ARNA - Arena Pharmaceuticals
Also ich habe ja in den letzten Wochen viel zu den drei Firmen gelesen und halte much für gut informiert. Warum ein Analyst jetzt das Kursziel ohne jegliche Bebründung auf 1 $ setzt ist mir schleierhaft - Tatsache ist aber, dass Arena eine gute Chance auf Zulassung hat, eine deutlich bessere als Vivus mittlerweile.
Zudem sollten wir nicht vergssen, dass Arena schon einen Vermarktungspartner hat und dafür schon 50 Mio $ Upfront bekommen hat, Vivus hattte das nicht..meines Erachtens war die Chance auf ein positives Votum für V ivus nicht 80:20 sondern 50:50 und viele Profis ahnten es.
Ich bleibe erst mal hier dabei, behalte mir aber offen vor der Entscheidung im September wieder auszusteigen...mal schauen wie die Stimmung ist.
Ich weiss leider nicht, ob die Zusammensetzung des Advisory Panels für Arena im september sich wieder ändert - ich könnte mir aber vorstellen, dass es die gleichen Mediziner sind, die auch bei Vivus vor Ort waren.
Heute geht es wieder 15 % für Arena nach oben...nicht schlecht.
Nach allem was ich gelese habe, ist das Arena Medikament ausreichend effizient und das beste Nebenwirkungsprofil.
Bei Vivus und solchen Dietpillen kommt wohl zum Tragen, dass das Advisory Board nur dann solche Nebenwirkungen toleriert, wenn es
sich um lebensbedrohliche Krankheiten handelt, z.B. Krebs. Übergewicht ist natürlich nicht lebensbedrohlich und wenn Millionenen Übergewichtige anfangen Pillen zu schlucken muss das Medikament sicher sein. Porbleme bei Herzerkrankungen und Schwangeren kann da niemand brauchen.
Ein andere Grund warum ich Vivus bie 9 Euro verkauft habe war auch der der Marktkapitalisierung:
Damals kostete Vivus ca. 12 $ / Aktie und hatte eine Marktkapitalisierung von mehr als 1 Millirade $; heute steht Vivus immer noch bei 340 Mill Euro, nicht schlecht, dafür das der Mega-Blockbuster gerdae ein Problem bekommen hat.
Umgekehrt war Arena vollkommen unterbewertet mit ca. 280 Millionen Euro und heuet stehen sie bei 400 Mio Euro...sind also weit weg von der Vivus Bewertungs vor 2 Wochen vor der Entscheidung. Wir jetzt Arena ähmlich positiv gesehen wie Vivus vor 2 Wocvhen, dann kann sich der Kurs locker noch mal verdoppeln. Und jetzt wird der potentielle Marktanteil von Arena sogar noch größer ohne Vivus als Konkurrent.
Wie sagte mal ein Analyst: Der Dietpillenmakrt ist so riesig, dann können auch alle drei Firmen (Vivus, Arena und Orexigen Therapeutics) gut von leben - tschia und jetzt hat eine scon deutlich geringere Zulassungschancen.
Das Adipositas Volk Nr.1 wird nicht alle Antifettpillen floppen lassen.
Das Board sieht halt in erster Linie die Risiken,und weniger den Nutzen,jener Nutzen,
der dem US Gesundheitssystem in Zukunft etliche Milliarden ersparen würde.
Daher würde ich auch Qunexa/Vivus noch nicht entgültig abschreiben.Die FDA war schon
für so einige Überraschungen gut.Ich werde jedenfalls den Kurs beobachten und im
Oktober,kurz vor FDA Termin mal einen Zocktausender riskieren.
Gruß und nochmals danke für Deine prompte Antwort.Wilbär.
Optionen
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und wir sind ja noch ein paar Wochen weit weg von der Begutahctung des Arena Produkts....ich frage mich ja wo die in einem Monat stehen...trotzdem sollten alle hoffentlich aus dem Vivus Dilemma lernen und Stopp-loss setzen oder vorher wieder die Hälft verkaufen.
die Obesity drugs sind schon der Renner in diesem Jahr...mal gespannt wo Arena am 14.September steht...Viel Glück allen und nicht den SL vergessen
zum Boardentscheid am 16.Sept. fortsetzt.
Was meinst Du Leo,wann kommt der kurzfristige Rücksetzer,wg.Gewinnmitnahmen?
Dein Hinweis auf SL ist sicher richtig,bis kurz vor dem Boardentscheid.
Dann macht ein SL keinen Sinn mehr,denn bei neg.Boardentscheid fällt sie wie ein Stein,
siehe Vivus,und der SL greift erst am Boden,wo die Aktie ev.schon zum Return ansetzt.
Habe da leider schon mehrere neg.Erfahrungen.Gruß und schönes WE,Wilbär.
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naja hier eine gute Strategie zu fahren ist nicht leicht...man hat tatsächlich das Gefühl, dass alle Arena links liegengelassen haben und nur auf Vivus geschaut haben...jetzt nachdem Vivus ein Problem sehen viele Investierte Arena sehr positiv.
Ich habe Arena bei 2,65 gekauft, allerdings nur mit 500 Stück. Biotechs dieser Form sind halt Hochrisikoanlagen, alles oder nichts, und häufig ist es dann nichts..ich glaube auch nicht, dass der Anstieg so weitergeht, allerdings ist Arena noch immer nicht so hoch bewertet wie Vivus vor der Sitzung am 15. Juli.
3 Möglicheiten gibt:
50 % verkaufen und die Rest mit SL stehen lassen und Daumen drücken
Alles vorher verkaufen und den sicheren Gewinn erst mal mitnehmen
oder alles behalten mit SL; nachdem aber auch bei Vivus die Entscheidung nicht zu den Börsenzeiten stattfand, nützt hier der SL einfach gar nichts, denn am nächsten Tag steh der Kurs 70 % niedrigrer.
Variante 1 + 2 erscheint mir am sinnvollsten; bei Vivus wa das auch so; alle waren sehr positiv, die Panelentscheidung ist aber auch bei Arena noch nicht so ganz 100 % klar.
Wie sehen denn die Zahlen aus:
Arean hat jetet eine Marktkapitalisierung von knapp 700 Mio Euro, Vivus steht jetzt bei einer Marktkapitalisisrung von 350 Mio Euro und stand schon ba etas mehr als 1 Mrd Euro. Arena liegt also nocht im Soll, aber es ist auch klar, wenn die noh mal 50 % setigen sollten,ist das Erwartungspotential erst mal ausgeschöpft...dann würde ich eher verkaufen, denn Gewinn nehmen und abwarten auf die Panelentscheidung.
Wenn die positiv ist, würde ich noch mal einsteigen, denn ich gehe nicht davon aus, das die Panelentscheidung den Kurs noch mal verdoppeln würde, dafür wäre er dann schon zu hoch...
selbst heute nach +20 % gibt Arena nichts ab - ich kann mir einen Kursrückgang nur vorstellen, wenn es noch mal negative Meinungen zu Arenas Pordukt gibt oder eventuell Vivus von den Halbtotel aufersteht.
Auf amerikanischen Finanzforen wird Arena sehr positiv gesehen, aber es hatte sich dort auch angekündigt bei Vicus vorsichtig zu sein. Ich behalte die Position mal im Auge und bin gespannt wie weit es noch nach oben geht mit den Vorschußlorbeeren.
But trading a bull move is often more stressful and less profitable than just buying and holding for the big payoff.
so what is you guess, how much will Arena go up up from now on until September 13th? The eraly movers will be already 100 % in plus now...
here is a nice report about Arena's http://seekingalpha.com/article/...-the-new-miracle-drug?source=yahoo
drug on Seeking Alpha with the title "Is Lorcaserin the New Miracle Drug?". It seems like many people are quite positive about Arena. I will follow the commenets form the US pages because there are many more people that write theier comments, doubts or positive ideas about a companies prospective.
In any case I think september be really interesting. What last year was Dendreon and Human Genome Sciences can be this year Arena Pharmaceuticals.
March 30, 2009
Arena Pharmaceuticals Announces Positive Lorcaserin Pivotal Phase 3 Obesity Trial Results: Meets All Primary Efficacy and Safety Endpoints
-- -- Lorcaserin Very Well Tolerated Throughout Two-Year Study -- Conference Call Scheduled for Today at 8:30 a.m. EDT
SAN DIEGO, March 30, 2009 /PRNewswire-FirstCall via COMTEX News Network/ -- Arena Pharmaceuticals, Inc. (Nasdaq: ARNA) announced today 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).
"The BLOOM results, demonstrating lorcaserin's medically important weight loss coupled with the tolerability and safety profile displayed in this trial, differentiate lorcaserin from approved drugs or other agents in clinical trials," commented Steven R. Smith, M.D., Co-Principal Investigator and Professor and Assistant Director for Clinical Research at the Pennington Biomedical Research Center. "Obesity is a widespread disease; having a well tolerated and effective therapy that can be used by the majority of patients who need weight reduction could also have beneficial effects on co-morbid conditions, such as diabetes, lipid disorders, and cardiovascular disease."
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.
"The BLOOM trial, having met all of its primary endpoints and the FDA categorical efficacy benchmark as stated in their guidance, suggests lorcaserin has the potential to become the first in a new class of effective and very well tolerated weight management therapeutics that selectively target the serotonin 2C receptor," said William R. Shanahan, M.D., Arena's Vice President and Chief Medical Officer. "We look forward to building on these positive top-line data with the BLOSSOM study results expected around the end of September leading to an NDA submission by the end of this year. We also look forward to working with the FDA during the approval process to bring this treatment to patients in need of new options."
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 Arena 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.
"The echocardiographic safety data is very reassuring," commented Neil J. Weissman, M.D., Co-Principal Investigator, Director, Cardiac Ultrasound and Ultrasound Core Labs, President, MedStar Research Institute, and Professor of Medicine, Georgetown University. "In this double-blind, prospective study, there was no evidence of a difference in the development of valve disease in the large number of patients on lorcaserin versus control for up to two years of continuous use. No prospective valvulopathy trial has ever studied this many patients for this period of time, particularly under such well-controlled circumstances."
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.
"The positive outcome of the BLOOM trial serves as a very significant milestone for Arena, demonstrating lorcaserin's potential to provide a new treatment option for patients who need to lose weight and keep it off," stated Jack Lief, Arena's President and Chief Executive Officer. "Given lorcaserin's status as the only novel, single agent weight loss therapeutic in Phase 3 development, as well as data that continues to support our expectation for a well-tolerated and efficacious drug, I expect to have a range of commercialization options to consider."
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. Arena is 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.
Conference Call & Webcast
Arena will host a conference call and webcast to discuss the results today, Monday, March 30, 2009 at 8:30 a.m. Eastern Time (5:30 a.m. Pacific Time). 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.
The conference call may be accessed by dialing 877.874.1565 for domestic callers and 719.325.4758 for international callers. Please specify to the operator that you would like to join the "Lorcaserin BLOOM Trial Results" conference call. The conference call 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.
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 located in areas of the brain involved in the control of appetite and metabolism, such as the hypothalamus. Stimulation of this receptor is strongly associated with feeding behavior and satiety. Lorcaserin is currently being evaluated in a Phase 3 program expected to enroll approximately 7,800 patients and potentially represents a targeted treatment option for the millions of patients who need to better manage their weight. 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 Obesity
A 2007 report by the US Department of Health and Human Services states that approximately one-third of US adults are obese and two-thirds have been told by a health care provider that they are overweight. Medical and related costs of obesity are $123 billion per year according to a 2005 report by the International Diabetes Federation. 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. Diet and exercise should form the basis of healthy weight loss, but pharmaceutical treatment options for obesity are currently limited for the many patients that require additional help in achieving and maintaining medically important weight loss.
About the FDA Draft Guidance
The FDA draft guidance document for 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 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's broad pipeline of novel compounds target G protein-coupled receptors, an important class of validated drug targets, and 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.
Forward-Looking Statements
Certain statements in this press release are forward-looking statements that involve a number of risks and uncertainties. Such forward-looking statements include statements about the development, therapeutic indication, tolerability, safety, selectivity, efficacy and potential of lorcaserin; the significance of the review of echocardiographic data and lorcaserin's effect on the development of FDA-defined valvulopathy; the protocol, design, scope, enrollment and other aspects of the lorcaserin trials; the continued advancement of the related program; the significance of the BLOOM results; the impact of weight loss on health, including improving cardiovascular risk factors and reducing type 2 diabetes; future activities, results and announcements relating to lorcaserin, including the BLOSSOM results, the submission of an NDA for lorcaserin and the submission of the BLOOM-DM results as a supplement to the NDA; the potential of lorcaserin to meet the FDA's requirements for approval and the approval of lorcaserin for marketing; commercialization options and the coverage of lorcaserin patents; and about Arena's strategy, internal and partnered programs, and ability to develop compounds and commercialize drugs. For such statements, Arena claims the protection of the Private Securities Litigation Reform Act of 1995. Actual events or results may differ materially from Arena's expectations. Factors that could cause actual results to differ materially from the forward-looking statements include, but are not limited to, Arena's ability to obtain additional funds, the timing, success and cost of Arena's lorcaserin program and other of its research and development programs, the results of clinical trials or preclinical studies may not be predictive of future results, clinical trials and studies may not proceed at the time or in the manner Arena expects or at all, Arena's ability to partner lorcaserin or other of its compounds or programs, the timing and ability of Arena to receive regulatory approval for its drug candidates, Arena's ability to obtain and defend its patents, and the timing and receipt of payments and fees, if any, from Arena's collaborators. Additional factors that could cause actual results to differ materially from those stated or implied by Arena's forward-looking statements are disclosed in Arena's filings with the Securities and Exchange Commission. These forward-looking statements represent Arena's judgment as of the time of this release. Arena disclaims any intent or obligation to update these forward-looking statements, other than as may be required under applicable law.
Contacts: Jack Lief Julie Normart
President and CEO WeissComm Partners
Media Relations
415.946.1087
David Walsey
Senior Director,
Corporate Communications
Arena Pharmaceuticals, Inc.
858.453.7200, ext. 1682
SOURCE Arena Pharmaceuticals, Inc.
http://www.arenapharm.com
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Qnexa Panel Bodes Well for Arena's Obesity Drug
This post is a long one but I promise it’s worthwhile for the Arena (ARNA) crowd. In order to more accurately determine the potential outcome of the Lorqess advisory committee meeting on September 16, I wanted to review the comments to go along with the votes for the Qnexa panel.
The transcript in its entirety can be found here (pdf).
First, some background on each panel. The panel for Qnexa consisted of both the Endocrinologic and Metabolic Drugs Advisory Committee (EMDAC) and the Drug Safety and Risk Management Advisory Committee ((DSRMAC)). The Lorqess panel, so far, is listed as only the EMDAC. Each panel also has voting members in the temporary Center for Drug Evaluation and Research (CDER) category. The CDER temporary members appear to be members of other panels that are called in for the current panel.
The members that are most likely to be present in the Lorqess panel are the core EMDAC members. The other panel positions could be completely up in the air. However, the FDA may try to keep the panel similar to the Qnexa panel as both a fairness issue and since the Qnexa panelists would already be exposed to many of the same issues that will be presented for Lorqess. Regardless if that is true or not, examining the issues the previous panel had should give us insight into how a future panel will vote.
I will provide a more in depth preview of Lorqess’ potential issues in the future, but at the moment I am operating under the assumption that side effects are generally separate from the potential valvulopathy issue. The valvulopathy data, however, appears to be sufficiently powered to rule out an increase in valvulopathy as requested by the FDA. Efficacy surpasses the FDA guidelines for weight loss for Lorqess as well.
And with that, the voting members of the Qnexa panel, selected commentary, and my estimation of a future Lorqess vote:
Dr. Rogawski (temporary member, CDER): YES
Well, clearly we need more information about this medication. But I think that the type of medication we need, particularly with respect to teratogenicity, can’t be gained in a clinical trial setting. It can only be gained once the drug is on the market and large numbers of individuals are exposed to it.
So I think, overall, there’s a greater concern with respect to public safety if we have non-approval because that means that we don’t have the benefit of the additional information and education, risk mitigation strategies, and so forth, being presented to the public. So that’s the reason why I voted in favor of approval.
So I definitely agree that there’s a significant obesity epidemic in the United States, and therefore the public health and medical need is great for effective and safe pharmacotherapy options to be approved. I also agree that the Qnexa was shown to be quite effective, and that the FDA’s guidelines for weight loss, it needs to be remembered, was in the context of a very proactive lifestyle modification and diet.
But my concerns were the public health consequences, given the long list of safety risks that were listed for the drug, and the strong pent-up market demand for effective weight loss pharmacotherapy. That is, the drug will be used by millions of patients over long periods of time, far exceeding the label indications for use and duration of clinical experience that we have.
Dr. Morrato also seems very supportive of obesity treatments but is concerned with the side effects of the phentermine/topiramate combination (suicidality, teratogenicity, cardiovascular events, etc.). She also makes reference to the FDA guidelines for efficacy. As Lorqess’ side effect profile is much more acceptable and exceeds FDA guidelines for efficacy, this too, should become a yes.
Dr. Henderson (temporary member, CDER): YES
I did vacillate between yes and no because of the lack of long-term safety data and also the real world applications that we all discuss we’re worried about.
But I voted yes because, number one, the sponsor did satisfy the criteria for the weight loss benchmarks. But mostly what made me vote yes is the quality of life survey data. Five out of the eight quality of life measurements were statistically significant in improvement.
A borderline yes. Again, side effect profile of Lorqess appears more acceptable and FDA guidelines for weight loss are met. Should stay a yes for Lorqess.
Dr. Goldfine (core member, EMDAC): YES
I would like to see the review of the two-year data before the approval of the drug.
Of all the things that concerned me most was the pregnancy issue, and that to me was veryproblematic because I don’t want a real world trial where the vulnerable are not the ones who agreed to the risk exposure that was enforced upon them. And yet I also clearly agreed that you would not be able to get this data from a clinical trial design, and I think that’s what finally swayed me.
Lorqess has two-year data and does not have teratogenicity issues. Should stay a yes.
Dr. Proschan (temporary member, CDER): NO
I think if we had had longer follow-up, I probably would have voted the other way. But I just don’t feel comfortable with one year follow-up.
Two-year follow up for Lorqess. Yes.
Dr. Burman (temporary member, CDER): NO
…I wouldn’t be upset if it were approved with a lot of explanation, as we mentioned.
As we know, obesity is a major health problem, and all efforts to address this issue should be lauded. Qnexa does meet or exceed the agency’s requirement for efficacy; I don’t think there’s any issue there. The related topic, though, of course, is that the patients will lose a percentage of weight, 6 to 10 percent, perhaps, and still may not reach their goal weight, but this will be helpful, especially in a longer term program.Disclosure: Long ARNA
On the other hand, the medication has serious potential adverse effects, including potential teratogenicity, increased suicidal ideation, cognitive issues, decreased bicarb, tachycardia, and possible renal stones. Some of these side effects are serious and could be life-threatening, and they have to be weighed against the potential of a relatively modest weight loss and its long-term health benefits.
Another pro-treatment response. Another allusion to the FDA guidelines for efficacy. Lorqess does not have the serious side effects of Qnexa. Should also become a yes. I have heard, however, that Dr. Burman is no longer with the committee and therefore will not be at the Lorqess panel.
Dr. Flegal (temporary member, CDER): NO
I think my views — I think it was both colored, maybe, by our experience with Avandia and the safety concerns that we should deal with them before rather than afterwards.
As Lynn McAfee said, this is like a public health experiment, a large gamble. And I think widespread usage even in inappropriate populations is difficult to prevent. We have one-year information, but this drug will likely be used for a long time.
Dr. Flegal appears to be the most conservative on the board. I’m going to go ahead and assume she would continue to vote no for Lorqess, especially if the valvulopathy data isn’t a slam dunk.
Dr. Thomas (core member, EMDAC): NO
So there’s a few things that I think have to be addressed, and I think it’s best that these are addressed before approval, or at least started before approval so that they can be finished soon after the medication is released.
The first is cardiovascular disease.
The second thing is I’m very concerned about bone health.
The third thing is the sponsor used a restricted fat diet, not a low carbohydrate diet. Most patients, when they’re going to use this, will pick a diet of their own, in spite of what we tell them.
We do need more information about suicide risk.
Then finally, I think we have to get away from the concept of usage for a short term. Obesity is a chronic disease.
Dr. Thomas is also fairly conservative with respect to Qnexa and lists a ton of concerns. Again, Lorqess doesn’t share these concerns, but due to the nature of the response and the emphasis on chromic disease I would consider Dr. Thomas to be a no to borderline yes response.
Dr. Bersot (core member, EMDAC): NO
Pretty much what’s been said are the reasons why I voted no. I realize that without a registry, the issue with regard to pregnancy can’t be resolved.
We need more evidence in the high risk cardiovascular disease patient. And then there are two elephants in the room that no one has mentioned today, and those are lorcaserin and the other drug that’s on its way to this committee that have probably not as great efficacy in terms of weight loss, but may be better risk factor profiles. But we don’t know that, and I would like to know more about all of these three different compounds before making a decision about any particular one.
Sounds like Dr. Bersot is strongly in favor of better risk factor profiles, which Lorqess is the clear front-runner of the three treatments. I don’t know if he is actually suggesting evaluating all three before making any decisions, but I think having viewed Qnexa and Lorqess he’d be more comfortable voting yes. I’m going to guess this as a borderline yes for Lorqess.
Dr. Weide (core member, EMDAC): NO
I voted no, and really, I’m glad to see… that we’re starting to call it a chronic disease.
And I think we just need longer term data with the people who are really going to be using it out there rather than a select group of patients in fairly good health.
Dr. Weide wants longer term data. Lorqess provides. Even so, the ‘chronic disease’ proponents seem to be more conservative with approval. I think this changes to yes, but it’s not a strong yes in my book.
Dr. Capuzzi (core member, EMDAC): yes… er NO.
I voted yes, but I actually made a mistake. I have to be very frank. This is my third meeting, and as Dr. Burman was jotting everything down and all the various concerns, my yes was predicated on the fact that these would all be met first. But I made a mistake, so it’s really no at this point.
I’m guessing yes, but who knows? He didn’t give a whole lot of explanation, so I’ll give this a 50/50 chance of yes with a possibility of leaning more towards yes.
Dr. Kaul (temporary member, CDER): YES.
My yes vote comes with a lot of conditions. And I will not hold it against the sponsor if they interpret my yes vote as a no vote.
First of all, it should only be approved for low to medium dose, not for the high dose, because all the safety signals appear to cluster in the high dose.
There should be a clinical outcome study designed to rule out cardiovascular risk.
An extremely borderline yes for Qnexa. Dr. Kraul seems to have a lot of concerns and seems to be of a more conservative mindset, but because of the ‘yes’ vote I will assume Lorqess also get’s the yes vote.
Dr. Hendricks (temporary member, CDER): YES
I voted yes. I agree that the population at large needs to be protected from dangerous drugs; however, one-third of that population is already obese, and there’s a very large segment of the population who are headed that way.
I think that Qnexa does meet the FDA efficacy thresholds.
I think it does fill a gap in our treatment spectrum. I think if the drug is disapproved, we’re going to send a very board message to the obese and the overweight, and that that will further drive them away from medical solutions to this problem to all the various quackery things that are out there.
Solid yes for Qnexa. Mentions meeting the FDA efficacy guidelines. Solid yes for Lorqess.
Ms. Coffin (patient representative): YES
And I do believe that the side effects that were listed here were reasonable, with a doctor’s care.
The funny stuff that’s on the market that does not go through FDA, people are clamoring for it hand over fist. And so, again, I do feel like we’re letting perfect get in the way of possible. If there are 100 drugs out there for high blood pressure for doctors and patients to choose from, there should be more than half a dozen for obesity and overweight treatment.
If side effects for Qnexa were reasonable, Lorqess will be fine. Solid yes.
Dr. Cragan (temporary member, CDER): NO
I voted no, and I also found it a very difficult decision. This drug is clearly effective and has the potential to change many people’s lives. And I really hate to be on record voting against that.
But in the end, I couldn’t really justify widespread use with the reproductive outcomes concerns that we have.
Again, no reproductive issues in Lorqess. I think there is a strong possibility of yes for Dr. Cragan for Lorqess.
Dr. Heckbert (temporary member, CDER): NO
We’ve talked here about how these two medications interfere with a number of different biological pathways. And as such, it’s very highly effective; that was clearly demonstrated by the sponsor, highly effective in achieving weight loss. But at the same time, we have a number of signals of adverse effects that really can’t be ignored that need more exploration. And the ones I’m most concerned about are the suicidality risk, the potential for cardiovascular risk based on the mechanism of action of these drugs and the heart rate signal, and of course the teratogenicity.
Dr. Heckbert has big concerns with a number of issues for Qnexa. Again, Lorqess has none of the serious side effects mentioned and should be sufficiently powered to rule out valvulopathy. This should move to yes.
Summary
So given my review of the explanations, I’m going to say that the most likely voting outcome is 12 yes, 2 no (Flegal and Thomas), and 2 that would be a toss up (Burman and Capuzzi).
So again, the most likely range of votes are:
12-4 to 14-2 for approval.
That, in my own estimation, seems extremely optimistic, and yet, the data seems to support that conslusion. However, let’s assume the yes votes I called borderline shift to no; whether it be for efficacy (I think unlikely) or unresolved valvulopathy issues (again unlikely) or some issue I haven’t completely considered to this point (slightly more likely). That means a ‘bad’ outcome would mean Bersot, Heckbert, and Weide joining Flegal and Thomas as no votes. Moratto, Proschan, and Cragan seem closer to approval so they would go to yes. In that case:
9-7 to 11-5 for approval.
For non-approval, Lorqess would have to receive the Qnexa vote total or worse. I think this is unlikely as Lorqess meets FDA efficacy guidelines, has a much lower side effect profile, and is sufficiently powered to rule out valvulopathy when BLOOM and BLOSSOM trial data are pooled. The only thing that worries me at this point is a demand for Lorq-Phen data – which the FDA has advised against collecting. I’m calling this a high probability of approval by the panel come September 16.
Re: Piper Jaffray/ Now on Schwab (finally!)
Piper Jaffray Tells Clients to Buy Arena Pharmaceuticals (ARNA) Ahead of 9/16 FDA FDA Meeting
9:00 am ET 09/07/2010- StreetInsider
Shares of Arena Pharmaceuticals (Nasdaq: ARNA) are seeing pre-open action following positive comments from analysts a Piper Jaffray, which is telling clients to buy the stock ahead of the 9/16 FDA advisory panel meeting.
The firm said, "Based on our interpretation of FDA guidance criteria for weight management products, we anticipate a positive committee vote. We recommend investors buy ARNA shares ahead of the upcoming panel meeting and October 22nd PDUFA date."
The firm has an Overweight rating and $10 price target on ARNA.
Shares of ARNA are up 5 percent to $7.20 in pre-open trading today.
Ich fand gestern übrigens folgenden (skeptischen) Aufsatz interessant zu lesen:
http://seekingalpha.com/article/...n-by-qnexa-and-meridia?source=feed
Der Autor hat die Idee man könne sichs besser ausrechnen, wenn man schaut was in der Sitzung der FDA am Tag zuvor rauskommt:
"Investors should note the Metabolic Drugs Advisory Committee plans to review Abbott's (ABT) Meridia on September 15th, the day before the review for Lorcaserin. Meridia has been pulled from the market in Europe on concerns about cardiovascular side effects and the FDA is contemplating the same action in the US. This sets up a situation similar the Qnexa review, when the same panel held a two-day safety review of GlaxoSmithKline’s (GSK) diabetes drug Avandia before evaluating Qnexa."
...ich mach mir diese Meinung nicht zu eigen, aber fands trotzdem interessant...aber letztlich ists alles nichts anderes als die Idee, die Eingeweide und den Vogelflug zu befragen...
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Phase 3 Results: BLOOM
In BLOOM (Behavioral modification and Lorcaserin for Overweight and Obesity Management), lorcaserin patients achieved highly statistically significant categorical and absolute weight loss in Year 1, and over two-thirds of lorcaserin patients that achieved at least 5% weight loss in Year 1 and continued lorcaserin treatment in Year 2 maintained at least 5% weight loss. Treatment with lorcaserin also resulted in statistically significant improvements as compared to placebo in multiple secondary endpoints associated with cardiovascular risk. Lorcaserin was very well tolerated, did not result in increased risk of depression or suicidal ideation and was not associated with the development of cardiac valvular insufficiency.
Efficacy
Patients who completed the one-year trial according to the trial’s protocol demonstrated the benefits of long-term treatment with lorcaserin:
66.4% of lorcaserin patients lost at least 5% of their body weight, compared to 32.1% for placebo, and the average weight loss in this responder population was 26 pounds.
36.2% of lorcaserin patients lost at least 10% of their body weight, compared to 13.6% for placebo.
Lorcaserin patients achieved an average weight loss of 8.2% of their body weight, or 17.9 pounds, compared to 3.4%, or 7.3 pounds, for placebo.
Measurements of efficacy using an intent-to-treat last observation carried forward, or ITT-LOCF, analysis showed that lorcaserin met all primary endpoints. Lorcaserin patients achieved highly statistically significant categorical and average weight loss after one year:
47.5% of lorcaserin patients lost at least 5% of their body weight, compared to 20.3% for placebo. This result satisfies one of two alternate efficacy benchmarks in the most recent FDA draft guidance, which provides that a weight-management product can be considered effective if after one year of treatment 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.
22.6% of lorcaserin patients lost at least 10% of their body weight, compared to 7.7% for placebo.
Lorcaserin patients achieved an average weight loss of 5.8% of their body weight, or 12.7 pounds, compared to 2.2%, or 4.7 pounds, for placebo.
Safety and Tolerability Profile
Treatment with lorcaserin was very well tolerated, resulting in few adverse events with greater frequency than the placebo group. 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%). Adverse events of depression, anxiety and suicidal ideation were infrequent and were reported at a similar rate in each treatment group.
The assessment of echocardiograms indicated that lorcaserin was not associated with valvular insufficiency: during two years of use, rates of change in individual valvular regurgitation scores and the development of FDA-defined valvulopathy were similar between treatment groups. Rates of new FDA-defined valvulopathy in BLOOM were as follows: lorcaserin 10 mg twice daily (2.7%) and placebo (2.3%) at Week 52 and lorcaserin 10 mg twice daily (2.6%) and placebo (2.7%) at Week 104.
Secondary Endpoints
Treatment with lorcaserin over one year was associated with statistically significant improvements compared to placebo in multiple secondary endpoints, including:
Blood Pressure: systolic blood pressure, diastolic blood pressure and heart rate
Lipids: total cholesterol, LDL cholesterol and triglycerides
Glycemic Parameters: fasting glucose, fasting insulin and insulin resistance
Inflammatory Markers of Cardiovascular Risk: high-sensitivity CRP and fibrinogen
Patient Disposition
BLOOM evaluated 3,182 patients with an average Body Mass Index, or BMI, of 36.2 and baseline weight of 220 pounds. The Week 52 completion rate was higher for patients on lorcaserin (54.9%) compared to patients on placebo (45.1%). Discontinuation rates for adverse events were similar in the lorcaserin and placebo groups for Year 1 (7.1% vs. 6.7%) and were the same in Year 2 (3.0% vs. 3.0%).
BLOOM Trial Design
We initiated BLOOM in September 2006, and completed enrollment in February 2007 in about 100 centers in the United States. BLOOM was a randomized, double-blind and placebo-controlled trial evaluating 10 mg of lorcaserin dosed twice daily versus placebo over a two-year treatment period in obese patients (BMI of 30 to 45) with or without co-morbid conditions and overweight patients (BMI of 27 to less than 30) with at least one co-morbid condition. BLOOM did not include a 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. All patients received echocardiograms at baseline, Months 6, 12 and 18, and at the end of the trial to assess heart valve function and other parameters over time. Patients with FDA-defined valvulopathy were excluded from enrolling in the trial.
Our drug candidates have not been approved by the U.S. Food and Drug Administration or any international regulatory agency.
(Keine Angst, ich bin ok, nur mein Ariva-Depot hat sie noch)
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Irgendwas durchgesickert?
Denn das Board tagt doch angeblich erst am Donnerstag.
Rätsel und Gruß Wilbär.
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die nächsten tage werden heiß
http://www.thestreet.com/story/10857306/2/...ail-hedge-fund-poll.html
75% von 30 befragten der auf biotechnologie spezialisierten investoren sagten das es keine empfhehlung geben wird...
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