Initiated Global Registrational Program for Feraheme for the
Treatment of Iron Deficiency Anemia
LEXINGTON, Mass. & OSAKA, Japan, Jun 29, 2010 (BUSINESS WIRE) — AMAG Pharmaceuticals, Inc. (NASDAQ: AMAG) and Takeda Pharmaceutical
Company Limited (TSE: 4502) today provided a regulatory and clinical
update for Feraheme(R) (ferumoxytol) Injection for intravenous (IV) use.
On June 1, 2010, AMAG submitted a marketing authorization application
(MAA) for Feraheme for the treatment of iron deficiency anemia
(IDA) in chronic kidney disease patients to the European Medicines
Agency (EMA). The EMA has since notified AMAG that the submission
has been validated for review.
The companies are also pleased to report that the global registrational
program to expand the indication of Feraheme to include the
treatment of IDA regardless of the underlying cause has been initiated.
The program consists of two phase III studies – one 800 patient,
double-blind, placebo-controlled study and the other a 600 patient open
label, active-controlled study comparing ferumoxytol to IV iron sucrose.
Both trials will evaluate changes in hemoglobin levels as well as other
efficacy and safety endpoints. The program is now enrolling patients;
the companies expect that it will take up to 18 months to complete
enrollment.
“We have thus far made great progress on our key objectives for this
year,” said Brian J.G. Pereira, MD, President and Chief Executive
Officer of AMAG Pharmaceuticals, Inc. “With the MAA filing validated by
the EMA and the global registrational program for Feraheme for
the broader indication of the treatment of iron deficiency anemia
underway, we are several steps closer to expanding the reach of Feraheme,
both geographically and to new patient populations.”
Dr. Erich Brunn, Chief Executive Officer, Takeda Pharmaceuticals Europe
said: “For Takeda in Europe, this represents an important first step
forward in our entry into a new therapeutic area. Feraheme has
the potential to provide physicians in Europe with an important new
approach in the treatment of patients with iron deficiency anemia.”
About Feraheme
In the United States, Feraheme(R) (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. Feraheme is under regulatory review in Canada and
Europe for the treatment of chronic kidney disease patients with iron
deficiency anemia.
AMAG is seeking to expand the label and geographic availability of Feraheme
to treat patients with iron deficiency anemia regardless of the
underlying cause by conducting additional clinical trials and by forming
strategic partnerships around the world. AMAG has two partners for the
development and commercialization of Feraheme outside of the
U.S.: 3SBio Inc. to develop and commercialize Feraheme for CKD in
China; and Takeda Pharmaceutical Company to develop and commercialize Feraheme
for all therapeutic applications in five ex-U.S. regions, including
Europe, Canada, Turkey, the Commonwealth of Independent States and
several Asia Pacific countries. AMAG has exclusive rights to
commercialize Feraheme in the U.S. and certain ex-U.S.
territories.
In addition to the global iron deficiency anemia registrational program,
AMAG is evaluating Feraheme in a clinical trial, the ferumoxytol
compared to iron sucrose trial (FIRST), which will
enroll 150 patients with chronic kidney disease and iron deficiency
anemia, and has plans to initiate pediatric studies and a Feraheme
retreatment study in the coming year.
Feraheme was discovered, developed and is manufactured by AMAG
Pharmaceuticals, Inc. For more information about Feraheme,
including full prescribing information, please visit www.feraheme.com.
About AMAG
AMAG Pharmaceuticals, Inc. is a biopharmaceutical company that utilizes
its proprietary technology for the development and commercialization of
a therapeutic iron compound to treat iron deficiency anemia and novel
imaging agents to aid in the diagnosis of cancer and cardiovascular
disease. AMAG manufactures and sells two commercial products, Feraheme(R)
(ferumoxytol) Injection for intravenous (IV) use and GastroMARK, an oral
contrast agent used in magnetic resonance imaging. For additional
company information, please visit www.amagpharma.com.
About Takeda
Located in Osaka, Japan, Takeda is a research-based global company with
its main focus on pharmaceuticals. As the largest pharmaceutical company
in Japan and one of the global leaders of the industry, Takeda is
committed to strive towards better health for patients worldwide through
leading innovation in medicine. Additional information about Takeda is
available through its corporate website, www.takeda.com.
Important Safety InformationAbout Feraheme
In the United States, Feraheme is contraindicated in patients
with evidence of iron overload, known hypersensitivity to Feraheme
or any of its components, and patients with anemia not caused by iron
deficiency.
In U.S. registrational 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. Patients should be observed for signs and
symptoms of hypersensitivity for at least 30 minutes following Feraheme
injection and the drug should only be administered when personnel and
therapies are readily available for the treatment of hypersensitivity
reactions. 1.9% (33/1,726) of Feraheme-treated subjects
experienced hypotension. Please 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 iron and transferrin bound iron
values in the 24 hours after 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 greater-than or equal to 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. For full prescribing information, please visit www.feraheme.com.
Forward Looking Statements Related to AMAG
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 AMAG’s plans to initiate pediatric studies and a Feraheme
retreatment study in the coming year and AMAG’s expectation that it will
take up to 18 months to complete enrollment in the two phase III studies
we recently initiated for the treatment of IDA regardless of the
underlying cause 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 ability to
successfully compete in the intravenous iron replacement market both in
the U.S. and outside the U.S., (2) uncertainties regarding our ability
to successfully and timely complete our clinical development programs
and obtain regulatory approval for Feraheme in new indications
and in territories outside of the U.S., (3) the fact that we have
limited experience developing and commercializing a pharmaceutical
product on our own or with a partner like Takeda, particularly outside
of the U.S., (4) uncertainties regarding our ability to ensure favorable
coverage, pricing and reimbursement for Feraheme, (5)
uncertainties regarding our ability to manufacture Feraheme, (6)
uncertainties relating to our patents and proprietary rights, (7) the
fact that significant safety or drug interaction problems could arise
with respect to Feraheme, and (8) other risks identified in our
Securities and Exchange Commission filings, including our Annual Report
on Form 10-K for the year ended December 31, 2009. 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.
Forward Looking Statements Related to Takeda
This press release contains forward-looking statements regarding the
Company’s plans, outlook, strategies, and results for the future.
All forward-looking statements are based on judgments derived from the
information available to the Company at this time. Forward looking
statements can sometimes be identified by the use of forward-looking
words such as “may,” “believe,” “will,” “expect,” “project,” “estimate,”
“should,” “anticipate,” “plan,” “continue,” “seek,” “pro forma,”
“potential,” “target, ” “forecast,” or “intend” or other similar words
or expressions of the negative thereof.
Certain risks and uncertainties could cause the Company’s actual results
to differ materially from any forward looking statements contained in
this press release. These risks and uncertainties include, but are not
limited to, (1) the economic circumstances surrounding the Company’s
business, including general economic conditions in the US and worldwide;
(2) competitive pressures; (3) applicable laws and regulations; (4) the
success or failure of product development programs; (5) decisions of
regulatory authorities and the timing thereof; (6) changes in exchange
rates; (7) claims or concerns regarding the safety or efficacy of
marketed products or product candidates; and (8) integration activities
with acquired companies.
We assume no obligation to update or revise any forward-looking
statements or other information contained in this press release, whether
as a result of new information, future events, or otherwise.
Feraheme is a registered trademark of AMAG Pharmaceuticals, Inc.
SOURCE: AMAG Pharmaceuticals, Inc.
AMAG Pharmaceuticals, Inc.
Amy Sullivan, 617-498-3303
or
Carol Miceli, 617-498-3361
or
Takeda
Seizo Masuda, +81-3-3278-2037
or
Nick Francis, +44 203 116 8861
