Aranesp Receives Positive Regulatory Opinion for Extended Dosing in Europe
THOUSAND OAKS, Calif., Aug 5, 2004 (BUSINESS WIRE) -- Amgen Inc.
(Nasdaq:AMGN), the world's largest biotechnology company, today
announced that the European Committee for Medicinal Products for Human
Use (CHMP) has issued a positive opinion to expand the marketing
authorization for Aranesp(R) (darbepoetin alfa) in the European Union
(EU). The CHMP opinion recommends authorization of
once-every-three-week Aranesp administration in the treatment of
anemia in adult cancer patients with non-myeloid malignancies who are
receiving chemotherapy and up to once-per-month administration in the
treatment of anemia in chronic kidney disease (CKD) patients not on
"With the majority of cancer patients receiving chemotherapy on a
21-day cycle, the opportunity to receive Aranesp once every three
weeks is a significant added benefit for patients and their
physicians. Once approved, patients with CKD not on dialysis, who
often visit their physician monthly, can greatly benefit from an up to
once-monthly Aranesp treatment regimen," said Beth Seidenberg, senior
vice president of development and chief medical officer at Amgen.
"Aranesp's ability to effectively correct hemoglobin with less
frequent dosing than other erythropoietic agents can simplify anemia
management for people with cancer receiving chemotherapy or those
afflicted with CKD."
Recommendations from the CHMP are typically endorsed by the
European Commission for marketing authorization within three to four
months. When approved, Aranesp will be the first and only
erythropoietic stimulating protein approved in the EU for
once-every-three-week and once-per-month dosing.
In Europe, marketing authorization for Aranesp was granted in 2001
for the treatment of anemia associated with kidney disease. The
authorization was expanded in 2002 to include patients with solid
tumors and chemotherapy-induced anemia. In 2003, the approval was
granted to include cancer patients with lymphoproliferative diseases.
Thus, Aranesp is indicated for the treatment of anemia in adult cancer
patients with non-myeloid malignancy who are receiving chemotherapy.
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) (Epoetin alfa)(i) and by Ortho Biotech Products,
LP, as Procrit(R) (Epoetin alfa)(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
Aranesp was approved by the U.S. Food and Drug Administration
(FDA) in September 2001 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 the treatment of chemotherapy-induced anemia in patients with
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.
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 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.
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
SOURCE: Amgen Inc.
Amgen Inc., Thousand Oaks
Michael Beckerich, 805-447-4587 (media)
Laura Biswas, 805-447-1060 (investors)
Customize your Business Wire news & multimedia to match your needs.
Get breaking news from companies and organizations worldwide.
Logon for FREE today at www.BusinessWire.com.