Orexigen Therapeutics, Inc., a biopharmaceutical company, focuses on the development of pharmaceutical product candidates for the treatment of obesity. The company’s product, Contrave, was approved in the United States by the U.S. Food and Drug Administration in 2014 as an adjunct to a reduced-calorie diet and increased physical activity for chronic weight management in adults with an initial body mass index of 30 kg/m2 or greater (obese), or 27 kg/m2 or greater (overweight) in the presence of at least one weight-related comorbid condition (hypertension, type 2 diabetes mellitus, or dyslipidemia). Contrave is a fixed dose combination of bupropion HCl extended release (ER) and naltrexone HCl ER. The company holds patents in the United States that cover the composition of Contrave (bupropion HCl/naltrexone HCl ER), as well as the use of Contrave for the treatment of obesity. The company has also filed additional U.S. patents covering various aspects of Contrave. In addition, it owns or has exclusive rights to various patent applications pending in various jurisdictions outside of the United States with respect to compositions, methods of use and formulations relating to Contrave. Naltrexone is approved in the United States for the treatment of opioid addiction and for the treatment of alcoholism. It is marketed under the brand names ReVia, and in an injectable extended release formulation, Vivitrol, which is approved for the treatment of alcohol dependence and expanded to include prevention of relapse to opioid dependence. In the company’s Contrave Phase II clinical trials, it used the generic immediate release formulation of naltrexone. In its Phase III clinical trials, naltrexone is delivered in the company’s proprietary ER formulation in order to improve its tolerability. Bupropion is approved for marketing in the United States for depression, marketed under the brand name Wellbutrin, and for smoking cessation, marketed under the brand name, Zyban. Bupropion is active at the neuronal uptake site for the neurotransmitters dopamine and norepinephrine. Sales and Marketing The company has a collaboration agreement with Takeda Pharmaceutical Company Limited to develop and commercialize Contrave in the United States, Canada and Mexico. Subject to certain terms and conditions, the collaboration agreement allows the company to co-promote Contrave in the United States. The company retains marketing rights for Contrave outside the United States, Canada and Mexico. The company might consider entering into additional collaborations with other pharmaceutical companies for territories outside the United States, Canada and Mexico with the sales force and marketing resources to adequately address the large primary care physician audience. Suppliers The company uses Patheon Pharmaceuticals and Patheon Inc. to manufacture Contrave and placebo tablets for the company’s clinical activities. Intellectual Property Contrave is protected by the U.S. patent number 7,375,111, which the company refers to as the Weber/Cowley composition patent, and the U.S. patent number 7,462,626, which the company refers to as the Weber/Cowley methods patent. The Weber/Cowley composition patent is expected to expire in March 2025 and the Weber/Cowley methods patent is expected to expire in July 2024. Use of the company’s proprietary tri-layer Contrave tablet for weight loss is protected in the United States by U.S. patent numbers 8,088,786 and 8,318,788, which are expected to expire in February 2029 and November 2027, respectively. In addition, use of its proprietary sustained-release formulation of Contrave for weight loss is protected by the U.S. patent number 8,916,195, which is expected to expire in February 2030. Additional patent applications related to Contrave remain pending in the U.S. and throughout the world. The company has received the U.S. trademark registration number 3393576 for the mark CONTRAVE for use in connection with pharmaceutical preparations for use in the treatment of obesity and inducing weight loss. An application for the CONTRAVE mark has been allowed in the United States in connection with certain printed materials and medical information services. The company has also obtained foreign trademark registrations for the mark CONTRAVE in Canada, Europe and Japan. In addition, applications for a Contrave logo for use in connection with pharmaceutical preparations for use in the treatment of obesity and inducing weight loss, certain printed materials and medical information services has been filed in the U.S., and is pending in Canada. The Contrave logo is also registered in Europe and Japan. The company has received the U.S. trademark registration number 3396021 for its corporate logo for use in connection with pharmaceutical preparations and substances for the treatment of obesity, inducement of weight loss and prevention of weight gain. The company has obtained trademark registrations in Canada, Europe and Japan for the same mark. In addition, the company has received the U.S. trademark registration number 3396807 for its corporate name OREXIGEN for use in connection with pharmaceutical preparations for the treatment of disorders of the central nervous system, printed instructional, educational and teaching materials in the field of treatment and management of disorders of the central nervous system, and providing medical information in the field of disorders of the central nervous system. The company has obtained trademark registrations in Canada, Europe and Japan for the same mark. The company has obtained foreign trademark registrations for the corporate name Orexigen Therapeutics, Inc. in Europe and Japan. Research and Development The company’s research and development expenses totaled $57.4 million in the year ended December 31, 2014. History Orexigen Therapeutics, Inc. was founded in 2002. The company was incorporated in Delaware in 2002.
orexigen therapeutics inc
3344 North Torrey Pines Court
La Jolla, CA 92037
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