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Orexigen® Therapeutics Issued a Key U.S. Patent Covering Composition of Contrave® into 2025


Tuesday, May 27, 2008

San Diego, CA -- Orexigen® Therapeutics, Inc. (Nasdaq: OREX), a biopharmaceutical company focused on the treatment of central nervous system disorders, including obesity, today announced that the U.S. Patent and Trademark Office (USPTO) issued U.S. Patent Number 7,375,111 with broad claims covering sustained release (SR) compositions of bupropion and naltrexone combined in a single dosage form. These two drugs are the active constituents in Contrave®, the Company’s lead obesity product candidate, now in Phase III clinical trials. Naltrexone SR, a proprietary formulation developed by Orexigen, was designed to improve patient tolerability by altering the pharmacokinetic profile of the original product.

The patent, referred to by the Company as the Weber/Cowley composition patent, provides protection for Contrave through March 2025. Allowance of this patent was first announced in January, and similar claims covering the composition and use of bupropion and naltrexone for affecting weight loss have also been allowed by the European Patent Office.

"The U.S. composition of matter patent significantly improves the net present value of the Contrave program. We now have exclusive rights to all uses and doses of Contrave for an additional 12 years," said Orexigen President and CEO, Gary Tollefson, M.D., Ph.D. "This is part of a broad patent portfolio that we believe gives us a strong intellectual property position for our lead product candidate."

Results from the first Contrave Phase III clinical trial are anticipated in late 2008 or early 2009 and the filing of a New Drug Application (NDA) with the FDA is projected for late 2009. Bupropion and naltrexone were selected as the components of Contrave based on pre-clinical trials that showed their ability to both initiate and sustain weight loss when used together. Moreover, these constituents also target the brain’s reward center that influences what, when and how much we eat. In a Phase IIb clinical trial, Contrave, in the absence of a significant diet or exercise regimen, demonstrated weight loss at 48 weeks ranging from 8.0% to 10.7% across the three dosage groups among patients who completed the trial.

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™, which is in the later stages of Phase II clinical 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," "projects" 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 enrollment, timing, execution and completion of clinical trials of Contrave, the timing of an NDA submission with the FDA for Contrave, the efficacy and safety of Contrave, the potential to obtain regulatory approval for, and effectively treat obesity with, Contrave, and the potential issuance of patents and the scope and duration of protection of issued patents relating to the Company'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 the Company's business, including, without limitation: the progress and timing of the Company's Contrave clinical trials or the development of Contrave; the potential that earlier clinical trials may not be predictive of future results; the potential for adverse safety findings relating to Contrave to delay or prevent regulatory approval or commercialization, or result in product liability claims; Orexigen or 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). 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.



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