Amgen 2009 Annual Report Download - page 23

Download and view the complete annual report

Please find page 23 of the 2009 Amgen annual report below. You can navigate through the pages in the report by either clicking on the pages listed below, or by using the keyword search tool below to find specific information within the annual report.

Page out of 180

  • 1
  • 2
  • 3
  • 4
  • 5
  • 6
  • 7
  • 8
  • 9
  • 10
  • 11
  • 12
  • 13
  • 14
  • 15
  • 16
  • 17
  • 18
  • 19
  • 20
  • 21
  • 22
  • 23
  • 24
  • 25
  • 26
  • 27
  • 28
  • 29
  • 30
  • 31
  • 32
  • 33
  • 34
  • 35
  • 36
  • 37
  • 38
  • 39
  • 40
  • 41
  • 42
  • 43
  • 44
  • 45
  • 46
  • 47
  • 48
  • 49
  • 50
  • 51
  • 52
  • 53
  • 54
  • 55
  • 56
  • 57
  • 58
  • 59
  • 60
  • 61
  • 62
  • 63
  • 64
  • 65
  • 66
  • 67
  • 68
  • 69
  • 70
  • 71
  • 72
  • 73
  • 74
  • 75
  • 76
  • 77
  • 78
  • 79
  • 80
  • 81
  • 82
  • 83
  • 84
  • 85
  • 86
  • 87
  • 88
  • 89
  • 90
  • 91
  • 92
  • 93
  • 94
  • 95
  • 96
  • 97
  • 98
  • 99
  • 100
  • 101
  • 102
  • 103
  • 104
  • 105
  • 106
  • 107
  • 108
  • 109
  • 110
  • 111
  • 112
  • 113
  • 114
  • 115
  • 116
  • 117
  • 118
  • 119
  • 120
  • 121
  • 122
  • 123
  • 124
  • 125
  • 126
  • 127
  • 128
  • 129
  • 130
  • 131
  • 132
  • 133
  • 134
  • 135
  • 136
  • 137
  • 138
  • 139
  • 140
  • 141
  • 142
  • 143
  • 144
  • 145
  • 146
  • 147
  • 148
  • 149
  • 150
  • 151
  • 152
  • 153
  • 154
  • 155
  • 156
  • 157
  • 158
  • 159
  • 160
  • 161
  • 162
  • 163
  • 164
  • 165
  • 166
  • 167
  • 168
  • 169
  • 170
  • 171
  • 172
  • 173
  • 174
  • 175
  • 176
  • 177
  • 178
  • 179
  • 180

The following table reflects companies and their currently marketed products that primarily compete with
ENBREL in the United States and Canada in the inflammatory disease setting. The table and discussion below of
competitor marketed products and potential competitor products may not be exhaustive.
Territory Therapeutic Area
Competitor
Marketed Product Competitor
U.S. & Canada Rheumatology & Dermatology REMICADE®Centocor Ortho Biotech Inc.
(“Centocor Ortho Biotech”)(1)/
Merck
U.S. & Canada Rheumatology & Dermatology HUMIRA®Abbott Laboratories (“Abbott”)
U.S. & Canada Rheumatology & Dermatology Trexall™Duramed Pharmaceuticals,
Inc.(2)
U.S. & Canada Rheumatology & Dermatology Simponi®Centocor Ortho Biotech(1)
U.S. & Canada Rheumatology Cimzia®UCB/ Nektar Therapeutics
U.S. & Canada Rheumatology Orencia®Bristol-Myers Squibb
Corporation (“BMS”)
U.S. & Canada Rheumatology Arava®Sanofi-Aventis
U.S. & Canada Rheumatology Rheumatrex®DAVA Pharmaceuticals, Inc.
U.S. & Canada Rheumatology Rituxan®Roche
U.S. Rheumatology Actemra®Roche
U.S. & Canada Dermatology Stelara®Centocor Ortho Biotech(1)
U.S. & Canada Dermatology Amevive®Biogen IDEC Inc.
(1) A subsidiary of J&J.
(2) A subsidiary of Teva Pharmaceutical.
In addition to competition from the above-noted marketed products, various companies are developing prod-
ucts which may compete with ENBREL in the future, including Abbott, which is developing ABT-874 in phase 3
trials for the treatment of psoriasis. Abbott has announced that they are planning to submit this indication for
regulatory approval in 2010. In addition, a number of companies have JAK kinase inhibitors in development for
RA, including Pfizer and Incyte Corporation.
Other
Our other marketed products are principally comprised of Sensipar®(cinacalcet), Vectibix®(panitumumab)
and Nplate®(romiplostim).
Sensipar®(cinacalcet)
Sensipar®is our registered trademark in the United States and Mimpara®is our registered trademark in Eu-
rope for our first small molecule medicine used in treating CKD patients on dialysis who produce too much
parathyroid hormone (“PTH”), a condition known as secondary hyperparathyroidism. In 2004, Sensipar®/
Mimpara®was approved in the United States and Europe for the treatment of secondary hyperparathyroidism in
CKD patients on dialysis and for the treatment of hypercalcemia in patients with parathyroid carcinoma. In 2008,
Mimpara®was approved in Europe (through an extension of the marketing authorization for Mimpara®) for the
reduction of hypercalcemia in patients with primary hyperparathyroidism where a parathyroidectomy is not clin-
ically appropriate or is contraindicated. We market Sensipar®/Mimpara®primarily in the United States and
Europe.
Worldwide Sensipar®sales for the years ended December 31, 2009, 2008 and 2007 were $651 million, $597
million and $463 million, respectively.
On September 15, 2009, the CMS released its proposed rule to implement a bundled prospective payment
system for ESRD. The proposed rule also includes in the bundled payment oral drugs that are not equivalent to
separately billable Part B drugs, which could impact reimbursement for Sensipar®. (See “Reimbursement.”)
11