Affymax and Takeda Announce Analyses from OMONTYS® (peginesatide) Injection
Phase 3 Dialysis Studies Presented at 2012 American Society of Nephrology
-- Post-Hoc Data Provide Additional Information on Iron Utilization --
PALO ALTO, Calif. & DEERFIELD, Ill. -- November 01, 2012
Affymax, Inc. (Nasdaq:AFFY) and Takeda Pharmaceuticals U.S.A., Inc. (TPUSA)
today announced the presentation of post-hoc sub-group analyses of the EMERALD
Phase 3 studies that evaluated OMONTYS^® (peginesatide) Injection, an
erythropoiesis-stimulating agent (ESA), for the treatment of anemia due to
chronic kidney disease (CKD) in adult dialysis patients. ^ The analyses, which
explore intravenous (IV) iron utilization in U.S. patients in the EMERALD
Phase 3 studies, were presented in an oral session at the 2012 American
Society of Nephrology (ASN) Kidney Week meeting.
In these exploratory post-hoc analyses, investigators pooled data on IV iron
dose, along with measures of iron deficiency -- serum ferritin and transferrin
saturation (TSAT), from U.S. patients enrolled in the EMERALD 1 and 2 studies
(approximately 80 percent of study population).
In the full analysis population (randomized patients receiving ≥1 study drug
dose; n=853 OMONTYS, n=436 epoetin) over a 60-week period, patients in the
OMONTYS group received an average of 148.8 mg of IV iron per month and
patients in the epoetin group received 168.5 mg per month. In the completer
population (≥60 weeks’ drug exposure; ferritin, TSAT measured at same visit;
n=604 OMONTYS; n=336 epoetin), patients in the OMONTYS group received an
average of 152.9 mg per month and patients in the epoetin group received an
average of 171.8 mg per month. TSAT at baseline was 30.2% and 29.4% in the
OMONTYS and epoetin groups, respectively. Beginning at the first time point
(week 12), TSAT for the full analysis population was 37.9% and 30.7% for
OMONTYS and epoetin, respectively, and TSAT for the completer analysis
population was 37.9% and 30.9% for OMONTYS and epoetin, respectively. Serum
ferritin levels at baseline were 686 ng/mL and 674 ng/mL in the OMONTYS and
epoetin groups, respectively. At week 60, serum ferritin levels for the full
analysis population were 742 ng/mL and 768 ng/mL in the OMONTYS and epoetin
groups, respectively, and serum ferritin levels for the completer analysis
population were 733 ng/mL and 752 ng/mL in the OMONTYS and epoetin groups,
respectively. The clinical significance of these analyses is unknown.
“Anemia management is multi-faceted and given the interdependence of irons and
ESAs in red blood cell production, it’s important to evaluate utilization of
these agents in dialysis patients who are being treated for the condition,”
said Robert Provenzano, MD, Chair, Division of Nephrology, St. John Hospital &
Medical Center, Detroit, and presenter of these EMERALD analyses. “The
observations of these post-hoc analyses from the EMERALD studies may warrant
further scientific evaluation.”
According to the OMONTYS prescribing information, healthcare professionals
should correct or exclude other causes of anemia, including iron deficiency,
before initiating treatment. The majority of patients with CKD will require
supplemental iron during the course of ESA therapy. Evaluate transferrin
saturation and serum ferritin prior to and during treatment, and administer
supplemental iron when serum ferritin is less than 100 mcg/L or when serum
ferritin saturation is less than 20%. For lack or loss of response to OMONTYS,
initiate a search for causative factors, including iron deficiency. Please see
full prescribing information, available at www.omontys.com.
About the EMERALD Studies
Evaluating approximately 1,600 dialysis patients across 172 sites in the U.S.
and Europe, the primary efficacy endpoint of the EMERALD 1 and 2 studies was a
mean change in Hb between the baseline and evaluation period (between weeks 29
through 36) following study entry.In these trials, CKD patients on dialysis
who were stable on epoetin were randomized to receive OMONTYS either once
monthly or to continue treatment with epoetin (according to its labeling),
with dose adjustments to maintain Hb levels within the study-specified range
(between 10.0-12.0 g/dL). 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 cardiovascular (CV) safety of different ESAs based on a composite
cardiovascular safety endpoint (CSE).The CSE was adjudicated by a blinded and
About Anemia Due to CKD in Adult Patients on Dialysis
Anemia is a common complication in CKD patients on dialysis because their
kidneys are unable to produce erythropoietin, the hormone responsible for red
blood cell production. Since adequate iron levels are needed for the
production of red blood cells and hemoglobin, treatment guidelines recommend
iron is used in conjunction with erythropoiesis-stimulating agents (ESAs) in
treating anemia in dialysis patients.
As of 2010, the United States Renal Data System noted there were 410,000
people in the United States who were on dialysis.
OMONTYS^® (peginesatide) Injection is a synthetic, pegylated, peptide-based
ESA, 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 FDA approved OMONTYS (dosed once-monthly) for the
treatment of anemia due to CKD in adult patients on dialysis.
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
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.
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.
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
and Medication Guide, 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.
Affymax Forward-Looking Statement
This release contains forward-looking statements, including statements
regarding the potential 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.
Sylvia Wheeler, 650-812-8861
Takeda Pharmaceuticals U.S.A., Inc.
Jocelyn M. Gerst, 224-554-5542
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