Amgen Responds to Reports About Use and Safety of EPOGEN and Aranesp in CKD Anemia Therapy
THOUSAND OAKS, Calif., Dec 04, 2006 (BUSINESS WIRE) -- Amgen (NASDAQ:AMGN), today posted to its corporate web site
documents intended to clarify Amgen's position on the use of EPOGEN(R)
(Epoetin alfa) and Aranesp(R) (darbepoetin alfa) and to correct what
the company believes are misleading and inaccurate news reports
regarding the use of its drugs. Amgen's mission is to serve patients
and the company is committed to ensuring the highest standards of
Documents supporting the following statements have been posted on
the company's web site (www.amgen.com) under the link Amgen Responds
to Reports About the Use and Safety of its Products. The documents
include: 1) Amgen's Response to Reports about the Use and Safety of
its Products in Anemia Therapy; 2) Amgen's Response to the CHOIR and
CREATE Clinical Trial Data; 3) Amgen's Letter to Nephrologists and 4)
an interview with the Center for Medicare & Medicaid Services (CMS)
Chief Medical Officer Barry Straube that was initially published in
-- EPOGEN and Aranesp are effective and safe medicines when
administered according to the Food and Drug Administration
-- Amgen only promotes the use of EPOGEN and Aranesp consistent
with the FDA label.
-- Hemoglobin maintenance is difficult and physicians are not
necessarily acting inappropriately when patients' hemoglobin
levels temporarily exceed the FDA label target range.
-- CMS reimbursement guidelines are consistent with the FDA
labeling policy and allow doctors to provide patients with the
best possible care.
-- Changes to current guidelines should be approached judiciously
and based on the rigorous review of data and patient care.
The company will also submit written testimony to the House Ways &
Means Committee, which is scheduled to hold a hearing Wednesday, Dec.
6, on safety and quality for Medicare beneficiaries with End Stage
Renal Disease. That testimony will be posted to the company's web site
under this link upon submission to the committee.
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)