Orexigen, Takeda Enter Contrave Commercialization Pact

Takeda Pharmaceutical Co. Ltd. has 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 U.S., Canada and Mexico. The two companies will work together on the development of the product, with Orexigen leading pre-approval activities, and Takeda leading post-approval activities. The parties will share development costs.

Contrave is a combination therapy developed to address both biological and behavioral drivers of obesity. The pathways targeted by this treatment involve controlling the balance of food intake and metabolism, and regulating reward-based eating behavior. Orexigen submitted a NDA to the FDA for Contrave in March 2010 and the Prescription Drug User Fee Act (PDUFA) action date has been set for January 31, 2011.

Orexigen will receive an upfront cash payment of $50 million and Takeda will have exclusive marketing rights in the U.S., Mexico and Canada, while Orexigen retains the right to co-promote in the U.S. Orexigen will be eligible to receive payments of more than $1 billion based on regulatory and sales-based milestones. If commercialized, Takeda will pay royalties on sales in the territory.

“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 chief executive officer 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.”