THOUSAND OAKS, Calif.--(BUSINESS WIRE)--May 6, 2005--Amgen Inc.
(Nasdaq:AMGN), the world´s largest biotechnology company, today
announced the submission of a supplemental Biologics License
Application (sBLA) to the U.S. Food and Drug Administration (FDA) for
Aranesp(R) (darbepoetin alfa). The sBLA is based on Phase 3 data that
Amgen believes will demonstrate Aranesp administered every three weeks
is safe and effective in the treatment of chemotherapy-induced anemia
in patients with non-myeloid malignancies. If approved, Aranesp will
be the first therapy indicated in the United States for once every
three week dosing in the treatment of anemia in these patients.
"As the first company to clone erythropoietin and develop
recombinant EPO as a therapy, Amgen is deeply committed to improving
the chemotherapy experience for cancer patients and their families,"
said Willard Dere, M.D., chief medical officer and senior vice
president of global development at Amgen. "Since chemotherapy is most
commonly given to patients every three weeks, an extended dosing
schedule for Aranesp has the potential to reduce the amount of
patient, physician and caregiver time required for anemia therapy."
About Chemotherapy-Induced Anemia
Chemotherapy can reduce the bone marrow´s ability to produce red
blood cells that transport oxygen from the lungs to all of the body´s
muscles and organs. Anemia occurs when there are too few red blood
cells and the body´s tissues are "starved" of oxygen, which can make a
patient feel short of breath, very weak, faint and tired.
This year, an estimated 1.3 million cancer patients will undergo
chemotherapy in the United States; approximately 800,000 (67 percent)
will become anemic. More than half of these patients report that
fatigue associated with anemia affects their daily lives more than any
other side effect of treatment, including nausea, pain and depression.
Although anemia is a common and often debilitating side effect of
chemotherapy, it is often not recognized and frequently under-treated.
In fact, 42 percent of patients with a hemoglobin (Hb) level less than
the recommended target level of 11 to 12 g/dL in the National
Comprehensive Cancer Network(R) (NCCN) guidelines for "Cancer and
Treatment-Related Anemia" are never treated with erythropoietic
Aranesp is a recombinant erythropoietic protein (a protein that
stimulates production of oxygen-carrying red blood cells). Amgen
revolutionized anemia treatment with the development of recombinant
erythropoietin, Epoetin alfa, which is currently marketed in the
United States by Amgen as EPOGEN(R) (Epoetin alfa)(i) and by Ortho
Biotech Products, LP, as Procrit(R) (Epoetin alfa)(ii). Building on
this heritage, Amgen developed Aranesp, a unique erythropoiesis
stimulating protein, which contains two additional sialic
acid-containing carbohydrate chains than the Epoetin alfa molecule and
remains in the bloodstream longer than Epoetin alfa because it has a
longer half-life. By virtue of its longer half-life, Aranesp should be
administered less frequently than Epoetin alfa in patients with
chronic kidney disease (CKD).
Aranesp is approved for multiple indications with varying dosage
instructions in both the United States and in Europe. Aranesp was
approved by the FDA in September 2001 for up to every two week dosing
for the treatment of anemia associated with chronic renal failure,
also known as CKD, for patients on dialysis and patients not on
dialysis. In July 2002, Aranesp was approved by the FDA for weekly
dosing for the treatment of chemotherapy-induced anemia in patients
with non-myeloid malignancies. In 2004, the European Committee for
Medicinal Products for Human Use approved Aranesp for extended dosing
intervals of once every three weeks in the treatment of anemia in
adult cancer patients with non-myeloid malignancies who are receiving
chemotherapy and monthly in the treatment of anemia associated with
Important Safety Information
Aranesp(R) is contraindicated in patients with uncontrolled
hypertension. Erythropoietic therapies may increase the risk of
thrombotic events, and other serious events. The target hemoglobin
(Hb) should not exceed 12 g/dL. If the Hb increase exceeds 1.0 g/dL in
any 2-week period, dose reductions are recommended. In a study with
another erythropoietic product, where the target Hb was 12-14 g/dL, an
increased incidence of thrombotic events, disease progression and
mortality was seen.
Pure red cell aplasia (PRCA) has been observed in patients treated
with recombinant erythropoietins. This has been reported predominantly
in patients with CRF. Aranesp(R) should be discontinued in any patient
with evidence of PRCA and the patient evaluated for the presence of
antibodies to erythropoietin products. The most commonly reported side
effects in clinical 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 Amgen´s Form 10-K for the year ended
December 31, 2004, 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 U.S.
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.
(i) EPOGEN(R) is a registered trademark of Amgen, Inc.
(ii) Procrit(R) is a registered trademark of Ortho Biotech Products,
CONTACT: Amgen, Thousand Oaks
Trish Hawkins, 805-447-4587 (media)
Arvind Sood, 805-447-1060 (investors)
SOURCE: Amgen Inc.