Ferumoxytol Abstract Recognized as a Presidential Poster Recipient at American
College of Gastroenterology Annual Scientific Meeting
WALTHAM, Mass., Oct. 14, 2013 (GLOBE NEWSWIRE) -- AMAG Pharmaceuticals, Inc.
(Nasdaq:AMAG) announced that a poster being presented today at the 2013
American College of Gastroenterology's (ACG) annual scientific meeting was
recognized as a Presidential Poster Award recipient. The abstract reported on
data from a sub-group analysis of IDA patients with gastrointestinal disease
from the company's IDA-301 study, a phase III, placebo-controlled clinical
trial that evaluated ferumoxytol treatment in adult IDA patients who have
failed or could not tolerate oral iron. The ACG Abstract Selection Committee
reviewed over 2,000 abstracts in advance of this year's scientific meeting.
Each year, less than 5 percent of accepted abstracts receive this distinction.
Poster No. P1016, titled "Phase III, Randomized, Placebo-Controlled Evaluation
of Ferumoxytol Treatment for Iron Deficiency Anemia in Patients who have a
History of Unsatisfactory Oral Iron Therapy: Fatigue and Health-Related
Quality of Life in Patients with Gastrointestinal Disorders" will be presented
on Monday, October 14, from 10:30 a.m. to 4:00 p.m. Poster authors will be
available for a question-and-answer session from 3:00 p.m. to 4:00 p.m.
IDA-301 was a randomized, double‐blind multicenter trial designed to compare
the safety and efficacy of a one gram course of ferumoxytol, an IV iron
treatment currently approved in the United States for the treatment of IDA in
adult chronic kidney disease patients, versus placebo in adult patients with
IDA who had failed or could not tolerate oral iron treatment, regardless of
the underlying cause. In the full IDA-301 study, 608 adult patients with iron
deficiency anemia (IDA) who had failed or could not tolerate oral iron were
treated with ferumoxytol and 200 received placebo. The sub-group analysis
being presented today at ACG is based on 231 patients in IDA-301 with
gastrointestinal (GI) disease. Of these patients, 173 were randomized to the
ferumoxytol treatment arm and 58 to the placebo arm.
About Iron Deficiency Anemia
More than 4 million Americans have iron deficiency anemia, many of whom are
patients with gastrointestinal disease including bleeding in the upper and/or
lower bowel, inflammatory bowel disease and malabsorption disorders.^1 Other
causes of IDA include chronic kidney disease, abnormal uterine bleeding,
inflammatory diseases and chemotherapy-induced anemia. Many IDA patients fail
treatment with oral iron due to intolerability, lack of absorption or side
AMAG Pharmaceuticals, Inc. is a specialty pharmaceutical company that markets
Feraheme® (ferumoxytol) Injection and MuGard® Mucoadhesive Oral Wound Rinse in
the United States. Along with driving organic growth of its products, AMAG
intends to expand its portfolio with additional commercial-stage specialty
products. 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
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 four 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®.
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. 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 conducted as part of the CKD development program, 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 of Feraheme. In clinical studies
conducted as part of the CKD development program, 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
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
In clinical trials of patients with IDA and CKD, the most commonly occurring
adverse reactions in Feraheme treated patients versus oral iron treated
patients (reported in ≥ 2% of 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 these
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.
For additional U.S. product information, including 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
sub-group analysis on patients in IDA-301 with gastrointestinal disease, the
expectations and expected timing for regulatory review of the submission and
outcome of the supplemental new drug application for the broader IDA
indication, the company's interactions with the FDA, and the patent term
extension 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 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
manufacture of Feraheme/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 our Securities and Exchange Commission filings, including
our Quarterly Report on Form 10-Q for the three months ended June 30, 2013 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
AMAG Pharmaceuticals and Feraheme are registered trademarks of AMAG
Pharmaceuticals, Inc. MuGard is a registered trademark of Access
Pharmaceuticals, Inc. Rienso is a registered trademark of Takeda
Pharmaceutical Company Limited.
^1Source: Cancer - US Census, Age-adjusted SEER incidence, primary market
research, "Managing patients with Chemotherapy induced
anemia":(2008),"Saving costs in cancer anemia management. Recognizing
functional iron deficiency (FID) and rationalizing EPO therapy." (2002). GI -
US Census, USRDS, DataMonitor Pipeline Insight: Inflammatory Bowel Disease,
studies by Kappelman, and Tack, http://www.uchospitals.edu/pdf/uch_007937.pdf,
http://www.haematologica.org/cgi/reprint/haematol.2009.009985v1.pdf. AUB and
PP - AMAG primary market research,
http://www.mdguidelines.com/dysfunctional-uterine-bleeding, National Vital
Statistics Reports (NVSR),
http://emedicine.medscape.com/article/257007-overview, "Have we forgotten the
significance of postpartum iron deficiency?" (2005).
CONTACT: AMAG Pharmaceuticals, Inc. Contact:
Amy Sullivan, 617-498-3303
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