Company is in Discussions with FDA About U.S. Prescribing
Information for Erythropoiesis-Stimulating Agents
THOUSAND OAKS, Calif.--(BUSINESS WIRE)--Feb. 28, 2007--Amgen
(NASDAQ: AMGN) today announced that the U.S. Food and Drug
Administration (FDA) has invited the Company to participate at an
upcoming meeting of the Oncologic Drugs Advisory Committee (ODAC). The
Company´s understanding is that the ODAC will review progress made by
Amgen and other sponsors in delineating the effects of
erythropoiesis-stimulating agents (ESAs) on survival and tumor
progression in cancer patients. The ODAC meeting is scheduled for May
"We look forward to providing an update to the ODAC on the
Aranesp(R) (darbepoetin alfa) 103 trial involving cancer patients with
anemia not due to chemotherapy. We have recently posted a detailed
synopsis of the study results on public Web sites, including
clinicalstudyresults.org and clinicaltrials.gov," said Roger M.
Perlmutter, M.D., Ph.D., executive vice president of research and
development for Amgen.
"The upcoming ODAC meeting will also provide a forum for the
review of our ongoing Aranesp pharmacovigilance program," Dr.
Perlmutter continued, "which we undertook following the May 2004 ODAC
meeting, including a review of data then available from the Aranesp
145 trial involving patients with previously untreated small cell lung
cancer." Dr. Perlmutter noted that the Aranesp 145 trial has reached
its pre-specified number of events. Amgen is now collecting data from
the trial and expects to announce topline results from this study in
Additionally, Amgen is in discussions with the FDA with the goal
of updating patient safety information on all ESA labels that will
take the form of a boxed warning and will apply to both nephrology and
oncology indications for the class of approved ESAs. While Amgen´s
interactions with the FDA are ongoing and exact language for the
updated prescribing information is not final, the company is committed
to providing timely and appropriate communications to patients and
physicians. When the updated prescribing information is final, Amgen
will inform healthcare professionals about the revisions to the U.S.
prescribing information through a "Dear Healthcare Professional"
letter and will post the letter and updated prescribing information on
Amgen´s web site, www.amgen.com.
Amgen´s top priority is patient safety. Aranesp is indicated for
the treatment of chemotherapy-induced anemia and anemia associated
with chronic kidney disease (CKD), for patients on dialysis and
patients not on dialysis. EPOGEN(R) (Epoetin alfa) is indicated for
the treatment of anemia associated with CKD, for patients on dialysis.
The dosing instructions recommend targeting hemoglobin levels not to
exceed 12 g/dL. Amgen always recommends that physicians and other
prescribers carefully follow FDA-approved prescribing instructions.
Amgen has also reconfirmed its 2007 financial guidance.
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 Dec.
31, 2006 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 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. 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 third party suppliers.
Amgen discovers, develops and delivers innovative human
therapeutics. A biotechnology pioneer since 1980, Amgen was one of the
first companies to realize the new science´s promise by bringing safe,
effective medicines from lab, to manufacturing plant, to patient.
Amgen therapeutics have changed the practice of medicine, helping
millions of people around the world in the fight against cancer,
kidney disease, rheumatoid arthritis, and other serious illnesses.
With a deep and broad pipeline of potential new medicines, Amgen
remains committed to advancing science to dramatically improve
people´s lives. To learn more about our pioneering science and our
vital medicines, visit www.amgen.com.
David Polk, 805-447-4613 (media)
Arvind Sood, 805-447-1060 (investors)