Amgen Receives CPMP Positive Recommendation For European Union Regulatory Approval Of Aranesp(R)n Oncology
Thousand Oaks, Calif., USA and Lucerne, Switzerland, June 3, 2002 -- Amgen (Nasdaq:AMGN)
today announced that the European Committee on Proprietary Medicinal Products
(CPMP) has recommended approval of darbepoetin alfa (Aranesp/Nespo(R)) for the
treatment of anaemia in adult cancer patients with solid tumours (non-haematological
malignancies) receiving chemotherapy. Aranesp is a powerful new erythropoietic
protein with greater in vivo activity than recombinant human erythropoietin (EPO).
Between 50 and 60 percent of patients with cancer undergoing chemotherapy
may be anaemic. This debilitating condition is associated with, for example,
dizziness, exhaustion, shortness of breath and difficulty in carrying out daily
activities. Anaemia is under-treated with transfusions being the primary treatment,
and currently only one-tenth of anaemic patients receive an erythropoietic agent
"This approval will represent a significant step forward for the
treatment of anaemia in patients with cancer. The less frequent dosing relative
to current agents and the speed of response obtained with Aranesp provide convenient,
well tolerated and highly effective therapy". said Professor Robert Pirker,
Vienna, Austria, primary investigator of the pivotal phase 3 study.
The CPMP's recommendation for approval will be forwarded to the
European Commission for ratification. Ratification usually requires three to
four months. When ratified, Amgen will obtain the extension to the indications
for Aranesp throughout the European Union (EU). Launch of this new indication
in each EU country will vary according to each nation's pricing and reimbursement
A Biological License Application (BLA) supplement for Aranesp
use in the oncology setting has also been submitted to the United States Food
and Drug Administration for approval. Aranesp for anaemia associated with chronic
renal failure was approved by the European Commission and the U.S. Food & Drug
Administration in 2001.
"This recommendation for approval, combined with the separately
announced Neulasta recommendation, will expand our commitment to dramatically
improving the lives of patients with cancer. We are tremendeously excited about
bringing these best in class therapeutics to oncology patients throughout Europe,"
said Keith Leonard, Vice President, Amgen Europe.
Aranesp(R) is a registered trademark in Europe.
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 biotechnology/pharmaceutical
field where movement from concept to product is uncertain; consequently, there
can be no guarantee that any particular product candidate will be successful
and become a commercial product.
Furthermore, our research, testing, pricing, marketing and other
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and technology, the protection offered by our 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 June 3, 2002 and expressly disclaims
any duty to update information contained in this press release.
Amgen is a global biotechnology company that discovers, develops,
manufactures and markets important human therapeutics based on advances in cellular
and molecular biology. Amgen is headquartered in Thousand Oaks, CA, USA, with
European headquarters in Lucerne, Switzerland.
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