SAN DIEGO, Calif. and RESEARCH TRIANGLE PARK, N.C., March 12 /PRNewswire-FirstCall/ -- Orexigen® Therapeutics, Inc. (Nasdaq: OREX), a biopharmaceutical company focused on the treatment of obesity, and Patheon Inc. (TSX: PTI), a global provider of drug development and manufacturing services, announced today a long-term agreement for commercial manufacturing of Contrave® (naltrexone HCL sustained release (SR)/bupropion HCL SR) as well as development of future formulations of Orexigen products. The financial terms of the deal were not disclosed.
"Patheon's manufacturing capabilities provide us a proven platform to help ensure successful market entry and stable commercial supply of Contrave in the event it is approved," said Mike Narachi, President and CEO of Orexigen. "This relationship also provides the means to accelerate the development and commercialization of next generation formulations of Orexigen products."
"We have crafted a strategic, long-term partnership predicated on a shared commitment to maximizing the potential of Contrave and Empatic and to the mission of addressing the significant health issue of obesity," said Wes Wheeler, President and CEO of Patheon.
About Orexigen Therapeutics
Orexigen Therapeutics, Inc. is a biopharmaceutical company focused on the treatment of obesity. The Company's lead investigational product, Contrave®, has completed Phase 3 clinical trials and is on track for a regulatory submission with the FDA by the end of April. The Company's second product, Empatic™, has completed 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, through combination therapeutic approaches. Further information about the Company can be found at http://www.Orexigen.com.
Patheon Inc. is a leading global provider of contract development and manufacturing services to the global pharmaceutical industry. Patheon prides itself in providing the highest quality products and services to approximately 300 of the world's leading pharmaceutical and biotechnology companies. Patheon's services range from preclinical development through commercial manufacturing of a full array of dosage forms including parenteral, solid, semi-solid and liquid forms. Patheon uses many innovative technologies including single-use disposables, multi-layer tablets, pre-filled syringes and a variety of modified release technologies.
Patheon's comprehensive range of fully integrated Pharmaceutical Development Services includes pre-formulation, formulation, analytical development, clinical manufacturing, scale-up and commercialization. Patheon can take customers directly to the clinic with global clinical packaging and distribution services and Patheon's Quick to Clinic™ programs can accelerate early phase development project to clinical trials while minimizing the consumption of valuable API.
Patheon, with an integrated development and manufacturing network of 11 facilities and eight development centers across North America and Europe, strives to ensure that customer products can be launched with confidence anywhere in the world.
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 potential for, and timing of, filing an NDA for 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: risks inherent in the continued analyses of clinical trial results, including Contrave Phase 3 trials; the uncertainty of the FDA approval process and other regulatory requirements; the therapeutic and commercial value of Contrave and Empatic; reliance on third parties to assist with the development of Contrave and Empatic and the regulatory submissions related thereto; the potential for adverse safety findings relating to Contrave or Empatic; 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.
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|SOURCE Orexigen Therapeutics, Inc.|
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