Aranesp(R) Administered Once Monthly Maintains Hemoglobin Levels in Patients With Chronic Kidney Disease
SAN DIEGO, Nov. 16 -- Amgen (Nasdaq: AMGN), the
world's largest biotechnology company, today announced study results that
suggest that Aranesp(R) (darbepoetin alfa) may be administered once monthly in
patients with anemia and chronic kidney disease.
This multicenter study enrolled 98 patients with chronic kidney disease
receiving Aranesp once every two weeks. Following enrollment, the dosing
interval was extended to once monthly by doubling the previous once every
2 week Aranesp dose. Of the 86 patients who completed the study, 85 percent
maintained their hemoglobin levels within the target range while receiving
Aranesp once monthly. The mean hemoglobin was maintained at 11.1 g/dL
following treatment with monthly administration. The cumulative monthly dose
requirement was similar when Aranesp was administered once or twice a month.
Adverse events were similar to those reported in previous clinical trials
with Aranesp in chronic kidney disease patients. The most common adverse
events included hypertension, peripheral edema, fatigue and upper respiratory
Further studies are planned to confirm these findings.
Aranesp was approved in the U.S. Food and Drug Administration (FDA); most
European countries in the European Union, Australia, New Zealand and Canada
for the treatment of anemia associated with chronic kidney disease, for
patients on dialysis and not on dialysis. The FDA also approved Aranesp(R)
for the treatment of chemotherapy-induced anemia in patients with nonmyeloid
Aranesp is contraindicated in patients with uncontrolled hypertension.
Increases in hemoglobin greater than approximately 1.0 g/dL during any
two-week period have been associated with serious side effects. The most
commonly reported side effects in Aranesp(R) trials were infection,
hypertension, hypotension, myalgia, headache, and diarrhea.
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 our Form 10-K for the year ended December 31,
2002, and in our 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. 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 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 US legislation affecting pharmaceutical
pricing and reimbursement. Government regulations and reimbursement policies
may affect the development, usage and pricing of our product. 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 third party suppliers.
Amgen is a global biotechnology company that discovers, develops,
manufactures and markets important human therapeutics based on advances in
cellular and molecular biology.
CONTACT: Amgen, Thousand Oaks
Kelly Stoddard, (805) 447-0821 (media)
Cary Rosansky, (805) 447-1060 (investors)
NOTE TO EDITORS: Copies of the study abstracts are available upon
request. Full prescribing information is available on the Web for Aranesp(R)
at www.aranesp.com or by calling toll-free 1-800-772-6436.
An Electronic version of this news release may be accessed via our Web
site at www.amgen.com . Visit the Corporate Center and click on Amgen News.
Journalists and media representatives may sign up to receive all news releases
electronically at the time of announcement by filling out a short form in the
Amgen News section of the Web site.