Amgen Receives CPMP Recommendation For European Union Marketing Approval Of Neulasta For The Reduction Of Chemotherapy - Induced Neutropenia
THOUSAND OAKS, Calif., USA and LUCERNE, Switzerland, -- June 3, 2002 -- Amgen
(Nasdaq:AMGN), the world's largest biotechnology company, today
announced that the European Committee on Proprietary Medicinal Products (CPMP)
has recommended approval of pegfilgrastim (Neulasta/Neupopeg) for the reduction
in the duration of neutropenia and the incidence of febrile neutropenia in patients
treated with cytotoxic chemotherapy for malignancy (with the exception of chronic
myeloid leukaemia and myelodysplastic syndromes).
The CPMP's recommendation will be forwarded to the European Commission
for its approval of the marketing authorization.
Neutropenia is a serious and frequent side effect of chemotherapy
treatment. In addition to killing cancer cells, chemotherapy also kills normal
cells, including those that protect against infection. This often results in
neutropenia, a severe drop in the numbers of a type of white blood cell called
neutrophils, which play a vital role in defending the body against most types
of infection. With a severe drop in white blood cells, even a seemingly minor
infection can become life threatening.
Neupogen(R) /Granulokine(R) (filgrastim), Amgen's other white blood
cell stimulating product, has been shown to decrease the risk of infection and
hospitalization as a result of chemotherapy-induced neutropenia. However, the
burden of daily injections (which sometimes continue for as many as 14 consecutive
days) has led many healthcare professionals to wait until after a chemotherapy
patient has developed a neutropenic infection before administering filgrastim.
Neulasta is a long-acting form of filgrastim which allows for once-per-chemotherapy
cycle dosing. In addition to reducing the burden associated with daily injections,
simple, once- per-chemotherapy-cycle administration of Neulasta may increase
adherence to treatment regimens and eliminate the potential for missed doses
of growth factor.
"This once-per-cycle product can have a very positive impact on
patients' quality of life," said Professor Martine Piccart, of the Institute
Jules Bordet, in Belgium, an investigator in the pivotal, fixed dose, pegfilgrastim
study conducted in Europe.
Neulasta is a pegylated recombinant protein that stimulates the
production of neutrophils that are depleted by cytotoxic chemotherapy.
Due to the relatively short time it remains circulating in the
blood, filgrastim requires up to two weeks of daily injections following each
cycle of chemotherapy. Almost half of chemotherapy patients who receive filgrastim
require 10 or more daily injections. With Neulasta, a polyethylene glycol molecule
or "PEG" unit is covalently bound to the filgrastim molecule, extending its
half-life and causing it to be cleared more slowly from the body mainly through
neutrophil and neutrophil precursor-mediated clearance mechanisms. This allows
for a single dose per chemotherapy cycle.
Consistent with self-regulation through neutrophil-mediated clearance
of Neulasta, the drug remains in the blood throughout the time during which
a patient is neutropenic -- when it is needed most -- and then is cleared rapidly
as neutrophils rise toward normal levels.
Data from two pivotal phase 3 studies in breast cancer patients
demonstrated that a single dose of Neulasta provided protection from infection
comparable to a median of 11 daily injections of filgrastim, reducing both the
duration of severe neutropenia and the frequency of neutropenia with fever.
The clinical trials showed that Neulasta is as safe and well-tolerated
as filgrastim. In these clinical trials (n=465), the most common adverse event
attributed to Neulasta therapy following chemotherapy was bone pain, which
was reported in 26 percent of patients. In most cases, bone pain was mild to
moderate, and controlled with non-narcotic analgesics.
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
operations are subject to extensive regulation by domestic and foreign government
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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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Jeff Richardson (805) 447-3227 (media)
Cary Rosansky, +805-447-4634 (investors)