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™ (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™ (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.
AMAG Pharmaceuticals, Inc.
Kristen Galfetti, 617-498-3362
kgalfetti@amagpharma.com