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Orexigen Therapeutics Reports Business and Financial Results for the Third Quarter Ended September 30, 2013
Date:11/12/2013

ber, enabling the potential resubmission of the Contrave New Drug Application to the FDA by year end. In October 2013, Orexigen submitted a Marketing Authorization Application for Contrave to the European Medicines Agency.

Orexigen has licensed North American Contrave commercial rights to Takeda Pharmaceuticals. Orexigen owns Contrave rights in Europe and throughout the rest of the world outside of North America and will seek a partner to commercialize Contrave in those territories.

Empatic™, a fixed dose combination of bupropion SR and zonisamide SR, for the treatment of obesity: In a series of discussions with the FDA on the continued development of Empatic, the FDA stated that Phase 3 data for Empatic may be sufficient to support submission of an NDA without data from a cardiovascular outcomes trial. The FDA indicated that as long as the placebo‐subtracted changes in body weight, blood pressure and heart rate for Empatic are similar to or more favorable than the placebo‐subtracted changes observed with Contrave, and there are no signals of cardiovascular concern in the Empatic development program, reassuring results of a cardiovascular outcomes trial with Contrave will be sufficient. In addition, while the FDA reiterated the belief that the teratogenicity potential for zonisamide is very concerning, the FDA will allow Phase 3 studies of Empatic to include women of childbearing potential who have a Body Mass Index that meets the FDA definition of overweight (>27kg/m2) in the presence of at least one weight‐related comorbidity.

Orexigen owns worldwide rights to Empatic. Prior to initiating Phase 3 studies of Empatic, the Company plans to seek a collaboration partner to help fund further clinical development and, if approved, commercialization.

Conference Call This Morning at 8:30 a.m. Eastern Time (5:30 a.m. Pacific Time) The Orexigen management team will host a teleconference and webcast t
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SOURCE Orexigen Therapeutics, Inc.
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