Orexigen Partners With Takeda To Commercialize Obesity Drug Contrave (Naltrexone SR/Bupropion SR)

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Main Category: Obesity / Weight Loss / Fitness
Also Included In: Pharma Industry / Biotech Industry
Article Date: 02 Sep 2010 - 9:00 PDT

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Contrave (naltrexone SR/bupropion SR), an investigational drug aimed at combination therapy to address both biological and behavioral drivers of obesity, will be developed and commercialized by Orexigen Therapeutics, Inc. and Takeda Pharmaceutical Company Limited in the USA, Canada and Mexico. The two drug firms have just signed an exclusive partnership for the North American area.

The Contrave combination treatment targets the central pathways involved in controlling the balance of both food consumption and metabolism, as well as regulating eating behavior, Orexigen informs.

The company submitted an NDA (New Drug Application) to the FDA (Food and Drug Administration, USA) for Contrave in March this year. The Prescription Drug User Fee Act (PDUFA) action date has been set for January 31, 2011.

In this exclusive partnership, Takeda gives an upfront cash payment of US$50 million to Orexigen, for which Takeda will have exclusive marketing rights in the USA, Canada and Mexico, but Orexigen still maintains the right to co-promote Contrave in the USA.

Orexigen will be entitled to receive payments over US$1 billion as soon as specific regulatory and sales-based milestones are met. Upon the commercialization of Contrave, Takeda is to pay tiered double-digit royalty payments on net sales in the agreed territory.

The two companies will collaborate on ongoing development of Contrave - Orexigen is to lead on pre-approval activities while Takeda leads on post-approval activities. Both companies are to share in any future development costs.

Michael Narachi, President and CEO of Orexigen, said:

Takeda is an ideal partner for Contrave given its proven track record in commercializing innovative medicines and its commitment to the treatment of obesity. 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.

Shinji Honda, President and CEO of Takeda Pharmaceuticals North America, Inc., a subsidiary of Takeda, Japan, said:

Contrave represents an important addition to Takeda's cardiovascular and metabolic disease franchise and we look forward to partnering with Orexigen. 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.

There are currently 75 million obese individuals in the USA; this figure is expected to rise to 103 million by 2018, Orexigen informs. People with obesity, often a chronic (long-term) condition, have a significantly higher risk of developing diabetes type 2, cardiovascular diseases, cancer and depression. At least two-thirds of the US adult population is either overweight or obese.

A considerable number of obese people cannot lose the percentage bodyweight necessary to have significantly improved blood sugar, blood pressure and cholesterol levels through diet and exercise alone.

About Contrave (naltrexone SR/bupropion SR)

In a press release today, Orexigen writes that 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.

Source: Orexigen Therapeutics, Inc.

Written by Christian Nordqvist


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