Date: 2013-11-06
Type of information: Production agreement
Compound: Contrave® (32 mg naltrexone sustained release (SR) / 360 mg bupropion SR)
Company: Orexigen Therapeutics (USA) Sanofi (France)
Therapeutic area: Metabolic diseases
Type agreement: manufacturing
production
Action mechanism:
Disease: obesity, including weight loss and maintenance of weight loss, in conjunction with lifestyle modification
Details: *On November 6, 2013, Orexigen Therapeutics, a biopharmaceutical company focused on the treatment of obesity, has 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.
Orexigen is currently 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 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 Contrav®e to the European Medicines Agency (EMA).
Orexigen has licensed North American Contrave® commercial rights to Takeda Pharmaceuticals. Orexigen owns Contrave® rights in Europe and throughout the rest of the world outside of North America and will seek a partner to commercialize Contrave® in those territories.
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