Affymax and Takeda Announce Permanent J-Code for OMONTYS® (peginesatide)
Injection is in Effect
Code J0890 Effective As of January 1, 2013
PALO ALTO, Calif. & DEERFIELD, Ill. -- January 3, 2013
Affymax, Inc. (Nasdaq:AFFY) and Takeda Pharmaceuticals U.S.A., Inc. (TPUSA)
today announced that the J-code assigned by the Centers for Medicare and
Medicaid Services (CMS) for OMONTYS^® (peginesatide) Injection is now
effective. This permanent OMONTYS-specific billing code, J0890, will continue
to provide for streamlined reimbursement for dialysis organizations
prescribing OMONTYS. 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 United
“We are excited by the strong level of interest in the dialysis community for
OMONTYS,” said John Orwin, chief executive officer, Affymax. “We believe the
J-code complements our efforts to make this once-monthly therapy broadly
available to the dialysis community, and importantly, to appropriate
According to Nicole Mowad-Nassar, vice president, marketing at Takeda, “We are
pleased to have an effective J-code in place approximately nine months
following the approval of OMONTYS.”
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.
Information on OMONTYS Reimbursement Support
Customers seeking additional information about accessing the product can refer
to the OMONTYS Reimbursement Access Support (RAS) program. RAS offers
comprehensive reimbursement access, and support services for healthcare
providers. For more information please call 1-855-GOMONTYS (1-855-466-6689)
for more information.
About OMONTYS^® (peginesatide) Injection
OMONTYS 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
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 United States.
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.
OMONTYS Indication and Limitations of Use
OMONTYS^® (peginesatide) Injection is indicated for the treatment of anemia
due to chronic kidney disease (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
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.
Affymax Forward-Looking Statement
This release contains forward-looking statements, including statements
regarding the importance of the J-code, the potential advantages of OMONTYS,
the continuation and success ofAffymax'scollaboration with Takeda and the
commercialization of OMONTYS. Affymax'sactual 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 theFDAor
other regulatory authorities, including post-marketing studies, trialsand
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'sQuarterly Report on Form 10-Q filed
with theSecurities 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.Affymaxundertakes no obligation to update any
forward-looking statement in this press release.
About 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 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.
Takeda Forward-Looking Statement
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.
Photos/Multimedia Gallery Available:
Sylvia Wheeler, 650-812-8861
Vice President, Corporate Communications
Takeda Pharmaceuticals U.S.A., Inc.
Jessica Tuquero, 224-554-2021
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