Amgen 2009 Annual Report Download - page 18
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non-inferiority study evaluating OS when comparing advanced non-small cell lung cancer (“NSCLC”) patients
on Aranesp®to patients receiving placebo (“Study 782”) as part of our Aranesp®pharmacovigilance program.
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 reimbursement
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 initially 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 pa-
tients with non-myeloid malignancies.
Worldwide Aranesp®sales for the years ended December 31, 2009, 2008 and 2007 were $2.65 billion,
$3.14 billion and $3.61 billion, respectively. For the years ended December 31, 2009, 2008 and 2007, U.S. Ara-
nesp®sales were $1.25 billion, $1.65 billion and $2.15 billion, respectively and international Aranesp®sales
were $1.40 billion, $1.49 billion and $1.46 billion, respectively.
Our outstanding material patents for darbepoetin alfa are described in the table below.
Territory General Subject Matter Expiration
U.S. Glycosylation analogs of erythropoietin proteins 5/15/2024
Europe(1) Glycosylation analogs of erythropoietin proteins 10/12/2010
Europe(1) Glycosylation analogs of erythropoietin proteins 8/16/2014
(1) In some cases, these European patents may also be entitled to supplemental protection in one or more coun-
tries in Europe and the length of any such extension will vary by country.
Our principal European patent relating to Epoetin alfa expired on December 12, 2004. Although we do not
market EPOGEN®in Europe, upon expiration of this patent, some companies have received approval to market
biosimilars or other products that compete with Aranesp®in Europe, presenting additional competition, as further
discussed below.
6