Deal could be worth $1 billion if Contrave is approved and hits sales milestones in Takeda’s territories.

Takeda Pharmaceutical is paying Orexigen Therapeutics $50 million up front as part of an exclusive agreement to develop the latter’s registrational obesity drug candidate, Contrave®, in the U.S., Canada, and Mexico. Orexigen could receive payments of over $1 billion if certain regulatory and sales-based milestones are met, plus tiered double-digit royalty payments.

Orexigen filed an NDA for the drug at the end of March and says the PDUFA action date has been set for January 31, 2011. Under terms of the deal the firms will work together on ongoing development of Contrave and share relevant costs. Orexigen will lead pre-approval activities, and Takeda will lead post-approval operations.

“It has been our belief that getting a partner involved early would be critical to a high-quality launch of Contrave,” comments Michael Narachi, Orexigen’s president and CEO. “With this partnership now in place, we are tightly focused on the regulatory review process and securing approval for Contrave.”

Contrave is a combination therapy comprising sustained-release naltrexone and sustained-release bupropion. Orexigen says the drug is believed to address both biological and behavioral drivers of obesity by impacting on pathways involved in controlling the balance of food intake and metabolism and regulating reward-based eating behavior.

Orexigen is focused on the development of treatments for obesity. The firm’s second clinical compound, Empatic™, is a fixed-dose combination of sustained-release zonisamide and sustained-release bupropion. Empatic is currently undergoing Phase II evaluation.

Zonisamide in an immediate-release formulation was approved in the U.S. in 2000 for the adjunctive treatment of partial seizures. Orexigen says that prior clinical trials conducted at Duke University suggest that when administered on its own, zonisamide leads to modest weight loss.

The firm claims that two-third of the U.S. adult population is either overweight or obese, with 75 million suffering from obesity. This number is expected to rise to 103 million by 2018.

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