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Affymax Completes Treatment and Last
Patient Follow-up in Phase 3 Program for Investigational Drug,
Hematide™, to Treat Anemia in Chronic Renal Failure
Topline Results Expected in Q2 2010
PALO ALTO, Calif., Jan 25, 2010 (BUSINESS WIRE) -- Affymax, Inc.
(Nasdaq:AFFY) today announced completion of treatment and
follow-up of patients with anemia due to chronic renal failure
enrolled in the four-trial, Phase 3 clinical program for the
investigational drug Hematide. The company expects to report
topline results from all four Phase 3 trials in the second
quarter of 2010. The Phase 3 clinical program enrolled
approximately 2,600 chronic renal failure patients at
approximately 400 clinical trial sites.
"Completion of this comprehensive Hematide program marks a major
milestone and we anticipate an intensive period of data
compilation and analysis," said Arlene Morris, president and
chief executive officer of Affymax, Inc. "We look forward to
sharing top-line data in the coming months that, if positive,
will support our plan to file a NDA for Hematide in chronic
renal failure later this year."
The Hematide Phase 3 program consisted of four open-label,
randomized active-controlled clinical trials in the U.S. and
Europe, including two trials in dialysis patients and two others
in patients not on dialysis. The PEARL 1 and PEARL 2 trials
conducted in non-dialysis patients were designed to evaluate the
safety and efficacy of Hematide compared with darbepoetin alfa
for treating anemia and maintaining hemoglobin levels over time
based on the trial protocol.
In dialysis patients, the EMERALD 1 and EMERALD 2 trials
evaluated the safety and efficacy of Hematide in its ability to
maintain hemoglobin levels in the target range when patients
were switched from epoetin alfa or epoetin beta to Hematide.
Analysis of efficacy for each of the four studies is based on
assessments of non-inferiority to the comparator drugs. The
primary efficacy endpoint is the mean change in hemoglobin from
baseline. The hemoglobin target range is 11-12 g/dL for
non-dialysis patients and 10-12 g/dL for those on dialysis.
In all studies, Hematide was dosed once every four weeks while
comparator drugs were dosed more frequently according to their
product labels. Treatment in each trial was continued until the
last patient had been treated for at least 52 weeks. The primary
safety assessment will be determined by the analysis of
non-inferiority to comparator drugs using a composite
cardiovascular endpoint from a safety database pooled from the
four Phase 3 trials. The duration of the Phase 3 program was
contingent on collecting a sufficient number of cardiovascular
safety events for statistical analysis.
About Hematide
Hematide is a novel synthetic, PEGylated peptidic compound that
binds to and activates the erythropoietin receptor and thus acts
as an erythropoiesis stimulating agent (ESA).
Affymax and Takeda are collaborating on the development of
Hematide and plan to co-commercialize the product once approved
in the United States. Phase 3 clinical trials investigated the
potential for Hematide to treat anemia associated with chronic
renal failure. The product, upon approval, will be
commercialized in the European Union by Takeda.
About Anemia in Chronic Renal Failure (CRF)
Anemia in CRF affects many individuals with Chronic Kidney
Disease (CKD). According to the National Kidney Foundation, 26
million Americans - 1 in 9 U.S. adults - have CKD. Anemia
develops in the early stages of CKD and worsens as patients
progress towards total kidney failure and need a dialysis
machine to eliminate waste and water from their blood. In severe
or prolonged cases of anemia, the lack of oxygen in the blood
can cause serious and sometimes fatal damage to the heart and
other organs. Benefits of anemia correction in patients with CKD
may include decreased morbidity, hospitalization, and
mortality.1
About Affymax, Inc.
Affymax, Inc. is a biopharmaceutical company committed to
developing novel drugs to improve the treatment of serious and
often life-threatening conditions. For additional information,
please visit www.affymax.com.
This release contains forward-looking statements, including
statements regarding the success of the collaboration, timing,
design and results of the Company's clinical trials and drug
development program and the timing and likelihood of the
commercialization of Hematide. The Company's actual results may
differ materially from those indicated in these forward-looking
statements due to risks and uncertainties, including risks
relating to the continued safety and efficacy of Hematide in
clinical development, the potential for once per month dosing
and room temperature stability, the cardiovascular event rate in
our Phase 3 program, the timing of patient accrual in ongoing
and planned clinical studies, regulatory requirements and
approvals, research and development efforts, industry and
competitive environment, intellectual property rights and
disputes 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. The Company undertakes no
obligation to update any forward-looking statement in this press
release.
1
http://www.anemia.org/pdf/mon_Anemia_and_CKD.pdf
Source
Affymax, Inc.
Sylvia Wheeler, 650-812-8861
Executive Director, Corporate Communications
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