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

pion HCl, was studied for its ability to help people with obesity initiate and sustain weight loss of at least 5 percent of their starting body weight in one year. Contrave was submitted for U.S. regulatory approval in March 2010. The original submission was based on multiple clinical trials that evaluated Contrave in more than 4500 patients. Orexigen received a Complete Response letter from FDA on January 31, 2011.

About Orexigen Therapeutics

Orexigen Therapeutics, Inc. is a biopharmaceutical company focused on the treatment of obesity. Contrave has completed Phase 3 clinical trials, and the Company's other product candidate, Empatic™, has completed Phase 2 clinical trials. Each of the components of the Company's product candidates has already received regulatory approval and has been commercialized previously. Further information about the Company can be found at www.orexigen.com.

Forward-Looking Statements Related to Orexigen

Orexigen cautions you that statements included in this press release and the conference call are not a description of historical facts are forward-looking statements. Words such as "believes," "anticipates," "plans," "expects," "indicates," "will," "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 study design for, and the timing and feasibility of, the CVOT; the potential for resubmission and approval of an NDA based on interim results of the CVOT; the prospects for ultimate approval of an NDA for Contrave; and the potential to complete a partnership or similar transaction for ex-North American rights to Contrave and maintain the Company's existing North American collaboration with Takeda Pharmaceuticals. The inclusion of
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1. Orexigen® Therapeutics Reports Second Quarter Ended June 30, 2011 Financial Results
2. Orexigen® Therapeutics Provides a Regulatory Update on Contrave® NDA
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5. Orexigen® Therapeutics Schedules March 10, 2011 Webcast Discussion of Financial Results for the Fourth Quarter and Year Ended December 31, 2010
6. Orexigen® Therapeutics, Inc. Announces Upcoming Departure of Chief Financial Officer
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