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Orexigen and FDA Identify a Clear and Feasible Path to Approval for Contrave®
Date:9/20/2011

erim and final analyses, respectively. Both FDA and Orexigen estimate that such a study would require approximately 87 total events by the interim analysis to enable resubmission of the NDA for approval.  Orexigen estimates that the entire study would require less than 10,000 patients and less than two years from study start to the interim analysis. The Company plans to meet with the review division to finalize a protocol with the objective of initiating the CVOT in the first half of 2012, with potential approval in 2014.

Based on this new feedback from FDA outlining a clear and feasible path forward for Contrave, the Company's three near-term priorities for the program are to: (1) finalize the trial protocol with FDA; (2) re-engage with parties that expressed interest in partnering the ex-North American markets for Contrave; and (3) implement the CVOT as soon as it is able.

"In my experience, Contrave demonstrated great potential for the treatment of obesity in a broad range of patients," said Ken Fujioka, MD, director of the Nutrition and Metabolic Research Center and The Center for Weight Management at the Scripps Clinic, and investigator for the Contrave Obesity Research Program.  "On behalf of those working hard to address this significant unmet need, I am pleased to see that a pragmatic approach to bringing this therapy to market appears to be taking shape."

Orexigen management will host a conference call and webcast to discuss this update today at 4:30 p.m. Eastern time.  The live call may be accessed by phone by calling (866) 730-5763 (domestic) or (857) 350-1587 (international), participant code 66064656.  The webcast can be accessed live on the investor relations section of the Orexigen web site at www.orexigen.com and will be archived for 14 days following the call.

About Contrave

Contrave, an investigational combination therapy of naltrexone HCl and bupro
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SOURCE Orexigen Therapeutics, Inc.
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