AMAG Pharmaceuticals, Inc. (NASDAQ: AMAG) announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation to ferumoxytol for its development as a diagnostic agent for Vascular-Enhanced Magnetic Resonance Imaging (VE-MRI) to improve the assessment of peripheral arterial disease in patients with known or suspected chronic kidney disease (CKD). If approved for an imaging indication, ferumoxytol could offer an alternative to gadolinium-based contrast agents, which are required to contain a black box warning highlighting the risks of using gadolinium-based agents in patients with advanced kidney disease.
“We are very pleased that the FDA has recognized ferumoxytol’s potential to address an important unmet medical need for a safe agent that facilitates the diagnosis of arterial abnormalities in patients with compromised kidney function,” stated Brian J.G. Pereira, MD, President and CEO of AMAG Pharmaceuticals, Inc. “We plan to initiate a Phase II study of ferumoxytol for VE-MRI for the detection of clinically significant arterial stenosis or occlusion in subjects with intermittent claudication (leg pain with walking) in the third quarter of 2008. We look forward to continuing our collaborative relationship with the FDA in the ongoing development of ferumoxytol.”
Fast Track is a designation that the FDA reserves for products intended to treat a serious or life threatening condition and that demonstrate the potential to address unmet medical needs for that condition. The Fast Track process is designed to facilitate the development and expedite the review of these products, and the FDA has a number of pathways intended to meet these goals, including more frequent interactions with the FDA throughout the development process. In addition, sponsors of drugs that receive Fast Track designation can file a new drug application (NDA) on a rolling basis as data become available and have the possibility to be considered for Priority Review, which could reduce the time it takes the FDA to review the NDA from ten to six months. Fast Track designation is intended to bring valuable treatments more quickly to patients in need.
About AMAG Pharmaceuticals, Inc.
AMAG Pharmaceuticals, Inc. is a biopharmaceutical company that utilizes its proprietary 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 and as a diagnostic agent for vascular-enhanced magnetic resonance imaging to assess peripheral arterial disease. The Company submitted an NDA for marketing approval of ferumoxytol as an intravenous iron replacement therapy in chronic kidney disease patients with the FDA in December 2007. The Company expects FDA action on its NDA in the second half of October 2008. amagpharma
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 herein which do not describe historical facts, including but not limited to, statements regarding the expected date of initiation of a Phase II clinical trial of ferumoxytol for VE-MRI in the third quarter of 2008 and our expectation of FDA action on our ferumoxytol NDA in the second half of October 2008 are forward looking statements which 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:
(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 our clinical trials, the failure of our trials to demonstrate that ferumoxytol is safe and effective, or any other factor causing an increase in expenses, a delay and/or a negative effect on the results of our clinical studies or the prospects for regulatory approval of 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 and imaging markets, (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, including our most recent Annual Report on Form 10-K.
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.
AMAG Pharmaceuticals, Inc.