OREXIGEN Therapeutics Initiates Fourth Phase III Trial For Contrave(TM) To Treat Obesity

Main Category: Obesity / Weight Loss / Fitness
Also Included In: Clinical Trials / Drug Trials
Article Date: 13 Dec 2007 - 3:00 PDT

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Orexigen Therapeutics, Inc. (Nasdaq: OREX), a biopharmaceutical company focused on the treatment of central nervous system disorders including obesity, today announced the initiation of the fourth trial in its Phase III clinical trial program for its lead product candidate Contrave™ as a treatment for obesity. The program includes a set of four Phase III trials evaluating a variety of obesity-related outcome measures, which together are expected to support the New Drug Application (NDA) for review and potential approval of Contrave by the US Food and Drug Administration (FDA).

This clinical trial is a 56-week study intended to assess the safety, tolerability and efficacy of Contrave in generally healthy, nondiabetic, obese patients. A unique aspect of this trial design is the blinded re-randomization of any Contrave patients who have not responded at week 28 to receive either a higher dose of Contrave or continue on the patient's original dose. The trial will take place at approximately 50 centers nationwide and is expected to enroll approximately 1500 individuals. Patient recruitment for the Contrave trials is now underway. Please see http://www.clinicaltrials.gov for more information.

"Contrave is a unique approach to weight loss that is based on our understanding of the brain as the master regulator of body weight-including appetite, energy expenditure, and the reward-based aspects of eating," said Gary Tollefson, M.D., Ph.D., Orexigen President and CEO. "With this study, Orexigen hopes to provide clinicians and patients with important information on dosing options in the event of a non-response to an initiation dose. This is the final Phase III clinical trial and we are pleased to have initiated each Phase III clinical trial on schedule in support of an NDA submission for Contrave in the second half of 2009."

Contrave is a proprietary fixed dose combination of bupropion SR (sustained release) and the company's novel formulation of naltrexone SR in a single tri-layer tablet. Orexigen chose these two constituent drugs based on the results of its model used to screen potential drug combinations and the company's understanding of circuitries in the brain that regulate appetite and energy balance. In a previous 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.

In April, Orexigen initiated enrollment in the first of its four Phase III clinical trials, a 56-week study designed to evaluate the weight loss potential of Contrave alone or when combined with intense diet, exercise and behavior modification. This trial is taking place at nine centers nationwide and has completed enrollment.

In May, Orexigen initiated enrollment in its second Phase III clinical trial, a 56-week study designed to assess both the safety and efficacy of Contrave in obese subjects who also have been diagnosed with Type II diabetes. Recent studies have demonstrated that obesity is a leading risk factor for various metabolic disorders, such as diabetes, and this trial is designed to evaluate weight loss and factors related to glucose metabolism. The trial is taking place at approximately 50 centers nationwide and is expected to enroll approximately 525 patients.

In October 2007, Orexigen initiated enrollment in its third Phase III clinical trial, a 58-week study designed to assess the safety, tolerability and efficacy of Contrave in generally healthy, nondiabetic, obese patients. The trial is designed to take place at approximately 40 centers nationwide and is expected to enroll approximately 1650 patients.

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. The Orexigen lead combination product candidates targeted for obesity are Contrave™, which is in Phase III clinical trials, and Empatic™, which is in the later stages of Phase II development. Both product candidates are designed to 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. Words such as "believes," "anticipates," "plans," "expects," "indicates," "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 enrollment of Phase III clinical trials and the efficacy and safety of Contrave, and the potential to obtain regulatory approval for, and effectively treat obesity with, Contrave. 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 progress and timing of the company'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 Contrave to delay or prevent regulatory approval or commercialization, or result in product liability claims; the potential that the scientific theories of Orexigen relating to the effects that Contrave may have on metabolic and behavioral indicators associated with obesity; 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 described in the company's filings with the Securities and Exchange Commission (SEC), including those detailed under the heading "Risk Factors" in company's Quarterly Report on Form 10-Q for the quarter ended September 30, 2007 filed with the SEC on November 9, 2007. 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. 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.

Orexigen Therapeutics