The latest news from academia, regulators
research labs and other things of interest
Posted: February 19, 2008
AMAG Pharmaceuticals, Inc. Announces FDA Acceptance for Filing of Ferumoxytol New Drug Application
(Nanowerk News) AMAG Pharmaceuticals, Inc. (NASDAQ: AMAG) today announced that the New Drug Application (NDA) for ferumoxytol in chronic kidney disease (CKD) has been accepted for standard review by the U.S. Food and Drug Administration (FDA). The Company is seeking marketing approval for ferumoxytol as an intravenous treatment of iron deficiency anemia in patients with CKD, including dialysis dependent and non-dialysis dependent patients. The Company expects FDA action on the NDA by late October 2008.
The NDA is supported by data from four Phase III studies, which consisted of three open-label, multi-center, randomized efficacy and safety clinical studies and a fourth double-blind, multi-center, randomized, placebo-controlled safety study. The results of each of the three efficacy and safety studies demonstrated a statistically significant achievement of all primary and secondary efficacy endpoints. In total, over 1,700 patients and healthy volunteers were treated with ferumoxytol in the Company’s eleven clinical studies.
“We are very pleased to receive the acceptance for filing of our NDA for ferumoxytol,” stated Brian J.G. Pereira, M.D., President and Chief Executive Officer of AMAG. “We believe that ferumoxytol has the potential to address the treatment of iron deficiency anemia in CKD patients and provide a more convenient and efficient method of intravenous iron administration.”
About Chronic Kidney Disease
Kidney disease is the ninth leading cause of death in the United States1. CKD is associated with premature mortality, decreased quality of life, and increased health care expenditures. CKD can progress to end-stage renal disease and require dialysis or kidney transplantation. The U.S. Renal Data System estimated that in 2005 the dialysis population was over 340,000 patients2.
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 key product candidate, is being developed for use as an intravenous iron replacement therapeutic for the treatment of iron deficiency anemia in patients with CKD. The Company has released data on all four of its planned Phase III clinical trials of ferumoxytol as an intravenous iron replacement therapeutic in patients with CKD. The Company submitted the NDA to the FDA in December 2007.
1. Arias E, Anderson RN, Kung HC, Murphy SL, Kockanek KD. Deaths: Final data for 2001. National Vital Statistics Reports 2003;52(3):1-115.
2. End-Stage Renal Disease Incidence and Prevalence: United States Renal Data Systems 2007 Annual Data Report. 2007, pp 81-98.
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 that we believe ferumoxytol has the potential to address iron deficiency anemia in CKD patients and provide a more convenient and efficient method of intravenous iron administration, 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 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 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.