Orexigen(R) Therapeutics Announces Third Quarter 2009 Financi...(ild to moderate transient and manageable...),Health

The results from the successfully completed COR program of more than 4,500 patients exceed the FDA categorical efficacy benchmark for clinically significant weight loss, supporting the Company's plan to file a New Drug Application with the FDA in the first half of 2010.

Empatic

Orexigen recently announced the data from the Phase 2b clinical trial of Empatic. The results of this trial demonstrated that patients completing 24 weeks of Empatic360 (bupropion SR 360mg/zonisamide SR 360 mg) therapy lost 9.9% of their baseline body weight, or 22 pounds, compared to 1.7% for placebo patients (p<0.001). Importantly, Empatic patients continued to lose weight through the end of the trial, with no evidence of a weight loss plateau. Improvements were observed in key markers of cardiometabolic risk such as waist circumference, triglycerides, fasting insulin and blood pressure. The most commonly reported adverse events for all Empatic patients were headache, insomnia and nausea, and the most common adverse events leading to discontinuation were insomnia, headache and urticaria (hives). Adverse events and laboratory findings appeared to be consistent with the individual components of Empatic. There were no serious adverse events attributed by investigators to study drug. There were no statistically or clinically meaningful differences between Empatic and placebo on measures of cognitive function, depression, suicidality or anxiety.

Conference Call Today at 5:00 p.m. Eastern Time (2:00 p.m. Pacific Time)

The Orexigen management team will host a teleconference and webcast to discuss the third quarter 2009 financial results and recent business highlights. The live call may be accessed by phone by calling (866) 783-2138 (domestic) or (857) 350-1597 (international), participant code 88599521. The webcast can be accessed live on the investor relations section of the
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