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OREXIGEN THERAPEUTICS

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Orexigen Therapeutics, Inc. : Orexigen Therapeutics Submits Contrave Marketing Authorization Application to European Medicines Agency

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10/03/2013 | 07:18am EDT

SAN DIEGO, Oct. 3, 2013 /PRNewswire/ -- Orexigen® Therapeutics, Inc. (Nasdaq: OREX), a biopharmaceutical company focused on the treatment of obesity, today announced that the company has submitted the Marketing Authorization Application (MAA) for Contrave® to the European Medicines Agency (EMA) utilizing the EMA's Centralized Procedure. Orexigen is seeking approval for Contrave (32 mg naltrexone sustained release (SR) / 360 mg bupropion SR) for the management of obesity, including weight loss and maintenance of weight loss, in conjunction with lifestyle modification.

Assuming successful completion of the review process and potential approval in the second half of 2014, Orexigen would expect Contrave to be available to physicians and their patients in Europe in early 2015.

"Obesity is one of Europe's great health care challenges, with the prevalence of obesity tripling in many European countries in the past few decades," said Michael Narachi, CEO of Orexigen. "We believe, if approved, a medicine with Contrave's safety and efficacy profile, including safety information derived from the ongoing cardiovascular outcomes trial, can be an important part of the solution for the management of obesity in Europe."

Orexigen is currently evaluating Contrave in the Light Study, a cardiovascular outcomes trial with more than 8,900 patients randomized to Contrave or placebo. The primary objective of the double

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