Profile: Orexigen Therapeutics Inc (OREX.OQ)

OREX.OQ on NASDAQ Stock Exchange Global Select Market

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Orexigen Therapeutics, Inc. (Orexigen), incorporated in September 2002, is a biopharmaceutical company focused on the development of pharmaceutical product candidates for the treatment of obesity. Its combination product candidates for obesity are Contrave, which has completed Phase III clinical trials and for which a New Drug Application (NDA), has been submitted and reviewed by the United States Food and Drug Administration (FDA), and Empatic, which has completed Phase II clinical trials. In January 2012, it received a complete response letter (CRL), for the Contrave NDA. In February 2012, it reached agreement with the FDA on a Special Protocol Assessment (SPA), for the cardiovascular outcomes trial (CVOT).

Contrave

Contrave is a fixed dose combination of bupropion sustained release (SR) and naltrexone SR. Naltrexone was chosen as a complement to bupropion in order to block compensating mechanisms that attempt to prevent long-term, sustained weight loss. It holds patents in the United States, which covers the composition of Contrave (bupropion SR and naltrexone SR), as well as the use of Contrave for the treatment of obesity. Naltrexone is used for the treatment of opioid addiction and for the treatment of alcoholism. In its Contrave Phase II clinical trials, it used the generic immediate release formulation of naltrexone. In its Phase III clinical trials, naltrexone was delivered in its SR formulation. Bupropion is used for depression and for smoking cessation. It has conducted controlled Phase II and Phase IIb clinical trials for Contrave in 657 patients.

Empatic

Empatic is a fixed dose combination of bupropion SR and zonisamide SR. It holds a license to an issued the United States patent covering the Empatic composition and methods of use in obesity, and it has filed additional patents covering various compositions, methods of use and formulations. Zonisamide immediate release is approved in the United States for the adjunctive treatment of partial seizures, a form of epilepsy.

The Company competes with Genentech, Inc., GlaxoSmithKline LLC, Arena Pharmaceuticals, Inc., Amylin Pharmaceuticals, Inc., Alizyme plc, Athersys, Inc., Genaera Corporation, Neurosearch A/S, Novo Nordisk A/S, Sanofi-Aventis, and Vivus, Inc., Eisai Pharmaceuticals, Inc., Takeda Pharmaceutical Company Limited, Allergan, Inc., Boston Scientific, Covidien Ltd., EnteroMedics, Inc., GI Dynamics, Inc., Johnson & Johnson, Medtronic, Inc. and Satiety, Inc.

Company Address

Orexigen Therapeutics Inc

Suite 200, 3344 N. Torrey Pines
LA JOLLA   CA   92037
P: +1858.8758600
F: +1858.8758650

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