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Orexigen Resubmits Contrave New Drug Application
Date:12/11/2013

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By agreement with the FDA, the independent Data Monitoring Committee's summary report of the Light Study interim analysis formed the basis of the resubmission of the NDA. The interim analysis clinical study report (CSR) will be supplied to the FDA within 60 days of the NDA resubmission. The review period for the resubmission is expected to be six months.

About the Light Study
The Contrave Light Study is a double-blind, placebo-controlled cardiovascular outcomes trial that randomized approximately 8,900 patients. The primary objective of the Light Study, which Orexigen is conducting under a Special Protocol Assessment with the FDA at approximately 260 clinical sites in the United States, is to rule out excess cardiovascular risk in overweight and obese patients receiving Contrave. In November 2013 Orexigen announced successful results of the interim analysis of the Light Study, stating that it met the prespecified criteria to exclude a hazard ratio of 2.0, using the upper bound of the 95% confidence interval, for excess risk of major adverse cardiovascular events (MACE) in patients receiving Contrave as compared to placebo.

About Contrave
Contrave (naltrexone sustained release (SR)/bupropion SR) is an investigational medication being evaluated for weight loss and maintenance of weight loss. Prior to initiation of the Light Study, Contrave was studied in clinical trials enrolling more than 4,500 people. In these clinical trials, 53 percent of study participants taking Contrave and 21 percent of those taking placebo lost five percent or more of their body weight over the 12 month trial duration. Many patients saw improvements in cholesterol levels, and blood sugar control. Those who combined Contrave with intensive diet and exercise experienced the most reduction in body weight. There is no guarantee that Contrave will help patients lose weight.

In the Contrave Phase 3 clinical development program, the
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SOURCE Orexigen Therapeutics, Inc.
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