SAN DIEGO, June 21, 2007 /PRNewswire-FirstCall/ -- Orexigen(TM) Therapeutics, Inc. , a biopharmaceutical company focused on the treatment of central nervous system disorders with an initial focus on obesity, today announced that the Company will present data about its lead obesity product candidate Contrave(TM) and its effect on markers of cardiovascular disease (visceral fat, serum cholesterol, and triglycerides) and insulin-resistance. The findings come from additional analyses of the Phase IIb multi-center clinical trial of Contrave. The data will be presented on Saturday, June 23rd, 6:00-7:15 pm and Monday, June 25th, 2007 at the 67th Annual Scientific Sessions of the American Diabetes Association (ADA) in Chicago, IL. Contrave data can be found in category 20B, poster number 45LB entitled, "Weight Loss with Bupropion and Naltrexone Improves Markers of Insulin-Resistance."
Contrave is a proprietary fixed dose combination of bupropion SR (sustained release) and Orexigen's novel formulation of naltrexone SR in a single tri-layer tablet. In a Phase IIb multi-center clinical trial, Contrave demonstrated statistically significant weight loss at 24 weeks compared to bupropion SR alone, naltrexone IR (immediate release) alone, and placebo. Contrave is now being studied in two separate multi-center Phase III studies, one of which is designed to further assess its safety and efficacy in obese subjects with Type II diabetes.
About Orexigen Therapeutics
Orexigen(TM) Therapeutics, Inc. is a biopharmaceutical company focused on the development of pharmaceutical product candidates for the treatment of central nervous system disorders, with an initial focus on obesity. Orexigen's lead combination product candidates targeted for obesity are Contrave(TM), which is in Phase III clinical trials, and Empatic(TM) (formerly Excalia(TM)), which is in a Phase IIb clinical trial. Both product candidates take ad vantage of the Company's understanding of how the brain appears to regulate appetite and energy expenditure, as well as the mechanisms that come into play to limit weight loss over time. Each product candidate is designed to act on a specific group of neurons in the central nervous system with the goal of achieving appetite suppression and sustained weight loss. Further information about the Company can be found at http://www.Orexigen.com.
Forward Looking Statements
Orexigen cautions you that statements included in this press release that are not a description of historical facts are forward-looking statements. The inclusion of forward-looking statements should not be regarded as a representation by Orexigen that any of its plans will be achieved. For example, statements regarding the potential efficacy of Contrave(TM) may be forward looking statements. Actual results may differ materially from those set forth in this release due to the risks and uncertainties inherent in Orexigen's business, including, without limitation: the results of this Phase IIb clinical trial and earlier clinical trials may not be predictive of future results; Orexigen's pending clinical trials may not proceed in the timeframes or in the manner Orexigen expects or at all; unexpected findings relating to Contrave(TM) or Empatic(TM) that could delay or prevent regulatory filings, approval or commercialization, or that could result in recalls or product liability claims; Orexigen and its licensors may not be able to obtain, maintain and successfully enforce adequate patent and other intellectual property protection of its product candidates; and other risks detailed in Orexigen's public 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. All forward-looking statements are qualified in their entirety by t his cautionary statement and Orexigen undertakes no obligation to revise or update this news release to reflect events or circumstances after the date hereof. This caution is made under the safe harbor provisions of Section 21E of the Private Securities Litigation Reform Act of 1995.
CONTACTS: OREXIGEN MEDIA INVESTORS Graham Cooper Stephen Gendel Jason Spark 858 436-8600 212 918-4650 619 849-6005
CONTACT: Graham Cooper, +1-858-436-8600, Stephen Gendel, +1-212-918-4650Jason Spark, +1-619-849-6005, all for Orexigen(TM) Therapeutics, Inc.
Web site: http://www.Orexigen.com/
Ticker Symbol: (NASDAQ-NMS:OREX)
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