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OREXIGEN(TM) Therapeutics to Present CONTRAVE(TM) Clinical Summary at CBI's 3rd Annual Obesity Drug Development Summit

Posted on: Friday, 27 July 2007, 09:05 CDT

Orexigen™ Therapeutics, Inc. (NASDAQ: OREX), a biopharmaceutical company focused on the treatment of central nervous system (CNS) disorders including obesity, will be presenting today at The Center for Business Intelligence's (CBI) 3rd Annual Obesity Drug Development Summit. Ronald Landbloom, M.D., Vice President of Medical and Regulatory Affairs at Orexigen, will discuss a summary of clinical trial results to date on Contrave™, the Company's lead obesity drug candidate.

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. Contrave is designed to act on neurons in the brain to suppress appetite, decrease food craving and sustain weight loss.

In April, Orexigen initiated enrollment in its first Phase III clinical trial for Contrave, a 56-week trial intended to evaluate Contrave's weight loss potential alone or when combined with intense diet, exercise and behavior modification. This trial is taking place at nine centers nationwide and plans to enroll approximately 800 subjects. Orexigen has also initiated another 56-week Phase III trial intended to assess both the safety and efficacy of Contrave in obese subjects who also manifest Type II diabetes. This trial will take place at approximately 40 centers nationwide and is designed to enroll approximately 525 individuals. Patient recruitment is now underway. Additionally, two large phase III trials are scheduled to start in the 3rd and 4th quarters of 2007. Please see www.clinicaltrials.gov for more information.

About Orexigen Therapeutics

Orexigen Therapeutics, Inc. is a biopharmaceutical company focused on the development of pharmaceutical product candidates for the treatment of central nervous system disorders including obesity. Orexigen's lead combination product candidates targeted for obesity are Contrave, which is in Phase III clinical trials, and Empatic™ (formerly Excalia™), which is in a Phase IIb clinical trial. Both product candidates take advantage 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. These forward-looking statements include statements regarding the efficacy and safety of Contrave, and the potential to obtain regulatory approval for, and effectively treat obesity with, any of Orexigen's product candidates. 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 Orexigen's business, including, without limitation: the progress and timing of Orexigen's clinical trials; the potential that earlier clinical trials may not be predictive of future results; the ability for Contrave to receive regulatory approval on a timely basis or at all; the potential for adverse safety findings relating to Empatic or Contrave to delay or prevent regulatory approval or commercialization, or result in 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 this 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.

Source: Business Wire

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