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Orexigen Therapeutics Reports Corporate and Financial Results for the Second Quarter Ended June 30, 2014
Date:8/7/2014

s review of the resubmitted New Drug Application (NDA) for NB32. The new Prescription Drug User Fee Act (PDUFA) action date has been set for September 11, 2014. The FDA indicated that the review extension is needed to reach agreement on the post-marketing obligation related to the previously agreed upon evaluation of cardiovascular (CV) outcomes for NB32. Discussions with the Agency on the post-marketing obligation are progressing, and Orexigen is confident it can reach agreement with the FDA. Orexigen has licensed North American NB32 rights to Takeda. Takeda is preparing a well resourced primary care U.S. launch for NB32 with approximately 900 sales representatives. In October 2013 Orexigen submitted a Marketing Authorization Application for NB32 to the European Medicines Agency (EMA). Orexigen received the Day 180 List of Outstanding Issues from the EMA's Committee for Medicinal Products for Human Use (CHMP) and will submit the Company's responses in September. Orexigen owns NB32 rights outside of North America and will seek a partner to commercialize NB32 in those territories.

Conference Call Today at 8 a.m. Eastern Time (5:00 a.m. Pacific Time)
The Orexigen management team will host a teleconference and webcast to discuss the second quarter 2014 financial results and recent business highlights. The live call may be accessed by calling (800) 708-4540 (domestic) or (847) 619-6397 (international), participant code 37792592. 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 Orexigen Therapeutics
Orexigen Therapeutics, Inc. is a biopharmaceutical company focused on the treatment of obesity. The Company's lead product candidate is NB32. Based on successful results of the Light Study, an ongoing cardiovascular outcomes trial, Orexigen's strategy for NB32 is to pursue approvals world
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