AMAG Pharmaceuticals Announces FDA Acceptance of Supplemental New Drug Application for Feraheme Label Expansion to Include Iron

  AMAG Pharmaceuticals Announces FDA Acceptance of Supplemental New Drug
  Application for Feraheme Label Expansion to Include Iron Deficiency Anemia
  Patients Who Cannot Take Oral Iron

Business Wire

LEXINGTON, Mass. -- March 6, 2013

AMAG Pharmaceuticals, Inc. (NASDAQ: AMAG) today announced that the United
States Food and Drug Administration (FDA) has accepted for review the
company’s supplemental new drug application (sNDA) for Feraheme® (ferumoxytol)
Injection for Intravenous (IV) use, which was submitted to the FDA in December
2012. The sNDA requests FDA approval to expand the indication for ferumoxytol
beyond the current indication for the treatment of iron deficiency anemia
(IDA) in adult patients with chronic kidney disease (CKD) to adult patients
with IDA who have failed or could not take oral iron treatment. Under the
Prescription Drug User Fee Act (PDUFA) guidelines, the sNDA is subject to a
10-month review by the FDA. With the acceptance of the submission, the FDA has
set October 21, 2013 as a target date for completion of their review.

“Now that our sNDA has been accepted, we look forward to working with the
Agency to ensure a timely review of our submission,” said William Heiden,
president and chief executive officer of AMAG. “If approved for use in this
patient population, Feraheme could provide an important new treatment option
for patients suffering from iron deficiency anemia who cannot take or do not
respond to oral iron therapy.”

The sNDA submission is based on data from a global phase III program that
evaluated the use of ferumoxytol in a broad range of adult IDA patients, all
of whom had failed or could not take oral iron treatment. More than 1,400
patients were enrolled in the two phase III clinical trials, known as IDA-301
(placebo comparator) and IDA-302 (active comparator). Both studies achieved
their primary efficacy endpoints, with statistically significant improvements
in hemoglobin from baseline to the 35-day endpoint of the studies. Adverse
events and serious adverse events commonly associated with ferumoxytol and
other IV iron therapies, including hypersensitivity reactions, were reported
in both studies. No new safety signals, outside of those described in the
current Feraheme® (ferumoxytol) label, were observed with ferumoxytol
treatment in these studies.

These clinical trials also included patient-reported outcomes data as
pre-specified secondary and exploratory endpoints. These outcomes endpoints,
including quantitative measures of patients’ fatigue and measures of quality
of life, captured the negative impact anemia has on these patients’ lives
pre-treatment – and the significant improvement in these scores following a
one gram course of therapy with ferumoxytol. These data, and the safety and
efficacy data from both IDA-301 and IDA-302 were presented at the 2012 Annual
Meeting of the American Society of Hematology.

About Iron Deficiency Anemia

More than 4 million Americans have IDA; 1.6 million of whom are estimated to
have CKD, while the other 2.4 million suffer from anemia due to other
causes.^1 For these patients with anemia due to other causes, the underlying
diseases or issues causing IDA include abnormal uterine bleeding,
gastrointestinal disorders, inflammatory diseases and chemotherapy-induced
anemia. Many IDA patients fail treatment with oral iron due to intolerability
or side effects.^2

About AMAG

AMAG Pharmaceuticals, Inc. is a specialty pharmaceutical company that
manufactures and markets Feraheme® in the United States. Along with driving
organic growth of its lead product, AMAG intends to expand its portfolio with
additional commercial-stage specialty pharmaceuticals. The company is seeking
complementary products that leverage the company’s commercial footprint and
focus on hematology and oncology centers and hospital infusion centers. For
additional company information, please visit www.amagpharma.com.

About Feraheme® (ferumoxytol)/Rienso

In the United States, Feraheme (ferumoxytol) Injection for Intravenous (IV)
use is indicated for the treatment of iron deficiency anemia in adult chronic
kidney disease (CKD) patients. Feraheme received marketing approval from the
U.S. Food and Drug Administration on June 30, 2009 and was commercially
launched by AMAG in the U.S. shortly thereafter.

Ferumoxytol is protected in the U.S. by three issued patents covering the
composition and dosage form of the product. Each issued patent is listed in
the FDA’s Orange Book. These patents are set to expire in 2020; a request for
patent term extension has been filed, which, if granted, may extend the patent
term to 2023 for one of the patents.

Ferumoxytol received marketing approval in Canada in December 2011, where it
is marketed by Takeda as Feraheme, and in the European Union in June 2012 and
Switzerland in August 2012, where it is marketed by Takeda as Rienso®. For
additional U.S. product information, please visit www.feraheme.com.

Feraheme is contraindicated in patients with known hypersensitivity to
Feraheme or any of its components.

Serious hypersensitivity reactions, including anaphylactic-type reactions,
some of which have been life-threatening and fatal, have been reported in
patients receiving Feraheme. Serious adverse reactions of clinically
significant hypotension have been reported. In the post-marketing setting,
life-threatening anaphylactic type reactions, cardiac/cardiorespiratory
arrest, clinically significant hypotension, syncope, unresponsiveness and
other safety events have been reported in patients being treated with
Feraheme. In clinical trials, the most commonly occurring adverse reactions
for Feraheme-treated patients were nausea, dizziness, hypotension, peripheral
edema, headache, edema and vomiting. A full list of adverse events can be
found in the full prescribing information for Feraheme.

For full prescribing information, please visit www.feraheme.com.

Forward-looking Statements

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: the
expected timing for regulatory review of the submission and outcome of the
supplemental new drug application for the broader IDA indication and the
availability of treatment options for patients; the company’s interactions
with the FDA; the patent term extension; the company’s intentions and beliefs
regarding the FDA’s recently published draft bioequivalence recommendation for
ferumoxytol; the company’s intent to drive organic growth of Feraheme; and the
company’s plans to seek complementary commercial products to add to its
portfolio 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) uncertainties regarding our and
Takeda's ability to successfully compete in the intravenous iron replacement
market both in the US and outside the US, including the EU, (2) uncertainties
regarding our ability to successfully and timely complete our clinical
development programs and obtain regulatory approval forFeraheme/Riensoin the
broader IDA indication both in the US and outside of the US, including theEU,
(3) the possibility that significant safety or drug interaction problems could
arise with respect toFeraheme/Rienso, (4) uncertainties regarding the
manufacture ofFeraheme/Rienso, (5) uncertainties relating to our patents and
proprietary rights, both in the US and outside of the US, (6) the risk of an
Abbreviated New Drug Application (ANDA) filing following the FDA’s recently
published draft bioequivalence recommendation for ferumoxytol, and (7) other
risks identified in ourSecurities and Exchange Commissionfilings, including
our Annual Report on Form 10-K for the year endedDecember 31, 2012 and
subsequent filings with the SEC. 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 and Feraheme are registered trademarks of AMAG
Pharmaceuticals, Inc.

Rienso is a registered trademark of Takeda Pharmaceutical Company Limited.

^1 U.S. Census; U.S. Renal Data System, USRDS 2010 Annual Data Report: Atlas
of Chronic Kidney Disease and End-Stage Renal Disease in the United States,
National Institutes of Health, National Institute of Diabetes and Digestive
and Kidney Diseases, Bethesda, MD, 2010: 41-42; Fishbane, S. et al. Iron
Indices in CKD in the NHANES 1998-2004. Clin J Am Soc Nephrol.2009
January;4(1): 57–61.

^2 Barton, James et al. Intravenous iron dextran therapy in patients with iron
deficiency and normal renal function who failed to respond to or did not
tolerate oral iron supplementation. Am J Medicine. 2000; 109: 27-32.

Contact:

AMAG Pharmaceuticals, Inc.
Amy Sullivan, 617-498-3303