Orexigen reports net loss of $10.4 million for first quarter 2012

Orexigen® Therapeutics, Inc. (Nasdaq: OREX), a biopharmaceutical company focused on the treatment of obesity, today announced financial results for the first quarter of 2012.  For the three months ended March 31, 2012, Orexigen reported a net loss of $10.4 million, or $0.16 per share, as compared to a net loss of $11.6 million, or $0.24 per share, for the first quarter of 2011.  As of March 31, 2012, Orexigen had $73.5 million in cash and cash equivalents and an additional $65.1 million in marketable securities, for a total of $138.6 million.

Total operating expenses for the first quarter of 2012 were $11.3 million compared to $13.3 million for the first quarter of 2011.  This overall decrease in operating expenses reflects a decrease in general and administrative costs principally related to decreases in salaries and personnel related costs and stock-based compensation expense.

"In March, an FDA advisory panel overwhelmingly recommended that every new obesity pharmacotherapy prior to approval should rule out excess cardiovascular risk with a large outcomes trial or with rigorous, prospectively designed analyses of Phase III clinical trial data," said Michael Narachi, president and CEO of Orexigen. "This recommendation is consistent with the FDA's 2008 guidance for diabetes drug development and also with the Special Protocol Agreement for the Contrave cardiovascular outcomes trial."

"We are eager to see how the FDA acts on the panel's recommendation," Narachi continued. "However the standards for obesity drug development evolve, we expect the standards to be logical and consistently applied so as to promote the development of critically needed obesity therapeutics."

Product candidate update:

• Contrave® (32 mg naltrexone sustained-release (SR)/360 mg bupropion SR) for the treatment of obesity: Late in the second quarter, Orexigen will initiate the Contrave cardiovascular outcomes trial (CVOT). The CVOT is an event driven trial that currently will be conducted at approximately 300 sites in the United States. Approximately 10,000 patients are expected to be enrolled into the trial. The primary objective of the double blind, randomized, placebo controlled CVOT, which Orexigen is conducting under a Special Protocol Assessment with the FDA, is to rule out excess cardiovascular risk in overweight and obese patients receiving Contrave. An interim analysis and New Drug Application resubmission is planned once at least 87 major adverse cardiovascular events have occurred, which is anticipated to be less than two years from the start of the trial.
• Empatic™, a fixed dose combination of bupropion SR and zonisamide SR, for the treatment of obesity: Orexigen has completed Phase II clinical trials evaluating Empatic. The company is closely following the regulatory progress of a competitor's product candidate, a combination product for the treatment of obesity which, similar to the zonisamide component of Empatic, contains an anti-convulsant. Orexigen believes the regulatory outcome and potential labeling for this competitor product will inform the development path and commercial prospects for Empatic. Once this information becomes available, Orexigen may request an End of Phase II meeting with FDA to discuss the Empatic Phase III Program.