LEXINGTON, Mass.--(BUSINESS WIRE)-- AMAG Pharmaceuticals, Inc. (NASDAQ:AMAG) today announced that it has not received an action letter from the U.S. Food and Drug Administration (FDA) for Feraheme(TM) (ferumoxytol) Injection for the treatment of iron deficiency anemia in adult chronic kidney disease patients. The Prescription Drug User Fee Act (PDUFA) action date was today, June 29, 2009. The FDA informed the Company that the Agency would not take action today, but expects to issue an action letter within the next few days. The FDA has not requested any additional information from the Company, and it is the Company's understanding that there are no outstanding issues regarding the Feraheme New Drug Application.
Conference Call and Webcast Access
AMAG Pharmaceuticals, Inc. will host a webcast and conference call tomorrow at 8:30 a.m. ET to discuss the announcement.
To access the conference call via telephone, please dial (866) 501-5516 from the U.S. or (702) 495-1202 for international callers. A telephone replay will be available from approximately 11:30 a.m. ET on June 30, 2009 through midnight July 2, 2009. To access a replay of the conference call, dial (800) 642-1687 from the U.S. or (706) 645-9291 for international access. The passcode for the live call and the replay is 17087311.
An audio webcast of the call will be available through the Investors section of the Company's website at www.amagpharma.com. A replay of the webcast will also be available from approximately 10:30 a.m. ET on June 30, 2009, through midnight July 6, 2009.
About AMAG Pharmaceuticals, Inc.
AMAG Pharmaceuticals, Inc. is a biopharmaceutical company that utilizes its proprietary technology for the development and commercialization of a therapeutic iron compound to treat anemia and novel imaging agents to aid in the diagnosis of cancer and cardiovascular disease.
Feraheme(TM) (ferumoxytol) Injection 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.
Forward Looking Statement
This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 and other federal securities laws. Any statements contained herein which do not describe historical facts, including but not limited to, statements regarding our expectation that the FDA will issue an action letter with respect to the Feraheme NDA in the next few days and that there are no outstanding issues regarding the Feraheme NDA, 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 adequately address the issues raised and provide the information requested in the Feraheme Complete Response letters, (2) uncertainties regarding our ability to manufacture Feraheme, (3) the fact that we have limited sales and marketing expertise, (4) uncertainties regarding our ability to successfully compete in the intravenous iron replacement and imaging markets, (5) uncertainties regarding our ability to obtain favorable coverage, pricing and reimbursement for Feraheme, 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 Annual Report on Form 10-K for the fiscal year ended December 31, 2008. 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.
Source: AMAG Pharmaceuticals, Inc.