Study Results Demonstrate Aranesp Dosed Once Every Three Weeks Achieves Treatment Goals in Managing Anemia in Cancer Patients Receiving Chemotherapy
Dosing Schedule Enabled Physicians to Better Coordinate
Chemotherapy And Anemia Treatment
NEW ORLEANS----June 8, 2004--
Amgen Inc. (Nasdaq:AMGN), the world's largest biotechnology
company, announced results of a new study demonstrating that
Aranesp(R) (darbepoetin alfa) dosed once every three weeks achieved
and maintained the target hemoglobin levels recommended by clinical
guidelines. Most patients who received Aranesp during the study
achieved therapeutic goals regardless of early or late treatment. The
results were presented by the study's investigator, Glen Justice,
M.D., Pacific Coast Hematology Oncology Medical, Fountain Valley,
Calif., at the 40th Annual American Society of Clinical Oncology
(ASCO) meeting. (Abstract #8064)
"These data demonstrate that Aranesp corrected anemia when
administered once every three weeks, which can simplify the treatment
of anemia and provide added benefit to patients and physicians by
fitting easily into the existing chemotherapy schedule," said Dr.
Justice. "Most patients can benefit with less frequent dosing which
results in less time spent receiving anemia treatment in the doctor's
The analysis includes data from a randomized, open-label
multi-center study of 204 patients with chemotherapy-induced anemia.
Patients were randomized into two groups: baseline hemoglobin of
greater than or equal to 10.5 g/dL (early intervention) and less than
or equal to 12 g/dL (observation/late intervention). The early
intervention group received Aranesp every three weeks from the start
of the treatment period. Patients in the observation group were not
treated with Aranesp unless their hemoglobin levels dropped below 10
Results of this study indicate that patients with
chemotherapy-induced anemia who received Aranesp 300 mcg every three
weeks were able to maintain optimal hemoglobin levels between 11 and
13 g/dL (in accordance with ASH/ASCO and National Comprehensive Cancer
Network (NCCN) guidelines) after early intervention as well as correct
anemia in patients with hemoglobin levels below 10 g/dL. Approximately
97 percent of patients in the early intervention group attained the
target hemoglobin range. After late treatment with Aranesp, mean
hemoglobin improved in most patients, with 90 percent of patients
achieving hemoglobin values within the target range. Greater than 90
percent of both early and late intervention patients achieve the
target hemoglobin of greater than or equal to 11 g/dL with mean
hemoglobin near 12 g/dL for the remainder of the study.
Two national evidence-based guidelines recommend the initiation of
erythropoietic therapy at different hemoglobin levels - at greater
than 10 per ASH/ASCO guidelines and at greater than 11 for NCCN
guidelines; maintenance of hemoglobin near 12 g/dL during anemia
therapy is recommended by ASH/ASCO guidelines and NCCN guidelines.
The number and type of adverse events were similar between the two
treatment groups and were consistent with the adverse event profile
for this population of anemic cancer patients receiving Aranesp.
Aranesp was approved by the U.S. Food and Drug Administration
(FDA) in July 2002 for the treatment of chemotherapy-induced anemia in
patients with nonmyeloid malignancies. Aranesp was approved by the FDA
in September 2001 for the treatment of anemia associated with chronic
renal failure, also known as chronic kidney disease, for patients on
dialysis and patients not on dialysis.
Aranesp is a recombinant erythropoietic protein (a protein that
stimulates production of oxygen-carrying red blood cells). Amgen
revolutionized anemia treatment with the discovery of recombinant
erythropoietin, epoetin alfa, which is currently marketed in the U.S.
by Amgen as EPOGEN(R)(1) and by Ortho Biotech Products, LP, as
Procrit(R)(2). Building on this heritage, Amgen developed Aranesp(R),
which contains two additional sialic acid-containing carbohydrate
chains than the epoetin alfa molecule resulting in more activity with
the added benefit of less-frequent administration.
Aranesp is contraindicated in patients with uncontrolled
hypertension. Erythropoietic therapies may increase the risk of
thrombotic and other serious events; dose reductions are recommended
if the hemoglobin increase exceeds 1.0 g/dL in any two-week period.
The most commonly reported side effects in Aranesp trials were
fatigue, edema, nausea, vomiting, diarrhea, fever, and dyspnea.
Amgen is a global biotechnology company that discovers, develops,
manufactures and markets important human therapeutics based on
advances in cellular and molecular biology.
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December 31, 2003, and in our periodic reports on Form 10-Q and Form
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Aranesp prescribing information can be accessed by calling
800-772-6436 or by logging onto www.aranesp.com.
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(1) EPOGEN(R) is a registered trademark of Amgen Inc.
(2) Procrit(R) is a registered trademark of Ortho Biotech
CONTACT: Amgen, Thousand Oaks, Calif.
Kelly Stoddard, (805) 447-4587 (media)
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