Amgen 2009 Annual Report Download - page 22

being sold under the brand name Tevagrastim®in several European countries. If approved in the United States,
this drug could compete with NEUPOGEN®and Neulasta®. On November 30, 2009, Teva Pharmaceutical filed a
declaratory judgment action against us alleging that certain of our NEUPOGEN®patents are invalid and not in-
fringed by Teva Pharmaceutical’s XM02 and on January 15, 2010, we filed an answer and counterclaims seeking
a declaratory judgment that our patents are valid and infringed. (See Note 20, “Contingencies and commitments”
to the Consolidated Financial Statements.) In addition, in September 2009, Hospira announced it acquired
worldwide rights to a biogeneric version of Filgrastim from Teva Pharmaceutical. If approved in Europe, this
drug could compete with NEUPOGEN®and Neulasta®.
Enbrel®(etanercept)
ENBREL is our registered trademark for our TNF receptor fusion protein that inhibits the binding of TNF to
its receptors, which can result in a significant reduction in inflammatory activity. TNF is one of the chemical
messengers that help regulate the inflammatory process. When the body produces too much TNF, it overwhelms
the immune system’s ability to control inflammation of the joints or of psoriasis-affected skin areas. ENBREL is
similar to a protein that the body produces naturally, and like this protein, it binds certain TNF molecules before
they can trigger inflammation.
We acquired the rights to ENBREL in July 2002 with our acquisition of Immunex Corporation
(“Immunex”).
We market ENBREL under a co-promotion agreement with Pfizer Inc. (“Pfizer”) in the United States and
Canada (see “Business Relationships — Pfizer Inc.”). The rights to market and sell ENBREL outside of the Unit-
ed States and Canada are reserved to Pfizer. ENBREL was initially launched in November 1998 by Immunex for
the treatment of rheumatoid arthritis (“RA”). In addition, ENBREL is now indicated for the treatment of adult
patients with the following conditions: moderately to severely active RA; chronic moderate to severe plaque
psoriasis patients who are candidates for systemic therapy or phototherapy; active psoriatic arthritis and active
ankylosing spondylitis. ENBREL is also approved for the treatment of moderately to severely active polyarticular
juvenile idopathic arthritis in patients ages 2 and older.
ENBREL sales for the years ended December 31, 2009, 2008 and 2007 were $3.5 billion, $3.6 billion and
$3.2 billion, respectively.
Our outstanding material patent for etanercept is described in the table below.
Territory General Subject Matter Expiration
U.S. TNFR DNA vectors, cells and processes for making proteins 10/23/2012
Any products or technologies that are directly or indirectly successful in treating rheumatology, which in-
cludes moderate to severe RA, moderate to severe polyarticular juvenile idiopathic arthritis, ankylosing
spondylitis and psoriatic arthritis; and dermatology, which includes moderate to severe plaque psoriasis, could
negatively impact product sales of ENBREL. Current treatments for these indications include generic methotrex-
ate and other products, as further discussed below.
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