Orexigen Therapeutics, Inc. and Takeda Pharmaceutical Company Limited announced that they have entered into an exclusive partnership to develop and commercialize Contrave (naltrexone SR/bupropion SR), Orexigen’s investigational drug for the treatment of obesity, in the United States, Canada and Mexico.

Contrave is a combination therapy believed to address both biological and behavioural drivers of obesity. The central pathways targeted by this treatment are involved in controlling the balance of food intake and metabolism, and regulating reward-based eating behaviour. Orexigen submitted a New Drug Application (NDA) to the US Food and Drug Administration (FDA) for Contrave on March 31, 2010 and the Prescription Drug User Fee Act (PDUFA) action date has been set for January 31, 2011.

Under the terms of the agreement, Orexigen will receive an upfront cash payment of $50 million from Takeda, and Takeda will obtain an exclusive marketing right from Orexigen in the United States, Mexico and Canada while Orexigen retains the right to co-promote with Takeda in the United States. Orexigen will be eligible to receive payments of over $1 billion upon achieving certain regulatory and sales-based milestones. Assuming Contrave is commercialized, Takeda will pay tiered double-digit royalty payments on net sales in the Territory.

Under the terms of the agreement, Orexigen and Takeda will work together on ongoing development of the product, with Orexigen leading pre-approval activities, and Takeda leading post-approval activities. The parties will share in the costs of any future development of the product.

“Takeda is an ideal partner for Contrave given its proven track record in commercializing innovative medicines and its commitment to the treatment of obesity,” said Michael Narachi, president and CEO of Orexigen. “We believe this is a great strategic partnership to enable our goal of a strong market entry for Contrave, if approved. It has been our belief that getting a partner involved early would be critical to a high-quality launch of Contrave, and with this partnership now in place, we are tightly focused on the regulatory review process and securing approval for Contrave.”

“Contrave represents an important addition to Takeda’s cardiovascular and metabolic disease franchise and we look forward to partnering with Orexigen,” said Shinji Honda, president and CEO of Takeda Pharmaceuticals North America, Inc., a wholly-owned subsidiary of Takeda that has commercial responsibility for the Americas. “Takeda has deep experience in providing important medicines to treat chronic disease and Contrave will help us provide a full spectrum of treatment to patients for the management of obesity.”

Approximately 75 million Americans suffer from obesity and that number is expected to rise to 103 million by 2018. Obesity is a chronic condition linked to serious medical consequences including type 2 diabetes, cardiovascular disease, cancer and depression. Despite increasing public health concerns regarding obesity, two-thirds of the US adult population is overweight or obese. Although weight loss of 5-10 percent may improve overall health, including blood sugar control, high blood pressure, high cholesterol, and overall quality of life, many individuals are not able to lose weight or maintain weight loss with diet and exercise alone.

Contrave is an investigational combination therapy believed to address both biological and behavioral drivers of obesity. The two components of this combination therapy act in a complementary manner in the central nervous system. The central pathways targeted by this treatment are involved in controlling the balance of food intake and metabolism, and regulating reward-based eating behavior. In clinical trials, Contrave was shown to help obese patients initiate and sustain significant weight loss, improve important markers of cardiometabolic risk and increase ability to control eating.

Orexigen Therapeutics, Inc. is a biopharmaceutical company focused on the treatment of obesity.

Located in Osaka, Japan, Takeda is a research-based global company with its main focus on pharmaceuticals. As the largest pharmaceutical company in Japan and one of the global leaders of the industry, Takeda is committed to strive towards better health for patients worldwide through leading innovation in medicine.