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SAN DIEGO, April 27 /PRNewswire-FirstCall/ -- Orexigen(R) Therapeutics, Inc. (Nasdaq: OREX), 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 an
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