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Orexigen's Obesity Drug Candidate Receives FDA Advisory Committee Recommendation

Orexigen Therapeutics, Inc. (OREX) and Takeda Pharmaceutical Company Limited reported Tuesday a non-binding recommendation by an FDA advisory committee that the potential benefits of Contrave for the treatment of obesity outweigh the potential risks. The committee also voted for a detailed study to examine the drug's effect on risk for major adverse cardiac events. A PDUFA action date of January 31, 2011 has been assigned for the review of the NDA.

Orexigen said the U.S. Food and Drug Administration's Endocrinologic and Metabolic Drugs Advisory Committee voted 13 to 7 that the available data adequately demonstrate that the potential benefits of Contrave or naltrexone sustained release-SR/bupropion SR outweigh the potential risks when used long-term in a population of overweight and obese individuals and support approval.

The committee also voted 11 to 8 that a dedicated study to examine the drug's effect on risk for major adverse cardiac events should be conducted as a post-approval requirement versus pre-approval.

Michael Narachi, president and CEO of La Jolla, California-based Orexigen said, "We look forward to continued discussions with the FDA regarding the design of a post-marketing study to evaluate cardiovascular risk and to address the questions raised at the meeting today in preparation for our PDUFA action date in January."

According to Orexigen, the two components of Contrave, naltrexone SR and bupropion SR, appeared to act in a complementary manner in the central nervous system and are believed to address both biological and behavioral drivers of obesity.

Osaka, Japan-based Takeda is a research-based global company with its main focus on pharmaceuticals.

OREX closed Tuesday's regular session at $4.87, up $0.11 or 2.31% on the Nasdaq. Over the past year, the stock traded in a range of $3.81 - $8.88. In the after hours, the stock is trading at $4.76, down $0.11 or 2.26%.

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