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AMAG Pharmaceuticals, Inc. (NASDAQ: AMAG), 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, today announced that eight abstracts on ferumoxtytol, its lead product candidate, have been accepted for presentation at the American Society of Nephrology (ASN) meeting to be held in San Francisco, CA, November 1-5, 2007.
At the ASN meeting, results will be presented on ferumoxytol, the Company's lead product candidate, which has been studied for use in the treatment of iron deficiency anemia in chronic kidney disease (CKD) patients. The results will include new data evaluating the safety and efficacy of ferumoxytol in CKD patients on hemodialysis, updated data evaluating the safety and efficacy of ferumoxytol in non-dialysis CKD patients, a preclinical biodistribution study, a plasma pharmacokinetic profile of ferumoxytol and a pharmacoeconomic profile comparing the use of ferumoxytol to oral iron. Full abstracts are available on the ASN website at http://www.asn-online.org .
"We are very excited to share additional data on ferumoxytol at the ASN meeting this year," stated Brian J.G. Pereira, M.D., President and Chief Executive Officer of AMAG Pharmaceuticals. "We are focused on bringing this new therapy to all CKD patients and remain on track to file our NDA for ferumoxytol as an intravenous iron replacement therapeutic in CKD patients during the fourth calendar quarter of this year."
The following abstracts will be presented as posters at this year's ASN meeting:
* R. Provenzano, et al. "Intravenous Ferumoxytol as Two IV Push Doses of 510 mg for Iron Replacement in Hemodialysis Patients", Friday, November 2, 2007, 10:00 am - 12:00 pm PT (Poster F-P0858b).
* R. Provenzano, et al. "Comparison of Two Regimens of Ferumoxytol for Treating Iron Deficiency Anemia in Hemodialysis Patients", Friday, November 2, 2007, 10:00 am - 12:00 pm PT (Poster F-P0859b).
* J. Lewis, et al. "Biodistribution of 59Fe-Labeled Ferumoxytol into Red Blood Cells Following Intravenous (IV) Administration in Rats", Friday, November 2, 2007, 10:00 am - 12:00 pm PT (Poster F-P0848).
* A. Singh, et al. "Safety of Ferumoxytol as Intravenous (IV) Iron Therapy for Iron Deficiency Anemia", Friday, November 2, 2007, 10:00 am - 12:00 pm PT (Poster F-P0857).
* W.K. Bolton, et al. "Ferumoxytol as an IV Iron Replacement Therapy: Efficacy Results from Two Phase III Studies in Subjects with Chronic Kidney Disease (CKD)", November 4, 2007, 10:00 am -12:00 pm PT (Poster SU-P0798).
* A. Besarab, et al. "Ferumoxytol as an Intravenous Iron Replacement Therapy: Safety Results from Two Phase III Studies in Subjects with Chronic Kidney Disease (CKD)", Sunday, November 4, 2007, 10:00 am - 12:00 pm PT (Poster SU-P0805).
* B. Spinowitz, et al. "Achievement of Target Hemoglobin with Ferumoxytol versus Oral Iron in Anemic CKD Patients", Sunday, November 4, 2007, 10:00 am - 12:00 pm PT (Poster SU-P01031).
* A. Pai, et al. "Plasma Pharmacokinetic (PK) Profile of Ferumoxytol in Healthy Subjects", Sunday, November 4, 2007, 10:00 am - 12:00 pm PT (Poster SU-P01032).
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 plans to file an NDA for marketing approval of ferumoxytol with the U.S. Food and Drug Administration during the fourth calendar quarter of 2007. The Company has previously released data on all four planned Phase III clinical trials of ferumoxytol as an intravenous iron replacement therapeutic in chronic kidney disease patients.
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. For further information about AMAG Pharmaceuticals please refer to http://www.amagpharma.com .
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 of our intent to bring ferumoxytol to CKD patients and that we are on track and 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) uncertainties relating to our patents and proprietary rights; and (5) 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.
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AMAG Pharmaceuticals, Inc.
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