THOUSAND OAKS, Calif.--(BUSINESS WIRE)--Dec. 11, 2004--Amgen Inc.
(Nasdaq:AMGN), the world´s largest biotechnology company, today
announced that data from a head-to-head study show that 200 mcg of
Aranesp(R) (darbepoetin alfa) dosed once every two weeks has similar
efficacy to 40,000 U of Epoetin alfa dosed once every week in boosting
hemoglobin and reducing the need for blood transfusions in breast
cancer patients with chemotherapy-induced anemia. The results were
presented by one of the study´s lead investigators, Lee Schwartzberg,
M.D., FACP, medical director of The West Clinic, Memphis, Tenn., at
the 27th annual San Antonio Breast Cancer Symposium (SABCS). (SABCS
"In this trial, no differences in the ability to achieve, in the
time to achieve or in the ability to maintain the target hemoglobin
range were observed between the two treatment groups," said Dr.
Schwartzberg. "These findings are important as they suggest that
Aranesp is effective in correcting anemia when administered every two
weeks, which is potentially more convenient than every week
administration for patients and caregivers."
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 American Society
of Hematology (ASH)/American Society of Clinical Oncology (ASCO) and
National Comprehensive Cancer Network (NCCN) guidelines for cancer and
treatment-related anemia). In the multi-center trial, 141 breast
cancer patients were randomized to receive either 200 mcg of Aranesp
dosed every two weeks (n=72) or 40,000 U of Epoetin alfa dosed once a
More than 90 percent of patients in both groups achieved
hemoglobin levels of greater than or equal to 11 g/dL (93 percent in
Aranesp group and 90 percent in Epoetin alfa group). The median time
to reach the target hemoglobin level was three weeks in the Aranesp
group and four weeks in the Epoetin alfa group. After achieving the
target hemoglobin level, 93 percent of patients in the Aranesp group
remained in the target hemoglobin range compared to 91 percent in the
Epoetin alfa group.
During the study, a lower proportion of patients treated with
Aranesp (six percent) required a blood transfusion compared with
patients treated with Epoetin alfa (16 percent). At the beginning of
the trial, mean baseline hemoglobin was 10.5 g/dL for the Aranesp
group and 10.6 g/dL for the Epoetin alfa group. At the end of
treatment, mean change in hemoglobin was 1.9 g/dL for Aranesp and 1.7
g/dL for Epoetin alfa.
Both Aranesp and Epoetin alfa had similar safety profiles in this
study. During the treatment period, 15 percent of Aranesp patients and
24 percent of Epoetin alfa patients had one or more serious adverse
events. These events were consistent with those observed in cancer
patients receiving chemotherapy and included general disorders,
administration site conditions and gastrointestinal disorders. No
thrombotic events occurred.
In July 2002, Aranesp was approved by the U.S. Food and Drug
Administration (FDA) for the treatment of chemotherapy-induced anemia
in patients with nonmyeloid malignancies. 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, 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 (for example, where Epoetin alfa is
administered three times a week, Aranesp should be administered
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.
The Aranesp dosage should be adjusted for each patient to achieve
and maintain a target hemoglobin not to exceed 12 g/dL. Doses must be
individualized to ensure that hemoglobin is maintained at an
appropriate level for each patient.
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 Amgen´s Form 10-K for the year ended
December 31, 2003, 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. Discovery or
identification of new product candidates or development of new
indications for existing products cannot be guaranteed and movement
from concept to product is uncertain; consequently, there can be no
guarantee that any particular product candidate or development of a
new indication for an existing product will be successful and become a
commercial product. Further, preclinical results do not guarantee safe
and effective performance of product candidates in humans. The
complexity of the human body cannot be perfectly or sometimes even
adequately modeled by computer or cell culture systems or animal
models. The length of time that it takes for us to complete clinical
trials and obtain regulatory approval for product marketing has in the
past varied and we expect similar variability in the future. We
develop product candidates internally and through licensing
collaborations, partnerships and joint ventures. Product candidates
that are derived from relationships may be subject to disputes between
the parties or may prove to be not as effective or as safe as we may
have believed at the time of entering into such relationship. Also, we
or others could identify side effects or manufacturing problems with
our products after they are on the market. In addition, sales of our
products are affected by the availability of reimbursement and the
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 products.
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. We believe that some of our newer products, product
candidates or new indications for existing products, may face
competition when and as they are approved and marketed. Our products
may compete against products that have lower prices, established
reimbursement, superior performance, are easier to administer, or that
are otherwise competitive with our products. 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 and there
can be no guarantee of our ability to obtain or maintain patent
protection for our products or product candidates. We cannot guarantee
that it will be able to produce commercially successful products or
maintain the commercial success of our existing products. Our stock
price may be affected by actual or perceived market opportunity,
competitive position, and success or failure of our products or
product candidates. Further, the discovery of significant problems
with a product similar to one of our products that implicate an entire
class of products could have a material adverse effect on sales of the
affected products and on our business and results of operations.
The scientific information discussed in this news release related
to our product candidates is preliminary and investigative. Such
product candidates are not approved by the U.S. Food and Drug
Administration (FDA), and no conclusions can or should be drawn
regarding the safety or effectiveness of the product candidates. Only
the FDA can determine whether the product candidates are safe and
effective for the use(s) being investigated. Further, the scientific
information discussed in this news release relating to new indications
for our products is preliminary and investigative and is not part of
the labeling approved by the U.S. Food and Drug Administration (FDA)
for the products. The products are not approved for the
investigational use(s) discussed in this news release, and no
conclusions can or should be drawn regarding the safety or
effectiveness of the products for these uses. Only the FDA can
determine whether the products are safe and effective for these uses.
Healthcare professionals should refer to and rely upon the
FDA-approved labeling for the products, and not the information
discussed in this news release.
Aranesp prescribing information can be accessed by calling
800-772-6436 or by logging on to 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.
(1) Epogen(R) is a registered trademark of Amgen, Inc.
(2) Procrit(R) is a registered trademark of Ortho Biotech
CONTACT: Amgen, Thousand Oaks
Kristen Davis, 805-447-4587 (media)
Investor Relations, 805-447-1060 (investors)
SOURCE: Amgen Inc.