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Orexigen Therapeutics Reports Business and Financial Results for the Third Quarter Ended September 30, 2013
Date:11/12/2013

igen. "We continue to expect we will receive the analysis from the DMC and complete our review by early December."

"We expect that an interim analysis that meets the pre-specified safety hurdles will enable a series of important steps in 2014 toward the global commercialization of Contrave, including potential approvals in the US and Europe, progression of partnership discussions for ex-North American Contrave rights, and the potential commercial launch of Contrave in North America by Takeda," Narachi continued.

Recent business highlights:

  • In October, Orexigen submitted the Marketing Authorization Application for Contrave to the European Medicines Agency. Cardiovascular outcomes data from the Light Study are expected to be available for the Committee for Medicinal Products for Human Use (CHMP) Day 120 List of Questions.
  • In preparation for the potential launch of Contrave, Takeda assumed from the Company the responsibility to package Contrave for commercial sale. The Company will continue to supply bulk tablets of Contrave to Takeda in accordance with the terms of the Collaboration Agreement.
  • Orexigen entered into a commercial supply agreement with Sanofi to manufacture and supply Contrave for territories outside North America.
  • Product candidates: Contrave (32 mg naltrexone sustained‐release (SR)/360 mg bupropion SR) for the treatment of obesity: In 2012, Orexigen screened more than 13,000 patients, enrolled more than 10,400 and ultimately completed recruitment of the Light Study with approximately 8,900 randomized patients. The primary objective of the double‐blind, randomized, placebo‐controlled Light Study, which Orexigen is conducting under a Special Protocol Assessment with the FDA (United States Food and Drug Administration), is to rule out excess cardiovascular risk in overweight and obese patients receiving Contrave. An interim analysis of the Light Study is anticipated by early Decem
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    SOURCE Orexigen Therapeutics, Inc.
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