Affymax to Receive $5 Million Milestone Payment for Acceptance of European Marketing Authorization Application for Peginesatide
PALO ALTO, Calif.--(BUSINESS WIRE)--
Affymax, Inc. (Nasdaq: AFFY) today announced that it will receive a $5
million development milestone payment from Takeda Pharmaceutical Company
as part of the companies' exclusive global agreement to develop and
commercialize peginesatide. The milestone is triggered by the European
Medicines Agency (EMA) acceptance of the Marketing Authorization
Application (MAA) for the investigational compound peginesatide for the
treatment of anemia associated with chronic kidney disease (CKD) in
adult patients on dialysis.
"We are delighted with Takeda's execution on the European front and are
encouraged by the EMA acceptance of the MAA," said John Orwin, president
and CEO of Affymax. "While we are concurrently preparing for potential
commercialization of peginesatide in the United States, we are pleased
that progress is being made to potentially make the product available
outside the U.S."
Peginesatide was discovered by Affymax, and if approved, will be
co-marketed by Affymax and Takeda in the United States. Takeda has
commercialization rights in the European Union. In the United States,
the scheduled Prescription Drug User Fee Act (PDUFA) date for
peginesatide is March 27, 2012.
About Peginesatide
Peginesatide is a synthetic PEGylated peptidic compound that binds to
and stimulates the erythropoietin receptor and thus acts as an
erythropoiesis stimulating agent (ESA). The peginesatide Phase 3
clinical program was the largest to support the new drug application of
an ESA in the treatment of anemia in chronic kidney disease and the
first to prospectively evaluate the cardiovascular safety of an ESA via
an analysis of independently adjudicated cardiovascular events. The
compound was discovered by Affymax and is being co-developed by Affymax
and Takeda. If approved, peginesatide may be the first once-monthly
product for anemia in CKD for dialysis patients available in the United
States.
About Anemia in Chronic Kidney Disease
Anemia is a common complication in CKD that impacts the overall health
and well-being of CKD patients and is associated with increased rates of
hospitalization and mortality. ESAs are medications commonly prescribed
to treat anemia and stimulate red blood cell production. Research has
shown that there may be challenges with anemia management due to factors
such as, hemoglobin (Hb) variability and stability, among other concerns.
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 continuation and success of our collaboration
with Takeda, the timing and potential for the EMA approval of the MAA
for peginesatide in Europe, the timing and potential for the U.S. Food
and Drug Administration (FDA) approval of the New Drug Application (NDA)
for peginesatide and the timing, design and progress of the peginesatide
development program. 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 EMA approval of the MAA,
risks relating to the FDA approval of the NDA, risks relating to
regulatory requirements, including pre-or post-marketing studies and
Risk Evaluation and Mitigation Strategy (REMS), in particular the FDA's
interpretation and review of the data in the NDA including issues
related to the subgroup analyses in non-dialysis, study design, the
completeness of the NDA, including data quality and integrity in our
non-inferiority designed trials, the continued safety and efficacy of
peginesatide in clinical development, the timing of patient accrual in
ongoing and planned clinical studies, research and development efforts,
industry and competitive environment, potential delays or additional
studies that may be required by the FDA or other regulatory authorities,
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.
Affymax, Inc.
Sylvia Wheeler, 650-812-8861
Vice President,
Corporate Communications
Source: Affymax, Inc.
News Provided by Acquire Media
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