SAN DIEGO, Dec. 6 -- Amgen (Nasdaq: AMGN), the
world´s largest biotechnology company, today announced interim data from a
randomized, multi-center study that evaluates Aranesp (darbepoetin alfa),
administered every two weeks in correcting anemia in cancer patients not
undergoing chemotherapy, a condition known as anemia of cancer. The results
were presented at the American Society of Hematology (ASH) Annual Meeting.
The interim analysis of the study´s first 150 anemic cancer patients with
a current diagnoses or history of a nonmyeloid malignancy shows that after
12 weeks of Aranesp treatment, the mean change in hemoglobin was 1.9 g/dL for
the Aranesp group and 0.2 g/dL in the control group, which received standard
care. The baseline hemoglobin was 10.1 and 10.4 g/dL for the Aranesp and
control groups, respectively. Patients were randomized to receive either
3 mcg/kg every other week for 21 weeks or to a control group in which there
was a 12-week observation period followed by nine weeks of Aranesp. The
Kaplan-Meier estimate (95 percent) of hematopoietic response was 81 percent
(71, 90) for the Aranesp group and 26 percent (8, 43) for the control group.
Further studies will be conducted to confirm these findings.
While anemia, an abnormally low level of red blood cells, is recognized as
a common problem in cancer patients receiving chemotherapy, other patients
suffer from anemia due to the cancer itself, unrelated to chemotherapy.
Approximately 475,000 cancer patients in the U.S. suffer from anemia of
cancer, whose common symptoms include physical and mental fatigue.
"Oncologists are beginning to focus not only on chemotherapy-induced
anemia, but anemia of cancer as well," said Dr. Veena Charu, Pacific Cancer
Medical Center. "Building on the findings of previous studies, we designed
this study to examine the efficacy of Aranesp in treating cancer patients with
anemia not receiving chemotherapy."
These data were recently evaluated by U.S. Pharmacopea Drug Index (US-PDI)
for inclusion in the monograph. They formed the basis for the acceptance of
Aranesp administered every two weeks in the treatment of anemia of cancer.
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
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)(i) and by Ortho
Biotech Products, LP, as Procrit(R)(ii). Building on this heritage, Amgen
developed Aranesp, 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; no important differences were observed between Aranesp and Epoetin
Amgen is a global biotechnology company that discovers, develops,
manufactures and markets important human therapeutics based on advances in
cellular and molecular biology.
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,
2002, 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 news release and does not
undertake any obligation to update any forward-looking statements contained in
this document as a result of new information, future events or otherwise.
No forward-looking statement can be guaranteed and actual results may
differ materially from those we project. Amgen´s results may be affected by
its ability to successfully market both new and existing products domestically
and internationally, sales growth of recently launched products, difficulties
or delays in manufacturing its products, and regulatory developments (domestic
or foreign) involving current and future products and manufacturing
facilities. In addition, sales of Amgen´s products are affected by
reimbursement policies imposed by third party payors, including governments,
private insurance plans and managed care providers, and may be affected by
domestic and international trends toward managed care and healthcare cost
containment as well as possible U.S. legislation affecting pharmaceutical
pricing and reimbursement. Government regulations and reimbursement policies
may affect the development, usage and pricing of Amgen´s products.
Furthermore, Amgen´s research, testing, pricing, marketing and other
operations are subject to extensive regulation by domestic and foreign
government regulatory authorities. Amgen or others could identify side
effects or manufacturing problems with its products after they are on the
market. In addition, Amgen competes with other companies with respect to some
of its marketed products as well as for the discovery and development of new
products. Discovery or identification of new product candidates cannot be
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there can be no guarantee that any particular product candidate will be
successful and become a commercial product. In addition, while Amgen
routinely obtain patents for its products and technology, the protection
offered by its patents and patent applications may be challenged, invalidated
or circumvented by its competitors. Further, some raw materials, medical
devices and component parts for Amgen´s products are supplied by sole third
Aranesp prescribing information can be accessed by calling 800-772-6436 or
by logging onto www.aranesp.com .
CONTACT: Amgen, Thousand Oaks
Kelly Stoddard, (805) 447-0821 (media)
Cary Rosansky, (805) 447-1060 (investors)
(i) EPOGEN(R) is a registered trademark of Amgen Inc.
(ii) Procrit(R) is a registered trademark of Ortho Biotech Products, L.P.
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