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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 patient safety.
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 Inside CMS.
-- 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)