Takeda and Affymax Announce Supply Agreement for OMONTYS® (Peginesatide) Injection with DSI Renal
DEERFIELD, Ill. & PALO ALTO, Calif.--(BUSINESS WIRE)--
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 disclosed.
"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.
About OMONTYS
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 RECURRENCE.
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
transfusions.
Contraindications
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 occurs.
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.
Adverse reactions
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 Center, Inc.
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 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.
Affymax, Inc.
Sylvia Wheeler, 650-812-8861
Vice President,
Corporate Communications
or
Takeda Pharmaceuticals U.S.A., Inc.
Jessica
Tuquero, 224-554-2021
Corporate Communications
Source: Takeda Pharmaceuticals U.S.A., Inc. and Affymax, Inc.
News Provided by Acquire Media
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