Amgen 2010 Annual Report Download - page 26

The following table reflects companies and their currently marketed products that compete with Neulasta»
and/or NEUPOGEN»in the United States and Europe in the supportive cancer care setting. The table and the
following discussion of competitor marketed products and products in development may not be exhaustive.
Territory Competitor Marketed Product Competitor
U.S. Leukine»Bayer HealthCare Pharmaceuticals
Europe Granocyte»Chugai Pharmaceuticals Co., Ltd./
Sanofi-Aventis
Europe Ratiograstim»(1)/Filgrastim
Ratiopharm»(1)/Biograstim»(1)
ratiopharm(2)/CT Arztneimittel
Europe Tevagrastim»(1) Teva Pharmaceutical
Europe Zarzio»(1)/Filgrastim Hexal»(1) Sandoz/Hexal
Europe Nivestim»(1) Hospira
(1) Biosimilar product.
(2) A subsidiary of Teva Pharmaceutical.
In February 2010, Teva Pharmaceutical announced that the FDA had accepted for review its BLA seeking
U.S. approval to market XM02 to boost white blood cells under the brand name Neutroval
TM
. On September 30,
2010, the FDA issued a Complete Response Letter requesting additional information from Teva Pharmaceutical to
complete the review of its applications for approval of Neutroval
TM
. Neutroval
TM
is currently sold under the brand
name Tevagrastim»in several European countries. If approved in the United States, this drug would 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 infringed by Neutroval
TM
, and on
January 15, 2010, we filed an answer and counterclaims seeking a declaratory judgment that our patents are valid
and infringed. Pretrial proceedings are ongoing and no trial date has yet been set. (See Note 19, Contingencies and
commitments to the Consolidated Financial Statements.)
Other companies with short-acting filgrastims in phase 3 clinical development for Europe are:
• Merck & Company, Inc. (“Merck”) (MK-4214).
• Intas/Apotex Inc. (Neukine).
• Reliance Life Sciences (Religrast).
• Biocon Ltd./Celgene Corporation (“Celgene”) (Nufil).
In addition, Teva Pharmaceutical has two long-acting filgrastims in phase 3 clinical development for Europe
(XM-22 and Neugranin).
Enbrel»(etanercept)
ENBREL is our registered trademark for etanercept, 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”).
ENBREL was launched in November 1998 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.
10