Editor’s Note: Related tickers: VIVUS, Inc. (NASDAQ:VVUS), Arena Pharmaceuticals, Inc. (NASDAQ:ARNA), ACADIA Pharmaceuticals Inc. (NASDAQ:ACAD), iShares NASDAQ Biotechnology Index (ETF) (NASDAQ:IBB), SPDR S&P Biotech (ETF) (NYSEARCA:XBI)
VIVUS Announces SPEDRA (avanafil) Approval in Europe (WSJ)
VIVUS, Inc. (NASDAQ:VVUS) (the “Company”) today announced that the European Commission (EC) has adopted the implementing decision granting marketing authorization for SPEDRA(TM) (avanafil) for the treatment of erectile dysfunction (ED) in the European Union (EU). The approval of the marketing authorization application (MAA) by the EC follows the positive recommendation by the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) in April 2013. SPEDRA, a PDE5 inhibitor, is the first new chemical entity (NCE) approved for ED in over a decade. The global market for ED therapies was approximately $5.5 billion in 2012.
Top shareholder in talks with candidates to replace Vivus CEO (Reuters)
First Manhattan Company (FMC) stepped up the pressure in its proxy fight with obesity drug maker VIVUS, Inc. (NASDAQ:VVUS), saying it was in advanced discussions with potential chief executive candidates to replace the current CEO should it prevail in gaining control of the VIVUS, Inc. (NASDAQ:VVUS) board. In a filing with U.S. securities regulators, FMC said it had gone as far as hiring executive recruiters with biopharma experience to identify top CEO candidates. “We are encouraged by the quality of those candidates and their level of interest,” First Manhattan, VIVUS, Inc. (NASDAQ:VVUS)’ largest shareholder with nearly 10 percent of outstanding shares, said on Tuesday in a news release and the filing.
VIVUS, Inc. : FMC = RISK: Vote the GOLD Proxy Card (4-Traders)
VIVUS, Inc. (NASDAQ:VVUS) (the “Company”) today mailed a letter to stockholders advising them to protect the value of their investment in VIVUS, Inc. (NASDAQ:VVUS) by voting the GOLD proxy card. The full text of the letter follows. …Sam Colin is a fund manager who has never run a pharmaceutical company (or ever worked in one) but believes he knows better than the experienced management team and Board of Directors of VIVUS, Inc. (NASDAQ:VVUS) who developed Qsymia, achieved its FDA approval, and are working tirelessly to launch into thousands of certified retail pharmacies and activate patients to seek medical treatment.
Arena Pharmaceuticals, Inc. (ARNA) Announces BELVIQ(TM) (lorcaserin HCl) New Drug Submission in Canada (LifeScience-Online)
Arena Pharmaceuticals, Inc. (NASDAQ:ARNA) announced today that Eisai Limited (based in Mississauga, Ontario), a subsidiary of Eisai Inc., has submitted a New Drug Submission (NDS) for BELVIQ (lorcaserin HCl) with Health Canada. BELVIQ is being evaluated in Canada as an adjunct to a reduced-calorie diet and increased physical activity for chronic weight management (including weight loss and weight maintenance) in adult obese patients (initial body mass index, or BMI, 30 kg/m2), or overweight patients (initial BMI 27 kg/m2) in the presence of at least one additional cardiovascular risk factor (e.g., hypertension, dyslipidemia, type 2 diabetes, or sleep apnea). In connection with the NDS, Arena Pharmaceuticals, Inc. (NASDAQ:ARNA) will receive a milestone payment of $500,000 from Eisai.