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Orexigen Announces June 10, 2014 PDUFA Action Date for Contrave
Date:1/7/2014

SAN DIEGO, Jan. 7, 2014 /PRNewswire/ -- Orexigen® Therapeutics, Inc. (Nasdaq: OREX), today announced that the United States Food and Drug Administration (FDA) considers the recent resubmission of the Contrave® (naltrexone sustained release (SR)/bupropion SR) New Drug Application to be a complete response to the FDA's prior January 31, 2011 action letter. For the resubmission, the FDA has assigned a Prescription Drug User Fee Act goal date of June 10, 2014. If approved, the Company expects commercial launch of Contrave by North American partner Takeda Pharmaceuticals in the second half of 2014.

"We will continue to work closely with the FDA during the review of the Contrave NDA resubmission, and, if approved, we and Takeda look forward to making Contrave available to patients soon thereafter," said Michael Narachi, CEO of Orexigen.

Orexigen resubmitted the Contrave NDA in December 2013 following the earlier announcement of the successful interim analysis of the Light Study, the Contrave cardiovascular outcomes trial.

About the Light Study
The Contrave Light Study is a double-blind, placebo-controlled cardiovascular outcomes trial that randomized approximately 8,900 patients. The primary objective of the Light Study, which Orexigen is conducting under a Special Protocol Assessment with the FDA at approximately 260 clinical sites in the United States, is to rule out excess cardiovascular risk in overweight and obese patients receiving Contrave. In November 2013 Orexigen announced successful results of the interim analysis of the Light Study, stating that it met the prespecified criteria to exclude a hazard ratio of 2.0, using the upper bound of the 95% confidence interval, for excess risk of major adverse cardiovascular events (MACE) in patients receiving Contrave as
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SOURCE Orexigen Therapeutics, Inc.
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