Healthcare Industry News: intravenous iron replacement
News Release - August 6, 2007
AMAG Pharmaceuticals, Inc. Announces Appointment of Lee F. Allen, M.D., Ph.D. as Chief Medical Officer and Senior Vice President of Clinical DevelopmentCAMBRIDGE, Mass.--(HSMN NewsFeed)--AMAG Pharmaceuticals, Inc. (NASDAQ: AMAG ) today announced the appointment of Lee F. Allen, M.D., Ph.D. to the position of Chief Medical Officer and Senior Vice President of Clinical Development. Dr. Allen brings over 20 years of medical and clinical development experience to the Company, having most recently served as Vice President of Clinical Research and Development of Wyeth Pharmaceuticals. In his new position at AMAG Pharmaceuticals, Dr. Allen will be responsible for the Company's clinical development and regulatory activities. Dr. Allen will also lead the continued advancement of the Company's drug and imaging development strategies.
"Lee's extensive medical and clinical development experience is important as we seek to file the New Drug Application for ferumoxytol as an IV iron replacement therapy in chronic kidney disease patients with the U.S. Food and Drug Administration during the fourth quarter of this year and as we seek to pursue opportunities for additional indications and geographies for ferumoxytol," stated Brian J.G. Pereira, M.D., President and CEO of AMAG Pharmaceuticals, Inc. "Lee has a proven track record in building a robust product development portfolio and a strong clinical development group. We are very pleased to welcome him to the management team at AMAG Pharmaceuticals."
Prior to joining AMAG Pharmaceuticals, Dr. Allen was at Wyeth Pharmaceuticals, where he established Cambridge as Wyeth's Center of Excellence for Oncology clinical development. Under his global leadership, Wyeth's Oncology group successfully advanced its product candidate portfolio bringing new products to market and managing as many as 13 compounds in clinical development simultaneously. Prior to joining Wyeth, Dr. Allen held positions of increasing responsibility at Pfizer and BASF's Knoll Pharmaceutical Company. Prior to entering the pharmaceutical industry in 1997, he was a faculty member at Duke University Medical Center and at the University of Utah's Huntsman Cancer Institute. Dr. Allen received his Ph.D. and subsequently his M.D. from the University of Medicine and Dentistry of New Jersey. His work has been published in several scientific journals including the Proceeding of the National Academy of Sciences, Nature and Science.
About AMAG Pharmaceuticals, Inc.
AMAG Pharmaceuticals, Inc. is a biopharmaceutical company that utilizes its proprietary nanoparticle technology for the development and commercialization of therapeutic iron compounds to treat anemia, as well as novel imaging agents to aid in the diagnosis of cancer and cardiovascular disease.
Ferumoxytol, the Company's lead product candidate, is being developed for use as an intravenous iron replacement therapeutic for the treatment of iron deficiency anemia in chronic kidney disease patients. The Company has released data on all four planned Phase III clinical trials of ferumoxytol as an intravenous iron replacement therapeutic in chronic kidney disease patients.
Combidex®, the Company's other product under development, is an investigational functional molecular imaging agent consisting of iron oxide nanoparticles for use in conjunction with MRI to aid in the differentiation of cancerous from normal lymph nodes. In March 2005, the Company received an approvable letter from the FDA with respect to Combidex, subject to certain conditions.
This document contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 and federal securities laws. Any statements contained in this press release that do not describe historical facts, including but not limited to, statements regarding our pursuit of additional indications and geographies for ferumoxytol, and our plan to file an NDA for ferumoxytol with the FDA during the fourth calendar quarter of 2007, are forward-looking statements that involve risks and uncertainties that could cause actual results to differ materially from those discussed in such forward-looking statements. Such risks and uncertainties include the following: (1) the possibility that we may not be able to successfully complete the development of ferumoxytol, or may not be able to complete the development in a timely or cost-effective manner, due to deficiencies in the design or oversight by us of these trials, the failure of our trials to demonstrate that ferumoxytol is safe and efficacious, inadequate performance by third-party service providers, or any other factor causing an increase in expenses, a delay and/or a negative effect on the results of the clinical studies for ferumoxytol; (2) the possibility that we may not be able to obtain the necessary regulatory approvals in order to market and sell ferumoxytol, or we may not obtain such approvals in a timely manner; (3) the fact that we have limited sales and marketing expertise; (4) the possibility that we may not be able to timely or cost-effectively resolve the questions raised by the FDA and satisfy the conditions specified for approval of Combidex, including the provision of additional data or the conduct of additional clinical trials to demonstrate the efficacy of Combidex; (5) uncertainties relating to our patents and proprietary rights; and (6) other risks identified in our Securities and Exchange Commission filings. We caution readers not to place undue reliance on any forward-looking statements which speak only as of the date they are made. We disclaim any obligation to publicly update or revise any such statements to reflect any change in expectations or in events, conditions or circumstances on which any such statements may be based, or that may affect the likelihood that actual results will differ from those set forth in the forward-looking statements.
Source: AMAG Pharmaceuticals
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