Orexigen Therapeutics, Inc. (OREX) Completes Light Study Patient Screening, Presents New Obesity Therapeutics Market Research

Obesity-focused biopharmaceutical company Orexigen Therapeutics has provided a clinical trial update of the Light Study and results of recent market research at its Analyst Day meeting in New York City, which took place Dec. 18.

The company has reported that the screening of new patients has been completed for the Light Study, which is a cardiovascular outcomes trial evaluating Contrave (Naltrexone SR/Bupropion SR). Within the next few weeks, around 9,000 patients will be randomized in the study. An interim analysis will occur after approximately 87 major adverse cardiovascular events (MACE) are accrued in the Light Study. While it is still too early to predict the rate of MACE, Orexigen anticipates resubmitting the Contrave New Drug Application and conducting the interim analysis in 2013, with potential approval as early as the fourth quarter of 2013, if the annual rate is close to the targeted 1.5 percent.

“With great performance from our clinical sites and with the help of our partners, including Blue Chip Marketing Worldwide, the Orexigen team deployed several innovative strategies and tactics to enroll the Light Study in just six-and-a-half months,” said Michael Narachi, CEO of Orexigen. “We now look forward to 2013, when we anticipate being able to provide interim data from the Light Study to the FDA and CHMP for review and potential approval in the U.S. and Europe.”

Orexigen also discussed recent physician and patient market research, which was conducted to determine potential growth of the obesity therapeutics market and preference shares between Contrave and two recently approved obesity therapeutics. Conducted with 1,000 physicians, the quantitative market research suggests that the market for obesity therapeutics could grow threefold to fourfold – from a 2012 base of around 7.8 million prescriptions – within five years. The physician research additionally indicates that, if approved, Contrave would be favorably perceived among the new product entrants. This was particularly true among certain important patient profiles, including some or all of the following characteristics: female, a body mass index between 30 and 40, and diabetes.

An additional market research study conducted by the company surveyed more than 5,000 patients in order to assess interest levels between Contrave and those same two recently approved obesity therapeutics. This study’s results suggest attractive patient interest levels for Contrave – particularly across specific important segments of the obese and overweight patient population, which supports the physician research findings.

“Our extensive market research demonstrates the potential for the obesity therapeutics market to grow three-to-fourfold in the next few years, as multiple new drugs with different mechanisms of action become available, giving prescribers and patients new tools to fight obesity,” said Mark Booth, chief commercial officer of Orexigen. “We were also pleased with how Contrave performed in this research across the most important patient demographic segments.”

A webcast of the presentations made at Analyst Day can be accessed live on the “Investor Relations” section of the Orexigen Web site, www.orexigen.com, and will be archived for 14 days following the event.

Orexigen Therapeutics is a biopharmaceutical company focused on the treatment of obesity. The company’s lead product candidate is Contrave, which has completed Phase III clinical trials and for which a New Drug Application has been submitted and reviewed by the FDA. The company has also reached agreement with the FDA on a Special Protocol Assessment (SPA) for the Light Study, the Contrave cardiovascular outcomes trial. The company’s other product candidate, Empatic, has completed Phase II clinical trials.

For more information, visit www.orexigen.com

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