Amgen 2012 Annual Report Download - page 39

Download and view the complete annual report

Please find page 39 of the 2012 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 150

  • 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

32
brand names GRAN®/Grasin®, Neulasta®, NESP®, ROMIPLATE® and ESPO®, respectively. Under these agreements, Kirin pays
K-A royalties based on product sales. In addition, Kirin also receives payments from K-A for conducting certain R&D activities
on its behalf.
K-A has also given J&J exclusive licenses to manufacture and market recombinant human erythropoietin for all geographic
areas of the world outside the United States, China and Japan. K-A has also given Roche exclusive licenses to market pegfilgrastim
and G-CSF in all territories not licensed to Amgen and Kirin. Under these agreements, J&J and Roche pay royalties to K-A based
on product sales.
Pfizer Inc.
We are in a collaboration with Pfizer to co-promote ENBREL in the United States and Canada. The rights to market ENBREL
outside the United States and Canada are reserved to Pfizer. Under the agreement, a management committee comprised of equal
representation from Amgen and Pfizer is responsible for overseeing the marketing and sales of ENBREL, including strategic
planning, the approval of an annual marketing plan, product pricing and the establishment of a brand team. Amgen and Pfizer
share in the agreed-upon selling and marketing expenses approved by the joint management committee. We currently pay Pfizer
a percentage of annual gross profits on our ENBREL sales in the United States and Canada attributable to all approved indications
on a scale that increases as gross profits increase; however, we maintain a majority share of ENBREL profits. After expiration of
the co-promotion term on October 31, 2013, we will be required to pay Pfizer residual royalties based on a declining percentage
of annual net ENBREL sales in the United States and Canada for three years, ranging from 12% to 10%. The amounts of such
payments are anticipated to be significantly less than what would be owed based on the terms of the current ENBREL profit share.
Effective November 1, 2016, there will be no further royalty payments.
Glaxo Group Limited
We are in a collaboration with Glaxo for the commercialization of denosumab for osteoporosis indications in Europe,
Australia, New Zealand and Mexico (the Primary Territories). We have retained the rights to commercialize denosumab for all
indications in the United States and Canada and for oncology indications in the Primary Territories. Under a related agreement,
Glaxo will commercialize denosumab for all indications in countries, excluding Japan, where we did not have a commercial
presence at the commencement of the agreement, including China, Brazil, India, Taiwan and South Korea (the Expansion
Territories). In the Expansion Territories, Glaxo is responsible for all development and commercialization costs and will purchase
denosumab from us to meet demand. We have the option of expanding our role in the commercialization of denosumab in the
Primary Territories and certain of the Expansion Territories. In the Primary Territories, we share equally in the commercialization
profits and losses related to the collaboration after accounting for expenses, including an amount payable to us in recognition of
our discovery and development of denosumab. Glaxo is also responsible for bearing a portion of the cost of certain specified
development activities in the Primary Territories.
Takeda Pharmaceutical Company Limited
In 2008, we entered into an arrangement with Takeda, that provided Takeda both: (i) the exclusive rights to develop and
commercialize for the Japanese market up to 12 molecules from our portfolio across a range of therapeutic areas, including oncology
and inflammation (collectively the “Japanese market products”) and (ii) the right to collaborate with us on the worldwide (outside
Japan) development and commercialization of our product candidate, motesanib. The Japanese market products include Vectibix®
and certain product candidates.
In 2011, we announced that the motesanib pivotal phase 3 trial (MONET1) did not meet its primary objective of demonstrating
an improvement in overall survival.
In June 2012, the parties materially modified this arrangement such that Amgen licensed all of its rights to motesanib to
Takeda which now has control over the worldwide development and commercialization of motesanib.
AstraZeneca Plc.
We are in a collaboration with AstraZeneca to jointly develop and commercialize certain monoclonal antibodies from Amgen's
clinical inflammation portfolio, including brodalumab, AMG 139, AMG 157, AMG 181 and AMG 557. The agreement covers
the worldwide development and commercialization, except for certain Asian countries for brodalumab and Japan for AMG 557,
that are licensed to other third parties.