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Orexigen Therapeutics Enters Into Agreement with Sanofi to Manufacture Contrave for Territories Outside North America
Date:11/6/2013

SAN DIEGO, Nov. 6, 2013 /PRNewswire/ -- Orexigen® Therapeutics, Inc. (Nasdaq: OREX), a biopharmaceutical company focused on the treatment of obesity, today announced that it has entered into a commercial supply agreement with Sanofi to act as Orexigen's contract manufacturer for Contrave® (32 mg naltrexone sustained release (SR) / 360 mg bupropion SR) for territories outside North America.  Sanofi will manufacture Contrave tablets at one of several facilities in France.

"We are pleased to engage a manufacturer with Sanofi's scale and expertise," said Michael Narachi, CEO of Orexigen. "This agreement expands and diversifies our existing commercial supply network and will help ensure we will be ready to supply Contrave globally if approved."

About Contrave
Orexigen is evaluating Contrave for the management of obesity, including weight loss and maintenance of weight loss, in conjunction with lifestyle modification, and is currently conducting the Light Study, a cardiovascular outcomes trial. The primary objective of the double‐blind, randomized, placebo‐controlled clinical trial, which Orexigen is conducting under a Special Protocol Assessment (SPA) with the U.S. Food and Drug Administration (FDA), is to rule out excess cardiovascular risk in overweight and obese patients receiving Contrave. An interim analysis of the Light Study is anticipated by early December, enabling the potential resubmission of the Contrave New Drug Application (NDA) to the FDA by year end.

In October Orexigen submitted a Marketing Authorization Application (MAA) for Contrave to the European Medicines Agency (EMA).

Orexigen has licensed North American Contrave commercial rights to Takeda Pharmaceuticals. Orexigen owns Contrave rights in Europe and
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SOURCE Orexigen Therapeutics, Inc.
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