Launch Triggers
Pharmaceutical Company Limited
ferumoxytol in its first
name Rienso®. The launch follows the European marketing authorization,
which was received in
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
The first commercial sale of Rienso in
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
executive officer of AMAG. “This first launch in the
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
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
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
About Feraheme (ferumoxytol)/Rienso
In
(IV) use is indicated for the treatment of iron deficiency anemia in
adult chronic kidney disease (CKD) patients. Feraheme received marketing
approval from the
was commercially launched by AMAG in the US shortly thereafter.
Ferumoxytol received marketing approval in
where it will be marketed by Takeda as Feraheme®, and in the
Union
marketed by Takeda as Rienso®. For additional product information,
please visit www.feraheme.com.
About AMAG
manufactures and markets Feraheme® in
additional company information, please visit www.amagpharma.com.
1
guidelines and clinical practice recommendations for anemia in chronic
kidney disease. Am J Kidney Dis 2006;47(suppl 3):11–1458
Pharmaceuticals, Inc.
Rienso is a registered trademark of
Limited
The important safety information below is based on
prescribing information.
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.
Adverse reactions
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 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 for Feraheme/Rienso in the broader IDA indication
both in the US and in territories outside of the US, including the EU,
(3) the possibility that significant safety or drug interaction problems
could arise with respect to Feraheme/Rienso, (4)
uncertainties regarding the 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 June 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 statements.
Source:
AMAG Pharmaceuticals, Inc.
Amy Sullivan, 617-498-3303
