Orexigen Therapeutics, Inc. Announces Executive Changes
Mar 30 15
Orexigen Therapeutics, Inc. announced that Tom Cannell has joined as Chief Commercial Officer. As the company prepares for global commercialization of Contrave /Mysimba (naltrexone HCl /bupropion HCl extended release), Cannell will lead all aspects of Orexigen's global commercial strategy, assuming responsibilities previously held by Mark Booth. After successfully leading Orexigen's commercial effort through the U.S. launch of Contrave, Booth plans to leave Orexigen later this year to pursue opportunities closer to his home in Chicago. Cannell joins Orexigen after 27 years at Merck where he held a variety of senior leadership roles. He brings strong experience in global commercialization, consumer marketing, and sales operations and management. Recent assignments have included President of Merck Canada and Head of Marketing and Strategy for MSD Japan. Earlier he served in general manager roles for a U.S. sales division and as leader of a Merck business unit, managing a multi-billion dollar product portfolio and thousands of employees. He has strong consumer experience, having served as General Manager, New Commercial Model, U.S., where he designed and successfully piloted an innovative customer centric commercial model for Merck's U.S. business.
European Commission Grants Marketing Authorization for Orexigen Therapeutics's Mysimba™
Mar 26 15
Orexigen Therapeutics, Inc. announced that the European Commission has granted marketing authorization for Mysimba™ (naltrexone HCl /bupropion HCl prolonged release) as an adjunct to a reduced-calorie diet and increased physical activity, for the management of weight in adult patients (=18 years) with an initial Body Mass Index (BMI) of = 30 kg/m2 (obese), or = 27 kg/m2 to < 30 kg/m2 (overweight) in the presence of one or more weight-related co-morbidities (e.g., type 2 diabetes, dyslipidaemia, or controlled hypertension). This authorization applies to all 28 European Union (EU) member states.
Robbins Geller Rudman & Dowd LLP Files Class Action Suit Against Orexigen Therapeutics, Inc
Mar 11 15
Robbins Geller Rudman & DowdLLP announced that a class action has been commenced in the United States District Court for the Southern District of California on behalf of purchasers of Orexigen Therapeutics, Inc. common stock during the period between March 3, 2015 and March 5, 2015, inclusive (the Class Period). The complaint charges Orexigen and certain of its officers and directors with violations of the Securities Exchange Act of 1934. The complaint alleged that as part of the FDA post-marketing approval process for Contrave, Orexigen was required to conduct 'a new randomized, double-blind, placebo-controlled study to evaluate the effects of long-term treatment with Contrave on the incidence of [major adverse cardiac events, or ‘MACE’] in overweight and obese subjects with [cardiovascular] disease or multiple [cardiovascular] risk factors,' referred to as the 'LIGHT study'. On March 3, 2015, in connection with reporting to investors the status of certain patent applications the Company had sought for Contrave, Orexigen disclosed detailed interim results of its ongoing LIGHT study, despite, the complaint alleges, having been previously admonished by the FDA for inappropriately releasing interim study data in the past. As a result of the Company’s March 3, 2015 disclosure of the interim study results, the complaint alleges that the price of Orexigen common stock significantly increased in intraday trading on March 3, 2015, on highly unusual trading volume. Then, after the close of trading on March 5, 2015, Forbes published a report entitled 'Top FDA Official Says Orexigen Study Result ‘Unreliable,’ ‘Misleading.’ The complaint alleged that this report contained commentary from an FDA official charged with overseeing the Contrave post-marketing clinical trial program who stated in pertinent part that the interim data from the study was probably 'unreliable,' 'misleading,’ and 'likely false,’ with the Forbes report warning that 'f Orexigen cannot find a way to set things right, it could face fines, civil penalties, or even the withdrawal of Contrave from the market.' On this news, the complaint alleged that the price of Orexigen stock fell substantially when trading resumed on March 6, 2015. Plaintiff seeks to recover damages on behalf of all purchasers of Orexigen common stock during the Class Period.