Amgen 2011 Annual Report Download - page 76

healthcare providers and payers could result in decreased use and/or dosage of our products. Some examples of
agency and organizational guidelines include:
• In August 2007, the National Kidney Foundation (NKF) distributed to the nephrology community final
updated Kidney Disease Outcomes Quality Initiative (KDOQI) clinical practice guidelines and clinical
practice recommendations for anemia in CKD. The NKF-KDOQI™ Anemia Work Group recommended
in its 2007 Update to the NKF-KDOQI™ Anemia Management Guidelines that physicians target Hb in
the range of 11 g/dL to 12 g/dL, and also stipulated that the target not be above 13 g/dL.
• In December 2008, the KDIGO, a not-for-profit foundation managed by NKF, announced that it was
developing a new global anemia guideline. The announcement stated that an updated anemia guideline is
necessary in light of new study results, particularly the data from the TREAT trial, which had become
available since the NKF-KDOQI™’s clinical practice guidelines and clinical practice recommendations
for anemia in CKD were released. On September 30, 2011, the KDIGO released its draft global anemia
clinical practice guidelines for public review and comment. KDIGO has indicated that final guidelines
could be available by early 2012.
• In February 2007, following the reported results from our Anemia of Cancer 103 Study, the U.S.
Pharmacopoeia Dispensing Information Drug Reference Guides removed Aranesp®in the treatment of
anemia of cancer.
In addition, HTA organizations, such as NICE in the UK and the Canadian Agency for Drugs and
Technologies in Health, make reimbursement recommendations to payers in their jurisdictions based on the clinical
effectiveness, cost-effectiveness and service impact of new, emerging and existing medicines and treatments.
Any recommendations or guidelines that result in decreased use, dosage or reimbursement of our products
could materially and adversely affect our product sales, business and operating results. In addition, the perception
by the investment community or stockholders that such recommendations or guidelines will result in decreased
use and dosage of our products could adversely affect the market price for our common stock.
The commercialization of certain of our product candidates and the marketing of certain of our products is
dependent in part on our partners.
We have entered into agreements with third parties to assist in the commercialization of certain of our
product candidates and the marketing of certain of our products in specified geographic areas. (See Item 1.
Business — Business Relationships.) Many of these agreements involve the sharing of certain decisions and a
division of responsibilities, costs and benefits. If our partners fail to effectively deliver on their marketing and
commercialization commitments to us or if we and our partners fail to coordinate our efforts effectively, sales of
our products may be materially and adversely affected.
Our corporate compliance and risk mitigation programs cannot guarantee that we are in compliance with
all potentially applicable U.S. federal and state regulations and all potentially applicable foreign
regulations and/or that we effectively manage all operational risks.
The development, manufacturing, distribution, pricing, sales, marketing and reimbursement of our products,
together with our general operations, are subject to extensive federal and state regulation in the United States and
to extensive regulation in foreign countries. (See Our current products and products in development cannot be
sold if we do not maintain or gain regulatory approval and manufacturing difficulties, disruptions or delays could
limit supply of our products and limit our product sales.) While we have developed and instituted a corporate
compliance program, we cannot guarantee that we, our employees, our consultants or our contractors are or will
be in compliance with all potentially applicable U.S. federal and state regulations and/or laws or all potentially
applicable foreign regulations and/or laws. If we or our agents fail to comply with any of those regulations and/or
laws, a range of actions could result, including, but not limited to, the termination of clinical trials, the failure to
approve a product candidate, restrictions on our products or manufacturing processes, withdrawal of our products
from the market, significant fines, exclusion from government healthcare programs or other sanctions or
litigation. Additionally, while we have implemented numerous risk mitigation measures, we cannot guarantee
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