LEXINGTON, Mass. & OSAKA, Japan, Apr 01, 2010 (BUSINESS WIRE) –AMAG Pharmaceuticals, Inc. (NASDAQ: AMAG) and Takeda Pharmaceutical
Company Limited (TSE: 4502) today jointly announced that the companies
have entered into a license, development and commercialization agreement
related to Feraheme(R) (ferumoxytol) Injection for intravenous (IV) use in
all therapeutic indications.
Takeda receives an exclusive license to Feraheme for all
therapeutic applications in 5 regions, including Europe, Canada,
Turkey, the Commonwealth of Independent States and Asia Pacific
countries, excluding Japan, China and Taiwan.
AMAG receives a $60 million upfront payment and is eligible to receive
up to $220 million in development and commercial milestones.
Additionally, AMAG will receive tiered, double-digit royalties based
on net sales of Feraheme in the licensed territories.
AMAG will execute and fund the global clinical development of Feraheme
in all potential therapeutic indications. AMAG will also be initially
responsible for the filing of regulatory applications for Feraheme
in Europe and Canada, with Takeda responsible for the regulatory
filings in all other regions covered by the agreement. Takeda will
eventually hold all marketing authorizations in the licensed
Takeda will be responsible for commercializing Feraheme in all
regions included in the licensed territories.
“One of our primary goals is to expand the reach of Feraheme to
patients around the world with iron deficiency anemia,” said Brian J.G.
Pereira, MD, President and Chief Executive Officer of AMAG
Pharmaceuticals, Inc. “Takeda’s global presence, their pipeline that
includes complementary products to Feraheme and their strength in
the marketing and commercialization of therapeutics across many
specialties where iron deficiency anemia is present makes them the ideal
partner for Feraheme.”
“This partnership provides an exciting opportunity to combine AMAG’s
unique development abilities with Takeda’s global commercialization
capabilities,” said Alan MacKenzie, Executive Vice President,
International Operations & CEO, Takeda Pharmaceuticals International,
Inc. “Takeda is poised to maximize Feraheme‘s entry into the
selected countries following approval.”
Currently, Feraheme is approved in the United States for the
treatment of iron deficiency anemia (IDA) in adult patients with chronic
kidney disease. AMAG plans to submit a marketing authorization
application to the European Medicines Agency (EMA) for Feraheme
for the treatment of IDA in adult patients with chronic kidney disease
in Europe in mid-2010. Additionally, AMAG plans to initiate a broad
global registrational program for Feraheme for the treatment of
IDA regardless of the underlying cause in mid-2010.
AMAG Conference Call and Webcast Access
AMAG Pharmaceuticals, Inc. will host a webcast and conference call today
at 8:00 a.m. ET to discuss this announcement.
To access the conference call via telephone, please dial (877) 412-6083
from the United States or (702) 495-1202 for international access. A
telephone replay will be available from approximately 11:00 a.m. ET on
April 1, 2010 through midnight April 2, 2010. To access a replay of the
conference call, dial (800) 642-1687 from the United States or (706)
645-9291 for international access. The passcode for the live call and
the replay is 64493010.
The call will be webcast and accessible through the Investors section of
the Company’s website at www.amagpharma.com.
The webcast replay will be available from approximately 11:00 a.m. ET on
April 1, 2010 through midnight April 15, 2010.
About AMAG Pharmaceuticals, Inc.
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. On June 30, 2009, AMAG received approval from the U.S. Food and
Drug Administration to market Feraheme(R) (ferumoxytol) Injection for
intravenous (IV) use for the treatment of iron deficiency anemia in
adult chronic kidney disease patients. For additional company and
product information, please visit www.amagpharma.com.
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 striving toward better health for individuals and progress
in medicine. Additional information about Takeda is available through
its corporate website, www.takeda.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 our plans to submit a market authorization application for
Feraheme for the treatment of IDA in chronic kidney disease patients in
the European Union and the timing of such submission and our plans to
initiate a broad global registrational program for Feraheme for the
treatment of IDA regardless of the underlying cause and the timing of
such program initiation, the fact that Takeda will eventually hold all
Marketing Authorization applications in the licensed territories, and
our obligations under the agreement with Takeda 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 and timely complete
our clinical development programs and obtain regulatory approval for
Feraheme and compete in the intravenous iron replacement market outside
of the U.S., (2) 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., (3) uncertainties
regarding our ability to ensure favorable coverage, pricing and
reimbursement for Feraheme, (4) uncertainties regarding our
ability to manufacture Feraheme, (5) uncertainties relating to
our patents and proprietary rights, (6) the fact that significant safety
or drug interaction problems could arise with respect to Feraheme, and
(7) 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.
Important Safety Information about Feraheme
Feraheme is indicated for the treatment of iron deficiency anemia
in adult patients with chronic kidney disease. 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 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.
Feraheme is a registered trademark of AMAG Pharmaceuticals, Inc.
SOURCE: AMAG Pharmaceuticals, Inc.
AMAG Pharmaceuticals Contacts:
Amy Sullivan: +1-617-498-3303
Carol Miceli: +1-617-498-3361
Takeda Pharmaceuticals Contacts:
Seizo Masuda: +81 3 3278 2037
Nick Francis: +44 20 3116 8861