Rienso® (Ferumoxytol) Launched in Europe for the Treatment of Iron
Deficiency Anemia in Adult Patients with Chronic Kidney Disease
Launch Triggers $15 Million Milestone Payment to AMAG
LEXINGTON, Mass. -- November 05, 2012
AMAG Pharmaceuticals, Inc. (NASDAQ: AMAG) today announced that Takeda
Pharmaceutical Company Limited, AMAG’s partner in Europe, has launched
ferumoxytol in its first European Union (EU) market, under the brand name
Rienso®. The launch follows the European marketing authorization, which was
received in June 2012, for the use of Rienso to treat iron deficiency anemia
in adult patients with chronic kidney disease. Ferumoxytol was approved for
the same indication in the US under the brand name Feraheme® in June 2009.
The first commercial sale of Rienso in Europe triggers a $15 million milestone
payment to AMAG from Takeda. Additionally, AMAG is entitled to receive tiered,
double-digit royalties on sales of Rienso® in the licensed territories.
“We have four significant organic growth opportunities globally for
ferumoxytol – continued share gains in the US CKD IDA market, international
launches and market penetration, potential label expansion in the US and
abroad, and overall IV iron market expansion – and we are making progress on
all fronts,” said William Heiden, president and chief executive officer of
AMAG. “This first launch in the European Union means patients and physicians
there can now benefit from treatment with Rienso. We are very fortunate to
have such a committed partner as Takeda for the launch of ferumoxytol in many
regions outside of the United States.”
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.
For more information, please see the Takeda Pharmaceuticals press release,
entitled ‘Launch of Rienso^® (ferumoxytol) offers adult patients with chronic
kidney disease a new option for the treatment of iron deficiency anaemia’
issued on November 1, 2012.
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
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 and Switzerland in August 2012, where
it will be marketed by Takeda as Rienso®. For additional product information,
please visit www.feraheme.com.
AMAG Pharmaceuticals, Inc. is a specialty pharmaceutical company that
manufactures and markets Feraheme® in the United States. For additional
company information, please visit www.amagpharma.com.
^1 National Kidney Foundation. KDOQI clinical practice guidelines and clinical
practice recommendations for anemia in chronic kidney disease. Am J Kidney Dis
AMAG Pharmaceuticals and Feraheme are registered trademarks of AMAG
Rienso is a registered trademark of Takeda Pharmaceutical Company Limited.
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 components.
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
For full prescribing information, please visit www.feraheme.com.
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 and any milestone
payments and royalties we may receive following Takeda’s launch of ferumoxytol
in the EU 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 in territories 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 ability to manufactureFeraheme/Rienso, (5)
uncertainties relating to our patents and proprietary rights, and (6) other
risks identified in ourSecurities and Exchange Commissionfilings, including
our Quarterly Report on Form 10-Q for the quarter endedJune 30, 2012. 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
AMAG Pharmaceuticals, Inc.
Amy Sullivan, 617-498-3303
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