Amgen 2010 Annual Report Download - page 22

transfusion avoidance is considered clinically important, including those in whom it is important to preserve
kidney transplant eligibility. In addition to narrowing the patient population, we are proposing a more
conservative dosing algorithm in those patients. We are working with the FDA to determine the appropriate
use of ESAs in CKD patients and to determine any future ESA labeling changes required in connection with
TREAT or the CRDAC meeting.
• We are working with the FDA to make ESA product package insert changes associated with the Physician’s
Labeling Rule (“PLR”) conversion process. During the process of converting from the existing format to the
new PLR format, the FDA and Amgen are evaluating the package insert information to ensure that it
accurately reflects current knowledge and may revise, add to or remove information appearing in the old
format that could substantively impact the content of the product package insert.
In addition to the above, following the FDA’s Oncologic Drugs Advisory Committee (“ODAC”) meeting in
May 2004, we proposed a pharmacovigilance program for Aranesp»comprised of five studies to explore the use of
ESAs in settings different from those outlined in the FDA approved label. The studies were subsequently designated
by the FDA as PMCs. Of the five studies, one was sponsored by Amgen while the other four were investigator-
sponsored. Results of certain of those studies contributed to safety-related product labeling changes for our ESA
products and changes in reimbursement, as noted above. Of the five studies, three are complete with final results of
the remaining studies expected in 2011. In addition, Johnson and Johnson Pharmaceutical Research & Development
(“J&JPRD”), a subsidiary of J&J, and/or its investigators have conducted numerous studies proposed at the 2004
ODAC meeting. All of these studies are closed to enrollment and summary results were submitted to the FDA.
Based on our discussions with the FDA in response to the May 2007 ODAC meeting, we and J&JPRD have
carefully considered potential new study designs to determine the effects of ESAs on survival and tumor outcomes
in anemic patients with metastatic cancer receiving concomitant myelosuppressive chemotherapy. Based on those
discussions, we have initiated a randomized, double-blind, placebo-controlled, phase 3 non-inferiority study
evaluating overall survival when comparing advanced NSCLC patients on Aranesp»to patients receiving placebo
(“Study’782”) as part of our Aranesp»pharmacovigilance program. In addition, J&JPRD’s EPO-ANE-3010 study
in breast cancer is also ongoing. Both studies are designated by the FDA as PMR clinical trials.
Adverse events or results of any of these studies could further affect product safety labeling, healthcare
provider prescribing behavior, regulatory or private healthcare organization medical guidelines and/or reimburse-
ment practices related to Aranesp».
Aranesp»(darbepoetin alfa)
We were granted an exclusive license by Kirin-Amgen, Inc. (“KA”), a joint venture between Kirin Holdings
Company, Limited (“Kirin”) and Amgen (see Business Relationships — Kirin Holdings Company, Limited), to
manufacture and market Aranesp»in the United States, all European countries, Canada, Australia, New Zealand,
Mexico, all Central and South American countries and certain countries in Central Asia, Africa and the Middle East.
We market Aranesp»primarily in the United States and Europe. Aranesp»was launched in 2001 in the
United States and Europe for the treatment of anemia associated with CRF (both in patients on dialysis and patients
not on dialysis) and is also indicated for the treatment of anemia due to concomitant chemotherapy in patients with
non-myeloid malignancies.
Worldwide Aranesp»sales for the years ended December 31, 2010, 2009 and 2008 were $2.5 billion,
$2.7 billion and $3.14 billion, respectively. For the years ended December 31, 2010, 2009 and 2008, U.S. Aranesp»
sales were $1.1 billion, $1.3 billion and $1.65 billion, respectively, and international Aranesp»sales were
$1.4 billion, $1.4 billion and $1.49 billion, respectively.
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