Arena Pharmaceuticals klarer Musterdepotkandidat - 500 Beiträge pro Seite
eröffnet am 02.02.09 15:11:36 von
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neuester Beitrag 28.12.09 13:18:21 von
Beiträge: 52
ID: 1.148.008
ID: 1.148.008
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Gesamt: 16.020
Gesamt: 16.020
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ISIN: US0400476075 · WKN: A2DR4A
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Letzter Kurs 11.03.22 NYSE
Werte aus der Branche Pharmaindustrie
| Wertpapier | Kurs | Perf. % |
|---|---|---|
| 2,4137 | +44,53 | |
| 6,0000 | +25,00 | |
| 56,69 | +20,00 | |
| 0,6400 | +18,52 | |
| 491,30 | +17,07 |
| Wertpapier | Kurs | Perf. % |
|---|---|---|
| 0,8074 | -12,71 | |
| 9,7200 | -19,60 | |
| 92,06 | -19,84 | |
| 2,7280 | -29,14 | |
| 14,510 | -32,32 |
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Analyse-Datum: 26.01.2009
Endingen (aktiencheck.de AG) - Für die Experten von "Global Biotech Investing" ist die Aktie von Arena Pharmaceuticals (ISIN US0400471027/ WKN 939027) ein glasklarer Kandidat für ihr Musterdepot.
Für die Gesellschaft und ihren Hoffnungsträger Lorcaserin gehe es 2009 in die heiße Phase. Das Unternehmen konzentriere sich voll und ganz auf einen erfolgreichen Ausgang der Testreihen zu Lorcaserin.
Für Ende März sei die Veröffentlichung der Phase III-Tests datiert.
Bei einem positiven Bescheid könne nach Ansicht der Experten ein entsprechender NDA bereits für Ende 2009 bei der US-Zulassungsstelle beantragt werden.
Die Spanne der Kurszieleinschätzungen für die Aktie liege zwischen 4 USD und 20 USD.
Zuletzt hätten die wenig überzeugenden Phase III-Daten des Konkurrenzproduktes Contrave vom Mitbewerber Orexigen die Aktie von Arena beflügelt. Aber auch wenn das Konkurrenzprodukt ebenfalls die Marktzulassung erhalte, würden die Analysten von Oppenheimer das Marktpotenzial von Lorcaserin für Arena Pharmaceuticals immer noch auf über eine Milliarde USD schätzen.
Für die Experten von "Global Biotech Investing" ist die Aktie von Arena Pharmaceuticals ein glasklarer Kandidat für ihr Musterdepot. (Ausgabe 2 vom 26.01.2009) (26.01.2009/ac/a/a)
Analyse-Datum: 26.01.2009
Endingen (aktiencheck.de AG) - Für die Experten von "Global Biotech Investing" ist die Aktie von Arena Pharmaceuticals (ISIN US0400471027/ WKN 939027) ein glasklarer Kandidat für ihr Musterdepot.
Für die Gesellschaft und ihren Hoffnungsträger Lorcaserin gehe es 2009 in die heiße Phase. Das Unternehmen konzentriere sich voll und ganz auf einen erfolgreichen Ausgang der Testreihen zu Lorcaserin.
Für Ende März sei die Veröffentlichung der Phase III-Tests datiert.
Bei einem positiven Bescheid könne nach Ansicht der Experten ein entsprechender NDA bereits für Ende 2009 bei der US-Zulassungsstelle beantragt werden.
Die Spanne der Kurszieleinschätzungen für die Aktie liege zwischen 4 USD und 20 USD.
Zuletzt hätten die wenig überzeugenden Phase III-Daten des Konkurrenzproduktes Contrave vom Mitbewerber Orexigen die Aktie von Arena beflügelt. Aber auch wenn das Konkurrenzprodukt ebenfalls die Marktzulassung erhalte, würden die Analysten von Oppenheimer das Marktpotenzial von Lorcaserin für Arena Pharmaceuticals immer noch auf über eine Milliarde USD schätzen.
Für die Experten von "Global Biotech Investing" ist die Aktie von Arena Pharmaceuticals ein glasklarer Kandidat für ihr Musterdepot. (Ausgabe 2 vom 26.01.2009) (26.01.2009/ac/a/a)
Analyse-Datum: 26.01.2009
Antwort auf Beitrag Nr.: 36.495.093 von josema am 02.02.09 15:11:36USA zeigt sich gut, schätze aufgrund der vergangenen Tage , das heute mit 4,50 geschlossen wird.
Antwort auf Beitrag Nr.: 36.496.584 von josema am 02.02.09 18:11:26mit eine der wenigen Aktien , die steigen und kein Kommentar ? :
Antwort auf Beitrag Nr.: 36.514.550 von josema am 04.02.09 21:16:28Nimm doch besser den alten enthistorisierten thread. 
spielt keine Rolle.
Aber die Aktie macht mir Freude.
Steigt seit Tagen super an und keiner schert sich drum, zumindest bei uns.In den staaten setzen die Täglich Milionen Stückzahlen um.
Aber die Aktie macht mir Freude.
Steigt seit Tagen super an und keiner schert sich drum, zumindest bei uns.In den staaten setzen die Täglich Milionen Stückzahlen um.
Trading Spotlight
Zeitraum Veränderung Zeitraum Datum Kurs
1 Woche +12,35% 52W Hoch 05.02.2008 7,90
1 Monat +11,29% 5 2W Tief 24.10.2008 2,70
1 Jahr -36,42% Jahreshoch 04.02.2009 5,29
laufendes Jahr +13,43% Jahrestief 21.01.2009 3,22
aktuell 5,30
1 Woche +12,35% 52W Hoch 05.02.2008 7,90
1 Monat +11,29% 5 2W Tief 24.10.2008 2,70
1 Jahr -36,42% Jahreshoch 04.02.2009 5,29
laufendes Jahr +13,43% Jahrestief 21.01.2009 3,22
aktuell 5,30
und weiter geht´s, aktuell 5,48
Lorcaserin (APD-356) is a serotonergic weight-loss drug developed by Arena Pharmaceuticals. It is currently undergoing the final phase of clinical trials in preparation for submission for FDA approval.
Overview
According to their published statements, Arena believes that lorcaserin is a selective 5-HT2C receptor agonist,[2] and in vitro testing of the drug showed reasonable selectivity for 5-HT2C over other related targets.[3] 5-HT2C receptors are located almost exclusively in the brain, and can be found in the choroid plexus, cortex, hippocampus, cerebellum, amygdala, thalamus, and hypothalamus. Arena believes that the activation of 5-HT2C receptors in the hypothalamus promotes weight loss through appetite suppression, and this is supported by animal studies, but it is unclear whether the dose range used in human trials will be sufficient to demonstrate the same level of weight loss. While it is generally thought that 5-HT2C receptors help to regulate appetite as well as mood, motor behavior, and endocrine secretion[4], the exact mechanism of appetite regulation is not yet known.
Side effects
Lorcaserin produced a variety of side effects in human clinical trials, although less than 10% of patients dropped out because of side effects. By far the most common side effect was headache, experienced by slightly under 1/3rd of trial participants. Other common side effects include dizziness and nausea.[5] These side effects are typical of better studied 5-HT2C agonists such as mCPP, and may be dose limiting factors in clinical use. Significantly, no evidence of dangerous effects on heart valves was seen with these initial trials of lorcaserin, although a 12 week study is too short to adequately assess side effects such as inappropriate proliferation of cardiac fibroblasts.
Other 5-HT2C agonists have been shown to elicit hyperactivity and oral dyskinesia (involuntary movements, "tics") in lab animals, leading one group of researchers to conclude that such results "[raise] questions about the use of the 5-HT2C receptor as a target for novel therapeutic agents for obesity".[6] Hypolocomotion, hyperthermia, and penile erection are other reactions that have been observed in animals as a result of 5-HT2C agonists.[7] The relevance of these side effects to therapeutic human use of 5-HT2C agonists is unclear as the doses used in animal research are generally significantly higher.
Clinical trial results
Arena states that "[d]ata from Phase 2 clinical trials of lorcaserin demonstrated that patients who received the drug experienced significantly greater weight loss than patients who received placebo." [8] At the end of 12 weeks, the groups which were administered lorcaserin lost an average of 4.0 pounds (10 mg/day), 5.7 pounds (15 mg/day), and 7.9 pounds (20 mg/day)[9]. The placebo group lost an average of 0.7 pounds, despite the fact that all groups received no diet or exercise instruction.
Upon discontinuation of lorcaserin treatment, lost weight is regained. In Phase 2 clinical trials, patients were tracked for 2 weeks post trial completion, and all groups regained weight more rapidly than they had lost.[10] In pre-clinical trial studies, lab rat weights returned to control levels.[11]
Arena is taking care to demonstrate [12] that lorcaserin does not cause heart valve damage in the same way as previously withdrawn serotonergic weight loss drugs such as fenfluramine and chlorphentermine. Arena stated that the Phase 2 clinical trials, the participants of which had been pre-screened to exclude valvulopathy, show that Lorcaserin "has no effect on heart valve regurgitation at 12 weeks."[13]
On March 17, 2008, Arena announced that 12-month echocardiograms of the participants of the first of three Phase 3 clinical trials ("BLOOM") did not meet the trial-stopping criteria developed by an independent Echocardiographic Data Safety Monitoring Board (EDSMB), and so the trial continues.[14] BLOOM participants will receive 18- and 24-month follow-up echocardiograms, but these results will not be reviewed by an EDSMB. Two other Phase 3 trials ("BLOSSOM", and "BLOOM-DM") provide echocardiograms but they will not be reviewed by an EDSMB. BLOOM participants were pre-screened to exclude valvulopathy, but BLOSSOM and BLOOM-DM participants were not.
Future prospects
Arena's projected release date for Lorcaserin is 2010. Arena has developed a marketing plan to target the massive base of overweight and obese consumers[15], including pre-launch marketing and brand positioning beginning in 2007, packaging, support, and internet development beginning in 2008, and a "Speaker's Program" beginning in 2009 during their New Drug Application process with the FDA[16]. This plan predicts an initial number of prescriptions of 10 million for revenue potential of $1 billion.[
Quelle: http://en.wikipedia.org/wiki/Lorcaserin
Overview
According to their published statements, Arena believes that lorcaserin is a selective 5-HT2C receptor agonist,[2] and in vitro testing of the drug showed reasonable selectivity for 5-HT2C over other related targets.[3] 5-HT2C receptors are located almost exclusively in the brain, and can be found in the choroid plexus, cortex, hippocampus, cerebellum, amygdala, thalamus, and hypothalamus. Arena believes that the activation of 5-HT2C receptors in the hypothalamus promotes weight loss through appetite suppression, and this is supported by animal studies, but it is unclear whether the dose range used in human trials will be sufficient to demonstrate the same level of weight loss. While it is generally thought that 5-HT2C receptors help to regulate appetite as well as mood, motor behavior, and endocrine secretion[4], the exact mechanism of appetite regulation is not yet known.
Side effects
Lorcaserin produced a variety of side effects in human clinical trials, although less than 10% of patients dropped out because of side effects. By far the most common side effect was headache, experienced by slightly under 1/3rd of trial participants. Other common side effects include dizziness and nausea.[5] These side effects are typical of better studied 5-HT2C agonists such as mCPP, and may be dose limiting factors in clinical use. Significantly, no evidence of dangerous effects on heart valves was seen with these initial trials of lorcaserin, although a 12 week study is too short to adequately assess side effects such as inappropriate proliferation of cardiac fibroblasts.
Other 5-HT2C agonists have been shown to elicit hyperactivity and oral dyskinesia (involuntary movements, "tics") in lab animals, leading one group of researchers to conclude that such results "[raise] questions about the use of the 5-HT2C receptor as a target for novel therapeutic agents for obesity".[6] Hypolocomotion, hyperthermia, and penile erection are other reactions that have been observed in animals as a result of 5-HT2C agonists.[7] The relevance of these side effects to therapeutic human use of 5-HT2C agonists is unclear as the doses used in animal research are generally significantly higher.
Clinical trial results
Arena states that "[d]ata from Phase 2 clinical trials of lorcaserin demonstrated that patients who received the drug experienced significantly greater weight loss than patients who received placebo." [8] At the end of 12 weeks, the groups which were administered lorcaserin lost an average of 4.0 pounds (10 mg/day), 5.7 pounds (15 mg/day), and 7.9 pounds (20 mg/day)[9]. The placebo group lost an average of 0.7 pounds, despite the fact that all groups received no diet or exercise instruction.
Upon discontinuation of lorcaserin treatment, lost weight is regained. In Phase 2 clinical trials, patients were tracked for 2 weeks post trial completion, and all groups regained weight more rapidly than they had lost.[10] In pre-clinical trial studies, lab rat weights returned to control levels.[11]
Arena is taking care to demonstrate [12] that lorcaserin does not cause heart valve damage in the same way as previously withdrawn serotonergic weight loss drugs such as fenfluramine and chlorphentermine. Arena stated that the Phase 2 clinical trials, the participants of which had been pre-screened to exclude valvulopathy, show that Lorcaserin "has no effect on heart valve regurgitation at 12 weeks."[13]
On March 17, 2008, Arena announced that 12-month echocardiograms of the participants of the first of three Phase 3 clinical trials ("BLOOM") did not meet the trial-stopping criteria developed by an independent Echocardiographic Data Safety Monitoring Board (EDSMB), and so the trial continues.[14] BLOOM participants will receive 18- and 24-month follow-up echocardiograms, but these results will not be reviewed by an EDSMB. Two other Phase 3 trials ("BLOSSOM", and "BLOOM-DM") provide echocardiograms but they will not be reviewed by an EDSMB. BLOOM participants were pre-screened to exclude valvulopathy, but BLOSSOM and BLOOM-DM participants were not.
Future prospects
Arena's projected release date for Lorcaserin is 2010. Arena has developed a marketing plan to target the massive base of overweight and obese consumers[15], including pre-launch marketing and brand positioning beginning in 2007, packaging, support, and internet development beginning in 2008, and a "Speaker's Program" beginning in 2009 during their New Drug Application process with the FDA[16]. This plan predicts an initial number of prescriptions of 10 million for revenue potential of $1 billion.[
Quelle: http://en.wikipedia.org/wiki/Lorcaserin
Dear Money Morning Reader,
I just learned about a remarkable situation...
On March 30th, there'll be an announcement of FDA results for a new drug that could become the bestselling pill in the history of medicine.
One medical source says, "It could tap the largest pharmaceutical market ever." Even more exciting, as you'll see below - early investors could make as much as $195,600, overnight... by getting in immediately.
Read on for the full details...
STANSBERRY & ASSOCIATES
Dear Reader,
We've waited 2 years for this day.
On March 30th, there'll be an announcement of FDA results for a new drug that could create the single biggest return of any investment we've ever found, in 10 years.
"All eyes are on the data," says Business Week. "It could be a multi-billion dollar drug, and so far, all the numbers have been positive." BioWorld writes: "It could be the largest pharmaceutical market ever."
When you see (below) what the drug treats... I think you'll see why S&A has now spent over $200,000 since 2006, uncovering the full details.
"It's the perfect storm," writes drug expert Jack Windin. "A totally new chemical entity with virtually no competition."
So far - the drug has successfully cleared both Phase 1 and 2 FDA clinical trials... and is just weeks from the announcement of Phase 3 results... the last trial before it could launch on a scale potentially unseen since the release of penicillin.
As Forbes reports: People across America are already writing letters to the small company who owns the patent... asking: "How can I get your drug?"
But the big question, of course, is: "Will the drug be approved by the FDA?"
By March 30 - we'll hear the official announcement of test results. It's a decision we've been following daily since trials first began more than 2 years ago.
And while most people have no idea what will happen... we've been able to access early results directly from the company, and they're even better than we hoped.
In short: as of Dec. 15, 2008, early clinical results suggest the drug is safe... has a near-perfect success rate... has a 500% efficiency... and finally, get this: will target 45% of the U.S. population - almost 1 out of 2 Americans.
As one FDA expert puts it: "If results on March 30th turn out even half as good as we expect... this could be the best-selling drug in the history of medicine."
Best of all: All the rights to the drug belong to a single company, a penny stock. At today's prices... a 4-point jump alone would double your money.
In other words: if the results are positive for this new drug on March 30th as we expect... a single stake in this company could make you a fortune, overnight. We estimate as much as $195,600... but only if you get in right now (you'll see why below).
Again, we've waited 2 years for this day. It's the kind of situation we built our firm on back in 1999... investments that can literally change your life.
Wer sich für die komplette Ausführung des Artikels interessiert: (Ich weiß, ein bisschen typisch amerikanisch übertrieben, aber wer weiß schon, wie sich das entwickeln wird?!?!)
http://www.stansberryresearch.com/pro/0902DILOVNSP/WDILK221/…
I just learned about a remarkable situation...
On March 30th, there'll be an announcement of FDA results for a new drug that could become the bestselling pill in the history of medicine.
One medical source says, "It could tap the largest pharmaceutical market ever." Even more exciting, as you'll see below - early investors could make as much as $195,600, overnight... by getting in immediately.
Read on for the full details...
STANSBERRY & ASSOCIATES
Dear Reader,
We've waited 2 years for this day.
On March 30th, there'll be an announcement of FDA results for a new drug that could create the single biggest return of any investment we've ever found, in 10 years.
"All eyes are on the data," says Business Week. "It could be a multi-billion dollar drug, and so far, all the numbers have been positive." BioWorld writes: "It could be the largest pharmaceutical market ever."
When you see (below) what the drug treats... I think you'll see why S&A has now spent over $200,000 since 2006, uncovering the full details.
"It's the perfect storm," writes drug expert Jack Windin. "A totally new chemical entity with virtually no competition."
So far - the drug has successfully cleared both Phase 1 and 2 FDA clinical trials... and is just weeks from the announcement of Phase 3 results... the last trial before it could launch on a scale potentially unseen since the release of penicillin.
As Forbes reports: People across America are already writing letters to the small company who owns the patent... asking: "How can I get your drug?"
But the big question, of course, is: "Will the drug be approved by the FDA?"
By March 30 - we'll hear the official announcement of test results. It's a decision we've been following daily since trials first began more than 2 years ago.
And while most people have no idea what will happen... we've been able to access early results directly from the company, and they're even better than we hoped.
In short: as of Dec. 15, 2008, early clinical results suggest the drug is safe... has a near-perfect success rate... has a 500% efficiency... and finally, get this: will target 45% of the U.S. population - almost 1 out of 2 Americans.
As one FDA expert puts it: "If results on March 30th turn out even half as good as we expect... this could be the best-selling drug in the history of medicine."
Best of all: All the rights to the drug belong to a single company, a penny stock. At today's prices... a 4-point jump alone would double your money.
In other words: if the results are positive for this new drug on March 30th as we expect... a single stake in this company could make you a fortune, overnight. We estimate as much as $195,600... but only if you get in right now (you'll see why below).
Again, we've waited 2 years for this day. It's the kind of situation we built our firm on back in 1999... investments that can literally change your life.
Wer sich für die komplette Ausführung des Artikels interessiert: (Ich weiß, ein bisschen typisch amerikanisch übertrieben, aber wer weiß schon, wie sich das entwickeln wird?!?!)
http://www.stansberryresearch.com/pro/0902DILOVNSP/WDILK221/…
Dazu muss ich sagen, dass ich nicht genau weiß, ob die Arena meinen. Aber es könnte passen?!?! 
...alles nur meine Vermutung!!!
...alles nur meine Vermutung!!!
Antwort auf Beitrag Nr.: 36.534.745 von mrbk1234 am 07.02.09 19:44:16Frankfurt Start € 4,54
und heute nachmittag geht´s in den usa weiter nach oben.
Die Spanne der Kurszieleinschätzungen für die Aktie liege zwischen 4 USD und 20 USD.
da ist noch einiges an Luft nach oben vorhanden
und heute nachmittag geht´s in den usa weiter nach oben.
Die Spanne der Kurszieleinschätzungen für die Aktie liege zwischen 4 USD und 20 USD.
da ist noch einiges an Luft nach oben vorhanden
Antwort auf Beitrag Nr.: 36.538.861 von josema am 09.02.09 09:13:56In den USA geht die Aktie gerade durch die Decke...Plus 12%!!!!!!!
Antwort auf Beitrag Nr.: 36.541.957 von Haendchen3 am 09.02.09 15:53:00ne wahre freude....
nur nicht nervös werden, die geht auch noch über die $ 10,--
nur nicht nervös werden, die geht auch noch über die $ 10,--
Antwort auf Beitrag Nr.: 36.543.929 von josema am 09.02.09 19:22:20nur nicht nervös werden, die geht auch noch über die $ 10,-
Wieso sollte die Aktie über 10$ gehen ? Ich würde das was gerade passiert als typischen "Pump and Dump" bezeichnen .
Es gibt wirklich viel bessere Investments als ARNA .
Marktkap : 420.000.000 US$ << defenitiv zu teuer
Ziemlich schwache Pipeline
Wieso sollte die Aktie über 10$ gehen ? Ich würde das was gerade passiert als typischen "Pump and Dump" bezeichnen .
Es gibt wirklich viel bessere Investments als ARNA .
Marktkap : 420.000.000 US$ << defenitiv zu teuer
Ziemlich schwache Pipeline
Antwort auf Beitrag Nr.: 36.544.279 von BrauchGeld am 09.02.09 20:03:43Klar ist das ein gepumpe, und besonders groß ist das Portfolio auch nicht.
Ich stelle mir bloß die Frage, ob sich das Mittelchen, was auf den Markt wirklich so durchsetzen wird?!?!?
Wenn du mich belehren kannst, dass das Produkt der reinster Sch..ß ist, bitte offenkundig hier im Bord preisgeben.
Weil letztendlich dreht sich der ganze Ruhn doch um das "Wunder-Pillchen"?!?!?
Ich bitte um fachkenntliche Beiträge....
Ich stelle mir bloß die Frage, ob sich das Mittelchen, was auf den Markt wirklich so durchsetzen wird?!?!?
Wenn du mich belehren kannst, dass das Produkt der reinster Sch..ß ist, bitte offenkundig hier im Bord preisgeben.
Weil letztendlich dreht sich der ganze Ruhn doch um das "Wunder-Pillchen"?!?!?
Ich bitte um fachkenntliche Beiträge....
Antwort auf Beitrag Nr.: 36.544.677 von mrbk1234 am 09.02.09 21:01:19Ich glaube selbst bei erfolgreicher Studie wird Lorcaserin kein Blockbuster ausserdem hat Arena bis jetzt noch kein Partner für Lorca gefunden das spricht wohl auch für sich .
http://www.deraktionaer.de/xist4c/web/BB-Biotech-mit-positiv…
Noch eine Frage zu einer kleineren Beteiligung: Arena Pharmaceuticals. Das Unternehmen hat vor kurzem positive Phase-II-Daten seines experimentellen Wirkstoffs Lorcaserin, einem Mittel gegen Fettleibigkeit, veröffentlicht. Eine solche Arznei wäre so etwas wie der „heilige Gral“ unter den Medikamenten, vergleichbar mit einem Heilmittel gegen Krebs, schließlich gilt Fettleibigkeit als Hauptauslöser von Herz-Kreislauf-Erkrankungen, der Killer-Krankheit Nummer 1 in den Industrienationen. Bisher sind alle Unternehmen bei der Entwicklung eines entsprechenden Medikamentes gescheitert. Warum sollte gerade Arena den Durchbruch auf diesem Gebiet schaffen?
Wir erwarten nicht, dass Lorcaserin von Arena sich zum ultimativen Mittel gegen Fettleibigkeit entwickeln wird. Dazu wird die Wirksamkeit nicht ausreichend sein. Lorcaserin ist eine Weiterentwicklung bereits bekannter Medikamente. Der Vorteil von Lorcaserin könnte darin liegen, dass ein signifikanter Gewichtsverlust bei gleichzeitig nur sehr geringen Nebenwirkungen ermöglicht wird. Angesichts des enormen medizinischen Problems, das Fettleibigkeit für die Medizin darstellt, wäre ein solches klinisches Profil ausreichend, um Lorcaserin zu einem bedeutenden Produkt zu machen.
http://www.deraktionaer.de/xist4c/web/BB-Biotech-mit-positiv…
Noch eine Frage zu einer kleineren Beteiligung: Arena Pharmaceuticals. Das Unternehmen hat vor kurzem positive Phase-II-Daten seines experimentellen Wirkstoffs Lorcaserin, einem Mittel gegen Fettleibigkeit, veröffentlicht. Eine solche Arznei wäre so etwas wie der „heilige Gral“ unter den Medikamenten, vergleichbar mit einem Heilmittel gegen Krebs, schließlich gilt Fettleibigkeit als Hauptauslöser von Herz-Kreislauf-Erkrankungen, der Killer-Krankheit Nummer 1 in den Industrienationen. Bisher sind alle Unternehmen bei der Entwicklung eines entsprechenden Medikamentes gescheitert. Warum sollte gerade Arena den Durchbruch auf diesem Gebiet schaffen?
Wir erwarten nicht, dass Lorcaserin von Arena sich zum ultimativen Mittel gegen Fettleibigkeit entwickeln wird. Dazu wird die Wirksamkeit nicht ausreichend sein. Lorcaserin ist eine Weiterentwicklung bereits bekannter Medikamente. Der Vorteil von Lorcaserin könnte darin liegen, dass ein signifikanter Gewichtsverlust bei gleichzeitig nur sehr geringen Nebenwirkungen ermöglicht wird. Angesichts des enormen medizinischen Problems, das Fettleibigkeit für die Medizin darstellt, wäre ein solches klinisches Profil ausreichend, um Lorcaserin zu einem bedeutenden Produkt zu machen.
Der Vorteil von Lorcaserin könnte darin liegen, dass ein signifikanter Gewichtsverlust bei gleichzeitig nur sehr geringen Nebenwirkungen ermöglicht wird. Angesichts des enormen medizinischen Problems, das Fettleibigkeit für die Medizin darstellt, wäre ein solches klinisches Profil ausreichend, um Lorcaserin zu einem bedeutenden Produkt zu machen.
Offensichtlich hat es das Profil...
Der Bock wird aufgrund der Erkenntnisse geritten, so oder so....
Offensichtlich hat es das Profil...
Der Bock wird aufgrund der Erkenntnisse geritten, so oder so....
Die Bids sind mit 6,48USD aufgeladen! Wir gehen entsprechend mit einem Plus ins Rennen
Und die Bids steigen...
Antwort auf Beitrag Nr.: 36.495.093 von josema am 02.02.09 15:11:36Für Ende März sei die Veröffentlichung der Phase III-Tests datiert.
steigt in den usa wieder an !
steigt in den usa wieder an !
Am 30. oder? Wir werden sehen..... Mal 4?
Mal 4?
Antwort auf Beitrag Nr.: 36.755.464 von mrbk1234 am 12.03.09 19:25:11Ende März ist relativEs durchaus auch passieren, dass es dann April wird. Hoffentlich kein Aprilscherz
Gruß
KLR
Es durchaus auch passieren, dass es dann April wird. Hoffentlich kein AprilscherzGruß
KLR
Antwort auf Beitrag Nr.: 36.814.596 von klr am 20.03.09 18:28:07die woche ist es eigentlich nur bergab gegangen, hoffe das wir nächste woche eine kräftige gegenbewegung sehen werden.....
mfg und schönes we!!!!!
mfg und schönes we!!!!!
Antwort auf Beitrag Nr.: 36.816.188 von stevemann am 20.03.09 22:49:20Eigentlich erwartet man kurz vor so wichtigen Ergebnissen genau die andere Richtung. Aber das Risiko, dass die Ergebnisse evtl. nicht so gut ausfallen spielt halt auch eine Rolle.
Es bleibt spannend und zum Kauf bietet sich der Kurs ja an.
Gruß
KLR
Es bleibt spannend und zum Kauf bietet sich der Kurs ja an.
Gruß
KLR
Bei Arena geht's los und keiner merkt's
Gruß
KLR
Gruß
KLR
Antwort auf Beitrag Nr.: 36.867.856 von klr am 27.03.09 18:04:28Die Daten kommen heute! Telefonkonferenz um 14:30 Uhr...
Antwort auf Beitrag Nr.: 36.878.917 von blb am 30.03.09 13:00:59Die Daten sind da, ARNA verkauft diese als Positiv aber wer genau hinschaut wird merken das Lorcaserin nichts taugt .
30-Mar-2009
Other Events
Item 8.01 Other Events.
On March 30, 2009, we announced positive top-line results from BLOOM (Behavioral modification and Lorcaserin for Overweight and Obesity Management), the first of two pivotal trials evaluating the safety and efficacy of lorcaserin for weight management. Statistical significance (p<0.0001) was achieved on all three of the hierarchically ordered co-primary endpoints for patients treated with lorcaserin versus placebo. Treatment with lorcaserin was generally very well tolerated. An assessment of echocardiograms indicates no apparent drug-related effect on the development of US Food and Drug Administration (FDA)-defined valvulopathy over the two-year treatment period.
Primary Endpoint Analysis
The hierarchically ordered endpoints were the proportion of patients achieving 5% or greater weight loss after 12 months, the difference in mean weight loss compared to placebo after 12 months, and the proportion of patients achieving 10% or greater weight loss after 12 months. Compared to placebo, using an intent-to-treat last observation carried forward (ITT-LOCF) analysis, treatment with lorcaserin was associated with highly statistically significant (p<0.0001) categorical and average weight loss from baseline after 12 months:
? 47.5% of lorcaserin patients lost greater than or equal to 5% of their body weight from baseline compared to 20.3% in the placebo group. This result satisfies the efficacy benchmark in the most recent FDA draft guidance.
? Average weight loss of 5.8% of body weight, or 12.7 pounds, was achieved in the lorcaserin group, compared to 2.2% of body weight, or 4.7 pounds, in the placebo group. Statistical separation from placebo was observed by Week 2, the first post-baseline measurement.
? 22.6% of lorcaserin patients lost greater than or equal to 10% of their body weight from baseline, compared to 7.7% in the placebo group.
Lorcaserin patients who completed 52 weeks of treatment according to the protocol lost an average of 8.2% of body weight, or 17.9 pounds, compared to 3.4%, or 7.3 pounds, in the placebo group (p<0.0001).
Safety and Tolerability Profile
Lorcaserin was generally very well tolerated. The most frequent adverse events reported in Year 1 and their rates for lorcaserin and placebo patients, respectively, were as follows: headache (18.0% vs. 11.0%), upper respiratory tract infection (14.8% vs. 11.9%), nasopharyngitis (13.4% vs. 12.0%), sinusitis (7.2% vs. 8.2%) and nausea (7.5% vs. 5.4%). The most frequent adverse events reported in Year 2 and their rates for lorcaserin and placebo patients, respectively, were as follows: upper respiratory tract infection (14.5% vs. 16.1%), nasopharyngitis (16.4% vs. 12.6%), sinusitis (8.6% vs. 6.9%), arthralgia (6.6% vs. 6.2%) and influenza (6.6% vs. 6.0%). In patients crossing over from lorcaserin to placebo after Year 1, the rates of these Year 2 adverse events were: 11.0%, 13.8%, 10.6%, 6.0% and 4.9%, respectively.
Adverse events of depression, anxiety and suicidal ideation were infrequent and reported at a similar rate in each treatment group, and no seizures were reported. Serious adverse events occurred with similar frequency in each group throughout the trial without apparent relationship to lorcaserin. One death occurred during the trial, which was a patient in the placebo arm.
Echocardiogram Assessment
Using an ITT-LOCF analysis, the assessment of echocardiograms performed at baseline and after patients completed 6, 12, 18 and 24 months of dosing indicated no apparent drug-related effect on the development of FDA-defined valvulopathy (moderate or greater mitral insufficiency and/or mild or greater aortic insufficiency).
--------------------------------------------------------------------------------
Lorcaserin met the primary safety endpoint of no significant difference in rates of valvulopathy at 12 months. Rates of valvulopathy at 6, 12, 18 and 24 months for lorcaserin versus placebo were 2.1% vs. 1.9%, 2.7% vs. 2.3%, 2.9% vs. 3.1% and 2.6% vs. 2.7%. At 18 and 24 months, rates of valvulopathy for lorcaserin patients crossing over to placebo were 3.6% and 1.9%, respectively.
The FDA has requested that we rule out a 1.5-fold or greater risk of valvulopathy with 80% power. Assuming similar results in BLOSSOM (Behavioral modification and LOrcaserin Second Study for Obesity Management), the integrated data set from the two trials will be more than sufficiently large to meet this requirement.
Secondary Endpoint Analysis
Treatment with lorcaserin was also associated with statistically significant improvements (ITT-LOCF) in a range of secondary endpoints compared to treatment with placebo, including:
? Total cholesterol
? LDL cholesterol
? Triglycerides
? Blood pressure
Changes in HDL cholesterol were similar in the two groups. Analysis of the above and additional endpoints, including glucose, insulin and waist circumference, is ongoing and will be announced at a later date.
During Year 2 of the trial, patients continuing on lorcaserin were better able to maintain more of the Week 52 weight loss than Year 1 lorcaserin patients re-randomized to placebo in Year 2.
Patient Disposition
Patient demographic characteristics at baseline were well balanced across the treatment groups. The Week 52 completion rate was higher for patients on lorcaserin (55.4%) compared to those on placebo (45.1%). The difference is primarily attributed to higher discontinuation rates for "Subject Decision" (19.2% lorcaserin vs. 27.7% placebo), which includes "Lack of Efficacy" (1.7% lorcaserin vs. 5.5% placebo). Discontinuations for adverse events (7.1% lorcaserin vs. 6.7% placebo) and other reasons were similar.
Completion rates for Year 2 were similar across the treatment groups: 74.3%, 72.7%, and 68.9% for patients continuing on lorcaserin for both years, patients taking placebo both years, and patients switching from lorcaserin to placebo in Year 2, respectively. Discontinuations for adverse events were also similar across the treatment groups.
BLOOM Trial Design
BLOOM, the first of three lorcaserin Phase 3 trials, is a double-blind, randomized, placebo-controlled trial involving 3,182 patients in approximately 100 sites in the US. The trial evaluated 10 mg of lorcaserin dosed twice daily versus placebo over a two-year treatment period in obese patients (Body Mass Index, or BMI, 30 to 45) with or without co-morbid conditions and overweight patients (BMI 27 to less than 30) with at least one co-morbid condition. The trial did not include any dose titration or run-in period. Patients were randomized in a 1:1 ratio to lorcaserin or placebo at baseline. At Week 52, 856 patients taking lorcaserin were re-randomized in a 2:1 ratio to continue lorcaserin or to switch to placebo, and 697 patients on placebo were continued on placebo. Patients received echocardiograms at screening, and at 6, 12, 18 and 24 months after initiating dosing in the trial; patients with FDA-defined valvulopathy were excluded from enrolling in the trial.
Phase 3 Program Overview
The Phase 3 program consists of three trials, BLOOM, BLOSSOM and BLOOM-DM (Behavioral modification and Lorcaserin for Overweight and Obesity Management in Diabetes Mellitus), and is planned to enroll a total of approximately 7,800 patients. BLOOM and BLOSSOM comprise the Phase 3 pivotal registration program. BLOSSOM has enrolled 4,008 patients and is evaluating 10 mg of lorcaserin dosed once or twice daily versus placebo over a one-year treatment period in obese patients with or without co-morbid conditions and overweight patients with at least one co-morbid condition at about 100 sites in the US. Results are expected around the end of September 2009. BLOOM-DM is currently enrolling and is evaluating 10 mg of lorcaserin dosed once or twice daily versus placebo over a one-year treatment period in obese and overweight patients with type 2 diabetes at about 60 sites in the US. Approximately 600 patients are expected to be enrolled in BLOOM-DM, which is planned as a supplement to the lorcaserin NDA.
--------------------------------------------------------------------------------
A standardized program of moderate diet and exercise guidance is included in the Phase 3 program. The program's hierarchically ordered co-primary efficacy endpoints are: the proportion of patients achieving 5% or greater weight loss after 12 months, the difference in mean weight loss compared to placebo after 12 months, and the proportion of patients achieving 10% or greater weight loss after 12 months. We are also studying several key secondary endpoints, including changes in serum lipids and HbA1c levels and, in the BLOOM-DM trial, other indicators of glycemic control. In BLOSSOM and BLOOM-DM all patients will receive echocardiograms at baseline, at month 6, and at the end of the study to assess heart valve function over time. In contrast to the BLOOM trial, however, there are no echocardiographic exclusion criteria for entry into these trials and there is no monitoring by an independent monitoring board.
30-Mar-2009
Other Events
Item 8.01 Other Events.
On March 30, 2009, we announced positive top-line results from BLOOM (Behavioral modification and Lorcaserin for Overweight and Obesity Management), the first of two pivotal trials evaluating the safety and efficacy of lorcaserin for weight management. Statistical significance (p<0.0001) was achieved on all three of the hierarchically ordered co-primary endpoints for patients treated with lorcaserin versus placebo. Treatment with lorcaserin was generally very well tolerated. An assessment of echocardiograms indicates no apparent drug-related effect on the development of US Food and Drug Administration (FDA)-defined valvulopathy over the two-year treatment period.
Primary Endpoint Analysis
The hierarchically ordered endpoints were the proportion of patients achieving 5% or greater weight loss after 12 months, the difference in mean weight loss compared to placebo after 12 months, and the proportion of patients achieving 10% or greater weight loss after 12 months. Compared to placebo, using an intent-to-treat last observation carried forward (ITT-LOCF) analysis, treatment with lorcaserin was associated with highly statistically significant (p<0.0001) categorical and average weight loss from baseline after 12 months:
? 47.5% of lorcaserin patients lost greater than or equal to 5% of their body weight from baseline compared to 20.3% in the placebo group. This result satisfies the efficacy benchmark in the most recent FDA draft guidance.
? Average weight loss of 5.8% of body weight, or 12.7 pounds, was achieved in the lorcaserin group, compared to 2.2% of body weight, or 4.7 pounds, in the placebo group. Statistical separation from placebo was observed by Week 2, the first post-baseline measurement.
? 22.6% of lorcaserin patients lost greater than or equal to 10% of their body weight from baseline, compared to 7.7% in the placebo group.
Lorcaserin patients who completed 52 weeks of treatment according to the protocol lost an average of 8.2% of body weight, or 17.9 pounds, compared to 3.4%, or 7.3 pounds, in the placebo group (p<0.0001).
Safety and Tolerability Profile
Lorcaserin was generally very well tolerated. The most frequent adverse events reported in Year 1 and their rates for lorcaserin and placebo patients, respectively, were as follows: headache (18.0% vs. 11.0%), upper respiratory tract infection (14.8% vs. 11.9%), nasopharyngitis (13.4% vs. 12.0%), sinusitis (7.2% vs. 8.2%) and nausea (7.5% vs. 5.4%). The most frequent adverse events reported in Year 2 and their rates for lorcaserin and placebo patients, respectively, were as follows: upper respiratory tract infection (14.5% vs. 16.1%), nasopharyngitis (16.4% vs. 12.6%), sinusitis (8.6% vs. 6.9%), arthralgia (6.6% vs. 6.2%) and influenza (6.6% vs. 6.0%). In patients crossing over from lorcaserin to placebo after Year 1, the rates of these Year 2 adverse events were: 11.0%, 13.8%, 10.6%, 6.0% and 4.9%, respectively.
Adverse events of depression, anxiety and suicidal ideation were infrequent and reported at a similar rate in each treatment group, and no seizures were reported. Serious adverse events occurred with similar frequency in each group throughout the trial without apparent relationship to lorcaserin. One death occurred during the trial, which was a patient in the placebo arm.
Echocardiogram Assessment
Using an ITT-LOCF analysis, the assessment of echocardiograms performed at baseline and after patients completed 6, 12, 18 and 24 months of dosing indicated no apparent drug-related effect on the development of FDA-defined valvulopathy (moderate or greater mitral insufficiency and/or mild or greater aortic insufficiency).
--------------------------------------------------------------------------------
Lorcaserin met the primary safety endpoint of no significant difference in rates of valvulopathy at 12 months. Rates of valvulopathy at 6, 12, 18 and 24 months for lorcaserin versus placebo were 2.1% vs. 1.9%, 2.7% vs. 2.3%, 2.9% vs. 3.1% and 2.6% vs. 2.7%. At 18 and 24 months, rates of valvulopathy for lorcaserin patients crossing over to placebo were 3.6% and 1.9%, respectively.
The FDA has requested that we rule out a 1.5-fold or greater risk of valvulopathy with 80% power. Assuming similar results in BLOSSOM (Behavioral modification and LOrcaserin Second Study for Obesity Management), the integrated data set from the two trials will be more than sufficiently large to meet this requirement.
Secondary Endpoint Analysis
Treatment with lorcaserin was also associated with statistically significant improvements (ITT-LOCF) in a range of secondary endpoints compared to treatment with placebo, including:
? Total cholesterol
? LDL cholesterol
? Triglycerides
? Blood pressure
Changes in HDL cholesterol were similar in the two groups. Analysis of the above and additional endpoints, including glucose, insulin and waist circumference, is ongoing and will be announced at a later date.
During Year 2 of the trial, patients continuing on lorcaserin were better able to maintain more of the Week 52 weight loss than Year 1 lorcaserin patients re-randomized to placebo in Year 2.
Patient Disposition
Patient demographic characteristics at baseline were well balanced across the treatment groups. The Week 52 completion rate was higher for patients on lorcaserin (55.4%) compared to those on placebo (45.1%). The difference is primarily attributed to higher discontinuation rates for "Subject Decision" (19.2% lorcaserin vs. 27.7% placebo), which includes "Lack of Efficacy" (1.7% lorcaserin vs. 5.5% placebo). Discontinuations for adverse events (7.1% lorcaserin vs. 6.7% placebo) and other reasons were similar.
Completion rates for Year 2 were similar across the treatment groups: 74.3%, 72.7%, and 68.9% for patients continuing on lorcaserin for both years, patients taking placebo both years, and patients switching from lorcaserin to placebo in Year 2, respectively. Discontinuations for adverse events were also similar across the treatment groups.
BLOOM Trial Design
BLOOM, the first of three lorcaserin Phase 3 trials, is a double-blind, randomized, placebo-controlled trial involving 3,182 patients in approximately 100 sites in the US. The trial evaluated 10 mg of lorcaserin dosed twice daily versus placebo over a two-year treatment period in obese patients (Body Mass Index, or BMI, 30 to 45) with or without co-morbid conditions and overweight patients (BMI 27 to less than 30) with at least one co-morbid condition. The trial did not include any dose titration or run-in period. Patients were randomized in a 1:1 ratio to lorcaserin or placebo at baseline. At Week 52, 856 patients taking lorcaserin were re-randomized in a 2:1 ratio to continue lorcaserin or to switch to placebo, and 697 patients on placebo were continued on placebo. Patients received echocardiograms at screening, and at 6, 12, 18 and 24 months after initiating dosing in the trial; patients with FDA-defined valvulopathy were excluded from enrolling in the trial.
Phase 3 Program Overview
The Phase 3 program consists of three trials, BLOOM, BLOSSOM and BLOOM-DM (Behavioral modification and Lorcaserin for Overweight and Obesity Management in Diabetes Mellitus), and is planned to enroll a total of approximately 7,800 patients. BLOOM and BLOSSOM comprise the Phase 3 pivotal registration program. BLOSSOM has enrolled 4,008 patients and is evaluating 10 mg of lorcaserin dosed once or twice daily versus placebo over a one-year treatment period in obese patients with or without co-morbid conditions and overweight patients with at least one co-morbid condition at about 100 sites in the US. Results are expected around the end of September 2009. BLOOM-DM is currently enrolling and is evaluating 10 mg of lorcaserin dosed once or twice daily versus placebo over a one-year treatment period in obese and overweight patients with type 2 diabetes at about 60 sites in the US. Approximately 600 patients are expected to be enrolled in BLOOM-DM, which is planned as a supplement to the lorcaserin NDA.
--------------------------------------------------------------------------------
A standardized program of moderate diet and exercise guidance is included in the Phase 3 program. The program's hierarchically ordered co-primary efficacy endpoints are: the proportion of patients achieving 5% or greater weight loss after 12 months, the difference in mean weight loss compared to placebo after 12 months, and the proportion of patients achieving 10% or greater weight loss after 12 months. We are also studying several key secondary endpoints, including changes in serum lipids and HbA1c levels and, in the BLOOM-DM trial, other indicators of glycemic control. In BLOSSOM and BLOOM-DM all patients will receive echocardiograms at baseline, at month 6, and at the end of the study to assess heart valve function over time. In contrast to the BLOOM trial, however, there are no echocardiographic exclusion criteria for entry into these trials and there is no monitoring by an independent monitoring board.
Antwort auf Beitrag Nr.: 36.879.399 von BrauchGeld am 30.03.09 13:59:35Nichts taugt würd ich jetzt nicht sagen, aber der Markt hatte sich wohl mehr erwartet. Man muss jetzt mal den CC abwarten...
Antwort auf Beitrag Nr.: 36.879.566 von blb am 30.03.09 14:20:54Hallo Allerseits,
wie steht es um Arena, testen sie jetzt wöchentlich neue Tiefs? Was ist hier in der nächsten Zeit zu erwarten. Vielleicht ist jemand so hilfsbereit und kann mir einen ganz kurzen Überblick sowie pers. Einschätzung liefern.
Mein Dank wird ihm / ihr auf ewig nachschleichen!
Grüße!
wie steht es um Arena, testen sie jetzt wöchentlich neue Tiefs? Was ist hier in der nächsten Zeit zu erwarten. Vielleicht ist jemand so hilfsbereit und kann mir einen ganz kurzen Überblick sowie pers. Einschätzung liefern.
Mein Dank wird ihm / ihr auf ewig nachschleichen!
Grüße!
Antwort auf Beitrag Nr.: 36.965.844 von orfmen am 14.04.09 16:31:22Ist ja interessant!!!
Danke für das Gespräch!
Danke für das Gespräch!
Blossom trial ends June 2009.
Blossom results Sept. 2009.
NDA submission end of 2009, say December.
PDUFA approval October 2010.
This is a best-case scenario, and one they have been on track for since December 2008.
Partnership agreement could come at any time, but many guess after Blossom results, after NDA, or after FDA approval.
A big pharma waiting for partnership or buy out after approval will end up paying substantially more, because the risk premium is removed.
This is a game of chess that Jack is playing with big pharma, and since he has experience sitting on the other side of the table, I would hope he truly does maximize ARNA shareholder value.
Blossom results Sept. 2009.
NDA submission end of 2009, say December.
PDUFA approval October 2010.
This is a best-case scenario, and one they have been on track for since December 2008.
Partnership agreement could come at any time, but many guess after Blossom results, after NDA, or after FDA approval.
A big pharma waiting for partnership or buy out after approval will end up paying substantially more, because the risk premium is removed.
This is a game of chess that Jack is playing with big pharma, and since he has experience sitting on the other side of the table, I would hope he truly does maximize ARNA shareholder value.
Im Ernst: Habe keine blassen Schimmer über BIO's - habe hier eigentlich auch garnichts zu suchen!
Allerdings so wie ich das mitbekommen habe, setzen die Ami's auf ne Übernahme bzw. Cooperationsdeals mit einem Major. In wieweit die weiteren Resultate damit zu tun haben, weiß ich nicht! Da müsste mich jetzt einer aufklären.
Die negaive Seite ist, dass es finanziell knapp werden kann. Wenn bis zum 2. Quartal 2010 nichts passiert, können wir mit ner Null-Runde rechnen!
Dennoch wird bei dem Play stark auf Dendreon Corporation geschielt und verglichen. Wer kennt die Verhältnisse?
Ich bin mit so ner Schei.e schon oft auf die Klappe geflogen und kann es dennoch nicht lassen - was kostet die Welt!!!!?? Ich liebe die Zockerei!
Allerdings so wie ich das mitbekommen habe, setzen die Ami's auf ne Übernahme bzw. Cooperationsdeals mit einem Major. In wieweit die weiteren Resultate damit zu tun haben, weiß ich nicht! Da müsste mich jetzt einer aufklären.
Die negaive Seite ist, dass es finanziell knapp werden kann. Wenn bis zum 2. Quartal 2010 nichts passiert, können wir mit ner Null-Runde rechnen!
Dennoch wird bei dem Play stark auf Dendreon Corporation geschielt und verglichen. Wer kennt die Verhältnisse?
Ich bin mit so ner Schei.e schon oft auf die Klappe geflogen und kann es dennoch nicht lassen - was kostet die Welt!!!!?? Ich liebe die Zockerei!
So wie es aussieht geben wir bis zum Wochenende noch richtig Gas - hoffen wir mal. Die Bids sind jetzt schon bei knapp 3,80USD
Oh mann - absoluter Toilettentiftaucher!
Geiles Chartbild!! Alles Kriminelle!
Heute gehts weiter up!
Sieht gut aus, oder???
As the U.S. obesity epidemic grows ever bigger–pardon the pun–with aging Baby Boomer and Generation X waistlines expanding and record numbers of obese Gen. Y children burgeoning into adulthood, three companies are vying to become first to market with potential blockbuster-status weight loss drugs. Arena Pharmaceuticals (ARNA), Orexigen Therapeutics (OREX) and Vivus Inc. (VVUS) are in play with weight loss drugs in late stage clinical trials, but all face hurdles in their quest for regulatory approval and it remains unclear whether a “blockbuster” victor may emerge.
While we believe that ARNA and OREX are heading to a photo-finish for regulatory approval, ARNA should have the edge based on safety. Meanwhile VVUS, which will likely cross the line for regulatory approval for its compound, faces the biggest stretch in making it an actual commercial winner.
Finding a weight loss drug that safely sheds pounds without causing dangerous or embarrassing side effects has long been a holy grail for many drug developers due to the potential for astronomical profits. Several weight loss drugs have been approved over the years for sale by the U.S. Food and Drug Administration (FDA), but their numerous side effects and limited weight loss gains have precluded any of them from gaining anything close to blockbuster status.
Orexigen on July 20 released results from three Phase III clinical trials of its weight loss drug Contrave that met its primary goals and surpassed FDA requirements for efficacy. The company reported that roughly 50 percent of the patients in the 56-week trials reported weight losses of at least 5 percent and that the mean weight loss was around 8 percent. While OREX said the data showed that Contrave is safe, side effects included two cases of gallbladder infection, two seizures, a report of heart palpitations, a case of poor circulation, and one of vertigo. Commonly reported side effects were nausea, constipation and headache.
Despite the side effects, investors bid the stock price up as much as 65 percent during the week, reaching a high of $9.32 before settling in at $8.33 at Friday’s close. Investors‘ confidence was boosted by the fact that Contrave met a key benchmark for regulatory approval. All weight-loss drug candidates must meet at least one of two benchmarks set by the FDA, and Contrave had missed meeting the other benchmark in another late stage trial, causing the stock price to plunge after those results were released in January.
Arena Pharmaceuticals released Phase III results in late March on its drug, “lorcaserin,” and while it met one of the key FDA benchmarks and showed hardly any signs of side effects, the resultant weight loss might not be enough to garner FDA approval, and perhaps not enough to make the drug a commercial success.
While ARNA executives played up the results and suggested they were good enough for eventual FDA approval, investors were not convinced and pushed the stock price down about 30 percent after the results were released. Company executives have also expressed confidence that a larger Phase III study will also prove safe and efficacious enough for eventual FDA approval when the results are released in September.
Vivus is expected to release results from its second Phase III study on “Qnexa,” a combination of two existing approved drugs, in the fourth quarter. Results of its first Phase III study released in January were trumpeted by VVUS management, but considered lackluster by investors, who bid the shares down as much as 30 percent after that release. Many analysts question Qnexa’s commercial viability, as the two drugs that make up the new compound are already available in generic form. The FDA is also reportedly concerned about the compound’s potential to cause mood-altering side effects.
Arena will likely be the first to face the FDA, as it plans to submit its new drug application (NDA) to the FDA by the end of the year. Orexigen’s management has stated that they plan to submit their NDA in early 2010, and Vivus executives have indicated that they plan to apply in the first half of 2010.
All three companies are looking for partnerships with bigger pharmaceutical companies, but most analysts believe that potential partners will want to wait until all Phase III results have been reported before stepping in with offers. Both Arena and Orexigen have recently raised cash through public offerings of their stock, OREX this past week after releasing its stock rising results, and ARNA in with a stock price rise in June, after reporting that patients on their drug were keeping the weight off one year after the study’s conclusion.
While Orexigen’s drug appears to be the most efficacious, Arena’s seems to have the safest profile with the fewest side effects. Vivus’s drug has potential “mood altering” side-effect problems and has not been as effective at taking the pounds off as OREX’s Contrave. All three companies claim that they have met or will meet FDA thresholds for approval. When it comes to approval the FDA considers safety first, and that is where Arena has the edge. And if the september results of Arena’s large Phase III trial meet or exceed the results of earlier Phase III trials, that edge will grow even sharper.
Whichever company gains the edge in this race for approval, and we believe it will be Arena, will likely be met with a lucrative partnership with a big pharmaceutical company, or an outright takeover at a premium price. In either case Arena’s stock price should rise as the company pushes closer to submitting its NDA, and, absent a takeover, we would consider taking profits in the $10 to $15 range ahead of the FDA’s ultimate approval decision.
Disclosure: Long Arena
http://seekingalpha.com/article/151303-arena-s-edge-in-the-o…
While we believe that ARNA and OREX are heading to a photo-finish for regulatory approval, ARNA should have the edge based on safety. Meanwhile VVUS, which will likely cross the line for regulatory approval for its compound, faces the biggest stretch in making it an actual commercial winner.
Finding a weight loss drug that safely sheds pounds without causing dangerous or embarrassing side effects has long been a holy grail for many drug developers due to the potential for astronomical profits. Several weight loss drugs have been approved over the years for sale by the U.S. Food and Drug Administration (FDA), but their numerous side effects and limited weight loss gains have precluded any of them from gaining anything close to blockbuster status.
Orexigen on July 20 released results from three Phase III clinical trials of its weight loss drug Contrave that met its primary goals and surpassed FDA requirements for efficacy. The company reported that roughly 50 percent of the patients in the 56-week trials reported weight losses of at least 5 percent and that the mean weight loss was around 8 percent. While OREX said the data showed that Contrave is safe, side effects included two cases of gallbladder infection, two seizures, a report of heart palpitations, a case of poor circulation, and one of vertigo. Commonly reported side effects were nausea, constipation and headache.
Despite the side effects, investors bid the stock price up as much as 65 percent during the week, reaching a high of $9.32 before settling in at $8.33 at Friday’s close. Investors‘ confidence was boosted by the fact that Contrave met a key benchmark for regulatory approval. All weight-loss drug candidates must meet at least one of two benchmarks set by the FDA, and Contrave had missed meeting the other benchmark in another late stage trial, causing the stock price to plunge after those results were released in January.
Arena Pharmaceuticals released Phase III results in late March on its drug, “lorcaserin,” and while it met one of the key FDA benchmarks and showed hardly any signs of side effects, the resultant weight loss might not be enough to garner FDA approval, and perhaps not enough to make the drug a commercial success.
While ARNA executives played up the results and suggested they were good enough for eventual FDA approval, investors were not convinced and pushed the stock price down about 30 percent after the results were released. Company executives have also expressed confidence that a larger Phase III study will also prove safe and efficacious enough for eventual FDA approval when the results are released in September.
Vivus is expected to release results from its second Phase III study on “Qnexa,” a combination of two existing approved drugs, in the fourth quarter. Results of its first Phase III study released in January were trumpeted by VVUS management, but considered lackluster by investors, who bid the shares down as much as 30 percent after that release. Many analysts question Qnexa’s commercial viability, as the two drugs that make up the new compound are already available in generic form. The FDA is also reportedly concerned about the compound’s potential to cause mood-altering side effects.
Arena will likely be the first to face the FDA, as it plans to submit its new drug application (NDA) to the FDA by the end of the year. Orexigen’s management has stated that they plan to submit their NDA in early 2010, and Vivus executives have indicated that they plan to apply in the first half of 2010.
All three companies are looking for partnerships with bigger pharmaceutical companies, but most analysts believe that potential partners will want to wait until all Phase III results have been reported before stepping in with offers. Both Arena and Orexigen have recently raised cash through public offerings of their stock, OREX this past week after releasing its stock rising results, and ARNA in with a stock price rise in June, after reporting that patients on their drug were keeping the weight off one year after the study’s conclusion.
While Orexigen’s drug appears to be the most efficacious, Arena’s seems to have the safest profile with the fewest side effects. Vivus’s drug has potential “mood altering” side-effect problems and has not been as effective at taking the pounds off as OREX’s Contrave. All three companies claim that they have met or will meet FDA thresholds for approval. When it comes to approval the FDA considers safety first, and that is where Arena has the edge. And if the september results of Arena’s large Phase III trial meet or exceed the results of earlier Phase III trials, that edge will grow even sharper.
Whichever company gains the edge in this race for approval, and we believe it will be Arena, will likely be met with a lucrative partnership with a big pharmaceutical company, or an outright takeover at a premium price. In either case Arena’s stock price should rise as the company pushes closer to submitting its NDA, and, absent a takeover, we would consider taking profits in the $10 to $15 range ahead of the FDA’s ultimate approval decision.
Disclosure: Long Arena
http://seekingalpha.com/article/151303-arena-s-edge-in-the-o…
Antwort auf Beitrag Nr.: 37.653.125 von mrbk1234 am 27.07.09 16:10:56Ich bin dabei und glaube, dass $20 im September nach der Veröffentlichung der zweiten phase III trial Daten möglich sind. Die Ergebnisse des ersten phase III trial haben meiner Meinung nach die Effektivität und Sicherheit bewiesen. Die zweiten phase III trials sollten vergleichbare Resultate aufzeigen.
Über die Meinung einiger Analysten nach den ersten phase III results, die Effektivität hätte besser ausfallen können, kann ich nur lachen, denn während Arena für die Studien Personen ab einem BMI ab 30 zugelassen hat, haben die Konkurrenten Personen mit einem BMI ab 35 für die Tests genommen, also wesentlich fettleibigere Personen.
Im Artikel wird die Sicherheit angesprochen und da hat Arena mit lorcaserin ein Medikament wesentlich geringere Nebenwirkungen.
Über die Meinung einiger Analysten nach den ersten phase III results, die Effektivität hätte besser ausfallen können, kann ich nur lachen, denn während Arena für die Studien Personen ab einem BMI ab 30 zugelassen hat, haben die Konkurrenten Personen mit einem BMI ab 35 für die Tests genommen, also wesentlich fettleibigere Personen.
Im Artikel wird die Sicherheit angesprochen und da hat Arena mit lorcaserin ein Medikament wesentlich geringere Nebenwirkungen.
Antwort auf Beitrag Nr.: 37.863.632 von chaosjosef am 27.08.09 13:07:38Arena Pharmaceuticals Reports Positive, Highly Significant BLOSSOM Trial Results for Weight Management; NDA Submission on Track for December
- Lorcaserin Meets all Primary Endpoints and FDA Benchmark - - 63% of Lorcaserin Patients Who Complied with the Protocol Lost at Least 5% of Their Weight - - Lorcaserin Patients in the Top Quartile Achieved Average Weight Loss of 16% or 35 Pounds - - Combined Phase 3 BLOOM and BLOSSOM Data Set Confirms Lorcaserin's Excellent Safety and Tolerability Profile and Rules Out Heart Valve Effect - - Conference Call and Webcast Presentation Scheduled for 8:00 a.m. ET on September 18, 2009 -
Press Release
Source: Arena Pharmaceuticals, Inc.
On Friday September 18, 2009, 12:00 am EDT
Buzz up! 0 Print
Companies:Arena Pharmaceuticals, Inc.
SAN DIEGO, Sept. 18, 2009 /PRNewswire-FirstCall/ -- Arena Pharmaceuticals, Inc. (Nasdaq: ARNA - News) reported today positive, highly significant top-line results from the BLOSSOM (Behavioral modification and LOrcaserin Second Study for Obesity Management) trial. BLOSSOM confirms the results previously reported for the BLOOM (Behavioral modification and Lorcaserin for Overweight and Obesity Management) trial and completes the lorcaserin Phase 3 pivotal registration program of 7,190 patients evaluated for up to two years. Arena plans to submit a New Drug Application, or NDA, for lorcaserin to the US Food and Drug Administration, or FDA, in December.
In the one-year BLOSSOM trial, lorcaserin met all primary efficacy and safety endpoints. Patients achieved highly significant categorical and absolute weight loss. Lorcaserin was very well tolerated and was not associated with depression or suicidal ideation. The integrated echocardiographic data set from BLOSSOM and BLOOM rules out a risk of valvulopathy in lorcaserin patients according to criteria requested by the FDA. Treatment with lorcaserin also resulted in significant improvements as compared to placebo in multiple secondary endpoints associated with cardiovascular risk.
"Today there are extremely limited options to meet the needs of physicians and patients in the real world clinical practice of weight management," said Steven R. Smith, M.D., Executive Director of the Florida Hospital Clinical Research Institute. "Physicians need options that have the potential to help the typical obese patient lose significant weight by staying on a safe and well-tolerated treatment. The clinical data show lorcaserin is a solution that could provide physicians with a weight-loss medication applicable for broad use in the majority of their patients who need to lose weight and improve their health. BLOSSOM demonstrated that nearly two-thirds of lorcaserin patients lost a medically meaningful amount of body weight while avoiding unwanted side effects and a complicated titration program."
"History has taught us that the marriage of efficacy and safety is of critical importance in treating patients. Neither is sufficient without the other. With its excellent safety and tolerability profile, we expect lorcaserin to change the way primary care doctors treat the broad cross-section of overweight and obese patients with pharmacotherapy," said Jack Lief, Arena's President and Chief Executive Officer. "With the completion of our robust Phase 3 pivotal program, we will focus on the NDA filing, work with the FDA during the review process and prepare for the commercialization of lorcaserin."
Arena plans to present detailed data from both the BLOOM and BLOSSOM trials at the 27th Annual Scientific Meeting of The Obesity Society, scheduled for October 24-28 in Washington, D.C.
Efficacy
Per Protocol Results
Lorcaserin was highly effective in helping patients achieve significant weight loss using multiple measurements. Patients treated with 10 mg of lorcaserin dosed twice daily (BID) who completed the 52-week trial according to protocol demonstrated the benefit of long-term treatment with lorcaserin:
63.2% of patients lost at least 5% of their body weight (p<0.0001);
35.1% of patients lost at least 10% of their body weight (p<0.0001);
Patients lost an average of 17.0 pounds, or 7.9% of their body weight; and
The quartile of lorcaserin patients with the greatest weight loss (among those with a Week 52 weight recorded) lost an average of 35.1 pounds, or 16.3% of their body weight.
Of the placebo patients who completed the trial, 34.9% and 16.1% achieved at least 5% and 10% weight loss, respectively, and the average weight loss was 8.7 pounds, or 3.9%. The top quartile of lorcaserin patients lost 36% more body weight than the top quartile of placebo patients.
For the patients treated with 10 mg of lorcaserin dosed once daily (QD) and completing the 52-week trial according to protocol, 53.1% lost at least 5% of their body weight and 26.3% lost at least 10% of their body weight. The average weight loss in the lorcaserin 10 mg once daily group was 14.3 pounds, or 6.5%. As with the higher dose, all results were highly statistically significant (p<0.0001 compared to placebo).
Intent-to-Treat Last Observation Carried Forward (ITT-LOCF) Results
Measurements of efficacy using ITT-LOCF analysis also showed that lorcaserin met all primary endpoints. This analysis includes all patients who were randomized and returned for at least one weight measurement. Patients treated with 10 mg of lorcaserin once or twice daily achieved highly statistically significant categorical and average weight loss after 12 months:
Lorcaserin 10 mg Twice Daily
47.2% of patients treated with 10 mg of lorcaserin dosed twice daily lost at least 5% of their body weight compared to 25.0% for placebo (p<0.0001). This result satisfies the efficacy benchmark in the most recent FDA draft guidance which provides that a weight-management product can be considered effective if the proportion of patients who lose at least 5% of baseline body weight in the active-product group is at least 35%, is approximately double the proportion in the placebo-treated group, and the difference between groups is statistically significant;
22.6% of patients treated with 10 mg of lorcaserin dosed twice daily lost at least 10% of their body weight compared to 9.7% for placebo (p<0.0001);
Lorcaserin 10 mg Once Daily
40.2% of patients treated with 10 mg of lorcaserin dosed once daily lost at least 5% of their body weight (p<0.0001); and
17.4% of patients treated with 10 mg of lorcaserin dosed once daily lost at least 10% of their body weight (p<0.0001).
Patients who took lorcaserin 10 mg twice daily achieved an average weight loss of 5.9% of their body weight, compared to 2.8% for placebo (p<0.0001). Similarly, patients who took lorcaserin 10 mg once daily achieved an average weight loss of 4.8% of their body weight (p<0.0001).
BLOSSOM Confirms BLOOM
In BLOSSOM, as in BLOOM, lorcaserin's excellent tolerability allowed patients to begin treatment at the full dose immediately, without a titration period, and achieve rapid weight loss. As in BLOOM, significant weight loss compared to placebo was shown at the first trial visit, two weeks following randomization.
The efficacy for the BLOOM and BLOSSOM trials after one year of treatment are summarized in the table below.
BLOOM BLOSSOM
----- -------
10 mg BID* Placebo 10 mg BID* 10 mg QD* Placebo
---------- ------- ---------- --------- -------
>/=5% weight loss
(Per protocol) 66.4% 32.1% 63.2% 53.1% 34.9%
--------------- ---- ---- ---- ---- ----
>/=5% weight loss
(ITT-LOCF) 47.5% 20.3% 47.2% 40.2% 25.0%
--------------- ---- ---- ---- ---- ----
>/=10% weight loss
(Per protocol) 36.2% 13.6% 35.1% 26.3% 16.1%
---------------- ---- ---- ---- ---- ----
>/=10% weight loss
(ITT-LOCF) 22.6% 7.7% 22.6% 17.4% 9.7%
---------------- ---- --- ---- ---- ---
Mean weight loss
(Per protocol) 8.2% 3.4% 7.9% 6.5% 3.9%
------------- --- --- --- --- ---
Mean weight loss
(ITT-LOCF) 5.8% 2.2% 5.9% 4.8% 2.8%
--------- --- --- --- --- ---
* p<0.0001 compared to placebo
"Lorcaserin demonstrated consistent results in the BLOOM and BLOSSOM trials, which together evaluated nearly 7,200 patients for up to two years," said William R. Shanahan, M.D., Arena's Vice President and Chief Medical Officer. "These results support lorcaserin's potential to meet the need for a safe, effective and well-tolerated weight loss medication. There are only two drugs that are approved by the FDA for long-term treatment, and new mechanistic and better tolerated approaches could greatly improve the treatment of patients who are obese or significantly overweight."
Safety and Tolerability Profile
Lorcaserin was very well tolerated. No adverse event rate in the lorcaserin group exceeded the placebo group by more than 4%. The most frequent adverse events and their rates for patients who took lorcaserin twice daily, lorcaserin once daily or placebo, respectively, were as follows: upper respiratory infection (12.7%, 14.5%, 12.6%); nasopharyngitis (12.5%, 11.7%, 11.8%) and headache (10.0%, 10.5%, 7.6%).
Adverse events of depression, anxiety and suicidal ideation were infrequent and were reported at a similar rate in each treatment group. Serious adverse events, or SAEs, occurred infrequently: one death occurred in the placebo group, no SAEs of seizure were reported and the number of neuropsychiatric SAEs in lorcaserin patients did not exceed the number in the placebo group.
Cardiovascular Safety
The integrated BLOOM and BLOSSOM echocardiography data set rules out a risk of valvulopathy in lorcaserin patients according to criteria requested by the FDA. Echocardiographic evaluations showed no association between lorcaserin and the development of heart valve insufficiency. Rates of new FDA-defined valvulopathy in BLOSSOM at Week 52 were as follows: lorcaserin 10 mg twice daily (2.0%), 10 mg once daily (1.4%) and placebo (2.0%).
"The echocardiographic safety data show no risk of valvulopathy," commented Neil J. Weissman, M.D., Director, Cardiac Ultrasound and Ultrasound Core Labs, President, MedStar Research Institute, and Professor of Medicine, Georgetown University. "In the individual and combined BLOOM and BLOSSOM data sets there is no evidence of a difference in the development of valve disease in lorcaserin patients versus control for up to two years of continuous use. No prospective echocardiographic program has ever studied this many patients for this period of time."
Secondary Endpoints
Treatment with lorcaserin over one year was associated with significant improvements or strongly favorable trends compared to placebo in multiple secondary endpoints, including blood pressure and lipids.
Patient Disposition
BLOSSOM evaluated 4,008 patients with an average body mass index, or BMI, of 35.9 and baseline weight of 220 pounds. The Week 52 completion rate was higher for patients on lorcaserin 10 mg twice daily (57.2%) and 10 mg once daily (59.0%) compared to patients on placebo (52.0%). Discontinuations for adverse events were low and as follows: lorcaserin 10 mg twice daily (7.2%), 10 mg once daily (6.2%) and placebo (4.6%).
Conference Call & Webcast
Arena will host a conference call and webcast presentation to discuss the results at 8:00 a.m. Eastern Time (5:00 a.m. Pacific Time) on September 18, 2009. Jack Lief, President and Chief Executive Officer; Dominic P. Behan, Ph.D., Senior Vice President and Chief Scientific Officer; William R. Shanahan, M.D., Vice President and Chief Medical Officer; and Christen M. Anderson, M.D., Ph.D., Vice President, Clinical Development, will host the conference call and webcast.
The conference call may be accessed by dialing 888.312.3047 for domestic callers and 719.325.2234 for international callers. Please specify to the operator that you would like to join the "Lorcaserin BLOSSOM Trial Results" conference call. The conference call and slide presentation will be webcast live under the investor relations section of Arena's website at www.arenapharm.com, and will be archived there for 30 days following the call. Please connect to Arena's website several minutes prior to the start of the broadcast to ensure adequate time for any software download that may be necessary.
BLOSSOM Trial Design
BLOSSOM is a double-blind, randomized, placebo-controlled trial that enrolled 4,008 patients in approximately 100 sites in the US. The trial evaluated 10 mg of lorcaserin dosed once or twice daily versus placebo over a one-year treatment period in obese patients (BMI 30 to 45) with or without co-morbid conditions and overweight patients (BMI 27 to less than 30) with at least one co-morbid condition. The trial did not include dose titration or a run-in period. Patients were randomized at baseline in a 2:2:1 ratio to lorcaserin 10 mg twice daily, placebo or lorcaserin 10 mg once daily. Patients received echocardiograms at baseline, month 6 and at the end of the trial to assess heart valve function over time. In contrast to the BLOOM trial, there were no echocardiographic exclusion criteria for entry into BLOSSOM and there was no oversight or interim data review monitoring by an independent safety monitoring board.
Phase 3 Program Overview
The lorcaserin Phase 3 program consists of three trials: BLOOM, BLOSSOM and BLOOM-DM (Behavioral modification and Lorcaserin for Overweight and Obesity Management in Diabetes Mellitus). Enrollment in the lorcaserin Phase 3 program is complete with approximately 7,800 patients. Positive results from BLOOM were presented at the 69th Scientific Sessions of the American Diabetes Association in June 2009. BLOOM and BLOSSOM comprise the Phase 3 pivotal registration program and will be the basis for the lorcaserin NDA submission. BLOOM-DM, which is planned as a supplement to the NDA, is evaluating 10 mg of lorcaserin dosed once or twice daily versus placebo over a one-year treatment period in obese and overweight patients with type 2 diabetes at about 60 sites in the US.
A standardized program of moderate diet and exercise guidance is included in the Phase 3 program. The program's hierarchically ordered co-primary efficacy endpoints are: the proportion of patients achieving 5% or greater weight loss after 12 months, the difference in mean weight loss compared to placebo after 12 months, and the proportion of patients achieving 10% or greater weight loss after 12 months. Arena is also studying several key secondary endpoints, including changes in serum lipids, markers of inflammation and insulin resistance, and in the BLOOM-DM trial, other indicators of glycemic control.
About the FDA Draft Guidance
The FDA draft guidance document "Developing Products for Weight Management" dated February 2007 provides recommendations regarding the development of drugs for the indication of weight management. It contains two alternate efficacy benchmarks. The guidance provides that, in general, a product can be considered effective for weight management if after one year of treatment either of the following occurs: (1) the difference in mean weight loss between the active-product and placebo-treated groups is at least 5% and the difference is statistically significant, or (2) the proportion of subjects who lose greater than or equal to 5% of baseline body weight in the active-product group is at least 35%, is approximately double the proportion in the placebo-treated group, and the difference between groups is statistically significant.
About Lorcaserin
Lorcaserin is a novel single agent that represents the first in a new class of selective serotonin 2C receptor agonists. The serotonin 2C receptor is expressed in the brain, including the hypothalamus, an area involved in the control of appetite and metabolism. Stimulation of this receptor is strongly associated with feeding behavior and satiety. Arena has patents that cover lorcaserin in the US and other jurisdictions, which in most cases are capable of continuing into 2023 without taking into account any patent term extensions or other exclusivity Arena might obtain.
About Weight Management
The National Institutes of Health reported in 2007 that about 65% of US adults are overweight or obese. A 2009 publication in Health Affairs estimated the annual medical burden of obesity in the US to be $147 billion in 2008. Studies have shown that weight loss of 5% to 10% is medically significant and results in meaningful improvements in cardiovascular risk factors and a significant reduction in the incidence of type 2 diabetes in patients with glucose intolerance.
About Arena Pharmaceuticals
Arena is a clinical-stage biopharmaceutical company focused on discovering, developing and commercializing oral drugs in four major therapeutic areas: cardiovascular, central nervous system, inflammatory and metabolic diseases. Arena's most advanced drug candidate, lorcaserin, is being investigated in a Phase 3 clinical trial program for weight management. Arena has a broad pipeline of novel compounds targeting G protein-coupled receptors, an important class of validated drug targets, which includes compounds being evaluated independently and with partners, including Merck & Co., Inc., and Ortho-McNeil-Janssen Pharmaceuticals, Inc.
Arena Pharmaceuticals® and Arena® are registered service marks of the company. "APD" is an abbreviation for Arena Pharmaceuticals Development.
- Lorcaserin Meets all Primary Endpoints and FDA Benchmark - - 63% of Lorcaserin Patients Who Complied with the Protocol Lost at Least 5% of Their Weight - - Lorcaserin Patients in the Top Quartile Achieved Average Weight Loss of 16% or 35 Pounds - - Combined Phase 3 BLOOM and BLOSSOM Data Set Confirms Lorcaserin's Excellent Safety and Tolerability Profile and Rules Out Heart Valve Effect - - Conference Call and Webcast Presentation Scheduled for 8:00 a.m. ET on September 18, 2009 -
Press Release
Source: Arena Pharmaceuticals, Inc.
On Friday September 18, 2009, 12:00 am EDT
Buzz up! 0 Print
Companies:Arena Pharmaceuticals, Inc.
SAN DIEGO, Sept. 18, 2009 /PRNewswire-FirstCall/ -- Arena Pharmaceuticals, Inc. (Nasdaq: ARNA - News) reported today positive, highly significant top-line results from the BLOSSOM (Behavioral modification and LOrcaserin Second Study for Obesity Management) trial. BLOSSOM confirms the results previously reported for the BLOOM (Behavioral modification and Lorcaserin for Overweight and Obesity Management) trial and completes the lorcaserin Phase 3 pivotal registration program of 7,190 patients evaluated for up to two years. Arena plans to submit a New Drug Application, or NDA, for lorcaserin to the US Food and Drug Administration, or FDA, in December.
In the one-year BLOSSOM trial, lorcaserin met all primary efficacy and safety endpoints. Patients achieved highly significant categorical and absolute weight loss. Lorcaserin was very well tolerated and was not associated with depression or suicidal ideation. The integrated echocardiographic data set from BLOSSOM and BLOOM rules out a risk of valvulopathy in lorcaserin patients according to criteria requested by the FDA. Treatment with lorcaserin also resulted in significant improvements as compared to placebo in multiple secondary endpoints associated with cardiovascular risk.
"Today there are extremely limited options to meet the needs of physicians and patients in the real world clinical practice of weight management," said Steven R. Smith, M.D., Executive Director of the Florida Hospital Clinical Research Institute. "Physicians need options that have the potential to help the typical obese patient lose significant weight by staying on a safe and well-tolerated treatment. The clinical data show lorcaserin is a solution that could provide physicians with a weight-loss medication applicable for broad use in the majority of their patients who need to lose weight and improve their health. BLOSSOM demonstrated that nearly two-thirds of lorcaserin patients lost a medically meaningful amount of body weight while avoiding unwanted side effects and a complicated titration program."
"History has taught us that the marriage of efficacy and safety is of critical importance in treating patients. Neither is sufficient without the other. With its excellent safety and tolerability profile, we expect lorcaserin to change the way primary care doctors treat the broad cross-section of overweight and obese patients with pharmacotherapy," said Jack Lief, Arena's President and Chief Executive Officer. "With the completion of our robust Phase 3 pivotal program, we will focus on the NDA filing, work with the FDA during the review process and prepare for the commercialization of lorcaserin."
Arena plans to present detailed data from both the BLOOM and BLOSSOM trials at the 27th Annual Scientific Meeting of The Obesity Society, scheduled for October 24-28 in Washington, D.C.
Efficacy
Per Protocol Results
Lorcaserin was highly effective in helping patients achieve significant weight loss using multiple measurements. Patients treated with 10 mg of lorcaserin dosed twice daily (BID) who completed the 52-week trial according to protocol demonstrated the benefit of long-term treatment with lorcaserin:
63.2% of patients lost at least 5% of their body weight (p<0.0001);
35.1% of patients lost at least 10% of their body weight (p<0.0001);
Patients lost an average of 17.0 pounds, or 7.9% of their body weight; and
The quartile of lorcaserin patients with the greatest weight loss (among those with a Week 52 weight recorded) lost an average of 35.1 pounds, or 16.3% of their body weight.
Of the placebo patients who completed the trial, 34.9% and 16.1% achieved at least 5% and 10% weight loss, respectively, and the average weight loss was 8.7 pounds, or 3.9%. The top quartile of lorcaserin patients lost 36% more body weight than the top quartile of placebo patients.
For the patients treated with 10 mg of lorcaserin dosed once daily (QD) and completing the 52-week trial according to protocol, 53.1% lost at least 5% of their body weight and 26.3% lost at least 10% of their body weight. The average weight loss in the lorcaserin 10 mg once daily group was 14.3 pounds, or 6.5%. As with the higher dose, all results were highly statistically significant (p<0.0001 compared to placebo).
Intent-to-Treat Last Observation Carried Forward (ITT-LOCF) Results
Measurements of efficacy using ITT-LOCF analysis also showed that lorcaserin met all primary endpoints. This analysis includes all patients who were randomized and returned for at least one weight measurement. Patients treated with 10 mg of lorcaserin once or twice daily achieved highly statistically significant categorical and average weight loss after 12 months:
Lorcaserin 10 mg Twice Daily
47.2% of patients treated with 10 mg of lorcaserin dosed twice daily lost at least 5% of their body weight compared to 25.0% for placebo (p<0.0001). This result satisfies the efficacy benchmark in the most recent FDA draft guidance which provides that a weight-management product can be considered effective if the proportion of patients who lose at least 5% of baseline body weight in the active-product group is at least 35%, is approximately double the proportion in the placebo-treated group, and the difference between groups is statistically significant;
22.6% of patients treated with 10 mg of lorcaserin dosed twice daily lost at least 10% of their body weight compared to 9.7% for placebo (p<0.0001);
Lorcaserin 10 mg Once Daily
40.2% of patients treated with 10 mg of lorcaserin dosed once daily lost at least 5% of their body weight (p<0.0001); and
17.4% of patients treated with 10 mg of lorcaserin dosed once daily lost at least 10% of their body weight (p<0.0001).
Patients who took lorcaserin 10 mg twice daily achieved an average weight loss of 5.9% of their body weight, compared to 2.8% for placebo (p<0.0001). Similarly, patients who took lorcaserin 10 mg once daily achieved an average weight loss of 4.8% of their body weight (p<0.0001).
BLOSSOM Confirms BLOOM
In BLOSSOM, as in BLOOM, lorcaserin's excellent tolerability allowed patients to begin treatment at the full dose immediately, without a titration period, and achieve rapid weight loss. As in BLOOM, significant weight loss compared to placebo was shown at the first trial visit, two weeks following randomization.
The efficacy for the BLOOM and BLOSSOM trials after one year of treatment are summarized in the table below.
BLOOM BLOSSOM
----- -------
10 mg BID* Placebo 10 mg BID* 10 mg QD* Placebo
---------- ------- ---------- --------- -------
>/=5% weight loss
(Per protocol) 66.4% 32.1% 63.2% 53.1% 34.9%
--------------- ---- ---- ---- ---- ----
>/=5% weight loss
(ITT-LOCF) 47.5% 20.3% 47.2% 40.2% 25.0%
--------------- ---- ---- ---- ---- ----
>/=10% weight loss
(Per protocol) 36.2% 13.6% 35.1% 26.3% 16.1%
---------------- ---- ---- ---- ---- ----
>/=10% weight loss
(ITT-LOCF) 22.6% 7.7% 22.6% 17.4% 9.7%
---------------- ---- --- ---- ---- ---
Mean weight loss
(Per protocol) 8.2% 3.4% 7.9% 6.5% 3.9%
------------- --- --- --- --- ---
Mean weight loss
(ITT-LOCF) 5.8% 2.2% 5.9% 4.8% 2.8%
--------- --- --- --- --- ---
* p<0.0001 compared to placebo
"Lorcaserin demonstrated consistent results in the BLOOM and BLOSSOM trials, which together evaluated nearly 7,200 patients for up to two years," said William R. Shanahan, M.D., Arena's Vice President and Chief Medical Officer. "These results support lorcaserin's potential to meet the need for a safe, effective and well-tolerated weight loss medication. There are only two drugs that are approved by the FDA for long-term treatment, and new mechanistic and better tolerated approaches could greatly improve the treatment of patients who are obese or significantly overweight."
Safety and Tolerability Profile
Lorcaserin was very well tolerated. No adverse event rate in the lorcaserin group exceeded the placebo group by more than 4%. The most frequent adverse events and their rates for patients who took lorcaserin twice daily, lorcaserin once daily or placebo, respectively, were as follows: upper respiratory infection (12.7%, 14.5%, 12.6%); nasopharyngitis (12.5%, 11.7%, 11.8%) and headache (10.0%, 10.5%, 7.6%).
Adverse events of depression, anxiety and suicidal ideation were infrequent and were reported at a similar rate in each treatment group. Serious adverse events, or SAEs, occurred infrequently: one death occurred in the placebo group, no SAEs of seizure were reported and the number of neuropsychiatric SAEs in lorcaserin patients did not exceed the number in the placebo group.
Cardiovascular Safety
The integrated BLOOM and BLOSSOM echocardiography data set rules out a risk of valvulopathy in lorcaserin patients according to criteria requested by the FDA. Echocardiographic evaluations showed no association between lorcaserin and the development of heart valve insufficiency. Rates of new FDA-defined valvulopathy in BLOSSOM at Week 52 were as follows: lorcaserin 10 mg twice daily (2.0%), 10 mg once daily (1.4%) and placebo (2.0%).
"The echocardiographic safety data show no risk of valvulopathy," commented Neil J. Weissman, M.D., Director, Cardiac Ultrasound and Ultrasound Core Labs, President, MedStar Research Institute, and Professor of Medicine, Georgetown University. "In the individual and combined BLOOM and BLOSSOM data sets there is no evidence of a difference in the development of valve disease in lorcaserin patients versus control for up to two years of continuous use. No prospective echocardiographic program has ever studied this many patients for this period of time."
Secondary Endpoints
Treatment with lorcaserin over one year was associated with significant improvements or strongly favorable trends compared to placebo in multiple secondary endpoints, including blood pressure and lipids.
Patient Disposition
BLOSSOM evaluated 4,008 patients with an average body mass index, or BMI, of 35.9 and baseline weight of 220 pounds. The Week 52 completion rate was higher for patients on lorcaserin 10 mg twice daily (57.2%) and 10 mg once daily (59.0%) compared to patients on placebo (52.0%). Discontinuations for adverse events were low and as follows: lorcaserin 10 mg twice daily (7.2%), 10 mg once daily (6.2%) and placebo (4.6%).
Conference Call & Webcast
Arena will host a conference call and webcast presentation to discuss the results at 8:00 a.m. Eastern Time (5:00 a.m. Pacific Time) on September 18, 2009. Jack Lief, President and Chief Executive Officer; Dominic P. Behan, Ph.D., Senior Vice President and Chief Scientific Officer; William R. Shanahan, M.D., Vice President and Chief Medical Officer; and Christen M. Anderson, M.D., Ph.D., Vice President, Clinical Development, will host the conference call and webcast.
The conference call may be accessed by dialing 888.312.3047 for domestic callers and 719.325.2234 for international callers. Please specify to the operator that you would like to join the "Lorcaserin BLOSSOM Trial Results" conference call. The conference call and slide presentation will be webcast live under the investor relations section of Arena's website at www.arenapharm.com, and will be archived there for 30 days following the call. Please connect to Arena's website several minutes prior to the start of the broadcast to ensure adequate time for any software download that may be necessary.
BLOSSOM Trial Design
BLOSSOM is a double-blind, randomized, placebo-controlled trial that enrolled 4,008 patients in approximately 100 sites in the US. The trial evaluated 10 mg of lorcaserin dosed once or twice daily versus placebo over a one-year treatment period in obese patients (BMI 30 to 45) with or without co-morbid conditions and overweight patients (BMI 27 to less than 30) with at least one co-morbid condition. The trial did not include dose titration or a run-in period. Patients were randomized at baseline in a 2:2:1 ratio to lorcaserin 10 mg twice daily, placebo or lorcaserin 10 mg once daily. Patients received echocardiograms at baseline, month 6 and at the end of the trial to assess heart valve function over time. In contrast to the BLOOM trial, there were no echocardiographic exclusion criteria for entry into BLOSSOM and there was no oversight or interim data review monitoring by an independent safety monitoring board.
Phase 3 Program Overview
The lorcaserin Phase 3 program consists of three trials: BLOOM, BLOSSOM and BLOOM-DM (Behavioral modification and Lorcaserin for Overweight and Obesity Management in Diabetes Mellitus). Enrollment in the lorcaserin Phase 3 program is complete with approximately 7,800 patients. Positive results from BLOOM were presented at the 69th Scientific Sessions of the American Diabetes Association in June 2009. BLOOM and BLOSSOM comprise the Phase 3 pivotal registration program and will be the basis for the lorcaserin NDA submission. BLOOM-DM, which is planned as a supplement to the NDA, is evaluating 10 mg of lorcaserin dosed once or twice daily versus placebo over a one-year treatment period in obese and overweight patients with type 2 diabetes at about 60 sites in the US.
A standardized program of moderate diet and exercise guidance is included in the Phase 3 program. The program's hierarchically ordered co-primary efficacy endpoints are: the proportion of patients achieving 5% or greater weight loss after 12 months, the difference in mean weight loss compared to placebo after 12 months, and the proportion of patients achieving 10% or greater weight loss after 12 months. Arena is also studying several key secondary endpoints, including changes in serum lipids, markers of inflammation and insulin resistance, and in the BLOOM-DM trial, other indicators of glycemic control.
About the FDA Draft Guidance
The FDA draft guidance document "Developing Products for Weight Management" dated February 2007 provides recommendations regarding the development of drugs for the indication of weight management. It contains two alternate efficacy benchmarks. The guidance provides that, in general, a product can be considered effective for weight management if after one year of treatment either of the following occurs: (1) the difference in mean weight loss between the active-product and placebo-treated groups is at least 5% and the difference is statistically significant, or (2) the proportion of subjects who lose greater than or equal to 5% of baseline body weight in the active-product group is at least 35%, is approximately double the proportion in the placebo-treated group, and the difference between groups is statistically significant.
About Lorcaserin
Lorcaserin is a novel single agent that represents the first in a new class of selective serotonin 2C receptor agonists. The serotonin 2C receptor is expressed in the brain, including the hypothalamus, an area involved in the control of appetite and metabolism. Stimulation of this receptor is strongly associated with feeding behavior and satiety. Arena has patents that cover lorcaserin in the US and other jurisdictions, which in most cases are capable of continuing into 2023 without taking into account any patent term extensions or other exclusivity Arena might obtain.
About Weight Management
The National Institutes of Health reported in 2007 that about 65% of US adults are overweight or obese. A 2009 publication in Health Affairs estimated the annual medical burden of obesity in the US to be $147 billion in 2008. Studies have shown that weight loss of 5% to 10% is medically significant and results in meaningful improvements in cardiovascular risk factors and a significant reduction in the incidence of type 2 diabetes in patients with glucose intolerance.
About Arena Pharmaceuticals
Arena is a clinical-stage biopharmaceutical company focused on discovering, developing and commercializing oral drugs in four major therapeutic areas: cardiovascular, central nervous system, inflammatory and metabolic diseases. Arena's most advanced drug candidate, lorcaserin, is being investigated in a Phase 3 clinical trial program for weight management. Arena has a broad pipeline of novel compounds targeting G protein-coupled receptors, an important class of validated drug targets, which includes compounds being evaluated independently and with partners, including Merck & Co., Inc., and Ortho-McNeil-Janssen Pharmaceuticals, Inc.
Arena Pharmaceuticals® and Arena® are registered service marks of the company. "APD" is an abbreviation for Arena Pharmaceuticals Development.
Antwort auf Beitrag Nr.: 38.006.107 von Magnetfeldfredy am 18.09.09 06:50:25wo findest du so schnell die Nachrichten?
DAnke
DAnke
So Ihr Spezialisten, ist das jetzt gut oder schlecht?
Hallo,
bin mal dabei zu 2,91€. Kann nach vorn oder nach hinten losgehen,
reine Interpretationsfrage
.... meinem Bauchgefühl nach.
Hatte gerade Zeit und Lust und Kohle, mal sehen was daraus wird.
Allen Investierten wünsche ich viel Glück, den shorties einen heissen Hintern!!!
Im Vergleich zur Konkurrenz sind die Ergebnisse auf den ersten Blick etwas schwach, aaaaaaaaaber man muss auch die Randbedingungen beachten!!! Wie siehts mit der Verträglichkeit aus....
Wie gesagt mal sehen, werde nicht lang bleiben, brauche das Geld bald wieder!
Stichwort brauche Geld, schöne Grüße an Brauchgeld!
Grüße!
bin mal dabei zu 2,91€. Kann nach vorn oder nach hinten losgehen,
reine Interpretationsfrage
.... meinem Bauchgefühl nach. Hatte gerade Zeit und Lust und Kohle, mal sehen was daraus wird.
Allen Investierten wünsche ich viel Glück, den shorties einen heissen Hintern!!!
Im Vergleich zur Konkurrenz sind die Ergebnisse auf den ersten Blick etwas schwach, aaaaaaaaaber man muss auch die Randbedingungen beachten!!! Wie siehts mit der Verträglichkeit aus....
Wie gesagt mal sehen, werde nicht lang bleiben, brauche das Geld bald wieder!
Stichwort brauche Geld, schöne Grüße an Brauchgeld!
Grüße!
Für den Anfang ganz okay, schonmal gut im plus.
Mal sehen, wie sie sich die nächste Woche halten.
Die Umsätze gestern waren der Wahnsinn. 127Mio Stücke bei einer MK von 480Mio.
Grüße!
Arena Pharmaceutical rallies after CEO, Piper defend weight loss drug
Shares of Arena Pharmaceutical (ARNA) jumped after Piper issued a somewhat optimistic note about the company's anti-obesity drug lorcaserin, and the company’s CEO told CNBC that Arena’s prospective corporate partners were "very excited" about the results of a lorcaserin trial... Piper believes that lorcaserin is still approvable. The firm also noted that patients taking lorcaserin lost approximately double the amount of weight as th ose taking placebo, which is the criteria required by the FDA for approval of weight loss drugs. Piper, which maintained an Overweight rating on the stock, still expects Arena to enter into a major partnership deal for lorcaserin next year. Arena CEO Jack Lief was very upbeat about lorcaserin’s chances, saying that the company believes the drug will be "successful in the marketplace." The side effects of patients taking lorcaserin were not meaningfully different than those taking a placebo, Lief pointed out. "We believe this combination of efficacy, safety and tolerability is what doctors and patients want, and it’s something that's lacking [in the market] now," the CEO added.
Mal sehen, wie sie sich die nächste Woche halten.
Die Umsätze gestern waren der Wahnsinn. 127Mio Stücke bei einer MK von 480Mio.
Grüße!
Arena Pharmaceutical rallies after CEO, Piper defend weight loss drug
Shares of Arena Pharmaceutical (ARNA) jumped after Piper issued a somewhat optimistic note about the company's anti-obesity drug lorcaserin, and the company’s CEO told CNBC that Arena’s prospective corporate partners were "very excited" about the results of a lorcaserin trial... Piper believes that lorcaserin is still approvable. The firm also noted that patients taking lorcaserin lost approximately double the amount of weight as th ose taking placebo, which is the criteria required by the FDA for approval of weight loss drugs. Piper, which maintained an Overweight rating on the stock, still expects Arena to enter into a major partnership deal for lorcaserin next year. Arena CEO Jack Lief was very upbeat about lorcaserin’s chances, saying that the company believes the drug will be "successful in the marketplace." The side effects of patients taking lorcaserin were not meaningfully different than those taking a placebo, Lief pointed out. "We believe this combination of efficacy, safety and tolerability is what doctors and patients want, and it’s something that's lacking [in the market] now," the CEO added.
wie sind die Ergebnisse im Vergleich zu Vivus zu sehen?
Merck To Discontinue Development Of MK-1903
Published: 24-Dec-2009
Company to terminate collaboration With Arena
Merck & Co has decided to discontinue development of MK-1903, an investigational niacin receptor agonist to treat atherosclerosis, being developed under its research collaboration with Arena Pharmaceuticals (Arena). Merck also informed Arena that the company will not continue with the collaboration.
Reportedly, the decision to discontinue development of MK-1903 was made following evaluation of the results of a recently completed phase 2a clinical trial. The randomised, double-blind, placebo-controlled trial evaluated the safety, tolerability and potential efficacy in patients with dyslipidemia.
According to Merck, elevation of HDL cholesterol relative to placebo did not meet the trial's pre-specified primary objective for efficacy; no safety signals were implicated as drivers of the decision to discontinue development.
Jack Lief, president and CEO of Arena, said: "We are disappointed that the trial results did not lead to further development of this program, but it has been a pleasure to work with Merck and we welcome the opportunity to collaborate again. We continue to focus on our other internal and partnered programs and the FDA approval of our lead drug candidate, lorcaserin for weight management."
Published: 24-Dec-2009
Company to terminate collaboration With Arena
Merck & Co has decided to discontinue development of MK-1903, an investigational niacin receptor agonist to treat atherosclerosis, being developed under its research collaboration with Arena Pharmaceuticals (Arena). Merck also informed Arena that the company will not continue with the collaboration.
Reportedly, the decision to discontinue development of MK-1903 was made following evaluation of the results of a recently completed phase 2a clinical trial. The randomised, double-blind, placebo-controlled trial evaluated the safety, tolerability and potential efficacy in patients with dyslipidemia.
According to Merck, elevation of HDL cholesterol relative to placebo did not meet the trial's pre-specified primary objective for efficacy; no safety signals were implicated as drivers of the decision to discontinue development.
Jack Lief, president and CEO of Arena, said: "We are disappointed that the trial results did not lead to further development of this program, but it has been a pleasure to work with Merck and we welcome the opportunity to collaborate again. We continue to focus on our other internal and partnered programs and the FDA approval of our lead drug candidate, lorcaserin for weight management."
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