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Amgen Inc.

Final Results of a Phase 3 European Study Demonstrate Aranesp(R) Dosed Once Every Three Weeks is at Least as Effective as Weekly Dosing in Treating Patients With Chemotherapy-Induced Anaemia

Stockholm, Sweden (ots/PRNewswire)

Amgen Inc., (NASDAQ: AMGN)
the world's largest biotechnology company, announced that new data
from a randomised, double-blind Phase 3 study demonstrate that
Aranesp(r) (darbepoetin alfa) administered as a fixed dose of 500 mcg
once every three weeks is at least as effective as 2.25 mcg/kg of
darbepoetin alfa administered once weekly with respect to the need
for red blood cell transfusions in cancer patients with
chemotherapy-induced Anaemia and is effective in increasing
haemoglobin to Evidence Based Practice Guidelines target levels[1].
The results were presented at the 10th Congress of the European
Hematology Association. [Abstract #471]
In 2004, darbepoetin alfa was approved by the European Committee
for Medicinal Products for Human Use (CHMP) for every-three-week
dosing in patients with chemotherapy-induced Anaemia.
"Anaemia is one of the most common side effects of chemotherapy.
However, it is often under-treated, despite the availability of
treatments that have  been available for more than a decade," said
Jean-Luc Canon, MD, Centre  Notre Dame et Reine Fabiola, Charleroi,
Belgium. "The every three-week dosing schedule of Aranesp is
consistent with most chemotherapy regimens and may  allow physicians
to effectively treat Anaemia while reducing the time spent  by
patients, physicians and caregivers for Anaemia management."
In this study, patients with chemotherapy-induced Anaemia from 110
centres in Europe were randomised to receive either a fixed dose of
500 mcg of darbepoetin alfa every three weeks or 2.25 mcg/kg of
darbepoetin alfa once a week. Of the 672 patients assessed from week
five through the end of  the treatment period, the difference between
treatment groups was 6.8 percent with respect to the need for red
blood cell transfusion (23 percent of  patients receiving darbepoetin
alfa once every three weeks compared to 30  percent who received once
weekly dosing). Additionally, from week five  through the end of the
treatment period, 82 percent of patients receiving  darbepoetin alfa
every three weeks compared to 70 percent of patient  receiving
darbepoetin alfa once a week achieved the target haemoglobin  range
(11 to 13 g/dL) consistent with the current evidence based practice
guidelines issued by the European Organisation for Research and
Treatment of Cancer, American Society of Clinical Oncology, American
Society of Hematology and the National Comprehensive Cancer Network.
There were no differences in the safety profile between the two
treatment groups. The most frequently reported adverse events were
nausea, vomiting, fatigue and pyrexia.
About Aranesp
Aranesp is a recombinant erythropoietic protein (a protein that
stimulates production of oxygen-carrying red blood cells). Amgen
revolutionized Anaemia treatment with the development of recombinant
erythropoietin, Epoetin alfa. Building on this heritage, Amgen
developed Aranesp, a unique erythropoiesis stimulating protein, which
contains two additional sialic acid-containing carbohydrate chains
than the Epoetin alfa molecule and remains in the bloodstream longer
than Epoetin alfa because it has a longer half-life. By virtue of its
longer half-life, Aranesp should be administered less frequently than
Epoetin alfa in patients with chronic kidney disease (CKD).
Darbepoetin alfa was initially granted marketing authorization by
the European Commission in 2001 for the treatment of Anaemia
associated with chronic renal failure in adults and paediatric
subjects 11 years of age or older. In 2002, the European Commission
approved darbepoetin alfa for the treatment of Anaemia in adult
cancer patients receiving chemotherapy with solid tumours. This
patient population was subsequently expanded in 2003 to include all
adult cancer patients with non-myeloid malignancies receiving
chemotherapy.
Important Safety Information
Aranesp is contraindicated in patients with uncontrolled
hypertension. Erythropoietic therapies may increase the risk of
thrombotic and other serious events; regional guidelines should be
referred to for target and maximum haemoglobin levels, and dose
adjustment rules should be performed in line with regional
prescribing information. In a study with another erythropoietic
product, where the target Hb was 12-14 g/dL, an increased incidence
of thrombotic events, disease progression and mortality was seen.
Pure red cell aplasia (PRCA) has been observed in patients treated
with recombinant erythropoietic proteins. This has been reported
predominantly in patients with chronic renal failure. Aranesp should
be  discontinued in any patient with evidence of PRCA and the patient
evaluated for the presence of antibodies to erythropoietin products.
The most commonly reported side effects in clinical trials were
fatigue, edema, nausea,  vomiting, diarrhoea, fever and dyspnea.
About Amgen
Amgen is a global biotechnology company that discovers, develops,
manufactures and markets important human therapeutics based on
advances in cellular and molecular biology.
www.amgen.com
Forward-Looking Statement
This news release contains forward-looking statements that involve
significant risks and uncertainties, including those discussed below
and others that can be found in Amgen's Form 10-K for the year ended
December 31, 2004, and in Amgen's periodic reports on Form 10-Q and
Form 8-K. Amgen is providing this information as of the date of this
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Reference:
[1] Evidence based Practice Guidelines target level is 11 to 13
g/dL according to the European Organisation for Research and
Treatment of Cancer, the National Comprehensive Cancer Network and
the American Society of Clinical Oncology.

Contact:

Contact: Amgen Europe: Sabeena Ahmad, Phone: +41-41-369-2530 or
Porter Novelli: Inge Boets, Phone: +32-2-413-03-40