SAN DIEGO, April 27 /PRNewswire-FirstCall/ -- Orexigen(R) Therapeutics, Inc. , a biopharmaceutical company focused on the treatment of obesity, today announced that Michael C. Scaife, Ph.D., has joined the organization as Senior Vice President of Regulatory Affairs and Product Development, Contrave(R) Program.
“Michael brings to Orexigen over 26 years of solid experience in biotechnology and pharmaceutical product development, including 15 successful product approvals by the FDA,” said Michael Narachi, the Company’s President and Chief Executive Officer. “His appointment is timely as our foremost priority is to submit to the FDA the highest quality NDA and bring Contrave, our lead obesity product candidate, to market expeditiously.”
In his role, Dr. Scaife will lead the development of Contrave (naltrexone sustained release (SR)/bupropion SR), which is on track for submission to the FDA in the first half of 2010. “I’m thrilled to join the Orexigen team, and I believe my development and regulatory experience will be invaluable as the Company works to help fill a significant unmet need in the fight against obesity,” said Dr. Scaife.
Dr. Scaife has worked in leadership roles for a variety of device, drug and biopharma companies in both Europe and the United States. Prior to joining Orexigen, Dr. Scaife was Principal of MChS Consultancy Inc., a leading pharmaceutical development services agency. He also served as Senior Vice President of Global Regulatory Affairs, Pharmacovigilance and Drug Safety, Drug Information Services, Compliance and Quality Operations at Chiron Biopharma. In addition, Dr. Scaife held the position of Vice President of Quality and Regulatory Affairs for Nektar Therapeutics, Vice President of Global Regulatory Affairs for Elan Pharmaceuticals, and various regulatory and clinical development positions for Novartis Pharma. Dr. Scaife began his career as the Regulatory and Medical Affairs Manager at Johnson & Johnson Medical Ltd., UK.
Dr. Scaife received a Ph.D. in Toxicology from Leicester School of Pharmacy, United Kingdom and a B.S. degree in Pharmacology from the University of Bath, United Kingdom.
About Orexigen 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” 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 enrollment, timing and completion of clinical trials of Contrave, and the potential to obtain regulatory approval for, and effectively treat obesity with, 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: the 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; the potential that earlier clinical trials may not be predictive of future results; Contrave may not receive regulatory approval on a timely basis or at all; 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; the ability of Orexigen and its licensors to obtain, maintain and successfully enforce adequate patent and other intellectual property protection of Contrave; 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.
CONTACT: Graham Cooper of Orexigen, +1-858-875-8600; or Media, Lori Rosen,
+1-212-301-7173, for Orexigen
Web site: http://www.orexigen.com/
