New England Journal of Medicine Publishes Pivotal Trial Data for OMONTYS®
(peginesatide) Injection for Treatment of Anemia in Adult Chronic Kidney
Disease Patients on Hemodialysis
-- Head-to-Head Comparison of Efficacy of Erythropoiesis-Stimulating Agents,
Including First Prospective Cardiovascular Safety Assessment --
PALO ALTO, Calif. & DEERFIELD, Ill. -- January 23, 2013
Affymax, Inc. (Nasdaq:AFFY) and Takeda Pharmaceuticals U.S.A., Inc. (TPUSA)
today announced that pivotal Phase 3 data on the safety and efficacy of
OMONTYS^® (peginesatide) Injection were published in the January 24^th issue
the New England Journal of Medicine (NEJM). These studies, known as EMERALD 1
and 2, compared OMONTYS given once monthly to epoetin administered
one-to-three times per week (according to epoetin product labeling) in the
treatment of anemia in adult chronic kidney disease (CKD) patients on
The EMERALD studies were part of the New Drug Application (NDA) upon which
theU.S. Food and Drug Administration’s (FDA) March 27, 2012 approval of
OMONTYS was based. These studies evaluated the use of the medication in
treating one of the common complications of CKD among dialysis patients. ^
OMONTYS is indicated 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.
The efficacy and cardiovascular (CV) safety assessment data published in NEJM
*Noninferiority to Epoetin in Maintenance of Hemoglobin (Hb): The
difference between the OMONTYS and epoetin-treated groups in the mean
change in Hb levels from baseline to the study evaluation period
(calculated as the mean of all measurements during weeks 29-36) in EMERALD
1 and 2 was -0.15 g/dL (95 percent CI: -0.30, -0.01) and 0.10 g/dL (95
percent CI: -0.05, 0.26) respectively.
*Similar Cardiovascular Safety in Hemodialysis Population: In the EMERALD
studies, 22.8 percent of OMONTYS patients experienced one of the composite
cardiovascular events, compared to 24.4 percent of epoetin patients
(hazard ratio for the cardiovascular composite safety endpoint was 0.95
(0.77, 1.17) (95 percent CI)). ^ OMONTYS is not indicated in patients with
CKD not on dialysis. These patients experienced increased specific
In these studies, the most common adverse events (greater than ≥10%) were
dyspnea, diarrhea, nausea, cough and arteriovenous fistula site complication.
"The EMERALDresults are important because they not only evaluated the
efficacy of OMONTYS and epoetin; they also represent data from the first
studies to prospectively compare the cardiovascular safety of different
erythropoiesis-stimulating agents (ESAs) for the treatment of anemia in
dialysis patients with CKD,” said Steven Fishbane, M.D., Professor of
Medicine, Hofstra North Shore-Long Island Jewish School of Medicine, lead
author of the NEJM publication, and principal investigator for the EMERALD
studies. “The EMERALD data demonstrated that OMONTYS administered once a month
has a similar efficacy and cardiovascular safety profile when compared to
epoetin administered one-to-three times weekly.”
About the EMERALD Studies and Cardiovascular Safety Assessment
Approximately 1,600 adult CKD hemodialysis patients across 178 sites in the
U.S. and Europe were evaluated in the EMERALD 1 and 2 trials (1,066 patients
received OMONTYS; 542 received epoetin). The primary efficacy endpoint of
these studies was the mean change in Hb from the baseline Hb level to the mean
level during the evaluation period (between weeks 29 through 36). In these
trials, CKD patients on hemodialysis who were stable on epoetin, were
randomized to receive OMONTYS either once every four weeks or to continue
treatment with epoetin (according to epoetin labeling), with the dose adjusted
as necessary to maintain Hb levels within the study-specified range (10.0-12.0
g/dL) for 52 weeks or more. Current Prescribing Information recommends
reducing or interrupting the dose as Hb levels approach or exceed 11 g/dL.
The EMERALD studies were part of the first Phase 3 program to prospectively
evaluate the CV safety of different ESAs based on a composite cardiovascular
safety endpoint (CSE). The CSE was adjudicated by a blinded and independent
committee. Events included in the CSE pre-specified analysis were death from
any cause, stroke, myocardial infarction, serious adverse events associated
with congestive heart failure, unstable angina, or arrhythmia.
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 more than 410,000 people in the United States who were on dialysis.
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 United States Food and Drug Administration approved
OMONTYS for the treatment of anemia due to CKD in adult patients on dialysis.
The product is the first ESA to be marketed in the United States (U.S.) in
over 10 years and 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 EMERALD results, 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.takeda.us.
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.
Sylvia Wheeler, 650-812-8861
Takeda Pharmaceuticals U.S.A., Inc.
Jocelyn M. Gerst, 224-554-5542
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