Amgen 2009 Annual Report Download - page 15

ESAs
• On February 16, 2010, we announced that the FDA approved a REMS program for our ESAs.
• We published detailed results from the Trial to Reduce Cardiovascular Endpoints with Aranesp®Therapy
(“TREAT”) and updated the ESA labels to incorporate certain of the trial results regarding the increased
risk of stroke and to reinforce the need to follow the approved label guidance to maintain appropriate he-
moglobin (“Hb”) levels.
• The FDA announced that it will call an advisory committee meeting in 2010 to re-evaluate the use of
ESAs to treat anemia in patients with chronic kidney disease (“CKD”) and could consider lowering tar-
geted Hb levels and reducing approved dosing for ESAs.
• The Centers for Medicare & Medicaid Services (“CMS”) has scheduled a Medicare Evidence Develop-
ment & Coverage Advisory Committee (“MEDCAC”) meeting on March 24, 2010 to examine currently
available evidence on the use of ESAs to manage anemia in patients who have CKD, which may consider
the results of the TREAT study.
• The CMS released its proposed rule to implement the bundled prospective payment system for end stage
renal disease (“ESRD”), which could impact reimbursement for EPOGEN®.
U.S. healthcare reform
• Healthcare reform, focused on expanding healthcare coverage to millions of uninsured Americans and re-
ducing the rate of increase in the costs of healthcare, remains a priority for President Obama, U.S.
Congress and a number of states. Developments in this area have been highly dynamic and difficult to
predict. As recently as February 23, 2010, President Obama released a new proposal for healthcare reform
which includes a combination of provisions from both the Senate and House of Representatives bills
passed in late 2009. Certain healthcare reform proposals being considered, which may or may not be
adopted into law, could:
Orestrict the coverage and reimbursement of our products by Medicare, Medicaid and other govern-
ment programs;
Oreduce the number of years of data exclusivity for innovative biological products potentially leading
to earlier biosimilar competition; and/or
Orequire additional healthcare reform costs be borne by pharmaceutical and biotechnology companies.
At this time, we cannot predict which or whether any reform measures will be adopted into law.
Other pipeline developments
• We announced detailed results from two key phase 3 trials evaluating Vectibix®as a first- and second-
line treatment in patients with KRAS wild-type metastatic colorectal cancer (“mCRC”).
• We announced plans to initiate a phase 3 trial for AMG 386 in ovarian cancer.
Marketed Products and Selected Product Candidates
We market our principal products, Aranesp®, EPOGEN®, Neulasta®, NEUPOGEN®and ENBREL, in the
areas of supportive cancer care, nephrology and inflammation. Our products’ competitive position among other
biologic and pharmaceutical products may be based on, among other things, patent position, product efficacy,
safety, reliability, availability, patient convenience/delivery devices, price and reimbursement. Certain of our
marketed products face, and our product candidates, if approved, are also expected to face, substantial competi-
tion from products marketed by large pharmaceutical corporations, which may have greater clinical, research,
regulatory, manufacturing, marketing, financial and human resources than we do. In addition, the introduction of
new products or the development of new processes or technologies by competitors or new information about ex-
isting products may result in increased competition for our marketed products, even for those protected by
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