD GBP0.10
as at 29 October 2002
Percentage holdings are calculated using an issued share capital of 172,767,353
ORD GBP0.10 shares
Registered Holder Holding %
Prudential Plc 7,556,607 4.37 Total Notifiable Interest
PRUCLT HSBC GIS NOM(UK) PAC AC 6,701,596
PRUCLT HSBC GIS NOM(UK) PPL AC 855,011
The Prudential Assurance Company Limited 7,556,607 4.37
PRUCLT HSBC GIS NOM(UK) PAC AC 6,701,596
PRUCLT HSBC GIS NOM(UK) PPL AC 855,011
Ob die nun in den bereits 16,36 % enthalten sind, welche bereits zu 32,5 pence gekauft haben, weiß ich nicht. Allerdings könnte ich mir vorstellen, daß gewisse Interessenten in diesen Zeiten bis zur letzten Minute warten und pokern, so wie wir auch, in der Hoffnung, etwas billiger zu kaufen. Diese Denkweise allerdings wird sehr rasche Kurssprünge nach oben bewirken.
Viele Grüße
Panospana
Ein ganz neuer Interessent :-), von dem ich bisher nichts weiß. Ich habe den Eindruck, das Interesse an XENOVA steigt!
LETTER TO XENOVA GROUP PLC - DATED 31ST OCTOBER 2002
DISCLOSURE OF INTEREST IN ORDINARY SHARES OF 10p
We hereby give notice for the purposes of Part VI of the Companies Act 1985 that
today we have become aware that Aberforth Smaller Companies Trust plc has a
notifiable interest in 5,703,521 Ordinary Shares of 10p each which, based on
the information available to us, represents 3.30% of the issued share capital of
the above company.
The shares to which this notification relates are, or will be, registered as
follows:
Registered Holder Number of Shares
Clydesdale Bank (Head Office) Nominees Limited 5,703,521
A/C ABERFIT1
FOR ABERFORTH PARTNERS, SECRETARIES
LETTER TO XENOVA GROUP PLC - DATED 31ST OCTOBER 2002
DISCLOSURE OF INTEREST IN ORDINARY SHARES OF 10p
We hereby give notice for the purposes of Part VI of the Companies Act 1985 that
today we have become aware that Aberforth Smaller Companies Trust plc has a
notifiable interest in 5,703,521 Ordinary Shares of 10p each which, based on
the information available to us, represents 3.30% of the issued share capital of
the above company.
The shares to which this notification relates are, or will be, registered as
follows:
Registered Holder Number of Shares
Clydesdale Bank (Head Office) Nominees Limited 5,703,521
A/C ABERFIT1
FOR ABERFORTH PARTNERS, SECRETARIES
Vor knapp 4 Tagen hatte Prudential ca. 9 % an Gesamt-XENOVA.
Nun sind es schon knapp 11,5 %!! Die kaufen wohl immer mehr und mehr! :-)
LETTER TO: XENOVA GROUP PLC
Companies Act 1985 (as amended):
Disclosure of Interests in Shares
In accordance with Part VI of the Companies Act 1985 (as amended) (the `Act`),
we write to inform you that Prudential plc and certain of its subsidiary
companies have a notifiable interest in the issued share capital of your company
as detailed in the schedule below.
For the purposes of S210 of the Act, the address for those companies identified
in the schedule below is Laurence Pountney Hill London EC4R 0HH.
Notifiable Position Report for XENOVA GROUP ORD GBP0.10
as at 31 October 2002
Percentage holdings are calculated using an issued share capital of 172,767,353
ORD GBP0.10 shares
Registered Holder Holding %
Prudential Plc 9,113,478 5.27 Total Notifiable Interest
PRUCLT HSBC GIS NOM(UK) PAC AC 8,258,467
PRUCLT HSBC GIS NOM(UK) PPL AC 855,011
The Prudential Assurance Company Limited 9,113,478 5.27
PRUCLT HSBC GIS NOM(UK) PAC AC 8,258,467
PRUCLT HSBC GIS NOM(UK) PPL AC 855,011
Nun sind es schon knapp 11,5 %!! Die kaufen wohl immer mehr und mehr! :-)
LETTER TO: XENOVA GROUP PLC
Companies Act 1985 (as amended):
Disclosure of Interests in Shares
In accordance with Part VI of the Companies Act 1985 (as amended) (the `Act`),
we write to inform you that Prudential plc and certain of its subsidiary
companies have a notifiable interest in the issued share capital of your company
as detailed in the schedule below.
For the purposes of S210 of the Act, the address for those companies identified
in the schedule below is Laurence Pountney Hill London EC4R 0HH.
Notifiable Position Report for XENOVA GROUP ORD GBP0.10
as at 31 October 2002
Percentage holdings are calculated using an issued share capital of 172,767,353
ORD GBP0.10 shares
Registered Holder Holding %
Prudential Plc 9,113,478 5.27 Total Notifiable Interest
PRUCLT HSBC GIS NOM(UK) PAC AC 8,258,467
PRUCLT HSBC GIS NOM(UK) PPL AC 855,011
The Prudential Assurance Company Limited 9,113,478 5.27
PRUCLT HSBC GIS NOM(UK) PAC AC 8,258,467
PRUCLT HSBC GIS NOM(UK) PPL AC 855,011
Heute abend werde ich mal den Bericht näher studieren!
Xenova Group plc Third Quarter Results Announcement
SLOUGH, England, Nov 7, 2002 /PRNewswire-FirstCall via COMTEX/ --
Year to Date Highlights:
* Tariquidar enters Phase III trials
* Tariquidar granted FDA `fast track` status
* Successful results of Phase IIa trial for therapeutic vaccine
TA-HPV
* Patient dosing begins in Phase IIa study for anti-cocaine addiction
vaccine TA-CD
* $63m (43.2m pounds) development and license agreement with
Genentech Inc for novel drugs in immune inflammatory disease
* Fully underwritten rights issue raising approximately
9.9m pounds ($15.6m) net of expenses
* Cash and liquid resources as at 30 September #10m ($15.7m),
excluding rights issue proceeds
Commenting, Chief Executive Officer, David Oxlade said:
"Xenova continues to make encouraging progress, both in terms of advancing its clinical and pre-clinical pipelines and in expanding its revenue-generating collaborations.
"We are delighted that tariquidar has been granted fast track status by the FDA so soon after its entry to Phase III clinical trials in both North America and Europe."
Notes to Editors
Xenova Group plc`s product pipeline focuses principally on the therapeutic areas of cancer and immune system disorders. Xenova has a broad pipeline of eight programs in clinical development. The Group has a well-established track record in the identification, development and partnering of innovative products and technologies and has partnerships with significant pharmaceutical companies including Lilly, Pfizer, Celltech, Genentech, QLT and Millennium Pharmaceuticals.
For further information about Xenova and its products please visit the Xenova website at http://www.xenova.co.uk .
For Xenova: Disclaimer to take advantage of the "Safe Harbor" provisions of the US Private Securities Litigation Reform Act of 1995. This press release contains "forward-looking statements," including statements about the discovery, development and commercialization of products. Various risks may cause Xenova`s actual results to differ materially from those expressed or implied by the forward looking statements, including: adverse results in our drug discovery and clinical development programs; failure to obtain patent protection for our discoveries; commercial limitations imposed by patents owned or controlled by third parties; our dependence upon strategic alliance partners to develop and commercialize products and services; difficulties or delays in obtaining regulatory approvals to market products and services resulting from our development efforts; the requirement for substantial funding to conduct research and development and to expand commercialization activities; and product initiatives by competitors. For a further list and description of the risks and uncertainties we face, see the reports we have filed with the Securities and Exchange Commission. We disclaim any intention or obligation to update or revise any forward-looking statements, whether as a result of new information, future events or otherwise.
Product Pipeline Year to Date Update - Clinical Trials
Cancer:
Tariquidar (XR9576) -- Discovered by Xenova, tariquidar, a potent small-molecule inhibitor of the P-glycoprotein pump, is being developed for the treatment of multidrug resistance (MDR) in cancer. In August 2001, Xenova signed an exclusive license agreement with QLT Inc for the development and marketing in the United States, Canada and Mexico of tariquidar for the treatment of MDR in cancer. In June 2002, tariquidar entered two pivotal Phase III clinical trials, in which tariquidar is being used as an adjunctive treatment in combination with first-line chemotherapy for non-small cell lung cancer (NSCLC) patients. The double-blind, randomized, placebo-controlled trials are being carried out in patients with stage IIIb/IV NSCLC at approximately 100 centers located throughout North America and Europe. Tariquidar was granted fast track status by the US Food and Drug Administration (FDA) in October 2002. Recruitment is currently progressing in line with expectations. An interim safety analysis is planned for mid- 2003 and, on successful completion of the Phase III program, it is anticipated that QLT will file for approval of tariquidar in North America for use in combination with first-line chemotherapy in advanced NSCLC by the end of 2005 and Xenova will file for marketing approval in Europe.
DISC-GMCSF -- DISC-GMCSF, an innovative immunotherapeutic vaccine, is designed as a treatment for a broad range of solid tumors. In preclinical studies DISC-GMCSF was shown to be effective in models of breast and colorectal cancer. As announced in June 2002, DISC-GMCSF successfully completed a Phase I dose-escalating safety study at three centers in the UK, in patients with metastatic melanoma. DISC-GMCSF was found to be well tolerated, with no serious adverse events reported. The DISC vector was shown to be localized at the site of injection and had not spread beyond the required therapeutic area, a key objective of the study.
XR11576 (MLN576) -- XR11576, XR5944 and XR11612 are novel DNA targeting agents, whose method of action includes dual inhibition of topoisomerases I and II. XR11576 is the subject of a license agreement with Millennium Pharmaceuticals Inc, announced in December 2001. The other compounds covered by this agreement, XR5944 (MLN944) and XR11612 (MLN612), are currently in preclinical development. XR11576 entered Phase I clinical trials in February 2002. The open label Phase I trial is being carried out at centers in the UK and the Netherlands and comprises multiple ascending oral doses in patients with solid tumors. Xenova retains responsibility for performing development activities associated with the program to the end of Phase II clinical trials. Millennium will provide funding for the program commencing in 2003, up to the agreed level of $20m.
Other:
TA-NIC -- Designed as a treatment for nicotine addiction, TA-NIC is a nicotine conjugate vaccine which is administered through a course of intramuscular injections. The successful results of a Phase I trial for TA-NIC, reported in June 2002, showed the vaccine to be safe and well tolerated both systemically and locally in the 60 smokers and non-smokers who took part in the trial, and that the vaccine generated a specific anti-nicotine response. This is the first time such a vaccine has been tested in man.
TA-CD -- TA-CD is a therapeutic vaccine which is under development for the treatment of cocaine addiction. Its mechanism of action is similar to that of TA-NIC. A Phase IIa dose escalation trial, supported by the US National Institute on Drug Abuse (NIDA), began in April 2002.
Product Pipeline Year to Date Update - Preclinical
Cancer:
OX40/OX40L -- OX40 is a platform technology which is capable of producing multiple drug candidates primarily targeting cancer and autoimmune disease. OX40 and OX40L (OX40 Ligand) are a pair of interacting cell-surface proteins. A development and license agreement worth up to $63m (43.2m pounds) was signed in April 2002 with Genentech for the worldwide rights to develop and market products, primarily targeting disorders of the immune system, based on Xenova`s OX40 receptor protein and anti-OX40 Ligand antibody programs. Under this agreement, Xenova retains all rights to the up-regulation of the immune system using the OX40:OX40L interaction, including for use in oncology and infectious disease therapy.
Financial Summary
Operating Performance
In the 3 months to 30 September 2002, the Group`s revenue from licensing deals, strategic partnerships and manufacturing outsourcing was 3.9m pounds ($6.1m) (2001: 0.7m pounds ($1.1m)).
In accordance with the Group`s revenue recognition policy, of the 6.9m pounds ($10.9m) received from QLT as part of the tariquidar licensing agreement, 1.0m pounds ($1.6m) was included in the quarter to 30 September 2002. Of the 7.9m pounds ($12.4m) received from Millennium, 2.2m pounds ($3.5m) was recognized by the Group in the 3 months to 30 September 2002. In respect of the OX40 licensing deal with Genentech, 0.3m pounds ($0.5m) of the upfront license fee of 2.7m pounds ($4.3m) received in 2002 was recognized in the 3 months to 30 September 2002. Included within the balance sheet at 30 September 2002 was 7.1m pounds ($11.1m) of deferred revenue in respect of the QLT, Millennium and Genentech licensing deals. Other revenue in the quarter included 0.3m pounds ($0.5m) primarily in respect of ongoing vaccine manufacture.
Total net operating expenses were 6.2m pounds ($9.7m) in the 3 months to 30 September 2002. Of this, research and development costs of 4.9m pounds ($7.7m) (2001: 4.4m pounds ($7.0m)) primarily reflects the ongoing clinical work on the tariquidar, topoisomerase and TA-NIC programs.
Of the total administrative expenses for the 9 months to 30 September 2002 of 4.2m pounds ($6.7m), 0.9m pounds ($1.4m) relates to the amortisation over a 10-year period of the goodwill in respect of the acquisition of Cantab.
Net interest income of 0.5m pounds ($0.7m) has been earned on the cash balance held throughout the nine months to 30 September 2002. Following a revaluation to the listed market price of the 88,668 Cubist Pharmaceuticals Inc shares held by the Group, 0.3m pounds ($0.4m) has been written off in the quarter to mark the shares to their market price, increasing the unrealized loss in the 9 months to 30 September 2002 to 1.9m pounds ($3.0m).
The net loss per share this quarter was 1.4p (2001: 3.2p).
Rights issue
On 11 September 2002, the Group announced a fully underwritten 8 for 33 rights issue to raise 9.9m pounds ($15.6m) net of expenses. The rights issue of approximately 33.7 million New Ordinary Shares was made at a price of 32.5 pence per New Ordinary Share. The total number of shares outstanding following the rights issue is approximately 172.8 million.
Cash and liquid investments
Cash and liquid resources at 30 September 2002 total 10.0m pounds ($15.7m) (30 September 2001: 17.5m pounds ($27.5m)).
Cash of 9.7m pounds ($15.3m) and liquid resources of 0.3m pounds ($0.4m) at 30 September 2002 (2001: cash of 15.5m pounds ($24.4m), liquid resources of 2.0m pounds ($3.1m)), excludes the receipt of 2.3m pounds ($3.6m) in respect of the 2001 R&D tax credit recovered in October this year and the net proceeds from the rights issue received in Q4 2002 of 9.9m pounds ($15.6m).
Based upon the expected monthly cash burn rate, this balance is sufficient to fund current operations for in excess of 12 months.
Share capital
The number of shares in issue and to be issued stood at 139.1 million as at 30 September 2002.
The Directors do not currently propose a dividend for 2002 (2001: nil).
Consolidated Profit and Loss Account (unaudited)
Three months ended
30 Sept 30 Sept 30 Sept
2002 2002 2001
$000 000 pounds 000 pounds
Turnover (including share of
joint venture) 6,329 4,025 774
Less: share of joint
venture revenue (193) (123) (47)
Turnover 6,136 3,902 727
Operating expenses
Research and development costs (7,709) (4,902) (4,421)
Administrative expenses (1,723) (1,096) (773)
Administrative expenses:
exceptional reorganization costs -- -- --
Administrative expenses:
amortization of goodwill (461) (293) (293)
Total administrative expenses (2,184) (1,389) (1,066)
Other operating income 168 107 --
Total net operating expenses (9,725) (6,184) (5,487)
Group Operating loss (3,589) (2,282) (4,760)
Share of operating profit
of joint venture 44 28 33
Total operating loss: Group
and share of joint venture (3,545) (2,254) (4,727)
Interest (net) 208 132 186
Amounts written (off)/back
on investments (403) (256) (423)
Loss on ordinary activities
before taxation (3,740) (2,378) (4,964)
Tax on loss on ordinary activities 661 420 512
Loss on ordinary activities
after taxation attributable to
members of Xenova Group plc (3,079) (1,958) (4,452)
Loss per share (basic and
diluted) (2.2c) (1.4p) (3.2p)
Shares used in computing net
loss per share (thousands) 139,057 139,057 139,044
Nine Months Ended
30 Sept 30 Sept 30 Sept
2002 2002 2001
$000 000 pounds 000 pounds
Turnover (including share of
joint venture) 17,203 10,939 1,278
Less: share of joint
venture revenue (431) (274) (50)
Turnover 16,772 10,665 1,228
Operating expenses
Research and development
costs (20,956) (13,326) (11,064)
Administrative expenses (5,270) (3,351) (2,180)
Administrative expenses:
exceptional reorganization costs -- -- (596)
Administrative expenses:
amortization of goodwill (1,382) (879) (586)
Total administrative expenses (6,652) (4,230) (3,362)
Other operating income 597 380 --
Total net operating expenses 27,011 (17,176) (14,426)
Group Operating loss (10,239) (6,511) (13,198)
Share of operating profit
of joint venture 99 63 4
Total operating loss: Group
and share of joint venture (10,140) (6,448) (13,194)
Interest (net) 738 469 586
Amounts written (off)/
back on investments (2,977) (1,893) 252
Loss on ordinary activities
before taxation (12,379) (7,872) (12,356)
Tax on loss on
ordinary activities 2,030 1,291 1,419
Loss on ordinary activities
after taxation attributable
to members of Xenova
Group plc (10,349) (6,581) (10,937)
Loss per share
(basic and diluted) (7.4c) (4.7p) (9.4p)
Shares used in computing
net loss per share
(thousands) 139,057
139,057 115,780
US Dollar amounts have been translated at the closing rate on 30 September 2002 (1.00 pound: $1.5726) solely for information.
Condensed Consolidated Balance Sheet (unaudited)
Unaudited Unaudited Unaudited
As at As at As at
30 Sept 30 Sept 30 Sept
2002 2002 2001
$000 000 pounds 000 pounds
Cash and investments 15,723 9,998 24,000
Other current assets 7,979 5,074 4,135
Fixed assets
(including Goodwill) 29,730 18,905 20,384
Total assets 53,432 33,977 48,519
Current liabilities (including
provisions & deferred income) 16,762 10,659 18,683
Shareholders` equity 36,670 23,318 29,836
Total liabilities and
shareholders` equity 53,432 33,977 48,519
US Dollar amounts have been translated at the closing rate on 30 September 2002 (1.00 pound: $1.5726) solely for information.
Notes to the Statement
Basis of preparation
These unaudited statements, which do not constitute statutory accounts within the meaning of Section 240 of the Companies Act 1985, have been prepared using the accounting policies set out in the Group`s 2001 Annual Report and Accounts. The 2001 Annual Report and Accounts received an unqualified auditor`s report and have been delivered to the Registrar of Companies.
Going concern
The Group is an emerging pharmaceutical business and as such expects to absorb cash until products are commercialized. The Directors have a reasonable expectation that the Group has, or can reasonably expect to obtain, adequate cash resources to enable it to continue in operational existence for the foreseeable future, and have therefore prepared the financial statements on the going concern basis.
Xenova Group plc Third Quarter Results Announcement
SLOUGH, England, Nov 7, 2002 /PRNewswire-FirstCall via COMTEX/ --
Year to Date Highlights:
* Tariquidar enters Phase III trials
* Tariquidar granted FDA `fast track` status
* Successful results of Phase IIa trial for therapeutic vaccine
TA-HPV
* Patient dosing begins in Phase IIa study for anti-cocaine addiction
vaccine TA-CD
* $63m (43.2m pounds) development and license agreement with
Genentech Inc for novel drugs in immune inflammatory disease
* Fully underwritten rights issue raising approximately
9.9m pounds ($15.6m) net of expenses
* Cash and liquid resources as at 30 September #10m ($15.7m),
excluding rights issue proceeds
Commenting, Chief Executive Officer, David Oxlade said:
"Xenova continues to make encouraging progress, both in terms of advancing its clinical and pre-clinical pipelines and in expanding its revenue-generating collaborations.
"We are delighted that tariquidar has been granted fast track status by the FDA so soon after its entry to Phase III clinical trials in both North America and Europe."
Notes to Editors
Xenova Group plc`s product pipeline focuses principally on the therapeutic areas of cancer and immune system disorders. Xenova has a broad pipeline of eight programs in clinical development. The Group has a well-established track record in the identification, development and partnering of innovative products and technologies and has partnerships with significant pharmaceutical companies including Lilly, Pfizer, Celltech, Genentech, QLT and Millennium Pharmaceuticals.
For further information about Xenova and its products please visit the Xenova website at http://www.xenova.co.uk .
For Xenova: Disclaimer to take advantage of the "Safe Harbor" provisions of the US Private Securities Litigation Reform Act of 1995. This press release contains "forward-looking statements," including statements about the discovery, development and commercialization of products. Various risks may cause Xenova`s actual results to differ materially from those expressed or implied by the forward looking statements, including: adverse results in our drug discovery and clinical development programs; failure to obtain patent protection for our discoveries; commercial limitations imposed by patents owned or controlled by third parties; our dependence upon strategic alliance partners to develop and commercialize products and services; difficulties or delays in obtaining regulatory approvals to market products and services resulting from our development efforts; the requirement for substantial funding to conduct research and development and to expand commercialization activities; and product initiatives by competitors. For a further list and description of the risks and uncertainties we face, see the reports we have filed with the Securities and Exchange Commission. We disclaim any intention or obligation to update or revise any forward-looking statements, whether as a result of new information, future events or otherwise.
Product Pipeline Year to Date Update - Clinical Trials
Cancer:
Tariquidar (XR9576) -- Discovered by Xenova, tariquidar, a potent small-molecule inhibitor of the P-glycoprotein pump, is being developed for the treatment of multidrug resistance (MDR) in cancer. In August 2001, Xenova signed an exclusive license agreement with QLT Inc for the development and marketing in the United States, Canada and Mexico of tariquidar for the treatment of MDR in cancer. In June 2002, tariquidar entered two pivotal Phase III clinical trials, in which tariquidar is being used as an adjunctive treatment in combination with first-line chemotherapy for non-small cell lung cancer (NSCLC) patients. The double-blind, randomized, placebo-controlled trials are being carried out in patients with stage IIIb/IV NSCLC at approximately 100 centers located throughout North America and Europe. Tariquidar was granted fast track status by the US Food and Drug Administration (FDA) in October 2002. Recruitment is currently progressing in line with expectations. An interim safety analysis is planned for mid- 2003 and, on successful completion of the Phase III program, it is anticipated that QLT will file for approval of tariquidar in North America for use in combination with first-line chemotherapy in advanced NSCLC by the end of 2005 and Xenova will file for marketing approval in Europe.
DISC-GMCSF -- DISC-GMCSF, an innovative immunotherapeutic vaccine, is designed as a treatment for a broad range of solid tumors. In preclinical studies DISC-GMCSF was shown to be effective in models of breast and colorectal cancer. As announced in June 2002, DISC-GMCSF successfully completed a Phase I dose-escalating safety study at three centers in the UK, in patients with metastatic melanoma. DISC-GMCSF was found to be well tolerated, with no serious adverse events reported. The DISC vector was shown to be localized at the site of injection and had not spread beyond the required therapeutic area, a key objective of the study.
XR11576 (MLN576) -- XR11576, XR5944 and XR11612 are novel DNA targeting agents, whose method of action includes dual inhibition of topoisomerases I and II. XR11576 is the subject of a license agreement with Millennium Pharmaceuticals Inc, announced in December 2001. The other compounds covered by this agreement, XR5944 (MLN944) and XR11612 (MLN612), are currently in preclinical development. XR11576 entered Phase I clinical trials in February 2002. The open label Phase I trial is being carried out at centers in the UK and the Netherlands and comprises multiple ascending oral doses in patients with solid tumors. Xenova retains responsibility for performing development activities associated with the program to the end of Phase II clinical trials. Millennium will provide funding for the program commencing in 2003, up to the agreed level of $20m.
Other:
TA-NIC -- Designed as a treatment for nicotine addiction, TA-NIC is a nicotine conjugate vaccine which is administered through a course of intramuscular injections. The successful results of a Phase I trial for TA-NIC, reported in June 2002, showed the vaccine to be safe and well tolerated both systemically and locally in the 60 smokers and non-smokers who took part in the trial, and that the vaccine generated a specific anti-nicotine response. This is the first time such a vaccine has been tested in man.
TA-CD -- TA-CD is a therapeutic vaccine which is under development for the treatment of cocaine addiction. Its mechanism of action is similar to that of TA-NIC. A Phase IIa dose escalation trial, supported by the US National Institute on Drug Abuse (NIDA), began in April 2002.
Product Pipeline Year to Date Update - Preclinical
Cancer:
OX40/OX40L -- OX40 is a platform technology which is capable of producing multiple drug candidates primarily targeting cancer and autoimmune disease. OX40 and OX40L (OX40 Ligand) are a pair of interacting cell-surface proteins. A development and license agreement worth up to $63m (43.2m pounds) was signed in April 2002 with Genentech for the worldwide rights to develop and market products, primarily targeting disorders of the immune system, based on Xenova`s OX40 receptor protein and anti-OX40 Ligand antibody programs. Under this agreement, Xenova retains all rights to the up-regulation of the immune system using the OX40:OX40L interaction, including for use in oncology and infectious disease therapy.
Financial Summary
Operating Performance
In the 3 months to 30 September 2002, the Group`s revenue from licensing deals, strategic partnerships and manufacturing outsourcing was 3.9m pounds ($6.1m) (2001: 0.7m pounds ($1.1m)).
In accordance with the Group`s revenue recognition policy, of the 6.9m pounds ($10.9m) received from QLT as part of the tariquidar licensing agreement, 1.0m pounds ($1.6m) was included in the quarter to 30 September 2002. Of the 7.9m pounds ($12.4m) received from Millennium, 2.2m pounds ($3.5m) was recognized by the Group in the 3 months to 30 September 2002. In respect of the OX40 licensing deal with Genentech, 0.3m pounds ($0.5m) of the upfront license fee of 2.7m pounds ($4.3m) received in 2002 was recognized in the 3 months to 30 September 2002. Included within the balance sheet at 30 September 2002 was 7.1m pounds ($11.1m) of deferred revenue in respect of the QLT, Millennium and Genentech licensing deals. Other revenue in the quarter included 0.3m pounds ($0.5m) primarily in respect of ongoing vaccine manufacture.
Total net operating expenses were 6.2m pounds ($9.7m) in the 3 months to 30 September 2002. Of this, research and development costs of 4.9m pounds ($7.7m) (2001: 4.4m pounds ($7.0m)) primarily reflects the ongoing clinical work on the tariquidar, topoisomerase and TA-NIC programs.
Of the total administrative expenses for the 9 months to 30 September 2002 of 4.2m pounds ($6.7m), 0.9m pounds ($1.4m) relates to the amortisation over a 10-year period of the goodwill in respect of the acquisition of Cantab.
Net interest income of 0.5m pounds ($0.7m) has been earned on the cash balance held throughout the nine months to 30 September 2002. Following a revaluation to the listed market price of the 88,668 Cubist Pharmaceuticals Inc shares held by the Group, 0.3m pounds ($0.4m) has been written off in the quarter to mark the shares to their market price, increasing the unrealized loss in the 9 months to 30 September 2002 to 1.9m pounds ($3.0m).
The net loss per share this quarter was 1.4p (2001: 3.2p).
Rights issue
On 11 September 2002, the Group announced a fully underwritten 8 for 33 rights issue to raise 9.9m pounds ($15.6m) net of expenses. The rights issue of approximately 33.7 million New Ordinary Shares was made at a price of 32.5 pence per New Ordinary Share. The total number of shares outstanding following the rights issue is approximately 172.8 million.
Cash and liquid investments
Cash and liquid resources at 30 September 2002 total 10.0m pounds ($15.7m) (30 September 2001: 17.5m pounds ($27.5m)).
Cash of 9.7m pounds ($15.3m) and liquid resources of 0.3m pounds ($0.4m) at 30 September 2002 (2001: cash of 15.5m pounds ($24.4m), liquid resources of 2.0m pounds ($3.1m)), excludes the receipt of 2.3m pounds ($3.6m) in respect of the 2001 R&D tax credit recovered in October this year and the net proceeds from the rights issue received in Q4 2002 of 9.9m pounds ($15.6m).
Based upon the expected monthly cash burn rate, this balance is sufficient to fund current operations for in excess of 12 months.
Share capital
The number of shares in issue and to be issued stood at 139.1 million as at 30 September 2002.
The Directors do not currently propose a dividend for 2002 (2001: nil).
Consolidated Profit and Loss Account (unaudited)
Three months ended
30 Sept 30 Sept 30 Sept
2002 2002 2001
$000 000 pounds 000 pounds
Turnover (including share of
joint venture) 6,329 4,025 774
Less: share of joint
venture revenue (193) (123) (47)
Turnover 6,136 3,902 727
Operating expenses
Research and development costs (7,709) (4,902) (4,421)
Administrative expenses (1,723) (1,096) (773)
Administrative expenses:
exceptional reorganization costs -- -- --
Administrative expenses:
amortization of goodwill (461) (293) (293)
Total administrative expenses (2,184) (1,389) (1,066)
Other operating income 168 107 --
Total net operating expenses (9,725) (6,184) (5,487)
Group Operating loss (3,589) (2,282) (4,760)
Share of operating profit
of joint venture 44 28 33
Total operating loss: Group
and share of joint venture (3,545) (2,254) (4,727)
Interest (net) 208 132 186
Amounts written (off)/back
on investments (403) (256) (423)
Loss on ordinary activities
before taxation (3,740) (2,378) (4,964)
Tax on loss on ordinary activities 661 420 512
Loss on ordinary activities
after taxation attributable to
members of Xenova Group plc (3,079) (1,958) (4,452)
Loss per share (basic and
diluted) (2.2c) (1.4p) (3.2p)
Shares used in computing net
loss per share (thousands) 139,057 139,057 139,044
Nine Months Ended
30 Sept 30 Sept 30 Sept
2002 2002 2001
$000 000 pounds 000 pounds
Turnover (including share of
joint venture) 17,203 10,939 1,278
Less: share of joint
venture revenue (431) (274) (50)
Turnover 16,772 10,665 1,228
Operating expenses
Research and development
costs (20,956) (13,326) (11,064)
Administrative expenses (5,270) (3,351) (2,180)
Administrative expenses:
exceptional reorganization costs -- -- (596)
Administrative expenses:
amortization of goodwill (1,382) (879) (586)
Total administrative expenses (6,652) (4,230) (3,362)
Other operating income 597 380 --
Total net operating expenses 27,011 (17,176) (14,426)
Group Operating loss (10,239) (6,511) (13,198)
Share of operating profit
of joint venture 99 63 4
Total operating loss: Group
and share of joint venture (10,140) (6,448) (13,194)
Interest (net) 738 469 586
Amounts written (off)/
back on investments (2,977) (1,893) 252
Loss on ordinary activities
before taxation (12,379) (7,872) (12,356)
Tax on loss on
ordinary activities 2,030 1,291 1,419
Loss on ordinary activities
after taxation attributable
to members of Xenova
Group plc (10,349) (6,581) (10,937)
Loss per share
(basic and diluted) (7.4c) (4.7p) (9.4p)
Shares used in computing
net loss per share
(thousands) 139,057
139,057 115,780
US Dollar amounts have been translated at the closing rate on 30 September 2002 (1.00 pound: $1.5726) solely for information.
Condensed Consolidated Balance Sheet (unaudited)
Unaudited Unaudited Unaudited
As at As at As at
30 Sept 30 Sept 30 Sept
2002 2002 2001
$000 000 pounds 000 pounds
Cash and investments 15,723 9,998 24,000
Other current assets 7,979 5,074 4,135
Fixed assets
(including Goodwill) 29,730 18,905 20,384
Total assets 53,432 33,977 48,519
Current liabilities (including
provisions & deferred income) 16,762 10,659 18,683
Shareholders` equity 36,670 23,318 29,836
Total liabilities and
shareholders` equity 53,432 33,977 48,519
US Dollar amounts have been translated at the closing rate on 30 September 2002 (1.00 pound: $1.5726) solely for information.
Notes to the Statement
Basis of preparation
These unaudited statements, which do not constitute statutory accounts within the meaning of Section 240 of the Companies Act 1985, have been prepared using the accounting policies set out in the Group`s 2001 Annual Report and Accounts. The 2001 Annual Report and Accounts received an unqualified auditor`s report and have been delivered to the Registrar of Companies.
Going concern
The Group is an emerging pharmaceutical business and as such expects to absorb cash until products are commercialized. The Directors have a reasonable expectation that the Group has, or can reasonably expect to obtain, adequate cash resources to enable it to continue in operational existence for the foreseeable future, and have therefore prepared the financial statements on the going concern basis.
Hallo Panospana,
haste den Bericht schon gelesen?Wenn ja, gib doch bitte deine Meinung dazu ab! Ich persönlich kann damit nicht viel anfangen, bei Rambus wäre es etwas anderes.
Apropos Rambus,würde wieder ein Auge auf Rambus werfen, denn Todgesagte leben länger. Weisst ja, wo du uns finden kannst.
Schönes Wochenende
jethor
haste den Bericht schon gelesen?Wenn ja, gib doch bitte deine Meinung dazu ab! Ich persönlich kann damit nicht viel anfangen, bei Rambus wäre es etwas anderes.
Apropos Rambus,würde wieder ein Auge auf Rambus werfen, denn Todgesagte leben länger. Weisst ja, wo du uns finden kannst.
Schönes Wochenende
jethor
Operational Review
Cost Reductions Estimated at £2m p.a. and Two New Projects
into Preclinical Development
Slough, UK, December 11, 2002 - Xenova Group plc (NASDAQ NM: XNVA; London
Stock Exchange: XEN) today announces that an operational review is expected to
produce annual cost savings of approximately £2m and that two new early stage
projects have entered preclinical research.
Operational Review
As a result of the good progress made by both the clinical and preclinical
biologics products acquired at the time of the Cantab merger, Xenova is now able
to apply the `virtual` development approach, which it has used successfully with
its pharmaceutics programmes, to a major part of the biologics portfolio. This
will allow the Company to reduce the level of in-house resources involved in the
early development and manufacturing of biologics, and will result in savings
which are expected to lower Xenova`s annualised costs by approximately £2
million.
In-house capabilities that are essential to the further development of the
portfolio, or which cannot efficiently be sourced externally, including the
pilot and early clinical phase manufacturing plant, are to be retained.
Two new projects enter preclinical research
Xenova is pleased to announce today that two further programmes, HIF-1 alpha for
cancer and a vaccine against Meningitis B, have entered preclinical research.
Hypoxia inducible factor (HIF)-1 alpha is a complex molecular structure which
plays a role in gene expression, promoting cell survival. Xenova is currently
developing small molecule inhibitors of HIF-1 alpha, which may have anti-cancer
and anti-angiogenic activity.
Xenova is also developing a vaccine for the prevention of meningitis caused by
meningococcal group B infections, the construct of which is intended to give
protection against all Group B strains.
An R&D update will be given at the time of Xenova`s announcement of its
preliminary results for the year to 31 December 2002. The date for this
announcement is to be confirmed shortly.
Commenting on today`s news, David Oxlade, Chief Executive of Xenova, said:
`Xenova remains focused on generating maximum value from its product pipeline
and breadth of science, whilst at the same time maintaining tight control over
its cost base.
`We have been particularly pleased with the progress made in the past year by a
number of our high potential drug candidates, including our most advanced drug,
tariquidar, and I am delighted to be able to announce the initiation of these
two new research programmes.`
Cost Reductions Estimated at £2m p.a. and Two New Projects
into Preclinical Development
Slough, UK, December 11, 2002 - Xenova Group plc (NASDAQ NM: XNVA; London
Stock Exchange: XEN) today announces that an operational review is expected to
produce annual cost savings of approximately £2m and that two new early stage
projects have entered preclinical research.
Operational Review
As a result of the good progress made by both the clinical and preclinical
biologics products acquired at the time of the Cantab merger, Xenova is now able
to apply the `virtual` development approach, which it has used successfully with
its pharmaceutics programmes, to a major part of the biologics portfolio. This
will allow the Company to reduce the level of in-house resources involved in the
early development and manufacturing of biologics, and will result in savings
which are expected to lower Xenova`s annualised costs by approximately £2
million.
In-house capabilities that are essential to the further development of the
portfolio, or which cannot efficiently be sourced externally, including the
pilot and early clinical phase manufacturing plant, are to be retained.
Two new projects enter preclinical research
Xenova is pleased to announce today that two further programmes, HIF-1 alpha for
cancer and a vaccine against Meningitis B, have entered preclinical research.
Hypoxia inducible factor (HIF)-1 alpha is a complex molecular structure which
plays a role in gene expression, promoting cell survival. Xenova is currently
developing small molecule inhibitors of HIF-1 alpha, which may have anti-cancer
and anti-angiogenic activity.
Xenova is also developing a vaccine for the prevention of meningitis caused by
meningococcal group B infections, the construct of which is intended to give
protection against all Group B strains.
An R&D update will be given at the time of Xenova`s announcement of its
preliminary results for the year to 31 December 2002. The date for this
announcement is to be confirmed shortly.
Commenting on today`s news, David Oxlade, Chief Executive of Xenova, said:
`Xenova remains focused on generating maximum value from its product pipeline
and breadth of science, whilst at the same time maintaining tight control over
its cost base.
`We have been particularly pleased with the progress made in the past year by a
number of our high potential drug candidates, including our most advanced drug,
tariquidar, and I am delighted to be able to announce the initiation of these
two new research programmes.`
Xenova buys out rights to smoking, cocaine vaccines for 1 mln usd
LONDON (AFX) - Xenova Group PLC said it has bought out, for 1 mln usd, all remaining rights to its anti-nicotine and anti-cocaine vaccine programmes from the trust overseeing the liquidation of bankrupt biotech company ImmuLogic Inc.
Xenova has raised 680,000 stg to fund the buyout through a placing of 1.8 mln new shares, representing 1 pct of the equity, at 38.5 pence per share, a discount of 9.9 pct to yesterday`s closing price.
Under the terms of the deal, Xenova will no longer be obliged to pay ImmuLogic future milestone and royalty payments on two development-stage vaccines, TA-CD and TA-NIC.
Cantab Pharmaceuticals, which merged with Xenova in 2001, had been liable to pay ImmuLogic milestone payments on TA-CD and TA-NIC up to about 11 mln usd, plus royalties on future sales.
ImmuLogic began voluntary liquidation proceedings in August 1999 and is now expected to complete its liquidation following a final cash distribution to its former shareholders.
Chief executive David Oxlade said the deal "releases Xenova from large potential payment obligations and consequently increases our commercial flexibility in relation to both TA-CD and TA-NIC."
Gruß Bogo!
LONDON (AFX) - Xenova Group PLC said it has bought out, for 1 mln usd, all remaining rights to its anti-nicotine and anti-cocaine vaccine programmes from the trust overseeing the liquidation of bankrupt biotech company ImmuLogic Inc.
Xenova has raised 680,000 stg to fund the buyout through a placing of 1.8 mln new shares, representing 1 pct of the equity, at 38.5 pence per share, a discount of 9.9 pct to yesterday`s closing price.
Under the terms of the deal, Xenova will no longer be obliged to pay ImmuLogic future milestone and royalty payments on two development-stage vaccines, TA-CD and TA-NIC.
Cantab Pharmaceuticals, which merged with Xenova in 2001, had been liable to pay ImmuLogic milestone payments on TA-CD and TA-NIC up to about 11 mln usd, plus royalties on future sales.
ImmuLogic began voluntary liquidation proceedings in August 1999 and is now expected to complete its liquidation following a final cash distribution to its former shareholders.
Chief executive David Oxlade said the deal "releases Xenova from large potential payment obligations and consequently increases our commercial flexibility in relation to both TA-CD and TA-NIC."
Gruß Bogo!
Addiction Treatment Vaccines; Xenova Buyout of Residual ImmuLogic Interests
Wednesday January 15, 2:00 am ET
SLOUGH, UK, Jan. 15 /PRNewswire-FirstCall/ -- Xenova Group plc (Nasdaq: XNVA - News; London Stock Exchange: XEN - News) today announces that it has reached an agreement with ImmuLogic Pharmaceutical Corporation Liquidating Trust ("ImmuLogic") under which Xenova will buy out all remaining ImmuLogic rights to future milestone and royalty payments relating to two of Xenova`s development stage vaccine programmes, TA-CD and TA-NIC.
Under the terms of the agreement announced today, ImmuLogic will receive US$1m from Xenova in return for ImmuLogic`s rights to all future payments relating to the two vaccine programmes. Mutual releases from claims, proceedings and any other liabilities were also exchanged.
Under a 1998 Purchase Agreement, Cantab Pharmaceuticals plc (which merged with Xenova in 2001) undertook to pay ImmuLogic certain milestone payments relating to the TA-CD and TA-NIC programmes, payable at the end of each clinical development phase and valued at up to $11m, plus royalties.
ImmuLogic began voluntary liquidation proceedings in August 1999 and is now expected to complete its liquidation following a final cash distribution to its former shareholders.
In order to fund the buyout of ImmuLogic`s interests, Xenova has raised 680,000 pounds Sterling before expenses through the placing for cash of 1,766,235 new ordinary shares of 10 pence each. The new shares, which represent approximately 1.02 per cent of the Company`s issued share capital prior to the placing, have been placed by Nomura International plc at a price of 38.5 pence per share. The placing represents a discount of approximately 9.9 per cent to the closing middle market price on the London Stock Exchange on 14 January 2003.
Application will be made today for the 1,766,235 new shares to be admitted to the Official List and to trading on the London Stock Exchange, with admission expected to become effective on 20 January 2003. When issued, the new shares will rank pari passu in all respects with the Company`s existing ordinary shares.
Gruß Bogo!
Wednesday January 15, 2:00 am ET
SLOUGH, UK, Jan. 15 /PRNewswire-FirstCall/ -- Xenova Group plc (Nasdaq: XNVA - News; London Stock Exchange: XEN - News) today announces that it has reached an agreement with ImmuLogic Pharmaceutical Corporation Liquidating Trust ("ImmuLogic") under which Xenova will buy out all remaining ImmuLogic rights to future milestone and royalty payments relating to two of Xenova`s development stage vaccine programmes, TA-CD and TA-NIC.
Under the terms of the agreement announced today, ImmuLogic will receive US$1m from Xenova in return for ImmuLogic`s rights to all future payments relating to the two vaccine programmes. Mutual releases from claims, proceedings and any other liabilities were also exchanged.
Under a 1998 Purchase Agreement, Cantab Pharmaceuticals plc (which merged with Xenova in 2001) undertook to pay ImmuLogic certain milestone payments relating to the TA-CD and TA-NIC programmes, payable at the end of each clinical development phase and valued at up to $11m, plus royalties.
ImmuLogic began voluntary liquidation proceedings in August 1999 and is now expected to complete its liquidation following a final cash distribution to its former shareholders.
In order to fund the buyout of ImmuLogic`s interests, Xenova has raised 680,000 pounds Sterling before expenses through the placing for cash of 1,766,235 new ordinary shares of 10 pence each. The new shares, which represent approximately 1.02 per cent of the Company`s issued share capital prior to the placing, have been placed by Nomura International plc at a price of 38.5 pence per share. The placing represents a discount of approximately 9.9 per cent to the closing middle market price on the London Stock Exchange on 14 January 2003.
Application will be made today for the 1,766,235 new shares to be admitted to the Official List and to trading on the London Stock Exchange, with admission expected to become effective on 20 January 2003. When issued, the new shares will rank pari passu in all respects with the Company`s existing ordinary shares.
Gruß Bogo!
LONDON (AFX) - Xenova Group PLC said the enrolment of patients in its
ongoing Phase III studies of tariquidar in non-small cell lung cancer patients
is being suspended by its licence partner QLT Inc for approximately three months
pending the outcome of a safety and efficacy study.
It cited a CLT statement as saying the Independent Data and Safety
Monitoring Committee (DSMC) has recommended that accrual to the trials be
temporarily halted until all patients currently enrolled have been followed for
a minimum of three months and that the patients should continue to be treated
and followed according to the protocol.
The DSMC - which is conducting the interim safety and efficacy analysis -
said all data should remain blinded and that the intention of this halt in
accrual is to permit, for those patients already entered, acquisition and review
of additional data on safety and efficacy.
ongoing Phase III studies of tariquidar in non-small cell lung cancer patients
is being suspended by its licence partner QLT Inc for approximately three months
pending the outcome of a safety and efficacy study.
It cited a CLT statement as saying the Independent Data and Safety
Monitoring Committee (DSMC) has recommended that accrual to the trials be
temporarily halted until all patients currently enrolled have been followed for
a minimum of three months and that the patients should continue to be treated
and followed according to the protocol.
The DSMC - which is conducting the interim safety and efficacy analysis -
said all data should remain blinded and that the intention of this halt in
accrual is to permit, for those patients already entered, acquisition and review
of additional data on safety and efficacy.
Xenova Group plc; QLT Temporarily Suspends New Patient Accrual in Phase III Studies of Tariquidar Pending Planned Interim Analysis
21 Feb 2003, 09:08am ET
Data From the Previously Planned Interim Analysis to be Available by the End of the Second Quarter
SLOUGH, England, Feb. 21 /PRNewswire-FirstCall/ --
Xenova Group plc (NASDAQ:XNVA; London Stock Exchange: XEN) today announces
that QLT Inc., (NASDAQ:QLTI; TSX: QLT) has today issued the following announcement. A conference call will be held today by QLT at 1.30pm GMT.
Details of the call, including replay information, can be found at the end of this announcement.
"Vancouver, Canada-QLT Inc. (NASDAQ:QLTI; TSX: QLT) announced today that enrolment of additional patients in its ongoing Phase III studies of tariquidar in non-small cell lung cancer patients is being suspended for
approximately three months pending the completion of the planned interim safety and efficacy analysis by an Independent Data and Safety Monitoring Committee (DSMC).
The DSMC has recommended that accrual to the trials be temporarily halted until all patients currently enrolled have been followed for a minimum of three months and that the patients should continue to be treated and followed
according to the protocol. The committee also stated that all data should remain blinded and that the intention of this halt in accrual is to permit, for those patients already entered, acquisition and review of additional data
on safety and efficacy. The DSMC concluded that the recommendations above "provided the best opportunity for these trials to remain intact and to serve, in their entirety as pivotal registration trials for regulatory
purposes."
The DSMC is an independent panel of experts who are not participating in the studies. The primary responsibility of the DSMC is to oversee the studies and safeguard the interests of current and future participants in these trials. The DSMC has not reviewed any efficacy data for the trials.
Accrual in the two Phase III studies had already reached the threshold number of patients required for the three-month interim analysis. The DSMC felt that a review of the patients enrolled to date would be sufficient "to permit an assessment of differences in response rates between the two arms of the trial, and to provide information on short to mid term differences in
survival" and to make an initial assessment of therapeutic benefit to potential risk.
About Tariquidar
Enrolment began in June 2002, for the two Phase III clinical trials using tariquidar as an adjunctive treatment in combination with first-line chemotherapy for non-small cell lung cancer (NSCLC) patients. Approximately
1000 patients were to be enrolled in two randomised, multi-centred, placebo-controlled trials using tariquidar in combination with two of the most commonly used chemotherapy regimens (paclitaxel plus carboplatin or
vinorelbine alone).
The trials, being conducted at roughly 100 centres located throughout North America and Europe, are designed to demonstrate the ability of tariquidar to enhance the efficacy of chemotherapy agents. This occurs by
preventing or overcoming resistance due to overexpression of P-glycoprotein (P-gp), a membrane protein that pumps chemotherapeutic agents out of cancer cells. Overall survival is the primary end-point in both trials. The U.S.
Food and Drug Administration (FDA) has granted fast track review status to tariquidar for the treatment of multi-drug resistance in first-line treatment of NSCLC patients.
Upon successful completion of the Phase III programme, it is anticipated that QLT will file for approval of tariquidar in North America for use in combination with first-line chemotherapy in advanced NSCLC in 2005. NSCLC is the first of several indications for which tariquidar will be investigated.
QLT is also continuing its Phase II trial with tariquidar in patients with refractory breast cancer at the University of Texas MD Anderson Cancer Center. Tariquidar was in-licensed from Xenova Group plc (NASDAQ:XNVA;
London Stock Exchange: XEN) for the development and marketing rights in North
America in August 2001.
About QLT
QLT Inc. is a global biopharmaceutical company dedicated to the discovery, development, and commercialization of innovative therapies to treat cancer, eye diseases and immune disorders. Combining expertise in ophthalmology, oncology and photodynamic therapy, QLT has commercialised two products to date, including Visudyne(R) therapy, which is the most successfully launched ophthalmology product ever. For more information,
visit our web site at http://www.qltinc.com .
Conference Call Information
QLT Inc. will hold an analyst and institutional investor conference call to discuss this item on Friday, February 21 at 8:30 a.m. EST (5:30 a.m. PST)(1.30 p.m GMT). The call will be broadcast live via the Internet at
www.qltinc.com .
You can also access this call at 001 416 695 5806. A
replay of the call will be available via the Internet and also via telephone
at (416) 695-5800, access code 1381104.
Notes to Editors
Xenova Group plc`s product pipeline focuses principally on the therapeutic areas of cancer and immune system disorders. Xenova has a broad pipeline of programmes in clinical development. The Group has a well-established track record in the identification, development and
partnering of innovative products and technologies and has partnerships with significant pharmaceutical companies including Lilly, Pfizer, Celltech, Genentech, QLT and Millennium Pharmaceuticals.
For further information about Xenova and its products please visit the Xenova website at http://www.xenova.co.uk .
For Xenova: Disclaimer to take advantage of the "Safe Harbor" provisions of the US Private Securities Litigation Reform Act of 1995. This press release contains "forward-looking statements," including statements about the
discovery, development and commercialisation of products. Various risks may cause Xenova`s actual results to differ materially from those expressed or implied by the forward looking statements, including: adverse results in our
drug discovery and clinical development programs; failure to obtain patent protection for our discoveries; commercial limitations imposed by patents owned or controlled by third parties; our dependence upon strategic alliance partners to develop and commercialise products and services; difficulties or delays in obtaining regulatory approvals to market products and services
resulting from our development efforts; the requirement for substantial funding to conduct research and development and to expand commercialisation activities; and product initiatives by competitors. For a further list and description of the risks and uncertainties we face, see the reports we have filed with the Securities and Exchange Commission. We disclaim any intention
or obligation to update or revise any forward-looking statements, whether as a result of new information, future events or otherwise.
SOURCE Xenova Group plc
-0- 02/21/2003
/CONTACT: UK - David A Oxlade, Chief Executive Officer, or Daniel Abrams,
Group Finance Director, or Hilary Reid Evans, Corporate Communications,
+44-1753-706600, all of Xenova Group plc; or US - Press - Brad Miles, ext.
17, or Lauren Tortorete, ext. 20, or Investors - Jonathan Fassberg, ext. 16,
or Lee Stern ext. 22, all of Trout Group - BMC Communications,
+1-212-477-9007; or David Yates, or Ben Atwell, +44-207-831-3113, both of
Financial Dynamics; or Therese Hayes, +1-604-707-7000, or Tamara Hicks,
+1-604-788-5144, both of QLT Inc. /
/Web site: http://www.xenova.co.uk
http://www.qltinc.com /
21 Feb 2003, 09:08am ET
Data From the Previously Planned Interim Analysis to be Available by the End of the Second Quarter
SLOUGH, England, Feb. 21 /PRNewswire-FirstCall/ --
Xenova Group plc (NASDAQ:XNVA; London Stock Exchange: XEN) today announces
that QLT Inc., (NASDAQ:QLTI; TSX: QLT) has today issued the following announcement. A conference call will be held today by QLT at 1.30pm GMT.
Details of the call, including replay information, can be found at the end of this announcement.
"Vancouver, Canada-QLT Inc. (NASDAQ:QLTI; TSX: QLT) announced today that enrolment of additional patients in its ongoing Phase III studies of tariquidar in non-small cell lung cancer patients is being suspended for
approximately three months pending the completion of the planned interim safety and efficacy analysis by an Independent Data and Safety Monitoring Committee (DSMC).
The DSMC has recommended that accrual to the trials be temporarily halted until all patients currently enrolled have been followed for a minimum of three months and that the patients should continue to be treated and followed
according to the protocol. The committee also stated that all data should remain blinded and that the intention of this halt in accrual is to permit, for those patients already entered, acquisition and review of additional data
on safety and efficacy. The DSMC concluded that the recommendations above "provided the best opportunity for these trials to remain intact and to serve, in their entirety as pivotal registration trials for regulatory
purposes."
The DSMC is an independent panel of experts who are not participating in the studies. The primary responsibility of the DSMC is to oversee the studies and safeguard the interests of current and future participants in these trials. The DSMC has not reviewed any efficacy data for the trials.
Accrual in the two Phase III studies had already reached the threshold number of patients required for the three-month interim analysis. The DSMC felt that a review of the patients enrolled to date would be sufficient "to permit an assessment of differences in response rates between the two arms of the trial, and to provide information on short to mid term differences in
survival" and to make an initial assessment of therapeutic benefit to potential risk.
About Tariquidar
Enrolment began in June 2002, for the two Phase III clinical trials using tariquidar as an adjunctive treatment in combination with first-line chemotherapy for non-small cell lung cancer (NSCLC) patients. Approximately
1000 patients were to be enrolled in two randomised, multi-centred, placebo-controlled trials using tariquidar in combination with two of the most commonly used chemotherapy regimens (paclitaxel plus carboplatin or
vinorelbine alone).
The trials, being conducted at roughly 100 centres located throughout North America and Europe, are designed to demonstrate the ability of tariquidar to enhance the efficacy of chemotherapy agents. This occurs by
preventing or overcoming resistance due to overexpression of P-glycoprotein (P-gp), a membrane protein that pumps chemotherapeutic agents out of cancer cells. Overall survival is the primary end-point in both trials. The U.S.
Food and Drug Administration (FDA) has granted fast track review status to tariquidar for the treatment of multi-drug resistance in first-line treatment of NSCLC patients.
Upon successful completion of the Phase III programme, it is anticipated that QLT will file for approval of tariquidar in North America for use in combination with first-line chemotherapy in advanced NSCLC in 2005. NSCLC is the first of several indications for which tariquidar will be investigated.
QLT is also continuing its Phase II trial with tariquidar in patients with refractory breast cancer at the University of Texas MD Anderson Cancer Center. Tariquidar was in-licensed from Xenova Group plc (NASDAQ:XNVA;
London Stock Exchange: XEN) for the development and marketing rights in North
America in August 2001.
About QLT
QLT Inc. is a global biopharmaceutical company dedicated to the discovery, development, and commercialization of innovative therapies to treat cancer, eye diseases and immune disorders. Combining expertise in ophthalmology, oncology and photodynamic therapy, QLT has commercialised two products to date, including Visudyne(R) therapy, which is the most successfully launched ophthalmology product ever. For more information,
visit our web site at http://www.qltinc.com .
Conference Call Information
QLT Inc. will hold an analyst and institutional investor conference call to discuss this item on Friday, February 21 at 8:30 a.m. EST (5:30 a.m. PST)(1.30 p.m GMT). The call will be broadcast live via the Internet at
www.qltinc.com .
You can also access this call at 001 416 695 5806. A
replay of the call will be available via the Internet and also via telephone
at (416) 695-5800, access code 1381104.
Notes to Editors
Xenova Group plc`s product pipeline focuses principally on the therapeutic areas of cancer and immune system disorders. Xenova has a broad pipeline of programmes in clinical development. The Group has a well-established track record in the identification, development and
partnering of innovative products and technologies and has partnerships with significant pharmaceutical companies including Lilly, Pfizer, Celltech, Genentech, QLT and Millennium Pharmaceuticals.
For further information about Xenova and its products please visit the Xenova website at http://www.xenova.co.uk .
For Xenova: Disclaimer to take advantage of the "Safe Harbor" provisions of the US Private Securities Litigation Reform Act of 1995. This press release contains "forward-looking statements," including statements about the
discovery, development and commercialisation of products. Various risks may cause Xenova`s actual results to differ materially from those expressed or implied by the forward looking statements, including: adverse results in our
drug discovery and clinical development programs; failure to obtain patent protection for our discoveries; commercial limitations imposed by patents owned or controlled by third parties; our dependence upon strategic alliance partners to develop and commercialise products and services; difficulties or delays in obtaining regulatory approvals to market products and services
resulting from our development efforts; the requirement for substantial funding to conduct research and development and to expand commercialisation activities; and product initiatives by competitors. For a further list and description of the risks and uncertainties we face, see the reports we have filed with the Securities and Exchange Commission. We disclaim any intention
or obligation to update or revise any forward-looking statements, whether as a result of new information, future events or otherwise.
SOURCE Xenova Group plc
-0- 02/21/2003
/CONTACT: UK - David A Oxlade, Chief Executive Officer, or Daniel Abrams,
Group Finance Director, or Hilary Reid Evans, Corporate Communications,
+44-1753-706600, all of Xenova Group plc; or US - Press - Brad Miles, ext.
17, or Lauren Tortorete, ext. 20, or Investors - Jonathan Fassberg, ext. 16,
or Lee Stern ext. 22, all of Trout Group - BMC Communications,
+1-212-477-9007; or David Yates, or Ben Atwell, +44-207-831-3113, both of
Financial Dynamics; or Therese Hayes, +1-604-707-7000, or Tamara Hicks,
+1-604-788-5144, both of QLT Inc. /
/Web site: http://www.xenova.co.uk
http://www.qltinc.com /
Dow Jones Business News
Xenova Seen Reducing Loss In Fiscal Year 02
Thursday February 20, 11:28 am ET
Call Us In London: 44-20-7842-9464
1612 GMT (Dow Jones) LONDON--Xenova to report FY earnings Mon. Consensus of 7 analysts` forecasts puts 02 pretax loss at GBP10.2M, vs loss of GBP17.2M in 01. Loss per share seen 6.1p vs 13p. Analysts want further evidence that 01 acquisition of Cantab Pharmaceuticals has helped bottom line, and reassurance that has enough cash to sustain R&D. Shares +0.7% at 38p. (SLR)
Dow Jones Business News
Xenova Group: QLT Suspends Tariquidar PhaseIII Trials
Friday February 21, 8:35 am ET
Edited Press Release
LONDON -(Dow Jones)- Xenova Group said Friday that QLT Inc., has said that enrolment of additional patients in its ongoing Phase III studies of tariquidar in non-small cell lung cancer patients is being suspended for three months pending the completion of the planned interim safety and efficacy analysis by an Independent Data and Safety Monitoring Committee (DSMC).
The DSMC has recommended that accrual to the trials be temporarily halted until all patients currently enrolled have been followed for a minimum of three months and that the patients should continue to be treated and followed according to the protocol.
The committee also stated that all data should remain blinded and that the intention of this halt in accrual is to permit, for those patients already entered, acquisition and review of additional data on safety and efficacy.
The DSMC concluded that the recommendations "provided the best opportunity for these trials to remain intact and to serve, in their entirety as pivotal registration trials for regulatory purposes."
The DSMC is an independent panel of experts who are not participating in the studies. The primary responsibility of the DSMC is to oversee the studies and safeguard the interests of current and future participants in these trials. The DSMC has not reviewed any efficacy data for the trials.
Accrual in the two Phase III studies had already reached the threshold number of patients required for the three-month interim analysis. The DSMC felt that a review of the patients enrolled to date would be sufficient "to permit an assessment of differences in response rates between the two arms of the trial, and to provide information on short to mid term differences in survival" and to make an initial assessment of therapeutic benefit to potential risk.
Enrolment began in June 2002, for the two Phase III clinical trials using tariquidar as an adjunctive treatment in combination with first-line chemotherapy for non-small cell lung cancer (NSCLC) patients. 1000 patients were to be enrolled in two randomised, multi-centred, placebo-controlled trials using tariquidar in combination with two of the most commonly used chemotherapy regimens (paclitaxel plus carboplatin or vinorelbine alone).
The trials are designed to demonstrate the ability of tariquidar to enhance the efficacy of chemotherapy agents. The U.S. Food and Drug Administration (News - Websites) (FDA) has granted fast track review status to tariquidar for the treatment of multi- drug resistance in first-line treatment of NSCLC patients.
Tariquidar was in-licensed from Xenova Group for the development and marketing rights in North America in August 2001.
Upon successful completion of the Phase III programme, it is anticipated that QLT will file for approval of tariquidar in North America for use in combination with first-line chemotherapy in advanced NSCLC in 2005.
NSCLC is the first of several indications for which tariquidar will be investigated. QLT is also continuing its Phase II trial with tariquidar in patients with refractory breast cancer at the University of Texas MD Anderson Cancer Center.
Tariquidar was in-licensed from Xenova Group plc for the development and marketing rights in North America in August 2001.
Xenova Seen Reducing Loss In Fiscal Year 02
Thursday February 20, 11:28 am ET
Call Us In London: 44-20-7842-9464
1612 GMT (Dow Jones) LONDON--Xenova to report FY earnings Mon. Consensus of 7 analysts` forecasts puts 02 pretax loss at GBP10.2M, vs loss of GBP17.2M in 01. Loss per share seen 6.1p vs 13p. Analysts want further evidence that 01 acquisition of Cantab Pharmaceuticals has helped bottom line, and reassurance that has enough cash to sustain R&D. Shares +0.7% at 38p. (SLR)
Dow Jones Business News
Xenova Group: QLT Suspends Tariquidar PhaseIII Trials
Friday February 21, 8:35 am ET
Edited Press Release
LONDON -(Dow Jones)- Xenova Group said Friday that QLT Inc., has said that enrolment of additional patients in its ongoing Phase III studies of tariquidar in non-small cell lung cancer patients is being suspended for three months pending the completion of the planned interim safety and efficacy analysis by an Independent Data and Safety Monitoring Committee (DSMC).
The DSMC has recommended that accrual to the trials be temporarily halted until all patients currently enrolled have been followed for a minimum of three months and that the patients should continue to be treated and followed according to the protocol.
The committee also stated that all data should remain blinded and that the intention of this halt in accrual is to permit, for those patients already entered, acquisition and review of additional data on safety and efficacy.
The DSMC concluded that the recommendations "provided the best opportunity for these trials to remain intact and to serve, in their entirety as pivotal registration trials for regulatory purposes."
The DSMC is an independent panel of experts who are not participating in the studies. The primary responsibility of the DSMC is to oversee the studies and safeguard the interests of current and future participants in these trials. The DSMC has not reviewed any efficacy data for the trials.
Accrual in the two Phase III studies had already reached the threshold number of patients required for the three-month interim analysis. The DSMC felt that a review of the patients enrolled to date would be sufficient "to permit an assessment of differences in response rates between the two arms of the trial, and to provide information on short to mid term differences in survival" and to make an initial assessment of therapeutic benefit to potential risk.
Enrolment began in June 2002, for the two Phase III clinical trials using tariquidar as an adjunctive treatment in combination with first-line chemotherapy for non-small cell lung cancer (NSCLC) patients. 1000 patients were to be enrolled in two randomised, multi-centred, placebo-controlled trials using tariquidar in combination with two of the most commonly used chemotherapy regimens (paclitaxel plus carboplatin or vinorelbine alone).
The trials are designed to demonstrate the ability of tariquidar to enhance the efficacy of chemotherapy agents. The U.S. Food and Drug Administration (News - Websites) (FDA) has granted fast track review status to tariquidar for the treatment of multi- drug resistance in first-line treatment of NSCLC patients.
Tariquidar was in-licensed from Xenova Group for the development and marketing rights in North America in August 2001.
Upon successful completion of the Phase III programme, it is anticipated that QLT will file for approval of tariquidar in North America for use in combination with first-line chemotherapy in advanced NSCLC in 2005.
NSCLC is the first of several indications for which tariquidar will be investigated. QLT is also continuing its Phase II trial with tariquidar in patients with refractory breast cancer at the University of Texas MD Anderson Cancer Center.
Tariquidar was in-licensed from Xenova Group plc for the development and marketing rights in North America in August 2001.
Reuters
UPDATE - QLT delays phase III cancer trial, stock slides
Friday February 21, 10:35 am ET
(Changes throughout)
VANCOUVER, British Columbia, Feb 21 (Reuters) - QLT Inc. (Toronto:QLT.TO - News; NasdaqNM:QLTI - News) said on Friday it had suspended enrollment for three months in phase III clinical trials of its tariquidar treatment for lung cancer after a monitoring committee expressed concern about the treatment`s safety.
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The news, a hitch in the approval process for the therapy, sent QLT shares falling more than 4 percent on the Toronto Stock Exchange (News - Websites).
Stock of Xenova Group (London:XEN.L - News), a British biotechnology company that has licensed tariquidar to QLT, tumbled nearly 40 percent in London.
QLT, a pharmaceutical firm developing treatments for cancer, eye diseases and immune disorders, said tariquidar is designed for use in combination with chemotherapy for non-small cell lung cancer.
But QLT Chief Executive Paul Hastings said an independent monitoring committee had expressed concerns "over safety of tariquidar". It wants to study data from about a third of the 1,000 patients who have already enrolled before giving the green light for further enrollments.
QLT said independent data and safety monitoring committee is expected to have a verdict in about three months.
"We must not draw conclusions about the future of tariquidar until the interim (report) is complete and we hear the recommendation," Hastings told a conference call.
He said the committee has "deliberately made no specific details about the nature of (its) concerns to keep the blindness and integrity of the trial."
Brett Pollard, an analyst at Seymour Pierce in London, described the suspension as "bad news" for QLT and Xenova.
"The potential of this product is vast. It is going into a billion dollar market," he said.
The company said it would inform patients enrolled in its phase II trials of breast cancer using tariquidar about the committee`s concerns.
"Although there is some overlap with the lung cancer trial, there are different agents (in both studies)," Hastings said.
QLT`s shares were down 57 Canadian cents, or 4.2 percent, at C$13.09. They fell as low as C$12 immediately after the market opened.
Shares of Xenova plunged 38.2 percent, or 14.5 pence, to 23 pence in London.
News about the suspension is the second setback for Europe`s biotechnology sector this week, after France`s Nicox (NCOX.LN) said its lead pain drug, being developed by AstraZeneca (London:AZN.L - News) had failed to reach a primary endpoint in Phase II clinical trials.
($1=$1.51 Canadian)
UPDATE - QLT delays phase III cancer trial, stock slides
Friday February 21, 10:35 am ET
(Changes throughout)
VANCOUVER, British Columbia, Feb 21 (Reuters) - QLT Inc. (Toronto:QLT.TO - News; NasdaqNM:QLTI - News) said on Friday it had suspended enrollment for three months in phase III clinical trials of its tariquidar treatment for lung cancer after a monitoring committee expressed concern about the treatment`s safety.
ADVERTISEMENT
The news, a hitch in the approval process for the therapy, sent QLT shares falling more than 4 percent on the Toronto Stock Exchange (News - Websites).
Stock of Xenova Group (London:XEN.L - News), a British biotechnology company that has licensed tariquidar to QLT, tumbled nearly 40 percent in London.
QLT, a pharmaceutical firm developing treatments for cancer, eye diseases and immune disorders, said tariquidar is designed for use in combination with chemotherapy for non-small cell lung cancer.
But QLT Chief Executive Paul Hastings said an independent monitoring committee had expressed concerns "over safety of tariquidar". It wants to study data from about a third of the 1,000 patients who have already enrolled before giving the green light for further enrollments.
QLT said independent data and safety monitoring committee is expected to have a verdict in about three months.
"We must not draw conclusions about the future of tariquidar until the interim (report) is complete and we hear the recommendation," Hastings told a conference call.
He said the committee has "deliberately made no specific details about the nature of (its) concerns to keep the blindness and integrity of the trial."
Brett Pollard, an analyst at Seymour Pierce in London, described the suspension as "bad news" for QLT and Xenova.
"The potential of this product is vast. It is going into a billion dollar market," he said.
The company said it would inform patients enrolled in its phase II trials of breast cancer using tariquidar about the committee`s concerns.
"Although there is some overlap with the lung cancer trial, there are different agents (in both studies)," Hastings said.
QLT`s shares were down 57 Canadian cents, or 4.2 percent, at C$13.09. They fell as low as C$12 immediately after the market opened.
Shares of Xenova plunged 38.2 percent, or 14.5 pence, to 23 pence in London.
News about the suspension is the second setback for Europe`s biotechnology sector this week, after France`s Nicox (NCOX.LN) said its lead pain drug, being developed by AstraZeneca (London:AZN.L - News) had failed to reach a primary endpoint in Phase II clinical trials.
($1=$1.51 Canadian)
COMPANIES & FINANCE: Xenova drug trials stopped
By Patrick Jenkins
Financial Times; Feb 22, 2003
Shares in Xenova fell 38 per cent to 23?p yesterday, after safety experts stopped patient recruitment to trials of the company`s lead drug amid toxicity fears.
QLT, the Canadian company to which the drug is licensed, said a data and safety monitoring committee had recommended suspension of the trial because of side effects noted among 300 lung cancer patients already recruited to the 1,000-person final-stage trial.
The drug, Tariquidar, is designed to stop tumours growing resistant to chemotherapy and has completed two phases of safety and efficacy studies in humans.
Daniel Abrams, finance director, said details of the trial problems remained undisclosed, but added: "QLT and Xenova are not unduly concerned about evidence of excess toxicity. I am led to believe that the toxicity issues are nothing that you would not expect to see with any chemotherapy."
Hair loss, vomiting and constipation are common side effects of the cancer treatment.
But analysts stressed the safety committee would need to see evidence of heightened efficacy as a pay-off for more severe side-effects. The committee will spend three months assessing tumour shrinkage in patients who have completed treatment before deciding whether the trial should continue.
Richard Parkes, analyst at ING, said: "If they halt the trial, Tariquidar is dead."
With the drug accounting for between 40 and 60 per cent of the company`s valuation, many believe failure would also spell the end of Xenova`s independence.
Analysts said Millennium Pharmaceuticals of the US, which collaborates with Xenova on another drug development project, or British Biotech, chaired by Peter Fellner, could be potential bidders. "One thing is certain," said Sam Fazeli, analyst at Nomura. "Xenova won`t be bidding for Oxford GlycoSciences now."
Xenova had been one of four companies that gained access to OGS`s data room in preparation for a possible counter-offer to the agreed £110m all-share bid made by Cambridge Antibody Technology last month.
Tariquidar, which was to be launched in 2005, is estimated to have peak-year annual sales potential of about $500m (£320m).
By Patrick Jenkins
Financial Times; Feb 22, 2003
Shares in Xenova fell 38 per cent to 23?p yesterday, after safety experts stopped patient recruitment to trials of the company`s lead drug amid toxicity fears.
QLT, the Canadian company to which the drug is licensed, said a data and safety monitoring committee had recommended suspension of the trial because of side effects noted among 300 lung cancer patients already recruited to the 1,000-person final-stage trial.
The drug, Tariquidar, is designed to stop tumours growing resistant to chemotherapy and has completed two phases of safety and efficacy studies in humans.
Daniel Abrams, finance director, said details of the trial problems remained undisclosed, but added: "QLT and Xenova are not unduly concerned about evidence of excess toxicity. I am led to believe that the toxicity issues are nothing that you would not expect to see with any chemotherapy."
Hair loss, vomiting and constipation are common side effects of the cancer treatment.
But analysts stressed the safety committee would need to see evidence of heightened efficacy as a pay-off for more severe side-effects. The committee will spend three months assessing tumour shrinkage in patients who have completed treatment before deciding whether the trial should continue.
Richard Parkes, analyst at ING, said: "If they halt the trial, Tariquidar is dead."
With the drug accounting for between 40 and 60 per cent of the company`s valuation, many believe failure would also spell the end of Xenova`s independence.
Analysts said Millennium Pharmaceuticals of the US, which collaborates with Xenova on another drug development project, or British Biotech, chaired by Peter Fellner, could be potential bidders. "One thing is certain," said Sam Fazeli, analyst at Nomura. "Xenova won`t be bidding for Oxford GlycoSciences now."
Xenova had been one of four companies that gained access to OGS`s data room in preparation for a possible counter-offer to the agreed £110m all-share bid made by Cambridge Antibody Technology last month.
Tariquidar, which was to be launched in 2005, is estimated to have peak-year annual sales potential of about $500m (£320m).
Xenova Group plc: Preliminary Results for the Year Ended 31 December 2002
24 Feb 2003, 02:00am ET
SLOUGH, England, Feb. 24 /PRNewswire-FirstCall/ --
Xenova Group plc (NASDAQ:XNVA; London Stock Exchange: XEN) today announces
its results for the year ended 31 December 2002.
Summary
-- Tariquidar (XR9576) commences Phase III clinical trials and granted
Fast Track status by FDA
-- Temporary suspension of new patient enrolment announced
21st February 2003
-- Novel DNA targeting agent XR11576 begins Phase I clinical trials
-- Anti-cocaine addiction vaccine TA-CD starts Phase IIa dose escalation
trial
-- Positive results of Phase I trials for anti-nicotine addiction
vaccine TA-NIC
-- Positive results of Phase IIa physician-initiated trials for anti-HPV
vaccine TA-HPV
-- Successful conclusion of Phase I trial for gene therapy
product DISC-GMCSF
-- Potential $63.0m (43.2m pounds sterling) Development and Licence
Agreement signed with Genentech Inc for Novel Drugs in Immune
Inflammatory Disease
Financial Highlights
-- Fully underwritten Rights Issue raises 9.8m pounds net of expenses
-- Revenues from licensing agreements, strategic partnerships and
manufacturing outsourcing 12.2m pounds (2001: 1.8m pounds)
-- Cash, short term deposits and investments at 31 December 2002
19.2m pounds (2001: 24.0m pounds)
Commenting, David Oxlade, Chief Executive Officer of Xenova Group plc,
said: "During 2002, Xenova made solid clinical progress with our portfolio of
mid and late stage products, strengthening the pipeline and expanding our
corporate partnerships. Although enrolment has been temporarily suspended for
tariquidar, the trials continues and both we and our partner QLT Inc. remain
confident in the long-term potential of the drug."
Notes to Editors
Xenova Group plc`s product pipeline focuses principally on the therapeutic
areas of cancer and immune system disorders. Xenova has a broad pipeline of
programmes in clinical development. The Group has a well-established track
record in the identification, development and partnering of innovative
products and technologies and has partnerships with significant pharmaceutical
companies including Lilly, Pfizer, Celltech, Genentech, QLT and Millennium
Pharmaceuticals.
For further information about Xenova and its products please visit the
Xenova website at www.xenova.co.uk .
For Xenova: Disclaimer to take advantage of the "Safe Harbor" provisions
of the US Private Securities Litigation Reform Act of 1995. This press release
contains "forward-looking statements," including statements about the
discovery, development and commercialisation of products. Various risks may
cause Xenova`s actual results to differ materially from those expressed or
implied by the forward looking statements, including: adverse results in our
drug discovery and clinical development programs; failure to obtain patent
protection for our discoveries; commercial limitations imposed by patents
owned or controlled by third parties; our dependence upon strategic alliance
partners to develop and commercialise products and services; difficulties or
delays in obtaining regulatory approvals to market products and services
resulting from our development efforts; the requirement for substantial
funding to conduct research and development and to expand commercialisation
activities; and product initiatives by competitors. For a further list and
description of the risks and uncertainties we face, see the reports we have
filed with the Securities and Exchange Commission. We disclaim any intention
or obligation to update or revise any forward-looking statements, whether as a
result of new information, future events or otherwise.
Chairman`s Statement and Chief Executive`s Review
The last financial year was a good year for Xenova. Following the merger
with Cantab Pharmaceuticals in 2001, Xenova has continued to focus its
resources on the research and development of both small molecule and biologic
drug candidates. Xenova currently has a development pipeline of 8 programmes
undergoing clinical trials, backed up by an extensive pipeline of research-
stage programmes. As a result of this year`s operational review, we have
applied our `virtual` development approach, which we have used successfully
with our pharmaceutics programmes, to our biologics portfolio. This has
allowed us to reduce the level of in-house resources involved in the early
development of biologics. Details of the latest stage of development of all
our programmes, including information relating to two new programmes, known as
HIF-1 alpha and MEN-B, (which entered preclinical research in 2002), can be
found in the following section headed Operating Review.
Xenova was amongst the small number of biotechnology companies who were
successful in raising funds in the market in 2002, raising 9.8m pounds net
through a fully underwritten 8 for 33 Rights Issue. As a result, Xenova had
19.2m pounds ($30.9m) in cash, short-term deposits and investments at the
year end. The impact of the December 2002 operational review is expected to
produce annual cost savings of approximately 2m pounds. Exceptional
reorganisation costs of 3.8m pounds ($6.2m) have been recognised in the
current year. This comprises (0.5m pounds ($0.9m) in respect of redundancy
and 3.3m pounds ($5.3m) in respect of fixed assed impairments.
Xenova employed approximately 147 people at 31 December 2002 at its
facilities in Slough and Cambridge, UK. The company`s head office and small
molecule discovery and development facilities are based in Slough, while the
Cambridge site houses Xenova`s biologics capabilities.
Our objectives for the coming year include the further advancement of our
clinical programmes and potentially further commercial partnerships for
certain products currently in development. We generally seek to finance the
development of new drugs up to the completion of Phase II trials, at which
point a licensing partner would be sought for further development and
marketing of the product. However, in certain instances we may consider
licensing a product at an earlier stage, for example, when an attractive
commercial arrangement can be negotiated. Within the area of oncology, it is
our practice to seek to retain rights to certain significant geographic
territories in order to maximise the value to Xenova of each product through
further out-licensing at a later stage.
Operating Review
Drug Candidates - Cancer
Tariquidar (XR9576) -- Discovered by Xenova, tariquidar, a potent
small-molecule inhibitor of the P-glycoprotein pump, is being developed for
the treatment of multidrug resistance (MDR) in cancer. There is a substantial
market opportunity for a drug that overcomes MDR, since it is estimated that,
depending on the type of cancer, between 30% and 80% of solid tumours will
develop resistance to anti-cancer drugs.
In August 2001, Xenova signed an exclusive licence agreement with QLT Inc.
for the development and marketing in the United States, Canada and Mexico of
tariquidar for the treatment of MDR in cancer.
In June 2002, tariquidar entered two pivotal Phase III clinical trials, in
which it is being used as an adjunctive treatment in combination with
first-line chemotherapy for non-small cell lung cancer (NSCLC) patients. The
double-blind, randomised, placebo-controlled trials are being carried out on
patients with stage IIIb/IV NSCLC at centres located throughout North America
and Europe. Tariquidar was granted fast track status by the US Food and Drug
Administration (FDA) in October 2002. On successful completion of the Phase
III programme, it is anticipated that QLT Inc. will file for approval of
tariquidar in North America for use in combination with first-line
chemotherapy in advanced NSCLC by the end of 2005 and Xenova will file for
marketing approval in Europe.
Xenova retains substantially all rights to commercialise tariquidar in
Europe and the Rest of the World, and we intend to establish further
collaborations in order to maximise the value of this potentially
first-in-class drug.
On 21st February 2003, QLT Inc. announced that enrolment of additional
patients in the ongoing Phase III studies of tariquidar in non-small cell lung
cancer patients was being suspended for approximately three months pending the
completion of the planned interim safety and efficacy analysis by an
Independent Data and Safety Monitoring Committee (DSMC).
The DSMC recommended to QLT Inc. that accrual to the trials be temporarily
halted until all patients currently enrolled have been followed for a minimum
of three months and that the patients should continue to be treated and
followed according to the protocol. The committee also stated that all data
should remain blinded and that the intention of this halt in accrual is to
permit, for those patients already entered, acquisition and review of
additional data on safety and efficacy. The DSMC concluded that the
recommendations above "provided the best opportunity for these trials to
remain intact and to serve, in their entirety as pivotal registration trials
for regulatory purposes."
The DSMC is an independent panel of experts who are not participating in
the studies. The primary responsibility of the DSMC is to oversee the studies
and safeguard the interests of current and future participants in these
trials. The DSMC has not reviewed any efficacy data for the trials. Accrual
in the two Phase III studies had already reached the threshold number of
patients required for the three-month interim analysis. The DSMC felt that a
review of the patients enrolled to date would be sufficient "to permit an
assessment of differences in response rates between the two arms of the trial,
and to provide information on short to mid term differences in survival" and
to make an initial assessment of therapeutic benefit to potential risk.
The Phase IIb trial underway at MD Anderson in chemo refractory breast
cancer is unaffected.
XR11576 (MLN576) -- XR11576, XR5944 and XR11612 are novel DNA targeting
agents, whose mode of action includes dual inhibition of topoisomerases I and
II. XR11576, XR5944 and XR11612 are the subject of a licence agreement with
Millennium Pharmaceuticals Inc, announced in December 2001. XR11576 entered
Phase I clinical trials in February 2002. The open label Phase I trial is
being carried out at centres in the UK and the Netherlands and comprises
multiple ascending oral doses in patients with solid tumours. The other
compounds covered by this agreement, XR5944 (MLN944) and XR11612 (MLN612), are
currently in preclinical development. Xenova retains responsibility for
performing development activities associated with the programme to the end of
Phase II clinical trials. Millennium will provide funding for the programme
commencing in 2003, up to the agreed level of $20.0m (12.4m pounds). Xenova
retains substantially all commercialisation rights for all products arising
from the collaboration outside the United States, Canada and Mexico.
DISC-GMCSF -- DISC-GMCSF, an innovative immunotherapeutic vaccine, is
designed as a treatment for a broad range of solid tumours. In preclinical
studies DISC-GMCSF was shown to be effective in models of breast and
colorectal cancer. As announced in June 2002, DISC-GMCSF successfully
completed a Phase I dose-escalating safety study at three centres in the UK,
in patients with metastatic melanoma. DISC-GMCSF was found to be well
tolerated, with no serious adverse events reported. The DISC vector was shown
to be localised at the site of injection and had not spread beyond the
required therapeutic area, a key objective of the study.
TA-HPV/TA-CIN -- TA-HPV is an immunotherapeutic vaccine, which is being
developed to prevent the recurrence of cervical cancer. The product is
intended to be used as a therapeutic vaccine alongside standard treatments,
such as surgery. The results of two physician-initiated Phase IIa trials, in
which TA-HPV was tested in patients with high-grade vulval intra-epithelial
neoplasia (VIN 3), have shown the vaccine to be safe and well tolerated, with
partial responses being shown in over 40% of cases in these studies.
TA-CIN is a recombinant fusion protein, designed as a treatment for women
with cervical dysplasia. Preclinical studies have suggested that use of this
product together with TA-HPV results in an immune response that is
significantly greater than that observed with either product alone. An open
label, physician-sponsored Phase II `prime-boost` study, targeting the
treatment of HPV associated ano-genital neoplasias, began in October 2001.
Results of this trial are anticipated during the course of 2003.
Drug Candidates - Other
TA-NIC -- Designed as a treatment for nicotine addiction, TA-NIC is a
nicotine conjugate vaccine which is administered through a course of
intramuscular injections. TA-NIC is intended as an aid to smoking cessation
and has been designed to generate anti-nicotine antibodies. The successful
results of a Phase I trial for TA-NIC, reported in June 2002, showed the
vaccine to be safe and well tolerated both systemically and locally in the 60
smokers and non-smokers who took part in the trial, and that the vaccine
generated a specific anti-nicotine response. This is the first time such a
vaccine has been tested in man. It is expected that TA-NIC will enter further
Phase I dose escalation trials during the course of 2003.
TA-CD -- TA-CD is a therapeutic vaccine which is under development for the
treatment of cocaine addiction. Its mechanism of action is similar to that of
TA-NIC. A Phase IIa dose escalation trial, supported by the US National
Institute on Drug Abuse (NIDA), began in April 2002. A Phase II `cocaine
administration` study, which has been designed to provide a preliminary
assessment of the efficacy of TA-CD, as determined by quantative behavioural
and other measurements, is expected to begin during the course of 2003.
DISC-PRO -- A prophylactic vaccine designed to prevent genital and
oro-labial herpes, DISC-PRO has completed Phase I trials. These Phase I trials
demonstrated that DISC-PRO was well tolerated and immunogenic. We intend to
secure a corporate partner ahead of Phase III clinical trials for the further
development of this programme.
DISC-VET -- DISC-VET is a programme to develop Xenova`s DISC technology
for the treatment of multiple diseases in animals. A product candidate,
DISC-BHV, for the treatment of bovine herpes virus induced respiratory disease
in cattle, is in the equivalent of Phase I clinical development in partnership
with Pfizer. Xenova`s DISC vaccine technology is applicable to multiple
disease targets including diseases which affect other animal species.
Preclinical
Cancer
OX40/OX40L -- OX40 is a platform technology which is capable of producing
multiple drug candidates primarily targeting cancer and autoimmune disease.
OX40 and OX40L (OX40 Ligand) are a pair of interacting cell-surface proteins.
A development and licence agreement worth up to $63.0m (43.2m pounds) was
entered into in April 2002 with Genentech for worldwide rights to develop and
market products, primarily targeting disorders of the immune system, based on
Xenova`s OX40 receptor protein and anti-OX40 Ligand antibody programmes. Under
this agreement, Xenova retains all rights to the up-regulation of the immune
system using the OX40:OX40L interaction, including use in oncology and
infectious disease therapy.
PAI-Cancer -- In collaboration with the Institute for Cancer Research,
Xenova has been developing an active novel inhibitor of a protein released by
platelets and the cells lining the blood vessels known as PAI-1. PAI is an
unfavourable prognostic indicator in many human cancers and is strongly
implicated in the metastatic process. Lilly has an option to acquire
exclusive rights to develop and commercialise PAI-1 inhibitors in the cancer
field, which, if exercised, would realise upfront and milestone payments of up
to $16.5m (10.0m pounds), with additional royalties payable on commercialised
products.
MRP -- Multi-Drug Resistance Protein (MRP) acts as a pump which, like the
P-glycoprotein pump, expels small molecules out of cells and thus can help
protect tumour cells from certain chemotherapeutic agents. We are currently
carrying out a lead optimisation programme for a compound for the inhibition
of MRP to further strengthen our position in the field of multi-drug
resistance.
Other
OX40 -- A partnership has been established with Celltech Group plc to
develop an antibody-based product against OX40 for the treatment of autoimmune
disease. Along with OX40L, OX40 is also the subject of a development and
licence agreement with Genentech (see above).
PAI-CV -- In conjunction with our partner Lilly, we have been carrying out
a research and development programme for the development of a new class of
oral anti-thrombotic drugs suitable for chronic use. Research is focused on
the development of small molecule inhibitors of PAI-1 that are designed to
enhance the break-up of blood clots without the side-effects of bleeding
associated with other marketed anti-thrombotic drugs. Xenova and Lilly
entered into this collaboration in 1998.
MEN-B -- Xenova is currently developing a vaccine for the prevention of
meningitis caused by meningococcal group B infections. The aim is to
construct a live attenuated vaccine, which should give good protection against
all group B strains, and which can be developed as a paediatric vaccine for
universal vaccination. We envisage a secondary market for adolescent
vaccination, and estimate the US and European markets for both paediatric and
adolescents to be valued at about $1b. The programme entered preclinical
development in late 2002.
HIF-1 Alpha -- Hypoxia inducible factor (HIF) 1 alpha is a complex
molecular structure which plays a role in gene expression, promoting cell
survival. Xenova is developing small molecule inhibitors of HIF-1 alpha,
which may have anti-cancer and anti-angiogenic activity.
Phogen:
A joint venture between Xenova and Marie Curie Cancer Care, Phogen Limited
is developing a novel technology, known as VP22, for the enhanced delivery of
gene-based therapeutics. Phogen entered into a licensing agreement with
Genencor International Inc, worth up to 15.0m pounds ($21.0m), for the
utilisation of Phogen`s VP22 technology in the area of therapeutic vaccines
for certain infectious viral diseases, in August 2001. A further research
collaboration was announced with Cell Genesys in October 2001 and a
collaboration with PowderJect Pharmaceuticals plc was announced in January
2003. Phogen intends to seek additional partnering opportunities for its novel
technologies.
Financial Summary
Operating Performance
In the year to 31 December 2002, the Group`s revenues from licensing
agreements, strategic partnerships and manufacturing outsourcing were
12.2m pounds ($19.7m) (2001: 1.8m pounds ($2.9m)).
In accordance with the Group`s revenue recognition policy, of the
6.9m pounds ($11.1m) received from QLT Inc. in 2001 as part of the tariquidar
licensing agreement, 2.5m pounds ($4.0m) was recognised in the year, with a
further 3.9m pounds ($6.2m) being deferred to future periods. All of the
7.9m pounds ($12.7m) received from Millennium in 2001 has been recognised by
the Group in the year to 31 December 2002, matching the commitments under this
agreement. Following the successful completion of a further licensing deal in
the year in respect of the OX40 programme with Genentech, 0.9m pounds ($1.5m)
of the upfront licence fee of 2.7m pounds ($4.4m) has been recognised this
year. Other revenue included 0.9m pounds ($1.5m) in respect of ongoing
contract vaccine manufacturing.
Total research and development (R&D) expenditure of 17.7m pounds ($28.4m)
(2001: 15.4m pounds, $24.7m) includes substantial preclinical and clinical
development of the programme of novel DNA targeting agents, one of which
(XR11576) entered Phase I clinical trials in February 2002. This programme
was licensed to Millennium Pharmaceuticals Inc in December 2001 and cost
reimbursement under this agreement commences in 2003. Additionally, Phase I
clinical development of the anti-nicotine vaccine, TA-NIC, was completed
during 2002 as was initial Phase II clinical development of the P-gp
inhibitor, tariquidar. Tariquidar, which is the subject of a North American
licensing agreement with QLT Inc. also entered Phase III clinical development
during the course of 2002.
Total administrative expenses of 9.3m pounds ($15.0m) (2001: 4.9m pounds
($7.8m)) have increased by 4.4m pounds ($7.2m) from the prior year primarily
due to the exceptional reorganisation costs of 3.8m pounds ($6.2m).
Amortisation costs of 1.2m pounds ($1.9m) (2001: 0.9m pounds ($1.5m)) relate
to the amortisation of goodwill arising on the acquisition of the Cantab
business in 2001 of 11.7m pounds ($18.8m). The goodwill is being amortised
over the 10 year estimated useful life of the business.
Total net operating expenses for the second half of the year increased to
15.5m pounds ($25.0m) from 11.0m pounds ($17.7m) in the first half of the year
principally as a result of the increased research and development activity
totalling 0.8m pounds ($1.3m) and the additional exceptional reorganisation
costs of 3.8m pounds ($6.2m).
The reduced net interest income reflects the lower average cash and liquid
resources balance held throughout the year. Following the fall, since 31
December 2001, in the listed market price of the 88,668 Cubist Pharmaceuticals
Inc shares held by the Group, 1.7m pounds ($2.8m) has been written off to the
profit and loss account.
Exceptional charge -- Reorganisation
On 11 December 2002, the Group announced the completion of an operational
review. Following this review, approximately 40 staff have been made redundant
resulting in an exceptional reorganisation charge of 0.5m pounds ($0.9m).
Additionally, excess property at the Cambridge facility is expected to be
sublet during the course of 2003. An impairment charge of 3.3m pounds ($5.3m)
has been provided against leasehold improvements, plant and equipment at the
Cambridge facility for those assets no longer expected to be used in the
business.
Rights issue
On 11 September 2002, the Group announced a fully underwritten 8 for
33 rights issue to raise 9.8m pounds ($15.8m) net of expenses. The rights
issue of approximately 33.7 million New Ordinary Shares was made at a price of
32.5 pence per New Ordinary Share. The total number of shares in issue
following the rights issue was approximately 172.8 million.
Cash, short-term deposits and investments
Cash, short-term deposits and investments at 31 December 2002 total
19.2m pounds ($30.9m) (2001: 24.0m pounds ($38.6m)). The Group had cash of
2.6m pounds ($4.2m) and liquid resources of 16.6m pounds ($26.7m) at
31 December 2002 (2001: cash 9.0m pounds ($14.5m), liquid resources
15.0m pounds ($24.1m)).
Included in liquid resources is an investment in Cubist Pharmaceuticals
Inc., which subsequent to the year end fell in value such that at 17 January
2003 the share price was $6.70 valuing the investment held at 0.4m pounds
($0.6m), representing a decline from the valuation at 31 December 2002 of
0.1m pounds ($0.1m).
Share capital
The number of shares in issue rose to 172.8 million as at 31 December 2002
from 139.0 million at 31 December 2001, due principally to the rights issue of
33.7 million shares.
The Directors do not propose a dividend for 2002 (2001: nil).
Subsequent Events
On 15 January 2003, the Group announced that it had reached agreement with
ImmuLogic Pharmaceutical Corporation Liquidating Trust ("ImmuLogic") under
which Xenova has bought out the remaining ImmuLogic rights to future milestone
and royalty payments relating to two of Xenova`s development stage vaccine
programmes, TA-CD and TA-NIC, for 0.6m pounds ($1.0m).
In order to fund the buyout of ImmuLogic`s interests, Xenova has raised
0.7m pounds ($1.1m), before expenses, through the placing for cash of
1,766,235 new ordinary shares of 10 pence each. The new shares, which
represent approximately 1.02 per cent of the Company`s issued share capital
prior to the placing, were placed by Nomura International plc at a price of
38.5 pence per share. Following this transaction, the total number of shares
in issue was 174.5 million.
Consolidated Profit and Loss Account (unaudited)
Unaudited Unaudited Unaudited Audited
Year Year Six months Year
Ended Ended Ended Ended
31 December 31 December 31 December 31 December
2002 2002 2002 2001
Notes $000 000 000 000
pounds pounds pounds
Turnover (including
share of joint
venture) 20,442 12,701 5,787 1,877
Less: share of joint
venture revenue (735) (457) (306) (95)
Turnover 19,707 12,244 5,481 1,782
Operating expenses
Research and
development costs (28,419) (17,657) (9,233) (15,374)
Administrative
expenses (6,983) (4,339) (2,084) (2,961)
Administrative
expenses:
exceptional
reorganisation costs 2 (6,150) (3,821) (3,821) (1,035)
Administrative
expenses:
amortisation of
goodwill (1,880) (1,168) (584) (879)
Total administrative
expenses (15,013) (9,328) (6,489) (4,875)
Other operating income 745 463 190 115
Total net operating
expenses (42,687) (26,522) (15,532) (20,134)
Group Operating loss (22,980) (14,278) (10,051) (18,352)
Share of operating
profit/(loss) of
joint venture 272 169 136 (33)
Total operating loss:
Group and share of
joint venture (22,708) (14,109) (9,915) (18,385)
Interest (net) 1,007 626 289 754
Amounts written (off)/
back to investments 3 (2,784) (1,730) (93) 463
Loss on ordinary
activities before
taxation (24,485) (15,213) (9,719) (17,168)
Tax on loss on
ordinary activities 4 3,236 2,011 1,140 1,797
Loss on ordinary
activities after
taxation attributable
to members of Xenova
Group plc (21,249) (13,202) (8,579) (15,371)
Loss per share
(basic and diluted) (14.4c) (9.0p) (5.5p) (12.6p)
Shares used in
computing net loss
per share (thousands) 147,484 147,484 155,912 121,596
US Dollar amounts have been translated at the closing rate on
31 December 2002 (1.00 pound: $1.6095) solely for information.
Statement of Total Recognised Gains and Losses (unaudited)
Unaudited Unaudited Unaudited Audited
Year Year Six Months Year
Ended Ended Ended Ended
31 December 31 December 31 December 31 December
2002 2002 2002 2001
$000 000 000 000
pounds pounds pounds
Loss attributable to
Xenova Group plc (21,505) (13,361) (8,700) (15,341)
Profit/(loss)
attributable to
joint venture 256 159 121 (30)
Total loss attributable
to members of Xenova
Group plc (21,249) (13,202) (8,579) (15,371)
Translation difference (2) (1) -- --
Total recognised gains
and losses in the period
attributable to members
of Xenova Group plc (21,251) (13,203) (8,579) (15,371)
US Dollar amounts have been translated at the closing rate on
31 December 2002 (1.00 pound: $1.6095) solely for information.
Consolidated Balance Sheet (unaudited)
Unaudited Unaudited Unaudited Audited
As at As at As at As at
31 December 31 December 30 June 31 December
2002 2002 2002 2001
Notes $000 000 000 000
pounds pounds pounds
Fixed Assets
Intangible assets 15,500 9,630 10,214 10,798
Tangible assets 2 8,839 5,492 9,053 9,586
Investment in
joint venture:
Share of gross
assets 312 194 418 438
Share of gross
liabilities (108) (67) (440) (500)
Goodwill arising
on acquisition -- -- 28 30
204 127 6 (32)
24,543 15,249 19,273 20,352
Current Assets
Debtors 5,092 3,164 4,506 4,135
Short-term deposits
and investments 8 26,694 16,585 12,650 15,027
Cash at bank
and in hand 8 4,236 2,632 2,419 8,973
36,022 22,381 19,575 28,135
Creditors: amounts
falling due within
one year 7 (17,878) (11,108) (13,386) (18,420)
Net current assets 18,144 11,273 6,189 9,715
Total assets less
current liabilities 42,687 26,522 25,462 30,067
Creditors: amounts
falling due after
more than one year -- -- (212) (221)
Provisions for
liabilities and
charges (19) (12) (13) (10)
Total net assets 42,668 26,510 25,237 29,836
Capital and reserves
Called up share
capital 27,807 17,277 13,906 13,904
Share premium account 129,304 80,338 73,872 73,870
Merger reserve 43,807 27,218 27,218 27,218
Other reserves 28,813 17,902 17,902 17,902
Profit and loss
account (187,063) (116,225) (107,661) (103,058)
Shareholders` funds
- equity interests 5 42,668 26,510 25,237 29,836
US Dollar amounts have been translated at the closing rate on
31 December 2002 (1.00 pound: $1.6095) solely for information.
Consolidated Cash Flow Statement (unaudited)
Unaudited Unaudited Unaudited Audited
Year Year Six months Year
Ended Ended Ended Ended
31 December 31 December 31 December 31 December
2002 2002 2002 2001
Notes $000 000 000 000
pounds pounds pounds
Net cash outflow
from operating
activities 6 (24,369) (15,141) (7,738) (3,836)
Returns on
investments and
servicing of finance
Interest received 996 619 280 1,023
Interest element of
finance lease rental
payments (6) (4) (2) (15)
Net cash inflow from
returns on investments
and servicing of
finance 990 615 278 1,008
Taxation 4 3,689 2,292 2,292 1,870
Capital expenditure
and financial
Investment
Purchase of tangible
fixed assets (1,045) (649) (419) (2,797)
Net cash outflow from
capital expenditure
and financial
investment (1,045) (649) (419) (2,797)
Acquisitions and
disposals
Purchase of subsidiary
undertakings -- -- -- (768)
Cash at bank and in
hand acquired with
subsidiary -- -- -- 16,822
Net cash inflow from
acquisitions -- -- -- 16,054
Management of
Liquid Resources
Increase in
short-term deposits 8 (5,292) (3,288) (4,028) (2,644)
Net cash (outflow)/
inflow before
financing (26,027) (16,171) (9,615) 9,655
Financing
Issue of ordinary
share capital 17,637 10,958 10,954 9
Expenses on issue
of shares (1,798) (1,117) (1,117) (919)
Capital element of
finance lease rental
payments (18) (11) (9) (87)
Net cash inflow/
(outflow) from
financing 15,821 9,830 9,828 (997)
(Decrease)/increase
in cash during
the period (10,206) (6,341) 213 8,658
US Dollar amounts have been translated at the closing rate on
31 December 2002 (1.00 pound: $1.6095) solely for information.
Reconciliation of Net Cash Flow to Movement in Net Funds (unaudited)
Unaudited Unaudited Unaudited Audited
Year Year Six Months Year
Ended Ended Ended Ended
31 December 31 December 31 December 31 December
2002 2002 2002 2001
$000 000 000 000
pounds pounds pounds
(Decrease)/increase in
cash during the period (10,206) (6,341) 213 8,658
Capital element of
finance lease payments 18 11 9 87
Cash outflow from
increase in liquid
resources 5,292 3,288 4,028 2,644
Change in net funds
resulting from cash flows (4,896) (3,042) 4,250 11,389
Finance leases acquired
with subsidiary operations -- -- -- (101)
Movement in value
of liquid investments (2,784) (1,730) (93) 463
Translation difference -- -- -- 2
Change in net funds (7,680) (4,772) 4,157 11,753
Net funds at 1 January /
1 July 38,605 23,986 15,057 12,233
Net funds at 31 December 30,925 19,214 19,214 23,986
US Dollar amounts have been translated at the closing rate on
31 December 2002 (1.00 pound: $1.6095) solely for information.
Notes to the Preliminary Announcement
1 Basis of preparation
These unaudited statements, which do not constitute statutory accounts
within the meaning of Section 240 of the Companies Act 1985, have been
prepared using the accounting policies set out in the Group`s 2001 Annual
Report and Accounts except as set out below. The 2001 Annual Report and
Accounts received an unqualified auditor`s report and have been delivered to
the Registrar of Companies.
Following the issue of Financial Reporting Standard Number 19 -- `Deferred
tax` the group has adopted the incremental liability approach (`Full`
provision basis) from 1 January 2002. The Group`s policy now states, `Deferred
tax is recognised in respect of timing differences that have originated but
not reversed by the balance sheet date, but only when transactions or events
that result in a right to pay less tax or an obligation to pay more tax in the
future have occurred at the balance sheet date. The likelihood of these rights
or obligations arising is based upon the estimated probabilities of future
events occurring, taking into account the relevant factors pertinent to the
industry sector in which the Group operates. Deferred tax is measured on a
non-discounted basis`. The deferred tax recognised in 2001 under the former
policy (nil) would not have been different under the revised policy adopted
from 2002.
There have been no other changes to the Group`s accounting policies in
2002.
2 Reorganisation
On 11 December 2002, the Group announced the completion of an operational
review. Following this review, approximately 40 staff have been made redundant
resulting in an exceptional reorganisation charge of 0.5m pounds ($0.9m).
Additionally, excess property at the Cambridge facility is expected to be
sublet during the course of 2003. An impairment charge of 3.3m pounds ($5.3m)
has been provided against leasehold improvements, plant and equipment at the
Cambridge facility for those assets no longer expected to be used in the
business.
3 Amounts written off investments
The 1.7m pounds written off investments reflects the write down on the
Group`s holding of 88,668 Cubist Pharmaceuticals Inc. shares following a fall
in the listed market price since 31 December 2001 (Note 10).
4 Taxation
Following the changes introduced as part of the Finance Act 2000 in
respect of Scientific Research Allowances (now renamed `Research and
Development Allowances`), the Group has recognised an R&D tax credit of 2.0m
pounds in respect of the year that will be received in 2003 (2001: 1.8m
pounds).
5 Reconciliation of movements in shareholders` funds
Unaudited Unaudited Audited
Year Six Months Year
Ended Ended Ended
31 December 31 December 31 December
2002 2002 2001
000 000 000
pounds pounds pounds
At start of period 29,836 25,237 11,876
Shares issued in the period 10,958 10,954 9
Issue of shares in
respect of acquisition -- -- 34,197
Expenses on issue of shares (1,117) (1,117) (919)
Shares to be issued under
long-term incentive
scheme 36 15 44
Retained loss for the period (13,202) (8,579) (15,371)
Exchange movement (1) -- --
At end of period 26,510 26,510 29,836
6 Reconciliation of operating loss to net cash outflow from operating
activities
Unaudited Unaudited Audited
Year Six Months Year
Ended Ended Ended
31 December 31 December 31 December
2002 2002 2001
Notes 000 000 000
pounds pounds pounds
Group operating loss (14,278) (10,051) (18,352)
Depreciation 1,478 715 1,201
Amortisation 1,168 584 879
Exceptional impairment
of fixed assets 2 3,265 3,265 --
Provision for liabilities
and charges 2 (1) (10)
Loss on disposal
of tangible fixed assets -- -- 16
Decrease in debtors 711 211 734
Increase/(decrease) in
creditors (excluding
deferred income) 975 2,451 (2,573)
(Decrease)/Increase in
deferred income (8,498) (4,927) 14,225
Charge for long term
incentive scheme 36 15 44
Net cash outflow from
operating activities (15,141) (7,738) (3,836)
Cash outflow in respect of exceptional reorganisation costs was nil pounds
(2001: 1,035,000 pounds).
7 Deferred income
Included within creditors is 5.7m pounds (2001: 14.2m pounds) in respect
of deferred revenue.
8 Cash and short-term deposits and investments
Cash and short-term deposits have been reclassified for the year ended 31
December 2001. Short-term deposits of 16.1m pounds ($25.9m) (2001:
12.8m pounds ($20.6m)) are now included in short-term deposits and investments
in the balance sheet, and as liquid resources in the cash flow statement. The
remaining balance in short-term deposits and investments relates to the
investment in Cubist Pharmaceuticals Inc. of 0.5m pounds ($0.7m) (2001:
2.2m pounds ($3.5m).
9 Going concern
The Group is an emerging pharmaceutical business and as such expects to
absorb cash until products are commercialised. The Directors have a reasonable
expectation that the Group has, or can reasonably expect to obtain, adequate
cash resources to enable it to continue in operational existence for the
foreseeable future, and have therefore prepared the financial statements on
the going concern basis.
10 Subsequent events
Included in liquid resources is an investment in Cubist Pharmaceuticals
Inc., which subsequent to the year end fell in value such that at 17 January
2003 the share price was $6.70 valuing the investment held at 0.4m pounds
($0.6m), representing a decline from the valuation at 31 December 2002 of
0.1m pounds ($0.1m).
On 15 January 2003, the Group announced that it had reached agreement with
ImmuLogic Pharmaceutical Corporation Liquidating Trust ("ImmuLogic") under
which Xenova has bought out the remaining ImmuLogic rights to future milestone
and royalty payments relating to two of Xenova`s development stage vaccine
programmes, TA-CD and TA-NIC, for 0.6m pounds (US$1.0m).
In order to fund the buyout of ImmuLogic`s interests, Xenova has raised
0.7m pounds before expenses through the placing for cash of 1,766,235 new
ordinary shares of 10 pence each. The new shares, which represent
approximately 1.02 per cent of the Company`s issued share capital prior to the
placing, were placed by Nomura International plc at a price of 38.5 pence per
share.
SOURCE Xenova Group plc
-0- 02/24/2003
/CONTACT: US - David A Oxlade, Chief Executive Officer, Daniel Abrams,
Group Finance Director, or Hilary Reid Evans, Corporate Communications, all of
Xenova Group plc, +44-1753-706600; or UK - Press - Brad Miles, ext. 17, or
Lauren Tortorete, ext. 20, or Investors - Jonathan Fassberg, ext. 16, or Lee
Stern, ext. 22, all of Trout Group-BMC Communications, +1-212-477-9007; or
David Yates or Ben Atwell, both of Financial Dynamics, +44-207-831-3113, for
Xenova Group plc /
/Web site: http://www.xenova.co.uk /
24 Feb 2003, 02:00am ET
SLOUGH, England, Feb. 24 /PRNewswire-FirstCall/ --
Xenova Group plc (NASDAQ:XNVA; London Stock Exchange: XEN) today announces
its results for the year ended 31 December 2002.
Summary
-- Tariquidar (XR9576) commences Phase III clinical trials and granted
Fast Track status by FDA
-- Temporary suspension of new patient enrolment announced
21st February 2003
-- Novel DNA targeting agent XR11576 begins Phase I clinical trials
-- Anti-cocaine addiction vaccine TA-CD starts Phase IIa dose escalation
trial
-- Positive results of Phase I trials for anti-nicotine addiction
vaccine TA-NIC
-- Positive results of Phase IIa physician-initiated trials for anti-HPV
vaccine TA-HPV
-- Successful conclusion of Phase I trial for gene therapy
product DISC-GMCSF
-- Potential $63.0m (43.2m pounds sterling) Development and Licence
Agreement signed with Genentech Inc for Novel Drugs in Immune
Inflammatory Disease
Financial Highlights
-- Fully underwritten Rights Issue raises 9.8m pounds net of expenses
-- Revenues from licensing agreements, strategic partnerships and
manufacturing outsourcing 12.2m pounds (2001: 1.8m pounds)
-- Cash, short term deposits and investments at 31 December 2002
19.2m pounds (2001: 24.0m pounds)
Commenting, David Oxlade, Chief Executive Officer of Xenova Group plc,
said: "During 2002, Xenova made solid clinical progress with our portfolio of
mid and late stage products, strengthening the pipeline and expanding our
corporate partnerships. Although enrolment has been temporarily suspended for
tariquidar, the trials continues and both we and our partner QLT Inc. remain
confident in the long-term potential of the drug."
Notes to Editors
Xenova Group plc`s product pipeline focuses principally on the therapeutic
areas of cancer and immune system disorders. Xenova has a broad pipeline of
programmes in clinical development. The Group has a well-established track
record in the identification, development and partnering of innovative
products and technologies and has partnerships with significant pharmaceutical
companies including Lilly, Pfizer, Celltech, Genentech, QLT and Millennium
Pharmaceuticals.
For further information about Xenova and its products please visit the
Xenova website at www.xenova.co.uk .
For Xenova: Disclaimer to take advantage of the "Safe Harbor" provisions
of the US Private Securities Litigation Reform Act of 1995. This press release
contains "forward-looking statements," including statements about the
discovery, development and commercialisation of products. Various risks may
cause Xenova`s actual results to differ materially from those expressed or
implied by the forward looking statements, including: adverse results in our
drug discovery and clinical development programs; failure to obtain patent
protection for our discoveries; commercial limitations imposed by patents
owned or controlled by third parties; our dependence upon strategic alliance
partners to develop and commercialise products and services; difficulties or
delays in obtaining regulatory approvals to market products and services
resulting from our development efforts; the requirement for substantial
funding to conduct research and development and to expand commercialisation
activities; and product initiatives by competitors. For a further list and
description of the risks and uncertainties we face, see the reports we have
filed with the Securities and Exchange Commission. We disclaim any intention
or obligation to update or revise any forward-looking statements, whether as a
result of new information, future events or otherwise.
Chairman`s Statement and Chief Executive`s Review
The last financial year was a good year for Xenova. Following the merger
with Cantab Pharmaceuticals in 2001, Xenova has continued to focus its
resources on the research and development of both small molecule and biologic
drug candidates. Xenova currently has a development pipeline of 8 programmes
undergoing clinical trials, backed up by an extensive pipeline of research-
stage programmes. As a result of this year`s operational review, we have
applied our `virtual` development approach, which we have used successfully
with our pharmaceutics programmes, to our biologics portfolio. This has
allowed us to reduce the level of in-house resources involved in the early
development of biologics. Details of the latest stage of development of all
our programmes, including information relating to two new programmes, known as
HIF-1 alpha and MEN-B, (which entered preclinical research in 2002), can be
found in the following section headed Operating Review.
Xenova was amongst the small number of biotechnology companies who were
successful in raising funds in the market in 2002, raising 9.8m pounds net
through a fully underwritten 8 for 33 Rights Issue. As a result, Xenova had
19.2m pounds ($30.9m) in cash, short-term deposits and investments at the
year end. The impact of the December 2002 operational review is expected to
produce annual cost savings of approximately 2m pounds. Exceptional
reorganisation costs of 3.8m pounds ($6.2m) have been recognised in the
current year. This comprises (0.5m pounds ($0.9m) in respect of redundancy
and 3.3m pounds ($5.3m) in respect of fixed assed impairments.
Xenova employed approximately 147 people at 31 December 2002 at its
facilities in Slough and Cambridge, UK. The company`s head office and small
molecule discovery and development facilities are based in Slough, while the
Cambridge site houses Xenova`s biologics capabilities.
Our objectives for the coming year include the further advancement of our
clinical programmes and potentially further commercial partnerships for
certain products currently in development. We generally seek to finance the
development of new drugs up to the completion of Phase II trials, at which
point a licensing partner would be sought for further development and
marketing of the product. However, in certain instances we may consider
licensing a product at an earlier stage, for example, when an attractive
commercial arrangement can be negotiated. Within the area of oncology, it is
our practice to seek to retain rights to certain significant geographic
territories in order to maximise the value to Xenova of each product through
further out-licensing at a later stage.
Operating Review
Drug Candidates - Cancer
Tariquidar (XR9576) -- Discovered by Xenova, tariquidar, a potent
small-molecule inhibitor of the P-glycoprotein pump, is being developed for
the treatment of multidrug resistance (MDR) in cancer. There is a substantial
market opportunity for a drug that overcomes MDR, since it is estimated that,
depending on the type of cancer, between 30% and 80% of solid tumours will
develop resistance to anti-cancer drugs.
In August 2001, Xenova signed an exclusive licence agreement with QLT Inc.
for the development and marketing in the United States, Canada and Mexico of
tariquidar for the treatment of MDR in cancer.
In June 2002, tariquidar entered two pivotal Phase III clinical trials, in
which it is being used as an adjunctive treatment in combination with
first-line chemotherapy for non-small cell lung cancer (NSCLC) patients. The
double-blind, randomised, placebo-controlled trials are being carried out on
patients with stage IIIb/IV NSCLC at centres located throughout North America
and Europe. Tariquidar was granted fast track status by the US Food and Drug
Administration (FDA) in October 2002. On successful completion of the Phase
III programme, it is anticipated that QLT Inc. will file for approval of
tariquidar in North America for use in combination with first-line
chemotherapy in advanced NSCLC by the end of 2005 and Xenova will file for
marketing approval in Europe.
Xenova retains substantially all rights to commercialise tariquidar in
Europe and the Rest of the World, and we intend to establish further
collaborations in order to maximise the value of this potentially
first-in-class drug.
On 21st February 2003, QLT Inc. announced that enrolment of additional
patients in the ongoing Phase III studies of tariquidar in non-small cell lung
cancer patients was being suspended for approximately three months pending the
completion of the planned interim safety and efficacy analysis by an
Independent Data and Safety Monitoring Committee (DSMC).
The DSMC recommended to QLT Inc. that accrual to the trials be temporarily
halted until all patients currently enrolled have been followed for a minimum
of three months and that the patients should continue to be treated and
followed according to the protocol. The committee also stated that all data
should remain blinded and that the intention of this halt in accrual is to
permit, for those patients already entered, acquisition and review of
additional data on safety and efficacy. The DSMC concluded that the
recommendations above "provided the best opportunity for these trials to
remain intact and to serve, in their entirety as pivotal registration trials
for regulatory purposes."
The DSMC is an independent panel of experts who are not participating in
the studies. The primary responsibility of the DSMC is to oversee the studies
and safeguard the interests of current and future participants in these
trials. The DSMC has not reviewed any efficacy data for the trials. Accrual
in the two Phase III studies had already reached the threshold number of
patients required for the three-month interim analysis. The DSMC felt that a
review of the patients enrolled to date would be sufficient "to permit an
assessment of differences in response rates between the two arms of the trial,
and to provide information on short to mid term differences in survival" and
to make an initial assessment of therapeutic benefit to potential risk.
The Phase IIb trial underway at MD Anderson in chemo refractory breast
cancer is unaffected.
XR11576 (MLN576) -- XR11576, XR5944 and XR11612 are novel DNA targeting
agents, whose mode of action includes dual inhibition of topoisomerases I and
II. XR11576, XR5944 and XR11612 are the subject of a licence agreement with
Millennium Pharmaceuticals Inc, announced in December 2001. XR11576 entered
Phase I clinical trials in February 2002. The open label Phase I trial is
being carried out at centres in the UK and the Netherlands and comprises
multiple ascending oral doses in patients with solid tumours. The other
compounds covered by this agreement, XR5944 (MLN944) and XR11612 (MLN612), are
currently in preclinical development. Xenova retains responsibility for
performing development activities associated with the programme to the end of
Phase II clinical trials. Millennium will provide funding for the programme
commencing in 2003, up to the agreed level of $20.0m (12.4m pounds). Xenova
retains substantially all commercialisation rights for all products arising
from the collaboration outside the United States, Canada and Mexico.
DISC-GMCSF -- DISC-GMCSF, an innovative immunotherapeutic vaccine, is
designed as a treatment for a broad range of solid tumours. In preclinical
studies DISC-GMCSF was shown to be effective in models of breast and
colorectal cancer. As announced in June 2002, DISC-GMCSF successfully
completed a Phase I dose-escalating safety study at three centres in the UK,
in patients with metastatic melanoma. DISC-GMCSF was found to be well
tolerated, with no serious adverse events reported. The DISC vector was shown
to be localised at the site of injection and had not spread beyond the
required therapeutic area, a key objective of the study.
TA-HPV/TA-CIN -- TA-HPV is an immunotherapeutic vaccine, which is being
developed to prevent the recurrence of cervical cancer. The product is
intended to be used as a therapeutic vaccine alongside standard treatments,
such as surgery. The results of two physician-initiated Phase IIa trials, in
which TA-HPV was tested in patients with high-grade vulval intra-epithelial
neoplasia (VIN 3), have shown the vaccine to be safe and well tolerated, with
partial responses being shown in over 40% of cases in these studies.
TA-CIN is a recombinant fusion protein, designed as a treatment for women
with cervical dysplasia. Preclinical studies have suggested that use of this
product together with TA-HPV results in an immune response that is
significantly greater than that observed with either product alone. An open
label, physician-sponsored Phase II `prime-boost` study, targeting the
treatment of HPV associated ano-genital neoplasias, began in October 2001.
Results of this trial are anticipated during the course of 2003.
Drug Candidates - Other
TA-NIC -- Designed as a treatment for nicotine addiction, TA-NIC is a
nicotine conjugate vaccine which is administered through a course of
intramuscular injections. TA-NIC is intended as an aid to smoking cessation
and has been designed to generate anti-nicotine antibodies. The successful
results of a Phase I trial for TA-NIC, reported in June 2002, showed the
vaccine to be safe and well tolerated both systemically and locally in the 60
smokers and non-smokers who took part in the trial, and that the vaccine
generated a specific anti-nicotine response. This is the first time such a
vaccine has been tested in man. It is expected that TA-NIC will enter further
Phase I dose escalation trials during the course of 2003.
TA-CD -- TA-CD is a therapeutic vaccine which is under development for the
treatment of cocaine addiction. Its mechanism of action is similar to that of
TA-NIC. A Phase IIa dose escalation trial, supported by the US National
Institute on Drug Abuse (NIDA), began in April 2002. A Phase II `cocaine
administration` study, which has been designed to provide a preliminary
assessment of the efficacy of TA-CD, as determined by quantative behavioural
and other measurements, is expected to begin during the course of 2003.
DISC-PRO -- A prophylactic vaccine designed to prevent genital and
oro-labial herpes, DISC-PRO has completed Phase I trials. These Phase I trials
demonstrated that DISC-PRO was well tolerated and immunogenic. We intend to
secure a corporate partner ahead of Phase III clinical trials for the further
development of this programme.
DISC-VET -- DISC-VET is a programme to develop Xenova`s DISC technology
for the treatment of multiple diseases in animals. A product candidate,
DISC-BHV, for the treatment of bovine herpes virus induced respiratory disease
in cattle, is in the equivalent of Phase I clinical development in partnership
with Pfizer. Xenova`s DISC vaccine technology is applicable to multiple
disease targets including diseases which affect other animal species.
Preclinical
Cancer
OX40/OX40L -- OX40 is a platform technology which is capable of producing
multiple drug candidates primarily targeting cancer and autoimmune disease.
OX40 and OX40L (OX40 Ligand) are a pair of interacting cell-surface proteins.
A development and licence agreement worth up to $63.0m (43.2m pounds) was
entered into in April 2002 with Genentech for worldwide rights to develop and
market products, primarily targeting disorders of the immune system, based on
Xenova`s OX40 receptor protein and anti-OX40 Ligand antibody programmes. Under
this agreement, Xenova retains all rights to the up-regulation of the immune
system using the OX40:OX40L interaction, including use in oncology and
infectious disease therapy.
PAI-Cancer -- In collaboration with the Institute for Cancer Research,
Xenova has been developing an active novel inhibitor of a protein released by
platelets and the cells lining the blood vessels known as PAI-1. PAI is an
unfavourable prognostic indicator in many human cancers and is strongly
implicated in the metastatic process. Lilly has an option to acquire
exclusive rights to develop and commercialise PAI-1 inhibitors in the cancer
field, which, if exercised, would realise upfront and milestone payments of up
to $16.5m (10.0m pounds), with additional royalties payable on commercialised
products.
MRP -- Multi-Drug Resistance Protein (MRP) acts as a pump which, like the
P-glycoprotein pump, expels small molecules out of cells and thus can help
protect tumour cells from certain chemotherapeutic agents. We are currently
carrying out a lead optimisation programme for a compound for the inhibition
of MRP to further strengthen our position in the field of multi-drug
resistance.
Other
OX40 -- A partnership has been established with Celltech Group plc to
develop an antibody-based product against OX40 for the treatment of autoimmune
disease. Along with OX40L, OX40 is also the subject of a development and
licence agreement with Genentech (see above).
PAI-CV -- In conjunction with our partner Lilly, we have been carrying out
a research and development programme for the development of a new class of
oral anti-thrombotic drugs suitable for chronic use. Research is focused on
the development of small molecule inhibitors of PAI-1 that are designed to
enhance the break-up of blood clots without the side-effects of bleeding
associated with other marketed anti-thrombotic drugs. Xenova and Lilly
entered into this collaboration in 1998.
MEN-B -- Xenova is currently developing a vaccine for the prevention of
meningitis caused by meningococcal group B infections. The aim is to
construct a live attenuated vaccine, which should give good protection against
all group B strains, and which can be developed as a paediatric vaccine for
universal vaccination. We envisage a secondary market for adolescent
vaccination, and estimate the US and European markets for both paediatric and
adolescents to be valued at about $1b. The programme entered preclinical
development in late 2002.
HIF-1 Alpha -- Hypoxia inducible factor (HIF) 1 alpha is a complex
molecular structure which plays a role in gene expression, promoting cell
survival. Xenova is developing small molecule inhibitors of HIF-1 alpha,
which may have anti-cancer and anti-angiogenic activity.
Phogen:
A joint venture between Xenova and Marie Curie Cancer Care, Phogen Limited
is developing a novel technology, known as VP22, for the enhanced delivery of
gene-based therapeutics. Phogen entered into a licensing agreement with
Genencor International Inc, worth up to 15.0m pounds ($21.0m), for the
utilisation of Phogen`s VP22 technology in the area of therapeutic vaccines
for certain infectious viral diseases, in August 2001. A further research
collaboration was announced with Cell Genesys in October 2001 and a
collaboration with PowderJect Pharmaceuticals plc was announced in January
2003. Phogen intends to seek additional partnering opportunities for its novel
technologies.
Financial Summary
Operating Performance
In the year to 31 December 2002, the Group`s revenues from licensing
agreements, strategic partnerships and manufacturing outsourcing were
12.2m pounds ($19.7m) (2001: 1.8m pounds ($2.9m)).
In accordance with the Group`s revenue recognition policy, of the
6.9m pounds ($11.1m) received from QLT Inc. in 2001 as part of the tariquidar
licensing agreement, 2.5m pounds ($4.0m) was recognised in the year, with a
further 3.9m pounds ($6.2m) being deferred to future periods. All of the
7.9m pounds ($12.7m) received from Millennium in 2001 has been recognised by
the Group in the year to 31 December 2002, matching the commitments under this
agreement. Following the successful completion of a further licensing deal in
the year in respect of the OX40 programme with Genentech, 0.9m pounds ($1.5m)
of the upfront licence fee of 2.7m pounds ($4.4m) has been recognised this
year. Other revenue included 0.9m pounds ($1.5m) in respect of ongoing
contract vaccine manufacturing.
Total research and development (R&D) expenditure of 17.7m pounds ($28.4m)
(2001: 15.4m pounds, $24.7m) includes substantial preclinical and clinical
development of the programme of novel DNA targeting agents, one of which
(XR11576) entered Phase I clinical trials in February 2002. This programme
was licensed to Millennium Pharmaceuticals Inc in December 2001 and cost
reimbursement under this agreement commences in 2003. Additionally, Phase I
clinical development of the anti-nicotine vaccine, TA-NIC, was completed
during 2002 as was initial Phase II clinical development of the P-gp
inhibitor, tariquidar. Tariquidar, which is the subject of a North American
licensing agreement with QLT Inc. also entered Phase III clinical development
during the course of 2002.
Total administrative expenses of 9.3m pounds ($15.0m) (2001: 4.9m pounds
($7.8m)) have increased by 4.4m pounds ($7.2m) from the prior year primarily
due to the exceptional reorganisation costs of 3.8m pounds ($6.2m).
Amortisation costs of 1.2m pounds ($1.9m) (2001: 0.9m pounds ($1.5m)) relate
to the amortisation of goodwill arising on the acquisition of the Cantab
business in 2001 of 11.7m pounds ($18.8m). The goodwill is being amortised
over the 10 year estimated useful life of the business.
Total net operating expenses for the second half of the year increased to
15.5m pounds ($25.0m) from 11.0m pounds ($17.7m) in the first half of the year
principally as a result of the increased research and development activity
totalling 0.8m pounds ($1.3m) and the additional exceptional reorganisation
costs of 3.8m pounds ($6.2m).
The reduced net interest income reflects the lower average cash and liquid
resources balance held throughout the year. Following the fall, since 31
December 2001, in the listed market price of the 88,668 Cubist Pharmaceuticals
Inc shares held by the Group, 1.7m pounds ($2.8m) has been written off to the
profit and loss account.
Exceptional charge -- Reorganisation
On 11 December 2002, the Group announced the completion of an operational
review. Following this review, approximately 40 staff have been made redundant
resulting in an exceptional reorganisation charge of 0.5m pounds ($0.9m).
Additionally, excess property at the Cambridge facility is expected to be
sublet during the course of 2003. An impairment charge of 3.3m pounds ($5.3m)
has been provided against leasehold improvements, plant and equipment at the
Cambridge facility for those assets no longer expected to be used in the
business.
Rights issue
On 11 September 2002, the Group announced a fully underwritten 8 for
33 rights issue to raise 9.8m pounds ($15.8m) net of expenses. The rights
issue of approximately 33.7 million New Ordinary Shares was made at a price of
32.5 pence per New Ordinary Share. The total number of shares in issue
following the rights issue was approximately 172.8 million.
Cash, short-term deposits and investments
Cash, short-term deposits and investments at 31 December 2002 total
19.2m pounds ($30.9m) (2001: 24.0m pounds ($38.6m)). The Group had cash of
2.6m pounds ($4.2m) and liquid resources of 16.6m pounds ($26.7m) at
31 December 2002 (2001: cash 9.0m pounds ($14.5m), liquid resources
15.0m pounds ($24.1m)).
Included in liquid resources is an investment in Cubist Pharmaceuticals
Inc., which subsequent to the year end fell in value such that at 17 January
2003 the share price was $6.70 valuing the investment held at 0.4m pounds
($0.6m), representing a decline from the valuation at 31 December 2002 of
0.1m pounds ($0.1m).
Share capital
The number of shares in issue rose to 172.8 million as at 31 December 2002
from 139.0 million at 31 December 2001, due principally to the rights issue of
33.7 million shares.
The Directors do not propose a dividend for 2002 (2001: nil).
Subsequent Events
On 15 January 2003, the Group announced that it had reached agreement with
ImmuLogic Pharmaceutical Corporation Liquidating Trust ("ImmuLogic") under
which Xenova has bought out the remaining ImmuLogic rights to future milestone
and royalty payments relating to two of Xenova`s development stage vaccine
programmes, TA-CD and TA-NIC, for 0.6m pounds ($1.0m).
In order to fund the buyout of ImmuLogic`s interests, Xenova has raised
0.7m pounds ($1.1m), before expenses, through the placing for cash of
1,766,235 new ordinary shares of 10 pence each. The new shares, which
represent approximately 1.02 per cent of the Company`s issued share capital
prior to the placing, were placed by Nomura International plc at a price of
38.5 pence per share. Following this transaction, the total number of shares
in issue was 174.5 million.
Consolidated Profit and Loss Account (unaudited)
Unaudited Unaudited Unaudited Audited
Year Year Six months Year
Ended Ended Ended Ended
31 December 31 December 31 December 31 December
2002 2002 2002 2001
Notes $000 000 000 000
pounds pounds pounds
Turnover (including
share of joint
venture) 20,442 12,701 5,787 1,877
Less: share of joint
venture revenue (735) (457) (306) (95)
Turnover 19,707 12,244 5,481 1,782
Operating expenses
Research and
development costs (28,419) (17,657) (9,233) (15,374)
Administrative
expenses (6,983) (4,339) (2,084) (2,961)
Administrative
expenses:
exceptional
reorganisation costs 2 (6,150) (3,821) (3,821) (1,035)
Administrative
expenses:
amortisation of
goodwill (1,880) (1,168) (584) (879)
Total administrative
expenses (15,013) (9,328) (6,489) (4,875)
Other operating income 745 463 190 115
Total net operating
expenses (42,687) (26,522) (15,532) (20,134)
Group Operating loss (22,980) (14,278) (10,051) (18,352)
Share of operating
profit/(loss) of
joint venture 272 169 136 (33)
Total operating loss:
Group and share of
joint venture (22,708) (14,109) (9,915) (18,385)
Interest (net) 1,007 626 289 754
Amounts written (off)/
back to investments 3 (2,784) (1,730) (93) 463
Loss on ordinary
activities before
taxation (24,485) (15,213) (9,719) (17,168)
Tax on loss on
ordinary activities 4 3,236 2,011 1,140 1,797
Loss on ordinary
activities after
taxation attributable
to members of Xenova
Group plc (21,249) (13,202) (8,579) (15,371)
Loss per share
(basic and diluted) (14.4c) (9.0p) (5.5p) (12.6p)
Shares used in
computing net loss
per share (thousands) 147,484 147,484 155,912 121,596
US Dollar amounts have been translated at the closing rate on
31 December 2002 (1.00 pound: $1.6095) solely for information.
Statement of Total Recognised Gains and Losses (unaudited)
Unaudited Unaudited Unaudited Audited
Year Year Six Months Year
Ended Ended Ended Ended
31 December 31 December 31 December 31 December
2002 2002 2002 2001
$000 000 000 000
pounds pounds pounds
Loss attributable to
Xenova Group plc (21,505) (13,361) (8,700) (15,341)
Profit/(loss)
attributable to
joint venture 256 159 121 (30)
Total loss attributable
to members of Xenova
Group plc (21,249) (13,202) (8,579) (15,371)
Translation difference (2) (1) -- --
Total recognised gains
and losses in the period
attributable to members
of Xenova Group plc (21,251) (13,203) (8,579) (15,371)
US Dollar amounts have been translated at the closing rate on
31 December 2002 (1.00 pound: $1.6095) solely for information.
Consolidated Balance Sheet (unaudited)
Unaudited Unaudited Unaudited Audited
As at As at As at As at
31 December 31 December 30 June 31 December
2002 2002 2002 2001
Notes $000 000 000 000
pounds pounds pounds
Fixed Assets
Intangible assets 15,500 9,630 10,214 10,798
Tangible assets 2 8,839 5,492 9,053 9,586
Investment in
joint venture:
Share of gross
assets 312 194 418 438
Share of gross
liabilities (108) (67) (440) (500)
Goodwill arising
on acquisition -- -- 28 30
204 127 6 (32)
24,543 15,249 19,273 20,352
Current Assets
Debtors 5,092 3,164 4,506 4,135
Short-term deposits
and investments 8 26,694 16,585 12,650 15,027
Cash at bank
and in hand 8 4,236 2,632 2,419 8,973
36,022 22,381 19,575 28,135
Creditors: amounts
falling due within
one year 7 (17,878) (11,108) (13,386) (18,420)
Net current assets 18,144 11,273 6,189 9,715
Total assets less
current liabilities 42,687 26,522 25,462 30,067
Creditors: amounts
falling due after
more than one year -- -- (212) (221)
Provisions for
liabilities and
charges (19) (12) (13) (10)
Total net assets 42,668 26,510 25,237 29,836
Capital and reserves
Called up share
capital 27,807 17,277 13,906 13,904
Share premium account 129,304 80,338 73,872 73,870
Merger reserve 43,807 27,218 27,218 27,218
Other reserves 28,813 17,902 17,902 17,902
Profit and loss
account (187,063) (116,225) (107,661) (103,058)
Shareholders` funds
- equity interests 5 42,668 26,510 25,237 29,836
US Dollar amounts have been translated at the closing rate on
31 December 2002 (1.00 pound: $1.6095) solely for information.
Consolidated Cash Flow Statement (unaudited)
Unaudited Unaudited Unaudited Audited
Year Year Six months Year
Ended Ended Ended Ended
31 December 31 December 31 December 31 December
2002 2002 2002 2001
Notes $000 000 000 000
pounds pounds pounds
Net cash outflow
from operating
activities 6 (24,369) (15,141) (7,738) (3,836)
Returns on
investments and
servicing of finance
Interest received 996 619 280 1,023
Interest element of
finance lease rental
payments (6) (4) (2) (15)
Net cash inflow from
returns on investments
and servicing of
finance 990 615 278 1,008
Taxation 4 3,689 2,292 2,292 1,870
Capital expenditure
and financial
Investment
Purchase of tangible
fixed assets (1,045) (649) (419) (2,797)
Net cash outflow from
capital expenditure
and financial
investment (1,045) (649) (419) (2,797)
Acquisitions and
disposals
Purchase of subsidiary
undertakings -- -- -- (768)
Cash at bank and in
hand acquired with
subsidiary -- -- -- 16,822
Net cash inflow from
acquisitions -- -- -- 16,054
Management of
Liquid Resources
Increase in
short-term deposits 8 (5,292) (3,288) (4,028) (2,644)
Net cash (outflow)/
inflow before
financing (26,027) (16,171) (9,615) 9,655
Financing
Issue of ordinary
share capital 17,637 10,958 10,954 9
Expenses on issue
of shares (1,798) (1,117) (1,117) (919)
Capital element of
finance lease rental
payments (18) (11) (9) (87)
Net cash inflow/
(outflow) from
financing 15,821 9,830 9,828 (997)
(Decrease)/increase
in cash during
the period (10,206) (6,341) 213 8,658
US Dollar amounts have been translated at the closing rate on
31 December 2002 (1.00 pound: $1.6095) solely for information.
Reconciliation of Net Cash Flow to Movement in Net Funds (unaudited)
Unaudited Unaudited Unaudited Audited
Year Year Six Months Year
Ended Ended Ended Ended
31 December 31 December 31 December 31 December
2002 2002 2002 2001
$000 000 000 000
pounds pounds pounds
(Decrease)/increase in
cash during the period (10,206) (6,341) 213 8,658
Capital element of
finance lease payments 18 11 9 87
Cash outflow from
increase in liquid
resources 5,292 3,288 4,028 2,644
Change in net funds
resulting from cash flows (4,896) (3,042) 4,250 11,389
Finance leases acquired
with subsidiary operations -- -- -- (101)
Movement in value
of liquid investments (2,784) (1,730) (93) 463
Translation difference -- -- -- 2
Change in net funds (7,680) (4,772) 4,157 11,753
Net funds at 1 January /
1 July 38,605 23,986 15,057 12,233
Net funds at 31 December 30,925 19,214 19,214 23,986
US Dollar amounts have been translated at the closing rate on
31 December 2002 (1.00 pound: $1.6095) solely for information.
Notes to the Preliminary Announcement
1 Basis of preparation
These unaudited statements, which do not constitute statutory accounts
within the meaning of Section 240 of the Companies Act 1985, have been
prepared using the accounting policies set out in the Group`s 2001 Annual
Report and Accounts except as set out below. The 2001 Annual Report and
Accounts received an unqualified auditor`s report and have been delivered to
the Registrar of Companies.
Following the issue of Financial Reporting Standard Number 19 -- `Deferred
tax` the group has adopted the incremental liability approach (`Full`
provision basis) from 1 January 2002. The Group`s policy now states, `Deferred
tax is recognised in respect of timing differences that have originated but
not reversed by the balance sheet date, but only when transactions or events
that result in a right to pay less tax or an obligation to pay more tax in the
future have occurred at the balance sheet date. The likelihood of these rights
or obligations arising is based upon the estimated probabilities of future
events occurring, taking into account the relevant factors pertinent to the
industry sector in which the Group operates. Deferred tax is measured on a
non-discounted basis`. The deferred tax recognised in 2001 under the former
policy (nil) would not have been different under the revised policy adopted
from 2002.
There have been no other changes to the Group`s accounting policies in
2002.
2 Reorganisation
On 11 December 2002, the Group announced the completion of an operational
review. Following this review, approximately 40 staff have been made redundant
resulting in an exceptional reorganisation charge of 0.5m pounds ($0.9m).
Additionally, excess property at the Cambridge facility is expected to be
sublet during the course of 2003. An impairment charge of 3.3m pounds ($5.3m)
has been provided against leasehold improvements, plant and equipment at the
Cambridge facility for those assets no longer expected to be used in the
business.
3 Amounts written off investments
The 1.7m pounds written off investments reflects the write down on the
Group`s holding of 88,668 Cubist Pharmaceuticals Inc. shares following a fall
in the listed market price since 31 December 2001 (Note 10).
4 Taxation
Following the changes introduced as part of the Finance Act 2000 in
respect of Scientific Research Allowances (now renamed `Research and
Development Allowances`), the Group has recognised an R&D tax credit of 2.0m
pounds in respect of the year that will be received in 2003 (2001: 1.8m
pounds).
5 Reconciliation of movements in shareholders` funds
Unaudited Unaudited Audited
Year Six Months Year
Ended Ended Ended
31 December 31 December 31 December
2002 2002 2001
000 000 000
pounds pounds pounds
At start of period 29,836 25,237 11,876
Shares issued in the period 10,958 10,954 9
Issue of shares in
respect of acquisition -- -- 34,197
Expenses on issue of shares (1,117) (1,117) (919)
Shares to be issued under
long-term incentive
scheme 36 15 44
Retained loss for the period (13,202) (8,579) (15,371)
Exchange movement (1) -- --
At end of period 26,510 26,510 29,836
6 Reconciliation of operating loss to net cash outflow from operating
activities
Unaudited Unaudited Audited
Year Six Months Year
Ended Ended Ended
31 December 31 December 31 December
2002 2002 2001
Notes 000 000 000
pounds pounds pounds
Group operating loss (14,278) (10,051) (18,352)
Depreciation 1,478 715 1,201
Amortisation 1,168 584 879
Exceptional impairment
of fixed assets 2 3,265 3,265 --
Provision for liabilities
and charges 2 (1) (10)
Loss on disposal
of tangible fixed assets -- -- 16
Decrease in debtors 711 211 734
Increase/(decrease) in
creditors (excluding
deferred income) 975 2,451 (2,573)
(Decrease)/Increase in
deferred income (8,498) (4,927) 14,225
Charge for long term
incentive scheme 36 15 44
Net cash outflow from
operating activities (15,141) (7,738) (3,836)
Cash outflow in respect of exceptional reorganisation costs was nil pounds
(2001: 1,035,000 pounds).
7 Deferred income
Included within creditors is 5.7m pounds (2001: 14.2m pounds) in respect
of deferred revenue.
8 Cash and short-term deposits and investments
Cash and short-term deposits have been reclassified for the year ended 31
December 2001. Short-term deposits of 16.1m pounds ($25.9m) (2001:
12.8m pounds ($20.6m)) are now included in short-term deposits and investments
in the balance sheet, and as liquid resources in the cash flow statement. The
remaining balance in short-term deposits and investments relates to the
investment in Cubist Pharmaceuticals Inc. of 0.5m pounds ($0.7m) (2001:
2.2m pounds ($3.5m).
9 Going concern
The Group is an emerging pharmaceutical business and as such expects to
absorb cash until products are commercialised. The Directors have a reasonable
expectation that the Group has, or can reasonably expect to obtain, adequate
cash resources to enable it to continue in operational existence for the
foreseeable future, and have therefore prepared the financial statements on
the going concern basis.
10 Subsequent events
Included in liquid resources is an investment in Cubist Pharmaceuticals
Inc., which subsequent to the year end fell in value such that at 17 January
2003 the share price was $6.70 valuing the investment held at 0.4m pounds
($0.6m), representing a decline from the valuation at 31 December 2002 of
0.1m pounds ($0.1m).
On 15 January 2003, the Group announced that it had reached agreement with
ImmuLogic Pharmaceutical Corporation Liquidating Trust ("ImmuLogic") under
which Xenova has bought out the remaining ImmuLogic rights to future milestone
and royalty payments relating to two of Xenova`s development stage vaccine
programmes, TA-CD and TA-NIC, for 0.6m pounds (US$1.0m).
In order to fund the buyout of ImmuLogic`s interests, Xenova has raised
0.7m pounds before expenses through the placing for cash of 1,766,235 new
ordinary shares of 10 pence each. The new shares, which represent
approximately 1.02 per cent of the Company`s issued share capital prior to the
placing, were placed by Nomura International plc at a price of 38.5 pence per
share.
SOURCE Xenova Group plc
-0- 02/24/2003
/CONTACT: US - David A Oxlade, Chief Executive Officer, Daniel Abrams,
Group Finance Director, or Hilary Reid Evans, Corporate Communications, all of
Xenova Group plc, +44-1753-706600; or UK - Press - Brad Miles, ext. 17, or
Lauren Tortorete, ext. 20, or Investors - Jonathan Fassberg, ext. 16, or Lee
Stern, ext. 22, all of Trout Group-BMC Communications, +1-212-477-9007; or
David Yates or Ben Atwell, both of Financial Dynamics, +44-207-831-3113, for
Xenova Group plc /
/Web site: http://www.xenova.co.uk /
Thursday May 8, 09:43 AM
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Xenova drops on cancer drug, cash worries
LONDON, May 8 (Reuters) - Shares in Xenova Group Plc (LSE: XEN.L - news) fell 10 percent on Thursday as the British biotech firm failed to give a hoped-for update on its lead drug candidate and highlighted a tight cash position in its first-quarter results.
Xenova suffered a setback in February when patient enrolment into final stage clinical trials of experimental cancer drug tariquidar was temporarily suspended due to safety concerns, pending a report by an independent panel in May or June.
Some investors had hoped for news alongside the quarterly results but Chief Executive David Oxlade said Xenova was still awaiting the report from the Data Safety Monitoring Committee.
Xenova unveiled a quarterly loss of 3.29 million pounds against 3.25 million a year earlier, leaving it with cash reserves of 12.9 million pounds.
The company said it had "a reasonable degree of confidence" it could secure adequate funding to continue as a going concern but added it would cut costs if funds were not available in order to conserve cash resources.
"They are definitively starting to run relatively short of cash," said Sally Bennett, biotech analyst at ING.
The stock, which had run up ahead of the results, was two pence lower at 17p by 0825 GMT from a 52-week high of 62-3/4p.
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Xenova drops on cancer drug, cash worries
LONDON, May 8 (Reuters) - Shares in Xenova Group Plc (LSE: XEN.L - news) fell 10 percent on Thursday as the British biotech firm failed to give a hoped-for update on its lead drug candidate and highlighted a tight cash position in its first-quarter results.
Xenova suffered a setback in February when patient enrolment into final stage clinical trials of experimental cancer drug tariquidar was temporarily suspended due to safety concerns, pending a report by an independent panel in May or June.
Some investors had hoped for news alongside the quarterly results but Chief Executive David Oxlade said Xenova was still awaiting the report from the Data Safety Monitoring Committee.
Xenova unveiled a quarterly loss of 3.29 million pounds against 3.25 million a year earlier, leaving it with cash reserves of 12.9 million pounds.
The company said it had "a reasonable degree of confidence" it could secure adequate funding to continue as a going concern but added it would cut costs if funds were not available in order to conserve cash resources.
"They are definitively starting to run relatively short of cash," said Sally Bennett, biotech analyst at ING.
The stock, which had run up ahead of the results, was two pence lower at 17p by 0825 GMT from a 52-week high of 62-3/4p.
LONDON (ShareCast) - Xenova Group (LSE: XEN.L - news) shares tumbled in early trading as the group said it was still awaiting the outcome of the safety investigation into its lung cancer treatment, Tariquidar.
New patient enrolment to Phase III trials of the treatment were suspended in February following a number of safety concerns, and the group said it expects to receive the findings by mid-year.
The group added that following on from the announcement of "clear clinical responses" to its two therapeutic vaccines for cancer and skin warts last month, initial stages of the trials are encouraging and warrant further development.
Xenova delivered a slight narrowing of pre-tax losses to £3.44m for the three months to March 2003 against £3.69m a year earlier. Turnover fell to £2.12m compared to £2.76m last time.
The vaccine group also reported a fall in its cash reserves to £12.9m at the end of the quarter compared to £17.0m a year earlier. The group`s total assets fell to £31.7m from £41.3m last time.
The group said it would not pay a dividend this year.
New patient enrolment to Phase III trials of the treatment were suspended in February following a number of safety concerns, and the group said it expects to receive the findings by mid-year.
The group added that following on from the announcement of "clear clinical responses" to its two therapeutic vaccines for cancer and skin warts last month, initial stages of the trials are encouraging and warrant further development.
Xenova delivered a slight narrowing of pre-tax losses to £3.44m for the three months to March 2003 against £3.69m a year earlier. Turnover fell to £2.12m compared to £2.76m last time.
The vaccine group also reported a fall in its cash reserves to £12.9m at the end of the quarter compared to £17.0m a year earlier. The group`s total assets fell to £31.7m from £41.3m last time.
The group said it would not pay a dividend this year.
Xenova shareholders get jitters
By David Firn FT.com, 19:20 BST May 8, 2003
Shares in Xenova fell more than 18 per cent at one point on Thursday as investors got the jitters over the biotechnology group`s dwindling cash position and continued delays to its lead product.
Recruitment of patients for key trials of Tariquidar, a lung cancer treatment, has been suspended since February when US drug regulators became concerned over the level of side effects.
David Oxlade, chief executive, said there was no evidence that the level of side effects was any higher than other cancer treatments and could have been caused by other drugs being used to treat patients in the clinical trials.
However, there would be no news on the drug`s future before mid-year when the safety date would be reviewed by experts, making a launch before 2005 extremely unlikely.
Sam Fazeli, analyst at Nomura, said the shares had risen of late because investors had been speculating that there would be good news on Tariquidar.
After digesting Thursday`s statement the shares fell as low as 15-1/2p before recovering slightly to close down 12 per cent, or 2-1/4p, at 16-3/4p.
Mr Oxlade said the group had cash and liquid assets of £12.9m ($20.6m) - enough for about a year`s trading - but would make no decision on fundraising until the future of Tariquidar was clear.
"People speculate," he said. "You can`t do anything about that. The reality is most investors would like to see what the situation is before they make a long-term decision."
Julie Simmonds, analyst at Evolution Beeson Gregory, said there were no surprises in the results statement but investors were worried that Xenova`s ability to refinance or negotiate f avourable terms in a merger both depended on Tariquidar.
"In this market, if this doesn`t work, no one is going to rescue them," she said.
Pre-tax losses were down from £3.7m to £3.44m for the three months to March 31. A cut in operating costs offset a sharp rise in R&D costs and a 24 per cent fall in revenues, which were down from £2.79m to £2.12m. Losses per share were 1.9p against 2.3p.
By David Firn FT.com, 19:20 BST May 8, 2003
Shares in Xenova fell more than 18 per cent at one point on Thursday as investors got the jitters over the biotechnology group`s dwindling cash position and continued delays to its lead product.
Recruitment of patients for key trials of Tariquidar, a lung cancer treatment, has been suspended since February when US drug regulators became concerned over the level of side effects.
David Oxlade, chief executive, said there was no evidence that the level of side effects was any higher than other cancer treatments and could have been caused by other drugs being used to treat patients in the clinical trials.
However, there would be no news on the drug`s future before mid-year when the safety date would be reviewed by experts, making a launch before 2005 extremely unlikely.
Sam Fazeli, analyst at Nomura, said the shares had risen of late because investors had been speculating that there would be good news on Tariquidar.
After digesting Thursday`s statement the shares fell as low as 15-1/2p before recovering slightly to close down 12 per cent, or 2-1/4p, at 16-3/4p.
Mr Oxlade said the group had cash and liquid assets of £12.9m ($20.6m) - enough for about a year`s trading - but would make no decision on fundraising until the future of Tariquidar was clear.
"People speculate," he said. "You can`t do anything about that. The reality is most investors would like to see what the situation is before they make a long-term decision."
Julie Simmonds, analyst at Evolution Beeson Gregory, said there were no surprises in the results statement but investors were worried that Xenova`s ability to refinance or negotiate f avourable terms in a merger both depended on Tariquidar.
"In this market, if this doesn`t work, no one is going to rescue them," she said.
Pre-tax losses were down from £3.7m to £3.44m for the three months to March 31. A cut in operating costs offset a sharp rise in R&D costs and a 24 per cent fall in revenues, which were down from £2.79m to £2.12m. Losses per share were 1.9p against 2.3p.
FOR IMMEDIATE RELEASE
Xenova Group plc
XENOVA AND QLT DISCONTINUE TARIQUIDAR PHASE III NSCLC TRIALS
Xenova and QLT will continue to explore the potential of tariquidar and
carefully review the data in order to plan future development
Slough, UK, 13 May, 2003 - Xenova Group plc (NASDAQ NM: XNVA; London Stock
Exchange: XEN) today announces that QLT Inc, (NASDAQ: QLTI; TSX: QLT) will stop
the current Phase III trials of tariquidar as an adjunctive treatment for
patients with non-small-cell-lung cancer (NSCLC). This decision follows a
recommendation by the Independent Data Safety Monitoring Committee (DSMC), which
completed the un-blinded interim review of the data for the two ongoing trials
in this indication. The Phase IIb trial for tariquidar in chemorefractory breast
cancer underway at MD Anderson, Texas is unaffected by this decision and this
trial continues.
Members of QLT`s clinical development team will now be un-blinded so that they
have an opportunity to review all of the data and make informed decisions about
plans for the future development of tariquidar. Data from the 304 patients
already enrolled in this study represent the largest collection of efficacy and
safety data from a randomized, placebo-controlled study of a third generation
P-gp inhibitor and will offer valuable insight into the potential for tariquidar
in this or other indications. It is QLT`s intention to exploit the value of this
database and make planning decisions for tariquidar after a thorough analysis of
such data.
David Oxlade, Chief Executive Officer of Xenova, said:
`Xenova continues to believe that tariquidar has potential as an MDR modulator
in cancer. We will explore further development opportunities once the un-blinded
data from these NSCLC studies have been assessed. The Phase IIb trial at MD
Anderson, in chemorefractory breast cancer continues.`
`Xenova has decided to take immediate steps to substantially reduce operating
costs. This will include a reduction in headcount as well as further programme
prioritisation. Going forward, Xenova will focus on its key clinical development
programmes.`
Conference Call Information
Xenova will hold a conference call on Tuesday, 13 May at 08:30 a.m. BST. For
details contact Claire Rowell at Financial Dynamics, telephone +44 (0) 20 7269
7285.
Xenova Group plc
XENOVA AND QLT DISCONTINUE TARIQUIDAR PHASE III NSCLC TRIALS
Xenova and QLT will continue to explore the potential of tariquidar and
carefully review the data in order to plan future development
Slough, UK, 13 May, 2003 - Xenova Group plc (NASDAQ NM: XNVA; London Stock
Exchange: XEN) today announces that QLT Inc, (NASDAQ: QLTI; TSX: QLT) will stop
the current Phase III trials of tariquidar as an adjunctive treatment for
patients with non-small-cell-lung cancer (NSCLC). This decision follows a
recommendation by the Independent Data Safety Monitoring Committee (DSMC), which
completed the un-blinded interim review of the data for the two ongoing trials
in this indication. The Phase IIb trial for tariquidar in chemorefractory breast
cancer underway at MD Anderson, Texas is unaffected by this decision and this
trial continues.
Members of QLT`s clinical development team will now be un-blinded so that they
have an opportunity to review all of the data and make informed decisions about
plans for the future development of tariquidar. Data from the 304 patients
already enrolled in this study represent the largest collection of efficacy and
safety data from a randomized, placebo-controlled study of a third generation
P-gp inhibitor and will offer valuable insight into the potential for tariquidar
in this or other indications. It is QLT`s intention to exploit the value of this
database and make planning decisions for tariquidar after a thorough analysis of
such data.
David Oxlade, Chief Executive Officer of Xenova, said:
`Xenova continues to believe that tariquidar has potential as an MDR modulator
in cancer. We will explore further development opportunities once the un-blinded
data from these NSCLC studies have been assessed. The Phase IIb trial at MD
Anderson, in chemorefractory breast cancer continues.`
`Xenova has decided to take immediate steps to substantially reduce operating
costs. This will include a reduction in headcount as well as further programme
prioritisation. Going forward, Xenova will focus on its key clinical development
programmes.`
Conference Call Information
Xenova will hold a conference call on Tuesday, 13 May at 08:30 a.m. BST. For
details contact Claire Rowell at Financial Dynamics, telephone +44 (0) 20 7269
7285.
Xenova loses half its value as trial dropped
Shares in Xenova tumbled more than 50 per cent on Tuesday after the UK cancer company halted the final round of clinical trials of Tariquidar, its experimental lung cancer treatment.
The company, which has only enough cash to survive for another year, said it would "significantly" cut jobs and re-prioritise its R&D activities to rein in spending.
The group`s shares, which have lost 84 per cent of their value over the past year, fell a further 52 per cent to 9-1/2p in morning trade in London.
Recruitment of patients for key trials of Tariquidar had been suspended since February when US drug regulators became concerned over the level of side effects.
As recently as last week David Oxlade, chief executive, said there was no evidence that the level of side effects was any higher than other cancer treatments and could have been caused by other drugs also being used to treat patients in the clinical trials.
On Tuesday he was forced to concede the company was abandoning the key lung cancer trial after the regulators said their concerns were well founded. But he said the drug may still have a future.
"We need to assess the data and decide how to take it forward," Mr Oxlade said. "This is not a question of the drug being dead but a question of the design of the study needing to be looked at."
Investors have told Mr Oxlade in no uncertain terms they are not willing to stump up more cash for the loss-making drug development company until the future of Tariquidar - which as recently as January accounted for about half the company`s valuation - was clear.
Analysts said the ending of the lung cancer trial would make it difficult for Xenova to refinance itself. "In the current climate investors are not supportive of early stage research," said Mr Oxlade. "We are now implementing a contingency plan to mount cost reductions that would create a company that would be supported by investors."
Xenova said only the lung cancer trials were affected by the regulator`s decision and evaluation of the drug against breast cancer - which is at an earlier stage than the lung cancer project - would continue.
"Xenova continues to believe that Tariquidar has potential as an MDR [multi-drug resistance] modulator in cancer," Mr Oxlade said. "We will explore further development opportunities once the un-blinded data from these NSCLC [non-small cell lung cancer] studies have been assessed."
Lung cancer would have been the biggest market for Tariquidar, which is intended to stop cancer cells becoming resistant to chemotherapy.
Shares in Xenova tumbled more than 50 per cent on Tuesday after the UK cancer company halted the final round of clinical trials of Tariquidar, its experimental lung cancer treatment.
The company, which has only enough cash to survive for another year, said it would "significantly" cut jobs and re-prioritise its R&D activities to rein in spending.
The group`s shares, which have lost 84 per cent of their value over the past year, fell a further 52 per cent to 9-1/2p in morning trade in London.
Recruitment of patients for key trials of Tariquidar had been suspended since February when US drug regulators became concerned over the level of side effects.
As recently as last week David Oxlade, chief executive, said there was no evidence that the level of side effects was any higher than other cancer treatments and could have been caused by other drugs also being used to treat patients in the clinical trials.
On Tuesday he was forced to concede the company was abandoning the key lung cancer trial after the regulators said their concerns were well founded. But he said the drug may still have a future.
"We need to assess the data and decide how to take it forward," Mr Oxlade said. "This is not a question of the drug being dead but a question of the design of the study needing to be looked at."
Investors have told Mr Oxlade in no uncertain terms they are not willing to stump up more cash for the loss-making drug development company until the future of Tariquidar - which as recently as January accounted for about half the company`s valuation - was clear.
Analysts said the ending of the lung cancer trial would make it difficult for Xenova to refinance itself. "In the current climate investors are not supportive of early stage research," said Mr Oxlade. "We are now implementing a contingency plan to mount cost reductions that would create a company that would be supported by investors."
Xenova said only the lung cancer trials were affected by the regulator`s decision and evaluation of the drug against breast cancer - which is at an earlier stage than the lung cancer project - would continue.
"Xenova continues to believe that Tariquidar has potential as an MDR [multi-drug resistance] modulator in cancer," Mr Oxlade said. "We will explore further development opportunities once the un-blinded data from these NSCLC [non-small cell lung cancer] studies have been assessed."
Lung cancer would have been the biggest market for Tariquidar, which is intended to stop cancer cells becoming resistant to chemotherapy.
Xenova Secures Further Manufacturing Contract With Pharmexa
5 Jun 2003, 02:00am ET
SLOUGH, England, June 5 /PRNewswire-FirstCall/ -- Xenova Group plc (Nasdaq: XNVA; London Stock Exchange: XEN) today announced the signing of a significant, two-year Manufacturing, Development and Clinical Supply Agreement with Pharmexa A/S (CSE: PHARMX) for the contract manufacture of clinical supplies of a vaccine targeting the human HER-2 protein. Manufacture will take place at Xenova`s Clinical Trial Manufacturing Facility in Cambridge.
The HER-2 protein is commonly found in association with several cancers, such as breast cancer. Pharmexa has developed the AutoVac(TM) Protein technology to raise a highly specific controllable antibody based immune response against this and other self-proteins. Pre-clinical studies indicate that AutoVac(TM) vaccination against the HER-2 protein may be an effective therapy against breast cancer.
Xenova has already supplied Pharmexa with clinical trial material under a previous agreement. Under this new agreement, additional supplies of the vaccine will be manufactured by Xenova for Pharmexa`s Phase II clinical trials scheduled to begin in 2004.
David Oxlade, CEO of Xenova commented, "We are excited to contribute to the development of a promising new product against breast cancer. This new contract for the manufacture of recombinant protein vaccine is a well-deserved endorsement of the expertise we have in this area and allows Xenova to maximise the efficient utilisation of our biological process development and manufacturing capabilities."
Jakob Schmidt, CFO of Pharmexa said of the agreement, "We recently received approval by the US health authorities to initiate a Phase I clinical trial in the United States of our HER-2 AutoVac(TM) protein vaccine in breast cancer, and are now preparing for a Phase II trial in 2004. We have worked with Xenova before and have been impressed by their expertise and commitment to this project."
Notes to Editors
About Pharmexa A/S
Pharmexa A/S (CSE: PHARMX) is a leading company in the field of active immunotherapy for the treatment of serious chronic diseases. Pharmexa`s proprietary AutoVac(TM) technology platform is broadly applicable, but the company has focused its resources on a number of cancer forms and chronic inflammatory diseases, with research and development programs targeted towards breast cancer, rheumatoid arthritis and bone degeneration. Collaborative agreements include Schering-Plough and H. Lundbeck.
About Xenova Group
Xenova Group plc`s product pipeline focuses principally on the therapeutic areas of cancer and immune system disorders. Xenova has a broad pipeline of programmes in clinical development. The Group has a well-established track record in the identification, development and partnering of innovative products and technologies and has partnerships with significant pharmaceutical and biopharmaceutical companies including Lilly, Pfizer, Celltech, Genentech, QLT and Millennium Pharmaceuticals.
For further information about Xenova and its products please visit the Xenova website at www.xenova.co.uk
For Xenova: Disclaimer to take advantage of the "Safe Harbor" provisions of the US Private Securities Litigation Reform Act of 1995. This press release contains "forward-looking statements," including statements about commercialization of products. Various risks may cause Xenova`s actual results to differ materially from those expressed or implied by the forward looking statements, including: our dependence upon strategic alliance partners to develop and commercialize products and services; and the difficulties inherent in scaling up the manufacture of biologic products. For a further list and description of the risks and uncertainties we face, see the reports we have filed with the Securities and Exchange Commission. We disclaim any intention or obligation to update or revise any forward-looking statements, whether as a result of new information, future events or otherwise.
SOURCE Xenova Group plc
-0- 06/05/2003
/CONTACT: UK: David A. Oxlade, Chief Executive Officer, Daniel Abrams, Group Finance Director, or Jon Davies, Corporate Communications, all of Xenova Group plc, +44-0-1753-706600; David Yates or Ben Atwell of Financial Dynamics,
+44-0-207-831-3113; US: Press - Brad Miles (Ext. 17), Daniel Budwick
(Ext. 14), or Investors - Jonathan Fassberg (Ext. 16), or Lee Stern (Ext. 22),
all of Trout Group-BMC Communications, +1-212-477-9007, all for Xenova Group
plc /
/Web site:
http://www.xenova.co.uk
5 Jun 2003, 02:00am ET
SLOUGH, England, June 5 /PRNewswire-FirstCall/ -- Xenova Group plc (Nasdaq: XNVA; London Stock Exchange: XEN) today announced the signing of a significant, two-year Manufacturing, Development and Clinical Supply Agreement with Pharmexa A/S (CSE: PHARMX) for the contract manufacture of clinical supplies of a vaccine targeting the human HER-2 protein. Manufacture will take place at Xenova`s Clinical Trial Manufacturing Facility in Cambridge.
The HER-2 protein is commonly found in association with several cancers, such as breast cancer. Pharmexa has developed the AutoVac(TM) Protein technology to raise a highly specific controllable antibody based immune response against this and other self-proteins. Pre-clinical studies indicate that AutoVac(TM) vaccination against the HER-2 protein may be an effective therapy against breast cancer.
Xenova has already supplied Pharmexa with clinical trial material under a previous agreement. Under this new agreement, additional supplies of the vaccine will be manufactured by Xenova for Pharmexa`s Phase II clinical trials scheduled to begin in 2004.
David Oxlade, CEO of Xenova commented, "We are excited to contribute to the development of a promising new product against breast cancer. This new contract for the manufacture of recombinant protein vaccine is a well-deserved endorsement of the expertise we have in this area and allows Xenova to maximise the efficient utilisation of our biological process development and manufacturing capabilities."
Jakob Schmidt, CFO of Pharmexa said of the agreement, "We recently received approval by the US health authorities to initiate a Phase I clinical trial in the United States of our HER-2 AutoVac(TM) protein vaccine in breast cancer, and are now preparing for a Phase II trial in 2004. We have worked with Xenova before and have been impressed by their expertise and commitment to this project."
Notes to Editors
About Pharmexa A/S
Pharmexa A/S (CSE: PHARMX) is a leading company in the field of active immunotherapy for the treatment of serious chronic diseases. Pharmexa`s proprietary AutoVac(TM) technology platform is broadly applicable, but the company has focused its resources on a number of cancer forms and chronic inflammatory diseases, with research and development programs targeted towards breast cancer, rheumatoid arthritis and bone degeneration. Collaborative agreements include Schering-Plough and H. Lundbeck.
About Xenova Group
Xenova Group plc`s product pipeline focuses principally on the therapeutic areas of cancer and immune system disorders. Xenova has a broad pipeline of programmes in clinical development. The Group has a well-established track record in the identification, development and partnering of innovative products and technologies and has partnerships with significant pharmaceutical and biopharmaceutical companies including Lilly, Pfizer, Celltech, Genentech, QLT and Millennium Pharmaceuticals.
For further information about Xenova and its products please visit the Xenova website at www.xenova.co.uk
For Xenova: Disclaimer to take advantage of the "Safe Harbor" provisions of the US Private Securities Litigation Reform Act of 1995. This press release contains "forward-looking statements," including statements about commercialization of products. Various risks may cause Xenova`s actual results to differ materially from those expressed or implied by the forward looking statements, including: our dependence upon strategic alliance partners to develop and commercialize products and services; and the difficulties inherent in scaling up the manufacture of biologic products. For a further list and description of the risks and uncertainties we face, see the reports we have filed with the Securities and Exchange Commission. We disclaim any intention or obligation to update or revise any forward-looking statements, whether as a result of new information, future events or otherwise.
SOURCE Xenova Group plc
-0- 06/05/2003
/CONTACT: UK: David A. Oxlade, Chief Executive Officer, Daniel Abrams, Group Finance Director, or Jon Davies, Corporate Communications, all of Xenova Group plc, +44-0-1753-706600; David Yates or Ben Atwell of Financial Dynamics,
+44-0-207-831-3113; US: Press - Brad Miles (Ext. 17), Daniel Budwick
(Ext. 14), or Investors - Jonathan Fassberg (Ext. 16), or Lee Stern (Ext. 22),
all of Trout Group-BMC Communications, +1-212-477-9007, all for Xenova Group
plc /
/Web site:
http://www.xenova.co.uk
ups - hat wohl mit dem Link nicht geklappt ... gleich noch ein Versuch
http://www.telegraph.co.uk/money/main.jhtml?xml=%2Fmoney%2F2…
http://www.telegraph.co.uk/money/main.jhtml?xml=%2Fmoney%2F2…
mal wieder was aus dem Hause Xenova
Xenova Initiates Second Clinical Trial for Anti-Smoking Vaccine
8 October 2003, 02:00am ET
SLOUGH, England, Oct. 8 /PRNewswire-FirstCall/ -- Xenova Group plc (Nasdaq: XNVA; London Stock Exchange: XEN) today announced that it has initiated a second clinical trial for TA-NIC, its therapeutic vaccine which is under development for the treatment of nicotine addiction.
This second Phase I study builds upon the findings of a previous Phase I trial which were announced in June 2002. The results of this first study, which was the first evaluation of an anti-nicotine vaccine in man, showed that the vaccine generated a specific anti-nicotine response and that it was safe and well tolerated both systemically and locally. The objective of the new Phase I trial is to further establish safety and tolerability, and to determine the vaccination dose and schedule required to induce the optimal anti-nicotine antibody response. Three different doses of the vaccine will be evaluated. The impact of vaccination on nicotine-induced changes in heart rate and skin temperature will also be monitored.
Approximately 60 smokers will be recruited into a double-blind, randomised, placebo-controlled study which will be run at a European clinical centre experienced in testing smoking related therapies. Results of this study will be used to design a Phase II trial that will assess the effect of vaccination with TA-NIC on tobacco consumption. This Phase II trial is expected to begin during the second half of 2004.
Commenting on this new trial David Oxlade, CEO of Xenova Group plc said, "TA-NIC offers the hope of substantial benefit to smokers wishing to quit their habit. With this new trial we will be directly assessing the impact of antibodies on the physiological effects of nicotine. It represents an important step forward in strengthening the concept of vaccination as a treatment for nicotine addiction."
Notes to Editors
Mentioned Last Change
XNVA 2.07 (Unchanged)
Xenova Group plc`s product pipeline focuses principally on the therapeutic areas of cancer and immune system disorders. Xenova has a broad pipeline of programmes in clinical development. The Group has a well-established track record in the identification, development and partnering of innovative products and technologies and has partnerships with significant pharmaceutical and biopharmaceutical companies including Lilly, Pfizer, Celltech, Genentech, QLT and Millennium Pharmaceuticals.
For further information about Xenova and its products please visit the Xenova website at www.xenova.co.uk
For Xenova: Disclaimer to take advantage of the "Safe Harbor" provisions of the US Private Securities Litigation Reform Act of 1995. This press release contains "forward-looking statements," including statements about the discovery, development and commercialization of products. Various risks may cause Xenova`s actual results to differ materially from those expressed or implied by the forward looking statements, including: adverse results in our drug discovery and clinical development programs; failure to obtain patent protection for our discoveries; commercial limitations imposed by patents owned or controlled by third parties; our dependence upon strategic alliance partners to develop and commercialize products and services; difficulties or delays in obtaining regulatory approvals to market products and services resulting from our development efforts; the requirement for substantial funding to conduct research and development and to expand commercialization activities; and product initiatives by competitors. For a further list and description of the risks and uncertainties we face, see the reports we have filed with the Securities and Exchange Commission. We disclaim any intention or obligation to update or revise any forward-looking statements, whether as a result of new information, future events or otherwise.
SOURCE Xenova Group plc
-0- 10/08/2003
/CONTACT: UK - David A Oxlade, Chief Executive Officer, Daniel Abrams,
Group Finance Director, or Jon Davies, Corporate Communications, all of Xenova
Group plc, +44-1753-706600; or David Yates or Ben Atwell, both of Financial
Dynamics for Xenova Group plc, +44-207-831-3113; or US - Press - Brad Miles,
+1-212-477-9007, Ext. 17, or Daniel Budwick, +1-212-477-9007, Ext. 14, or
Investors - Jonathan Fassberg, +1-212-477-9007, Ext. 16, or Lee Stern,
+1-212-477-9007, Ext. 22 all of Trout Group-BMC Communications, for Xenova
Group plc/
/Web site:
http://www.xenova.co.uk
Xenova Initiates Second Clinical Trial for Anti-Smoking Vaccine
8 October 2003, 02:00am ET
SLOUGH, England, Oct. 8 /PRNewswire-FirstCall/ -- Xenova Group plc (Nasdaq: XNVA; London Stock Exchange: XEN) today announced that it has initiated a second clinical trial for TA-NIC, its therapeutic vaccine which is under development for the treatment of nicotine addiction.
This second Phase I study builds upon the findings of a previous Phase I trial which were announced in June 2002. The results of this first study, which was the first evaluation of an anti-nicotine vaccine in man, showed that the vaccine generated a specific anti-nicotine response and that it was safe and well tolerated both systemically and locally. The objective of the new Phase I trial is to further establish safety and tolerability, and to determine the vaccination dose and schedule required to induce the optimal anti-nicotine antibody response. Three different doses of the vaccine will be evaluated. The impact of vaccination on nicotine-induced changes in heart rate and skin temperature will also be monitored.
Approximately 60 smokers will be recruited into a double-blind, randomised, placebo-controlled study which will be run at a European clinical centre experienced in testing smoking related therapies. Results of this study will be used to design a Phase II trial that will assess the effect of vaccination with TA-NIC on tobacco consumption. This Phase II trial is expected to begin during the second half of 2004.
Commenting on this new trial David Oxlade, CEO of Xenova Group plc said, "TA-NIC offers the hope of substantial benefit to smokers wishing to quit their habit. With this new trial we will be directly assessing the impact of antibodies on the physiological effects of nicotine. It represents an important step forward in strengthening the concept of vaccination as a treatment for nicotine addiction."
Notes to Editors
Mentioned Last Change
XNVA 2.07 (Unchanged)
Xenova Group plc`s product pipeline focuses principally on the therapeutic areas of cancer and immune system disorders. Xenova has a broad pipeline of programmes in clinical development. The Group has a well-established track record in the identification, development and partnering of innovative products and technologies and has partnerships with significant pharmaceutical and biopharmaceutical companies including Lilly, Pfizer, Celltech, Genentech, QLT and Millennium Pharmaceuticals.
For further information about Xenova and its products please visit the Xenova website at www.xenova.co.uk
For Xenova: Disclaimer to take advantage of the "Safe Harbor" provisions of the US Private Securities Litigation Reform Act of 1995. This press release contains "forward-looking statements," including statements about the discovery, development and commercialization of products. Various risks may cause Xenova`s actual results to differ materially from those expressed or implied by the forward looking statements, including: adverse results in our drug discovery and clinical development programs; failure to obtain patent protection for our discoveries; commercial limitations imposed by patents owned or controlled by third parties; our dependence upon strategic alliance partners to develop and commercialize products and services; difficulties or delays in obtaining regulatory approvals to market products and services resulting from our development efforts; the requirement for substantial funding to conduct research and development and to expand commercialization activities; and product initiatives by competitors. For a further list and description of the risks and uncertainties we face, see the reports we have filed with the Securities and Exchange Commission. We disclaim any intention or obligation to update or revise any forward-looking statements, whether as a result of new information, future events or otherwise.
SOURCE Xenova Group plc
-0- 10/08/2003
/CONTACT: UK - David A Oxlade, Chief Executive Officer, Daniel Abrams,
Group Finance Director, or Jon Davies, Corporate Communications, all of Xenova
Group plc, +44-1753-706600; or David Yates or Ben Atwell, both of Financial
Dynamics for Xenova Group plc, +44-207-831-3113; or US - Press - Brad Miles,
+1-212-477-9007, Ext. 17, or Daniel Budwick, +1-212-477-9007, Ext. 14, or
Investors - Jonathan Fassberg, +1-212-477-9007, Ext. 16, or Lee Stern,
+1-212-477-9007, Ext. 22 all of Trout Group-BMC Communications, for Xenova
Group plc/
/Web site:
http://www.xenova.co.uk
gerade die richtige Jahreszeit
Xenova Statement on Imperial College Research Into Novel Strategy for Treatment of Flu
21 October 2003, 07:00am ET
SLOUGH, England, Oct. 21 /PRNewswire-FirstCall/ -- Xenova Group plc (Nasdaq: XNVA; London Stock Exchange: XEN) notes that the following announcement was issued late yesterday by Imperial College with respect to a research collaboration involving the company`s OX40 technology and its potential for the treatment of influenza. OX40 is a platform technology capable of producing multiple drug candidates targeting cancer, autoimmune and other diseases where the immune system is involved.
David Oxlade, Chief Executive of Xenova, said, "We are very encouraged by these novel findings from the work conducted by Imperial College on our OX40 platform technology. The demonstration in pre-clinical studies that down-regulation of the immune response by blocking the OX40-OX40 ligand interaction alleviates the symptoms of influenza, without affecting the ability to clear the virus, is very exciting. This new research suggests that the down-regulation of OX40 signaling could play an important role in the fight against the symptoms of influenza and perhaps other diseases similarly characterised by excessive immune response."
Xenova`s rights to the OX40 technology include rights relating to the up-regulation of the immune system which may be used for the development of novel treatments for cancer and infectious disease. Xenova`s rights to down-regulate the immune system have been the subject of development and licence agreements entered into with Celltech and Genentech.
The full text of the Imperial announcement follows overleaf:
Notes to Editors
Xenova Group plc`s product pipeline focuses principally on the therapeutic areas of cancer and immune system disorders. Xenova has a broad pipeline of programmes in clinical development. The Group has a well-established track record in the identification, development and partnering of innovative products and technologies and has partnerships with significant pharmaceutical and biopharmaceutical companies including Lilly, Pfizer, Celltech, Genentech, QLT and Millennium Pharmaceuticals.
About OX40/OX40L
Inflammation is part of the body`s normal response to the presence of infection or other unwanted foreign material. In certain circumstances this process can cause damage to the body`s own tissues. In many cases this pathology is orchestrated by activated T cells. Consequently drugs that are capable of inhibiting the action of these activated T cells have potential as therapeutics for control of inflammatory disease.
OX40 is a receptor molecule found on the surface of activated T cells at the site of inflammation and offers an important potential target for development of a selective inhibitor of inflammation. Through collaboration and license agreements with Stanford University, and the Providence Medical Center, Portland, Xenova has intellectual property covering therapeutic use of the OX40 and OX40 Ligand proteins and their related antibodies.
Xenova has developed a modified form of the OX40 molecule which can be used to block the interaction between the OX40 receptor and its ligand and hence inhibit T cell activation. This product candidate has been shown effective in a preclinical model of autoimmune disease, and has moved into preclinical development.
Development of a monoclonal antibody against OX40 presents an alternative approach to target and destroy OX40-bearing activated T cells and hence treat autoimmune disease. This strategy is being pursued by Celltech Group under a license agreement with Xenova, which began in September 1999.
A development and license agreement worth up to $63m (43.2m pounds sterling) was signed in April 2002 with Genentech Inc ("Genentech") for the worldwide rights to develop and market products, primarily targeting disorders of the immune system, based on Xenova`s OX40 receptor protein and anti-OX40 Ligand antibody programs. Under this agreement, Xenova retains all rights to the up-regulation of the immune system using the OX40:OX40L interaction, including for use in oncology and infectious disease therapy.
For further information about Xenova and its products please visit the Xenova website at www.xenova.co.uk
For Xenova: Disclaimer to take advantage of the "Safe Harbor" provisions of the US Private Securities Litigation Reform Act of 1995. This press release contains "forward-looking statements," including statements about the discovery, development and commercialization of products. Various risks may cause Xenova`s actual results to differ materially from those expressed or implied by the forward-looking statements, including: adverse results in our drug discovery and clinical development programs; failure to obtain patent protection for our discoveries; commercial limitations imposed by patents owned or controlled by third parties; our dependence upon strategic alliance partners to develop and commercialize products and services; difficulties or delays in obtaining regulatory approvals to market products and services resulting from our development efforts; the requirement for substantial funding to conduct research and development and to expand commercialization activities; and product initiatives by competitors. For a further list and description of the risks and uncertainties we face, see the reports we have filed with the Securities and Exchange Commission. We disclaim any intention or obligation to update or revise any forward-looking statements, whether as a result of new information, future events or otherwise.
Imperial researchers show novel flu treatment eliminates symptoms in mice
Imperial College London researchers report today in the Journal of Experimental Medicine that they have developed a novel strategy for effectively treating the symptoms of the most deadly type of flu.
Working with influenza A virus, they show in mice that their novel treatment eliminates symptoms by reducing the response of active T white blood cells by a third.
Flu A is the type of influenza responsible for pandemics such as the 1919 outbreak of `Spanish flu,` which globally killed more than 20 million people.
Unlike current attempts to prevent or treat flu, which rely on either yearly vaccinations that try to predict how the virus might mutate, or anti viral drugs that must be administered as soon as there is contact with the virus, this new treatment can be given after symptoms present.
Dr. Tracy Hussell of Imperial`s Centre for Molecular Microbiology and Infection and senior author of the paper says: "Three times in recent history the flu virus has evolved from a disease characterised by coughs and sneezes to a world killer. The recent SARS epidemic highlights how quickly a deadly virus can spread in modern society and we are long overdue for the next flu pandemic. The sobering reality is that influenza is one of the grand masters at evading human immune response.
"During flu infection the immune system has an `all hands on deck` attitude to the viral assault. But it`s this that causes most of the damage. The exaggerated immune response produces inflammatory molecules that lead to what`s known as a `cytokine storm.` Essentially too many cells clog up the airways and prevent efficient transfer of oxygen into the bloodstream.
"By selectively reducing this cellular load we`ve shown it`s possible to eliminate clinical symptoms whilst effectively tackling and clearing the infection."
The body has two major classes of white blood cells, T and B lymphocytes. While B cells produce tailor-made antibodies that help the body remember and quickly respond to invaders, T cells patrol the body, seek out and destroy diseased cells. But the T cell response also produces inflammatory mediators that lead to the `cytokine storm.`
Until now, treatments to eliminate the cytokine storm have focused on inhibiting all T cells. But this leaves the patient unable to clear the virus and susceptible to other infections. Dr. Hussell`s team have developed a way of down regulating a molecule known as OX40 that only targets T cells that have recently been alerted to the presence of the flu virus.
"OX40 sends out a `survival signal` instructing activated T cells to remain in the lungs for longer to help fight the infection. However, because new cells are arriving all the time this prolonged presence is not needed," explains lead researcher Ian Humphreys of Imperial`s Centre for Molecular Microbiology and Infection.
"Inhibiting this signal therefore allows T cells to vacate the lungs earlier whilst leaving behind a sufficient immune presence."
Using a fusion protein OX40:Ig supplied by the pharmaceutical company Xenova Research, the scientists were able to demonstrate that OX40:Ig blocks active T cells.
Results show six days after infection with flu, mice treated with OX40:Ig were indistinguishable from uninfected control mice. But infected mice that had not been treated lost 25 per cent of their body weight, appeared hunched, withdrawn and lost their appetite -- all characteristic symptoms of flu.
When treatment with OX40:Ig was delayed for several days after infection, until the mice had lost 20 per cent of their body weight and OX40:Ig was administered, symptoms were reversed.
Re-infection also indicated that the ability of mice to respond to a second infection was not affected by the reduced T cell immunity during the initial infection.
Dr. Hussell added: "There is tremendous scope for this treatment. Basically any disease that is characterised by an excessive T cell inflammatory response, whether in the lungs, in the case of Bronchitis, Asthma and Pneumonia, or in the joints, such as Rheumatoid arthritis, could be a candidate for this type of treatment. If the clinical symptoms of SARS are caused by excessive immune responses it too could be effectively treated."
Notes to editor
Journal: Journal of Experimental Medicine
Title: "A critical role for OX40 in T Cell mediated immunopathology during lung viral infection"
Authors: Humphreys, Ian R (1); Walzl, Gerhard (1); Edwards, Lorna (1); Rae, Aaron (1); Hill, Sue (2); Hussell, Tracy (1).
(1) Imperial College London, Exhibition Road, London SW7 2AZ, UK
(2) Xenova Research Ltd, 310 Cambridge Science Park, CB4 0WG
Facts about flu
There are three main types of influenza virus A, B and C. Of these, A and B are of most concern because of the way in which their genomes evolve.
The organisation and type of genetic material flu virus is made from helps it hide from the immune system. RNA viruses, such as flu have a higher mutation rate because they don`t proof check their genetic material when they make new viral particles. As a result, there`s a huge amount of genetic variability within a new generation of virus particles. Although many of the mutation will be detrimental there will be enough that are able exploit a weakness in the immune system.
Influenza A is particularly dangerous because it readily undergoes `gene swapping` or reassortment. This means two strains of the virus can infect the same cell and swap genetic information. Add this to influenza`s ability to infect certain animals and birds, and you have a situation where two very distinct strains can infect a cell and hybridise to create a new strain that is very different from anything the immune system has encountered before. It is this process of gene swapping that has been linked with the emergence of most pandemics.
About Imperial College London
Consistently rated in the top three UK university institutions, Imperial College London is a world leading science-based university whose reputation for excellence in teaching and research attracts students (10,000) and staff (5,000) of the highest international quality.
Innovative research at the College explores the interface between science, medicine, engineering and management and delivers practical solutions that enhance the quality of life and the environment -- underpinned by a dynamic enterprise culture.
Website: www.imperial.ac.uk
SOURCE Xenova Group plc
-0- 10/21/2003
/CONTACT: UK - David A Oxlade, Chief Executive Officer, or Daniel Abrams, Group Finance Director, or Jon Davies, Corporate Communications, all of Xenova Group plc, +44-1753-706600; or David Yates, or Ben Atwell, both of Financial Dynamics, +44-207-831-3113; US - Press - Brad Miles, Ext 17, or Daniel Budwick, Ext 14, Investors - Jonathan Fassberg, Ext 16, or Lee Stern, Ext 22, all of Trout Group-BMC Communications, +1-212-477-9007, all for Xenova Group plc; or Judith H Moore of Imperial College London Press Office,
+44-0-20-7594-6702, Mobile - +44-0-7803-886-248,
j.h.moore@imperial.ac.uk
http://www.xenova.co.uk
http://www.imperial.ac.uk
Xenova Statement on Imperial College Research Into Novel Strategy for Treatment of Flu
21 October 2003, 07:00am ET
SLOUGH, England, Oct. 21 /PRNewswire-FirstCall/ -- Xenova Group plc (Nasdaq: XNVA; London Stock Exchange: XEN) notes that the following announcement was issued late yesterday by Imperial College with respect to a research collaboration involving the company`s OX40 technology and its potential for the treatment of influenza. OX40 is a platform technology capable of producing multiple drug candidates targeting cancer, autoimmune and other diseases where the immune system is involved.
David Oxlade, Chief Executive of Xenova, said, "We are very encouraged by these novel findings from the work conducted by Imperial College on our OX40 platform technology. The demonstration in pre-clinical studies that down-regulation of the immune response by blocking the OX40-OX40 ligand interaction alleviates the symptoms of influenza, without affecting the ability to clear the virus, is very exciting. This new research suggests that the down-regulation of OX40 signaling could play an important role in the fight against the symptoms of influenza and perhaps other diseases similarly characterised by excessive immune response."
Xenova`s rights to the OX40 technology include rights relating to the up-regulation of the immune system which may be used for the development of novel treatments for cancer and infectious disease. Xenova`s rights to down-regulate the immune system have been the subject of development and licence agreements entered into with Celltech and Genentech.
The full text of the Imperial announcement follows overleaf:
Notes to Editors
Xenova Group plc`s product pipeline focuses principally on the therapeutic areas of cancer and immune system disorders. Xenova has a broad pipeline of programmes in clinical development. The Group has a well-established track record in the identification, development and partnering of innovative products and technologies and has partnerships with significant pharmaceutical and biopharmaceutical companies including Lilly, Pfizer, Celltech, Genentech, QLT and Millennium Pharmaceuticals.
About OX40/OX40L
Inflammation is part of the body`s normal response to the presence of infection or other unwanted foreign material. In certain circumstances this process can cause damage to the body`s own tissues. In many cases this pathology is orchestrated by activated T cells. Consequently drugs that are capable of inhibiting the action of these activated T cells have potential as therapeutics for control of inflammatory disease.
OX40 is a receptor molecule found on the surface of activated T cells at the site of inflammation and offers an important potential target for development of a selective inhibitor of inflammation. Through collaboration and license agreements with Stanford University, and the Providence Medical Center, Portland, Xenova has intellectual property covering therapeutic use of the OX40 and OX40 Ligand proteins and their related antibodies.
Xenova has developed a modified form of the OX40 molecule which can be used to block the interaction between the OX40 receptor and its ligand and hence inhibit T cell activation. This product candidate has been shown effective in a preclinical model of autoimmune disease, and has moved into preclinical development.
Development of a monoclonal antibody against OX40 presents an alternative approach to target and destroy OX40-bearing activated T cells and hence treat autoimmune disease. This strategy is being pursued by Celltech Group under a license agreement with Xenova, which began in September 1999.
A development and license agreement worth up to $63m (43.2m pounds sterling) was signed in April 2002 with Genentech Inc ("Genentech") for the worldwide rights to develop and market products, primarily targeting disorders of the immune system, based on Xenova`s OX40 receptor protein and anti-OX40 Ligand antibody programs. Under this agreement, Xenova retains all rights to the up-regulation of the immune system using the OX40:OX40L interaction, including for use in oncology and infectious disease therapy.
For further information about Xenova and its products please visit the Xenova website at www.xenova.co.uk
For Xenova: Disclaimer to take advantage of the "Safe Harbor" provisions of the US Private Securities Litigation Reform Act of 1995. This press release contains "forward-looking statements," including statements about the discovery, development and commercialization of products. Various risks may cause Xenova`s actual results to differ materially from those expressed or implied by the forward-looking statements, including: adverse results in our drug discovery and clinical development programs; failure to obtain patent protection for our discoveries; commercial limitations imposed by patents owned or controlled by third parties; our dependence upon strategic alliance partners to develop and commercialize products and services; difficulties or delays in obtaining regulatory approvals to market products and services resulting from our development efforts; the requirement for substantial funding to conduct research and development and to expand commercialization activities; and product initiatives by competitors. For a further list and description of the risks and uncertainties we face, see the reports we have filed with the Securities and Exchange Commission. We disclaim any intention or obligation to update or revise any forward-looking statements, whether as a result of new information, future events or otherwise.
Imperial researchers show novel flu treatment eliminates symptoms in mice
Imperial College London researchers report today in the Journal of Experimental Medicine that they have developed a novel strategy for effectively treating the symptoms of the most deadly type of flu.
Working with influenza A virus, they show in mice that their novel treatment eliminates symptoms by reducing the response of active T white blood cells by a third.
Flu A is the type of influenza responsible for pandemics such as the 1919 outbreak of `Spanish flu,` which globally killed more than 20 million people.
Unlike current attempts to prevent or treat flu, which rely on either yearly vaccinations that try to predict how the virus might mutate, or anti viral drugs that must be administered as soon as there is contact with the virus, this new treatment can be given after symptoms present.
Dr. Tracy Hussell of Imperial`s Centre for Molecular Microbiology and Infection and senior author of the paper says: "Three times in recent history the flu virus has evolved from a disease characterised by coughs and sneezes to a world killer. The recent SARS epidemic highlights how quickly a deadly virus can spread in modern society and we are long overdue for the next flu pandemic. The sobering reality is that influenza is one of the grand masters at evading human immune response.
"During flu infection the immune system has an `all hands on deck` attitude to the viral assault. But it`s this that causes most of the damage. The exaggerated immune response produces inflammatory molecules that lead to what`s known as a `cytokine storm.` Essentially too many cells clog up the airways and prevent efficient transfer of oxygen into the bloodstream.
"By selectively reducing this cellular load we`ve shown it`s possible to eliminate clinical symptoms whilst effectively tackling and clearing the infection."
The body has two major classes of white blood cells, T and B lymphocytes. While B cells produce tailor-made antibodies that help the body remember and quickly respond to invaders, T cells patrol the body, seek out and destroy diseased cells. But the T cell response also produces inflammatory mediators that lead to the `cytokine storm.`
Until now, treatments to eliminate the cytokine storm have focused on inhibiting all T cells. But this leaves the patient unable to clear the virus and susceptible to other infections. Dr. Hussell`s team have developed a way of down regulating a molecule known as OX40 that only targets T cells that have recently been alerted to the presence of the flu virus.
"OX40 sends out a `survival signal` instructing activated T cells to remain in the lungs for longer to help fight the infection. However, because new cells are arriving all the time this prolonged presence is not needed," explains lead researcher Ian Humphreys of Imperial`s Centre for Molecular Microbiology and Infection.
"Inhibiting this signal therefore allows T cells to vacate the lungs earlier whilst leaving behind a sufficient immune presence."
Using a fusion protein OX40:Ig supplied by the pharmaceutical company Xenova Research, the scientists were able to demonstrate that OX40:Ig blocks active T cells.
Results show six days after infection with flu, mice treated with OX40:Ig were indistinguishable from uninfected control mice. But infected mice that had not been treated lost 25 per cent of their body weight, appeared hunched, withdrawn and lost their appetite -- all characteristic symptoms of flu.
When treatment with OX40:Ig was delayed for several days after infection, until the mice had lost 20 per cent of their body weight and OX40:Ig was administered, symptoms were reversed.
Re-infection also indicated that the ability of mice to respond to a second infection was not affected by the reduced T cell immunity during the initial infection.
Dr. Hussell added: "There is tremendous scope for this treatment. Basically any disease that is characterised by an excessive T cell inflammatory response, whether in the lungs, in the case of Bronchitis, Asthma and Pneumonia, or in the joints, such as Rheumatoid arthritis, could be a candidate for this type of treatment. If the clinical symptoms of SARS are caused by excessive immune responses it too could be effectively treated."
Notes to editor
Journal: Journal of Experimental Medicine
Title: "A critical role for OX40 in T Cell mediated immunopathology during lung viral infection"
Authors: Humphreys, Ian R (1); Walzl, Gerhard (1); Edwards, Lorna (1); Rae, Aaron (1); Hill, Sue (2); Hussell, Tracy (1).
(1) Imperial College London, Exhibition Road, London SW7 2AZ, UK
(2) Xenova Research Ltd, 310 Cambridge Science Park, CB4 0WG
Facts about flu
There are three main types of influenza virus A, B and C. Of these, A and B are of most concern because of the way in which their genomes evolve.
The organisation and type of genetic material flu virus is made from helps it hide from the immune system. RNA viruses, such as flu have a higher mutation rate because they don`t proof check their genetic material when they make new viral particles. As a result, there`s a huge amount of genetic variability within a new generation of virus particles. Although many of the mutation will be detrimental there will be enough that are able exploit a weakness in the immune system.
Influenza A is particularly dangerous because it readily undergoes `gene swapping` or reassortment. This means two strains of the virus can infect the same cell and swap genetic information. Add this to influenza`s ability to infect certain animals and birds, and you have a situation where two very distinct strains can infect a cell and hybridise to create a new strain that is very different from anything the immune system has encountered before. It is this process of gene swapping that has been linked with the emergence of most pandemics.
About Imperial College London
Consistently rated in the top three UK university institutions, Imperial College London is a world leading science-based university whose reputation for excellence in teaching and research attracts students (10,000) and staff (5,000) of the highest international quality.
Innovative research at the College explores the interface between science, medicine, engineering and management and delivers practical solutions that enhance the quality of life and the environment -- underpinned by a dynamic enterprise culture.
Website: www.imperial.ac.uk
SOURCE Xenova Group plc
-0- 10/21/2003
/CONTACT: UK - David A Oxlade, Chief Executive Officer, or Daniel Abrams, Group Finance Director, or Jon Davies, Corporate Communications, all of Xenova Group plc, +44-1753-706600; or David Yates, or Ben Atwell, both of Financial Dynamics, +44-207-831-3113; US - Press - Brad Miles, Ext 17, or Daniel Budwick, Ext 14, Investors - Jonathan Fassberg, Ext 16, or Lee Stern, Ext 22, all of Trout Group-BMC Communications, +1-212-477-9007, all for Xenova Group plc; or Judith H Moore of Imperial College London Press Office,
+44-0-20-7594-6702, Mobile - +44-0-7803-886-248,
j.h.moore@imperial.ac.uk
http://www.xenova.co.uk
http://www.imperial.ac.uk
ich rauche gern..
Xenova Initiates Phase IIb Clinical Trial for Anti-Cocaine Vaccine
24 October 2003, 07:01am ET
SLOUGH, England, Oct. 24 /PRNewswire-FirstCall/ -- Xenova Group plc (Nasdaq: XNVA; LSE: XEN) today announced that it has initiated the first randomised, placebo controlled Phase IIb clinical trial for TA-CD, the company`s therapeutic vaccine which is under development for the treatment of cocaine addiction.
TA-CD is being developed with the goal of assisting cocaine addicts in their attempt to quit cocaine. In previous clinical trials TA-CD has been shown to be both safe and well-tolerated, with vaccination generating a dose- related immune response. Preclinical studies have demonstrated that vaccination produces a reduced self-administered consumption of cocaine. The primary objective of this new Phase IIb trial is to determine the efficacy of TA-CD in addicts seeking treatment for cocaine abuse, and to determine appropriate end-points for a Phase III study.
Up to 132 subjects, all of whom are methadone-dependent cocaine addicts being treated for drug dependency, will be recruited into the placebo- controlled, randomised, double-blinded clinical study. The trial will comprise two equal cohorts. Half the subjects will be treated with active TA- CD and half will be given a placebo. Subjects will be monitored three times a week to assess cocaine usage, including testing for cocaine metabolites in urine, for a period of 20 weeks. Patients will also undergo medical examinations and blood tests for anti-cocaine antibodies to assess the immunogenicity of the dosing schedule. The trial, which is being supported by the US National Institute for Drug Abuse (NIDA), is expected to last up to two years (depending upon the rate of recruitment) and will be conducted in the US at a clinical centre with experience of drug treatment.
Commenting David Oxlade, CEO of Xenova Group plc said, "Cocaine abuse is a serious and growing problem both for the addicts themselves and for society. Currently there is no effective pharmacotherapy available for the estimated 900,000 individuals in the USA each year who seek help in overcoming their cocaine addiction."
"Previous clinical studies have indicated that vaccination with TA-CD can play an important role in diminishing the effects of cocaine. However, to date, the many indications of efficacy have largely been anecdotal. This new trial will allow an objective assessment of the efficacy of the TA-CD vaccine against placebo."
Notes to Editors
Xenova Group plc`s product pipeline focuses principally on the therapeutic areas of cancer and immune system disorders. Xenova has a broad pipeline of programmes in clinical development. The Group has a well-established track record in the identification, development and partnering of innovative products and technologies and has partnerships with significant pharmaceutical and biopharmaceutical companies including Celltech, Genentech, Lilly, Millennium Pharmaceuticals, Nycomed, Pfizer and QLT.
About TA-CD
TA-CD is a therapeutic vaccine which is currently under development for the treatment of cocaine addiction. Cocaine is a very small molecule that is not normally seen by the immune system. This is reflected by the fact that addicts who are exposed to cocaine on a regular basis do not have anti-cocaine antibodies in their blood stream.
The objective of vaccination with TA-CD is to produce anti-cocaine antibodies that bind to cocaine in the blood stream creating a complex that is too large to cross the blood-brain barrier, and thereby preventing stimulation of the reward centres. In order to stimulate the immune system to recognise cocaine we have to attach it to a much bigger molecule that the immune system can see; the non-toxic subunit of cholera toxin.
The start of a Phase IIa cocaine administration trial was announced on 14 April 2003. The ten-patient open label trial is being conducted in the United States and is designed to evaluate the effect of TA-CD on behavioural changes associated with cocaine administration.
The results of a second Phase IIa dose escalation trial were reported on 17 June 2003. This study, which started in April 2002, was designed to evaluate the safety and immunogenicity of TA-CD using 4 or 5 dose vaccination schedules. As for the previous Phase I study, the results showed the vaccine to be safe and well tolerated with a dose-related immune response. Of the 16 patients in the two Phase IIa studies who used cocaine at any time following vaccination, 14 reported a reduction of the usual euphoric effect normally associated with cocaine use, providing further anecdotal evidence of the vaccine`s proposed mode of action.
The TA-CD investigations were funded in part by the National Institute on Drug Abuse (NIDA) who recognises cocaine abuse to be a major problem in the U.S. NIDA has also supported earlier clinical work as part of this program.
For further information about Xenova and its products please visit the Xenova website at www.xenova.co.uk
For Xenova: Disclaimer to take advantage of the "Safe Harbor" provisions of the US Private Securities Litigation Reform Act of 1995. This press release contains "forward-looking statements," including statements about the discovery, development and commercialization of products. Various risks may cause Xenova`s actual results to differ materially from those expressed or implied by the forward looking statements, including: adverse results in our drug discovery and clinical development programs; failure to obtain patent protection for our discoveries; commercial limitations imposed by patents owned or controlled by third parties; our dependence upon strategic alliance partners to develop and commercialize products and services; difficulties or delays in obtaining regulatory approvals to market products and services resulting from our development efforts; the requirement for substantial funding to conduct research and development and to expand commercialization activities; and product initiatives by competitors. For a further list and description of the risks and uncertainties we face, see the reports we have filed with the Securities and Exchange Commission. We disclaim any intention or obligation to update or revise any forward-looking statements, whether as a result of new information, future events or otherwise.
SOURCE Xenova Group plc
-0- 10/24/2003
/CONTACT: David A Oxlade, Chief Executive Officer, Daniel Abrams, Group
Finance Director, Jon Davies, Corporate Communications, all of Xenova Group
plc, +44 (0)1753 706600; David Yates or Ben Atwell, both of Financial
Dynamics, +44 (0)207 831 3113; or Brad Miles (ext. 17) and Daniel Budwick
(ext. 14), Press Relations for Trout Group/BMC Communications, or Jonathan
Fassberg (ext. 16) and Lee Stern (ext. 22), Investor Relations for Trout
Group/BMC Communications, +1-212-477-9007/
/Web Sites:
http://www.xenova.co.uk
Xenova Initiates Phase IIb Clinical Trial for Anti-Cocaine Vaccine
24 October 2003, 07:01am ET
SLOUGH, England, Oct. 24 /PRNewswire-FirstCall/ -- Xenova Group plc (Nasdaq: XNVA; LSE: XEN) today announced that it has initiated the first randomised, placebo controlled Phase IIb clinical trial for TA-CD, the company`s therapeutic vaccine which is under development for the treatment of cocaine addiction.
TA-CD is being developed with the goal of assisting cocaine addicts in their attempt to quit cocaine. In previous clinical trials TA-CD has been shown to be both safe and well-tolerated, with vaccination generating a dose- related immune response. Preclinical studies have demonstrated that vaccination produces a reduced self-administered consumption of cocaine. The primary objective of this new Phase IIb trial is to determine the efficacy of TA-CD in addicts seeking treatment for cocaine abuse, and to determine appropriate end-points for a Phase III study.
Up to 132 subjects, all of whom are methadone-dependent cocaine addicts being treated for drug dependency, will be recruited into the placebo- controlled, randomised, double-blinded clinical study. The trial will comprise two equal cohorts. Half the subjects will be treated with active TA- CD and half will be given a placebo. Subjects will be monitored three times a week to assess cocaine usage, including testing for cocaine metabolites in urine, for a period of 20 weeks. Patients will also undergo medical examinations and blood tests for anti-cocaine antibodies to assess the immunogenicity of the dosing schedule. The trial, which is being supported by the US National Institute for Drug Abuse (NIDA), is expected to last up to two years (depending upon the rate of recruitment) and will be conducted in the US at a clinical centre with experience of drug treatment.
Commenting David Oxlade, CEO of Xenova Group plc said, "Cocaine abuse is a serious and growing problem both for the addicts themselves and for society. Currently there is no effective pharmacotherapy available for the estimated 900,000 individuals in the USA each year who seek help in overcoming their cocaine addiction."
"Previous clinical studies have indicated that vaccination with TA-CD can play an important role in diminishing the effects of cocaine. However, to date, the many indications of efficacy have largely been anecdotal. This new trial will allow an objective assessment of the efficacy of the TA-CD vaccine against placebo."
Notes to Editors
Xenova Group plc`s product pipeline focuses principally on the therapeutic areas of cancer and immune system disorders. Xenova has a broad pipeline of programmes in clinical development. The Group has a well-established track record in the identification, development and partnering of innovative products and technologies and has partnerships with significant pharmaceutical and biopharmaceutical companies including Celltech, Genentech, Lilly, Millennium Pharmaceuticals, Nycomed, Pfizer and QLT.
About TA-CD
TA-CD is a therapeutic vaccine which is currently under development for the treatment of cocaine addiction. Cocaine is a very small molecule that is not normally seen by the immune system. This is reflected by the fact that addicts who are exposed to cocaine on a regular basis do not have anti-cocaine antibodies in their blood stream.
The objective of vaccination with TA-CD is to produce anti-cocaine antibodies that bind to cocaine in the blood stream creating a complex that is too large to cross the blood-brain barrier, and thereby preventing stimulation of the reward centres. In order to stimulate the immune system to recognise cocaine we have to attach it to a much bigger molecule that the immune system can see; the non-toxic subunit of cholera toxin.
The start of a Phase IIa cocaine administration trial was announced on 14 April 2003. The ten-patient open label trial is being conducted in the United States and is designed to evaluate the effect of TA-CD on behavioural changes associated with cocaine administration.
The results of a second Phase IIa dose escalation trial were reported on 17 June 2003. This study, which started in April 2002, was designed to evaluate the safety and immunogenicity of TA-CD using 4 or 5 dose vaccination schedules. As for the previous Phase I study, the results showed the vaccine to be safe and well tolerated with a dose-related immune response. Of the 16 patients in the two Phase IIa studies who used cocaine at any time following vaccination, 14 reported a reduction of the usual euphoric effect normally associated with cocaine use, providing further anecdotal evidence of the vaccine`s proposed mode of action.
The TA-CD investigations were funded in part by the National Institute on Drug Abuse (NIDA) who recognises cocaine abuse to be a major problem in the U.S. NIDA has also supported earlier clinical work as part of this program.
For further information about Xenova and its products please visit the Xenova website at www.xenova.co.uk
For Xenova: Disclaimer to take advantage of the "Safe Harbor" provisions of the US Private Securities Litigation Reform Act of 1995. This press release contains "forward-looking statements," including statements about the discovery, development and commercialization of products. Various risks may cause Xenova`s actual results to differ materially from those expressed or implied by the forward looking statements, including: adverse results in our drug discovery and clinical development programs; failure to obtain patent protection for our discoveries; commercial limitations imposed by patents owned or controlled by third parties; our dependence upon strategic alliance partners to develop and commercialize products and services; difficulties or delays in obtaining regulatory approvals to market products and services resulting from our development efforts; the requirement for substantial funding to conduct research and development and to expand commercialization activities; and product initiatives by competitors. For a further list and description of the risks and uncertainties we face, see the reports we have filed with the Securities and Exchange Commission. We disclaim any intention or obligation to update or revise any forward-looking statements, whether as a result of new information, future events or otherwise.
SOURCE Xenova Group plc
-0- 10/24/2003
/CONTACT: David A Oxlade, Chief Executive Officer, Daniel Abrams, Group
Finance Director, Jon Davies, Corporate Communications, all of Xenova Group
plc, +44 (0)1753 706600; David Yates or Ben Atwell, both of Financial
Dynamics, +44 (0)207 831 3113; or Brad Miles (ext. 17) and Daniel Budwick
(ext. 14), Press Relations for Trout Group/BMC Communications, or Jonathan
Fassberg (ext. 16) and Lee Stern (ext. 22), Investor Relations for Trout
Group/BMC Communications, +1-212-477-9007/
/Web Sites:
http://www.xenova.co.uk
Ergebnisse 3. Quartal
Xenova Group plc: Third Quarter Results
Slough, UK, 6th November, 2003
Quarterly Highlights
Acquisition of KS Biomedix Holdings plc
XR5944: start of Phase I clinical trial of novel DNA targeting agent
Cash, short-term deposits and investments £10.6m ($17.5m) at 30 September 2003 (30 September 2002: £10.0m ($16.6m))
Subsequent Events
TA-NIC: start of second Phase I clinical trial for anti-smoking vaccine
TA-CD: start of Phase IIb clinical trial for anti-cocaine vaccine
Publication of novel findings relating to use of Xenova`s OX-40 technology and its potential for the treatment of influenza
David Oxlade, Chief Executive Officer, said: "We have now completed the acquisition of KS Biomedix and made good progress with the integration of the business. The acquisition has strengthened our clinical portfolio and helped to lay the foundations for Xenova to become a broader-based oncology business. In addition, it has created substantial opportunities for synergies and cost savings across the enlarged Group which we have already started to exploit."
"By focusing on our key clinical development programmes we believe we will be able to deliver greater shareholder value and significantly improve the long-term prospects of the Group."
ganzer Bericht unter: http://www.xenova.co.uk/PressReleases/pr_20031106_01.html
Xenova Group plc: Third Quarter Results
Slough, UK, 6th November, 2003
Quarterly Highlights
Acquisition of KS Biomedix Holdings plc
XR5944: start of Phase I clinical trial of novel DNA targeting agent
Cash, short-term deposits and investments £10.6m ($17.5m) at 30 September 2003 (30 September 2002: £10.0m ($16.6m))
Subsequent Events
TA-NIC: start of second Phase I clinical trial for anti-smoking vaccine
TA-CD: start of Phase IIb clinical trial for anti-cocaine vaccine
Publication of novel findings relating to use of Xenova`s OX-40 technology and its potential for the treatment of influenza
David Oxlade, Chief Executive Officer, said: "We have now completed the acquisition of KS Biomedix and made good progress with the integration of the business. The acquisition has strengthened our clinical portfolio and helped to lay the foundations for Xenova to become a broader-based oncology business. In addition, it has created substantial opportunities for synergies and cost savings across the enlarged Group which we have already started to exploit."
"By focusing on our key clinical development programmes we believe we will be able to deliver greater shareholder value and significantly improve the long-term prospects of the Group."
ganzer Bericht unter: http://www.xenova.co.uk/PressReleases/pr_20031106_01.html
Xenova Announces Publication of New Research Into Method of Action of XR5944 (MLN944) at AACR-NCI-EORTC Conference
19 November 2003, 02:00am ET
SLOUGH, England, Nov. 19 /PRNewswire-FirstCall/ -- Xenova Group plc (Nasdaq: XNVA; LSE: XEN) today announces the publication of four abstracts relating to new research into the mechanism of action of its novel cytotoxic agent XR5944 (MLN944) at the meeting of the annual AACR-NCI-EORTC International Conference held in Boston 17-21 November 2003. This research supports the conclusion that XR5944 is a novel DNA/RNA targeting agent and that its mechanism of action is distinct from current cytotoxic agents. XR5944 is currently in Phase I clinical development in patients with advanced solid tumours.
Preclinical studies have shown XR5944 to be a highly active and potent cytotoxic agent. XR5944 was previously thought to exert its cytotoxic action by dual inhibition of topoisomerases I and II. However, evidence now suggests that XR5944 has a different mechanism of action. For example, it has been shown that XR5944 maintains its cytotoxicity in yeast cells deficient in topoisomerases (Fleming et al; Proceedings of the 94th AACR 2003). Moreover, XR5944 arrests human tumour cell lines in both the G1 and G2 phases of the cell cycle, in contrast to topoisomerase inhibitors which arrest at the S/G2 phase (Freathy et al; Proceedings of the 94th AACR 2003). Although not active against topoisomerases, recent biochemical studies suggest that the anti-tumour activity of XR5944 does involve nucleic acid binding and intercalation into DNA (Sappal et al. Mol Cancer Therapeutics in press).
The new studies reported in Boston have further investigated the mechanism of action of XR5944. Blackman et al reported yeast functional genomics studies with XR5944 suggesting a pattern indicative of alterations in cellular RNA synthesis and metabolism. Pulse labelling experiments confirmed inhibition of cellular RNA synthesis which appeared to result from inhibition of RNA polymerases I and II.
Byers et al reported studies on the effect of XR5944 on RNA polymerase II. They tested XR5944 for its ability to inhibit the kinase activity of positive transcription elongation factor b (P-TEFb). XR5944 did not inhibit the kinase activity of P-TEFb in vitro; however treatment of cells with XR5944 caused a shift in the large predominantly inactive form of P-TEFb to the small active form. They propose that the increased sensitivity of cancer cells to XR5944 is through modifications in their P-TEFb environment.
Yang et al have reported results of NMR structural binding studies which suggest XR5944 bis-intercalates and binds through the major groove of DNA. Sappal et al measured the primary effects of XR5944 treatment on DNA, RNA and protein synthesis in human tumour cell lines. By measuring the incorporation of radiolabeled precursors after short-term exposure to XR5944, the data showed inhibition of RNA synthesis at concentrations consistent with growth inhibition. A modest reduction in DNA synthesis was also observed at higher XR5944 concentrations. These results are consistent with a mechanism of action for XR5944 that involves DNA binding and inhibition of RNA synthesis.
Mentioned Last Change
XNVA 2.32 0.08dollars or (3.57%)
Commenting on this new research David Oxlade, Chief Executive of Xenova, said, "We are delighted with the progress made in elucidating the mechanism by which XR5944 achieves its highly potent cancer cell killing effect and we look forward to further developments that will clearly differentiate XR5944 from other drugs being developed to improve the treatment of cancer patients."
Notes to Editors
Xenova Group plc`s product pipeline focuses principally on the therapeutic areas of cancer and immune system disorders. Xenova has a broad pipeline of programmes in clinical development. The Group has a well-established track record in the identification, development and partnering of innovative products and technologies and has partnerships with significant pharmaceutical and biopharmaceutical companies including Lilly, Pfizer, Celltech, Genentech, QLT and Millennium Pharmaceuticals.
About XR5944
In preclinical studies XR5944 has demonstrated highly potent cytotoxic activity, both in vitro and in vivo, against a number of human tumour models. In human tumour xenograft models, treatment with XR5944 caused both partial and complete regression of large established tumours without concomitant weight loss indicating excellent efficacy with minimal toxicity. XR5944 entered Phase I clinical trials in July 2003.
Millennium licensed XR5944 from Xenova Group plc in December 2001 as part of a larger collaboration including two other compounds XR11576 (MLN576) and XR11612 (MLN612). Millennium is currently funding Xenova to implement development activities associated with the programme to the completion of Phase II clinical trials, at which time Millennium has the right to assume development responsibility in North America. Xenova retains commercialisation and development responsibility for the rest of the world.
For further information about Xenova and its products please visit the Xenova website at www.xenova.co.uk
For Xenova: Disclaimer to take advantage of the "Safe Harbor" provisions of the US Private Securities Litigation Reform Act of 1995. This press release contains "forward-looking statements," including statements about the discovery, development and commercialization of products. Various risks may cause Xenova`s actual results to differ materially from those expressed or implied by the forward looking statements, including: adverse results in our drug discovery and clinical development programs; failure to obtain patent protection for our discoveries; commercial limitations imposed by patents owned or controlled by third parties; our dependence upon strategic alliance partners to develop and commercialize products and services; difficulties or delays in obtaining regulatory approvals to market products and services resulting from our development efforts; the requirement for substantial funding to conduct research and development and to expand commercialization activities; and product initiatives by competitors. For a further list and description of the risks and uncertainties we face, see the reports we have filed with the Securities and Exchange Commission. We disclaim any intention or obligation to update or revise any forward-looking statements, whether as a result of new information, future events or otherwise.
SOURCE Xenova Group plc
-0- 11/19/2003
/CONTACT: David A Oxlade, Chief Executive Officer, Daniel Abrams, Group
Finance Director, Jon Davies, Corporate Communications, all of Xenova Group
plc, +44-1753-706600; David Yates or Ben Atwell, both of Financial Dynamics,
+44-207-831-3113; or Brad Miles (ext. 17) and Daniel Budwick (ext. 14), Press
Relations for Trout Group/BMC Communications, or Jonathan Fassberg (ext. 16)
and Lee Stern (ext. 22), Investor Relations for Trout Group/BMC
Communications, +1-212-477-9007/
/Web site:
http://www.xenova.co.uk
Xenova Group plc: Sale of Farnham Research Facility to Bioventix
Slough, UK, 6 January 2004 - Xenova Group plc (NASDAQ, NY: XNVA, London Stock Exchange, XEN) today announced that it has sold certain premises at its Farnham research facility together with related assets to Bioventix Limited ("Bioventix"). The sale assets constitute part of the business acquired by the Group upon the acquisition of KS Biomedix Holdings plc. The consideration for the sale assets was £0.8m paid in cash.
The sale includes certain rights to intellectual property relating to super high-affinity antibodies that are not being developed by Xenova, and provides for the continuation of work by Bioventix on novel three-part proteins ("trimers") being developed under an option agreement with Isis Innovations Ltd. Xenova has retained an option to develop any promising therapeutic candidates arising from this work. In addition, a team of 7 research scientists is transferring with the business to Bioventix.
The sale is in line with Xenova`s declared strategy following the acquisition of KS Biomedix Holdings plc on 12 September 2003, of focusing on its clinical development portfolio and achieving cost savings through the disposal of non-core business activities and facilities.
Commenting on the disposal, David Oxlade, Chief Executive of Xenova, said, "We are pleased to announce continuing progress in achieving the cost savings expected at the time of the acquisition of KS Biomedix Holdings plc and to realise value from non-core assets for our shareholders. The sale to Bioventix, which is being run by Peter Harrison formerly of KS Biomedix, also provides Xenova an option to in-licence certain therapeutic candidates."
-ends-
CONTACTS
UK:
Xenova Group plc
Tel: +44 (0)1753 706600
David A Oxlade, Chief Executive Officer
Daniel Abrams, Finance Director
Veronica Cefis Sellar, Corporate Communications
Financial Dynamics
Tel: +44 (0)207 831 3113
David Yates/Ben Atwell
US:
Trout Group/BMC Communications
Tel: 001 212 477 9007
Press: Brad Miles (Ext 17)
Daniel Budwick (Ext 14)
Investors: Jonathan Fassberg (Ext 16)
Lee Stern (Ext 22)
http://www.xenova.co.uk/PressReleases/pr_20040106_01.html
Slough, UK, 6 January 2004 - Xenova Group plc (NASDAQ, NY: XNVA, London Stock Exchange, XEN) today announced that it has sold certain premises at its Farnham research facility together with related assets to Bioventix Limited ("Bioventix"). The sale assets constitute part of the business acquired by the Group upon the acquisition of KS Biomedix Holdings plc. The consideration for the sale assets was £0.8m paid in cash.
The sale includes certain rights to intellectual property relating to super high-affinity antibodies that are not being developed by Xenova, and provides for the continuation of work by Bioventix on novel three-part proteins ("trimers") being developed under an option agreement with Isis Innovations Ltd. Xenova has retained an option to develop any promising therapeutic candidates arising from this work. In addition, a team of 7 research scientists is transferring with the business to Bioventix.
The sale is in line with Xenova`s declared strategy following the acquisition of KS Biomedix Holdings plc on 12 September 2003, of focusing on its clinical development portfolio and achieving cost savings through the disposal of non-core business activities and facilities.
Commenting on the disposal, David Oxlade, Chief Executive of Xenova, said, "We are pleased to announce continuing progress in achieving the cost savings expected at the time of the acquisition of KS Biomedix Holdings plc and to realise value from non-core assets for our shareholders. The sale to Bioventix, which is being run by Peter Harrison formerly of KS Biomedix, also provides Xenova an option to in-licence certain therapeutic candidates."
-ends-
CONTACTS
UK:
Xenova Group plc
Tel: +44 (0)1753 706600
David A Oxlade, Chief Executive Officer
Daniel Abrams, Finance Director
Veronica Cefis Sellar, Corporate Communications
Financial Dynamics
Tel: +44 (0)207 831 3113
David Yates/Ben Atwell
US:
Trout Group/BMC Communications
Tel: 001 212 477 9007
Press: Brad Miles (Ext 17)
Daniel Budwick (Ext 14)
Investors: Jonathan Fassberg (Ext 16)
Lee Stern (Ext 22)
http://www.xenova.co.uk/PressReleases/pr_20040106_01.html
jetzt als Immobilienfirma zugange?
Xenova Signs Lease Agreement with Genzyme
7 April 2004, 02:16am ET
SLOUGH, U.K., April 7, 2004 (PRIMEZONE) -- Xenova Group plc (LSE:XEN) (Nasdaq:XNVA) announced today that it has signed a 10 year agreement with Genzyme Limited ("Genzyme") leasing to them the vacant space in the 310 Cambridge Science Park site.
Genzyme will establish its first European discovery research facility on the site this month. Xenova will continue to occupy part of the Cambridge site together with its adjacent manufacturing facility.
David Oxlade, Chief Executive Officer said: "We are pleased to welcome Genzyme as a tenant at our Cambridge facility. This, together with the disposal of research premises in Farnham in December, largely completes the planned reduction in UK facilities occupation following the acquisition of KS Biomedix Holdings plc in September 2003. Genzyme`s occupation will substantially reduce our facilities overheads over the coming years."
Xenova Group plc is a UK-based biopharmaceutical company focused on the development of novel drugs to treat cancer and addiction with a secondary focus in immunotherapy. The Company has a broad pipeline of products in clinical development, including three cancer programmes: its lead product TransMID(tm), for the treatment of high-grade glioma, is ready to enter Phase III trials, and in addition has novel DNA targeting agents and XR303 both in Phase I for cancer indications. Xenova is also developing two therapeutic vaccines for cocaine and nicotine addiction, which are in Phase II and Phase I trials respectively. Quoted on the London Stock Exchange (XEN) and on NASDAQ (XNVA), Xenova employs approximately 112 people throughout its sites in the UK and North America. (Reuters XEN.L; Bloomberg XEN LN)
Genzyme Corporation is a global biotechnology company dedicated to making a major positive impact on the lives of people with serious diseases. Genzyme`s research activities in Cambridge will focus on antibody technology and its application in renal disease, oncology, and immune-mediated diseases.
For further information about Xenova and its products please visit the Xenova website at www.xenova.co.uk
For Xenova: Disclaimer to take advantage of the "Safe Harbor" provisions of the US Private Securities Litigation Reform Act of 1995. This press release contains "forward-looking statements," including statements about our ability to integrate acquired businesses and realize cost savings from integration, and the discovery, development and commercialization of products. Various risks may cause Xenova`s actual results to differ materially from those expressed or implied by the forward looking statements, including: unexpected costs and delays in integrating acquired businesses into our group, adverse results in our drug discovery and clinical development programs; failure to obtain patent protection for our discoveries; commercial limitations imposed by patents owned or controlled by third parties; our dependence upon strategic alliance partners to develop and commercialize products and services; difficulties or delays in obtaining regulatory approvals to market products and services resulting from our development efforts; the requirement for substantial funding to conduct research and development and to expand commercialization activities; and product initiatives by competitors. For a further list and description of the risks and uncertainties we face, see the reports we have filed with the Securities and Exchange Commission. We disclaim any intention or obligation to update or revise any forward-looking statements, whether as a result of new information, future events or otherwise.
http://hugin.info/133161/R/940951/131123.pdf
CONTACT: Xenova Group plc
David A Oxlade, Chief Executive Officer
Daniel Abrams, Group Finance Director
Veronica Cefis Sellar, Head of Corporate Communications
+44 (0)1753 706600
UK -- Financial Dynamics
David Yates
Ben Atwell
+44 (0)20 7831 3113
US -- Trout Group BMC Communications
Media: Brad Miles, ext 17
Daniel Budwick, ext 14
Investors: Jonathan Fassberg, ext 16
Lee Stern, ext 22
+1 212 477 9007
Xenova Signs Lease Agreement with Genzyme
7 April 2004, 02:16am ET
SLOUGH, U.K., April 7, 2004 (PRIMEZONE) -- Xenova Group plc (LSE:XEN) (Nasdaq:XNVA) announced today that it has signed a 10 year agreement with Genzyme Limited ("Genzyme") leasing to them the vacant space in the 310 Cambridge Science Park site.
Genzyme will establish its first European discovery research facility on the site this month. Xenova will continue to occupy part of the Cambridge site together with its adjacent manufacturing facility.
David Oxlade, Chief Executive Officer said: "We are pleased to welcome Genzyme as a tenant at our Cambridge facility. This, together with the disposal of research premises in Farnham in December, largely completes the planned reduction in UK facilities occupation following the acquisition of KS Biomedix Holdings plc in September 2003. Genzyme`s occupation will substantially reduce our facilities overheads over the coming years."
Xenova Group plc is a UK-based biopharmaceutical company focused on the development of novel drugs to treat cancer and addiction with a secondary focus in immunotherapy. The Company has a broad pipeline of products in clinical development, including three cancer programmes: its lead product TransMID(tm), for the treatment of high-grade glioma, is ready to enter Phase III trials, and in addition has novel DNA targeting agents and XR303 both in Phase I for cancer indications. Xenova is also developing two therapeutic vaccines for cocaine and nicotine addiction, which are in Phase II and Phase I trials respectively. Quoted on the London Stock Exchange (XEN) and on NASDAQ (XNVA), Xenova employs approximately 112 people throughout its sites in the UK and North America. (Reuters XEN.L; Bloomberg XEN LN)
Genzyme Corporation is a global biotechnology company dedicated to making a major positive impact on the lives of people with serious diseases. Genzyme`s research activities in Cambridge will focus on antibody technology and its application in renal disease, oncology, and immune-mediated diseases.
For further information about Xenova and its products please visit the Xenova website at www.xenova.co.uk
For Xenova: Disclaimer to take advantage of the "Safe Harbor" provisions of the US Private Securities Litigation Reform Act of 1995. This press release contains "forward-looking statements," including statements about our ability to integrate acquired businesses and realize cost savings from integration, and the discovery, development and commercialization of products. Various risks may cause Xenova`s actual results to differ materially from those expressed or implied by the forward looking statements, including: unexpected costs and delays in integrating acquired businesses into our group, adverse results in our drug discovery and clinical development programs; failure to obtain patent protection for our discoveries; commercial limitations imposed by patents owned or controlled by third parties; our dependence upon strategic alliance partners to develop and commercialize products and services; difficulties or delays in obtaining regulatory approvals to market products and services resulting from our development efforts; the requirement for substantial funding to conduct research and development and to expand commercialization activities; and product initiatives by competitors. For a further list and description of the risks and uncertainties we face, see the reports we have filed with the Securities and Exchange Commission. We disclaim any intention or obligation to update or revise any forward-looking statements, whether as a result of new information, future events or otherwise.
http://hugin.info/133161/R/940951/131123.pdf
CONTACT: Xenova Group plc
David A Oxlade, Chief Executive Officer
Daniel Abrams, Group Finance Director
Veronica Cefis Sellar, Head of Corporate Communications
+44 (0)1753 706600
UK -- Financial Dynamics
David Yates
Ben Atwell
+44 (0)20 7831 3113
US -- Trout Group BMC Communications
Media: Brad Miles, ext 17
Daniel Budwick, ext 14
Investors: Jonathan Fassberg, ext 16
Lee Stern, ext 22
+1 212 477 9007
Hi Wunram
Wieviel Cash besitzt das Unternmehmen noch ?
Und wann ungefähr kommt das erste Medikament auf den Markt ?
Danke
Gruss
B.M.
Wieviel Cash besitzt das Unternmehmen noch ?
Und wann ungefähr kommt das erste Medikament auf den Markt ?
Danke
Gruss
B.M.
Xenova and FDA reach agreement on SPA Phase III trial programme for TransMID -- Enrollment to Begin Immediately
11 May 2004, 04:35am ET
SLOUGH, U.K. May 11, 2004 (PRIMEZONE) -- Xenova Group plc (LSE:XEN) (Nasdaq:XNVA) announced today that it has reached agreement with the US Food and Drug Administration (FDA) under the Special Protocol Assessment (SPA) procedure for the revised Phase III clinical trial programme proposed for TransMID(TM). Prior to its acquisition by Xenova, KS Biomedix Holdings plc (KS Biomedix) had obtained FDA agreement for a single Phase III clinical trial for TransMID(TM) under the SPA process. Following the acquisition of KS Biomedix, Xenova submitted a revised programme involving two smaller sequential Phase III clinical trials rather than one larger study, which has now been agreed with the FDA. The adoption of a two study approach reduces the level of risk associated with a large single study.
The initial Phase III clinical trial is designed to enrol 323 patients with non-resectable, progressive or recurrent Glioblastoma Multiforme (GBM) who have failed conventional therapy. The study will be a randomised, open-labelled, multi-centre trial and will compare TransMID(TM) against a number of presently used chemotherapeutic agents regarded as "best standard of care" (BSC). The 323 patients will be randomised in a 2:1 ratio of TransMID(TM):BSC across approximately 50 sites in the EU, Israel and North America.
The primary end-point is overall survival time with a planned interimanalysis to be conducted after 50% of the required events have beenobserved. In an earlier, open label, Phase II study, patientsreceiving TransMID(TM) achieved a significant increase in overallsurvival compared with historical survival figures. In this study,median survival for patients receiving TransMIDTM was approximately37 weeks. This compares to the average life expectancy for thesepatients which is currently approximately 26 weeks.
Edward Oldfield MD, Chairman of the Surgical Neurology Branch of the National Institute of Neurological Disorders and Stroke (NINDS) at the National Institutes of Health, Bethesda, Maryland said: "Glioblastoma Multiforme has been a very difficult tumour to treat. This novel approach combines a potent new drug with a targeted delivery method that can distribute the drug directly to the region involved with tumour. In earlier Phase I and Phase II clinical trials, the combination produced complete and partial radiographic responses in several patients."
David A Oxlade, Chief Executive Officer said: "We are pleased to have reached agreement with FDA for the revised programme and we will be starting to enrol patients immediately. People with non-resectable Glioblastoma Multiforme currently have few treatment options and there is a clear need for improved outcomes for these patients."
TransMID(TM) received Fast Track status from the FDA in August 2001 and orphan drug status in December 2001. In addition, the European Commission granted TransMID(TM) orphan designation in March 2002.
Xenova Group plc is a UK-based biopharmaceutical company focused on the development of novel drugs to treat cancer and addiction with a secondary focus in immunotherapy. The Group has a broad pipeline of products in clinical development, including three cancer programmes: its lead product TransMID(TM), for the treatment of high-grade glioma, now beginning Phase III trials, and the novel DNA targeting agents and XR303 both in Phase I for cancer indications. In addition to its cancer drugs, Xenova is developing two therapeutic vaccines for cocaine and nicotine addiction, in Phase II and Phase I trials respectively. In April 2001 Xenova acquired Cantab Pharmaceuticals plc and in September 2003 it acquired KS Biomedix Holdings plc. Quoted on the London Stock Exchange (XEN) and on NASDAQ (XNVA), Xenova employs approximately 112 people throughout its sites in the UK and North America. (Reuters XEN.L; Bloomberg XEN LN).
Notes to Editors
TransMID(TM)
TransMID(TM) is a treatment initially being developed for high-grade glioma (a type of brain cancer), a disease for which improved treatment is essential, as there remains a poor prognosis for patients. TransMID(TM) is a modified diphtheria toxin conjugated to transferrin. When TransMID(TM) binds to transferrin receptors on the surface of the cell, the diphtheria toxin gains entry to the cell. Once inside the cell, the diphtheria toxin interferes with protein synthesis and ultimately kills the cell. Transferrin receptors are particularly prevalent on rapidly dividing cells, and the high level of transferrin receptor expression on glioma cells relative to normal brain tissue makes transferrin an appropriate targeting mechanism for the diseased cells.
TransMID(TM) is pumped directly into the brain tumour using CED (Convection Enhanced Delivery -- licensed from the National Institutes of Health, Bethesda, Maryland, USA). CED enhances the distribution of TransMID(TM) through the tumour mass and produces high local concentrations of drug. TransMIDTM is directly infused into the tumour in order to reduce systemic side effects. This also has the benefit of circumventing the usual obstacles present in drug delivery to the brain caused by the blood-brain barrier.
Phase I and Phase II clinical trials for TransMID(TM) have been successfully completed in patients suffering from inoperable, recurrent high grade gliomas who have failed to respond to other forms of treatment. A Phase I dose-escalating study was performed at the National Institutes of Health in the US and was followed by a Phase II multi-centre study at nine premier US medical centres.
In a Phase II study, 50% or greater reduction in tumour volume was noted in 35% of evaluable patients, with a corresponding increase in life expectancy in those patients that did respond. Median survival time for patients receiving TransMID(TM) was approximately 37 weeks. This compares to the average life expectancy of approximately 26 weeks for patients with this condition being treated with best standard of care.
TransMID(TM) is currently licensed to Nycomed Denmark A/S in Europe, Sosei Co Ltd in Japan, Medison Pharma Ltd in Israel and Ranbaxy Laboratories Limited in India. The rights to TransMID(TM) in North America have been retained.
Convection Enhanced Delivery
Convection enhanced delivery (CED) involves the slow continuous infusion of TransMID(TM) over several days via one or more catheters directly into the tumour. This technique maximises perfusion of the drug into the target area. Xenova has an exclusive license from the NIH for the use of CED with TransMID(TM) for cancers of the CNS, head and neck.
Special Protocol Assessment
The Prescription Drug User Fee Act of 1992 (PDUFA) goals for special protocol assessment and agreement provide that, upon request, FDA will evaluate within 45 days certain protocols and issues relating to the protocols to assess whether they are adequate to meet scientific and regulatory requirements identified by the sponsor. Three types of protocols related to PDUFA products are eligible for this special protocol assessment under the PDUFA goals: (1) animal carcinogenicity protocols, (2) final product stability protocols, and (3) clinical protocols for Phase III trials whose data will form the primary basis for an efficacy claim if the trials had been the subject of discussion at an end-of-Phase II/pre-Phase III meeting with the review division. For more information on Special Protocol Assessment, please visit www.fda.gov.
For further information about Xenova and its products please visit the Xenova website at www.xenova.co.uk
For Xenova: Disclaimer to take advantage of the "Safe Harbor" provisions of the US Private Securities Litigation Reform Act of 1995. This press release contains "forward-looking statements," including statements about the discovery, development and commercialization of products. Various risks may cause Xenova`s actual results to differ materially from those expressed or implied by the forward looking statements, including: adverse results in our drug discovery and clinical development programs; failure to obtain patent protection for our discoveries; commercial limitations imposed by patents owned or controlled by third parties; our dependence upon strategic alliance partners to develop and commercialize products and services; difficulties or delays in obtaining regulatory approvals to market products and services resulting from our development efforts; the requirement for substantial funding to conduct research and development and to expand commercialization activities; and product initiatives by competitors. For a further list and description of the risks and uncertainties we face, see the reports we have filed with the Securities and Exchange Commission. We disclaim any intention or obligation to update or revise any forward-looking statements, whether as a result of new information, future events or otherwise.
http://hugin.info/133161/R/945165/132951.pdf
CONTACT:
Xenova Group plc
+44 (0)1753 706600
David A Oxlade, Chief Executive Officer
Daniel Abrams, Group Finance Director
Veronica Cefis Sellar, Head of Corporate Communications
UK - Financial Dynamics
+44 (0)20 7831 3113
David Yates
Ben Atwell
US - Trout Group BMC Communications
+1 212 477 9007
Media: Brad Miles Investors: Lee Stern
11 May 2004, 04:35am ET
SLOUGH, U.K. May 11, 2004 (PRIMEZONE) -- Xenova Group plc (LSE:XEN) (Nasdaq:XNVA) announced today that it has reached agreement with the US Food and Drug Administration (FDA) under the Special Protocol Assessment (SPA) procedure for the revised Phase III clinical trial programme proposed for TransMID(TM). Prior to its acquisition by Xenova, KS Biomedix Holdings plc (KS Biomedix) had obtained FDA agreement for a single Phase III clinical trial for TransMID(TM) under the SPA process. Following the acquisition of KS Biomedix, Xenova submitted a revised programme involving two smaller sequential Phase III clinical trials rather than one larger study, which has now been agreed with the FDA. The adoption of a two study approach reduces the level of risk associated with a large single study.
The initial Phase III clinical trial is designed to enrol 323 patients with non-resectable, progressive or recurrent Glioblastoma Multiforme (GBM) who have failed conventional therapy. The study will be a randomised, open-labelled, multi-centre trial and will compare TransMID(TM) against a number of presently used chemotherapeutic agents regarded as "best standard of care" (BSC). The 323 patients will be randomised in a 2:1 ratio of TransMID(TM):BSC across approximately 50 sites in the EU, Israel and North America.
The primary end-point is overall survival time with a planned interimanalysis to be conducted after 50% of the required events have beenobserved. In an earlier, open label, Phase II study, patientsreceiving TransMID(TM) achieved a significant increase in overallsurvival compared with historical survival figures. In this study,median survival for patients receiving TransMIDTM was approximately37 weeks. This compares to the average life expectancy for thesepatients which is currently approximately 26 weeks.
Edward Oldfield MD, Chairman of the Surgical Neurology Branch of the National Institute of Neurological Disorders and Stroke (NINDS) at the National Institutes of Health, Bethesda, Maryland said: "Glioblastoma Multiforme has been a very difficult tumour to treat. This novel approach combines a potent new drug with a targeted delivery method that can distribute the drug directly to the region involved with tumour. In earlier Phase I and Phase II clinical trials, the combination produced complete and partial radiographic responses in several patients."
David A Oxlade, Chief Executive Officer said: "We are pleased to have reached agreement with FDA for the revised programme and we will be starting to enrol patients immediately. People with non-resectable Glioblastoma Multiforme currently have few treatment options and there is a clear need for improved outcomes for these patients."
TransMID(TM) received Fast Track status from the FDA in August 2001 and orphan drug status in December 2001. In addition, the European Commission granted TransMID(TM) orphan designation in March 2002.
Xenova Group plc is a UK-based biopharmaceutical company focused on the development of novel drugs to treat cancer and addiction with a secondary focus in immunotherapy. The Group has a broad pipeline of products in clinical development, including three cancer programmes: its lead product TransMID(TM), for the treatment of high-grade glioma, now beginning Phase III trials, and the novel DNA targeting agents and XR303 both in Phase I for cancer indications. In addition to its cancer drugs, Xenova is developing two therapeutic vaccines for cocaine and nicotine addiction, in Phase II and Phase I trials respectively. In April 2001 Xenova acquired Cantab Pharmaceuticals plc and in September 2003 it acquired KS Biomedix Holdings plc. Quoted on the London Stock Exchange (XEN) and on NASDAQ (XNVA), Xenova employs approximately 112 people throughout its sites in the UK and North America. (Reuters XEN.L; Bloomberg XEN LN).
Notes to Editors
TransMID(TM)
TransMID(TM) is a treatment initially being developed for high-grade glioma (a type of brain cancer), a disease for which improved treatment is essential, as there remains a poor prognosis for patients. TransMID(TM) is a modified diphtheria toxin conjugated to transferrin. When TransMID(TM) binds to transferrin receptors on the surface of the cell, the diphtheria toxin gains entry to the cell. Once inside the cell, the diphtheria toxin interferes with protein synthesis and ultimately kills the cell. Transferrin receptors are particularly prevalent on rapidly dividing cells, and the high level of transferrin receptor expression on glioma cells relative to normal brain tissue makes transferrin an appropriate targeting mechanism for the diseased cells.
TransMID(TM) is pumped directly into the brain tumour using CED (Convection Enhanced Delivery -- licensed from the National Institutes of Health, Bethesda, Maryland, USA). CED enhances the distribution of TransMID(TM) through the tumour mass and produces high local concentrations of drug. TransMIDTM is directly infused into the tumour in order to reduce systemic side effects. This also has the benefit of circumventing the usual obstacles present in drug delivery to the brain caused by the blood-brain barrier.
Phase I and Phase II clinical trials for TransMID(TM) have been successfully completed in patients suffering from inoperable, recurrent high grade gliomas who have failed to respond to other forms of treatment. A Phase I dose-escalating study was performed at the National Institutes of Health in the US and was followed by a Phase II multi-centre study at nine premier US medical centres.
In a Phase II study, 50% or greater reduction in tumour volume was noted in 35% of evaluable patients, with a corresponding increase in life expectancy in those patients that did respond. Median survival time for patients receiving TransMID(TM) was approximately 37 weeks. This compares to the average life expectancy of approximately 26 weeks for patients with this condition being treated with best standard of care.
TransMID(TM) is currently licensed to Nycomed Denmark A/S in Europe, Sosei Co Ltd in Japan, Medison Pharma Ltd in Israel and Ranbaxy Laboratories Limited in India. The rights to TransMID(TM) in North America have been retained.
Convection Enhanced Delivery
Convection enhanced delivery (CED) involves the slow continuous infusion of TransMID(TM) over several days via one or more catheters directly into the tumour. This technique maximises perfusion of the drug into the target area. Xenova has an exclusive license from the NIH for the use of CED with TransMID(TM) for cancers of the CNS, head and neck.
Special Protocol Assessment
The Prescription Drug User Fee Act of 1992 (PDUFA) goals for special protocol assessment and agreement provide that, upon request, FDA will evaluate within 45 days certain protocols and issues relating to the protocols to assess whether they are adequate to meet scientific and regulatory requirements identified by the sponsor. Three types of protocols related to PDUFA products are eligible for this special protocol assessment under the PDUFA goals: (1) animal carcinogenicity protocols, (2) final product stability protocols, and (3) clinical protocols for Phase III trials whose data will form the primary basis for an efficacy claim if the trials had been the subject of discussion at an end-of-Phase II/pre-Phase III meeting with the review division. For more information on Special Protocol Assessment, please visit www.fda.gov.
For further information about Xenova and its products please visit the Xenova website at www.xenova.co.uk
For Xenova: Disclaimer to take advantage of the "Safe Harbor" provisions of the US Private Securities Litigation Reform Act of 1995. This press release contains "forward-looking statements," including statements about the discovery, development and commercialization of products. Various risks may cause Xenova`s actual results to differ materially from those expressed or implied by the forward looking statements, including: adverse results in our drug discovery and clinical development programs; failure to obtain patent protection for our discoveries; commercial limitations imposed by patents owned or controlled by third parties; our dependence upon strategic alliance partners to develop and commercialize products and services; difficulties or delays in obtaining regulatory approvals to market products and services resulting from our development efforts; the requirement for substantial funding to conduct research and development and to expand commercialization activities; and product initiatives by competitors. For a further list and description of the risks and uncertainties we face, see the reports we have filed with the Securities and Exchange Commission. We disclaim any intention or obligation to update or revise any forward-looking statements, whether as a result of new information, future events or otherwise.
http://hugin.info/133161/R/945165/132951.pdf
CONTACT:
Xenova Group plc
+44 (0)1753 706600
David A Oxlade, Chief Executive Officer
Daniel Abrams, Group Finance Director
Veronica Cefis Sellar, Head of Corporate Communications
UK - Financial Dynamics
+44 (0)20 7831 3113
David Yates
Ben Atwell
US - Trout Group BMC Communications
+1 212 477 9007
Media: Brad Miles Investors: Lee Stern
Xenova Group plc -- Positive Results from TA-CD Cocaine Vaccine Trial
14 June 2004, 02:35am ET
SLOUGH, U.K., June 14, 2004 (PRIMEZONE) -- Xenova Group plc (LSE:XEN) (Nasdaq:XNVA) announced today the presentation of results of two dose escalation Phase II studies of TA-CD, a vaccine being developed for the treatment of cocaine addiction, at the College on Problems of Drug Dependence 66th Annual Scientific Meeting in Puerto Rico, June 12-17. Presented by Dr. Bridget Martell, the trials were carried out by Professor Thomas Kosten and his team at Yale University School of Medicine.
The two open-labelled, dose-escalation studies carried out on an out-patient basis, evaluated safety, immunogenicity and clinical efficacy of TA-CD in a total of 22 cocaine users. One of the two studies comprised nine cocaine dependent subjects receiving the TA-CD vaccine and assessed for relapse prevention; these subjects were required to have been free of cocaine use for the two weeks prior to entering the study. The second study included 13 cocaine dependent subjects for abstinence initiation, who were not required to have negative urine cocaine tests prior to enrolment.
Subjects received between three 100 mcg doses and five 400 mcg doses of the TA-CD vaccine (up to 2000 mcg in total). TA-CD was well tolerated in the 20 subjects who completed the two studies.
Results from both studies showed that the maximum mean antibody response occurred between 70 and 90 days post vaccination with specific cocaine antibodies persisting for at least six months. Eight subjects also received a booster 15-18 months post vaccination with TA-CD, all of whom showed increased levels of antibodies two to four weeks later.
Three quarters (75%) of the relapse prevention study group maintained abstinence from cocaine use during the 12-week study duration with 100% relapsing after 12 months when antibody levels had dropped.
In the abstinence initiation study group, 58% achieved and maintained abstinence during the 12-week study and 42% continued to be cocaine free after six months.
The authors additionally reported that the likelihood of using cocaine decreased in those subjects who received a more intense vaccination schedule and as a result were observed to produce higher levels of anti-cocaine antibodies. 88% of subjects in one study and 63% of subjects in the other, who relapsed within six months, reported a reduction in the euphoric effects of cocaine.
Bridget Martell, MD, MA, Associate Research Scientist at Yale University and involved in the TA-CD trials said, "Cocaine dependent users have a serious need for assistance with achieving and maintaining abstinence. We are impressed with these results which, although on a comparatively small number of subjects, are particularly significant as a number of addicts receiving the TA-CD vaccine were able to remain abstinent during the study periods."
David Oxlade, Chief Executive Officer of Xenova said, "These very encouraging results give a strong indication of proof of concept for the TA-CD cocaine vaccine and further validate its potential in assisting cocaine addicts to achieve abstinence."
This study was supported by the US National Institute of Drug Abuse (NIDA). NIDA has also supported earlier clinical work on TA-CD. NIDA has no rights to the commercialisation of TA-CD nor is funding required to be repaid by Xenova.
Mentioned Last Change
XNVA 1.58 (Unchanged)
Xenova Group plc is a UK-based biopharmaceutical company focused on the development of novel drugs to treat cancer and addiction with a secondary focus in immunotherapy. The Company has a broad pipeline of products in clinical development, including three cancer programmes: its lead product TransMIDTM, for the treatment of high-grade glioma, is in Phase III trials, and its novel DNA targeting agents and XR303 are both in Phase I for cancer indications. Xenova is also developing two therapeutic vaccines for cocaine and nicotine addiction, which are in Phase II and Phase I trials respectively. Quoted on the London Stock Exchange (XEN) and on NASDAQ (XNVA), Xenova employs approximately 112 people throughout its sites in the UK and North America. (Reuters XEN.L; Bloomberg XEN LN) For further information about Xenova and its products please visit the Xenova website at www.xenova.co.uk.
Cocaine Prevalence
The Office of National Statistics estimate that there are currently 475,000 powder cocaine and 200,000 crack cocaine addicts in Britain. UK Government figures indicate that deaths caused by Class A drugs rose from 96 in 2001 to 139 in 2002 and that deaths from cocaine poisoning have more than doubled with medical evidence that cocaine causes the heart to age prematurely and leads to the rupture of blood vessels. According to Home Office figures, more than 3 million people in the UK spend a total of 6.6 billion on illegal drugs per year.
In the US, it is estimated that there are approximately 1.7 million addicts, some 3 million occasional users and about 900,000 cocaine users seek medical help for their cocaine addiction every year (Lewin Group report from 1997 based on data from SAMHSA Substance Abuse Mental Health Services Administration).
The US Department of Health and Human Services 2002 National Survey on Drug Use found that more than 33 million people age 12 and older had used cocaine at least once in their lifetime. According to What America`s Users Spend in Illegal Drugs, users spent $35.3 billion on cocaine in 2000, consuming 259 metric tons of cocaine.
Background on cocaine
Cocaine is extracted from the leaves of the coca plant and originally used in South America in the mid-19th Century by natives to relieve fatigue and then for anaesthetic in surgery. Recreational use of powder cocaine, the most potent stimulant of natural origin, increased substantially throughout the 1970`s and crack, the freebase form of cocaine which derives its name from heating the sodium bicarbonate or ammonia used during production, became popular in the mid-1980`s due to its immediate high and inexpensive production cost.
For Xenova: Disclaimer to take advantage of the "Safe Harbor" provisions of the US Private Securities Litigation Reform Act of 1995. This press release contains "forward-looking statements," including statements about development and commercialization of products. Various risks may cause Xenova`s actual results to differ materially from those expressed or implied by the forward looking statements, including: unexpected costs and delays, adverse results in our drug discovery and clinical development programs; failure to obtain patent protection for our discoveries; commercial limitations imposed by patents owned or controlled by third parties; our dependence upon strategic alliance partners to develop and commercialize products and services; difficulties or delays in obtaining regulatory approvals to market products and services resulting from our development efforts; the requirement for substantial funding to conduct research and development and to expand commercialization activities; and product initiatives by competitors. For a further list and description of the risks and uncertainties we face, see the reports we have filed with the Securities and Exchange Commission. We disclaim any intention or obligation to update or revise any forward-looking statements, whether as a result of new information, future events or otherwise.
CONTACT: Xenova Group plc
David A. Oxlade, Chief Executive Officer
Daniel Abrams, Finance Director
Veronica Cefis Sellar, Head of Corporate Communications
+44 (0)1753 706600
UK -- Financial Dynamics
David Yates
Ben Atwell
+44 (0)20 7831 3113
US -- Trout Group/BMC Communications
Media: Brad Miles
Investors: Lee Stern
(212) 477-9007
14 June 2004, 02:35am ET
SLOUGH, U.K., June 14, 2004 (PRIMEZONE) -- Xenova Group plc (LSE:XEN) (Nasdaq:XNVA) announced today the presentation of results of two dose escalation Phase II studies of TA-CD, a vaccine being developed for the treatment of cocaine addiction, at the College on Problems of Drug Dependence 66th Annual Scientific Meeting in Puerto Rico, June 12-17. Presented by Dr. Bridget Martell, the trials were carried out by Professor Thomas Kosten and his team at Yale University School of Medicine.
The two open-labelled, dose-escalation studies carried out on an out-patient basis, evaluated safety, immunogenicity and clinical efficacy of TA-CD in a total of 22 cocaine users. One of the two studies comprised nine cocaine dependent subjects receiving the TA-CD vaccine and assessed for relapse prevention; these subjects were required to have been free of cocaine use for the two weeks prior to entering the study. The second study included 13 cocaine dependent subjects for abstinence initiation, who were not required to have negative urine cocaine tests prior to enrolment.
Subjects received between three 100 mcg doses and five 400 mcg doses of the TA-CD vaccine (up to 2000 mcg in total). TA-CD was well tolerated in the 20 subjects who completed the two studies.
Results from both studies showed that the maximum mean antibody response occurred between 70 and 90 days post vaccination with specific cocaine antibodies persisting for at least six months. Eight subjects also received a booster 15-18 months post vaccination with TA-CD, all of whom showed increased levels of antibodies two to four weeks later.
Three quarters (75%) of the relapse prevention study group maintained abstinence from cocaine use during the 12-week study duration with 100% relapsing after 12 months when antibody levels had dropped.
In the abstinence initiation study group, 58% achieved and maintained abstinence during the 12-week study and 42% continued to be cocaine free after six months.
The authors additionally reported that the likelihood of using cocaine decreased in those subjects who received a more intense vaccination schedule and as a result were observed to produce higher levels of anti-cocaine antibodies. 88% of subjects in one study and 63% of subjects in the other, who relapsed within six months, reported a reduction in the euphoric effects of cocaine.
Bridget Martell, MD, MA, Associate Research Scientist at Yale University and involved in the TA-CD trials said, "Cocaine dependent users have a serious need for assistance with achieving and maintaining abstinence. We are impressed with these results which, although on a comparatively small number of subjects, are particularly significant as a number of addicts receiving the TA-CD vaccine were able to remain abstinent during the study periods."
David Oxlade, Chief Executive Officer of Xenova said, "These very encouraging results give a strong indication of proof of concept for the TA-CD cocaine vaccine and further validate its potential in assisting cocaine addicts to achieve abstinence."
This study was supported by the US National Institute of Drug Abuse (NIDA). NIDA has also supported earlier clinical work on TA-CD. NIDA has no rights to the commercialisation of TA-CD nor is funding required to be repaid by Xenova.
Mentioned Last Change
XNVA 1.58 (Unchanged)
Xenova Group plc is a UK-based biopharmaceutical company focused on the development of novel drugs to treat cancer and addiction with a secondary focus in immunotherapy. The Company has a broad pipeline of products in clinical development, including three cancer programmes: its lead product TransMIDTM, for the treatment of high-grade glioma, is in Phase III trials, and its novel DNA targeting agents and XR303 are both in Phase I for cancer indications. Xenova is also developing two therapeutic vaccines for cocaine and nicotine addiction, which are in Phase II and Phase I trials respectively. Quoted on the London Stock Exchange (XEN) and on NASDAQ (XNVA), Xenova employs approximately 112 people throughout its sites in the UK and North America. (Reuters XEN.L; Bloomberg XEN LN) For further information about Xenova and its products please visit the Xenova website at www.xenova.co.uk.
Cocaine Prevalence
The Office of National Statistics estimate that there are currently 475,000 powder cocaine and 200,000 crack cocaine addicts in Britain. UK Government figures indicate that deaths caused by Class A drugs rose from 96 in 2001 to 139 in 2002 and that deaths from cocaine poisoning have more than doubled with medical evidence that cocaine causes the heart to age prematurely and leads to the rupture of blood vessels. According to Home Office figures, more than 3 million people in the UK spend a total of 6.6 billion on illegal drugs per year.
In the US, it is estimated that there are approximately 1.7 million addicts, some 3 million occasional users and about 900,000 cocaine users seek medical help for their cocaine addiction every year (Lewin Group report from 1997 based on data from SAMHSA Substance Abuse Mental Health Services Administration).
The US Department of Health and Human Services 2002 National Survey on Drug Use found that more than 33 million people age 12 and older had used cocaine at least once in their lifetime. According to What America`s Users Spend in Illegal Drugs, users spent $35.3 billion on cocaine in 2000, consuming 259 metric tons of cocaine.
Background on cocaine
Cocaine is extracted from the leaves of the coca plant and originally used in South America in the mid-19th Century by natives to relieve fatigue and then for anaesthetic in surgery. Recreational use of powder cocaine, the most potent stimulant of natural origin, increased substantially throughout the 1970`s and crack, the freebase form of cocaine which derives its name from heating the sodium bicarbonate or ammonia used during production, became popular in the mid-1980`s due to its immediate high and inexpensive production cost.
For Xenova: Disclaimer to take advantage of the "Safe Harbor" provisions of the US Private Securities Litigation Reform Act of 1995. This press release contains "forward-looking statements," including statements about development and commercialization of products. Various risks may cause Xenova`s actual results to differ materially from those expressed or implied by the forward looking statements, including: unexpected costs and delays, adverse results in our drug discovery and clinical development programs; failure to obtain patent protection for our discoveries; commercial limitations imposed by patents owned or controlled by third parties; our dependence upon strategic alliance partners to develop and commercialize products and services; difficulties or delays in obtaining regulatory approvals to market products and services resulting from our development efforts; the requirement for substantial funding to conduct research and development and to expand commercialization activities; and product initiatives by competitors. For a further list and description of the risks and uncertainties we face, see the reports we have filed with the Securities and Exchange Commission. We disclaim any intention or obligation to update or revise any forward-looking statements, whether as a result of new information, future events or otherwise.
CONTACT: Xenova Group plc
David A. Oxlade, Chief Executive Officer
Daniel Abrams, Finance Director
Veronica Cefis Sellar, Head of Corporate Communications
+44 (0)1753 706600
UK -- Financial Dynamics
David Yates
Ben Atwell
+44 (0)20 7831 3113
US -- Trout Group/BMC Communications
Media: Brad Miles
Investors: Lee Stern
(212) 477-9007
Xenova Receives Manufacturer`s Authorisation from MHRA
21 June 2004, 02:18am ET
SLOUGH, U.K., June 21, 2004 (PRIMEZONE) -- Xenova Group plc (LSE:XEN) (Nasdaq:XNVA) announced today that it has received a Manufacturer`s Authorisation -- Investigational Medicinal Products from the Medicines and Healthcare products Regulatory Agency (MHRA) for its clinical trials manufacturing facility (CTMF) in Cambridge.
This authorisation allows Xenova to manufacture and release investigational medicinal products (IMPs) in compliance with the new Clinical Trials Directive which came into force in May of this year. The authorisation will apply to Xenova`s own products and those manufactured at Xenova under contract for clients. The licence was awarded after the MHRA inspected the company`s premises and confirmed compliance with the EU Good Manufacturing Practices (GMP), which Xenova received in September 2003.
Mike Johnston, Director of Manufacturing and Process Development at Xenova, said, "This authorisation confirms that we are compliant with manufacturing standards that are required under the new clinical trials directive and through the utilisation of excess capacity we can assist other companies in the production of GMP products as well as ensure all Xenova products manufactured at the CTMF are of the highest clinical standard."
Xenova Group plc is a UK-based biopharmaceutical company focused on the development of novel drugs to treat cancer and addiction with a secondary focus in immunotherapy. The Company has a broad pipeline of products in clinical development, including three cancer programmes: its lead product TransMIDTM, for the treatment of high-grade glioma, is in Phase III trials, and its novel DNA targeting agents and XR303 are both in Phase I for cancer indications. Xenova is also developing two therapeutic vaccines for cocaine and nicotine addiction, which are in Phase II and Phase I trials respectively. Quoted on the London Stock Exchange (XEN) and on NASDAQ (XNVA), Xenova employs approximately 112 people throughout its sites in the UK and North America. (Reuters XEN.L; Bloomberg XEN LN)For further information about Xenova and its products please visit the Xenova website at www.xenova.co.uk.
Disclaimer to take advantage of the "Safe Harbor" provisions of the US Private Securities Litigation Reform Act of 1995. This press release contains "forward-looking statements," including statements about our ability to commercialize products. Various risks may cause Xenova`s actual results to differ materially from those expressed or implied by the forward looking statements, including: unexpected costs; commercial limitations imposed by patents owned or controlled by third parties; our dependence upon strategic alliance partners to develop and commercialize products and services; difficulties or delays in obtaining regulatory approvals to market products and services resulting from our development efforts; the requirement for substantial funding to conduct research and development and to expand commercialization activities; and product initiatives by competitors. For a further list and description of the risks and uncertainties we face, see the reports we have filed with the Securities and Exchange Commission. We disclaim any intention or obligation to update or revise any forward-looking statements, whether as a result of new information, future events or otherwise.
http://hugin.info/133161/R/949584/134420.pdf
CONTACT: Xenova Group plc
David A. Oxlade, Chief Executive Officer
Daniel Abrams, Finance Director
Veronica Cefis Sellar, Head of Corporate Communications
+44 (0)1753 706600
UK -- Financial Dynamics
David Yates
Ben Atwell
+44 (0)20 7831 3113
US -- Trout Group/BMC Communications
Media: Brad Miles
Investors: Lee Stern
(212) 477-9007
21 June 2004, 02:18am ET
SLOUGH, U.K., June 21, 2004 (PRIMEZONE) -- Xenova Group plc (LSE:XEN) (Nasdaq:XNVA) announced today that it has received a Manufacturer`s Authorisation -- Investigational Medicinal Products from the Medicines and Healthcare products Regulatory Agency (MHRA) for its clinical trials manufacturing facility (CTMF) in Cambridge.
This authorisation allows Xenova to manufacture and release investigational medicinal products (IMPs) in compliance with the new Clinical Trials Directive which came into force in May of this year. The authorisation will apply to Xenova`s own products and those manufactured at Xenova under contract for clients. The licence was awarded after the MHRA inspected the company`s premises and confirmed compliance with the EU Good Manufacturing Practices (GMP), which Xenova received in September 2003.
Mike Johnston, Director of Manufacturing and Process Development at Xenova, said, "This authorisation confirms that we are compliant with manufacturing standards that are required under the new clinical trials directive and through the utilisation of excess capacity we can assist other companies in the production of GMP products as well as ensure all Xenova products manufactured at the CTMF are of the highest clinical standard."
Xenova Group plc is a UK-based biopharmaceutical company focused on the development of novel drugs to treat cancer and addiction with a secondary focus in immunotherapy. The Company has a broad pipeline of products in clinical development, including three cancer programmes: its lead product TransMIDTM, for the treatment of high-grade glioma, is in Phase III trials, and its novel DNA targeting agents and XR303 are both in Phase I for cancer indications. Xenova is also developing two therapeutic vaccines for cocaine and nicotine addiction, which are in Phase II and Phase I trials respectively. Quoted on the London Stock Exchange (XEN) and on NASDAQ (XNVA), Xenova employs approximately 112 people throughout its sites in the UK and North America. (Reuters XEN.L; Bloomberg XEN LN)For further information about Xenova and its products please visit the Xenova website at www.xenova.co.uk.
Disclaimer to take advantage of the "Safe Harbor" provisions of the US Private Securities Litigation Reform Act of 1995. This press release contains "forward-looking statements," including statements about our ability to commercialize products. Various risks may cause Xenova`s actual results to differ materially from those expressed or implied by the forward looking statements, including: unexpected costs; commercial limitations imposed by patents owned or controlled by third parties; our dependence upon strategic alliance partners to develop and commercialize products and services; difficulties or delays in obtaining regulatory approvals to market products and services resulting from our development efforts; the requirement for substantial funding to conduct research and development and to expand commercialization activities; and product initiatives by competitors. For a further list and description of the risks and uncertainties we face, see the reports we have filed with the Securities and Exchange Commission. We disclaim any intention or obligation to update or revise any forward-looking statements, whether as a result of new information, future events or otherwise.
http://hugin.info/133161/R/949584/134420.pdf
CONTACT: Xenova Group plc
David A. Oxlade, Chief Executive Officer
Daniel Abrams, Finance Director
Veronica Cefis Sellar, Head of Corporate Communications
+44 (0)1753 706600
UK -- Financial Dynamics
David Yates
Ben Atwell
+44 (0)20 7831 3113
US -- Trout Group/BMC Communications
Media: Brad Miles
Investors: Lee Stern
(212) 477-9007
Press Release Source: Xenova Group PLC
Xenova to Host R&D Days
Thursday June 24, 2:11 am ET
SLOUGH, U.K., June 24, 2004 (PRIMEZONE) -- Xenova Group plc (London:XEN.L - News) (NasdaqNM:XNVA - News) will next week host an Investor/Analyst R&D Day in both New York and London. The event in New York will be held at 08:30 a.m. EDT on Tuesday 29 June and the London event will take place at 08:30 a.m. BST on Friday 2 July. The New York R&D Day will be webcast and can be accessed by going to the Company website at http://www.xenova.co.uk. Xenova`s senior management and senior scientific staff will discuss the Company`s clinical development programmes, with a focus on TransMID(tm), the Company`s candidate for treatment of Glioblastoma Multiforme, and will also include presentations on TA-CD and TA-NIC, the Company`s addiction vaccines, the Novel DNA Targeting Agents, and XR303, a candidate for the treatment of pancreatic cancer.
To attend the event in New York, please contact Lee Stern at The Trout Group at 212-477-9007 x22. For the London event, contact Mo Noonan at Financial Dynamics at 020 7831 3113.
http://biz.yahoo.com/pz/040624/59732.html
Xenova to Host R&D Days
Thursday June 24, 2:11 am ET
SLOUGH, U.K., June 24, 2004 (PRIMEZONE) -- Xenova Group plc (London:XEN.L - News) (NasdaqNM:XNVA - News) will next week host an Investor/Analyst R&D Day in both New York and London. The event in New York will be held at 08:30 a.m. EDT on Tuesday 29 June and the London event will take place at 08:30 a.m. BST on Friday 2 July. The New York R&D Day will be webcast and can be accessed by going to the Company website at http://www.xenova.co.uk. Xenova`s senior management and senior scientific staff will discuss the Company`s clinical development programmes, with a focus on TransMID(tm), the Company`s candidate for treatment of Glioblastoma Multiforme, and will also include presentations on TA-CD and TA-NIC, the Company`s addiction vaccines, the Novel DNA Targeting Agents, and XR303, a candidate for the treatment of pancreatic cancer.
To attend the event in New York, please contact Lee Stern at The Trout Group at 212-477-9007 x22. For the London event, contact Mo Noonan at Financial Dynamics at 020 7831 3113.
http://biz.yahoo.com/pz/040624/59732.html
Successful Results from Second Clinical Trial of Anti-Smoking Vaccine, TA-NIC
14 July 2004, 03:59am ET
SLOUGH, U.K., July 14, 2004 (PRIMEZONE) -- Xenova Group plc (LSE:XEN) (Nasdaq:XNVA) announced today initial results from the second clinical trial of TA-NIC, the Company`s therapeutic vaccine being developed for the treatment of nicotine addiction. 60 smokers, divided into three cohorts of 20 subjects, have been recruited into this double-blind, randomised, placebo-controlled study. The objectives of this second Phase I clinical study were to explore the safety, tolerability and level of anti-nicotine antibody response to increasing doses of the vaccine TA-NIC, and to select a dose for Phase II/III evaluation.
Key findings from the study were:
* No drug-related serious adverse events were seen in any
cohort
* Minimal injection-site effects were seen at the dose
selected for Phase II/III studies
* Anti-nicotine antibody responses were dose dependent
* The selected dose showed an improved anti-nicotine
antibody response profile compared to the lowest dose tested:
* Approximately twice the level of anti-nicotine antibodies
were observed
* Faster and more rapid onset of anti-nicotine antibody
response was achieved
* Although not designed to test the effect of the TA-NIC vaccine
on smoker`s quit rates, there was a clear reduction across all
groups receiving TA-NIC compared to those with the placebo group,
in terms of those smokers who voluntarily quit during the
12-week period or self-reported a reduction in smoking pleasure
* At week six, 19 out of the 44 (43%) subjects receiving TA-NIC
voluntarily gave up smoking or reported reduced pleasure when
smoking compared to only 1 out of 11 (9%) receiving the placebo
* On the basis of these results, a Phase II/III dose has been
selected for further clinical evaluation. The final data from
this Phase I study is expected at the end of this year (2004)
with Phase II trials commencing shortly thereafter.
David Oxlade, Chief Executive Officer of Xenova said, "We are most encouraged by these results. The next stage of trials will test TA-NIC`s ability to help smokers break the habit and thereby reduce the serious consequences to health caused by smoking."
Xenova Group plc is a UK-based biopharmaceutical company focused on the development of novel drugs to treat cancer and addiction with a secondary focus in immunotherapy. The Company has a broad pipeline of products in clinical development, including three cancer programmes: its lead product TransMID(TM), for the treatment of high-grade glioma, is in Phase III trials, and its novel DNA targeting agents and XR303 are both in Phase I for cancer indications. Xenova is also developing two therapeutic vaccines for cocaine and nicotine addiction, which are in Phase II and Phase I trials respectively. Quoted on the London Stock Exchange (XEN) and on NASDAQ (XNVA), Xenova employs approximately 112 people throughout its sites in the UK and North America. (Reuters XEN.L; Bloomberg XEN LN) For further information about Xenova and its products please visit the Xenova website at www.xenova.co.uk.
Notes to Editors
Clinical Data
The first Phase I placebo controlled clinical trial was completed in 60 smokers and non-smokers in June 2002. The vaccine was well tolerated locally and systemically up to a course of 5 vaccinations of 50 mcg over 8-20 weeks and a booster vaccine given at 9 months after the initial injection. Nicotine-specific antibodies capable of binding free nicotine were generated, unaffected by smoking status, during the initial primary vaccination course. These antibody levels declined over 3-6 months, but a further significant increase in antibody levels was seen rapidly after the single booster injection.
Smoking Statistics
The World Health Organisation (WHO) notes that the tobacco epidemic is still expanding, especially in developing countries where currently 84% of smokers live. Tobacco use kills 4.9 million people each year and this toll is expected to double in the next 20 years. At current rates, the total number of tobacco users is expected to rise to 1.7 billion by 2025 from 1.3 billion now (May 2004).
Smoking cessation in the UK
Long term (and short term) success rates in terms of smokers reducing or stopping smoking remain low, with only approximately 5% of smokers being able to stop smoking after receiving advice from their doctor; a maximum of approximately 18% succeed when intensive support from specialists as well as nicotine replacement therapy are provided in addition.
Of the 1.3 billion smokers globally, it is estimated that some 4 million smokers each year in the UK attempt to quit, but that only 3-6% (or 1-2% of all smokers) are successful in giving up tobacco. Conventional treatment of nicotine addiction concentrates on psychosocial interventions (counselling, smoking cessation clinics) together with pharmacotherapy, including nicotine replacement therapy (NRT) and bupropion (Zyban(R), GlaxoSmithKline). Even with effective behavioural and pharmacological therapies, many individuals dependant on nicotine fail in their attempts to remain abstinent, with smoking cessation rates of only approximately 10-20% at 1 year. Long term cessation rates are even lower with 40% of ex-smokers relapsing after 12 months abstinence.
Inhaled nicotine is highly addictive. Absorption of nicotine from cigarette smoke through the lung is rapid, producing with each inhalation a high concentration arterial bolus of nicotine that reaches the brain within 10-16 seconds, faster than by intravenous injection. Nicotine is able to cross the blood brain barrier where it binds to acetyl-choline receptors, triggering the release of neurotransmitters, such as dopamine and serotonin. These give rise to positive feelings (pleasure, relaxation, lack of anxiety, suppressed appetite, improved concentration) which are reinforced with each cigarette. Nicotine has a distribution half life of 15-20 minutes and a terminal half life in the blood of two hours. Smokers therefore experience a pattern of repetitive and transient high blood nicotine concentrations from each cigarette, with regular hourly cigarettes needed to maintain raised concentrations, and overnight blood levels dropping near to those of non-smokers. Smoking cessation is difficult to achieve due to the addictive properties of nicotine and the unpleasant withdrawal symptoms (irritability, lack of concentration, weight gain, nicotine craving).
TA-NIC mode of action
TA-NIC is a therapeutic vaccine in development for the treatment of nicotine addiction. Nicotine is a small molecule which, by itself, does not trigger an immune response. However, when nicotine is carried by an immunogenic protein it can prime the immune system to produce anti-nicotine antibodies. The active ingredient of TA-NIC vaccine is a protein conjugate: nicotine butyric acid (NBA) covalently linked to recombinant cholera toxin B (rCTB). rCTB was chosen as the carrier protein because it is known to be highly immunogenic and has been used for many years as a component of cholera vaccine. rCTB has been approved by the Swedish Medical Products Agency for use in an oral cholera vaccine that is marketed in Sweden and Norway and in 2003 was approved by the CPMP.
Nicotine is bound by the induced circulating anti-nicotine antibodies in the bloodstream and the resulting antigen-antibody complex is too large to cross the blood-brain barrier, so the pleasurable stimulus which usually accompanies smoking will be absent or reduced. Without this reward, the motivation to smoke again is reduced, preventing the reinforcement which is required to maintain the nicotine addiction.
References:
NICE Guidance on the use of nicotine replacement therapy (NRT) and bupropion for smoking cessation. March 2002
For Xenova: Disclaimer to take advantage of the "Safe Harbor" provisions of the US Private Securities Litigation Reform Act of 1995. This press release contains "forward-looking statements," including statements about development and commercialization of products. Various risks may cause Xenova`s actual results to differ materially from those expressed or implied by the forward looking statements, including: unexpected costs and delays, adverse results in our drug discovery and clinical development programs; failure to obtain patent protection for our discoveries; commercial limitations imposed by patents owned or controlled by third parties; our dependence upon strategic alliance partners to develop and commercialize products and services; difficulties or delays in obtaining regulatory approvals to market products and services resulting from our development efforts; the requirement for substantial funding to conduct research and development and to expand commercialization activities; and product initiatives by competitors. For a further list and description of the risks and uncertainties we face, see the reports we have filed with the Securities and Exchange Commission. We disclaim any intention or obligation to update or revise any forward-looking statements, whether as a result of new information, future events or otherwise.
To view this release as a .pdf visit the following link:
http://hugin.info/133161/R/952796/135492.pdf
CONTACT:
Xenova Group plc +44 (0)1753 706600
David A. Oxlade, Chief Executive Officer
Daniel Abrams, Finance Director
Veronica Cefis Sellar, Head of Corporate Communications
UK - Financial Dynamics +44 (0)20 7831 3113
David Yates/Ben Atwell
US - Trout Group/BMC Communications
+1 212 477 9007
Media: Brad Miles
Investors: Lee Stern
14 July 2004, 03:59am ET
SLOUGH, U.K., July 14, 2004 (PRIMEZONE) -- Xenova Group plc (LSE:XEN) (Nasdaq:XNVA) announced today initial results from the second clinical trial of TA-NIC, the Company`s therapeutic vaccine being developed for the treatment of nicotine addiction. 60 smokers, divided into three cohorts of 20 subjects, have been recruited into this double-blind, randomised, placebo-controlled study. The objectives of this second Phase I clinical study were to explore the safety, tolerability and level of anti-nicotine antibody response to increasing doses of the vaccine TA-NIC, and to select a dose for Phase II/III evaluation.
Key findings from the study were:
* No drug-related serious adverse events were seen in any
cohort
* Minimal injection-site effects were seen at the dose
selected for Phase II/III studies
* Anti-nicotine antibody responses were dose dependent
* The selected dose showed an improved anti-nicotine
antibody response profile compared to the lowest dose tested:
* Approximately twice the level of anti-nicotine antibodies
were observed
* Faster and more rapid onset of anti-nicotine antibody
response was achieved
* Although not designed to test the effect of the TA-NIC vaccine
on smoker`s quit rates, there was a clear reduction across all
groups receiving TA-NIC compared to those with the placebo group,
in terms of those smokers who voluntarily quit during the
12-week period or self-reported a reduction in smoking pleasure
* At week six, 19 out of the 44 (43%) subjects receiving TA-NIC
voluntarily gave up smoking or reported reduced pleasure when
smoking compared to only 1 out of 11 (9%) receiving the placebo
* On the basis of these results, a Phase II/III dose has been
selected for further clinical evaluation. The final data from
this Phase I study is expected at the end of this year (2004)
with Phase II trials commencing shortly thereafter.
David Oxlade, Chief Executive Officer of Xenova said, "We are most encouraged by these results. The next stage of trials will test TA-NIC`s ability to help smokers break the habit and thereby reduce the serious consequences to health caused by smoking."
Xenova Group plc is a UK-based biopharmaceutical company focused on the development of novel drugs to treat cancer and addiction with a secondary focus in immunotherapy. The Company has a broad pipeline of products in clinical development, including three cancer programmes: its lead product TransMID(TM), for the treatment of high-grade glioma, is in Phase III trials, and its novel DNA targeting agents and XR303 are both in Phase I for cancer indications. Xenova is also developing two therapeutic vaccines for cocaine and nicotine addiction, which are in Phase II and Phase I trials respectively. Quoted on the London Stock Exchange (XEN) and on NASDAQ (XNVA), Xenova employs approximately 112 people throughout its sites in the UK and North America. (Reuters XEN.L; Bloomberg XEN LN) For further information about Xenova and its products please visit the Xenova website at www.xenova.co.uk.
Notes to Editors
Clinical Data
The first Phase I placebo controlled clinical trial was completed in 60 smokers and non-smokers in June 2002. The vaccine was well tolerated locally and systemically up to a course of 5 vaccinations of 50 mcg over 8-20 weeks and a booster vaccine given at 9 months after the initial injection. Nicotine-specific antibodies capable of binding free nicotine were generated, unaffected by smoking status, during the initial primary vaccination course. These antibody levels declined over 3-6 months, but a further significant increase in antibody levels was seen rapidly after the single booster injection.
Smoking Statistics
The World Health Organisation (WHO) notes that the tobacco epidemic is still expanding, especially in developing countries where currently 84% of smokers live. Tobacco use kills 4.9 million people each year and this toll is expected to double in the next 20 years. At current rates, the total number of tobacco users is expected to rise to 1.7 billion by 2025 from 1.3 billion now (May 2004).
Smoking cessation in the UK
Long term (and short term) success rates in terms of smokers reducing or stopping smoking remain low, with only approximately 5% of smokers being able to stop smoking after receiving advice from their doctor; a maximum of approximately 18% succeed when intensive support from specialists as well as nicotine replacement therapy are provided in addition.
Of the 1.3 billion smokers globally, it is estimated that some 4 million smokers each year in the UK attempt to quit, but that only 3-6% (or 1-2% of all smokers) are successful in giving up tobacco. Conventional treatment of nicotine addiction concentrates on psychosocial interventions (counselling, smoking cessation clinics) together with pharmacotherapy, including nicotine replacement therapy (NRT) and bupropion (Zyban(R), GlaxoSmithKline). Even with effective behavioural and pharmacological therapies, many individuals dependant on nicotine fail in their attempts to remain abstinent, with smoking cessation rates of only approximately 10-20% at 1 year. Long term cessation rates are even lower with 40% of ex-smokers relapsing after 12 months abstinence.
Inhaled nicotine is highly addictive. Absorption of nicotine from cigarette smoke through the lung is rapid, producing with each inhalation a high concentration arterial bolus of nicotine that reaches the brain within 10-16 seconds, faster than by intravenous injection. Nicotine is able to cross the blood brain barrier where it binds to acetyl-choline receptors, triggering the release of neurotransmitters, such as dopamine and serotonin. These give rise to positive feelings (pleasure, relaxation, lack of anxiety, suppressed appetite, improved concentration) which are reinforced with each cigarette. Nicotine has a distribution half life of 15-20 minutes and a terminal half life in the blood of two hours. Smokers therefore experience a pattern of repetitive and transient high blood nicotine concentrations from each cigarette, with regular hourly cigarettes needed to maintain raised concentrations, and overnight blood levels dropping near to those of non-smokers. Smoking cessation is difficult to achieve due to the addictive properties of nicotine and the unpleasant withdrawal symptoms (irritability, lack of concentration, weight gain, nicotine craving).
TA-NIC mode of action
TA-NIC is a therapeutic vaccine in development for the treatment of nicotine addiction. Nicotine is a small molecule which, by itself, does not trigger an immune response. However, when nicotine is carried by an immunogenic protein it can prime the immune system to produce anti-nicotine antibodies. The active ingredient of TA-NIC vaccine is a protein conjugate: nicotine butyric acid (NBA) covalently linked to recombinant cholera toxin B (rCTB). rCTB was chosen as the carrier protein because it is known to be highly immunogenic and has been used for many years as a component of cholera vaccine. rCTB has been approved by the Swedish Medical Products Agency for use in an oral cholera vaccine that is marketed in Sweden and Norway and in 2003 was approved by the CPMP.
Nicotine is bound by the induced circulating anti-nicotine antibodies in the bloodstream and the resulting antigen-antibody complex is too large to cross the blood-brain barrier, so the pleasurable stimulus which usually accompanies smoking will be absent or reduced. Without this reward, the motivation to smoke again is reduced, preventing the reinforcement which is required to maintain the nicotine addiction.
References:
NICE Guidance on the use of nicotine replacement therapy (NRT) and bupropion for smoking cessation. March 2002
For Xenova: Disclaimer to take advantage of the "Safe Harbor" provisions of the US Private Securities Litigation Reform Act of 1995. This press release contains "forward-looking statements," including statements about development and commercialization of products. Various risks may cause Xenova`s actual results to differ materially from those expressed or implied by the forward looking statements, including: unexpected costs and delays, adverse results in our drug discovery and clinical development programs; failure to obtain patent protection for our discoveries; commercial limitations imposed by patents owned or controlled by third parties; our dependence upon strategic alliance partners to develop and commercialize products and services; difficulties or delays in obtaining regulatory approvals to market products and services resulting from our development efforts; the requirement for substantial funding to conduct research and development and to expand commercialization activities; and product initiatives by competitors. For a further list and description of the risks and uncertainties we face, see the reports we have filed with the Securities and Exchange Commission. We disclaim any intention or obligation to update or revise any forward-looking statements, whether as a result of new information, future events or otherwise.
To view this release as a .pdf visit the following link:
http://hugin.info/133161/R/952796/135492.pdf
CONTACT:
Xenova Group plc +44 (0)1753 706600
David A. Oxlade, Chief Executive Officer
Daniel Abrams, Finance Director
Veronica Cefis Sellar, Head of Corporate Communications
UK - Financial Dynamics +44 (0)20 7831 3113
David Yates/Ben Atwell
US - Trout Group/BMC Communications
+1 212 477 9007
Media: Brad Miles
Investors: Lee Stern
Kann mich Jemand aufklären?
Name Symbol
890281 XENOVA GROUP PLC XGP
694626 XENOVA GRP ADR/10 XNVA
- XENOVA GRP PLC ORD XNVAF
Bei beiden Boards steht das mit dem Rauchen drinn, aber die Kurse sind gewaltig unterschiedlich!
jethor
Name Symbol
890281 XENOVA GROUP PLC XGP
694626 XENOVA GRP ADR/10 XNVA
- XENOVA GRP PLC ORD XNVAF
Bei beiden Boards steht das mit dem Rauchen drinn, aber die Kurse sind gewaltig unterschiedlich!
jethor
@jethor tull
Es handelt sich in beiden Fällen um das gleiche Unternehmen.
Die unter der WKN 890281 in D gehandelten Aktien sind vergleichbar mit den an der Heimatbörse London gehandelten Stücken. Die ADR/10 sind wegen der NASDAQ-Listung (Kurs > 1 $) gedacht. 1 ADR entspricht in der Relation 10 Aktien. Allerdings ist es leider nicht sonderlich empfehlenswert in D zu ordern. Bid und Ask sind nur für den Makler bestens
Es handelt sich in beiden Fällen um das gleiche Unternehmen.
Die unter der WKN 890281 in D gehandelten Aktien sind vergleichbar mit den an der Heimatbörse London gehandelten Stücken. Die ADR/10 sind wegen der NASDAQ-Listung (Kurs > 1 $) gedacht. 1 ADR entspricht in der Relation 10 Aktien. Allerdings ist es leider nicht sonderlich empfehlenswert in D zu ordern. Bid und Ask sind nur für den Makler bestens
GelbeSeiten,
hab vielen Dank!
jethor
Schau dir doch mal Rambus an, 906870, ist meine Favorit!
jethor
hab vielen Dank!
jethor
Schau dir doch mal Rambus an, 906870, ist meine Favorit!
jethor
Xenova Group PLC -- Third Quarter Results, 2004
4 November 2004, 02:43am ET
SLOUGH, U.K., Nov. 4, 2004 (PRIMEZONE) -- Xenova Group plc (Nasdaq:XNVA) (LSE:XEN) today announced its results for the quarter ended 30 September 2004.
Quarterly Highlights
-- TransMID(tm) - pivotal Phase III study in glioblastoma
multiforme commenced and patient recruitment progressing
-- TA-NIC -- successful results from a second Phase I clinical
trial of the anti-smoking therapy provided anecdotal
indications of efficacy
-- Canadian manufacturing facility sold to QSV Biologics for
C$7.0m (3.1m, $5.5m) completing the planned disposal programme
-- Cash, short term deposits and investments 15.6m ($28.0m) (31
December 2003: 27.5m ($49.5m))
Commenting, Chief Executive Officer, David Oxlade said: "This quarter has seen steady progress across the portfolio with the highlight being the commencement of the Phase III trial of TransMID(tm). Patient recruitment is advancing with most clinical centres now up and running. The positive initial results of TA-NIC`s second Phase I study have provided further anecdotal evidence of efficacy in the treatment of nicotine addiction."
Quarterly Review
Development has continued throughout the quarter on the Group`s prioritised programmes and corporate objectives, with the current status being:
TransMID(tm)
TransMID(tm) is Xenova`s most advanced clinical product, for the treatment of progressive and/or recurrent non-resectable glioblastoma multiforme (the most common form of high-grade glioma or brain cancer). Patient dosing for the Phase III clinical study began in July 2004 and recruitment is progressing.
The Phase III trial will enrol up to 323 patients with non-resectable, progressive and/or recurrent glioblastoma multiforme who have failed conventional therapy. The study is a randomised, open-labelled, multi-centre trial designed to compare TransMID(tm) against a number of presently used chemotherapeutic agents regarded as "best standard of care" (BSC). The 323 patients will be randomised in a 2:1 ratio of TransMID(TM) to BSC across 50 centres -- 25 in the EU, 21 in the U.S. and 4 in Israel.
TransMID(tm) is pumped directly into the brain tumour using Convection Enhanced Delivery (CED) -- licensed from the National Institutes of Health in the U.S. CED enhances the distribution of TransMID(tm) through the tumour mass, producing high local concentrations of the drug and reducing systemic side effects. This also has the benefit of circumventing the usual obstacles present in drug delivery to the brain caused by the blood brain barrier.
In an earlier Phase II study involving 44 patients, a 50% or greater reduction in tumour volume was noted in 35% of evaluable patients. In this study, median survival for patients receiving TransMID(tm) on an intent to treat (ITT) basis was approximately 37 weeks. This compares to a historical average life expectancy of approximately 26 weeks for patients being treated with BSC, as determined from the literature.
TransMID(tm) is licensed to Nycomed Danmark ApS in Europe, Sosei Co Ltd in Japan, Medison Pharma Ltd in Israel and Ranbaxy Laboratories Limited in India. Xenova retains all rights to countries outside these territories including North America.
Novel DNA Targeting Agents
This programme consists of three compounds being developed for the treatment of solid tumours, two of which are in Phase I, XR5944 and XR11576.
In late September a paper was published in the British Journal of Cancer relating to the first Phase I study of XR11576, an oral DNA targeting agent. The objectives of this Phase I study were to:
-- Assess the dose-limiting toxicities (DLT)
-- Determine the maximum tolerated dose (MTD)
-- Describe the pharmacokinetics of XR11576
The trial was conducted in patients with advanced solid tumours with the drug administered orally on days 1-5 every three weeks. In all, 21 patients received a total of 47 courses of treatment. The MTD was reached at 180mg/day, with diarrhoea and fatigue identified as the DLT. Four patients experienced stable disease for periods of 12-30 weeks. Alternative regimens are currently being explored in a second Phase I setting.
During the period, drug candidate XR5944 has continued in Phase I studies.
Millennium Pharmaceuticals Inc. has commercial rights to this programme in North America in return for funding the clinical development programme and Xenova retains commercial rights to the rest of the world.
XR303
XR303 is a radioimmunotherapy product targeted at late stage pancreatic cancer. Following encouraging results from a Phase I imaging study in colorectal cancer patients, XR303 is now undergoing a Phase I/II clinical trial in patients with pancreatic cancer which is expected to complete in 2005.
On 22 October 2004, XR303 was the subject of a presentation by The Royal Liverpool and Broadgreen University Hospitals at the 10th Conference on Cancer Therapy with Antibodies and Immunoconjugates in Princeton, U.S. The presentation provided an update on the on-going clinical trial in pancreatic cancer with seven patients recruited in total.
Xenova retains all rights to XR303.
Tariquidar Tariquidar, discovered by Xenova, is a potent small-molecule inhibitor of the P-glycoprotein pump, designed to treat multi-drug resistance (MDR) in cancer. Following the cessation of the Phase III clinical trial in early 2003, the National Cancer Institute (NCI) in the U.S. has continued to undertake exploratory clinical trials using tariquidar in combination with different cytotoxic drugs, including a Phase II study in patients with recurrent, metastatic, or primary unresectable adrenocortical cancer.
Xenova will review the future development prospects of tariquidar once the NCI reports on the results of the above three trials. Xenova is not providing funding for any of the NCI trials. An existing development and North American marketing agreement exists between Xenova and QLT Inc for the tariquidar programme.
TA-CD
TA-CD, Xenova`s treatment for cocaine addiction, is undergoing a Phase IIa administration study designed to evaluate the effect of TA-CD on behavioural changes associated with cocaine administration under laboratory conditions. Results of this trial are expected in 2005. Results of two dose escalation Phase II studies (relapse prevention study and abstinence initiation study) of TA-CD were reported in June showing that the maximum mean antibody response occurred between 70 and 90 days post vaccination, with cocaine-specific antibodies persisting for at least six months.
Three quarters (75%) of the relapse prevention group maintained abstinence from cocaine use during the 12 week study duration with 100% relapsing after 12 months when antibody levels had dropped. In the abstinence initiation group, 58% achieved and maintained abstinence during the 12-week study period and 42% continued to be cocaine free after six months.
The authors also reported that the likelihood of using cocaine decreased in those subjects who received a more intense vaccination schedule and as a result were observed to produce higher levels of anti-cocaine antibodies. 88% of subjects from one study and 63% from the other, who relapsed within six months, reported a reduction in the euphoric effects of cocaine.
A randomised, placebo-controlled Phase IIb study of TA-CD in up to 132 patients is underway with recruitment in progress. The primary objective of this study is to determine the efficacy of TA-CD in methadone-dependent cocaine addicts seeking treatment for cocaine abuse, and to determine the appropriate end points for a Phase III trial.
The National Institute on Drug Abuse is supporting these studies but Xenova retains all commercial rights to TA-CD.
TA-NIC
Initial results of the second Phase I clinical trial of TA-NIC, a product being developed for the treatment of nicotine addiction, were announced during the quarter on 14 July 2004. These results showed that there were no drug-related serious adverse events in any of the three cohorts with minimal injection-site effects seen at the dose selected for Phase II/III studies.
The anti-nicotine antibody responses were dose dependent and at the selected dose, an improved anti-nicotine antibody response profile was observed compared to the lowest dose tested. The data showed that the level of anti-nicotine antibodies obtained with the chosen dose was approximately double that seen at the low dose. There was also a faster rise and more rapid onset of anti-nicotine antibody response.
Although not designed to test the effect of TA-NIC on smokers` quit rates, there was a clear reduction across all groups receiving the vaccine in terms of those smokers who voluntarily quit during the 12-week period or self-reported a reduction in smoking pleasure compared to those receiving the placebo.
Mentioned Last Change
XNVA 1.55 0.03dollars or (1.97%)
Final results of this study are expected by the end of 2004 and commencement of a rolling Phase II/III study is expected in 2005. Xenova retains all commercial rights to TA-NIC.
OX40
OX40 is a platform technology capable of producing multiple drug candidates targeting cancer, autoimmune and other diseases where the immune system is involved. In 2003, a research group at Imperial College demonstrated that by blocking the OX40-OX40 ligand (OX40L) interaction (down-regulation), symptoms of influenza could be alleviated without affecting the ability to clear the virus. In contrast, the use of agents such as OX40L-IgG that bind to OX40 and up-regulate the immune response, has been shown to be effective at promoting anti-tumour responses in a number of cancer models.
Xenova retains all rights for the use of OX40 in up-regulation whilst Genentech Inc and UCB Pharma (previously Celltech Group plc and part of UCB Group SA) have rights for down-regulation of the immune system.
Corporate Events
During the quarter, Xenova announced the disposal of its manufacturing facility in Edmonton, Canada, to QSV Biologics Ltd (QSV) for C$7.0 million (3.1 million, $5.5 million). The sale concluded the planned disposals and cost reduction programme announced at the time of the acquisition of KS Biomedix Holdings plc.
The proceeds of the Edmonton facility, together with the disposal announced in January 2004 of surplus facilities in Farnham, U.K., amount to a total of 3.9 million ($7.0 million). In addition, in April 2004, a 10 year lease agreement was signed with Genzyme Limited for vacant space in Xenova`s facilities on the Cambridge Science Park, U.K.
Financial Summary
Operating Performance
In the nine months to 30 September 2004, the Group`s revenues recognised from licensing agreements, strategic partnerships and manufacturing outsourcing were 3.8m ($6.9m) (2003: 6.9m ($12.4m)).
Revenue included 2.1m ($3.7m) recognised under the revenue recognition policy in respect of the tariquidar licensing agreement with QLT and the OX40 licensing agreement with Genentech Inc. 0.5m ($1.0m) was also recognised in respect of the milestone due from Nycomed Danmark ApS for the first patient treated in the TransMID(tm) trial. Contract development revenue of 0.5m ($0.9m) arose in respect of the Millennium Pharmaceuticals Inc. collaboration on the DNA targeting agents and manufacturing revenue was 0.7m ($1.3m).
Total net operating expenses for the nine months ended 30 September 2004 were 17.1m ($30.8m) (2003: 18.8m ($33.8m)). Excluding the exceptional reorganisation costs to 30 September 2003 of 3.4m ($6.0m), the impact of increased goodwill amortisation charges in 2004 and the costs of discontinued operations, net operating expenses in the period to 30 September 2004 were 3% lower than the prior year.
Research and development expenditure for the nine months ended 30 September 2004 were 11.9m ($21.4m) (2003: 11.7m ($21.1m)). R&D expenditure, excluding the costs of discontinued operations, was 10.7m ($19.3m) which is 9% lower than the prior year. This reduction is mainly due to a fall in the costs of the DNA targeting agents programme in the period. Expenditure was incurred primarily in respect of the TransMID(tm) programme, the Phase I/II dose escalation trial of XR303, and the vaccines of addiction programmes including the second Phase I study in TA-NIC. The development costs under the Millennium license agreement of 0.5m ($0.9m) have been recovered as in previous periods.
Total administrative expenditure for the nine months to 30 September 2004 of 5.8m ($10.4m) (2003: 7.4m ($13.3m)) included 1.6m ($2.9m) in respect of goodwill amortisation related to the acquisitions of Cantab Pharmaceuticals plc (Cantab) and KS Biomedix Holdings plc (KS Biomedix). Administrative expenses, excluding the costs of discontinued operations, amortisation of goodwill and exceptional reorganisation costs were 3.8m ($6.9m) (2003: 3.1m ($5.6m)). The subletting of vacant space in Slough and Cambridge reduced net expenses in the period by 0.5m ($1.0m) (2003: 0.3m ($0.6m)).
The increase in investment income recorded for the period compared with the prior year reflects the higher average cash and liquid resources balances held following the fundraising in December 2003 and the impact of higher interest rates. The R&D tax credits recoverable for the nine months have increased to reflect the impact of the KS Biomedix acquisition and the revised impact of the reorganisation announced in June 2003.
The net loss per share for the nine months to 30 September 2004 was 2.7p (2003: 6.1p).
Cash, Short-Term Deposits and Investments
Cash, short-term deposits and investments at 30 September 2004 totalled 15.6m ($28.0m) (31 December 2003: 27.5m ($49.5m)). The Group held cash of 2.2m ($4.0m) and short-term deposits and investments of 13.4m ($24.0m) at 30 September 2004 (31 December 2003: cash 12.1m ($21.7m), short-term deposits and investments 15.4m ($27.8m)).
Included in short-term deposits and investments is an investment in Cubist Pharmaceuticals Inc. As at 30 September 2004 the share price was $9.88 valuing the investment at 0.4m ($0.6m).
Share Capital
The number of shares in issue stood at 431.5 million as at 30 September 2004.
The Directors do not currently propose a dividend for 2004 (2003: nil).
Sale of Edmonton Facility
On 3 September 2004, Xenova announced the completion of the sale of its manufacturing facility based in Edmonton, Canada, to QSV Biologics Limited for C$7.0m (3.1m, $5.5m). The consideration comprises C$5.0m payable in cash on completion and C$2.0m deferred in two equal secured promissory notes maturing 12 and 18 months following completion. Xenova has also agreed terms for a manufacturing and supply contract for TransMID(tm) with the purchaser. The disposal resulted in 30 employees transferring from Xenova to the purchaser. The Directors estimate that the annualised reduction in net operating expenses as a result of the disposal, ignoring the impact of the manufacturing contract, will be approximately 1.8m ($3.2m). Net assets disposed as part of the transaction amounted to C$6.7m (2.9m, $5.3m).
Going Concern
Xenova is an emerging pharmaceutical business and as such expects to absorb cash until products are commercialised. The Directors have a reasonable expectation that the Group has, or can reasonably expect to obtain, adequate cash resources in order to enable it to continue in operational existence for the foreseeable future, and have therefore prepared the financial statements on the going concern basis.
Xenova Group plc is a UK-based biopharmaceutical company focused on the development of novel drugs to treat cancer and addiction with a secondary focus in immunotherapy. The Company has a broad pipeline of products in clinical development, including three cancer programmes: its lead product TransMID(tm), for the treatment of high-grade glioma, is in Phase III trials, and its novel DNA targeting agents and XR303 are both in Phase I for cancer indications. Xenova is also developing two therapeutic vaccines for cocaine and nicotine addiction, which are in Phase II and Phase I trials respectively. Quoted on the London Stock Exchange (XEN) and on NASDAQ (XNVA), Xenova employs approximately 75 people throughout its sites in the UK and North America. (Reuters XEN.L; Bloomberg XEN LN) For further information about Xenova and its products please visit the Xenova website at www.xenova.co.uk.
For Xenova: Disclaimer to take advantage of the "Safe Harbor" provisions of the US Private Securities Litigation Reform Act of 1995. This press release contains "forward-looking statements," including statements about our ability to integrate acquired businesses and realize cost savings from integration, and the discovery, development and commercialization of products and the ability to raise finance. Various risks may cause Xenova`s actual results to differ materially from those expressed or implied by the forward looking statements, including: unexpected costs and delays in integrating acquired businesses into our group, adverse results in our drug discovery and clinical development programs; failure to obtain patent protection for our discoveries; commercial limitations imposed by patents owned or controlled by third parties; our dependence upon strategic alliance partners to develop and commercialize products and services; difficulties or delays in obtaining regulatory approvals to market products and services resulting from our development efforts; the requirement for substantial funding to conduct research and development and to expand commercialization activities; and product initiatives by competitors. For a further list and description of the risks and uncertainties we face, see the reports we have filed with the Securities and Exchange Commission. We disclaim any intention or obligation to update or revise any forward-looking statements, whether as a result of new information, future events or otherwise.
To view the full press release including financial tables, please click on the link provided.
CONTACT: Xenova Group plc
David A Oxlade, Chief Executive Officer
Daniel Abrams, Finance Director
Veronica Cefis Sellar, Head of Corporate Communications
+44 (0)1753 706600
UK -- Financial Dynamics
David Yates
Ben Atwell
+44 (0)20 7831 3113
U.S. -- Trout Group/BMC Communications
Media: Brad Miles
Investors: Lee Stern
(212) 477-9007
4 November 2004, 02:43am ET
SLOUGH, U.K., Nov. 4, 2004 (PRIMEZONE) -- Xenova Group plc (Nasdaq:XNVA) (LSE:XEN) today announced its results for the quarter ended 30 September 2004.
Quarterly Highlights
-- TransMID(tm) - pivotal Phase III study in glioblastoma
multiforme commenced and patient recruitment progressing
-- TA-NIC -- successful results from a second Phase I clinical
trial of the anti-smoking therapy provided anecdotal
indications of efficacy
-- Canadian manufacturing facility sold to QSV Biologics for
C$7.0m (3.1m, $5.5m) completing the planned disposal programme
-- Cash, short term deposits and investments 15.6m ($28.0m) (31
December 2003: 27.5m ($49.5m))
Commenting, Chief Executive Officer, David Oxlade said: "This quarter has seen steady progress across the portfolio with the highlight being the commencement of the Phase III trial of TransMID(tm). Patient recruitment is advancing with most clinical centres now up and running. The positive initial results of TA-NIC`s second Phase I study have provided further anecdotal evidence of efficacy in the treatment of nicotine addiction."
Quarterly Review
Development has continued throughout the quarter on the Group`s prioritised programmes and corporate objectives, with the current status being:
TransMID(tm)
TransMID(tm) is Xenova`s most advanced clinical product, for the treatment of progressive and/or recurrent non-resectable glioblastoma multiforme (the most common form of high-grade glioma or brain cancer). Patient dosing for the Phase III clinical study began in July 2004 and recruitment is progressing.
The Phase III trial will enrol up to 323 patients with non-resectable, progressive and/or recurrent glioblastoma multiforme who have failed conventional therapy. The study is a randomised, open-labelled, multi-centre trial designed to compare TransMID(tm) against a number of presently used chemotherapeutic agents regarded as "best standard of care" (BSC). The 323 patients will be randomised in a 2:1 ratio of TransMID(TM) to BSC across 50 centres -- 25 in the EU, 21 in the U.S. and 4 in Israel.
TransMID(tm) is pumped directly into the brain tumour using Convection Enhanced Delivery (CED) -- licensed from the National Institutes of Health in the U.S. CED enhances the distribution of TransMID(tm) through the tumour mass, producing high local concentrations of the drug and reducing systemic side effects. This also has the benefit of circumventing the usual obstacles present in drug delivery to the brain caused by the blood brain barrier.
In an earlier Phase II study involving 44 patients, a 50% or greater reduction in tumour volume was noted in 35% of evaluable patients. In this study, median survival for patients receiving TransMID(tm) on an intent to treat (ITT) basis was approximately 37 weeks. This compares to a historical average life expectancy of approximately 26 weeks for patients being treated with BSC, as determined from the literature.
TransMID(tm) is licensed to Nycomed Danmark ApS in Europe, Sosei Co Ltd in Japan, Medison Pharma Ltd in Israel and Ranbaxy Laboratories Limited in India. Xenova retains all rights to countries outside these territories including North America.
Novel DNA Targeting Agents
This programme consists of three compounds being developed for the treatment of solid tumours, two of which are in Phase I, XR5944 and XR11576.
In late September a paper was published in the British Journal of Cancer relating to the first Phase I study of XR11576, an oral DNA targeting agent. The objectives of this Phase I study were to:
-- Assess the dose-limiting toxicities (DLT)
-- Determine the maximum tolerated dose (MTD)
-- Describe the pharmacokinetics of XR11576
The trial was conducted in patients with advanced solid tumours with the drug administered orally on days 1-5 every three weeks. In all, 21 patients received a total of 47 courses of treatment. The MTD was reached at 180mg/day, with diarrhoea and fatigue identified as the DLT. Four patients experienced stable disease for periods of 12-30 weeks. Alternative regimens are currently being explored in a second Phase I setting.
During the period, drug candidate XR5944 has continued in Phase I studies.
Millennium Pharmaceuticals Inc. has commercial rights to this programme in North America in return for funding the clinical development programme and Xenova retains commercial rights to the rest of the world.
XR303
XR303 is a radioimmunotherapy product targeted at late stage pancreatic cancer. Following encouraging results from a Phase I imaging study in colorectal cancer patients, XR303 is now undergoing a Phase I/II clinical trial in patients with pancreatic cancer which is expected to complete in 2005.
On 22 October 2004, XR303 was the subject of a presentation by The Royal Liverpool and Broadgreen University Hospitals at the 10th Conference on Cancer Therapy with Antibodies and Immunoconjugates in Princeton, U.S. The presentation provided an update on the on-going clinical trial in pancreatic cancer with seven patients recruited in total.
Xenova retains all rights to XR303.
Tariquidar Tariquidar, discovered by Xenova, is a potent small-molecule inhibitor of the P-glycoprotein pump, designed to treat multi-drug resistance (MDR) in cancer. Following the cessation of the Phase III clinical trial in early 2003, the National Cancer Institute (NCI) in the U.S. has continued to undertake exploratory clinical trials using tariquidar in combination with different cytotoxic drugs, including a Phase II study in patients with recurrent, metastatic, or primary unresectable adrenocortical cancer.
Xenova will review the future development prospects of tariquidar once the NCI reports on the results of the above three trials. Xenova is not providing funding for any of the NCI trials. An existing development and North American marketing agreement exists between Xenova and QLT Inc for the tariquidar programme.
TA-CD
TA-CD, Xenova`s treatment for cocaine addiction, is undergoing a Phase IIa administration study designed to evaluate the effect of TA-CD on behavioural changes associated with cocaine administration under laboratory conditions. Results of this trial are expected in 2005. Results of two dose escalation Phase II studies (relapse prevention study and abstinence initiation study) of TA-CD were reported in June showing that the maximum mean antibody response occurred between 70 and 90 days post vaccination, with cocaine-specific antibodies persisting for at least six months.
Three quarters (75%) of the relapse prevention group maintained abstinence from cocaine use during the 12 week study duration with 100% relapsing after 12 months when antibody levels had dropped. In the abstinence initiation group, 58% achieved and maintained abstinence during the 12-week study period and 42% continued to be cocaine free after six months.
The authors also reported that the likelihood of using cocaine decreased in those subjects who received a more intense vaccination schedule and as a result were observed to produce higher levels of anti-cocaine antibodies. 88% of subjects from one study and 63% from the other, who relapsed within six months, reported a reduction in the euphoric effects of cocaine.
A randomised, placebo-controlled Phase IIb study of TA-CD in up to 132 patients is underway with recruitment in progress. The primary objective of this study is to determine the efficacy of TA-CD in methadone-dependent cocaine addicts seeking treatment for cocaine abuse, and to determine the appropriate end points for a Phase III trial.
The National Institute on Drug Abuse is supporting these studies but Xenova retains all commercial rights to TA-CD.
TA-NIC
Initial results of the second Phase I clinical trial of TA-NIC, a product being developed for the treatment of nicotine addiction, were announced during the quarter on 14 July 2004. These results showed that there were no drug-related serious adverse events in any of the three cohorts with minimal injection-site effects seen at the dose selected for Phase II/III studies.
The anti-nicotine antibody responses were dose dependent and at the selected dose, an improved anti-nicotine antibody response profile was observed compared to the lowest dose tested. The data showed that the level of anti-nicotine antibodies obtained with the chosen dose was approximately double that seen at the low dose. There was also a faster rise and more rapid onset of anti-nicotine antibody response.
Although not designed to test the effect of TA-NIC on smokers` quit rates, there was a clear reduction across all groups receiving the vaccine in terms of those smokers who voluntarily quit during the 12-week period or self-reported a reduction in smoking pleasure compared to those receiving the placebo.
Mentioned Last Change
XNVA 1.55 0.03dollars or (1.97%)
Final results of this study are expected by the end of 2004 and commencement of a rolling Phase II/III study is expected in 2005. Xenova retains all commercial rights to TA-NIC.
OX40
OX40 is a platform technology capable of producing multiple drug candidates targeting cancer, autoimmune and other diseases where the immune system is involved. In 2003, a research group at Imperial College demonstrated that by blocking the OX40-OX40 ligand (OX40L) interaction (down-regulation), symptoms of influenza could be alleviated without affecting the ability to clear the virus. In contrast, the use of agents such as OX40L-IgG that bind to OX40 and up-regulate the immune response, has been shown to be effective at promoting anti-tumour responses in a number of cancer models.
Xenova retains all rights for the use of OX40 in up-regulation whilst Genentech Inc and UCB Pharma (previously Celltech Group plc and part of UCB Group SA) have rights for down-regulation of the immune system.
Corporate Events
During the quarter, Xenova announced the disposal of its manufacturing facility in Edmonton, Canada, to QSV Biologics Ltd (QSV) for C$7.0 million (3.1 million, $5.5 million). The sale concluded the planned disposals and cost reduction programme announced at the time of the acquisition of KS Biomedix Holdings plc.
The proceeds of the Edmonton facility, together with the disposal announced in January 2004 of surplus facilities in Farnham, U.K., amount to a total of 3.9 million ($7.0 million). In addition, in April 2004, a 10 year lease agreement was signed with Genzyme Limited for vacant space in Xenova`s facilities on the Cambridge Science Park, U.K.
Financial Summary
Operating Performance
In the nine months to 30 September 2004, the Group`s revenues recognised from licensing agreements, strategic partnerships and manufacturing outsourcing were 3.8m ($6.9m) (2003: 6.9m ($12.4m)).
Revenue included 2.1m ($3.7m) recognised under the revenue recognition policy in respect of the tariquidar licensing agreement with QLT and the OX40 licensing agreement with Genentech Inc. 0.5m ($1.0m) was also recognised in respect of the milestone due from Nycomed Danmark ApS for the first patient treated in the TransMID(tm) trial. Contract development revenue of 0.5m ($0.9m) arose in respect of the Millennium Pharmaceuticals Inc. collaboration on the DNA targeting agents and manufacturing revenue was 0.7m ($1.3m).
Total net operating expenses for the nine months ended 30 September 2004 were 17.1m ($30.8m) (2003: 18.8m ($33.8m)). Excluding the exceptional reorganisation costs to 30 September 2003 of 3.4m ($6.0m), the impact of increased goodwill amortisation charges in 2004 and the costs of discontinued operations, net operating expenses in the period to 30 September 2004 were 3% lower than the prior year.
Research and development expenditure for the nine months ended 30 September 2004 were 11.9m ($21.4m) (2003: 11.7m ($21.1m)). R&D expenditure, excluding the costs of discontinued operations, was 10.7m ($19.3m) which is 9% lower than the prior year. This reduction is mainly due to a fall in the costs of the DNA targeting agents programme in the period. Expenditure was incurred primarily in respect of the TransMID(tm) programme, the Phase I/II dose escalation trial of XR303, and the vaccines of addiction programmes including the second Phase I study in TA-NIC. The development costs under the Millennium license agreement of 0.5m ($0.9m) have been recovered as in previous periods.
Total administrative expenditure for the nine months to 30 September 2004 of 5.8m ($10.4m) (2003: 7.4m ($13.3m)) included 1.6m ($2.9m) in respect of goodwill amortisation related to the acquisitions of Cantab Pharmaceuticals plc (Cantab) and KS Biomedix Holdings plc (KS Biomedix). Administrative expenses, excluding the costs of discontinued operations, amortisation of goodwill and exceptional reorganisation costs were 3.8m ($6.9m) (2003: 3.1m ($5.6m)). The subletting of vacant space in Slough and Cambridge reduced net expenses in the period by 0.5m ($1.0m) (2003: 0.3m ($0.6m)).
The increase in investment income recorded for the period compared with the prior year reflects the higher average cash and liquid resources balances held following the fundraising in December 2003 and the impact of higher interest rates. The R&D tax credits recoverable for the nine months have increased to reflect the impact of the KS Biomedix acquisition and the revised impact of the reorganisation announced in June 2003.
The net loss per share for the nine months to 30 September 2004 was 2.7p (2003: 6.1p).
Cash, Short-Term Deposits and Investments
Cash, short-term deposits and investments at 30 September 2004 totalled 15.6m ($28.0m) (31 December 2003: 27.5m ($49.5m)). The Group held cash of 2.2m ($4.0m) and short-term deposits and investments of 13.4m ($24.0m) at 30 September 2004 (31 December 2003: cash 12.1m ($21.7m), short-term deposits and investments 15.4m ($27.8m)).
Included in short-term deposits and investments is an investment in Cubist Pharmaceuticals Inc. As at 30 September 2004 the share price was $9.88 valuing the investment at 0.4m ($0.6m).
Share Capital
The number of shares in issue stood at 431.5 million as at 30 September 2004.
The Directors do not currently propose a dividend for 2004 (2003: nil).
Sale of Edmonton Facility
On 3 September 2004, Xenova announced the completion of the sale of its manufacturing facility based in Edmonton, Canada, to QSV Biologics Limited for C$7.0m (3.1m, $5.5m). The consideration comprises C$5.0m payable in cash on completion and C$2.0m deferred in two equal secured promissory notes maturing 12 and 18 months following completion. Xenova has also agreed terms for a manufacturing and supply contract for TransMID(tm) with the purchaser. The disposal resulted in 30 employees transferring from Xenova to the purchaser. The Directors estimate that the annualised reduction in net operating expenses as a result of the disposal, ignoring the impact of the manufacturing contract, will be approximately 1.8m ($3.2m). Net assets disposed as part of the transaction amounted to C$6.7m (2.9m, $5.3m).
Going Concern
Xenova is an emerging pharmaceutical business and as such expects to absorb cash until products are commercialised. The Directors have a reasonable expectation that the Group has, or can reasonably expect to obtain, adequate cash resources in order to enable it to continue in operational existence for the foreseeable future, and have therefore prepared the financial statements on the going concern basis.
Xenova Group plc is a UK-based biopharmaceutical company focused on the development of novel drugs to treat cancer and addiction with a secondary focus in immunotherapy. The Company has a broad pipeline of products in clinical development, including three cancer programmes: its lead product TransMID(tm), for the treatment of high-grade glioma, is in Phase III trials, and its novel DNA targeting agents and XR303 are both in Phase I for cancer indications. Xenova is also developing two therapeutic vaccines for cocaine and nicotine addiction, which are in Phase II and Phase I trials respectively. Quoted on the London Stock Exchange (XEN) and on NASDAQ (XNVA), Xenova employs approximately 75 people throughout its sites in the UK and North America. (Reuters XEN.L; Bloomberg XEN LN) For further information about Xenova and its products please visit the Xenova website at www.xenova.co.uk.
For Xenova: Disclaimer to take advantage of the "Safe Harbor" provisions of the US Private Securities Litigation Reform Act of 1995. This press release contains "forward-looking statements," including statements about our ability to integrate acquired businesses and realize cost savings from integration, and the discovery, development and commercialization of products and the ability to raise finance. Various risks may cause Xenova`s actual results to differ materially from those expressed or implied by the forward looking statements, including: unexpected costs and delays in integrating acquired businesses into our group, adverse results in our drug discovery and clinical development programs; failure to obtain patent protection for our discoveries; commercial limitations imposed by patents owned or controlled by third parties; our dependence upon strategic alliance partners to develop and commercialize products and services; difficulties or delays in obtaining regulatory approvals to market products and services resulting from our development efforts; the requirement for substantial funding to conduct research and development and to expand commercialization activities; and product initiatives by competitors. For a further list and description of the risks and uncertainties we face, see the reports we have filed with the Securities and Exchange Commission. We disclaim any intention or obligation to update or revise any forward-looking statements, whether as a result of new information, future events or otherwise.
To view the full press release including financial tables, please click on the link provided.
CONTACT: Xenova Group plc
David A Oxlade, Chief Executive Officer
Daniel Abrams, Finance Director
Veronica Cefis Sellar, Head of Corporate Communications
+44 (0)1753 706600
UK -- Financial Dynamics
David Yates
Ben Atwell
+44 (0)20 7831 3113
U.S. -- Trout Group/BMC Communications
Media: Brad Miles
Investors: Lee Stern
(212) 477-9007
Eine Impfung gegen die Kokainsucht
NZZ Online - Zurich,Switzerland
... Wissenschafter der britischen Pharmafirma Xenova haben dieses Problem nun umgangen, indem sie Kokain mit einer Untereinheit des Choleratoxins gekoppelt haben
Eine Impfung gegen die Kokainsucht
Antikörper fangen die Droge vor dem Eintritt ins Gehirn ab
Drogen wirken unterschiedlich. Dies hat auch für die Behandlung von Süchtigen Auswirkungen. Mit einer neuen Impfung sollen etwa Kokainabhängige therapiert werden können. Noch gibt es damit aber wissenschaftliche und ethische Probleme.
Weltweit gibt es mehr als zwei Millionen Kokainabhängige. Die direkten und indirekten Kosten durch Krankheit, Arbeitsausfall und Beschaffungskriminalität schlagen allein für die rund 1,5 Millionen «Kokser» in den USA mit 70 Milliarden Dollar jährlich zu Buche. Mit Suchttherapie hat sich das Problem bisher nirgends nachhaltig lösen lassen, denn bei Kokainabhängigen haben medizinische Massnahmen nur geringen Erfolg. Die meisten brechen ihre Entzugstherapie ab, und Rückfälle sind die Regel.
Dies hat auch biologische Gründe. Der Wirkungsmechanismus von Kokain unterscheidet sich nämlich von dem anderer Drogen. Kokain blockiert die Wiederaufnahme verschiedener Neurotransmitter, vor allem von Dopamin, in die Gehirnzelle. Das führt dazu, dass im Überschuss vorhandenes Dopamin an den Synapsen für lange Zeit wirksam ist. Das Resultat ist eine dauerhafte Aktivierung des Belohnungssystems, was der Süchtige als «Kick» wahrnimmt. Andere Drogen dagegen fördern die vorübergehende Freisetzung bestimmter Neurotransmitter, verstärken also normalerweise ablaufende Vorgänge. Während sich Drogen, die Neurotransmitter freisetzen, theoretisch durch geeignete chemische Substanzen blockieren lassen, ist es deutlich schwieriger, ein Rauschgift wie Kokain zu hemmen. Von der chemisch-pharmakologischen Seite sind deshalb derzeit keine Lösungen für die Behandlung von Kokainabhängigen zu erwarten.
Da liegt die Überlegung nahe, Kokain mit im Blut zirkulierenden Antikörpern zu neutralisieren. Diese Idee liess sich bisher jedoch nicht in die Praxis umsetzen, weil das Kokainmolekül zu klein ist, um vom Immunsystem als fremd erkannt zu werden; es führt deshalb nicht zur Bildung von Antikörpern. Wissenschafter der britischen Pharmafirma Xenova haben dieses Problem nun umgangen, indem sie Kokain mit einer Untereinheit des Choleratoxins gekoppelt haben. Zusammen mit einem Impfverstärker injiziert, führt dieser Kokain-Choleratoxin-Komplex zur Bildung von Anti-Kokain-Antikörpern. Allerdings sind für eine ausreichende Antikörperkonzentration drei bis vier Impfungen nötig.
Gelangt das Kokain nun nach dem Schnupfen, Rauchen oder Spritzen ins Blut, wird es durch die Antikörper gebunden. Da der Antikörper-Kokain-Komplex zu gross ist, um die Blut-Hirn- Schranke zu passieren, erlebt der Konsument in diesem Fall keinen «Kick». Sucht, so die Überlegung der britischen Forscher, wird dann erst gar nicht entstehen; falls sie schon vorhanden ist, wird sie immerhin nicht perpetuiert.
Die Sicherheits- und Dosis-Findungs-Studien hat die Kokainvakzine bereits bestanden. In einer ersten Wirksamkeitsstudie mit 22 Kokainabhängigen, deren Ergebnisse im Sommer auf einer Tagung des College of Problems of Drug Dependence auf der Karibikinsel Puerto Rico vorgestellt wurden, schafften es 75 Prozent der Geimpften, für mindestens drei Monate «clean» zu bleiben. Diejenigen, die rückfällig wurden, berichteten, dass der «Kick» nach Kokaingenuss deutlich schwächer gewesen sei als vor der Impfung. Eine grössere Studie mit 132 Süchtigen wurde im Oktober 2003 begonnen. Die Resultate sollen schon bald vorliegen.
Das auf den ersten Blick einleuchtende Konzept hat allerdings einen Haken: Durch die Vakzine wird nur die Wirkung des Kokains im Gehirn unterbunden, nicht aber sein Konsum. Um den gewohnten «Kick» zu erreichen, kann ein Süchtiger immer noch die Dosis oder die Häufigkeit der Einnahme steigern. Ausserdem benötigen Abhängige regelmässig Auffrischungsimpfungen, weil die Antikörperkonzentration im Blut rasch abfällt.
Selbst wenn sich dieses Problem beheben lässt, sind noch wichtige ethische Fragen zu klären. Was passiert etwa mit Kokainsüchtigen, die sich nicht impfen lassen wollen? Sollen diese durch eine amtsärztliche Anordnung zwangsweise geimpft werden? Und sollen auch Menschen geimpft werden, die aufgrund einer genetischen Veranlagung ein erhöhtes Risiko für die Kokainsucht haben? Über solche Fragen wird derzeit in Grossbritannien in einer Expertenkommission diskutiert.
Hermann Feldmeier
Quellen: Nature Medicine 10, 1007 (2004); Vaccine 20, 1196-1204 (2002); www.foresight.gov.uk
jethor
NZZ Online - Zurich,Switzerland
... Wissenschafter der britischen Pharmafirma Xenova haben dieses Problem nun umgangen, indem sie Kokain mit einer Untereinheit des Choleratoxins gekoppelt haben
Eine Impfung gegen die Kokainsucht
Antikörper fangen die Droge vor dem Eintritt ins Gehirn ab
Drogen wirken unterschiedlich. Dies hat auch für die Behandlung von Süchtigen Auswirkungen. Mit einer neuen Impfung sollen etwa Kokainabhängige therapiert werden können. Noch gibt es damit aber wissenschaftliche und ethische Probleme.
Weltweit gibt es mehr als zwei Millionen Kokainabhängige. Die direkten und indirekten Kosten durch Krankheit, Arbeitsausfall und Beschaffungskriminalität schlagen allein für die rund 1,5 Millionen «Kokser» in den USA mit 70 Milliarden Dollar jährlich zu Buche. Mit Suchttherapie hat sich das Problem bisher nirgends nachhaltig lösen lassen, denn bei Kokainabhängigen haben medizinische Massnahmen nur geringen Erfolg. Die meisten brechen ihre Entzugstherapie ab, und Rückfälle sind die Regel.
Dies hat auch biologische Gründe. Der Wirkungsmechanismus von Kokain unterscheidet sich nämlich von dem anderer Drogen. Kokain blockiert die Wiederaufnahme verschiedener Neurotransmitter, vor allem von Dopamin, in die Gehirnzelle. Das führt dazu, dass im Überschuss vorhandenes Dopamin an den Synapsen für lange Zeit wirksam ist. Das Resultat ist eine dauerhafte Aktivierung des Belohnungssystems, was der Süchtige als «Kick» wahrnimmt. Andere Drogen dagegen fördern die vorübergehende Freisetzung bestimmter Neurotransmitter, verstärken also normalerweise ablaufende Vorgänge. Während sich Drogen, die Neurotransmitter freisetzen, theoretisch durch geeignete chemische Substanzen blockieren lassen, ist es deutlich schwieriger, ein Rauschgift wie Kokain zu hemmen. Von der chemisch-pharmakologischen Seite sind deshalb derzeit keine Lösungen für die Behandlung von Kokainabhängigen zu erwarten.
Da liegt die Überlegung nahe, Kokain mit im Blut zirkulierenden Antikörpern zu neutralisieren. Diese Idee liess sich bisher jedoch nicht in die Praxis umsetzen, weil das Kokainmolekül zu klein ist, um vom Immunsystem als fremd erkannt zu werden; es führt deshalb nicht zur Bildung von Antikörpern. Wissenschafter der britischen Pharmafirma Xenova haben dieses Problem nun umgangen, indem sie Kokain mit einer Untereinheit des Choleratoxins gekoppelt haben. Zusammen mit einem Impfverstärker injiziert, führt dieser Kokain-Choleratoxin-Komplex zur Bildung von Anti-Kokain-Antikörpern. Allerdings sind für eine ausreichende Antikörperkonzentration drei bis vier Impfungen nötig.
Gelangt das Kokain nun nach dem Schnupfen, Rauchen oder Spritzen ins Blut, wird es durch die Antikörper gebunden. Da der Antikörper-Kokain-Komplex zu gross ist, um die Blut-Hirn- Schranke zu passieren, erlebt der Konsument in diesem Fall keinen «Kick». Sucht, so die Überlegung der britischen Forscher, wird dann erst gar nicht entstehen; falls sie schon vorhanden ist, wird sie immerhin nicht perpetuiert.
Die Sicherheits- und Dosis-Findungs-Studien hat die Kokainvakzine bereits bestanden. In einer ersten Wirksamkeitsstudie mit 22 Kokainabhängigen, deren Ergebnisse im Sommer auf einer Tagung des College of Problems of Drug Dependence auf der Karibikinsel Puerto Rico vorgestellt wurden, schafften es 75 Prozent der Geimpften, für mindestens drei Monate «clean» zu bleiben. Diejenigen, die rückfällig wurden, berichteten, dass der «Kick» nach Kokaingenuss deutlich schwächer gewesen sei als vor der Impfung. Eine grössere Studie mit 132 Süchtigen wurde im Oktober 2003 begonnen. Die Resultate sollen schon bald vorliegen.
Das auf den ersten Blick einleuchtende Konzept hat allerdings einen Haken: Durch die Vakzine wird nur die Wirkung des Kokains im Gehirn unterbunden, nicht aber sein Konsum. Um den gewohnten «Kick» zu erreichen, kann ein Süchtiger immer noch die Dosis oder die Häufigkeit der Einnahme steigern. Ausserdem benötigen Abhängige regelmässig Auffrischungsimpfungen, weil die Antikörperkonzentration im Blut rasch abfällt.
Selbst wenn sich dieses Problem beheben lässt, sind noch wichtige ethische Fragen zu klären. Was passiert etwa mit Kokainsüchtigen, die sich nicht impfen lassen wollen? Sollen diese durch eine amtsärztliche Anordnung zwangsweise geimpft werden? Und sollen auch Menschen geimpft werden, die aufgrund einer genetischen Veranlagung ein erhöhtes Risiko für die Kokainsucht haben? Über solche Fragen wird derzeit in Grossbritannien in einer Expertenkommission diskutiert.
Hermann Feldmeier
Quellen: Nature Medicine 10, 1007 (2004); Vaccine 20, 1196-1204 (2002); www.foresight.gov.uk
jethor
Hi
Xenova Licenses TA-CIN to Cancer Research Technology
Monday January 10, 2:21 am ET
SLOUGH, U.K., Jan. 10, 2005 (PRIMEZONE) -- Xenova Group plc (NasdaqNM:XNVA - News) (London:XEN.L - News) today announced that it has entered into a licensing agreement with Cancer Research Technology Limited (CRT) in respect of Xenova`s intellectual property relating to TA-CIN. TA-CIN is a vaccine developed by Xenova as a treatment for women with cervical dysplasia, and has proved safe and immunogenic in Phase I and Phase II clinical trials.
CRT will facilitate a further Phase II clinical trial to be undertaken at St. Mary`s Hospital Manchester and associated laboratory studies at the Paterson Institute for Cancer Research in Manchester to evaluate TA-CIN in combination with an immune modulator in subjects with vulval intra-epithelial neoplasia (VIN). This trial, expected to start shortly, will recruit between 20 and 30 women with known, pre-treated, or newly diagnosed VIN3. The primary end point is objective response of vulval intraepithelial lesions to treatment as well as evaluating safety, toxicity and tolerability of the combination treatment.
CRT will license TA-CIN patents, know-how and materials from Xenova and will undertake marketing of TA-CIN to potential commercial partners with a view to sub-licensing the development and commercialisation of the product. Net receipts from the sub-licensing of TA-CIN will be shared between Xenova and CRT after certain direct costs have been recouped.
Cervical dysplasia (also known as cervical intra-epithelial neoplasia, CIN) is one of a group of conditions, including VIN, known collectively as ano-genital intraepithelial neoplasia (AGIN), which are precursors to invasive cancers such as cervical cancer. Infection with certain high risk types of Human Papillomavirus such as HPV16, is closely associated with these dysplasias and cancers, which are difficult to treat and have a high recurrence rate.
David Oxlade, Chief Executive Officer of Xenova said: ``We are delighted that the promising TA-CIN vaccine is now progressing into further Phase II studies through this relationship with CRT. This collaboration provides further evidence of the potential value of Xenova`s portfolio of novel cancer drugs.``
Dr. Keith Blundy, Chief Operating Officer of CRT stated: ``We are pleased to in-license and develop this opportunity from Xenova, which clearly demonstrates CRT`s strategy for expanding our oncology portfolio and addressing our goal of cancer patient benefit.``
Notes to Editors
TA-CIN is a subunit vaccine comprising L2/E6/E7 proteins from Human Papillomavirus (HPV16), designed to generate a strong cellular immune response against HPV-infected cells. The vaccine is targeted at patients with cervical dysplasia (pre-invasive cervical disease), thus potentially preventing the onset of invasive cervical cancer. The initial product candidate for clinical trials is a genetically engineered fusion of three proteins from HPV 16 known to play a role in the progression of cervical disease. Published data have reported that tumour cells in more than 90 percent of patients with cervical cancer contain DNA from the HPV virus, specifically types 16 and 18.
Human papillomavirus (HPV) is a large family of small DNA viruses associated with a number of conditions ranging from skin warts and genital warts to cervical cancer. Infection with high risk types of HPV (such as HPV16 and HPV18) is strongly associated with ano-genital cancer and its precursor AGIN. These diseases are difficult to treat and have a high recurrence rate.
The successful results of a Phase I safety and immunogenicity study for TA-CIN were presented at the 19th International Human Papillomavirus Conference (September 2001). In this placebo-controlled, dose-escalating study, the vaccine was administered by intramuscular injection to 40 healthy volunteers. TA-CIN was found to be well tolerated. No serious adverse events were reported during the study. The vaccine was also found to be immunogenic. TA-CIN specific antibody responses, and positive T cell responses were seen in all of the cohorts receiving active vaccine.
In addition, TA-CIN has been evaluated in a prime boost strategy, in combination with TA-HPV. Pre-clinical studies, conducted by Xenova in conjunction with scientists at Leiden University Medical Centre, The Netherlands, demonstrated that use of TA-CIN together with TA-HPV, resulted in an immune response that was significantly greater than that observed with either product alone. In a subsequent Phase II prime boost clinical trial conducted at St. Mary`s Hospital Manchester and the Paterson Institute for Cancer Research in Manchester, both products proved safe and well tolerated, and some clear clinical responses were demonstrated, even in women with long-standing disease.
Xenova originally licensed the rights to an L2 patent from CRT but returned these rights in early 2004 following the rationalisation of Xenova`s patent portfolio following the acquisition of KS Biomedix Holdings plc.
TA-HPV is an immunotherapeutic vaccine developed for use alongside surgery in the treatment of cervical cancer and for the treatment of high-grade AGIN.
Xenova Group plc is a U.K.-based biopharmaceutical company focused on the development of novel drugs to treat cancer and addiction with a secondary focus in immunotherapy. The Company has a broad pipeline of products in clinical development, including three cancer programmes: its lead product TransMIDTM, for the treatment of high-grade glioma, is in Phase III trials, and its novel DNA targeting agents and XR303 are both in Phase I for cancer indications. Xenova is also developing two therapeutic vaccines for cocaine and nicotine addiction, which are in Phase II and Phase I trials respectively. Quoted on the London Stock Exchange (XEN) and on NASDAQ (XNVA), Xenova employs approximately 75 people throughout its sites in the UK and North America. (Reuters XEN.L; Bloomberg XEN LN) For further information about Xenova and its products please visit the Xenova website at http://www.xenova.co.uk and http://www.gbmtrial.com
Cancer Research Technology Limited (CRT) is a specialist technology transfer company which aims to develop new discoveries in cancer research for the benefit of cancer patients. CRT is wholly owned by Cancer Research U.K., the largest independent funder of cancer research in the world. CRT works closely with leading international cancer scientists and their institutes to protect intellectual property arising from their research and to establish links with commercial partners. CRT facilitates the discovery, development and marketing of new cancer therapeutics, vaccines, diagnostics and enabling technologies. Further information about CRT can be found at http://www.cancertechnology.co.uk.
Cancer Research UK is Europe`s leading cancer charity, dedicated to research into the causes, prevention and treatment of cancer. The charity supports the work of 3,000 scientists, doctors and nurses in over 80 academic centres across the U.K., with an annual scientific spend of more than (Pounds) 213 million. Further information about Cancer Research UK can be found at http://www.cancerresearchuk.org.
For Xenova: Disclaimer to take advantage of the ``Safe Harbor`` provisions of the US Private Securities Litigation Reform Act of 1995. This press release contains ``forward-looking statements,`` including statements about development and commercialization of products. Various risks may cause Xenova`s actual results to differ materially from those expressed or implied by the forward looking statements, including: our dependence upon strategic alliance partners to develop and commercialize products and services. For a further list and description of the risks and uncertainties we face, see the reports we have filed with the Securities and Exchange Commission. We disclaim any intention or obligation to update or revise any forward-looking statements, whether as a result of new information, future events or otherwise.
Gruss
B.M.
Xenova Licenses TA-CIN to Cancer Research Technology
Monday January 10, 2:21 am ET
SLOUGH, U.K., Jan. 10, 2005 (PRIMEZONE) -- Xenova Group plc (NasdaqNM:XNVA - News) (London:XEN.L - News) today announced that it has entered into a licensing agreement with Cancer Research Technology Limited (CRT) in respect of Xenova`s intellectual property relating to TA-CIN. TA-CIN is a vaccine developed by Xenova as a treatment for women with cervical dysplasia, and has proved safe and immunogenic in Phase I and Phase II clinical trials.
CRT will facilitate a further Phase II clinical trial to be undertaken at St. Mary`s Hospital Manchester and associated laboratory studies at the Paterson Institute for Cancer Research in Manchester to evaluate TA-CIN in combination with an immune modulator in subjects with vulval intra-epithelial neoplasia (VIN). This trial, expected to start shortly, will recruit between 20 and 30 women with known, pre-treated, or newly diagnosed VIN3. The primary end point is objective response of vulval intraepithelial lesions to treatment as well as evaluating safety, toxicity and tolerability of the combination treatment.
CRT will license TA-CIN patents, know-how and materials from Xenova and will undertake marketing of TA-CIN to potential commercial partners with a view to sub-licensing the development and commercialisation of the product. Net receipts from the sub-licensing of TA-CIN will be shared between Xenova and CRT after certain direct costs have been recouped.
Cervical dysplasia (also known as cervical intra-epithelial neoplasia, CIN) is one of a group of conditions, including VIN, known collectively as ano-genital intraepithelial neoplasia (AGIN), which are precursors to invasive cancers such as cervical cancer. Infection with certain high risk types of Human Papillomavirus such as HPV16, is closely associated with these dysplasias and cancers, which are difficult to treat and have a high recurrence rate.
David Oxlade, Chief Executive Officer of Xenova said: ``We are delighted that the promising TA-CIN vaccine is now progressing into further Phase II studies through this relationship with CRT. This collaboration provides further evidence of the potential value of Xenova`s portfolio of novel cancer drugs.``
Dr. Keith Blundy, Chief Operating Officer of CRT stated: ``We are pleased to in-license and develop this opportunity from Xenova, which clearly demonstrates CRT`s strategy for expanding our oncology portfolio and addressing our goal of cancer patient benefit.``
Notes to Editors
TA-CIN is a subunit vaccine comprising L2/E6/E7 proteins from Human Papillomavirus (HPV16), designed to generate a strong cellular immune response against HPV-infected cells. The vaccine is targeted at patients with cervical dysplasia (pre-invasive cervical disease), thus potentially preventing the onset of invasive cervical cancer. The initial product candidate for clinical trials is a genetically engineered fusion of three proteins from HPV 16 known to play a role in the progression of cervical disease. Published data have reported that tumour cells in more than 90 percent of patients with cervical cancer contain DNA from the HPV virus, specifically types 16 and 18.
Human papillomavirus (HPV) is a large family of small DNA viruses associated with a number of conditions ranging from skin warts and genital warts to cervical cancer. Infection with high risk types of HPV (such as HPV16 and HPV18) is strongly associated with ano-genital cancer and its precursor AGIN. These diseases are difficult to treat and have a high recurrence rate.
The successful results of a Phase I safety and immunogenicity study for TA-CIN were presented at the 19th International Human Papillomavirus Conference (September 2001). In this placebo-controlled, dose-escalating study, the vaccine was administered by intramuscular injection to 40 healthy volunteers. TA-CIN was found to be well tolerated. No serious adverse events were reported during the study. The vaccine was also found to be immunogenic. TA-CIN specific antibody responses, and positive T cell responses were seen in all of the cohorts receiving active vaccine.
In addition, TA-CIN has been evaluated in a prime boost strategy, in combination with TA-HPV. Pre-clinical studies, conducted by Xenova in conjunction with scientists at Leiden University Medical Centre, The Netherlands, demonstrated that use of TA-CIN together with TA-HPV, resulted in an immune response that was significantly greater than that observed with either product alone. In a subsequent Phase II prime boost clinical trial conducted at St. Mary`s Hospital Manchester and the Paterson Institute for Cancer Research in Manchester, both products proved safe and well tolerated, and some clear clinical responses were demonstrated, even in women with long-standing disease.
Xenova originally licensed the rights to an L2 patent from CRT but returned these rights in early 2004 following the rationalisation of Xenova`s patent portfolio following the acquisition of KS Biomedix Holdings plc.
TA-HPV is an immunotherapeutic vaccine developed for use alongside surgery in the treatment of cervical cancer and for the treatment of high-grade AGIN.
Xenova Group plc is a U.K.-based biopharmaceutical company focused on the development of novel drugs to treat cancer and addiction with a secondary focus in immunotherapy. The Company has a broad pipeline of products in clinical development, including three cancer programmes: its lead product TransMIDTM, for the treatment of high-grade glioma, is in Phase III trials, and its novel DNA targeting agents and XR303 are both in Phase I for cancer indications. Xenova is also developing two therapeutic vaccines for cocaine and nicotine addiction, which are in Phase II and Phase I trials respectively. Quoted on the London Stock Exchange (XEN) and on NASDAQ (XNVA), Xenova employs approximately 75 people throughout its sites in the UK and North America. (Reuters XEN.L; Bloomberg XEN LN) For further information about Xenova and its products please visit the Xenova website at http://www.xenova.co.uk and http://www.gbmtrial.com
Cancer Research Technology Limited (CRT) is a specialist technology transfer company which aims to develop new discoveries in cancer research for the benefit of cancer patients. CRT is wholly owned by Cancer Research U.K., the largest independent funder of cancer research in the world. CRT works closely with leading international cancer scientists and their institutes to protect intellectual property arising from their research and to establish links with commercial partners. CRT facilitates the discovery, development and marketing of new cancer therapeutics, vaccines, diagnostics and enabling technologies. Further information about CRT can be found at http://www.cancertechnology.co.uk.
Cancer Research UK is Europe`s leading cancer charity, dedicated to research into the causes, prevention and treatment of cancer. The charity supports the work of 3,000 scientists, doctors and nurses in over 80 academic centres across the U.K., with an annual scientific spend of more than (Pounds) 213 million. Further information about Cancer Research UK can be found at http://www.cancerresearchuk.org.
For Xenova: Disclaimer to take advantage of the ``Safe Harbor`` provisions of the US Private Securities Litigation Reform Act of 1995. This press release contains ``forward-looking statements,`` including statements about development and commercialization of products. Various risks may cause Xenova`s actual results to differ materially from those expressed or implied by the forward looking statements, including: our dependence upon strategic alliance partners to develop and commercialize products and services. For a further list and description of the risks and uncertainties we face, see the reports we have filed with the Securities and Exchange Commission. We disclaim any intention or obligation to update or revise any forward-looking statements, whether as a result of new information, future events or otherwise.
Gruss
B.M.
Hi
Super Nachrichten
Xenova Licenses DISC-HSV and DISC-GM-CSF Vector Technologies to Oxxon
Thursday January 13, 2:21 am ET
SLOUGH, U.K., Jan. 13, 2005 (PRIMEZONE) -- Xenova Group plc (NasdaqNM:XNVA - News) (London:XEN.L - News) today announced it has signed an exclusive licensing agreement with Oxxon Therapeutics Ltd (Oxxon) potentially worth up to 44 million ($83 million*) in up-front and milestone payments, in addition to royalties on product sales.
ADVERTISEMENT
The agreement provides Oxxon with the right to use the DISC-HSV Vector (Disabled Infectious Single Cycle -- Herpes Simplex Virus) in a number of specified indications in the areas of oncology and infectious diseases. Oxxon also has the option to further, as yet unspecified, indications subject to payment of additional fees. The agreement includes global development, manufacturing and marketing rights to DISC-GM-CSF, an oncology product developed using the DISC-HSV Vector platform which has successfully completed a Phase I dose-escalating safety study. Xenova retains the rights to the DISC-PRO vaccine programme for the prophylaxis of herpes virus diseases.
Oxxon will pay Xenova an upfront fee spread over 24 months and milestone payments on the first four products to complete commercialisation, potentially worth up to 44 million ($83 million). Royalties will be paid on future sales of all products derived from the DISC-HSV Vector platform.
David Oxlade, Chief Executive Officer of Xenova said: ``This new license is in line with Xenova`s strategy of focusing on its prioritised products and maximising the value of other assets in the pipeline through out-licensing. Xenova`s DISC-HSV Vector platform provides an excellent strategic fit with Oxxon`s proprietary Heterologous PrimeBoost system and enables this promising technology to be actively progressed with appropriate resources and expertise.``
Notes to Editors
DISC-HSV Vector Platform
The DISC-HSV (Disabled Infectious Single Cycle -- Herpes Simplex Virus) Vector platform was designed for the safe delivery of heterologous genes to the immune system in order to stimulate a comprehensive range of immunological responses, including helper and cytotoxic T cell responses. The virus is genetically inactivated through the deletion of a single gene from the genome that is essential for the reproduction of the virus.
The DISC-HSV vector has a number of features, which may offer significant advantages over alternative vector systems. These include the ability to target cell types for which other vectors have proved unsatisfactory and the capacity to carry and deliver large amounts of foreign DNA.
In addition, they combine the immunological advantages of conventional live virus vaccines with the safety normally associated with chemically inactivated or subunit vaccines. DISC-HSV Vectors also have potential for generation of effective immune responses after direct administration to mucosal surfaces, which may be an important element of protection against pathogens that enter the body at those sites.
These characteristics, coupled with the inability of the DISC-HSV Vector to replicate within the body and its excellent safety profile, demonstrated in extensive pre-clinical and clinical trials of DISC-HSV as a vaccine, indicate that the DISC-HSV Vector has considerable potential for the development of a number of new product opportunities.
DISC-GM-CSF
DISC-GM-CSF (Granulocyte Macrophage Colony Stimulating Factor) is an immunotherapy product that uses the DISC-HSV Vector to deliver the GM-CSF gene to tumour cells. GM-CSF is a cytokine and a potent stimulator of immune responses. DISC-GM-CSF has broad potential for use across a wide range of solid tumour types.
In pre-clinical studies, DISC-GM-CSF was shown to be effective in models of breast, renal and colorectal cancer. The product was capable of inducing regression when injected directly into these tumours in vivo, and this regression was mediated by the induction of an anti-tumour immune response.
DISC-GM-CSF successfully completed a Phase I dose-escalating safety study at three centres in the U.K., in patients with metastatic melanoma. DISC-GM-CSF was found to be well tolerated, with no serious adverse events reported. Following injection it was not possible to retrieve DISC-GM-CSF from either the injection site or from the patients` serum, showing that the DISC Vector was localised and had not spread beyond the required therapeutic area.
Xenova Group plc is a U.K.-based biopharmaceutical company focused on the development of novel drugs to treat cancer and addiction with a secondary focus in immunotherapy. The Company has a broad pipeline of products in clinical development, including three cancer programmes: its lead product TransMID(tm), for the treatment of high-grade glioma, is in Phase III trials, and its novel DNA targeting agents and XR303 are both in Phase I for cancer indications. Xenova is also developing two therapeutic vaccines for cocaine and nicotine addiction, which are in Phase II and Phase I trials respectively. Quoted on the London Stock Exchange (XEN) and on NASDAQ (XNVA), Xenova employs approximately 75 people throughout its sites in the UK and North America. (Reuters XEN.L; Bloomberg XEN LN) For further information about Xenova and its products please visit the Xenova website at http://www.xenova.co.uk.
Oxxon Therapeutics is a mid-stage biotechnology company developing a portfolio of immunotherapeutics for infectious disease and cancer based on its proprietary Heterologous PrimeBoost approach. Founded in 1999 as a spin out from the University of Oxford, Oxxon has already advanced its products for the treatment of melanoma and hepatitis B to Phase II clinical trials, and has a number of pre-clinical products in development on its own or through collaborations. For further information about Oxxon please visit http://www.oxti.com.
For Xenova: Disclaimer to take advantage of the ``Safe Harbor`` provisions of the US Private Securities Litigation Reform Act of 1995. This press release contains ``forward-looking statements,`` including statements about development and commercialization of products. Various risks may cause Xenova`s actual results to differ materially from those expressed or implied by the forward looking statements, including: our dependence upon strategic alliance partners to develop and commercialize products and services. For a further list and description of the risks and uncertainties we face, see the reports we have filed with the Securities and Exchange Commission. We disclaim any intention or obligation to update or revise any forward-looking statements, whether as a result of new information, future events or otherwise.
-- U.S. Dollar amounts have been translated at a rate of 1.00:$1.88 purely for information
Gruss
B.M.
Super Nachrichten
Xenova Licenses DISC-HSV and DISC-GM-CSF Vector Technologies to Oxxon
Thursday January 13, 2:21 am ET
SLOUGH, U.K., Jan. 13, 2005 (PRIMEZONE) -- Xenova Group plc (NasdaqNM:XNVA - News) (London:XEN.L - News) today announced it has signed an exclusive licensing agreement with Oxxon Therapeutics Ltd (Oxxon) potentially worth up to 44 million ($83 million*) in up-front and milestone payments, in addition to royalties on product sales.
ADVERTISEMENT
The agreement provides Oxxon with the right to use the DISC-HSV Vector (Disabled Infectious Single Cycle -- Herpes Simplex Virus) in a number of specified indications in the areas of oncology and infectious diseases. Oxxon also has the option to further, as yet unspecified, indications subject to payment of additional fees. The agreement includes global development, manufacturing and marketing rights to DISC-GM-CSF, an oncology product developed using the DISC-HSV Vector platform which has successfully completed a Phase I dose-escalating safety study. Xenova retains the rights to the DISC-PRO vaccine programme for the prophylaxis of herpes virus diseases.
Oxxon will pay Xenova an upfront fee spread over 24 months and milestone payments on the first four products to complete commercialisation, potentially worth up to 44 million ($83 million). Royalties will be paid on future sales of all products derived from the DISC-HSV Vector platform.
David Oxlade, Chief Executive Officer of Xenova said: ``This new license is in line with Xenova`s strategy of focusing on its prioritised products and maximising the value of other assets in the pipeline through out-licensing. Xenova`s DISC-HSV Vector platform provides an excellent strategic fit with Oxxon`s proprietary Heterologous PrimeBoost system and enables this promising technology to be actively progressed with appropriate resources and expertise.``
Notes to Editors
DISC-HSV Vector Platform
The DISC-HSV (Disabled Infectious Single Cycle -- Herpes Simplex Virus) Vector platform was designed for the safe delivery of heterologous genes to the immune system in order to stimulate a comprehensive range of immunological responses, including helper and cytotoxic T cell responses. The virus is genetically inactivated through the deletion of a single gene from the genome that is essential for the reproduction of the virus.
The DISC-HSV vector has a number of features, which may offer significant advantages over alternative vector systems. These include the ability to target cell types for which other vectors have proved unsatisfactory and the capacity to carry and deliver large amounts of foreign DNA.
In addition, they combine the immunological advantages of conventional live virus vaccines with the safety normally associated with chemically inactivated or subunit vaccines. DISC-HSV Vectors also have potential for generation of effective immune responses after direct administration to mucosal surfaces, which may be an important element of protection against pathogens that enter the body at those sites.
These characteristics, coupled with the inability of the DISC-HSV Vector to replicate within the body and its excellent safety profile, demonstrated in extensive pre-clinical and clinical trials of DISC-HSV as a vaccine, indicate that the DISC-HSV Vector has considerable potential for the development of a number of new product opportunities.
DISC-GM-CSF
DISC-GM-CSF (Granulocyte Macrophage Colony Stimulating Factor) is an immunotherapy product that uses the DISC-HSV Vector to deliver the GM-CSF gene to tumour cells. GM-CSF is a cytokine and a potent stimulator of immune responses. DISC-GM-CSF has broad potential for use across a wide range of solid tumour types.
In pre-clinical studies, DISC-GM-CSF was shown to be effective in models of breast, renal and colorectal cancer. The product was capable of inducing regression when injected directly into these tumours in vivo, and this regression was mediated by the induction of an anti-tumour immune response.
DISC-GM-CSF successfully completed a Phase I dose-escalating safety study at three centres in the U.K., in patients with metastatic melanoma. DISC-GM-CSF was found to be well tolerated, with no serious adverse events reported. Following injection it was not possible to retrieve DISC-GM-CSF from either the injection site or from the patients` serum, showing that the DISC Vector was localised and had not spread beyond the required therapeutic area.
Xenova Group plc is a U.K.-based biopharmaceutical company focused on the development of novel drugs to treat cancer and addiction with a secondary focus in immunotherapy. The Company has a broad pipeline of products in clinical development, including three cancer programmes: its lead product TransMID(tm), for the treatment of high-grade glioma, is in Phase III trials, and its novel DNA targeting agents and XR303 are both in Phase I for cancer indications. Xenova is also developing two therapeutic vaccines for cocaine and nicotine addiction, which are in Phase II and Phase I trials respectively. Quoted on the London Stock Exchange (XEN) and on NASDAQ (XNVA), Xenova employs approximately 75 people throughout its sites in the UK and North America. (Reuters XEN.L; Bloomberg XEN LN) For further information about Xenova and its products please visit the Xenova website at http://www.xenova.co.uk.
Oxxon Therapeutics is a mid-stage biotechnology company developing a portfolio of immunotherapeutics for infectious disease and cancer based on its proprietary Heterologous PrimeBoost approach. Founded in 1999 as a spin out from the University of Oxford, Oxxon has already advanced its products for the treatment of melanoma and hepatitis B to Phase II clinical trials, and has a number of pre-clinical products in development on its own or through collaborations. For further information about Oxxon please visit http://www.oxti.com.
For Xenova: Disclaimer to take advantage of the ``Safe Harbor`` provisions of the US Private Securities Litigation Reform Act of 1995. This press release contains ``forward-looking statements,`` including statements about development and commercialization of products. Various risks may cause Xenova`s actual results to differ materially from those expressed or implied by the forward looking statements, including: our dependence upon strategic alliance partners to develop and commercialize products and services. For a further list and description of the risks and uncertainties we face, see the reports we have filed with the Securities and Exchange Commission. We disclaim any intention or obligation to update or revise any forward-looking statements, whether as a result of new information, future events or otherwise.
-- U.S. Dollar amounts have been translated at a rate of 1.00:$1.88 purely for information
Gruss
B.M.
... ganz was Neues:O. Xenova scheint das Geld auszugehen
Als ob das nicht schon längst bekannt war. Dafür heute 15 % Minus in London. Tendenz weiter fallend.
http://www.londonstockexchange.com/LSECWS/IFSPages/MarketNew…
Als ob das nicht schon längst bekannt war. Dafür heute 15 % Minus in London. Tendenz weiter fallend.
http://www.londonstockexchange.com/LSECWS/IFSPages/MarketNew…
noch jemand da??
First Quarter Results, 2005
...
Operating Performance
In the three months to 31 March 2005, revenues from licensing agreements, strategic
partnerships and manufacturing outsourcing were £1.1m ($2.0m), (2004: £0.9m ($1.6m)).
Revenue included license fees and milestones of £0.7m ($1.2m) and manufacturing revenue of
£0.4m ($0.8m).
Cost of sales fell to £0.4m ($0.8m) from £0.8m ($1.5m) in 2004 as manufacturing activities
focused more on internal projects in the quarter, compared to the same period last year.
Research and development expenditure of £3.2m ($5.9m) (2004: £3.2m ($6.1m)) was in line
with the prior year. Costs were mainly incurred in respect of the TransMIDTM Phase III trial as
well as the TA-NIC Phase I trial.
Administrative expenses of £1.5m ($2.9m) (2004: £1.0m ($1.9m)) increased by £0.5m from
2004 as a result of increased professional fees incurred in corporate activities.
Other income generated from sub-letting space in Cambridge and Slough increased to £0.2m
($0.5m) in 2005 from £0.1m ($0.2m) last year reflecting the impact of the Genzyme lease at
Cambridge which commenced in Q2 2004.
The net loss per share in Q1 was 0.8p (1.5c) (2004: 0.9p (1.7c)).
Cash, short-term deposits and investments
Cash, short-term deposits and investments at 31 March 2005 totalled £9.4m ($17.6m) (2004:
£22.0m ($41.3m)). The Group held cash of £0.5m ($0.9m) and short-term deposits and
investments of £8.9m ($16.7m) at 31 March 2005 (2004: cash £1.1m ($2.1m), short-term
deposits and investments £20.9m ($39.3m)).....
der ganze Bericht: http://hugin.info/133161/R/995342/150885.pdf
Gruss Wunram
First Quarter Results, 2005
...
Operating Performance
In the three months to 31 March 2005, revenues from licensing agreements, strategic
partnerships and manufacturing outsourcing were £1.1m ($2.0m), (2004: £0.9m ($1.6m)).
Revenue included license fees and milestones of £0.7m ($1.2m) and manufacturing revenue of
£0.4m ($0.8m).
Cost of sales fell to £0.4m ($0.8m) from £0.8m ($1.5m) in 2004 as manufacturing activities
focused more on internal projects in the quarter, compared to the same period last year.
Research and development expenditure of £3.2m ($5.9m) (2004: £3.2m ($6.1m)) was in line
with the prior year. Costs were mainly incurred in respect of the TransMIDTM Phase III trial as
well as the TA-NIC Phase I trial.
Administrative expenses of £1.5m ($2.9m) (2004: £1.0m ($1.9m)) increased by £0.5m from
2004 as a result of increased professional fees incurred in corporate activities.
Other income generated from sub-letting space in Cambridge and Slough increased to £0.2m
($0.5m) in 2005 from £0.1m ($0.2m) last year reflecting the impact of the Genzyme lease at
Cambridge which commenced in Q2 2004.
The net loss per share in Q1 was 0.8p (1.5c) (2004: 0.9p (1.7c)).
Cash, short-term deposits and investments
Cash, short-term deposits and investments at 31 March 2005 totalled £9.4m ($17.6m) (2004:
£22.0m ($41.3m)). The Group held cash of £0.5m ($0.9m) and short-term deposits and
investments of £8.9m ($16.7m) at 31 March 2005 (2004: cash £1.1m ($2.1m), short-term
deposits and investments £20.9m ($39.3m)).....
der ganze Bericht: http://hugin.info/133161/R/995342/150885.pdf
Gruss Wunram
ja, wahrscheinlich bis zum bitteren Ende
Übernahme!!!!!!!!!!!
http://biz.yahoo.com/pz/050624/80505.html
http://biz.yahoo.com/pz/050624/80505.html
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