SAN DIEGO, June 11 /PRNewswire-FirstCall/ -- Orexigen(R) Therapeutics, Inc. (Nasdaq: OREX), a biopharmaceutical company focused on the treatment of obesity, today announced the licensing of certain intellectual property (IP) from GlaxoSmithKline (GSK) that expands the Company's IP position underlying Contrave, its lead product candidate for the treatment of obesity.
"This license agreement with GSK complements the IP foundation of Contrave, providing us with additional product formulation options as we pursue regulatory approval and potential commercialization of Contrave," said Michael Narachi, President and Chief Executive Officer, Orexigen Therapeutics.
In exchange for undisclosed upfront and future milestone payments, Orexigen secured non-exclusive rights to certain formulation patents related to bupropion, one of the constituents of Contrave. The transaction is not expected to materially impact the Company's financial position. Top line results of the first of four Phase 3 clinical trials for Contrave, NB-302, were announced January 2009. Results from the three other Phase 3 clinical trials (NB-301, NB-303, NB-304) are expected to be announced in the third quarter of 2009. Pending positive results, the Company is on track to submit a New Drug Application (NDA) with the FDA in the first half of 2010.
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(R), 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.
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 scope and duration of intellectual property protection for Contrave, the timing of completion and announcement of results for the remaining Phase 3 clinical trials for Contrave, the potential for, and timing of, an NDA submission for Contrave, the potential to obtain regulatory approval for, and effectively treat obesity with, Contrave, the potential to commercialize Contrave and the expected impact of the license agreement with GSK on Orexigen's financial position. 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: Orexigen and its licensors may not be able to obtain, maintain and successfully enforce adequate patent and other intellectual property protection of Contrave; the final analyses of data from the remaining clinical trials of Contrave may produce negative or inconclusive results, or may be inconsistent with previously conducted clinical trials, and the FDA may not agree with the Company's interpretation of efficacy and safety results; earlier clinical trials may not be predictive of future results; Contrave may not receive regulatory approval on a timely basis or at all, and the FDA may require Orexigen to complete additional clinical, non-clinical or other requirements prior to the submission or the approval of NDAs for either product candidate; the potential for adverse safety findings relating to Contrave to delay or prevent regulatory approval or commercialization, or result in product liability claims; the third parties on whom Orexigen relies to assist with the development programs for Contrave, including clinical investigators, contract laboratories, clinical research organizations and manufacturing organizations, may not successfully carry out their contractual duties or obligations or meet expected deadlines, and the quality or accuracy of the data or materials generated by such third parties may be of insufficient quality to include in the Company's regulatory submissions; and other risks described in the Company's 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, 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.
SOURCE Orexigen Therapeutics, Inc.
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