Amgen 2009 Annual Report Download - page 57

Patients may also suffer adverse medical events or side effects in the course of our, our licensees, partners or
independent investigator’s clinical trials which could:
• delay the clinical trial program
• require additional or longer trials to gain approval
• prohibit regulatory approval of our product candidates or new indications for existing products
• render the product candidate commercially unfeasible or limit our ability to market existing products
completely or in certain therapeutic areas.
Clinical trials must be designed based on the current standard of medical care. However in certain diseases,
such as cancer, the standard of care is evolving rapidly. In these diseases, the duration of time needed to complete
certain clinical trials may result in the design of such clinical trials being based on an out of date standard of
medical care, limiting the utility and application of such trials. We may not obtain favorable clinical trial results
and may not be able to obtain regulatory approval for new product candidates, new indications for existing prod-
ucts or maintenance of our current labels on this basis. Further, clinical trials conducted by others, including our
licensees, partners or independent investigators, may result in unfavorable clinical trials results that may call into
question the safety of our products in off-label or on label uses that may result in label restrictions and/or addi-
tional trials.
Even after a product is on the market, safety concerns may require additional or more extensive clinical tri-
als as part of a pharmacovigilance program of our product or for approval of a new indication. For example, we
are moving forward with Study 782 as part of our Aranesp®pharmacovigilance program. (See “— Our ESA
products continue to be under review and receive scrutiny by regulatory authorities.”) Additional clinical trials
we initiate, including those required by the FDA, could result in substantial additional expense and the outcomes
could result in additional label restrictions or the loss of regulatory approval for an approved indication, each of
which may have a material adverse effect on our business and results of operations. Additionally, any negative
results from such trials could materially affect the extent of approvals, the use, reimbursement and sales of our
products.
Our sales depend on coverage and reimbursement from third-party payers.
Sales of all of our principal products are dependent on the availability and extent of coverage and reimburse-
ment from third-party payers, including government healthcare programs and private insurance plans. We rely in
large part on the reimbursement of our principal products through government programs such as Medicare and
Medicaid in the United States and similar programs in foreign countries. (See “Item 1. Business —
Reimbursement”) The government-sponsored healthcare systems in Europe and other foreign countries are the
primary payers of healthcare costs in those regions. Governments and private payers may regulate prices, re-
imbursement levels and/or access to our products to control costs or to affect levels of use of our products. We
cannot predict the availability or level of coverage and reimbursement for our approved products or product can-
didates and a reduction in coverage and/or reimbursement for our products could have a material adverse effect
on our product sales and results of operations.
Healthcare reform, focused on expanding healthcare coverage to millions of uninsured Americans and re-
ducing the rate of increase in the cost 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 re-
form proposals being considered, which may or may not be adopted into law, could:
• restrict the coverage and reimbursement of our products by Medicare, Medicaid and other government
programs
• reduce the number of years of data exclusivity for innovative biological products potentially leading to
earlier biosimilar competition and/or
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