Die FDA hat noch nicht dagegen gestimmt, jedoch das Advisory Board, welches aus Medizinern unterschiedlicher Disziplinen besteht.
Die FDA stimmt erst im Oktober endgültig darüber ab und muss nicht nicht an das Votum von gestern halten - trotzdem ist die Zulassung weniger wahrscheinlich damit geworden.
Ich habe Vivus bei 9,00 Euro (+120 %) vor 2-3 Wochen verkauft, weil ich sowas schon erlebt habe und bin stattdessen bei Arena eingstiegen. Wer sich ein wenig mehr mit diesen Dietpillen befasst hatt in den vergangenen Wochen wusste, dass es knapp werdne würde, weil das Vivus Präparat zwar die höchste Effizienz auswies jedoch auch die meisten Nebenwirkungen.
Bei den beiden Konkurrenten sieht es dagegen besser aus, weniger effizient (aber ausreichend) dafür weniger Nebenwirkungen.
Ich empfehle allen Investierten sich mehr auf US-Internetseiten wie yahoo.finance oder Seeking Alpha zu informieren. Dort gibt es einfach wesentlich mehr Infos zu amerkanischen Firmen, Interviews und natürlich viele Meinungen. Viele haben bei Vivus gehofft, dass es klappt aber es gab dort auch genügend warnende Stimmen.
VIVUS Comments on FDA Advisory Committee Panel Meeting on QNEXA(R) (phentermine/topiramate) Controlled Release Capsules for the Treatment of Obesity MOUNTAIN VIEW, Calif., July 15, 2010 /PRNewswire via COMTEX/ -- VIVUS, Inc. /quotes/comstock/15*!vvus/quotes/nls/vvus (VVUS 12.11, 0.00, 0.00%) today announced that the Endocrinologic and Metabolic Drugs Advisory Committee of the U.S. Food and Drug Administration (FDA) voted against the following question: "Based on the current available data, do you believe the overall benefit-risk assessment of PHEN/TPM (QNEXA) is favorable to support its approval for the treatment of obesity in individuals with a BMI > 30 kg/m2 or > 27 kg/m2 with weight-related co-morbidities?" The three co-morbidities included hypertension, diabetes and dyslipidemia.
The vote from the Endocrinologic and Metabolic Drugs Advisory Committee is a recommendation. The FDA will take the Committee's recommendation into consideration during its review of the current application and will make a determination. The FDA may or may not follow the Committee's recommendation.
"We appreciate the Advisory Committee's recognition of obesity as a significant health crisis, and the challenges associated with the treatment of this disease," stated Leland Wilson, chief executive officer, VIVUS. "We are disappointed with the Advisory Committee's vote. While the final vote was close, and we are encouraged that the Committee recognized the efficacy demonstrated in the QNEXA clinical trials, we will work closely with the FDA leading up to our October 28, 2010 PDUFA date to address the labeling and safety questions raised during today's proceedings. We remain committed to patients living with obesity and weight-related disease."
Note to Investors
VIVUS will hold a conference call to discuss this update today, July 15, 2010, beginning at 6:00 p.m. Eastern Time. You can listen to this call by dialing toll free 877-359-2916 or 224-357-2386. A 30-day archive of the call can be accessed at http://ir.vivus.com/.
To access the webcast of this event, please visit: VIVUS' Investors site at http://ir.vivus.com/events.cfm. Replay will also be available on demand from the website at the conclusion of the program.
VIVUS is a biopharmaceutical company developing therapies to address obesity, sleep apnea, diabetes and male sexual health. The company's lead product in clinical development, QNEXA(R), has completed phase 3 clinical trials for the treatment of obesity and an NDA has been filed and accepted by the FDA, with an action date of October 28, 2010. QNEXA is also in phase 2 clinical development for the treatment of type 2 diabetes and obstructive sleep apnea. In the area of sexual health, VIVUS is in phase 3 development with avanafil, a PDE5 inhibitor being studied for the treatment of erectile dysfunction. MUSE(R) (alprostadil), a first generation therapy for the treatment of ED, is already on the market and generating revenue for VIVUS. For more information about the company, please visit www.vivus.com.
Certain statements in this press release are forward-looking within the meaning of the Private Securities Litigation Reform Act of 1995. These statements may be identified by the use of forward-looking words such as "anticipate," "believe," "forecast," "estimated" and "intend," among others. These forward-looking statements are based on VIVUS' current expectations and actual results could differ materially. There are a number of factors that could cause actual events to differ materially from those indicated by such forward-looking statements. These factors include, but are not limited to, substantial competition; uncertainties of patent protection and litigation; uncertainties of government or third party payer reimbursement; reliance on sole source suppliers; limited sales and marketing efforts and dependence upon third parties; risks related to the development of innovative products; and risks related to failure to obtain FDA clearances or approvals and noncompliance with FDA regulations. As with any pharmaceutical under development, there are significant risks in the development, regulatory approval and commercialization of new products. There are no guarantees that future clinical studies discussed in this press release will be completed or successful or that any product will receive regulatory approval for any indication or prove to be commercially successful. VIVUS does not undertake an obligation to update or revise any forward-looking statement. Investors should read the risk factors set forth in VIVUS' Form 10-K for the year ended December 31, 2009 and periodic reports filed with the Securities and Exchange Commission.
sehr gutes Posting,dem ich mich nur anschließen kann. Das Arena gleich in Sippenhaft genommen wird,hätte ich so eigentlich nicht erwartet. Schließlich verfügt Lorcaserin über ein anderes Wirkstoffspectrum,und hat zuletzt in Langzeitstudien keine Nebenwirkungen gezeigt.Im Gegensatz zu Qunexa. Am 16 Sept.sind wir schlauer,dann muß Arena/Lorcaserin vors Board. Weißt Du,ob das Board immer neu besetzt wird,oder entscheiden die gleichen Mitglieder wie bei Qunexa? Da das Board,wie von Dir beschrieben mehr die Nebenwirkungen als den Nutzen beurteilt,sehe ich für Arena bessere Chancen,außer es wird so ein Gleichheitskamm angelegt.Gruß Wilbär.
----------- Das Geld gleicht dem Seewasser,jemehr man davon trinkt,umso durstiger wird man.
1412108648a9a10a11a12p1p2p3pLONDON (MarketWatch) -- Shares of Vivus /quotes/comstock/15*!vvus/quotes/nls/vvus (VVUS 5.65, -6.46, -53.34%) lost more than half their value in premarket trade as a Food and Drug Administration advisory panel late Thursday recommended a rejection of weight-loss drug Qnexa by a 9-to-7 vote on worries of a lack of long-term safety data. Analysts at Brean Murray Carret cut their view to hold from buy, citing lowered revenue
Tja Chalif....Das ne gute Frage...Zumindestens hat gestern der Kurs von Arena auch mächtig gewackelt... Abwarten und beobachten...Diese PanelMeetings sind in letzter Zeit doch ganz schön unberechenbar geworden...
wieso sollte es den für diabetes zugelassen werden wenn anscheinend zuviel nebenwirkungen bestehen? selbst wenn man ne kosten/nutzenabwägung macht und diabetes schwerwiegender als adipostas einschätzt, ist es fraglich ob die fda es zulässt...
VIVUS had cash, cash equivalents and available-for-sale securities of $158.2 million at September 30, 2010, as compared to $206.8 million at December 31, 2009. The decrease in cash, cash equivalents and available-for-sale securities of $48.6 million is primarily due to cash used in operations and other net cash uses offset by proceeds of $2.4 million from the exercise of common stock options and ESPP purchases.
PRESS RELEASE Sept. 15, 2011, 6:45 a.m. EDT VIVUS Provides Regulatory Update on QNEXA Agreement Reached with FDA to Re-Submit QNEXA NDA Prior to Completion of FORTRESS
MOUNTAIN VIEW, Calif., Sept. 15, 2011 /PRNewswire via COMTEX/ -- VIVUS, Inc. VVUS +9.62% today announced that following a recent teleconference it has reached agreement with officials of the Endocrine and Metabolic Division of the Food and Drug Administration on a plan that allows for an early resubmission of the QNEXA New Drug Application for the treatment of obesity. The resubmission plan allows VIVUS to seek approval for an initial indication that includes obese men and women of non-child bearing potential. Based on this agreement, VIVUS intends to resubmit the QNEXA NDA by the end of October 2011, prior to completion of the FORTRESS study. Top-line results from FORTRESS are expected in December 2011, with validation of FORTRESS expected in the third quarter of 2012. The FDA also stated that an Advisory Committee meeting for QNEXA will be held in the first quarter of 2012.
"Recent epidemiology study results, which show that topiramate is not a major teratogen, were an important consideration in our plan to resubmit the QNEXA NDA ahead of the FORTRESS results. The planned October resubmission will also allow for an early 2012 Advisory Committee meeting and a second quarter 2012 PDUFA date," commented Peter Y. Tam, president of VIVUS. "In this initial indication, we plan to include a contraindication for women of childbearing potential. We believe this is a sound approach that, if approved, will potentially allow early commercialization in a higher-risk population with a significant unmet medical need. The FORTRESS study remains important in our plan to more precisely define the teratogenic potential of topiramate and may enable us to expand the indication to include obese women of child-bearing potential. If the FORTRESS results are favorable, we expect to file for the full indication in late 2012."
According to the CDC, over 108 million adult Americans are estimated to have a BMI >30 (obese) or BMI >27 (overweight) with at least one weight-related health risk, such as diabetes, hypertension or dyslipidemia. Of these, over three-quarters, or an estimated 80 million adults, are men and women of non-childbearing potential who are at an increased risk of developing obesity-related cardiovascular and metabolic diseases.
"Topiramate teratogencity data published and presented since our last meeting with the FDA in April 2011 includes two case-control studies utilizing the CDC's National Birth Defects Prevention Study and the Slone Epidemiology Birth Defect Study presented at the 27th International Conference on Pharmacoepidemiology and Therapeutic Risk Management in Chicago; and the Wolters Kluwer Study presented at International Epilepsy Congress in Rome. In addition, a birth defect study from Denmark on Newer Generation Antiepileptic Drugs including topiramate was published in JAMA. In all of these studies, the authors concluded that topiramate was not a major teratogen," commented Wesley Day, vice-president clinical development. "The conclusions reached in all of these studies were instrumental in the development of the QNEXA NDA resubmission plan."
FDA panel greenlights Vivus anti-obesity drug. Vivus (VVUS) shares are up 109% in premarket trading (as of 7:15 ET) after an FDA advisory panel voted 20-2 yesterday to recommend anti-obesity drug Qnexa. The news lifted shares of rivals with weight-loss drugs pending approval, including Arena Pharmaceuticals (ARNA) and Orexigen Therapeutics (OREX), +20.4% and +23% respectively premarket.