AMAG Pharmaceuticals, Inc. to Present Additional Positive Results from Phase III Studies of Ferumoxytol as an Intravenous Iron Replacement Therapeutic at National Kidney Foundation Spring Clinical Meetings
The first poster, "Evaluation of Ferumoxytol Safety and Efficacy in all Stages of Chronic Kidney Disease" presents results from the Company's three Phase III efficacy and safety studies, which included 875 patients with all stages of chronic kidney disease (CKD). Patients received either two doses of 510 mg intravenous (IV) ferumoxytol within approximately one week or 200 mg of oral iron daily for three weeks and were followed for 35 days. Efficacy and safety were assessed overall and by stage of kidney disease. The aggregate results demonstrated that there was a statistically significant greater mean increase in hemoglobin from baseline to Day 35 in patients receiving ferumoxytol compared to patients receiving oral iron (mean +/- standard deviation, ferumoxytol 1.04 +/- 1.22 g/dL vs. oral iron 0.43 +/- 1.04 g/dL, p=0.0115). When these results were stratified by stage of CKD, ferumoxytol treatment produced approximately a 1 g/dL increase in hemoglobin from baseline to Day 35 for each stage.
The second poster, "Evaluation of the Safety of Ferumoxytol IV Iron Therapy in Peritoneal Dialysis Patients," presents results from the Company's Phase III, randomized, double-blind, placebo-controlled, crossover safety study. Safety results were evaluated in 40 peritoneal dialysis patients, in 255 hemodialysis patients, and in 413 non-dialysis dependent patients. Patients received one IV injection of either 510 mg ferumoxytol or saline placebo at day zero and received the other treatment at day seven. Overall adverse event rates for patients on peritoneal dialysis were lower following ferumoxytol administration (12.5%) versus following placebo administration (20.5%), and drug-related adverse event rates were similar following ferumoxytol administration (5.0%) and placebo administration (7.7%).
"We are delighted to share additional positive analyses generated from our ferumoxytol pivotal studies at the NKF meeting this year," stated Brian J.G. Pereira, M.D., President and Chief Executive Officer of AMAG Pharmaceuticals. "We are committed to commercializing ferumoxytol for the treatment of iron deficiency anemia in CKD patients and look forward to a decision from the FDA in late October of this year regarding our New Drug Application."
Full abstracts are available on the NKF website at http://www.kidney.org/news/meetings/clinical/CM08_Abstracts.cfm.
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 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. The Company submitted a New Drug Application for marketing approval of ferumoxytol with the U.S. Food and Drug Administration in December 2007, which was accepted for filing in February 2008.
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 that do not describe historical facts, including but not limited to, statements regarding the potential commercialization of ferumoxytol and the expected FDA decision on the ferumoxytol NDA in late October 2008 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 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 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; and (6) other risks identified in our Securities and Exchange Commission filings. We caution you 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.
Carol Miceli, 617-498-3361
Posted: April 2008