SAN DIEGO, Jan. 5 /PRNewswire-FirstCall/ -- Orexigen(R) Therapeutics, Inc. , a biopharmaceutical company focused on the treatment of obesity, today announced that the United States Patent and Trademark Office (USPTO) has issued a patent for what the Company refers to as the “Weber/Cowley methods patent” (U.S. Patent No. 7,462,626), which provides coverage for Contrave(R), the Company’s lead obesity product candidate now in Phase 3 clinical trials.
The patent broadly covers 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. Patent No. 7,375,111) which was issued by the USPTO in May 2008 and broadly covers sustained release (SR) compositions of bupropion and naltrexone combined in a single dosage form. The Weber/Cowley methods patent will provide protection for Contrave through mid 2024.
“The issuance of this patent adds another layer of protection for Contrave, which we believe enhances its net present value,” said Eckard Weber, M.D., the Company’s Interim President and CEO. “Contrave is now protected by four patents that we believe will provide broad intellectual property coverage.”
About Contrave(R)
Contrave is an investigational oral weight loss medication with a mechanism of action that works at two levels within the central nervous system: one that controls the balance of food intake and metabolism and another which controls food preference and cravings (also known as the reward center). In fact, we believe that Contrave may be the first treatment for obesity to target these reward centers. In clinical trials, Contrave is believed to initiate and sustain significant weight loss over one year of treatment we believe by reducing appetite, increasing metabolism and allowing the body to continue losing weight by offsetting its natural tendency to fight back and slow down the weight loss process. Contrave is being studied in four Phase 3 trials, all of which have completed enrollment. We expect to provide results from all four Phase 3 trials by mid-2009. We remain on target to file a New Drug Application (NDA) with the FDA in late 2009.
About Orexigen(R) Therapeutics
Orexigen Therapeutics, Inc. is a biopharmaceutical company focused on the treatment of obesity. 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. 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.
CONTACT: Graham Cooper of Orexigen Therapeutics, Inc., +1-858-875-8600; or
Media, Liz Frank, +1-212-301-7216, for Orexigen Therapeutics, Inc.
Web site: http://www.Orexigen.com/
