The United States Pharmacopeia Accepts Amgen's Aranesp for Treatment of Chemotherapy-Associated Anemia
THOUSAND OAKS, Calif., Feb 4, 2002 -- Amgen (Nasdaq:AMGN) today
announced that the United States Pharmacopeia (USP), an independent source for
labeled and unlabeled drug information, has reviewed published clinical data on
Aranesp(TM) (darbepoetin alfa) and accepted it for the treatment of
chemotherapy-associated anemia and anemia associated with chronic renal failure.
The USP promotes the public health by establishing and disseminating officially
recognized standards of quality and authoritative information for the use of
medicines and other health care technologies by health professionals, patients
and consumers. USP expert committees routinely evaluate information on the use
of drugs. The use of Aranesp(TM) for the treatment of chemotherapy-associated
anemia and for anemia associated with chronic renal failure has been classified
by the USP as "Accepted," or, supported by evidence and current medical
practice. The USP will accept comments on the proposed monograph for the
treatment of chemotherapy-associated anemia through March 4, 2002.
In the third quarter of 2001, Amgen submitted to the U.S. Food & Drug
Administration (FDA) a Biologics License Application Supplement for Aranesp(TM)
for the treatment of cancer patients suffering from anemia associated with
certain types of chemotherapy. The company is awaiting FDA action. In September
of 2001, the FDA approved Aranesp(TM) for the treatment of anemia associated
with chronic renal failure including patients on and not on dialysis.
This news release contains forward-looking statements that involve significant
risks and uncertainties, including those discussed below and more fully
described in the Securities and Exchange Commission reports filed by Amgen,
including our most recent Form 10-Q. Amgen conducts research in the
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candidate will be successful and become a commercial product.
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technology, the protection offered by Amgen patents and patent applications may
be challenged, invalidated or circumvented by our competitors.
Because forward-looking statements involve risks and uncertainties, actual
results may differ materially from current results expected by Amgen. Amgen is
providing this information as of February 4, 2002 and does not plan to update
this information until its next press release and expressly disclaims any duty
to update information contained in this press release.
Amgen is a global biotechnology company that discovers, develops and
manufactures important human therapeutics based on advances in cellular and
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Jeff Richardson, 805/447-3227 (media)
Cary Rosansky, 805/447-4634 (investors)