AMAG Pharmaceuticals, Inc. : Rienso® (Ferumoxytol) Receives European Marketing Authorization for the Treatment of Iron Deficiency Anemia in Adult Patients with Chronic Kidney Disease
06/22/2012| 11:55am US/Eastern
Marketing Authorization Triggers $15 Million Milestone Payment to AMAG
AMAG Pharmaceuticals, Inc. (NASDAQ: AMAG) today announced that the
European Commission has granted marketing authorization for ferumoxytol,
an intravenous (IV) iron therapy to treat iron deficiency anemia (IDA)
in adult patients with chronic kidney disease (CKD). The marketing
authorization follows a positive opinion, issued on April 19, 2012, by
the Committee for Medicinal Products for Human Use (CHMP) of the
European Medicines Agency. Ferumoxytol was approved for the same
indication in the US under the brand name Feraheme® in June 2009.
The marketing authorization is valid in the current European Union
Member States as well as in Iceland and Norway, and is based on data
obtained from an extensive clinical development program. Takeda
Pharmaceutical Company Limited, AMAG's partner in Europe, plans to
launch ferumoxytol in Europe under the brand name Rienso® in 2012. The
EU marketing authorization triggers a $15 million milestone payment to
AMAG from Takeda; the first commercial sale of Rienso® in
Europe will trigger another $15 million milestone payment to AMAG.
Additionally, AMAG is entitled to receive tiered, double-digit royalties
on sales of Rienso® in the licensed territories.
"AMAG has four significant organic growth opportunities for ferumoxytol
- continued share gains in the US CKD IDA market, international launches
and market penetration, label expansion in the US and abroad, and
overall IV iron market expansion," said William Heiden, president and
chief executive officer of AMAG. "We are very fortunate to have a
committed partner with an outstanding reputation in the pharmaceutical
industry responsible for the launch of ferumoxytol in many regions
outside of the United States. Through Takeda's efforts, patients outside
the US with CKD will soon benefit from a new therapy to treat their IDA."
Iron deficiency is a common cause of anemia in CKD patients, and is very
common in the later stages of CKD as renal function deteriorates and
erythropoiesis (red blood cell production) declines. IDA can have a
profound impact on patients' lives, causing fatigue, shortness of breath
and an increase in the risk of cardiovascular complications including
congestive heart failure.1 IV iron is recommended for use to
increase hemoglobin levels in CKD patients with IDA.1
Approximately one million grams of IV iron are administered to IDA
patients in the EU each year.
"While treatments for iron deficiency anemia have been widely available
for many years, the disease continues to place a significant burden on
the everyday life of CKD patients worldwide, and its management should
be tailored to appropriately address the clinical consequences of this
debilitating condition," said Francesco Locatelli, Scientific Director,
Division of Nephrology and Dialysis, Alessandro Manzoni Hospital, Lecco,
Italy. "Ferumoxytol offers an effective alternative to current therapies
in the management of anemia, and news of its approval will be warmly
received by the European renal community."
About AMAG Pharmaceuticals, Inc.
AMAG Pharmaceuticals, Inc. is a biopharmaceutical company that
manufactures and markets ferumoxytol under the brand name Feraheme® in
the United States. For additional company information, please visit www.amagpharma.com.
About Feraheme (ferumoxytol)
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 US Food and Drug Administration on June 30,
2009 and was commercially launched by AMAG in the US shortly thereafter.
Ferumoxytol received marketing approval in Canada in December
2011, where it will be marketed by Takeda as Feraheme®, and in the
European Union in June 2012, where it will be marketed by Takeda as
Rienso®. For additional product information, please visit www.feraheme.com.
AMAG Pharmaceuticals and Feraheme are registered trademarks of
AMAG Pharmaceuticals, Inc.
Rienso is a registered trademark of Takeda Pharmaceutical Company
1 National Kidney Foundation. KDOQI clinical practice
guidelines and clinical practice recommendations for anemia in chronic
kidney disease. Am J Kidney Dis 2006;47(suppl 3):11-1458
The important safety information below is based on the United States
Important Safety Information About Feraheme
Indication and contraindications
Feraheme is indicated for the treatment of iron deficiency anemia in
adult patients with chronic kidney disease. Feraheme is contraindicated
in patients with known hypersensitivity to Feraheme or any of its
Warnings and precautions
Serious hypersensitivity reactions, including anaphylactic-type
reactions, some of which have been life-threatening and fatal, have been
reported in patients receiving Feraheme. Observe patients for
signs and symptoms of hypersensitivity during and after Feraheme
administration for at least 30 minutes and until clinically stable
following completion of each administration. Only administer the
drug when personnel and therapies are immediately available for the
treatment of anaphylaxis and other hypersensitivity reactions.
Anaphylactic type reactions, presenting with cardiac/cardiorespiratory
arrest, clinically significant hypotension, syncope, and
unresponsiveness have been reported in the post-marketing experience.
In clinical studies, serious hypersensitivity reactions were reported in
0.2% (3/1,726) of subjects receiving Feraheme. Other adverse reactions
potentially associated with hypersensitivity (e.g., pruritus, rash,
urticaria or wheezing) were reported in 3.7% (63/1,726) of subjects.
Severe adverse reactions of clinically significant hypotension have
been reported in the post-marketing experience. In clinical studies,
hypotension was reported in 1.9% (33/1,726) of subjects, including three
patients with serious hypotensive reactions. Monitor for signs and
symptoms of hypotension following each Feraheme injection. Excessive
therapy with parenteral iron can lead to excess storage of iron with the
possibility of iatrogenic hemosiderosis. Patients should be regularly
monitored for hematologic response during parenteral iron therapy,
noting that lab assays may overestimate serum iron and transferrin bound
iron values in the 24 hours following administration of Feraheme. As a
superparamagnetic iron oxide, Feraheme may transiently affect magnetic
resonance diagnostic imaging studies for up to 3 months following the
last Feraheme dose. Feraheme will not affect X-ray, CT, PET, SPECT,
ultrasound, or nuclear imaging.
In clinical trials, the most commonly occurring adverse reactions in
Feraheme treated patients versus oral iron treated patients reported in
? 2% of chronic kidney disease patients were diarrhea (4.0% vs. 8.2%),
nausea (3.1% vs. 7.5%), dizziness (2.6% vs. 1.8%), hypotension (2.5% vs.
0.4%), constipation (2.1% vs. 5.7%) and peripheral edema (2.0% vs.
3.2%). In clinical trials, adverse reactions leading to treatment
discontinuation and occurring in 2 or more Feraheme treated patients
included hypotension, infusion site swelling, increased serum ferritin
level, chest pain, diarrhea, dizziness, ecchymosis, pruritus, chronic
renal failure, and urticaria.
Post-marketing safety experience
The following adverse reactions have been identified during
post-approval use of Feraheme. Because these reactions are reported
voluntarily from a population of uncertain size, it is not always
possible to reliably estimate their frequency or establish a causal
relationship to drug exposure.
The following serious adverse reactions have been reported from the
post-marketing spontaneous reports with Feraheme: life-threatening
anaphylactic-type reactions, cardiac/cardiorespiratory arrest,
clinically significant hypotension, syncope, unresponsiveness, loss of
consciousness, tachycardia/rhythm abnormalities, angioedema, ischemic
myocardial events, congestive heart failure, pulse absent, and cyanosis.
These adverse reactions have occurred up to 30 minutes after the
administration of Feraheme injection. Reactions have occurred following
the first dose or subsequent doses of 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 areas of significant organic growth opportunities for
ferumoxytol, Takeda's expected 2012 launch of ferumoxytol in the EU and
Canada, and any milestone payments and royalties we may receive
following such launch 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 for Feraheme/Rienso in the broader IDA indication
both in the US and in territories outside of the US, including the EU,
(3) the fact that significant safety or drug interaction problems could
arise with respect to Feraheme/Rienso, (4) uncertainties
regarding our ability to manufacture Feraheme/Rienso, (5)
uncertainties relating to our patents and proprietary rights, and (6)
other risks identified in our Securities and Exchange
Commission filings, including our Quarterly Report on Form 10-Q for the
quarter ended March 31, 2012. We caution you not to place undue reliance
on any forward-looking statements, which speak only as of the date they
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.
Amy Sullivan, 617-498-3303
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