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Orexigen Therapeutics Announces European Filing Strategy and Reports Business and Financial Results for the Second Quarter Ended June 30, 2013
Date:8/6/2013

strative expenses. As of June 30, 2013, Orexigen had $55.8 million in cash and cash equivalents and an additional $40.2 million in marketable securities, for a total of $96.0 million.

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 and NDA resubmission is planned once the independent Data Monitoring Committee (DMC) 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 the remaining months of 2013. Orexigen has licensed North American commercial rights to Takeda Pharmaceuticals. Orexigen owns Contrave rights throughout the rest of the world and intends to license commercial rights outside North America.

Empatic™, a fixed dose combination of bupropion SR and zonisamide SR, for the treatment of obesity: In a series of discussions with the FDA on the continued development of Empatic, the FDA stated that Phase 3 data for Empatic may be sufficient to support submission of an NDA without data from a cardiovascular outcomes trial. The FDA indicated that as long as the placebo-subtracted changes in body weight, blood pressure
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SOURCE Orexigen Therapeutics, Inc.
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