Takeda and Affymax Announce Supply Agreement for OMONTYS® (Peginesatide)
Injection with DSI Renal
DEERFIELD, Ill. & PALO ALTO, Calif. -- January 7, 2013
Takeda Pharmaceuticals U.S.A., Inc. (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 with DSI Renal, one of the largest dialysis providers in the United
States (U.S.). OMONTYS is the only once-monthly erythropoiesis-stimulating
agent (ESA) for anemia available to the adult dialysis patient population with
chronic kidney disease (CKD) in the U.S.
The agreement allows DSI Renal to purchase OMONTYS for use within its
organization and provides for discounts and rebates on the product, subject to
certain requirements. DSI Renal has indicated that they plan to initially
evaluate OMONTYS in selected centers, and then, based on experience, evaluate
the potential to expand to additional centers. Financial terms were not
“We look forward to working with DSI Renal as they integrate OMONTYS into
their dialysis centers,” stated John Orwin, chief executive officer of
Affymax. “With this agreement, we now have supply agreements in place with
five out of the six medium-sized dialysis organizations in the U.S.”
OMONTYS was approved by the U.S. Food and Drug Administration (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 WARNINGS below.
OMONTYS^® (peginesatide) Injection is a synthetic, pegylated 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 erythropoietin).
On March 27, 2012, the FDA approved OMONTYS for the treatment of anemia due to
CKD in adult patients on dialysis. OMONTYS is the first ESA to be introduced
to the U.S. market in over 10 years. It is the only once-monthly ESA for
anemia available to this patient population in the U.S.
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 2010, the United States Renal Data System noted there
were 410,000 people in the United States who were on dialysis.
IMPORTANT SAFETY INFORMATION
WARNING: ESAs INCREASE THE RISK OF DEATH, MYOCARDIAL INFARCTION, STROKE,
VENOUS THROMBOEMBOLISM, THROMBOSIS OF VASCULAR ACCESS AND TUMOR PROGRESSION OR
Chronic Kidney Disease:
*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 RBC
OMONTYS is contraindicated in patients with uncontrolled hypertension and in
patients who have had serious allergic reactions to OMONTYS.
Warnings and Precautions
Increased mortality, myocardial infarction, stroke, and thromboembolism:
*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. 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 including
myocardial infarction and stroke was observed.
*There is increased mortality and/or increased risk of tumor progression or
recurrence in patients with cancer receiving ESAs.
*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 orthopedic procedures.
*In 2 trials of OMONTYS, patients with CKD not on dialysis experienced
increased specific cardiovascular events.
Hypertension (see Contraindications): Appropriately control hypertension prior
to initiation of and during treatment with OMONTYS. Reduce or withhold OMONTYS
if blood pressure becomes difficult to control.
Serious allergic reactions (see Contraindications): Serious allergic reactions
have been reported with OMONTYS. Immediately and permanently discontinue
OMONTYS and administer appropriate therapy if a serious allergic reaction
Lack or loss of 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 adjustments to
dialysis prescriptions and/or 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 100mcg/L or when serum transferrin saturation
is less than 20%. Monitor hemoglobin every 2 weeks until stable and the need
for RBC transfusions is minimized. Then, monitor monthly.
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,
also available at www.omontys.com.
About DSI Renal
DSI Renal is a leading provider of dialysis services in the United States. The
company provides state-of-the-art treatment for patients suffering from
chronic kidney failure and renal disease. Together with its physician
partners, DSI Renal owns and operates 88 dialysis clinics in 23 states. The
company plans to grow through acquisition and development of new clinics as
well as organic growth. For more information, please visit www.dsi-corp.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 DSI Renal, the
potential 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 factors affecting
the commercial potential of OMONTYS, 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 potential for disruptions to
supply, 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.
Takeda Pharmaceuticals U.S.A., Inc. and Takeda Global Research & Development
Based in Deerfield, Ill., Takeda Pharmaceuticals U.S.A., Inc. and Takeda
Global Research & Development Center, 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 treatments and seek to
bring innovative products to patients through a pipeline that includes
compounds in development for metabolic and cardiovascular disease,
gastroenterology, neurology and other conditions. To learn more about these
Takeda companies, visit www.takeda.us.
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
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.
Sylvia Wheeler, 650-812-8861
Vice President, Corporate Communications
Takeda Pharmaceuticals U.S.A., Inc.
Jessica Tuquero, 224-554-2021
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