NEW ORLEANS----June 8, 2004--Amgen Inc.
(Nasdaq:AMGN), the world´s largest biotechnology company, today
presented final results from an analysis of three identical
head-to-head trials showing that Aranesp(R) (darbepoetin alfa) dosed
once every two weeks provided similar results as epoetin alfa dosed
once every week in boosting hemoglobin and reducing the need for blood
transfusions in cancer patients with chemotherapy-induced anemia. The
results were presented by the study´s lead investigator, Lee
Schwartzberg, M.D., medical director of The West Clinic, Memphis,
Tenn., at the 40th Annual American Society of Clinical Oncology (ASCO)
meeting. (Abstract #8063)
"These are the first clinical data from head-to-head comparisons
that show the comparability of Aranesp dosed every two weeks versus
epoetin alfa dosed once a week," said Dr. Schwartzberg. "These results
are important as the data implies that less frequent dosing with
Aranesp may provide increased patient convenience without compromising
The analysis includes data on 312 patients across the three
studies with breast, non-small cell lung cancer, and gynecological
cancer who were randomized to receive either Aranesp 200 mcg every two
weeks or epoetin alfa 40,000 U every week. Whether treated with
Aranesp or epoetin alfa, patients in this study achieved target
hemoglobin of greater than or equal to 11 g/dL and had similar
The results were analyzed based upon the achievement and
maintenance of target hemoglobin threshold (greater than or equal to
11 g/dL) and range (11-13 g/dL, which is based on the ASH/ASCO and
National Comprehensive Cancer Network (NCCN) guidelines for cancer and
treatment-related anemia). Patients in both arms of the studies
achieved and maintained hemoglobin levels of 11-13 g/dL. The median
time to reach the target hemoglobin level was five weeks in the
Aranesp group and four weeks in the epoetin alfa group. After
achieving the target hemoglobin level, 81 percent of patients in the
Aranesp group remained in the target range compared to 75 percent in
the epoetin alfa group.
Aranesp allows patients to reach therapeutic goals while providing
the convenience of less frequent dosing. Results of a patient
satisfaction questionnaire given to study participants demonstrate
that medical visits for anemia treatment incur a clinically meaningful
burden on patients and caregivers. Patients spend on average two hours
traveling to and from their oncologist´s office and two hours at the
office receiving treatment. In addition, the survey shows that the
majority of patients would prefer to spend time with family and
"These survey results reveal that cancer patients and their
caregivers spend a considerable amount of time for cancer treatments
resulting in more time away from family, friends and work," said Dr.
Schwartzberg. "Our results imply that patients and caregivers can
benefit from every two week dosing of Aranesp, which can result in
less travel and less time in the physician´s office. It is a win-win
situation for everyone."
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(R) 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. The FDA approved Aranesp 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)(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.
Amgen is a global biotechnology company that discovers, develops,
manufactures and markets important human therapeutics based on
advances in cellular and molecular biology.
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, 2003, 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 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
representatives may sign up to receive all news releases
electronically at time of announcement by filling out a short form in
the Media section of the Web site.
(i)EPOGEN(R) is a registered trademark of Amgen Inc.
(ii)Procrit(R) is a registered trademark of Ortho Biotech
CONTACT: Amgen, Thousand Oaks
Kelly Stoddard, 805-447-4587 (media)
Investor Relations, 805-447-1060 (investors)