Orexigen Therapeutics reports net loss of $16.7 million for second quarter 2012

Orexigen^® Therapeutics, Inc. (Nasdaq: OREX), a biopharmaceutical company focused on the treatment of obesity, today announced financial results for the second quarter of 2012. For the three months ended June 30, 2012, Orexigen reported a net loss of $16.7 million, or $0.25 per share, as compared to a net loss of $7.6 million, or $0.16 per share, for the second quarter of 2011. As of June 30, 2012, Orexigen had $67.4 million in cash and cash equivalents and an additional $58.8 million in marketable securities, for a total of $126.2 million.

Total operating expenses for the second quarter of 2012 were $17.6 million compared to $8.3 million for the second quarter of 2011. This overall increase in operating expenses reflects an increase in research and development expenses associated with the conduct of the Light Study, the Contrave® cardiovascular outcomes trial.

"We are pleased to see that the coordinated effort of our team and our partners is resulting in terrific progress for the Light Study, which continues to rapidly enroll the targeted patient population," said Michael Narachi, president and CEO of Orexigen. "We remain focused on doing everything we can to pull forward the time to resubmission of the Contrave NDA."

"We are encouraged that the FDA has recently approved two weight loss drugs, and we congratulate our colleagues at Arena and Vivus on their recent success," Narachi continued. "With a pipeline of two late stage obesity therapeutics, this is clearly also good news for Orexigen."

Product candidate update:

• Contrave® (32 mg naltrexone sustained-release (SR)/360 mg bupropion SR) for the treatment of obesity: In the second quarter, Orexigen initiated the Light Study which is designed to be conducted at approximately 300 sites in the United States. 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. Within six weeks of initiation in early June, more than 1,500 patients had enrolled into the trial, and Orexigen now expects to complete enrollment of patients required for the interim analysis of the Light Study in the first quarter of 2013. An interim analysis and New Drug Application resubmission is planned once at least 87 major adverse cardiovascular events (MACE) have occurred, which is anticipated in the second half of 2013. Orexigen has licensed North American rights to Contrave to partner, Takeda Pharmaceutical U.S.A.
• Empatic™, a fixed dose combination of bupropion SR and zonisamide SR, for the treatment of obesity: In Phase II clinical trials Empatic demonstrated robust weight loss of as much as 9.9% after completing six months of treatment. Before advancing Empatic into Phase III clinical development, Orexigen awaited completion of the FDA review of another weight loss combination drug containing an anticonvulsant, topiramate, which like zonisamide, is known to carry risk of birth defects. Orexigen believes that the recent approval of the weight loss drug containing topiramate and the package insert clarifies the potential viability of Empatic. The Company is planning to meet with the FDA later this year to discuss Empatic Phase III clinical development plans as well as whether Empatic may need a separate cardiovascular outcomes trial distinct from the Company's ongoing Light Study which is evaluating Contrave. In prior correspondence, the FDA has communicated that since both compounds contain bupropion, reassuring results from the Light Study may sufficiently characterize the cardiovascular risk of Empatic, so long as the weight loss and blood pressure/heart rate data for Empatic are similar to or more favorable than those of Contrave. Orexigen owns  worldwide rights to Empatic.