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Orexigen Therapeutics Reports Financial Results for the Fourth Quarter and Year Ended December 31, 2012
Date:3/13/2013

Orexigen. "A successful primary care launch is a large and complex undertaking, and as such we are working with our partner Takeda on detailed commercialization plans for Contrave while simultaneously conducting the Light Study according to very high standards."

Product candidates update:

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 and NDA resubmission is planned once the independent Data Monitoring Committee has determined that sufficient information has been gathered for the analysis that would include at least 87 adjudicated major adverse cardiovascular events (MACE). Orexigen enrolled into the Light Study a patient population that the company predicted would have an annualized MACE rate between 1% and 2%.  Orexigen is preparing to be ready to conduct the interim analysis and resubmit the Contrave NDA in 2013.  However, if the observed MACE rate is at or near the low end of the range of 1% to 2%, the resubmission of the Contrave NDA may not occur until early 2014.

In January, the Division of Metabolism and Endocrinology Products (DMEP) at the FDA proposed an NDA resubmission procedure that would allow the independent Data Monitoring Committee's summary report of the Light Study interim analysis to form the basis of the resubmission of the Contrave NDA. The complete clinical study report (CSR) for the interim analysis, which would ordinarily form the basis for the
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SOURCE Orexigen Therapeutics, Inc.
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