NEW ORLEANS--(BUSINESS WIRE)--June 6, 2004--Amgen Inc.
(NASDAQ:AMGN), the world´s largest biotechnology company, today
announced final results from a multi-center study demonstrating that
Aranesp(R) (darbepoetin alfa) used in treating anemia in cancer
patients not undergoing chemotherapy, a condition known as anemia of
cancer, may improve hemoglobin levels, reduce the need for transfusion
and improve the extreme fatigue experienced by patients. The results
were presented by the study´s lead investigator, Veena Charu, M.D.,
Pacific Cancer Medical Center, Anaheim, Calif., at the 40th Annual
American Society of Clinical Oncology (ASCO) meeting. (Abstract #8084)
Nearly 350,000 cancer patients in the U.S. suffer from anemia of
cancer, with common symptoms including physical and mental fatigue.
While anemia, an abnormally low level of oxygen-carrying red blood
cells, is recognized as a common problem in cancer patients receiving
chemotherapy, some patients suffer from anemia due to the cancer
itself, unrelated to chemotherapy. Despite its prevalence, anemia of
cancer has been under-recognized and under-treated.
"While oncologists are familiar with anemia related to
chemotherapy, we are now beginning to fully realize the extent to
which early diagnosis and treatment of anemia of cancer can benefit
patients," said Dr. Charu. "In this study, Aranesp was shown to
correct anemia of cancer and reduce the need for transfusions."
The analysis included 285 anemic cancer patients with a current
diagnosis or history of nonmyeloid malignancy who had not received
chemotherapy within four weeks before screening or during the study.
Patients were randomized to receive Aranesp 3.0 mcg/kg every two weeks
for 21 weeks (Aranesp group) or 12 weeks of observation followed by
nine weeks of Aranesp every two weeks (control group). The primary
endpoint of the study was the number of hospital days during weeks one
through 12. Additional endpoints included the incidence of
transfusion, change in hemoglobin and the change of Functional
Assessment of Cancer Therapy-Fatigue Scale (Fact-F) scores from
After 12 weeks of treatment, hospitalization was comparable for
treated and control patients. Throughout the study, patients treated
with Aranesp also showed improvements in hemoglobin and fatigue and a
reduction in transfusion requirements. Mean change in hemoglobin was
2.1 g/dL in patients in the Aranesp group compared to 0.1 g/dL in the
control group. Patients also reported a significant reduction in
fatigue with a mean Fact-F score change of 7.7 in the Aranesp group
and 1.8 in the control group. During weeks one through 12, 12 percent
of patients in the Aranesp group received a transfusion compared to 22
percent in the control group. Further studies are underway to confirm
The adverse event profile is consistent with what would be
expected in this patient population.
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, L.P., 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.
This news release contains forward-looking statements that involve
significant risks and uncertainties, including those discussed below
and others that can be found in our Form 10-K for the year ended
December 31, 2003, and in our periodic reports on Form 10-Q and Form
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. The Company´s results may
be affected by our ability to successfully market both new and
existing products domestically and internationally, sales growth of
recently launched products, difficulties or delays in manufacturing
our products, and regulatory developments (domestic or foreign)
involving current and future products and manufacturing facilities. In
addition, sales of our products are affected by reimbursement policies
imposed by first 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 US legislation affecting
pharmaceutical pricing and reimbursement. Government regulations and
reimbursement policies may affect the development, usage and pricing
of our products. Furthermore, our research, testing, pricing,
marketing and other operations are subject to extensive regulation by
domestic and foreign government regulatory authorities. We, or others
could identify side effects or manufacturing problems with our
products after they are on the market. In addition, we compete with
other companies with respect to some of our marketed products as well
as for the discovery and development of new products. Discovery or
identification of new product candidates cannot be guaranteed and
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. In addition, while we
routinely obtain patents for our products and technology, the
protection offered by our patents and patent applications may be
challenged, invalidated or circumvented by our competitors. Further,
some raw materials, medical devices, and component parts for our
products are supplied by sole first party suppliers.
Aranesp prescribing information can be accessed by calling
800-772-6436 or by logging onto www.aranesp.com.
EDITOR´S NOTE: An electronic version of this news release may be
accessed via our Web site at www.amgen.com. Journalists and media
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(1) EPOGEN(R) is a registered trademark of Amgen Inc.
(2) Procrit(R) is a registered trademark of Ortho Biotech Products,
CONTACT: Amgen, Thousand Oaks, Calif.
Kelly Stoddard, 805-447-4587 (media)
Investor Relations, 805-447-1060 (investors)