These results support the recently published National Comprehensive Cancer
Network Guidelines on Cancer and Treatment Related Anemia
SAN DIEGO, Dec. 7 - Amgen (Nasdaq: AMGN), the
world´s largest biotechnology company, today presented data from head-to-head
trials suggesting that Aranesp (darbepoetin alfa) dosed 200 mcg once every two
weeks provided similar results to epoetin alfa dosed 40,000 units once weekly
in boosting hemoglobin and reducing the need for blood transfusions in cancer
patients undergoing chemotherapy. The results were presented by the study´s
lead investigator, Dr. Lee Schwartzberg, medical director of The West Clinic,
Memphis, Tenn., at the American Society of Hematology (ASH) Annual Meeting.
"This analysis should provide the oncology community with further trial
data that Aranesp can treat anemia and offer the benefit of less frequent
dosing. Fewer injections can translate into less office visits, which is a
meaningful benefit for patients and caregivers. Studies have shown that, on
average, a simple injection requires two or more hours of a patient´s day and
more than an hour of a caregiver´s day," said Schwartzberg.
The interim analysis evaluated the first 210 patients enrolled in three
identical, randomized, open-label, multi-centered studies in patients with
breast, lung, and gynecologic cancers. Patients in both arms of the studies
had similar hemoglobin responses, hematopoietic responses, transfusion rates
and mean change in hemoglobin. In addition, the results were analyzed based
upon the outcome hemoglobin targets defined within the new National
Comprehensive Cancer Network (NCCN) guidelines on cancer and treatment-related
The NCCN guidelines set an important standard for clinical oncology
practice stating that physicians should initiate therapy when hemoglobin is
less than 11 g/dL and target treatment to maintain patients´ hemoglobin
between 11-12 g/dL for optimal care. These guidelines are the first to
recognize the use of Aranesp dosed at 200 mcg every other week.
More than 90 percent of Aranesp patients in the analysis reached the NCCN
guideline target range (11-12g/dL) and almost all of the patients were
maintained successfully. The time to reaching target range was comparable in
both treatment groups. Further studies to confirm these findings are planned.
For the analysis, there were 105 patients in each arm with a mean baseline
hemoglobin of 10.4 g/dL. The mean change in hemoglobin after 17 weeks of
treatment was similar between the treatment groups (1.4 g/dL for the Aranesp
group and 1.5 g/dL for the epoetin alfa group, using the intent-to-treat
approach (missing values or values within 28 days of a transfusion were
imputed using the last-value-carried-forward method)). No difference in the
incidence of severity of adverse events was observed between treatment groups.
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
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
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 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.
NOTE TO EDITORS: 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