Takeda and Affymax Announce Supply Agreement for OMONTYS® (peginesatide) Injection with Fresenius Medical Care North America
DEERFIELD, Ill. & PALO ALTO, Calif.--(BUSINESS WIRE)--
Takeda Pharmaceuticals U.S.A. (TPUSA) and Affymax, Inc. (Nasdaq:AFFY)
today announced that Takeda Pharmaceuticals America, Inc. (TPA) has
entered into a supply agreement for sourcing and supply of OMONTYS®
(peginesatide) Injection to Fresenius Medical Care North America and
certain of its affiliates. OMONTYS is the only once-monthly
erythropoiesis-stimulating agent (ESA) for anemia available to the
dialysis patient population with chronic kidney disease (CKD) in the
The agreement, which ends in April 2013, allows Fresenius Medical Care
North America to purchase OMONTYS for use in U.S. centers within its
organization and provides for discounts and rebates on the product,
subject to certain requirements. Fresenius Medical Care North America
has stated that its initial plans are to adopt the product into more
than 100 dialysis centers in the U.S. over the next few weeks, and then,
based on its experience, evaluate the potential to expand to additional
centers. Financial terms were not disclosed.
"We are excited to partner with Fresenius Medical Care North America,
one of the world's leading dialysis providers, to offer a new
therapeutic option for the treatment of anemia in its chronic kidney
disease patients on dialysis," said Nicole Mowad-Nassar, vice president,
marketing at Takeda.
"As a biotechnology company dedicated to advancing new therapies for
renal diseases, Affymax shares Fresenius Medical Care North America's
commitment to innovation," stated John Orwin, chief executive officer of
Affymax. "We are very pleased to support Fresenius Medical Care in these
efforts to integrate OMONTYS into its organization and to collaborate
with them moving forward."
OMONTYS was approved by the FDA on March 27, 2012, for the treatment of
anemia due to CKD in adult patients on dialysis. OMONTYS is not
indicated, and is not recommended, for use in patients with CKD not on
dialysis, in patients receiving treatment for cancer and whose anemia is
not due to CKD, or as a substitute for red blood cell (RBC) transfusions
in patients who require immediate correction of anemia. OMONTYS has not
been shown to improve symptoms, physical functioning, or health-related
quality of life. Please see Important Safety Information including Boxed
OMONTYS® (peginesatide) Injection is a synthetic, pegylated,
peptide-based ESA. It is the only ESA that is peptide-based and its
building blocks (amino acids) are arranged in a different order than
erythropoietin (i.e., it has no sequence homology to endogenous
On March 27, 2012, the United States Food and Drug Administration
approved OMONTYS for the treatment of anemia due to CKD in adult
patients on dialysis. OMONTYS is the only once-monthly
erythropoiesis-stimulating agent (ESA) for anemia available to this
patient population in the United States.
About Anemia Due to CKD in Adult Patients on Dialysis
Anemia is a complication of CKD and is associated with cardiovascular
illness and mortality. As of 2009, the United States Renal Data System
noted there were nearly 400,000 people in the United States who were on
About Fresenius Medical Care
Fresenius Medical Care is the world's largest integrated provider of
products and services for individuals undergoing dialysis because of
chronic kidney failure, a condition that affects more than 2.1 million
individuals worldwide. Through its network of 3,119 dialysis clinics in
North America, Europe, Latin America, Asia-Pacific and Africa, Fresenius
Medical Care provides dialysis treatment to 253,041 patients around the
globe. Fresenius Medical Care is also the world's leading provider of
dialysis products such as hemodialysis machines, dialyzers and related
For more information about Fresenius Medical Care, visit the company's
website at www.fmc-ag.com.
IMPORTANT SAFETY INFORMATION
WARNING: ESAs INCREASE THE RISK OF DEATH, MYOCARDIAL
INFARCTION, STROKE, VENOUS THROMBOEMBOLISM, THROMBOSIS OF VASCULAR
ACCESS AND TUMOR PROGRESSION OR RECURRENCE.
• In controlled trials, patients experienced greater risks for
death, serious adverse cardiovascular reactions, and stroke when
administered erythropoiesis-stimulating agents (ESAs) to target a
hemoglobin level of greater than 11 g/dL.
• No trial has identified a hemoglobin target level, ESA dose,
or dosing strategy that does not increase these risks.
• Use the lowest OMONTYS dose sufficient to reduce the need for
red blood cell (RBC) transfusions.
OMONTYS is contraindicated in patients with uncontrolled hypertension.
Warnings and Precautions
Increased mortality, myocardial infarction, stroke, and
Using ESAs to target a hemoglobin level of greater than 11 g/dL
increases the risk of serious adverse cardiovascular reactions and has
not been shown to provide additional benefit. Use caution in patients
with coexistent cardiovascular disease and stroke. Patients with CKD
and an insufficient hemoglobin response to ESA therapy may be at even
greater risk for cardiovascular reactions and mortality than other
patients. A rate of hemoglobin rise of > 1 g/dL over 2 weeks may
contribute to these risks
In controlled clinical trials of ESAs in patients with cancer,
increased risk for death and serious adverse cardiovascular reactions
was observed. These adverse reactions included myocardial infarction
In controlled clinical trials of ESAs, ESAs increased the risk of
death in patients undergoing coronary artery bypass graft surgery
(CABG) and deep venous thrombosis (DVT) in patients undergoing
In 2 trials of OMONTYS, patients with CKD not on dialysis experienced
increased specific cardiovascular events
Increased mortality and/or increased risk of tumor progression or
recurrence in patients with cancer: The safety and efficacy of
OMONTYS have not been established for use in patients with anemia due to
cancer chemotherapy. OMONTYS is not indicated in patients with cancer
Hypertension: OMONTYS is contraindicated in patients with
uncontrolled hypertension. Appropriately control hypertension prior to
initiation of and during treatment with OMONTYS. Reduce or withhold
OMONTYS if blood pressure becomes difficult to control. Advise patients
of the importance of compliance with antihypertensive therapy and
Lack or loss of response to OMONTYS: For lack or loss of
hemoglobin response to OMONTYS, initiate a search for causative factors.
If typical causes of lack or loss of hemoglobin response are excluded,
evaluate for antibodies to peginesatide.
Dialysis management: Patients receiving OMONTYS may require
increased anticoagulation with heparin to prevent clotting of the
extracorporeal circuit during hemodialysis.
Laboratory monitoring: Evaluate transferrin saturation and serum
ferritin prior to and during OMONTYS treatment. Administer supplemental
iron therapy when serum ferritin is less than 100 mcg/L or when serum
transferrin saturation is less than 20%.
The most common adverse reactions in clinical studies in patients with
CKD on dialysis treated with OMONTYS were dyspnea, diarrhea, nausea,
cough, and arteriovenous fistula site complication.
Please click here
for Full Prescribing Information, including Boxed WARNINGS, or visit www.omontys.com.
About Affymax, Inc.
Affymax, Inc. is a biopharmaceutical company based in Palo Alto,
California. Affymax's mission is to discover, develop and deliver
innovative therapies that improve the lives of patients with kidney
disease and other serious and often life-threatening illnesses. The
company's first marketed product, OMONTYS, was approved by the U.S. Food
and Drug Administration (FDA) in March 2012. For additional information
on Affymax, please visit www.affymax.com.
This release contains forward-looking statements, including
statements regarding the timing, terms and potential of an agreement
with Fresenius Medical Care North America, the potential advantages of
OMONTYS, the continuation and success of Affymax's collaboration with
Takeda and the commercialization of OMONTYS. Affymax's actual
results may differ materially from those indicated in these
forward-looking statements due to risks and uncertainties, including
risks relating to the continued safety and efficacy of OMONTYS, industry
and competitive environment, regulatory requirements by the FDA or other
regulatory authorities, including post-marketing studies, trials and
Risk Evaluation and Mitigation Strategy, the timing of patient accrual
in ongoing and planned clinical studies, financing requirements and our
ability to access capital and other matters that are described in
Affymax's Quarterly Report on Form 10-Q filed with the Securities and
Exchange Commission. Investors are cautioned not to place undue
reliance on these forward-looking statements, which speak only as of the
date of this release. Affymax undertakes no obligation to update any
forward-looking statement in this press release.
About Takeda Pharmaceuticals U.S.A., Inc. and Takeda Development
Center Americas, Inc.
Based in Deerfield, Ill., Takeda Pharmaceuticals U.S.A., Inc. and Takeda
Development Center Americas, Inc. are subsidiaries of Takeda
Pharmaceutical Company Limited, the largest pharmaceutical company in
Japan. The respective companies currently market oral diabetes,
insomnia, rheumatology, gastroenterology and cardiovascular disease
treatments and seek to bring innovative products to patients through a
pipeline that includes compounds in development for diabetes,
gastroenterology, neurology and other conditions. To learn more about
these Takeda companies, visit www.tpna.com.
This press release contains forward-looking statements.
Forward-looking statements include statements regarding Takeda's plans,
outlook, strategies, results for the future, and other statements that
are not descriptions of historical facts. Forward-looking statements may
be identified by the use of forward-looking words such as "may,"
"believe," "will," "expect," "project," "estimate," "should,"
"anticipate," "plan," "assume," "continue," "seek," "pro forma,"
"potential," "target," "forecast," "guidance," "outlook" or "intend" or
other similar words or expressions of the negative thereof.
Forward-looking statements are based on estimates and assumptions made
by management that are believed to be reasonable, though they are
inherently uncertain and difficult to predict. Investors are cautioned
not to unduly rely on such forward-looking statements.
Forward-looking statements involve risks and uncertainties that could
cause actual results or experience to differ materially from that
expressed or implied by the forward-looking statements. Some of these
risks and uncertainties include, but are not limited to, (1) the
economic circumstances surrounding Takeda's business, including general
economic conditions in Japan, the United States and worldwide; (2)
competitive pressures and developments; (3) applicable laws and
regulations; (4) the success or failure of product development programs;
(5) actions 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 in development;
and (8) integration activities with acquired companies.
The forward-looking statements contained in this press release speak
only as of the date of this press release, and Takeda undertakes no
obligation to revise or update any forward-looking statements to reflect
new information, future events or circumstances after the date of the
forward-looking statement. If Takeda does update or correct one or more
of these statements, investors and others should not conclude that
Takeda will make additional updates or corrections.
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Sylvia Wheeler, 650-812-8861
Takeda Pharmaceuticals U.S.A., Inc.
M. Gerst, 224-554-5542
Source: Takeda Pharmaceuticals U.S.A. and Affymax, Inc.
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