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[virus]

peptide therapeutics sind noch unterbewertet. wurden erst kürzlich auf strong buy gesetzt.

in den letzten tagen wurde bekannt das sich zwei biotechfirmen ( Cantab und Powderject ) für eine übernahme
von peptide therapeutics interessiert sind.

und hier noch einige News zu Finanzen und ProduktePreliminary results for the year ended 31 December 1999
and R&D update

Cambridge, UK – 4 April 2000 - Peptide Therapeutics Group plc (LSE: PTE) ("Peptide") announces its preliminary results for the year ended 31 December 1999 and an update on its Research & Development programmes.

Highlights

OraVax acquisition completed and fully integrated
Arilvax® pivotal Phase III trial completed - results expected in early May 2000
100% of US marketing rights to Arilvax® granted to Peptide by Medeva Pharma Limited
Sale of drug discovery activities to Medivir for up to £6 million
Several clinical trials underway for H. pylori vaccine
Positive results for Phase I/II trial of C. difficile vaccine – feasibility of active vaccine being evaluated in addition to passive vaccine approach
Successful completion of second Phase I ETEC vaccine trial - proof-of-principle trial planned for Q4 2000
Clinical grade product manufactured for Japanese Encephalitis vaccine - Phase I trial to commence shortly
Collaboration with SmithKline Beecham amended and extended, after discontinuation of decapeptide allergy vaccine
Negotiations on sale of manufacturing facility ongoing with shortlist of interested parties
Loss for the year and cash burn in line with budget
Strong balance sheet with over £19.5 million in cash at 31 December 1999
Dr John Brown, Chief Executive of Peptide, said:

"Peptide is now a financially strong, focussed vaccines company, with a broad portfolio of therapeutic and preventative vaccines, particularly for the travellers market. The successful sale of our drug discovery activities is the final stage of a process to focus our resources on vaccines. Our first product, Arilvax®, is scheduled for launch in the second half of 2001. This, coupled with our existing financial resources, provides a solid platform from which to become one of the leading companies in the vaccines field.

"Enquiries:

Peptide Therapeutics Group plc Tel: [phone]

Dr John Brown, Chief Executive
Gordon Cameron, Finance Director

Financial Dynamics Tel: [phone]

David Yates / Sophie Pender-Cudlip

For further information visit our web site at www.peptide.co.uk.

Overview

The first half of 1999 saw Peptide achieve two significant milestones in its growth and development. We completed the acquisition of OraVax and successfully raised over £20 million through a rights issue. Integration of Oravax with Peptide is complete and the acquisition is already bearing fruit in terms of successful clinical progress in several areas. The second half of the year began disappointingly when our decapeptide allergy vaccine did not meet expectations in clinical trials and work on that product candidate was discontinued. However, we agreed with our partner on the project, SmithKline Beecham, to continue and extend the existing collaboration to identify alternative allergy vaccine candidates. That collaboration is progressing very well.

Our most advanced project, Arilvax®, started and completed a pivotal Phase III trial in the US. Results from this important trial are expected around the beginning of May. We expect to file a product licence application for the US market in the middle of the year. Medeva Pharma Limited granted to Peptide 100% of the US marketing rights to Arilvax®, thereby enabling us to receive a potentially greater portion of the product`s sales. Our ETEC vaccine has successfully completed two Phase I trials with very encouraging results to date. Our C. difficile vaccine also completed a Phase I trial with results that exceeded expectations such that we are now evaluating a parallel approach to develop an active vaccine as well as a passive vaccine. The programme of trials for our H. pylori vaccine is underway and our Japanese Encephalitis vaccine is ready to begin clinical trials before the middle of this year. Several promising pre-clinical projects have also had encouraging results, including pre-clinical data for our dengue fever vaccine that gives us a high degree of confidence to move rapidly towards the clinical development phase.

The sale of Mimetrix (our drug discovery activities) to Medivir, anticipated to complete this month, finalises the previously announced programme of measures to focus Peptide’s resources on the research, development and commercialisation of vaccines. These measures will lead to a reduction in Peptide`s ongoing cash burn to approximately £0.7 million per month. Our financial position is strong with around £19.5 million in cash at 31 December 1999. We hope to strengthen this further through the completion of the sale of our US manufacturing facility as well as through additional licensing and collaboration revenues.

We made an announcement on 30 March 2000 regarding press speculation surrounding potential merger/acquisition activity involving Peptide. We confirmed at that time that we were in preliminary talks which may or may not lead to an offer being made for the company. That position remains the same and additional announcements will be made if the situation develops further.

Our strategy is to be one of the leading companies in the rapidly-expanding and dynamic world of vaccines. We have talented people, proprietary leading-edge technology, a broad range of products and financial strength. Having each of these components gives us every reason to be confident of our future prospects.

Sale of drug discovery activities

On 27 March 2000, we announced that we had entered into an agreement to sell our drug discovery activities, called Mimetrix, to Medivir AB for up to £6 million.

Under the terms of the agreement, Peptide will receive on completion new shares in Medivir AB, a listed Swedish biotechnology company, valued at £2 million, calculated with reference to Medivir’s share price at the time of signing the agreement. In addition Peptide may receive up to a further £4 million in cash in milestones and royalty payments from Mimetrix` existing projects. Mimetrix` projects include research into inhibitors of Cathepsin S (in collaboration with Genzyme) and Asparaginyl Endopeptidase (AEP) and the RAPiD protease inhibitor drug discovery technology. Completion of the sale is conditional upon Medivir completing a fund-raising that is planned to take place during April.

Upon completion, 28 Mimetrix employees will transfer to Medivir although the activities of Mimetrix will continue to operate out of Peptide’s existing R&D facility at Cambridge, UK. Under a central services agreement, Medivir will pay Peptide for the use of facilities, administration and other support staff. Mimetrix has net assets of approximately £0.8 million and incurs approximately £3 million of losses on an annualised basis.

Update on principal product programmes

Arilvax® - vaccine to prevent yellow fever

Arilvax® (a registered trademark of Medeva Europe Limited) is a yellow fever vaccine that is marketed by Medeva Pharma Limited in the UK but is not currently available in the US. Medeva Europe Limited and Medeva Pharma Limited are both subsidiaries of Celltech Group plc. A US Phase III trial is required for US registration. The pivotal Phase III trial was completed on schedule in December 1999. It compared Arilvax® with YF-Vax®, the only other yellow fever vaccine currently commercially available in the US. The trial was conducted in 1,440 healthy adult subjects in the US. Equal numbers of subjects (720 per group) were randomised to receive Arilvax® or YF-Vax®.

Testing of serum samples from the Phase III trial is well underway, and it is expected that the results will be available in early May 2000. A Biologicals Licence Application ("BLA") submission is then targeted for the middle of this year, with an anticipated launch in the US in the second half of 2001. Ahead of such a launch, we anticipate recruiting a small sales and marketing team towards the end of this year. Our internal forecasts give potential sales of up to $25 million, split between the US travellers and military markets.

Oral Typhoid Vaccine – single dose, live attenuated, oral vaccine to prevent typhoid fever

A Phase II trial of the Oral Typhoid Vaccine was successfully completed in January 1999. The results confirmed that, when given as a single oral dose, the vaccine is well tolerated, does not cause bacteraemia, and elicits both a mucosal and systemic immune response. We are now seeking a partner to conduct further development of the product and are in discussions with various parties, with several potential collaboration structures being proposed. We are keen to achieve the optimal deal structure that delivers the maximum value to Peptide shareholders. The potential market for a travellers vaccine to prevent typhoid fever is estimated at over $200 million per year.

H. pylori Vaccine – vaccine to prevent and/or treat peptic ulcers

This programme is being conducted under a joint venture with Aventis Pasteur. Several trials are underway and are planned over the next 12/18 months, to investigate the safety and immunogenicity of a variety of vaccine candidates, delivery routes and delivery systems. These include a vaccine based on Peptide’s S. typhi oral vaccine delivery system, to deliver H. pylori antigens. Following satisfactory completion of these trials, the selected vaccine candidates will then be tested for efficacy in challenge studies. Our challenge model to test vaccine candidates has been established and is being validated at several centres. World-wide annual sales of anti-ulcer products are estimated to be approximately $13 billion.

C. difficile vaccine – vaccine to prevent or treat C. difficile associated diarrhoea (CDAD)

A Phase I/II safety and immunogenicity trial in 30 healthy adult volunteers was completed in December 1999. The results of the trial showed that the vaccine was safe, well-tolerated and highly immunogenic at all of the dose levels studied. The magnitude and kinetics of the immune response were such that we are evaluating the development of an active vaccine, in addition to a passive vaccine. An exploratory trial using the active vaccine could be conducted this year in patients who have chronic relapsing CDAD.

For the passive vaccine, the next stage of development is to vaccinate plasma donors in order to generate a hyperimmune globulin for the treatment and/or prevention of CDAD. Vaccination will generate clinical grade hyperimmune globulin that will then be used in Phase II efficacy trials in 2001.

CDAD is an increasingly common hospital-acquired infection, principally arising through the over-use of antibiotics in hospitals and nursing homes. Up to 500,000 cases of CDAD occur in hospitalised patients in the US each year, leading to additional hospitalisation costs of $10,000 per case. We estimate the potential market for our C. difficile vaccine to be worth up to $500 million per annum.

Oral ETEC Vaccine – oral, live, attenuated vaccine to prevent travellers diarrhoea

On 29 March 2000, we announced that we had successfully completed the second Phase I trial in the development of an Oral ETEC Vaccine. The trial was a randomised, double-blind, placebo-controlled study comparing two different vaccine constructs in 40 healthy adult volunteers. The objective of the trial was to confirm the immunogenicity and safety of the two constructs and to select one of the constructs for further development. The results showed that:

Both ETEC vaccine constructs were well-tolerated and immunogenic (stimulated an immune response)
One of the constructs produced a significantly higher immune response, thereby making it the preferred choice for further development
The immune response to the preferred construct was equivalently strong whether one or two doses were given
The two constructs were derived from one ETEC strain by employing two different attenuation (gene deletion) strategies. The attenuation strategy applied to develop the preferred construct will now be applied to four other ETEC strains most commonly associated with disease to create a final, multi-strain vaccine formulation. In parallel, the preferred construct itself will be taken forward into a proof-of-principle efficacy trial, in which vaccinated subjects will be challenged with a virulent strain of ETEC. It is anticipated that this trial will begin before the end of this year.

ETEC (enterotoxigenic E. coli) is the major cause of travellers diarrhoea. The vaccine is aimed at the rapidly growing travellers vaccine market. The potential market for a travellers vaccine to prevent ETEC infection is estimated at over $400 million per year.

ChimeriVaxÔ JE – single-dose vaccine to prevent Japanese Encephalitis ("JE")

ChimeriVaxÔ is a technology platform broadly applicable to develop vaccines to protect against infections caused by flaviviruses. Two recent publications from data presented by our scientists at the 11th International Congress of Virology in Sydney demonstrated the safety and efficacy of ChimeriVaxÔ in pre-clinical models.

The most advanced project employing the ChimeriVaxÔ technology is to develop a JE vaccine, in collaboration with Aventis Pasteur. Pre-clinical work and manufacture of clinical lots for the Phase I trial has been completed. An IND is now being prepared for a Phase I safety and immunogenicity trial, which is expected to commence during the summer. Results from this trial are expected before the end of the year. The market potential for a new, improved single-dose JE vaccine is estimated to be between $150 million and $200 million.

ChimeriVaxÔ Dengue - vaccine to prevent dengue fever

In January 2000, we announced that we had made significant progress towards developing the world’s first vaccine against dengue fever. In pre-clinical studies our tetravalent (four component) vaccine formulation was shown to be safe and induce high levels of neutralising antibodies against all four dengue serotypes. Protection against challenge with dengue virus was also demonstrated. Clinical trials are expected to commence in 2001. The project is being conducted in collaboration with Aventis Pasteur.

Dengue fever is a mosquito-borne disease characterised by fever, rash, headache and muscle aches. It is a rapidly growing problem, affects over 100 million people annually and is given a very high priority by the World Health Organisation. Dengue occurs principally in tropical regions, but recent outbreaks have affected the southern US, most recently in Texas. No vaccine against dengue currently exists.

Allergy vaccine

Excellent progress has been made, in conjunction with SmithKline Beecham, towards validating a number of alternative epitopes (short peptide sequences) which could form the basis for new allergy vaccine candidates. We are on course to produce a potential clinical candidate during the second half of this year.

Manufacturing facility

In September 1999, we appointed a selling agent to assist us in seeking buyers for the Canton, Massachusetts biologics manufacturing facility, including the leasehold improvements and equipment in the facility. Having received widespread interest in the facility, we are now in negotiations with a shortlist of potential buyers. Proceeds from the sale will further strengthen the group’s financial position.

Financial review

The financial results for the year include the contribution from OraVax, Inc. from the date of completion of the acquisition, 11 May 1999.

Turnover for the year was £5.6 million (1998 - £0.7 million) and comprised income and funding from various collaborations, including those with Aventis Pasteur and SmithKline Beecham. The increase was attributable to the additional R&D funding now being received.

Expenditure on R&D increased to £14.1 million (1998 - £8.1 million) reflecting the increased expenditure from OraVax. £2.6 million of the R&D costs were attributable to the Arilvax® Phase III trial which will continue to be incurred through the first half of 2000 as the trial concludes and the BLA filing is made. The Arilvax® trial and associated regulatory filing costs are being financed through an overdraft facility underwritten by Celltech (formerly Medeva).

In addition to the above, our share of the expenditure on the H. pylori joint venture with Aventis Pasteur was £2.3 million for the period from 11 May 1999. For 2000, our share of the expenditure is expected to be less than £3 million.

Administrative costs increased to £2.0 million for the year (1998 - £1.3 million). Excluding OraVax, administrative costs remained at a similar level to those in 1998. Interest receivable remained at a similar level in 1999 at £1.1 million (1998 - £1.1 million) primarily as a result of the £20.2 million cash received from the Rights Issue in March 1999.

The goodwill arising on the acquisition of OraVax amounted to £18.0 million, reflecting the acquisition cost of £13.7 million (including fees) plus the net liabilities acquired at completion of £4.3 million. The goodwill is being carried on the balance sheet and written off over a period of 15 years, resulting in a charge to the profit and loss account of £0.8 million for the eight month period since the acquisition.

Capital expenditure for the year was £1.9 million (1998 - £1.5 million). This includes £0.8 million related to the final fit out and other costs on our new premises, which we moved into in March 1999. During the year we also recovered £0.5 million from the sale of the leasehold improvements at our previous premises. The other capital expenditure mainly related to additional laboratory equipment required within the new building. We anticipate capital expenditure for the Group to be significantly lower in 2000.

In March, we successfully completed a rights issue that raised £21.7 million, net of expenses. In addition, at the time of completion of the OraVax acquisition, Aventis Pasteur subscribed for £1.8 million of new Peptide shares in settlement of the $3 million loan that Aventis Pasteur had provided to OraVax. These proceeds, less the cash utilised during the year, resulted in Peptide’s cash and liquid resources increasing to £19.5 million at 31 December 1999. The balance on the Arilvax® overdraft facility was £2.0 million at 31 December 1999.

Although the acquisition of OraVax led to an increase in the level of cash burn for Peptide during 1999, several initiatives have been implemented to minimise the increase in expenditure. Following completion of the sale of the drug discovery activities of the business to Medivir AB, the combined group cash burn rate is expected to run at a level of around £0.7 million per month for the remainder of 2000.

This news release contains forward looking statements that involve risks and uncertainties, including the timing and results of clinical trials and other product development and commercialisation risks, the risks of satisfying the regulatory approval process in a timely manner, the need for and the availability of additional capital, and other risks detailed in the Company’s filings with the Securities and Exchange Commission.













4. Long-term overdraft facility


In September 1999, the Group entered into an agreement with Medeva Pharma Limited to perform a Phase III multi-centre US trial for Arilvaxâ . The Group is funding 100% of the costs of the clinical trial and regulatory submission. The costs will be financed through an overdraft facility up to a maximum of $7 million, being underwritten by Medeva. Medeva has granted to Peptide 100% of the marketing rights to Arilvaxâ in the US, whilst still retaining an option to buy back 50% of the profits from the US sales, in return for refunding to the Group the costs the Group have incurred on the Arilvaxâ programme.

Gruss virus

[hevchen]

werden noch sehr viel freude an dieser aktie haben. jetzt bei diesen kursen gross einkaufen und dann in ein paar monaten zum vielfachen verkaufen.

diese aktie hat sehr viel potential weil sie eine super Produktepipeline haben und zudem noch als übernahmekandidat sogar von 2 firmen umworben werden.

das heisst kaufen
STONG BUY

Hevchen

[CharlieB]

Ich gehe recht in der Annahme, daß es sich um *VORBÖRSLICHEN* Handel handelt?

CB

[virus]

nächste woche werden wir wieder die alten höchststände sehen.
diese aktie ist noch total unterbewertet und die kurschancen sind enorm.

und wenn noch der übernahmekampf hinzukommt CTB.L und PJP.L haben interesse an Peptide Therapeutics werden wir ein vielfaches von diesem kurs ( 1.08 Pfund ) sehen.

jetzt oder nie einsteigen, denn billiger könnt ihr diese aktie fast nicht mehr haben.