Amgen 2011 Annual Report Download - page 24

psoriasis, could negatively impact ENBREL sales. Certain of the treatments for these indications include generic
methotrexate and other products.
The following table reflects companies and their currently marketed products that compete with ENBREL
in the United States and Canada in the inflammatory disease setting. The table below and the following
discussion of competitor marketed products and products in development may not be exhaustive.
Territory Therapeutic Area
Competitor
Marketed
Product Competitor
U.S. & Canada Rheumatology & Dermatology REMICADE®Janssen Biotech, Inc. (Janssen)(1)/
Merck
U.S. & Canada Rheumatology & Dermatology HUMIRA®Abbott Laboratories (Abbott)
U.S. & Canada Rheumatology & Dermatology Simponi®Janssen (1)
U.S. & Canada Rheumatology Cimzia®UCB/Nektar Therapeutics
(Nektar)
U.S. & Canada Rheumatology Orencia®Bristol-Myers Squibb Company
(BMS)
U.S. & Canada Rheumatology Rituxan®Roche
U.S. Rheumatology Actemra®Roche
U.S. & Canada Dermatology Stelara®Janssen (1)
(1) A subsidiary of Johnson & Johnson (J&J) formerly known as Centocor Ortho Biotech Products, L.P.
In December 2011, the FDA accepted a new drug application (NDA) from Pfizer for approval of tofacitinib
in RA. In addition, several competitors have product candidates in phase 3 clinical development that may
compete with ENBREL in the future:
• Celgene (apremilast), in both psoriasis and psoriatic arthritis.
• AstraZeneca PLC and Rigel Pharmaceuticals Inc. (fostamatinib) in RA.
• Eli Lilly and Company (Eli Lilly) (LY 2439821) for moderate to severe plaque psoriasis.
• UCB/Nektar’s Cimzia®in psoriatic arthritis,
• Janssen’s Simponi®IV in RA and Stelara®in psoriatic arthritis.
• Roche’s Actemra®SC in RA.
ESAs
Aranesp®and EPOGEN®are our registered trademarks for darbepoetin alfa and epoetin alfa, respectively,
both of which are proteins that stimulate red blood cell production in a process known as erythropoiesis. Red
blood cells transport oxygen to all cells of the body. Without adequate amounts of a protein called erythropoietin,
the red blood cell count is reduced. A deficient red blood cell count can result in anemia, a condition in which
insufficient oxygen is delivered to the body’s organs and tissues. Anemia can be associated with CKD in patients
either on or not on dialysis. Individuals with CKD may suffer from anemia because they do not produce
sufficient amounts of erythropoietin, which is normally produced in healthy kidneys and stimulates
erythropoiesis. Anemia can also result from chemotherapy treatments for patients with non-myeloid
malignancies.
ESAs, including ours, have faced and continue to face challenges. For example, based on adverse safety
results observed beginning in late 2006 in various studies, performed by us and by others, that explored the use of
ESAs in settings different from those outlined in the FDA approved label, the product labeling of our ESAs in the
United States and the EU has been updated several times to reflect those safety concerns. In addition, due in part
to certain of these developments, reimbursement of our ESAs in the United States was also revised resulting in
changes in the way ESAs are used in clinical practice, including by decreasing the number of treated patients,
average dose and duration of ESA therapy.
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