Orexigen Therapeutics, Inc. operates as a biopharmaceutical company that focuses on the treatment of obesity. Contrave (Mysimba) The company’s sole product, Contrave (naltrexone HCl/bupropion HCl prolonged release), is approved in the United States by the U.S. Food and Drug Administration 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 approximately one weight-related comorbid condition. Contrave is a combination of generic drug components, each of which has already received regulatory approval for other indications and has been commercialized in the United States and in a majority of the member countries of the European Union. 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, the company owns or has 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, the company used the generic immediate release formulation of naltrexone. In the company’s Phase III clinical trials, naltrexone was delivered in its proprietary ER formulation 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 In July 2015, the company entered into an amended and restated collaboration agreement with Takeda Pharmaceutical Company Limited to develop and commercialize Contrave in the United States. 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 and South Korea, and is advancing plans for the commercial launch of Mysimba in certain markets of the European Union while in parallel continuing partnering discussions for the rights to Contrave and Mysimba in markets in the European Union and other territories outside the United States. The company is coordinating efforts with Takeda Pharmaceutical Company Limited to ensure that the company maintains an integrated educational and promotional Contrave brand campaign to targeted health care providers that treat obesity as a chronic medical disease. Suppliers The company uses Patheon Pharmaceuticals, Inc. 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. In addition, use of the company’s proprietary sustained-release formulation of Contrave for weight loss is protected by the U.S. patent numbers 8,916,195 and 9,107,837, which are expected to expire in February 2030 and June 2027, respectively. The dose escalation schedule of Contrave is protected by the U.S. patent numbers 8,722
orexigen therapeutics inc
3344 North Torrey Pines Court
La Jolla, CA 92037
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