SAN DIEGO, March 2 /PRNewswire-FirstCall/ -- Orexigen® Therapeutics, Inc. (Nasdaq: OREX), a biopharmaceutical company focused on the treatment of obesity, today announced the appointment of Peter K. Honig, MD, MPH to its board of directors. Dr. Honig brings over 20 years of clinical and regulatory policy experience from past roles with Merck & Company and the U.S. Food and Drug Administration (FDA). Most recently, he was Senior Vice President of Worldwide Regulatory Affairs and Product Safety at Merck & Company and co-Chair of Merck's Late Development Review Committee overseeing the company's late stage pipeline.
"Contrave® approval, pursuing potential partnerships and optimizing our launch plans are our top priorities," said Michael Narachi, President and Chief Executive Officer of Orexigen. "Peter brings direct, relevant experience in late stage development and global regulatory policy in primary care markets, expertise that will be valuable as Orexigen transitions to a commercial enterprise."
"The need for new effective therapies to manage the growing obesity epidemic is unquestionable. Orexigen has taken a thoughtful and proactive approach in developing Contrave with regulatory and commercial success clearly in mind," added Dr. Honig. "I look forward to being a member of the Orexigen board as the Company prepares to commercialize Contrave, develop Empatic™, and explore valuable lifecycle opportunities."
Prior to joining Merck, Dr. Honig was a Director in the Office of Drug Safety in the FDA's Center for Drug Evaluation and Research (CDER). He originally joined CDER as a medical officer in the Division of Oncology and Pulmonary Drug Products. Dr. Honig has served in various leadership roles in the American Society of Clinical Pharmacology and Therapeutics (ASCPT) including President, Vice President and member of the Board of Directors. He is the current PhRMA representative to the International Conference on Harmonization (ICH) Steering Committee.
Dr. Honig received his Bachelors, Medical and Public Health degrees from Columbia University in New York and is board certified in Internal Medicine and Clinical Pharmacology.
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 in the first half of 2010. 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.
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" 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: additional analyses of data from the Contrave Phase 3 trials and any other clinical trials of Contrave may produce negative or inconclusive results, or may be inconsistent with previously announced results or previously conducted clinical trials; the FDA may not agree with the Company's interpretation of efficacy and safety results; the FDA may require Orexigen to complete additional clinical, non-clinical or other requirements prior to the submission or the approval of NDA for Contrave; 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. All conclusions and determinations contained herein are subject to the Company's further analysis of the clinical data. The ultimate determination of the safety and efficacy of Contrave will be made by the FDA and other relevant regulatory authorities.
SOURCE Orexigen Therapeutics, Inc.
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"Contrave® approval, pursuing potential partnerships and optimizing our launch plans are our top priorities," said Michael Narachi, President and Chief Executive Officer of Orexigen. "Peter brings direct, relevant experience in late stage development and global regulatory policy in primary care markets, expertise that will be valuable as Orexigen transitions to a commercial enterprise."
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"The need for new effective therapies to manage the growing obesity epidemic is unquestionable. Orexigen has taken a thoughtful and proactive approach in developing Contrave with regulatory and commercial success clearly in mind," added Dr. Honig. "I look forward to being a member of the Orexigen board as the Company prepares to commercialize Contrave, develop Empatic™, and explore valuable lifecycle opportunities."
Prior to joining Merck, Dr. Honig was a Director in the Office of Drug Safety in the FDA's Center for Drug Evaluation and Research (CDER). He originally joined CDER as a medical officer in the Division of Oncology and Pulmonary Drug Products. Dr. Honig has served in various leadership roles in the American Society of Clinical Pharmacology and Therapeutics (ASCPT) including President, Vice President and member of the Board of Directors. He is the current PhRMA representative to the International Conference on Harmonization (ICH) Steering Committee.
Dr. Honig received his Bachelors, Medical and Public Health degrees from Columbia University in New York and is board certified in Internal Medicine and Clinical Pharmacology.
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 in the first half of 2010. 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.
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" 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: additional analyses of data from the Contrave Phase 3 trials and any other clinical trials of Contrave may produce negative or inconclusive results, or may be inconsistent with previously announced results or previously conducted clinical trials; the FDA may not agree with the Company's interpretation of efficacy and safety results; the FDA may require Orexigen to complete additional clinical, non-clinical or other requirements prior to the submission or the approval of NDA for Contrave; 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. All conclusions and determinations contained herein are subject to the Company's further analysis of the clinical data. The ultimate determination of the safety and efficacy of Contrave will be made by the FDA and other relevant regulatory authorities.
SOURCE Orexigen Therapeutics, Inc.
