Source: BUSINESS WIRE
Wednesday, November 11, 2009
PALO ALTO, Calif.--(BUSINESS WIRE)--Affymax, Inc. (Nasdaq:AFFY) today announced that the independent Data
Monitoring Committee (DMC), which provides oversight for the Phase 3
program for Hematide™, has completed its final scheduled review and has
informed the company that the cumulative safety data generated thus far
from the EMERALD and PEARL Phase 3 trials support continuation of the
studies. While no additional meetings are planned, the DMC, under its
charter, can request additional information regarding the studies at any
time. In the Phase 3 program, Hematide is being evaluated to treat
anemia in chronic renal failure patients on dialysis and not on dialysis.
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The Phase 3 program, which consists of four trials, was initiated in
October 2007. Affymax reiterated its expectation for a NDA submission in
2010.
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 Pharmaceutical Company Limited are collaborating on
the development of Hematide and plan to co-commercialize the product in
the United States. The product, upon approval, will be commercialized in
the European Union by Takeda. Affymax is conducting Phase 3 clinical
trials which may support a NDA submission for Hematide to treat anemia
associated with chronic renal failure.
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 include
decreased morbidity, hospitalization, and mortality.1
About Affymax, Inc.
Affymax, Inc. is a biopharmaceutical company 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 clinical program, the timing of patient accrual and
treatment 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