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Orexigen Resubmits Contrave New Drug Application
Date:12/11/2013

most frequent adverse events in patients on Contrave were nausea, constipation, headache, vomiting, dizziness, insomnia, dry mouth, and diarrhea. These were mostly mild to moderate in severity.

Orexigen has licensed North American Contrave 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. In October 2013, Orexigen submitted a Marketing Authorization Application (MAA) for Contrave to the European Medicines Agency (EMA).

About Orexigen TherapeuticsOrexigen Therapeutics, Inc. is a biopharmaceutical company focused on the treatment of obesity. The Company's lead product candidate is Contrave, which the Company is evaluating in the Light Study, a cardiovascular outcomes trial being conducted under a Special Protocol Assessment (SPA) with the FDA. Based on successful results of the Light Study, the Company resubmitted the Contrave NDA to the FDA. The Company's other product candidate, Empatic, has completed Phase 2 clinical trials. Further information about the Company can be found at www.orexigen.com.

Forward‐Looking Statements
Orexigen cautions you that statements included in this press release that are not a description of historical facts are forward‐looking statements. Words such as "believes," "anticipates," "plans," "expects," "indicates," "will," "should," "intends," "potential," "suggests," "assuming," "designed" and similar expressions are intended to identify forward‐looking statements. These statements are based on the Company's current beliefs and expectations. These forward‐looking statements include statements regarding: the timing of potential approval of the NDA for Contrave in the U.S. and the MAA for Contrave by the European Medicines Agency (EMA); the benefit
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SOURCE Orexigen Therapeutics, Inc.
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