Healthcare Industry News: intravenous iron replacement
News Release - May 19, 2008
AMAG Pharmaceuticals, Inc. Announces Appointment of Robert M. Brenner, M.D. as Senior Vice President of Medical AffairsCAMBRIDGE, Mass.--(HSMN NewsFeed)--AMAG Pharmaceuticals, Inc. (NASDAQ: AMAG ) today announced the appointment of Robert M. Brenner, M.D. to the position of Senior Vice President of Medical Affairs. Dr. Brenner brings nearly a decade of clinical development and medical affairs experience to the Company, having served most recently as Executive Director and Global Renal Anemia Program Area Leader at Amgen Inc. Dr. Brenner will be responsible for the Company’s medical affairs and nephrology clinical development activities.
“Dr. Brenner’s extensive knowledge and experience in building strong teams, working with different government agencies and his relationships with the nephrology community will be invaluable as we plan for the expected launch of ferumoxytol in the first quarter of 2009,” commented Brian J.G. Pereira, MD, President and CEO of AMAG Pharmaceuticals, Inc. “The addition of Rob strengthens our management team as we continue our transition to a commercial biopharmaceutical company,” concluded Dr. Pereira.
Prior to joining AMAG Pharmaceuticals, Dr. Brenner was at Amgen for nine years where he served in a variety of nephrology leadership roles both in clinical development and medical affairs. During his career at Amgen, Dr. Brenner contributed to the approval of new products, led the design of clinical trials, and was a key liaison to the nephrology community, professional societies and regulatory agencies. Dr. Brenner received his B.A. from Johns Hopkins University and his M.D. from Albert Einstein College of Medicine. He completed his medical residency in internal medicine at the Brigham and Women’s Hospital in Boston and his fellowship in nephrology at Stanford University Medical Center.
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 and novel imaging agents to aid in the diagnosis of cancer and cardiovascular disease.
Ferumoxytol, the Company’s key product candidate, is being developed for use as an intravenous iron replacement therapeutic agent 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 agent in chronic kidney disease patients. The Company submitted a New Drug Application for marketing approval of ferumoxytol with the U.S. Food and Drug Administration (FDA) in December 2007, which was accepted for filing by the FDA in February 2008.
Forward Looking Statements
This document contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 and other federal securities laws. Any statements contained in this press release that do not describe historical facts, including but not limited to statements regarding the expected U.S. launch of ferumoxytol in the first quarter of 2009 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 obtain the necessary regulatory approvals in order to market and sell ferumoxytol, or we may not obtain such approvals in a timely 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, or any other factor causing an increase in expenses, a delay and/or a negative effect on the results of the clinical studies or the prospects of regulatory approval for ferumoxytol; (2) the fact that we have limited sales and marketing expertise; (3) uncertainties regarding our ability to successfully compete in the intravenous iron replacement therapy market; (4) uncertainties regarding our ability to obtain favorable coverage, pricing and reimbursement for ferumoxytol, if approved; (5) uncertainties regarding our ability to manufacture sufficient quantities of ferumoxytol to meet demand, if approved; (6) uncertainties relating to our patents and proprietary rights; and (7) 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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