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Posted: January 8, 2008
AMAG Pharmaceuticals, Inc. Reports on Progress Toward Commercialization and Discusses Key Activities for 2008 at 26th Annual JPMorgan Healthcare Conference
(Nanowerk News) AMAG Pharmaceuticals, Inc. (NASDAQ: AMAG) today announced that Brian J.G. Pereira, MD, President and CEO of AMAG Pharmaceuticals, Inc., will provide a company update at the 26th Annual JPMorgan Healthcare Conference at 11:00 a.m. PT on Tuesday, January 8, 2008, at the Westin St. Francis Hotel in San Francisco, CA.
Brian J.G. Pereira, MD, President and CEO, will present a market overview and discuss commercialization opportunities for ferumoxytol, the Company's key product candidate being developed as an intravenous iron replacement therapy for the treatment of iron deficiency anemia in patients with chronic kidney disease (CKD). Dr. Pereira will also discuss additional opportunities for ferumoxytol in oncology and women's health.
Highlights of the presentation will include:
The current and future market opportunity, commercialization strategy and growth opportunities for ferumoxytol in CKD and other indications.
The role of ferumoxytol in anemia management including its safety, efficacy and convenience profile and the increased focus on optimizing iron therapy for anemia management.
Details of two new planned clinical trials for ferumoxytol in chemotherapy-induced anemia (CIA) and abnormal uterine bleeding (AUB) scheduled to begin in mid 2008.
Preparation for the anticipated U.S. ferumoxytol launch in the first half of 2009.
Analyst day event planned for the second quarter of 2008.
A live webcast of the presentation will be accessible through the Investors section of the Company's web site at www.amagpharma.com. Following the conference, the webcast will be archived on the AMAG Pharmaceuticals, Inc. web site until February 8, 2008.
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 filed a New Drug Application for ferumoxytol with the U.S. FDA in December 2007.
Combidex(R), 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, AMAG Pharmaceuticals, Inc. received an approvable letter from the U.S. Food and Drug Administration with respect to Combidex subject to certain conditions.
About Chronic Kidney Disease
Kidney disease is the ninth leading cause of death in the United States(1). 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 patients(2).
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 our potential ferumoxytol opportunities in oncology and women's health, new clinical trials for ferumoxytol in CIA and AUB scheduled to begin in mid 2008, the anticipated ferumoxytol launch in the first half of 2009 and a potential analyst day event in the second quarter of 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; (2) the fact that we have limited sales and marketing expertise; (3) uncertainties relating to our patents and proprietary rights; and (4) 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.
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.