SAN DIEGO, Oct. 14 /PRNewswire-FirstCall/ -- Orexigen(R) Therapeutics, Inc. , a biopharmaceutical company focused on the treatment of obesity and other central nervous system-related disorders, today announced that it has received a Notice of Allowance from the United States Patent and Trademark Office (USPTO) for what the Company refers to as the "Weber/Cowley methods patent" (U.S. patent application no.11/356,839) which provides coverage for Contrave(R), the Company's lead obesity product candidate now in Phase 3 clinical trials.
Upon issuance, the patent will broadly cover methods of treating obesity with combinations of bupropion and naltrexone, the two active agents in Contrave. It is a companion to the Weber/Cowley composition patent (U.S. 7,375,111) which was issued by the USPTO in May 2008, which broadly covers sustained release (SR) compositions of bupropion and naltrexone combined in a single dosage form. It is anticipated that the Weber/Cowley methods patent will provide protection for Contrave through mid 2024.
"This patent represents another successful milestone for Orexigen. Upon issuance, Contrave would be protected by four patents that collectively will provide broad intellectual property coverage," said Orexigen President and CEO, Gary Tollefson, M.D., Ph.D. "With this additional patent allowance, we have added another layer of protection in support of Contrave which we believe enhances its net present value."
Contrave is an investigational weight loss medication with a mechanism of action that works at two sites within the central nervous system. The first is a hypothalamic site that controls the balance of food intake and metabolism. We believe that Contrave is possibly the first treatment for obesity to address a second site, the reward systems in the brain that are associated with food preference and food cravings. In clinical trials, Contrave has initiated and sustained significant weight loss over one year of treatment (approximately 8-10.7% in patients completing 48 weeks of therapy) we believe by reducing appetite, increasing metabolism and offsetting the body's natural tendency to fight back and slow down the weight loss process. We expect to announce data from the first of our Contrave Phase 3 trials in January of 2009 and the remaining three trials by mid next year.
About Orexigen Therapeutics
Orexigen Therapeutics, Inc. is a biopharmaceutical company focused on the treatment of obesity and other central nervous system-related disorders. The Company's lead combination product candidates targeted for obesity are Contrave, which is in Phase 3 clinical trials, and Empatic(TM), which is in the later stages of Phase 2 clinical development. 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. Beyond obesity, Orexigen is developing drug combinations for use in schizophrenia and obsessive-compulsive disorder. Further information about the company can be found at http://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," "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.
CONTACT: Graham Cooper of Orexigen, +1-858-875-8600, or media, Liz Frank,
+1-212-301-7216, for Orexigen Therapeutics, Inc.
Web site: http://www.Orexigen.com/
