Alizyme PLC -- significant upside potential - 500 Beiträge pro Seite
eröffnet am 25.07.07 12:30:56 von
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Meistdiskutierte Wertpapiere
Platz | vorher | Wertpapier | Kurs | Perf. % | Anzahl | ||
---|---|---|---|---|---|---|---|
1. | 1. | 18.019,42 | +0,50 | 249 | |||
2. | 2. | 1,2700 | -7,97 | 95 | |||
3. | 3. | 0,1890 | 0,00 | 93 | |||
4. | 4. | 161,38 | +1,70 | 82 | |||
5. | 5. | 9,4000 | +1,68 | 79 | |||
6. | 6. | 7,1200 | +1,74 | 45 | |||
7. | 11. | 6,7600 | +0,60 | 35 | |||
8. | 8. | 0,0160 | -24,17 | 33 |
Hier wieder eine traumhafte Aktie die mit höchster wahrscheinlichkeit bald wieder neue höhen sehen wird.
Alizyme hat 4 prdoukte in der Pipeline davon 3 in PhaseIII und 1 in Phase IIb , 2 davon mit Blockbuster potential .
Hab soeben in münchen 3000st für 1,35€ gekauft ich bin sicher das ich die bald wieder teuerer verkaufen kann.
Clinical development milestones
Partner für cetilistat in 2H 2007
Commence cetilistat Phase III clinical studies in US / EU (H2 2007)
Commence ATL-104 Phase II/III clinical study (H1 2008)
Results from renzapridePhase III clinical study in US (H1 2008)
Results from COLAL-PRED®Phase III clinical study in EU (H1 2008)
Alizyme Plc
Marktkap: 179 mio pfund (267 mio€)
Cash: 19,1mio pfund ( 28,5 mio€)
Kurs: 89p (1,33€)
Pipeline:
http://www.alizyme.com/alizyme/products/overview/
Präsentation 19.07.2007 :
http://www.alizyme.com/alizyme/uploads/reports/07.19InterimP…
Potential Business Drivers Over the Next 12 Months:
On track to complete commercial deals in 2007
Cetilistat -start of Phase III development
Renzapride -US IBS-C Phase III preliminary results
COLAL-PRED® -EU UC Phase III preliminary results
ATL-104 -agree regulatory pathway with authorities
Summary –Investment Proposition
Alizyme hat 4 prdoukte in der Pipeline davon 3 in PhaseIII und 1 in Phase IIb , 2 davon mit Blockbuster potential .
Hab soeben in münchen 3000st für 1,35€ gekauft ich bin sicher das ich die bald wieder teuerer verkaufen kann.
Clinical development milestones
Partner für cetilistat in 2H 2007
Commence cetilistat Phase III clinical studies in US / EU (H2 2007)
Commence ATL-104 Phase II/III clinical study (H1 2008)
Results from renzapridePhase III clinical study in US (H1 2008)
Results from COLAL-PRED®Phase III clinical study in EU (H1 2008)
Alizyme Plc
Marktkap: 179 mio pfund (267 mio€)
Cash: 19,1mio pfund ( 28,5 mio€)
Kurs: 89p (1,33€)
Pipeline:
http://www.alizyme.com/alizyme/products/overview/
Präsentation 19.07.2007 :
http://www.alizyme.com/alizyme/uploads/reports/07.19InterimP…
Potential Business Drivers Over the Next 12 Months:
On track to complete commercial deals in 2007
Cetilistat -start of Phase III development
Renzapride -US IBS-C Phase III preliminary results
COLAL-PRED® -EU UC Phase III preliminary results
ATL-104 -agree regulatory pathway with authorities
Summary –Investment Proposition
ALIZYME PLC Product & Company Update
Cambridge UK 4 April 2007, Alizyme plc ('Alizyme' or 'the Company') (LSE: AZM) announces an update on its product development and corporate activities.
• Agreement with FDA under Special Protocol Assessment for Phase III clinical trial with cetilistat
• New patent granted in relation to manufacture of renzapride
• Patient recruitment on track for Phase III clinical trials with renzapride and COLAL-PRED(R)
Cetilistat
As indicated in our preliminary results announcement in February 2007, we have agreed with FDA the outline of the Phase III development programme for cetilistat. This programme will comprise three Phase III clinical trials involving obese patients, obese diabetic patients and obese patients with associated co-morbidities.
We are now pleased to announce that FDA has given approval of the protocol for the Phase III clinical trial in obese patients under the Special Protocol Assessment ('SPA') procedure.
The trial will be a multicentre, randomised, double blind, placebo controlled, parallel group study to assess the efficacy, safety and tolerability of cetilistat in obese patients. The trial will involve up to 1,350 obese patients being treated over a 52-week period. The primary endpoint will be the weight loss effect of cetilistat at dose levels of 60mg and 120mg, three times daily, compared to placebo. The secondary endpoints include the effect of cetilistat on other metabolic risk factors associated with obesity such as blood pressure and cholesterol.
Applications under the SPA procedure for approval of the two remaining clinical trial protocols will be made in due course. The Phase III development programme is now ready to commence, subject to the conclusion of a commercial deal.
Renzapride
We note that, on Friday 30 March 2007, Novartis announced that it had suspended marketing and sale in the US of Zelnorm(R), which is indicated for the treatment of constipation-predominant irritable bowel syndrome ('IBS-C') and chronic constipation. This action was taken after Novartis notified FDA about a retrospective analysis of data from more than 18,000 patients in its clinical trial database, in which a statistically significant imbalance in the incidence of cardiovascular ischemic events in patients taking Zelnorm(R) compared to those taking placebo was identified. These events included myocardial infarction (heart attack), stroke and unstable angina pectoris.
In our completed clinical trials with renzapride, involving more than 700 patients with IBS, there have been no cases of cardiovascular ischemic events reported either in subjects taking renzapride or placebo. Although renzapride, like Zelnorm(R), has 5-HT4 receptor agonist properties, renzapride and Zelnorm (R) are not members of the same chemical class and there is no reason for concluding that a similar pattern of cardiovascular ischemic events would be expected.
The ongoing Phase III clinical trial for IBS-C is not affected. To date, more than 1,000 patients have been recruited into the trial and we are on target to complete recruitment of up to 1,700 patients in 2007, with results to be reported in early 2008.
As part of our strategy to broaden our intellectual property position and enhance the commercial value in our products, we applied for two patents in relation to the large scale manufacture of renzapride and to the novel crystal form of renzapride being used in the current Phase III clinical trial. We are pleased to announce that we have been granted a US patent for the manufacture of renzapride, and patent applications are being prosecuted in other territories.
Prosecutions for the patent application on the novel crystal form of renzapride (including the US) are ongoing. These patents should enhance the value of this product and provide protection on renzapride until 2024.
COLAL-PRED(R)
Recruitment in our ongoing EU Phase III registration clinical trial in up to 750 patients with active moderate to severe ulcerative colitis is on target for completion in 2007. Results are expected to be reported in early 2008, followed by an application for registration in the EU.
ATL-104
We are making good progress in preparation for the next phase of development, including manufacturing scale-up for Phase III clinical trials and commercialisation.
Commenting on the announcement, Tim McCarthy, Chief Executive Officer, of Alizyme said:
'I am delighted with the continuing advancement of our products through development and especially the agreement with FDA on cetilistat. This clearly establishes the Phase III development programme for this product.
In addition, I am pleased with the ongoing discussions with potential partners for the commercialisation of our products and remain confident that Alizyme will successfully conclude a number of transforming deals this year.
Cambridge UK 4 April 2007, Alizyme plc ('Alizyme' or 'the Company') (LSE: AZM) announces an update on its product development and corporate activities.
• Agreement with FDA under Special Protocol Assessment for Phase III clinical trial with cetilistat
• New patent granted in relation to manufacture of renzapride
• Patient recruitment on track for Phase III clinical trials with renzapride and COLAL-PRED(R)
Cetilistat
As indicated in our preliminary results announcement in February 2007, we have agreed with FDA the outline of the Phase III development programme for cetilistat. This programme will comprise three Phase III clinical trials involving obese patients, obese diabetic patients and obese patients with associated co-morbidities.
We are now pleased to announce that FDA has given approval of the protocol for the Phase III clinical trial in obese patients under the Special Protocol Assessment ('SPA') procedure.
The trial will be a multicentre, randomised, double blind, placebo controlled, parallel group study to assess the efficacy, safety and tolerability of cetilistat in obese patients. The trial will involve up to 1,350 obese patients being treated over a 52-week period. The primary endpoint will be the weight loss effect of cetilistat at dose levels of 60mg and 120mg, three times daily, compared to placebo. The secondary endpoints include the effect of cetilistat on other metabolic risk factors associated with obesity such as blood pressure and cholesterol.
Applications under the SPA procedure for approval of the two remaining clinical trial protocols will be made in due course. The Phase III development programme is now ready to commence, subject to the conclusion of a commercial deal.
Renzapride
We note that, on Friday 30 March 2007, Novartis announced that it had suspended marketing and sale in the US of Zelnorm(R), which is indicated for the treatment of constipation-predominant irritable bowel syndrome ('IBS-C') and chronic constipation. This action was taken after Novartis notified FDA about a retrospective analysis of data from more than 18,000 patients in its clinical trial database, in which a statistically significant imbalance in the incidence of cardiovascular ischemic events in patients taking Zelnorm(R) compared to those taking placebo was identified. These events included myocardial infarction (heart attack), stroke and unstable angina pectoris.
In our completed clinical trials with renzapride, involving more than 700 patients with IBS, there have been no cases of cardiovascular ischemic events reported either in subjects taking renzapride or placebo. Although renzapride, like Zelnorm(R), has 5-HT4 receptor agonist properties, renzapride and Zelnorm (R) are not members of the same chemical class and there is no reason for concluding that a similar pattern of cardiovascular ischemic events would be expected.
The ongoing Phase III clinical trial for IBS-C is not affected. To date, more than 1,000 patients have been recruited into the trial and we are on target to complete recruitment of up to 1,700 patients in 2007, with results to be reported in early 2008.
As part of our strategy to broaden our intellectual property position and enhance the commercial value in our products, we applied for two patents in relation to the large scale manufacture of renzapride and to the novel crystal form of renzapride being used in the current Phase III clinical trial. We are pleased to announce that we have been granted a US patent for the manufacture of renzapride, and patent applications are being prosecuted in other territories.
Prosecutions for the patent application on the novel crystal form of renzapride (including the US) are ongoing. These patents should enhance the value of this product and provide protection on renzapride until 2024.
COLAL-PRED(R)
Recruitment in our ongoing EU Phase III registration clinical trial in up to 750 patients with active moderate to severe ulcerative colitis is on target for completion in 2007. Results are expected to be reported in early 2008, followed by an application for registration in the EU.
ATL-104
We are making good progress in preparation for the next phase of development, including manufacturing scale-up for Phase III clinical trials and commercialisation.
Commenting on the announcement, Tim McCarthy, Chief Executive Officer, of Alizyme said:
'I am delighted with the continuing advancement of our products through development and especially the agreement with FDA on cetilistat. This clearly establishes the Phase III development programme for this product.
In addition, I am pleased with the ongoing discussions with potential partners for the commercialisation of our products and remain confident that Alizyme will successfully conclude a number of transforming deals this year.
Broker Recommendations - Thursday 19th July 2007, 12:15 pm
Merrill says buy Alizyme (LSE: AZM.L - news) (175p target),
Falls einer mit diskutieren will:
http://www.iii.co.uk/investment/detail?code=cotn:AZM.L&displ…
Merrill says buy Alizyme (LSE: AZM.L - news) (175p target),
Falls einer mit diskutieren will:
http://www.iii.co.uk/investment/detail?code=cotn:AZM.L&displ…
super, endlich mal ein Kracher!
Hi, guter Pick!
Habe ich das richtig verstanden, dass die Phase III zu Cetilistat erst beginnen kann, wenn ein Partner gefunden worden ist?
Habe ich das richtig verstanden, dass die Phase III zu Cetilistat erst beginnen kann, wenn ein Partner gefunden worden ist?
Antwort auf Beitrag Nr.: 30.857.157 von Der.Eroberer am 26.07.07 12:02:37@Linker_Verteidiger
Falls das ironisch gemeint war dann warte ein paar wochen ab und wir sprechen uns nochmal mein kaufkurs steht oben.
@Der.Eroberer
Absolut richtig Phase III beginnt nur mit einem Partner an der seite und da es sich um einen blockbuster handelt rechne ich mit einem big deal und das noch in 2007.
Ich hab schon in der vergangenheit gut geld verdient mit Alizyme bei diesen kursen musste ich einfach zuschlagen .
Falls das ironisch gemeint war dann warte ein paar wochen ab und wir sprechen uns nochmal mein kaufkurs steht oben.
@Der.Eroberer
Absolut richtig Phase III beginnt nur mit einem Partner an der seite und da es sich um einen blockbuster handelt rechne ich mit einem big deal und das noch in 2007.
Ich hab schon in der vergangenheit gut geld verdient mit Alizyme bei diesen kursen musste ich einfach zuschlagen .
Ich bin mal mit von der Partie. Habe auch mal den alten Thread studiert
und bin der Meinung, dass Alizyme jetzt reif dafür ist, um die Früchte
der jahrelangen Arbeit zu ernten.
und bin der Meinung, dass Alizyme jetzt reif dafür ist, um die Früchte
der jahrelangen Arbeit zu ernten.
Antwort auf Beitrag Nr.: 30.866.789 von Der.Eroberer am 26.07.07 21:10:37Wir werden noch viel freude mit Alizyme haben allerdings hättest du vielleicht ein paar tage warten sollen möglich das wir die alten lows testen .
Falls das passieren sollte werde ich weitere dazu kaufen.
Hier kannst Du sehen wie die Instis in den letzten monate zugeschlagen haben:
http://moneyextra.uk-wire.com/cgi-bin/index?search_type=3&wo…
Falls das passieren sollte werde ich weitere dazu kaufen.
Hier kannst Du sehen wie die Instis in den letzten monate zugeschlagen haben:
http://moneyextra.uk-wire.com/cgi-bin/index?search_type=3&wo…
Antwort auf Beitrag Nr.: 30.867.106 von BrauchGeld am 26.07.07 21:27:45Es kann immer ein bisschen tiefer gehen, aber was zählt sind die
langfristigen Aussichten. Und die stimmen mich positiv. Alleine die
Verkündung einer Partnerschaft kann den Wert um mindestens 10-20%
springen lassen. Da lässt mich ein down-risk von 10% ziemlich kalt.
langfristigen Aussichten. Und die stimmen mich positiv. Alleine die
Verkündung einer Partnerschaft kann den Wert um mindestens 10-20%
springen lassen. Da lässt mich ein down-risk von 10% ziemlich kalt.
Also von mir aus kann Alizyme gerne nochmal ein wenig abrutschen, damit ich nochmal nachladen kann. Je länger ich mich mit Alizyme beschäftige, desto begeisterter bin ich.
@ BrauchGeld
Wieso hast Du den letzten Thread aufgegeben?
@ BrauchGeld
Wieso hast Du den letzten Thread aufgegeben?
Antwort auf Beitrag Nr.: 30.878.796 von Der.Eroberer am 27.07.07 16:29:43@Der.Eroberer
Ich hatte zu dem zeitpunkt die Aktie verkauft deshalb ist es schwachsinnig den Thread weiter zu verfolgen.
Ich hatte noch nicht erwähnt das nur eine PhaseIII studie die 12monate dauert erforderlich ist um anschliessend den zulassungsantrag zustellen.
Alizyme PLC - FDA Discussions RNS
ALIZYME ANNOUNCES SUCCESSFUL END OF PHASE II MEETING WITH FDA FOR CETILISTAT
Cambridge UK, 02 August 2006: Alizyme plc (LSE:AZM) is pleased to announce that it has concluded a successful end of Phase II meeting with the United States Food and Drug Administration ("FDA") for cetilistat. Cetilistat is the Company's product candidate in development for the treatment of obesity and management of related diseases such as Type II diabetes.
The meeting with the FDA followed successful completion of cetilistat's Phase II clinical programme. Following a broad review of cetilistat's current data package, the FDA has accepted the Company's overall plans for the manufacture, remaining pre-clinical development and the outline of the Phase III clinical development programme for the registration of cetilistat in the US.
As a result, the Phase III programme for registration will dose patients for one year and will enrol approximately 4,000 in total, in three or four placebo-controlled pivotal studies, such that up to 1,500 patients, treated for one year, are included in the safety database.
The primary endpoint in the obesity trials would be the proportion of patients who lose at least 5% of their body weight, as well as a range of secondary endpoints, including absolute weight loss and the proportion of patients who lose over 10% of their body weight compared to placebo. Key endpoints for the co-morbidity focused trials, such as with Type II diabetes, will include reduction in levels of HbA1c, a marker of diabetic control.
Following further discussions on protocol-specific details with the FDA, the Company will make final preparations for commencing Phase III clinical development in H1 2007. In addition, the Company will progress discussions with European regulatory agencies in order to finalise requirements for registration in Europe.
Cetilistat is a gastrointestinal lipase inhibitor with potential for the treatment of obesity and related diseases, such as Type II diabetes. Cetilistat acts in the gut (peripherally), through inhibition of the principal enzymes (pancreatic and gastric lipase) involved in the digestion of fat, preventing absorption of calories as fat and thus reducing body weight and improving the associated risk factors in obese patients. Cetilistat is differentiated from treatments that affect the central nervous system (centrally acting), such that it has not been found to cause the side effects normally associated with obesity drugs affecting the brain, which include nausea and dizziness, as well as other compound specific side-effects. In addition, as a peripherally acting drug with a good safety profile over a wide range of doses, cetilistat is not subject to the same concerns regarding the consequences of deliberate or accidental overdose.
Evidence of the safety and efficacy of cetilistat has been established through extensive Phase I and Phase II clinical trials in Europe, the US and Japan in over 1,000 subjects (over 800 subjects on active drug). In a Phase IIb study involving 372 clinically obese patients, cetilistat showed statistically significant weight loss compared to placebo. In a second Phase IIb study involving 612 clinically obese diabetic patients, cetilistat was compared with placebo and also with Xenical(R). Cetilistat was shown to cause statistically significant weight loss, compared to placebo. Cetilistat was also shown to cause statistically significant reductions in HbA1c, a marker of diabetic control. Furthermore, the proportion of subjects discontinuing treatment for adverse events was lower with cetilistat than with placebo. Although Xenical(R) showed efficacy results similar to those for cetilistat, the proportion of patients discontinuing for reasons of adverse events and the total number of gastrointestinal adverse events were substantially higher with Xenical(R) than with cetilistat, confirming earlier studies showing that cetilistat has a superior tolerability profile.
Dr. Richard Palmer, Chief Executive Officer commented:
"We are extremely pleased with the positive and constructive outcome of the end of Phase II meeting with the FDA which followed our robust clinical development of cetilistat to date. We believe that with its distinctive and very attractive risk/benefit profile, cetilistat will be a major contributor to the long term management of obesity and its consequences.
"The scope of the FDA agreement on the development plan provides an efficient and effective pathway for approval of cetilistat for the management of obesity and related disease and will aid our discussions with potential partners for cetilistat."
Ich hatte zu dem zeitpunkt die Aktie verkauft deshalb ist es schwachsinnig den Thread weiter zu verfolgen.
Ich hatte noch nicht erwähnt das nur eine PhaseIII studie die 12monate dauert erforderlich ist um anschliessend den zulassungsantrag zustellen.
Alizyme PLC - FDA Discussions RNS
ALIZYME ANNOUNCES SUCCESSFUL END OF PHASE II MEETING WITH FDA FOR CETILISTAT
Cambridge UK, 02 August 2006: Alizyme plc (LSE:AZM) is pleased to announce that it has concluded a successful end of Phase II meeting with the United States Food and Drug Administration ("FDA") for cetilistat. Cetilistat is the Company's product candidate in development for the treatment of obesity and management of related diseases such as Type II diabetes.
The meeting with the FDA followed successful completion of cetilistat's Phase II clinical programme. Following a broad review of cetilistat's current data package, the FDA has accepted the Company's overall plans for the manufacture, remaining pre-clinical development and the outline of the Phase III clinical development programme for the registration of cetilistat in the US.
As a result, the Phase III programme for registration will dose patients for one year and will enrol approximately 4,000 in total, in three or four placebo-controlled pivotal studies, such that up to 1,500 patients, treated for one year, are included in the safety database.
The primary endpoint in the obesity trials would be the proportion of patients who lose at least 5% of their body weight, as well as a range of secondary endpoints, including absolute weight loss and the proportion of patients who lose over 10% of their body weight compared to placebo. Key endpoints for the co-morbidity focused trials, such as with Type II diabetes, will include reduction in levels of HbA1c, a marker of diabetic control.
Following further discussions on protocol-specific details with the FDA, the Company will make final preparations for commencing Phase III clinical development in H1 2007. In addition, the Company will progress discussions with European regulatory agencies in order to finalise requirements for registration in Europe.
Cetilistat is a gastrointestinal lipase inhibitor with potential for the treatment of obesity and related diseases, such as Type II diabetes. Cetilistat acts in the gut (peripherally), through inhibition of the principal enzymes (pancreatic and gastric lipase) involved in the digestion of fat, preventing absorption of calories as fat and thus reducing body weight and improving the associated risk factors in obese patients. Cetilistat is differentiated from treatments that affect the central nervous system (centrally acting), such that it has not been found to cause the side effects normally associated with obesity drugs affecting the brain, which include nausea and dizziness, as well as other compound specific side-effects. In addition, as a peripherally acting drug with a good safety profile over a wide range of doses, cetilistat is not subject to the same concerns regarding the consequences of deliberate or accidental overdose.
Evidence of the safety and efficacy of cetilistat has been established through extensive Phase I and Phase II clinical trials in Europe, the US and Japan in over 1,000 subjects (over 800 subjects on active drug). In a Phase IIb study involving 372 clinically obese patients, cetilistat showed statistically significant weight loss compared to placebo. In a second Phase IIb study involving 612 clinically obese diabetic patients, cetilistat was compared with placebo and also with Xenical(R). Cetilistat was shown to cause statistically significant weight loss, compared to placebo. Cetilistat was also shown to cause statistically significant reductions in HbA1c, a marker of diabetic control. Furthermore, the proportion of subjects discontinuing treatment for adverse events was lower with cetilistat than with placebo. Although Xenical(R) showed efficacy results similar to those for cetilistat, the proportion of patients discontinuing for reasons of adverse events and the total number of gastrointestinal adverse events were substantially higher with Xenical(R) than with cetilistat, confirming earlier studies showing that cetilistat has a superior tolerability profile.
Dr. Richard Palmer, Chief Executive Officer commented:
"We are extremely pleased with the positive and constructive outcome of the end of Phase II meeting with the FDA which followed our robust clinical development of cetilistat to date. We believe that with its distinctive and very attractive risk/benefit profile, cetilistat will be a major contributor to the long term management of obesity and its consequences.
"The scope of the FDA agreement on the development plan provides an efficient and effective pathway for approval of cetilistat for the management of obesity and related disease and will aid our discussions with potential partners for cetilistat."
Na wenn das keine schöne erholung ist ,Alizyme ist wieder bei 90p.
Ich könnte mir in denn A... beissen, daß ich bei 1,20 Euro nicht
mehr zugekauft habe. Naja, die Posi ist groß genug und jetzt kann
es dann mal losgehen. Mit den kommenden Nachrichten in Aussicht, wird
der Kurs von selbst anspringen.
BrauchGeld, Glückwunsch zu Pipex! Hab leider viel zu früh wieder
geschmissen. Das wird mir bei Alizyme nicht passieren...
mehr zugekauft habe. Naja, die Posi ist groß genug und jetzt kann
es dann mal losgehen. Mit den kommenden Nachrichten in Aussicht, wird
der Kurs von selbst anspringen.
BrauchGeld, Glückwunsch zu Pipex! Hab leider viel zu früh wieder
geschmissen. Das wird mir bei Alizyme nicht passieren...
Antwort auf Beitrag Nr.: 30.941.746 von Der.Eroberer am 30.07.07 19:59:09Danke . Alizyme bleibt bei mir auch erstmal im depot die aussichten einfach top.
http://www.finanzen.net/eurams/eurams_aktuell.asp?pkBerichtN…
Serie Life Sciences, Teil 4: Übergewicht
20.07.2007
http://www.finanzen.net/eurams/eurams_aktuell.asp?pkBerichtN…
Serie Life Sciences, Teil 4: Übergewicht
20.07.2007
Taxe in Frankfurt: 1,35/1,41!
Es geht los...
Es geht los...
Da hat sich einer richtig eingedeckt mit über 570.000 aktien .
http://telegraph.digitallook.com/telegraph/security.cgi?csi=…
Value Price Volume Time Buy/Sell Type
£509,960 89.00p 572,989 10:22 Buy X
http://telegraph.digitallook.com/telegraph/security.cgi?csi=…
Value Price Volume Time Buy/Sell Type
£509,960 89.00p 572,989 10:22 Buy X
Wenn Alizyme es schafft heute über 96p zuschliessen gehts ruckzuck wieder über die 100p ,auch heute überwiegen die käufer .
Das war ja eine Punktlandung. Genau 96p...
Das Volumen ist heute auch angesprungen. Über das Doppelte des
normalen Tagesvolumens.
Das Volumen ist heute auch angesprungen. Über das Doppelte des
normalen Tagesvolumens.
Cetilistat (Obesity) PhaseIII <<Blockbuster Potential
Renzapride (Irritable Bowel Syndrome) PhaseIII <<Blockbuster potential
COLAL-PRED® (Ulcerative Colitis) PhaseIII << 250mio$ potential
ATL-104 (Mucositis) PhaseII/III << 500mio$ potential
Ausblick :
Renzapride (Irritable Bowel Syndrome) PhaseIII results 1H 2008
COLAL-PRED® (Ulcerative Colitis) PhaseIII results 1H 2008
Cetilistat (Obesity) PhaseIII start 2H 2007
Shares Magazine 29 August 2007
Alizyme has been looking for a partner to develop its anti-obesity product Cetilistat since it completed Phase II trials in August 2006. Hopes have been raised that it could soon be on the cards by Chairman Brian Richard’s comments at its interim results in July that it expects to ‘conclude a number of transforming deals,’ this year. The course of Phase III trials has already been agreed with US regulators the FDA and future sales of the product are forecast to tip $1 billion a year, so when a deal comes it could be huge. There is always an element of risk with drug discovery companies but Alizyme has a good chance of securing a lucrative deal which would send its shares soaring. Numis analyst Brett Pollard has a 150p target price for the shares – some 78% above their current level.
Renzapride (Irritable Bowel Syndrome) PhaseIII <<Blockbuster potential
COLAL-PRED® (Ulcerative Colitis) PhaseIII << 250mio$ potential
ATL-104 (Mucositis) PhaseII/III << 500mio$ potential
Ausblick :
Renzapride (Irritable Bowel Syndrome) PhaseIII results 1H 2008
COLAL-PRED® (Ulcerative Colitis) PhaseIII results 1H 2008
Cetilistat (Obesity) PhaseIII start 2H 2007
Shares Magazine 29 August 2007
Alizyme has been looking for a partner to develop its anti-obesity product Cetilistat since it completed Phase II trials in August 2006. Hopes have been raised that it could soon be on the cards by Chairman Brian Richard’s comments at its interim results in July that it expects to ‘conclude a number of transforming deals,’ this year. The course of Phase III trials has already been agreed with US regulators the FDA and future sales of the product are forecast to tip $1 billion a year, so when a deal comes it could be huge. There is always an element of risk with drug discovery companies but Alizyme has a good chance of securing a lucrative deal which would send its shares soaring. Numis analyst Brett Pollard has a 150p target price for the shares – some 78% above their current level.
Der grund das Alizyme in den letzten wochen nicht so gut gelaufen ist lag daran das die meisten nicht mehr mit einem Deal für dieses jahr gerechnet haben, vorgestern kam endlich die erlösende nachricht vom ceo...
In addition, I continue to be pleased with the ongoing discussions with potential partners for the further development and commercialisation of our products and remain confident of successfully concluding a number of deals across the portfolio this year."
ALIZYME PLC
Phase III Clinical Product Development Update
Renzapride and COLAL-PRED(R)
Cambridge UK, 8 October 2007: Alizyme plc (LSE: AZM) announces an update on its Phase III clinical product development.
Renzapride
COMPLETION OF PATIENT RECRUITMENT INTO FIRST PHASE III PIVOTAL EFFICACY STUDY
HEADLINE RESULTS EXPECTED IN APRIL 2008
SPECIAL PROTOCOL ASSESSMENT AGREED WITH FDA FOR SECOND PHASE III PIVOTAL
efficacy study
We are pleased to announce the completion of patient recruitment into the first Phase III pivotal efficacy study of renzapride in constipation-predominant irritable bowel syndrome (IBS-C).
The study (Study 038), a multi-centre, randomised, double-blind, placebo-controlled, parallel group, pivotal efficacy study, has recruited over 1,800 female patients with IBS-C. Patients are treated for a 12-week period. The primary endpoint is patients' self assessment of relief of their overall IBS symptoms. Secondary endpoints include adequate relief of abdominal pain/ discomfort and of bowel problems. Headline trial results are expected to be reported in April 2008.
At the end of the 12-week treatment period in Study 038, patients can elect to continue into an open label extension study (Study 052) to evaluate the long-term safety and tolerability of renzapride taken for 12 months. Patients continue to be recruited into this study with results expected to be reported in Q2 2009.
We are also pleased to announce that agreement has been reached with FDA on the clinical protocol for the second Phase III pivotal efficacy study (Study 109) of renzapride in IBS-C under the Special Protocol Assessment ("SPA") procedure. Recruitment into Study 109 is expected to commence in 2008.
COLAL-PRED(R)
PATIENT RECRUITMENT ON TRACK IN EU PHASE III CLINICAL TRIAL AND DUE TO
complete by end of 2007
HEADLINE RESULTS EXPECTED IN Q2 2008
Recruitment into our EU Phase III registration clinical trial in up to 750 patients with active moderate to severe ulcerative colitis remains on target for completion in 2007. Subject to the recruitment being completed this year, headline results are expected to be reported in Q2 2008.
Successful results from the EU Phase III trial would allow a Marketing Authorisation Application (MAA) to be submitted for the EU in H2 2008.
Commenting, Tim McCarthy, Chief Executive Officer said:
"We are delighted to have closed recruitment for this key pivotal study with renzapride. The headline results, expected in April 2008, will mark the completion of the first Phase III clinical trial of renzapride and are expected to confirm its product profile and competitive position. We anticipate commencement of a second Phase III study in 2008, which has now been agreed with FDA under the SPA procedure.
The first half of 2008 will see significant clinical news flow from the renzapride and COLAL-PRED(R) Phase III clinical trials and emphasises the late stage nature of our product portfolio.
In addition, I continue to be pleased with the ongoing discussions with potential partners for the further development and commercialisation of our products and remain confident of successfully concluding a number of deals across the portfolio this year."
ALIZYME PLC
Phase III Clinical Product Development Update
Renzapride and COLAL-PRED(R)
Cambridge UK, 8 October 2007: Alizyme plc (LSE: AZM) announces an update on its Phase III clinical product development.
Renzapride
COMPLETION OF PATIENT RECRUITMENT INTO FIRST PHASE III PIVOTAL EFFICACY STUDY
HEADLINE RESULTS EXPECTED IN APRIL 2008
SPECIAL PROTOCOL ASSESSMENT AGREED WITH FDA FOR SECOND PHASE III PIVOTAL
efficacy study
We are pleased to announce the completion of patient recruitment into the first Phase III pivotal efficacy study of renzapride in constipation-predominant irritable bowel syndrome (IBS-C).
The study (Study 038), a multi-centre, randomised, double-blind, placebo-controlled, parallel group, pivotal efficacy study, has recruited over 1,800 female patients with IBS-C. Patients are treated for a 12-week period. The primary endpoint is patients' self assessment of relief of their overall IBS symptoms. Secondary endpoints include adequate relief of abdominal pain/ discomfort and of bowel problems. Headline trial results are expected to be reported in April 2008.
At the end of the 12-week treatment period in Study 038, patients can elect to continue into an open label extension study (Study 052) to evaluate the long-term safety and tolerability of renzapride taken for 12 months. Patients continue to be recruited into this study with results expected to be reported in Q2 2009.
We are also pleased to announce that agreement has been reached with FDA on the clinical protocol for the second Phase III pivotal efficacy study (Study 109) of renzapride in IBS-C under the Special Protocol Assessment ("SPA") procedure. Recruitment into Study 109 is expected to commence in 2008.
COLAL-PRED(R)
PATIENT RECRUITMENT ON TRACK IN EU PHASE III CLINICAL TRIAL AND DUE TO
complete by end of 2007
HEADLINE RESULTS EXPECTED IN Q2 2008
Recruitment into our EU Phase III registration clinical trial in up to 750 patients with active moderate to severe ulcerative colitis remains on target for completion in 2007. Subject to the recruitment being completed this year, headline results are expected to be reported in Q2 2008.
Successful results from the EU Phase III trial would allow a Marketing Authorisation Application (MAA) to be submitted for the EU in H2 2008.
Commenting, Tim McCarthy, Chief Executive Officer said:
"We are delighted to have closed recruitment for this key pivotal study with renzapride. The headline results, expected in April 2008, will mark the completion of the first Phase III clinical trial of renzapride and are expected to confirm its product profile and competitive position. We anticipate commencement of a second Phase III study in 2008, which has now been agreed with FDA under the SPA procedure.
The first half of 2008 will see significant clinical news flow from the renzapride and COLAL-PRED(R) Phase III clinical trials and emphasises the late stage nature of our product portfolio.
Die Käufer sind zurückgekehrt jetzt wo es sogut wie sicher ist das noch dieses jahr einige deals abgeschlossen werden.
http://telegraph.digitallook.com/telegraph/security.cgi?csi=…
http://telegraph.digitallook.com/telegraph/security.cgi?csi=…
ABN AMRO steigert anteil um 500.000st auf 8,4 mio aktien.
http://www.iii.co.uk/investment/detail?code=cotn:AZM.L&displ…
http://www.iii.co.uk/investment/detail?code=cotn:AZM.L&displ…
Es sind nur noch etwa 75 tage bis zum Neujahr .
ABN AMRO war wieder aktiv neuer stand jetzt bei 9,35 mio aktien.
http://www.iii.co.uk/investment/detail?code=cotn:AZM.L&displ…
http://www.iii.co.uk/investment/detail?code=cotn:AZM.L&displ…
Der Kurs deutet schon an das in sehr naher zukunft gute nachrichten veröffentlicht werden.
TimesOnline :
"Keith Redpath, the JM Finn biotech analyst, believes that Alizyme is close to announcing development partners for its key irritable bowel, colitis and obesity treatments and that the shares – up 7¼p at 90¾p – are not pricing this in. It has enough cash to last until the end of 2008. He initiates coverage with a 106p price target."
TimesOnline :
"Keith Redpath, the JM Finn biotech analyst, believes that Alizyme is close to announcing development partners for its key irritable bowel, colitis and obesity treatments and that the shares – up 7¼p at 90¾p – are not pricing this in. It has enough cash to last until the end of 2008. He initiates coverage with a 106p price target."
Allzu lang ist das Jahr nicht mehr, Mr. McCarthy:
Zitat aus dem clinical update v. 10.10.07:
"In addition, I continue to be pleased with the ongoing discussions with potential partners for the further development and commercialisation of our products and remain confident of successfully concluding a number of deals across the portfolio this year."
Jedenfalls habe ich mir in den letzten Wochen genügend "Eintrittskarten" gesichert, um an der Geschenkverteilung teilnehmen zu dürfen. Schau´mer mal, wann die Vollzugsmeldung kommt.
Zitat aus dem clinical update v. 10.10.07:
"In addition, I continue to be pleased with the ongoing discussions with potential partners for the further development and commercialisation of our products and remain confident of successfully concluding a number of deals across the portfolio this year."
Jedenfalls habe ich mir in den letzten Wochen genügend "Eintrittskarten" gesichert, um an der Geschenkverteilung teilnehmen zu dürfen. Schau´mer mal, wann die Vollzugsmeldung kommt.
Der erste Streich:
ALIZYME LICENSES COLAL-PRED(R) TO PROMETHEUS
FOR NORTH AMERICA
Cambridge UK, 29 November 2007: Alizyme plc (LSE: AZM) ("Alizyme") announces
that its wholly owned subsidiary, Alizyme Therapeutics Limited, has granted an
exclusive licence to Prometheus Laboratories Inc. ("Prometheus"), a US specialty
pharmaceutical company, for the rights to COLAL-PRED(R), for gastrointestinal
diseases and other applications in North America.
- Prometheus is a leader in the provision of GI therapeutics and
diagnostics to GI specialists throughout the US
- Exclusive licence agreement for COLAL-PRED(R) in North America
- Upfront payment and development milestones worth $17.5 million
- $2.5 million: - payable immediately
- $15.0 million: - payable on future development milestones
- Prometheus will be primarily responsible for clinical development costs
for the licensed territory
- Royalty rates which increase with higher annual net sales levels
- Actively seeking other parties for territorial deals in Europe and Rest
of the World
Under the terms of the agreement, Prometheus is granted an exclusive licence to
develop and market COLAL-PRED(R) for gastrointestinal diseases and other
applications in North America, comprising the United States, Canada and Mexico
(the "Territory"). Alizyme will immediately receive $2.5 million, followed by
additional payments of up to $15.0 million on the achievement of future
development milestones up to registration of the product in the US. Prometheus
will be primarily responsible for clinical development costs for the licensed
Territory. Prometheus will also bear commercialisation costs in the Territory
and pay royalty rates to Alizyme which increase with higher annual net sales
levels of COLAL-PRED(R).
Prometheus will initiate the clinical development of COLAL-PRED(R) in the US
with a Phase II study for ulcerative colitis commencing in H1 2008. Subject to
the successful completion of clinical trials, Prometheus anticipates that it
will file a new drug application ("NDA") with the FDA in 2011. Prometheus has
already shown outstanding commitment to the partnership and to the development
of COLAL-PRED(R) in the US ahead of entering into the licence agreement
announced today through extensive involvement in preparation for Alizyme's
regulatory discussions with the FDA in relation to the US development program.
Alizyme is currently developing COLAL-PRED(R) for the treatment of ulcerative
colitis in Europe and recently announced that recruitment into the current EU
Phase III registration clinical trial in up to 750 patients with active
moderate-to-severe ulcerative colitis remained on target for completion in 2007.
Subject to the recruitment being completed this year, headline results are
expected to be reported in Q2 2008. Successful results from this EU Phase III
trial would allow a Marketing Authorisation Application (MAA) to be submitted
for the EU in H2 2008.
The ulcerative colitis market is currently dominated by anti-inflammatory
steroids and 5-ASA products, which have safety and/or efficacy issues.
COLAL-PRED(R) has a unique competitive profile based on Alizyme's proprietary
drug delivery technology, COLAL(R), which clinical trials to date have shown to
provide effective treatment of ulcerative colitis with an anti-inflammatory
steroid without the usual debilitating side effects typically associated with
such steroids.
Currently around 2 million people in major territories suffer from ulcerative
colitis, of which an estimated 700,000 are in the US. Current projections of
sales of COLAL-PRED(R) in the major territories are in excess of $250m pa.
Ferghana Partners Group (New York, Boston, London and Australia), a specialist
investment bank in the life sciences field, acted as exclusive financial and
transaction advisor to Alizyme in this corporate partnering transaction.
Commenting on today's announcement, Tim McCarthy, Alizyme's Chief Executive
Officer said:
"We are delighted to partner with Prometheus in North America for the
development and commercialisation of COLAL-PRED(R). As a leader in the provision
of therapeutics and complementary diagnostics to gastrointestinal specialists
throughout the United States, we believe Prometheus is uniquely positioned to
maximise the commercial potential of COLAL-PRED(R). This partnership with
Prometheus marks an important step in the commercialisation of COLAL-PRED(R) in
North America in parallel with our own development and commercialisation plans
in Europe and the Rest of the World (ROW).
"Separate discussions are ongoing with other parties for territorial deals in
Europe and ROW for COLAL-PRED(R). In addition we remain focused on delivering
further commercialisation deals across the remainder of the product portfolio."
Commenting on today's announcement, Joseph M. Limber, Chief Executive Officer of
Prometheus said:
"We are excited to have entered into this partnership with Alizyme. COLAL-PRED
(R) adds a therapeutically and commercially attractive development stage product
to our portfolio of proprietary, marketed pharmaceutical products, thus
strengthening our gastrointestinal franchise for the future. COLAL-PRED(R) can
provide a complementary therapeutic to our IBD Serology 7 diagnostic test, which
helps physicians diagnose ulcerative colitis and Crohn's disease."
Jetzt müssen noch cetilistad und renzapride folgen.
ALIZYME LICENSES COLAL-PRED(R) TO PROMETHEUS
FOR NORTH AMERICA
Cambridge UK, 29 November 2007: Alizyme plc (LSE: AZM) ("Alizyme") announces
that its wholly owned subsidiary, Alizyme Therapeutics Limited, has granted an
exclusive licence to Prometheus Laboratories Inc. ("Prometheus"), a US specialty
pharmaceutical company, for the rights to COLAL-PRED(R), for gastrointestinal
diseases and other applications in North America.
- Prometheus is a leader in the provision of GI therapeutics and
diagnostics to GI specialists throughout the US
- Exclusive licence agreement for COLAL-PRED(R) in North America
- Upfront payment and development milestones worth $17.5 million
- $2.5 million: - payable immediately
- $15.0 million: - payable on future development milestones
- Prometheus will be primarily responsible for clinical development costs
for the licensed territory
- Royalty rates which increase with higher annual net sales levels
- Actively seeking other parties for territorial deals in Europe and Rest
of the World
Under the terms of the agreement, Prometheus is granted an exclusive licence to
develop and market COLAL-PRED(R) for gastrointestinal diseases and other
applications in North America, comprising the United States, Canada and Mexico
(the "Territory"). Alizyme will immediately receive $2.5 million, followed by
additional payments of up to $15.0 million on the achievement of future
development milestones up to registration of the product in the US. Prometheus
will be primarily responsible for clinical development costs for the licensed
Territory. Prometheus will also bear commercialisation costs in the Territory
and pay royalty rates to Alizyme which increase with higher annual net sales
levels of COLAL-PRED(R).
Prometheus will initiate the clinical development of COLAL-PRED(R) in the US
with a Phase II study for ulcerative colitis commencing in H1 2008. Subject to
the successful completion of clinical trials, Prometheus anticipates that it
will file a new drug application ("NDA") with the FDA in 2011. Prometheus has
already shown outstanding commitment to the partnership and to the development
of COLAL-PRED(R) in the US ahead of entering into the licence agreement
announced today through extensive involvement in preparation for Alizyme's
regulatory discussions with the FDA in relation to the US development program.
Alizyme is currently developing COLAL-PRED(R) for the treatment of ulcerative
colitis in Europe and recently announced that recruitment into the current EU
Phase III registration clinical trial in up to 750 patients with active
moderate-to-severe ulcerative colitis remained on target for completion in 2007.
Subject to the recruitment being completed this year, headline results are
expected to be reported in Q2 2008. Successful results from this EU Phase III
trial would allow a Marketing Authorisation Application (MAA) to be submitted
for the EU in H2 2008.
The ulcerative colitis market is currently dominated by anti-inflammatory
steroids and 5-ASA products, which have safety and/or efficacy issues.
COLAL-PRED(R) has a unique competitive profile based on Alizyme's proprietary
drug delivery technology, COLAL(R), which clinical trials to date have shown to
provide effective treatment of ulcerative colitis with an anti-inflammatory
steroid without the usual debilitating side effects typically associated with
such steroids.
Currently around 2 million people in major territories suffer from ulcerative
colitis, of which an estimated 700,000 are in the US. Current projections of
sales of COLAL-PRED(R) in the major territories are in excess of $250m pa.
Ferghana Partners Group (New York, Boston, London and Australia), a specialist
investment bank in the life sciences field, acted as exclusive financial and
transaction advisor to Alizyme in this corporate partnering transaction.
Commenting on today's announcement, Tim McCarthy, Alizyme's Chief Executive
Officer said:
"We are delighted to partner with Prometheus in North America for the
development and commercialisation of COLAL-PRED(R). As a leader in the provision
of therapeutics and complementary diagnostics to gastrointestinal specialists
throughout the United States, we believe Prometheus is uniquely positioned to
maximise the commercial potential of COLAL-PRED(R). This partnership with
Prometheus marks an important step in the commercialisation of COLAL-PRED(R) in
North America in parallel with our own development and commercialisation plans
in Europe and the Rest of the World (ROW).
"Separate discussions are ongoing with other parties for territorial deals in
Europe and ROW for COLAL-PRED(R). In addition we remain focused on delivering
further commercialisation deals across the remainder of the product portfolio."
Commenting on today's announcement, Joseph M. Limber, Chief Executive Officer of
Prometheus said:
"We are excited to have entered into this partnership with Alizyme. COLAL-PRED
(R) adds a therapeutically and commercially attractive development stage product
to our portfolio of proprietary, marketed pharmaceutical products, thus
strengthening our gastrointestinal franchise for the future. COLAL-PRED(R) can
provide a complementary therapeutic to our IBD Serology 7 diagnostic test, which
helps physicians diagnose ulcerative colitis and Crohn's disease."
Jetzt müssen noch cetilistad und renzapride folgen.
Und der nächste Streich:
ALIZYME ENTERS STRATEGIC PARTNERSHIP WITH TSD JAPAN INCLUDING A CO-DEVELOPMENT
AGREEMENT FOR COLAL-PRED(R) IN JAPAN
Cambridge UK, 03 December 2007: Alizyme plc (LSE: AZM) ("Alizyme") announces
that its wholly owned subsidiary, Alizyme Therapeutics Limited, has entered into
a strategic partnership and co-development agreement with TSD Japan Inc.
("TSD"), a bio-venture company, including the exclusive rights to co-develop
COLAL-PRED(R) for ulcerative colitis in Japan.
- TSD is a business focused on strategic partnering activities that
involve in-licensing pharmaceutical drug candidates for development and
commercialisation in Japan
- TSD to identify new drug candidates in Japan for in-licensing/
acquisition by Alizyme for development ex-Japan
- Exclusive licence agreement with TSD for co-development of COLAL-PRED(R)
in Japan
- TSD will be predominantly responsible for Phase I and Phase II clinical
development costs
- All future milestones and royalties in Japan shared equally
- TSD to actively seek partner for late stage development and
commercialisation of COLAL-PRED(R) in Japan
Alizyme has formed a strategic partnership with TSD that offers the opportunity
to access one of the world's major pharmaceuticals markets via a Japan based
organisation. The corporate strategy to develop and commercialize Alizyme's
products in this important major territory is exemplified by this agreement for
COLAL-PRED(R). In addition, the relationship with TSD provides opportunity to
introduce further products from our portfolio into the Japanese market, and
provides the opportunity to access additional products via TSD for development
by Alizyme in the West.
Commenting on today's announcement, Tim McCarthy, Alizyme's Chief Executive
Officer said:
"We are delighted to enter into this strategic partnership with TSD in Japan,
which is exemplified by our co-development agreement for COLAL-PRED(R) as the
first step in our partnership. We have maintained a strong relationship with Dr
Shiho, the CEO and founder of TSD, following his time with Takeda Pharmaceutical
Company Limited and are excited by the many new opportunities that this
partnership will offer in the overall corporate development of Alizyme. We
believe Dr Shiho and his experienced team at TSD are uniquely positioned to
optimise the development and commercialisation of COLAL-PRED(R) for Japan, and
offer Alizyme further access to the Japanese market."
Today's announcement follows last week's announced partnership with Prometheus
for North American rights for COLAL-PRED(R) and marks another important step in
our commercialisation activities."
Commenting on today's announcement, Dr. Osamu Shiho, Chief Executive Officer TSD
Japan commented:
"COLAL-PRED(R), developed by Alizyme, is a unique compound to be co-developed by
TSD Japan's pharmaceutical partnering business and I believe that its
significant potential as a pharmaceutical agent will greatly assist us in
realising our corporate objective of developing and commercializing innovative
products for the Japanese market. I would like to see our collaborative
relationship broaden in the future, both in providing Alizyme access to new
products for their portfolio and providing TSD access to other promising
compounds from the Alizyme portfolio."
ALIZYME ENTERS STRATEGIC PARTNERSHIP WITH TSD JAPAN INCLUDING A CO-DEVELOPMENT
AGREEMENT FOR COLAL-PRED(R) IN JAPAN
Cambridge UK, 03 December 2007: Alizyme plc (LSE: AZM) ("Alizyme") announces
that its wholly owned subsidiary, Alizyme Therapeutics Limited, has entered into
a strategic partnership and co-development agreement with TSD Japan Inc.
("TSD"), a bio-venture company, including the exclusive rights to co-develop
COLAL-PRED(R) for ulcerative colitis in Japan.
- TSD is a business focused on strategic partnering activities that
involve in-licensing pharmaceutical drug candidates for development and
commercialisation in Japan
- TSD to identify new drug candidates in Japan for in-licensing/
acquisition by Alizyme for development ex-Japan
- Exclusive licence agreement with TSD for co-development of COLAL-PRED(R)
in Japan
- TSD will be predominantly responsible for Phase I and Phase II clinical
development costs
- All future milestones and royalties in Japan shared equally
- TSD to actively seek partner for late stage development and
commercialisation of COLAL-PRED(R) in Japan
Alizyme has formed a strategic partnership with TSD that offers the opportunity
to access one of the world's major pharmaceuticals markets via a Japan based
organisation. The corporate strategy to develop and commercialize Alizyme's
products in this important major territory is exemplified by this agreement for
COLAL-PRED(R). In addition, the relationship with TSD provides opportunity to
introduce further products from our portfolio into the Japanese market, and
provides the opportunity to access additional products via TSD for development
by Alizyme in the West.
Commenting on today's announcement, Tim McCarthy, Alizyme's Chief Executive
Officer said:
"We are delighted to enter into this strategic partnership with TSD in Japan,
which is exemplified by our co-development agreement for COLAL-PRED(R) as the
first step in our partnership. We have maintained a strong relationship with Dr
Shiho, the CEO and founder of TSD, following his time with Takeda Pharmaceutical
Company Limited and are excited by the many new opportunities that this
partnership will offer in the overall corporate development of Alizyme. We
believe Dr Shiho and his experienced team at TSD are uniquely positioned to
optimise the development and commercialisation of COLAL-PRED(R) for Japan, and
offer Alizyme further access to the Japanese market."
Today's announcement follows last week's announced partnership with Prometheus
for North American rights for COLAL-PRED(R) and marks another important step in
our commercialisation activities."
Commenting on today's announcement, Dr. Osamu Shiho, Chief Executive Officer TSD
Japan commented:
"COLAL-PRED(R), developed by Alizyme, is a unique compound to be co-developed by
TSD Japan's pharmaceutical partnering business and I believe that its
significant potential as a pharmaceutical agent will greatly assist us in
realising our corporate objective of developing and commercializing innovative
products for the Japanese market. I would like to see our collaborative
relationship broaden in the future, both in providing Alizyme access to new
products for their portfolio and providing TSD access to other promising
compounds from the Alizyme portfolio."
Wird wohl keinen schönen Jahresausklang für Alizyme geben, obwohl die letzten Nachrichten ja alles andere als negativ waren.
Aber im Moment ist angesichts der Risikoaversion der Anleger an den Märkten und damit auch schlechter Stimmung für Biotechs wenig zu holen. Sicher hat man auch mehr Deals von Alizyme erwartet, insbesondere was die potentiellen Blockbuster Cetilistat und Renzapride angeht.
Ich jedenfalls werde die Kurse weiter zum Nachladen nutzen und auf bessere Zeiten warten. Für 2008 sind weitere Commercial-Deals und auch beträchtlicher klinischer Newsflow zu erwarten. Wenn hier positive Meldungen kommen sollten, sind die heutigen Kurse im Rückblick ein Geschenk des Himmels. Die Market-cap ist mit unter 120 Mio. Pfund für ein Unternehmen, dass alleine zwei potentielle Mrd.-Dollar Medikamente in der late-stage Phase III hat, ein Witz.
Aber im Moment ist angesichts der Risikoaversion der Anleger an den Märkten und damit auch schlechter Stimmung für Biotechs wenig zu holen. Sicher hat man auch mehr Deals von Alizyme erwartet, insbesondere was die potentiellen Blockbuster Cetilistat und Renzapride angeht.
Ich jedenfalls werde die Kurse weiter zum Nachladen nutzen und auf bessere Zeiten warten. Für 2008 sind weitere Commercial-Deals und auch beträchtlicher klinischer Newsflow zu erwarten. Wenn hier positive Meldungen kommen sollten, sind die heutigen Kurse im Rückblick ein Geschenk des Himmels. Die Market-cap ist mit unter 120 Mio. Pfund für ein Unternehmen, dass alleine zwei potentielle Mrd.-Dollar Medikamente in der late-stage Phase III hat, ein Witz.
ALIZYME PLC
Product & Company Update
Cambridge, UK, 7 January 2008, Alizyme plc ("Alizyme" or "the Company") (LSE:
AZM) announces completion of recruitment into its COLAL-PRED(R) Phase III
clinical trial and provides an update on its other product development and
corporate activities.
- COLAL-PRED(R) - completion of patient recruitment into Phase III
registration clinical trial with results anticipated end June 2008
- Cetilistat - partnering discussions ongoing ahead of commencing Phase
III development programme
- Renzapride - on schedule to report pivotal efficacy Phase III results in
April 2008
- ATL-104 - preparing to commence second Phase II trial in H2 2008
- Partnering and commercialisation interest across the portfolio
COLAL-PRED(R)
We are pleased to announce the completion of patient recruitment into the
pivotal registration Phase III study (Study 020) of COLAL-PRED(R) in patients
with active moderate to severe ulcerative colitis (UC). Headline trial results
are expected to be reported by the end of June 2008.
Successful results from the Phase III trial would allow a Marketing
Authorisation Application (MAA) to be submitted for the EU in H2 2008.
We were extremely pleased to announce the two transactions for the development
and commercialisation of COLAL-PRED(R) in North America and Japan during 2007.
There continues to be partnering and commercialisation interest in COLAL-PRED(R)
and we anticipate concluding additional territorial transactions during 2008.
Cetilistat
There continues to be significant partnering and development interest in
cetilistat with discussions ongoing. The Phase III development programme is now
ready to commence following the conclusion of a commercial deal.
The Phase III development programme agreed with FDA comprises three clinical
trials involving obese patients with or without co-morbidities (including
diabetes). During 2007 discussions with FDA on the Phase III continued and in
April 2007 we announced that FDA had given approval, under the Special Protocol
Assessment ("SPA") procedure, of the protocol for a Phase III clinical trial in
obese patients who do not have diabetes. We anticipate receiving similar
approval under the SPA procedure for the two remaining clinical trial protocols
for the Phase III programme.
Renzapride
Headline trial results from Study 038, the first pivotal efficacy Phase III
study of renzapride in constipation-predominant irritable bowel syndrome
(IBS-C), remain on schedule to be reported in April 2008.
We announced in October 2007 that agreement had been reached with FDA on the
clinical protocol for the second Phase III pivotal efficacy study (Study 109) of
renzapride in IBS-C under the Special Protocol Assessment ("SPA") procedure.
Given positive results from Study 038, recruitment into Study 109 is expected to
commence in 2008.
There continues to be partnering and commercialisation interest in renzapride
with discussions ongoing. We would anticipate that this interest will increase
following the announcement of positive Phase III results in April 2008.
ATL-104
We continue to make good progress in the preparation for the next phase of
development of ATL-104, including manufacturing scale-up for Phase III clinical
trials and commercialisation. We anticipate commencing a second Phase II study
in H2 2008, this time in patients with solid cancer tumours suffering from
mucositis, which could allow for expansion of the commercial opportunity for
ATL-104.
Commenting on today's announcement, Tim McCarthy, Chief Executive Officer, of
Alizyme said:
"I am delighted with the continuing advancement of our products through clinical
development and also the progress made on the commercialisation of our portfolio
through 2007.
We continue with a number of ongoing discussions with potential partners for the
commercialisation of our products and this activity together with results from
our two Phase III clinical studies and further clinical development progress
will provide for significant news flow through 2008."
Product & Company Update
Cambridge, UK, 7 January 2008, Alizyme plc ("Alizyme" or "the Company") (LSE:
AZM) announces completion of recruitment into its COLAL-PRED(R) Phase III
clinical trial and provides an update on its other product development and
corporate activities.
- COLAL-PRED(R) - completion of patient recruitment into Phase III
registration clinical trial with results anticipated end June 2008
- Cetilistat - partnering discussions ongoing ahead of commencing Phase
III development programme
- Renzapride - on schedule to report pivotal efficacy Phase III results in
April 2008
- ATL-104 - preparing to commence second Phase II trial in H2 2008
- Partnering and commercialisation interest across the portfolio
COLAL-PRED(R)
We are pleased to announce the completion of patient recruitment into the
pivotal registration Phase III study (Study 020) of COLAL-PRED(R) in patients
with active moderate to severe ulcerative colitis (UC). Headline trial results
are expected to be reported by the end of June 2008.
Successful results from the Phase III trial would allow a Marketing
Authorisation Application (MAA) to be submitted for the EU in H2 2008.
We were extremely pleased to announce the two transactions for the development
and commercialisation of COLAL-PRED(R) in North America and Japan during 2007.
There continues to be partnering and commercialisation interest in COLAL-PRED(R)
and we anticipate concluding additional territorial transactions during 2008.
Cetilistat
There continues to be significant partnering and development interest in
cetilistat with discussions ongoing. The Phase III development programme is now
ready to commence following the conclusion of a commercial deal.
The Phase III development programme agreed with FDA comprises three clinical
trials involving obese patients with or without co-morbidities (including
diabetes). During 2007 discussions with FDA on the Phase III continued and in
April 2007 we announced that FDA had given approval, under the Special Protocol
Assessment ("SPA") procedure, of the protocol for a Phase III clinical trial in
obese patients who do not have diabetes. We anticipate receiving similar
approval under the SPA procedure for the two remaining clinical trial protocols
for the Phase III programme.
Renzapride
Headline trial results from Study 038, the first pivotal efficacy Phase III
study of renzapride in constipation-predominant irritable bowel syndrome
(IBS-C), remain on schedule to be reported in April 2008.
We announced in October 2007 that agreement had been reached with FDA on the
clinical protocol for the second Phase III pivotal efficacy study (Study 109) of
renzapride in IBS-C under the Special Protocol Assessment ("SPA") procedure.
Given positive results from Study 038, recruitment into Study 109 is expected to
commence in 2008.
There continues to be partnering and commercialisation interest in renzapride
with discussions ongoing. We would anticipate that this interest will increase
following the announcement of positive Phase III results in April 2008.
ATL-104
We continue to make good progress in the preparation for the next phase of
development of ATL-104, including manufacturing scale-up for Phase III clinical
trials and commercialisation. We anticipate commencing a second Phase II study
in H2 2008, this time in patients with solid cancer tumours suffering from
mucositis, which could allow for expansion of the commercial opportunity for
ATL-104.
Commenting on today's announcement, Tim McCarthy, Chief Executive Officer, of
Alizyme said:
"I am delighted with the continuing advancement of our products through clinical
development and also the progress made on the commercialisation of our portfolio
through 2007.
We continue with a number of ongoing discussions with potential partners for the
commercialisation of our products and this activity together with results from
our two Phase III clinical studies and further clinical development progress
will provide for significant news flow through 2008."
Jetzt kommen die positiven Meldungen, die zu der schönen Kursentwicklung der letzten paar Tage passen (Gruß an alle Insider !). Gleich drei Nachrichten an einem Tag:
LIZYME PLC
PRELIMINARY RESULTS FOR THE YEAR ENDED 31 DECEMBER 2007
Cambridge UK, 6 March 2008: Alizyme plc ("Alizyme") (LSE: AZM) today announces
its preliminary results for the year ended 31 December 2007.
Highlights
Operational
Cetilistat (obesity and diabetes)
- Agreed protocols of all three studies for the Phase III programme with
FDA under SPA procedure
- FDA has indicated a potential labelling for type 2 diabetes, as well as
for obesity
o See separate announcement today
Renzapride (irritable bowel syndrome)
- Completed recruitment for pivotal efficacy Phase III clinical trial in
over 1,800 female IBS-C patients
o Results scheduled to be reported in April 2008
- Agreed protocol for second pivotal Phase III clinical trial in
approximately 1,700 female IBS-C patients with FDA under SPA procedure
COLAL-PRED(R) (ulcerative colitis)
- Completed recruitment for EU Phase III registration clinical trial in
approximately 800 patients with active moderate to severe ulcerative colitis
- Results scheduled to be reported in July 2008
- Licence agreement with Prometheus Laboratories, Inc. for
gastrointestinal disorders and other conditions for North America
o US$2.5 million up front payment received, additional milestones of up
to US$15 million
o Royalty rates which increase with higher annual net sales levels
- Co-development agreement with TSD Japan for ulcerative colitis in Japan
ATL-104 (mucositis)
- Transfer of manufacturing technology to commercial facility initiated
- Preparations for Phase II study in patients with solid cancer tumours
underway
Financial
- Revenues of £0.01 million (2006: £1.1 million) recognised in the period
- Net loss after tax of £31.2 million (2006: £18.0 million)
- Cash, cash equivalents and money market investments of £5.8 million at
31 December 2007 (2006: £27.7 million)
- £10.0 million gross raised from shareholders in the placing closed on 5
March 2008
Commenting on the announcement, Chief Executive Officer, Tim McCarthy said:
"Having secured two new commercial partners in 2007, we continue with a number
of ongoing discussions with potential partners to further enable completion of
development, registration and ultimately marketing of all products in our
existing late-stage portfolio. Simultaneously we will continue to identify
further promising assets to expand our pipeline and expect to bring in new drugs
for development when suitable opportunities arise. We anticipate that these
activities, together with results from our two Phase III clinical studies and
further clinical development progress, will provide for significant news flow
throughout 2008."
---------------------------------------------------------------------------
ALIZYME PLC
£10 MILLION INSTITUTIONAL PLACING
Cambridge UK, 6 March 2008: Alizyme plc ("Alizyme" or "the Company"), today
announces that it has raised approximately £10 million before expenses through a
placing for cash of 20,033,352 new ordinary shares of 2 pence each (the "New
Shares").
Today the Company also announces its 2007 preliminary results and an update on
the cetilistat Phase III development plan (please see separate press releases).
Key Highlights of the Placing:
- Oversubscribed transaction, well supported by Alizyme's major
shareholders
- Priced at a premium to the underlying share price
- Provides the Company with financial stability, supporting the
negotiation of optimal deal terms on the out-licensing of its late stage
product portfolio
The New Shares, which represent approximately 10 per cent. of the Company's
issued share capital prior to the placing, have been placed with a number of the
Company's major shareholders by Piper Jaffray Ltd. at a placing price of 50
pence per share. The placing price represents a premium of 3.6 per cent. to the
closing middle market price on the London Stock Exchange on 5 March 2008. This
placing was undertaken pursuant to a resolution of the shareholders at the
Company's Annual General Meeting in June 2007 which approved the disapplication
of shareholders' pre-emption rights in relation to the issue of equity
securities up to an aggregate nominal amount of £400,667.04, being approximately
10 per cent. of the then issued share capital of the Company.
Application will be made today for the New Shares to be admitted to the Official
List and to trading on the London Stock Exchange. The placing is conditional on
admission, which is expected to become effective no later than 11 March 2008.
When issued, the New Shares will rank pari passu in all respects with the
Company's existing ordinary shares. Following the placing, Alizyme will have a
total of 221,098,686 ordinary shares in issue.
Commenting on the Placing, Tim McCarthy, Chief Executive Officer, said:
"We are delighted with the strong support shown in this placing by our leading
UK institutional shareholders. Importantly, the cash raised provides the Company
with financial stability, supporting the negotiation of optimal deal terms on
the out-licensing of our late stage products. The Board remains confident of the
potential of Alizyme's valuable product pipeline and is fully committed to
realising optimal value for all shareholders."
ALIZYME PLC
CETILISTAT PHASE III DEVELOPMENT PLAN
Opportunity for label for type 2 diabetes as well as for obesity
Cambridge UK, 6 March 2008: Alizyme plc ("Alizyme") (LSE: AZM) today announces
that FDA has agreed the remaining two protocols for its Phase III development
programme for cetilistat under the Special Protocol Assessment ("SPA") procedure
and recommended that Alizyme open a separate diabetes IND.
Cetilistat
Cetilistat is Alizyme's metabolic product under development for the treatment of
obesity and associated co-morbidities, including type 2 diabetes. It is a
gastrointestinal lipase inhibitor that blocks fat digestion and absorption,
leading to reduced energy intake, and thus weight loss.
Following successful end of Phase II discussions, FDA approved Alizyme's outline
plan for the Phase III clinical development programme of cetilistat. This
comprises three 12 month studies involving:
(i) obese patients without co-morbidities and obese patients with treated or
untreated co-morbidities (other than type 2 diabetes);
(ii) obese patients without co-morbidities and obese patients
with untreated co-morbidities (other than type 2 diabetes); and
(iii) obese patients with treated type 2 diabetes and who may
have treated or untreated other co-morbidities.
In April 2007, Alizyme announced that the protocol for the first study was
agreed with FDA under the SPA procedure. The protocols for the second and third
studies have now also been agreed with FDA under the SPA procedure. The second
study will involve a direct comparison with Xenical(R), as well as placebo.
FDA issued draft guidance on the development of diabetes drugs at the end of
February 2008. Under this guidance, it has acknowledged that improvement in
HbA1c has become the standard surrogate outcome measure for diabetes studies.
Evidence of the safety and efficacy of cetilistat has been established through
extensive Phase I and Phase II studies. Furthermore, in Phase II studies,
cetilistat was shown to cause statistically significant weight loss, compared to
placebo and, in clinically obese diabetic patients, to cause statistically
significant reductions in HbA1c.
FDA has corresponded directly with Alizyme in relation to its planned Phase III
programme and recommended that Alizyme open a separate diabetes IND for
cetilistat, since it is not now requiring that a drug's effect on glycemic
control be independent of its effect on body weight in order for the drug to be
considered for a stand alone diabetes indication. Although FDA has publicly
stated that long-term safety studies lasting longer than one year may be
required for some therapeutics in which substantial safety issues or questions
arise, it has indicated that a 12 month study would be sufficient for a pivotal
study with cetilistat for obese diabetics.
The Phase III development programme for cetilistat, which provides a clear route
to registration as an obesity product, is now ready to commence following the
conclusion of a commercial deal. There continues to be significant partnering
and development interest in cetilistat; discussions are ongoing.
Commenting on the announcement, Chief Executive Officer, Tim McCarthy said:
"I am delighted with this news. Not only is the regulatory pathway for
cetilistat as an obesity product firmly established with FDA, giving clarity to
potential partners with respect to the route to market for cetilistat, but the
opportunity to develop the market for cetilistat further by opening an IND for diabetes is of great commercial significance."
LIZYME PLC
PRELIMINARY RESULTS FOR THE YEAR ENDED 31 DECEMBER 2007
Cambridge UK, 6 March 2008: Alizyme plc ("Alizyme") (LSE: AZM) today announces
its preliminary results for the year ended 31 December 2007.
Highlights
Operational
Cetilistat (obesity and diabetes)
- Agreed protocols of all three studies for the Phase III programme with
FDA under SPA procedure
- FDA has indicated a potential labelling for type 2 diabetes, as well as
for obesity
o See separate announcement today
Renzapride (irritable bowel syndrome)
- Completed recruitment for pivotal efficacy Phase III clinical trial in
over 1,800 female IBS-C patients
o Results scheduled to be reported in April 2008
- Agreed protocol for second pivotal Phase III clinical trial in
approximately 1,700 female IBS-C patients with FDA under SPA procedure
COLAL-PRED(R) (ulcerative colitis)
- Completed recruitment for EU Phase III registration clinical trial in
approximately 800 patients with active moderate to severe ulcerative colitis
- Results scheduled to be reported in July 2008
- Licence agreement with Prometheus Laboratories, Inc. for
gastrointestinal disorders and other conditions for North America
o US$2.5 million up front payment received, additional milestones of up
to US$15 million
o Royalty rates which increase with higher annual net sales levels
- Co-development agreement with TSD Japan for ulcerative colitis in Japan
ATL-104 (mucositis)
- Transfer of manufacturing technology to commercial facility initiated
- Preparations for Phase II study in patients with solid cancer tumours
underway
Financial
- Revenues of £0.01 million (2006: £1.1 million) recognised in the period
- Net loss after tax of £31.2 million (2006: £18.0 million)
- Cash, cash equivalents and money market investments of £5.8 million at
31 December 2007 (2006: £27.7 million)
- £10.0 million gross raised from shareholders in the placing closed on 5
March 2008
Commenting on the announcement, Chief Executive Officer, Tim McCarthy said:
"Having secured two new commercial partners in 2007, we continue with a number
of ongoing discussions with potential partners to further enable completion of
development, registration and ultimately marketing of all products in our
existing late-stage portfolio. Simultaneously we will continue to identify
further promising assets to expand our pipeline and expect to bring in new drugs
for development when suitable opportunities arise. We anticipate that these
activities, together with results from our two Phase III clinical studies and
further clinical development progress, will provide for significant news flow
throughout 2008."
---------------------------------------------------------------------------
ALIZYME PLC
£10 MILLION INSTITUTIONAL PLACING
Cambridge UK, 6 March 2008: Alizyme plc ("Alizyme" or "the Company"), today
announces that it has raised approximately £10 million before expenses through a
placing for cash of 20,033,352 new ordinary shares of 2 pence each (the "New
Shares").
Today the Company also announces its 2007 preliminary results and an update on
the cetilistat Phase III development plan (please see separate press releases).
Key Highlights of the Placing:
- Oversubscribed transaction, well supported by Alizyme's major
shareholders
- Priced at a premium to the underlying share price
- Provides the Company with financial stability, supporting the
negotiation of optimal deal terms on the out-licensing of its late stage
product portfolio
The New Shares, which represent approximately 10 per cent. of the Company's
issued share capital prior to the placing, have been placed with a number of the
Company's major shareholders by Piper Jaffray Ltd. at a placing price of 50
pence per share. The placing price represents a premium of 3.6 per cent. to the
closing middle market price on the London Stock Exchange on 5 March 2008. This
placing was undertaken pursuant to a resolution of the shareholders at the
Company's Annual General Meeting in June 2007 which approved the disapplication
of shareholders' pre-emption rights in relation to the issue of equity
securities up to an aggregate nominal amount of £400,667.04, being approximately
10 per cent. of the then issued share capital of the Company.
Application will be made today for the New Shares to be admitted to the Official
List and to trading on the London Stock Exchange. The placing is conditional on
admission, which is expected to become effective no later than 11 March 2008.
When issued, the New Shares will rank pari passu in all respects with the
Company's existing ordinary shares. Following the placing, Alizyme will have a
total of 221,098,686 ordinary shares in issue.
Commenting on the Placing, Tim McCarthy, Chief Executive Officer, said:
"We are delighted with the strong support shown in this placing by our leading
UK institutional shareholders. Importantly, the cash raised provides the Company
with financial stability, supporting the negotiation of optimal deal terms on
the out-licensing of our late stage products. The Board remains confident of the
potential of Alizyme's valuable product pipeline and is fully committed to
realising optimal value for all shareholders."
ALIZYME PLC
CETILISTAT PHASE III DEVELOPMENT PLAN
Opportunity for label for type 2 diabetes as well as for obesity
Cambridge UK, 6 March 2008: Alizyme plc ("Alizyme") (LSE: AZM) today announces
that FDA has agreed the remaining two protocols for its Phase III development
programme for cetilistat under the Special Protocol Assessment ("SPA") procedure
and recommended that Alizyme open a separate diabetes IND.
Cetilistat
Cetilistat is Alizyme's metabolic product under development for the treatment of
obesity and associated co-morbidities, including type 2 diabetes. It is a
gastrointestinal lipase inhibitor that blocks fat digestion and absorption,
leading to reduced energy intake, and thus weight loss.
Following successful end of Phase II discussions, FDA approved Alizyme's outline
plan for the Phase III clinical development programme of cetilistat. This
comprises three 12 month studies involving:
(i) obese patients without co-morbidities and obese patients with treated or
untreated co-morbidities (other than type 2 diabetes);
(ii) obese patients without co-morbidities and obese patients
with untreated co-morbidities (other than type 2 diabetes); and
(iii) obese patients with treated type 2 diabetes and who may
have treated or untreated other co-morbidities.
In April 2007, Alizyme announced that the protocol for the first study was
agreed with FDA under the SPA procedure. The protocols for the second and third
studies have now also been agreed with FDA under the SPA procedure. The second
study will involve a direct comparison with Xenical(R), as well as placebo.
FDA issued draft guidance on the development of diabetes drugs at the end of
February 2008. Under this guidance, it has acknowledged that improvement in
HbA1c has become the standard surrogate outcome measure for diabetes studies.
Evidence of the safety and efficacy of cetilistat has been established through
extensive Phase I and Phase II studies. Furthermore, in Phase II studies,
cetilistat was shown to cause statistically significant weight loss, compared to
placebo and, in clinically obese diabetic patients, to cause statistically
significant reductions in HbA1c.
FDA has corresponded directly with Alizyme in relation to its planned Phase III
programme and recommended that Alizyme open a separate diabetes IND for
cetilistat, since it is not now requiring that a drug's effect on glycemic
control be independent of its effect on body weight in order for the drug to be
considered for a stand alone diabetes indication. Although FDA has publicly
stated that long-term safety studies lasting longer than one year may be
required for some therapeutics in which substantial safety issues or questions
arise, it has indicated that a 12 month study would be sufficient for a pivotal
study with cetilistat for obese diabetics.
The Phase III development programme for cetilistat, which provides a clear route
to registration as an obesity product, is now ready to commence following the
conclusion of a commercial deal. There continues to be significant partnering
and development interest in cetilistat; discussions are ongoing.
Commenting on the announcement, Chief Executive Officer, Tim McCarthy said:
"I am delighted with this news. Not only is the regulatory pathway for
cetilistat as an obesity product firmly established with FDA, giving clarity to
potential partners with respect to the route to market for cetilistat, but the
opportunity to develop the market for cetilistat further by opening an IND for diabetes is of great commercial significance."
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