Orexigen Therapeutics Concludes Light Study Patient Screening, Expecting to Randomize Approximately 9,000 Patients, and Presents New Obesity Therapeutics Market Research -- At Analyst Day meeting in NYC, management highlighted Light Study next steps, obesity therapeutics market growth potential and attractive Contrave® preference shares --
SAN DIEGO, Dec. 18, 2012 /PRNewswire/ -- 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.
About Orexigen Therapeutics
Orexigen Therapeutics, Inc. 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. Further information about the Company can be found at www.orexigen.com.
Orexigen cautions you that statements included in this press release that are not a description of historical facts are forward-looking statements. Words such as "believes," "anticipates," "plans," "expects," "indicates," "should," "will," "intends," "potential," "suggests," "assuming," "designed" and similar expressions are intended to identify forward-looking statements. These statements are based on the Company's current beliefs and expectations. These forward-looking statements include statements regarding: the potential to accelerate resubmission of the Contrave NDA prior to the interim data from the Light Study; the ability to enroll the targeted patient population; the ability to randomize approximately 9,000 patients; the potential for, and timing of, the accrual and adjudication of MACE and the potential resubmission of the Contrave NDA; the safety and effectiveness of Contrave; the potential for, and timing of, approval for Contrave; and the potential that the market research results are predictive of actual market results. The inclusion of forward-looking statements should not be regarded as a representation by Orexigen that any of its plans will be achieved. Actual results may differ from those set forth in this release due to the risk and uncertainties inherent in the Orexigen business, including, without limitation: the possibility that the procedural details are not able to be worked out with the FDA resulting in the inability to resubmit the NDA prior to the receipt of the interim data from the Light Study; the SPA is not binding on the FDA if public health concerns unrecognized at the time the SPA agreement was entered into become evident, other new scientific concerns regarding product safety or efficacy arise, or if Orexigen fails to comply with the agreed upon trial protocol; Orexigen's ability to conduct the Light Study and the progress and timing thereof, including risks associated with recruiting and enrolling patients in the Light Study; Orexigen's ability to demonstrate in the Light Study that the risk of MACE in overweight and obese subjects treated with Contrave does not adversely affect the product candidate's benefit-risk profile; the potential that earlier clinical trials may not be predictive of future results in the Light Study; the potential for the FDA to not approve Contrave even after the resubmission with the MACE event data; the potential for the Light Study to cost more than what is projected; the potential for early termination of the collaboration agreement between Orexigen and Takeda; the costs and time required to complete additional clinical, non-clinical or other requirements prior to any resubmission of an NDA; the therapeutic and commercial value of Contrave; Orexigen's ability to maintain sufficient capital; and other risks described in the Company's filings with the Securities and Exchange Commission. You are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date hereof, and Orexigen undertakes no obligation to revise or update this news release to reflect events or circumstances after the date hereof. Further information regarding these and other risks is included under the heading "Risk Factors" in Orexigen's Quarterly Report on Form 10-Q filed with the Securities and Exchange Commission November 9, 2012 and which is available from the SEC's website (www.sec.gov) and on Orexigen's website (www.orexigen.com) under the heading "Investor Relations." All forward-looking statements are qualified in their entirety by this cautionary statement. This caution is made under the safe harbor provisions of Section 21E of the Private Securities Litigation Reform Act of 1995.
Vice President, Corporate Communications & Business Development
SOURCE Orexigen Therapeutics, Inc.