Orexigen Concludes Light Study Patient Screening, to Randomize ~9,000 Patients, Sees Resubmission in Q4
Orexigen® Therapeutics, Inc. (Nasdaq: OREX), a biopharmaceutical company focused on the treatment of obesity, today provided a clinical trial update of the Light Study as well as results of recent market research at its Analyst Day meeting in New York City. Orexigen reported that the screening of new patients for the Light Study, the cardiovascular outcomes trial evaluating Contrave® (Naltrexone SR/Bupropion SR), is now complete. Approximately 9,000 patients will be randomized in the study within the next few weeks. An interim analysis of the Light Study will occur after approximately 87 major adverse cardiovascular events (MACE) are accrued in the study. Although it is still too early to predict the rate of MACE, if the annual rate is close to the target of 1.5%, Orexigen anticipates resubmitting the Contrave New Drug Application and conducting the interim analysis in 2013, with potential approval as early as fourth quarter 2013.
"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 US and Europe."
Today the Company also discussed recent physician and patient market research which was conducted to assess potential growth of the obesity therapeutics market as well as preference shares between Contrave® and two recently approved obesity therapeutics. The quantitative market research conducted with 1,000 physicians suggests the market for obesity therapeutics could grow 3 to 4 fold within five years from a 2012 base of approximately 7.8 million prescriptions. The physician research also suggests that Contrave, if approved, would be perceived favorably among the new product entrants. This was especially true among certain important patient profiles that included some or all of the following characteristics: female; a body mass index between 30 and 40; and diabetes.
The Company conducted another market research study that surveyed more than 5,000 patients to assess interest levels between Contrave and the same two recently approved obesity therapeutics. The results of this research indicate attractive levels of patient interest for Contrave, especially across certain important segments of the obese and overweight patient population, supporting the physician research findings.
"Our extensive market research demonstrates the potential for the obesity therapeutics market to grow 3 to 4 fold 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."
The webcast of the Analyst Day presentations can be accessed live on the Investor Relations section of the Orexigen website at www.orexigen.com and will be archived for 14 days following the Analyst Day.
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