Amgen 2009 Annual Report Download - page 81

International Aranesp®sales for year ended December 31, 2009 decreased 6%, due to the unfavorable im-
pact of changes in foreign currency exchange rates. For the year ended December 31, 2009, excluding the impact
of foreign currency exchange rate changes of approximately $85 million, international Aranesp®sales remained
unchanged.
The decrease in U.S. Aranesp®sales for the year ended December 31, 2008 reflects the negative impact on
demand, primarily in the supportive cancer care setting, of physician conformance to regulatory and reimburse-
ment developments which principally occurred in the second half of 2007, additional product label changes
which occurred in 2008, and to a lesser extent, loss of segment share. The decline in demand was partially offset
by an increase in the average net sales price. In addition, U.S. sales of Aranesp®for the year ended December 31,
2008 benefited from a slight change in an accounting estimate related to product sales return reserves. The regu-
latory and reimbursement developments negatively impacting sales, included (i) the loss of Aranesp®for use in
the treatment AoC following the reported results of our AoC phase 3 study in February 2007, (ii) various ESA
product safety-related label changes in the United States during 2008 and 2007 and (iii) the CMS’ NCD issued in
July 2007, which significantly restricted Medicare reimbursement for use of Aranesp®in chemotherapy induced
anemia (“CIA”) and which we believe has also negatively impacted Aranesp®use in CIA for patients covered by
private insurance plans.
The increase in international Aranesp®sales for the year ended December 31, 2008 was due to changes in
foreign currency exchange rates, which positively impacted sales growth by approximately $104 million. Exclud-
ing the impact of foreign currency exchange rate changes, international Aranesp®sales decreased 5%. This
decrease reflects dosing conservatism in the oncology segment and pricing pressures across all ESAs in Europe,
which resulted in an overall decrease in the ESA market.
In addition to other factors mentioned in the “Product sales” section above, future Aranesp®sales will be
dependent, in part, on such factors as:
• regulatory developments, including:
Othe REMS for our ESAs, which has been recently approved by the FDA, or other risk management ac-
tivities undertaken by us or required by the FDA or other regulatory authorities;
Othe ESA product label changes reflecting certain results of our TREAT study (“TREAT label
changes”);
Othe proposed FDA advisory committee meeting in 2010 to re-evaluate the use of ESAs to treat anemia
in patients with CKD;
Ofuture product label changes, including those we are currently discussing with regulatory authorities;
• reimbursement developments, including those resulting from:
Othe CMS’ MEDCAC meeting in March 2010 to examine currently available evidence on the use of
ESAs to manage anemia in patients who have CKD;
Ogovernment’s and/or third-party payer’s reaction to regulatory developments, including the REMS for
our ESAs, the TREAT label changes and future product label changes;
Ochanges in reimbursement rates or changes in the basis for reimbursement by the federal and state gov-
ernments , including Medicare and Medicaid;
Ocost containment pressures by third-party payers, including governments and private insurance plans;
• our ability to maintain worldwide segment share and differentiate Aranesp®from current and potential fu-
ture competitive therapies or products, including J&J’s Epoetin alfa product marketed in the United States
and certain other locations outside of the United States and other competitors’ products outside of the
United States, including biosimilar products that have been launched;
• proposed healthcare reform in the United States;
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