Pharmaceuticals of the Future August 2012

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CHAPTER ONE: EXECUTIVE SUMMARY ..........................................................1

Introduction ......................................................................................................................... 1
Scope and Methodology ...................................................................................................... 1
Potential Market Opportunity ........................................................................................... 2
Issues and Trends Affecting Market.................................................................................. 5
Leading Companies .............................................................................................................6

CHAPTER TWO: INTRODUCTION .......................................................................5

Global Pharmaceutical Market .......................................................................................... 5
Pharmaceutical Research & Development Overview ...................................................... 9
Expanded Options in Treating Diseases .......................................................................... 12

CHAPTER THREE: ISSUES AND TRENDS ........................................................16

Biotechnology Drug Development.................................................................................... 16
Orphan Drugs .................................................................................................................... 19
Fast Track Drug Status ..................................................................................................... 22
Other Accelerated Methods for Drug Approval ............................................................. 25
Pharmaceutical Regulatory Exclusivity .......................................................................... 26
Pediatric Extensions ........................................................................................................ 27
Biopharmaceutical IndustryBiosimilar (Biogeneric) Development and Exclusivity
Legislation .......................................................................................................................... 28
Aging Population ............................................................................................................... 29
Mergers, Acquisitions, and Collaborations ..................................................................... 34
Contributors To R&D Success ......................................................................................... 37
R&D Spending ................................................................................................................... 37
The Role of Contract Research Organizations ............................................................... 43
Sustainability in a Changing Pharmaceutical Industry ................................................. 44

CHAPTER FOUR: WORLDWIDE PHARMACEUTICAL INDUSTRY

LEADERS...................................................................................................................77
Introduction ....................................................................................................................... 77
Pfizer, Inc. .......................................................................................................................... 79
Overview ......................................................................................................................... 79
Financial Performance and Investments ......................................................................... 79
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Late Stage Pipeline .......................................................................................................... 82
Merck & Co., Inc. .............................................................................................................. 85
Overview ......................................................................................................................... 85
Financial Performance and Investments ......................................................................... 85
Late Stage Pipeline .......................................................................................................... 88
Novartis AG ....................................................................................................................... 91
Overview ......................................................................................................................... 91
Financial Performance and Investments ......................................................................... 91
Late Stage Pipeline .......................................................................................................... 93
Sanofi .................................................................................................................................. 97
Overview ......................................................................................................................... 97
Financial Performance and Investments ......................................................................... 97
Late Stage Pipeline ........................................................................................................ 100
Roche Ltd. ........................................................................................................................ 103
Overview ....................................................................................................................... 103
Financial Performance and Investments ....................................................................... 104
Late Stage Pipeline ........................................................................................................ 106
GlaxoSmithKline plc ....................................................................................................... 110
Overview ....................................................................................................................... 110
Financial Performance and Investments ....................................................................... 110
Late Stage Pipeline ........................................................................................................ 113
AstraZeneca plc ............................................................................................................... 117
Overview ....................................................................................................................... 117
Financial Performance and Investments ....................................................................... 117
Late Stage Pipeline ........................................................................................................ 119
Johnson & Johnson ......................................................................................................... 121
Overview ....................................................................................................................... 121
Financial Performance and Investments ....................................................................... 122
Late Stage Pipeline ........................................................................................................ 124
Eli Lilly & Company ....................................................................................................... 127
Overview ....................................................................................................................... 127
Financial Performance and Investments ....................................................................... 127
Late Stage Pipeline ........................................................................................................ 130
Abbott Laboratories ........................................................................................................ 133
Overview ....................................................................................................................... 133
Financial Performance and Investments ....................................................................... 133
Late Stage Pipeline ........................................................................................................ 136
Bristol-Myers Squibb Company .................................................................................... 138
Overview ....................................................................................................................... 138
Financial Performance and Investments ....................................................................... 138
Late Stage Pipeline ........................................................................................................ 141
Takeda Pharmaceutical Co., Ltd. .................................................................................. 144
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Overview ....................................................................................................................... 144
Financial Performance and Investments ....................................................................... 144
Late Stage Pipeline ........................................................................................................ 147
TEVA Pharmaceutical Industries, Ltd. ......................................................................... 152
Overview ....................................................................................................................... 152
Financial Performance and Investments ....................................................................... 152
Late Stage Pipeline ........................................................................................................ 155
Amgen, Inc. ...................................................................................................................... 158
Overview ....................................................................................................................... 158
Financial Performance and Investments ....................................................................... 158
Late Stage Pipeline ........................................................................................................ 161
Boehringer Ingelheim GmbH ......................................................................................... 164
Overview ....................................................................................................................... 164
Financial Performance and Investments ....................................................................... 164
Late Stage Pipeline ........................................................................................................ 167
Bayer AG .......................................................................................................................... 170
Overview ....................................................................................................................... 170
Financial Performance and Investments ....................................................................... 170
Late Stage Pipeline ........................................................................................................ 173
Novo Nordisk ................................................................................................................... 176
Overview ....................................................................................................................... 176
Financial Performance and Investments ....................................................................... 176
Late Stage Pipeline ........................................................................................................ 178
Astellas .............................................................................................................................. 180
Overview ....................................................................................................................... 180
Financial Performance and Investments ....................................................................... 180
Late Stage Pipeline ........................................................................................................ 184
Daiichi Sankyo ................................................................................................................. 187
Overview ....................................................................................................................... 187
Financial Performance and Investments ....................................................................... 187
Late Stage Pipeline ........................................................................................................ 190
Otsuka............................................................................................................................... 192
Overview ....................................................................................................................... 192
Financial Performance and Investments ....................................................................... 192
Late Stage Pipeline ........................................................................................................ 194

CHAPTER FIVE: COMPANIES OF INTEREST ...............................................199

Introduction ..................................................................................................................... 199
Merck KGaA.................................................................................................................... 201
Late Stage Pipeline ........................................................................................................ 201
Gilead Sciences ................................................................................................................ 203
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Late Stage Pipeline ........................................................................................................ 203
Eisai................................................................................................................................... 205
Late Stage Pipeline ........................................................................................................ 205
Mylan ................................................................................................................................ 207
Pipeline.......................................................................................................................... 207
Baxter International ........................................................................................................ 208
Pipeline.......................................................................................................................... 208
Servier, Les Laboratories ............................................................................................... 209
Pipeline.......................................................................................................................... 209
Celgene Corporation ....................................................................................................... 210
Late Stage Pipeline ........................................................................................................ 210
Mitsubishi Tanabe ........................................................................................................... 212
Late Stage Pipeline ........................................................................................................ 212
Allergan ............................................................................................................................ 214
Late Stage Pipeline ........................................................................................................ 214
Forest Laboratories ......................................................................................................... 215
Late Stage Pipeline ........................................................................................................ 215
CSL Limited ..................................................................................................................... 216
Late Stage Pipeline ........................................................................................................ 216
UCB SA ............................................................................................................................ 217
Late Stage Pipeline ........................................................................................................ 217
Dainippon Sumitomo Pharma, Co., Ltd. ....................................................................... 218
Late Stage Pipeline ........................................................................................................ 218
Shire .................................................................................................................................. 220
Late Stage Pipeline ........................................................................................................ 220
Biogen Idec ....................................................................................................................... 221
Late Stage Pipeline ........................................................................................................ 221
Watson .............................................................................................................................. 223
Pipeline.......................................................................................................................... 223
Hospira ............................................................................................................................. 224
Late Stage Pipeline ........................................................................................................ 224
Lundbeck A/S .................................................................................................................. 225
Late Stage Pipeline ........................................................................................................ 225
Kyowa Kirin ..................................................................................................................... 226
Late Stage Pipeline ........................................................................................................ 226
Warner Chilcott plc .........................................................................................................228
Late Stage Pipeline ........................................................................................................ 228
Menarini Group ...............................................................................................................229
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Late Stage Pipeline ........................................................................................................ 229
Valeant Pharmaceuticals ................................................................................................ 229
Late Stage Pipeline ........................................................................................................ 230
Purdue Pharma................................................................................................................ 230
Late Stage Pipeline ........................................................................................................ 231
Grifols SA ......................................................................................................................... 232
Late Stage Pipeline ........................................................................................................ 232
Shionogi & Co., Ltd. ........................................................................................................ 232
Late Stage Pipeline ........................................................................................................ 233
Actelion ............................................................................................................................. 234
Late Stage Pipeline ........................................................................................................ 234
Ono Pharmaceutical Co. ................................................................................................. 235
Late Stage Pipeline ........................................................................................................ 235
Santen Pharmaceutical Co.............................................................................................. 236
Late Stage Pipeline ........................................................................................................ 236
Reckitt Benckiser ............................................................................................................. 237
Late Stage Pipeline ........................................................................................................ 237
Taisho Pharmaceutical Co. ............................................................................................. 238
Late Stage Pipeline ........................................................................................................ 238

CHAPTER SIX: MARKET FORECAST .............................................................241

Overview........................................................................................................................... 241
Company Analysis ........................................................................................................... 242
Pipeline Snapshot: Top 20 Companies .......................................................................... 245
Market Trends and Value............................................................................................... 248
Evaluating Changes in 2011 Market Value ................................................................... 252
Market Forecast............................................................................................................... 255
The Traditional Biotechnology Market ......................................................................... 260
Biotechnology Market Facts and Forecast .................................................................... 264

APPENDIX: LIST OF COMPANIES ...................................................................268

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T

CHAPTER ONE: EXECUTIVE SUMMARY ..........................................................1

Table 1-1: Global Pharmaceutical Market Forecast by Therapeutic Segment,
2016based on late stage development projects evaluated ............................................ 3
Figure 1-1: Global Pharmaceutical Market Forecast by Therapeutic Segment,
2016Potential Impact from Late-Stage Development ................................................. 4

CHAPTER TWO: INTRODUCTION .......................................................................9

Table 2-1: Total Healthcare Expenditures as a Percent of GDP by Country
1990, 2000 and 2009 .......................................................................................................... 11
Figure 2-1: Total Healthcare Expenditures as a Percent of GDP by Country
1990, 2000, and 2009 ......................................................................................................... 12
Table 2-2: Phases of Clinical Drug Development ........................................................... 15
Table 2-3: Components of a Clinical Trial ...................................................................... 16
Figure 2-2: Biotechnology Approvals by Year Range (FDA) ........................................ 19

CHAPTER THREE: ISSUES AND TRENDS ........................................................20

Table 3-1: International Population Trend Age 65+ ...................................................... 34
Table 3-2: United States Population Trend Age 65+ ...................................................... 36
Table 3-3: Recent Pharmaceutical Business Mergers and Acquisitions....................... 39
Table 3-4: Pharmaceutical/Biopharmaceutical R&D Statistics .................................... 43
Table 3-5: Total Industry R&D Spending 2004-2010 .................................................... 45

CHAPTER FOUR: WORLDWIDE PHARMACEUTICAL

INDUSTRY LEADERS ............................................................................................77
Table 4-1: Top Biopharmaceutical Companies, 1-20 by 2011 Sales ............................. 78
Table 4-2: Pfizers Total Company Revenue and R&D Spending 2007-2011.............. 80
Figure 4-1: Pfizers Total Company Revenue and R&D Spending 2007-2011 ............ 81
Table 4-3: Pfizers Late Stage Product Pipeline ............................................................. 82
Figure 4-2: Pfizers Late Stage Product Pipeline by Therapeutic Area ....................... 84
Table 4-4: Mercks* Total Company Revenue and R&D Spending 2007-2011 .......... 86
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Table 4-5: Mercks Late Stage Product Pipeline ............................................................ 88
Table 4-5 (continued): Mercks Late Stage Product Pipeline ....................................... 89
Figure 4-4: Mercks Late Stage Product Pipeline by Therapeutic Area ...................... 90
Table 4-6: Novartis Total Company Revenue and R&D Spending 2007-2011 ........... 92
Table 4-7: Novartis Late Stage Product Pipeline .......................................................... 94
Figure 4-7: Novartis Late Stage Product Pipeline by Therapeutic Area .................... 96
Table 4-8: Sanofis Total Company Revenue and R&D Spending 2007-2011 ............. 98
Table 4-9: Sanofi-Aventis Late Stage Product Pipeline .............................................. 100
Figure 4-8: Sanofi Aventis Late Stage Product Pipeline by
Therapeutic Area ............................................................................................................ 102
Table 4-10: Roches Total Company Revenue and R&D Spending 2007-2011 ......... 104
Table 4-11: Roches Late Stage Product Pipeline......................................................... 106
Figure 4-10: Roches Late Stage Product Pipeline by Therapeutic Area ................... 109
Table 4-12: GlaxoSmithKlines Total Company Revenue and R&D
Spending 2007-2011 ........................................................................................................ 111
Table 4-13: GlaxoSmithKlines Late Stage Product Pipeline...................................... 113
Figure 4-12: GlaxoSmithKlines Late Stage Product Pipeline by
Therapeutic Area ............................................................................................................ 116
Table 4-14: AstraZenecas Total Company Revenue and R&D
Spending 2007-2011 ........................................................................................................ 117
Table 4-15: AstraZenecas Late Stage Product Pipeline.............................................. 119
Figure 4-14: AstraZeneca Late Stage Product Pipeline by Therapeutic Area ......... 121
Table 4-16: Johnson & Johnsons Total Company Revenue and R&D
Spending 2007-2011 ......................................................................................................... 122
Table 4-17: Johnson & Johnsons Late Stage Product Pipeline.................................. 124
Table 4-18: Eli Lillys Total Company Revenue and R&D Spending 2007-2011 ...... 128
Table 4-19: Eli Lillys Late Stage Product Pipeline ..................................................... 130
Figure 4-18: Eli Lilly & Co.s Late Stage Product Pipeline by
Therapeutic Area ............................................................................................................ 132
Table 4-20: Abbotts Total Company Revenue and R&D Spending 2007-2011 ........ 134
Table 4-21: Abbotts Late Stage Product Pipeline ....................................................... 136
Figure 4-20: Abbotts Late Stage Product Pipeline by Therapeutic Area ................. 137
Table 4-22: Bristol-Myers Squibbs Total Company Revenue and
R&D Spending 2007-2011 .............................................................................................. 139
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Table 4-23: Bristol-Myers Squibbs Late Stage Product Pipeline .............................. 141
Table 4-23: Bristol-Myers Squibbs Late Stage Product Pipeline .............................. 142
Figure 4-22: Bristol-Myers Late Stage Product Pipeline by
Therapeutic Area ............................................................................................................ 143
Table 4-24: Takedas Total Company Revenue* and R&D
Spending 2007-2011 ........................................................................................................ 145
Table 4-25: Takeda Pharmaceuticals Late Stage Product Pipeline........................... 148
Figure 4-24: Takeda Pharmaceuticals Late Stage Product Pipeline
by Therapeutic Area....................................................................................................... 151
Table 4-26: TEVAs Total Company Revenue and R&D Spending 2007-2011 ......... 153
Table 4-27: TEVAs Late Stage Product Pipeline ........................................................ 155
Figure 4-26: TEVAs Late Stage Product Pipeline by Therapeutic Area .................. 157
Table 4-28: Amgens Total Company Revenue and R&D Spending 2007-2011........ 159
Table 4-29: Amgens Late Stage Product Pipeline ....................................................... 161
Figure 4-28: Amgens Late Stage Product Pipeline by Therapeutic Area ................. 163
Table 4-30: Boehringer Ingelheims Total Company Revenue and
R&D Spending 2007-2011 .............................................................................................. 165
Table 4-31: Boehringer Ingelheims Late Stage Product Pipeline .............................. 167
Figure 4-30: Boehringer Ingelheims Late Stage Product Pipeline
by Therapeutic Area....................................................................................................... 169
Table 4-32: Bayers Total Company Revenue and R&D Spending 2007-2011.......... 171
Table 4-33: Bayers Late Stage Product Pipeline ......................................................... 173
Figure 4-32: Bayers Late Stage Product Pipeline by Therapeutic Area ................... 175
Table 4-34: Novo Nordisks Total Company Revenue and R&D
Spending 2007-2011 ........................................................................................................ 176
Table 4-35: Novo Nordisks Late Stage Product Pipeline ............................................ 178
Figure 4-34: Novo Nordisks Late Stage Product Pipeline by Therapeutic Area ...... 179
Table 4-36: Astellas Total Company Revenue and R&D Spending 2007-2011 ........ 182
Table 4-37: Astellas Late Stage Product Pipeline ....................................................... 184
Figure 4-36: Astellas Late Stage Product Pipeline by Therapeutic Area.................. 186
Table 4-38: Daiichi Sankyos Total Company Revenue and
R&D Spending 2007-2011 .............................................................................................. 188
Table 4-39: Daiichi Sankyos Late Stage Product Pipeline ......................................... 190
Figure 4-38: Daiichi Sankyos Late Stage Product Pipeline by
Therapeutic Area ............................................................................................................ 191
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Table 4-40: Otsuka Holdings Total Company Revenue and R&D
Spending 2007-2011 ........................................................................................................ 193
Table 4-41: Otsuka Pharmaceuticals Late Stage Product Pipeline ........................... 195
Figure 4-40: Otsuka Pharmaceuticals Late Stage Product Pipeline
by Therapeutic Area....................................................................................................... 197

CHAPTER FIVE: COMPANIES OF INTEREST ...............................................199

Table 5-1: Top Biopharmaceutical Companies, 21-50 by 2011 Sales ......................... 200
Table 5-2: Merck KGaAs Late Stage Product Pipeline .............................................. 201
Table 5-3: Gilead Sciences Late Stage Product Pipeline ............................................ 204
Table 5-4: Eisais Late Stage Product Pipeline ............................................................. 205
Table 5-5: Celgenes Late Stage Product Pipeline ........................................................ 210
Table 5-6: Mitsubishi Tanabes Late Stage Product Pipeline ..................................... 212
Table 5-7: Allergans Late Stage Product Pipeline ...................................................... 214
Table 5-8: Forest Laboratories Late Stage Product Pipeline ..................................... 215
Table 5-9: UCB Pharmas Late Stage Product Pipeline .............................................. 217
Table 5-10: Dainippon Sumitomos Late Stage Product Pipeline ............................... 218
Table 5-11: Shires Late Stage Product Pipeline .......................................................... 220
Table 5-12: Biogen Idecs Late Stage Product Pipeline ............................................... 222
Table 5-13: Hospiras Late Stage Product Pipeline ..................................................... 224
Table 5-14: Lundbecks Late Stage Product Pipeline .................................................. 225
Table 5-15: Kyowa Kirins Late Stage Product Pipeline ............................................. 226
Table 5-16: Menarinis Late Stage Product Pipeline ................................................... 229
Table 5-17: Valeants Late Stage Product Pipeline ...................................................... 230
Table 5-18: Shionogis Late Stage Product Pipeline .................................................... 233
Table 5-19: Actelions Late Stage Product Pipeline ..................................................... 234
Table 5-20: Ono Pharmaceuticals Late Stage Product Pipeline ................................ 235
Table 5-21: Santens Late Stage Product Pipeline ....................................................... 236
Table 5-22: Taishos Late Stage Product Pipeline ........................................................ 238

CHAPTER SIX: MARKET FORECAST .............................................................241

Table 6-1: Top Biopharmaceutical Companies, 1-50 by 2011 Sales ........................... 243
Table 6-1 (Continued): Top Pharmaceutical/Biopharmaceutical Companies, 1-50 by
2011 Sales ......................................................................................................................... 244
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Table 6-2: Company Pipelines by Total Late Stage Development Projects ............... 246
(Top 20 Companies by Revenues) .................................................................................. 246
Figure 6-1: Company Pipelines by Total Late Stage Development Projects
(Top 20 Companies by Revenues) .................................................................................. 247
Table 6-3: Global Pharmaceutical Market Value by Therapeutic Segment,
2005-2010 .......................................................................................................................... 250
Figure 6-2: Global Pharmaceutical Market Value by Therapeutic Segment,
2005-2010 ......................................................................................................................... 251
Table 6-4: Global Pharmaceutical Market Value by Therapeutic Segment,
2010 vs. 2011 .................................................................................................................... 253
Figure 6-3: Global Pharmaceutical Market Value by Therapeutic Segment,
2010 vs. 2011 ................................................................................................................... 254
Table 6-5: Global Pharmaceutical Market Forecast by Therapeutic Segment,
2016based on late stage development projects evaluated ....................................... 256
Figure 6-4: Global Pharmaceutical Market Forecast by Therapeutic Segment,
2016based on late stage development projects evaluated ....................................... 257
Figure 6-5: Global Pharmaceutical Market Forecast by Therapeutic
Segment, 2016Potential Impact from Late-Stage Development ............................. 258
Figure 6-6: Global Pharmaceutical Market Forecast by, 2016Potential
Impact from Late-Stage Development ........................................................................... 259
Table 6-6: Top 5 Biotechnology Companies*, 2011 Sales ............................................ 261
Table 6-7: Top 10 Biotechnology and Pharmaceutical Products, by
2011 Revenues ................................................................................................................. 265
Figure 6-7: Top 10 Biotechnology and Pharmaceutical Products, by
2011 Revenues ................................................................................................................. 267



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Three: Issues and Trends

22

In 1991, an agreement between the CDER and the CBER created a regulatory framework
for biopharmaceuticals. Prior to this resolution, all ethical products were reviewed by CDER.
Afterwards, drug molecules fell under the CDER domain, while products from living organisms/
tissues were governed by CBER. As part of the agreement, a dividing scheme was laid out,
which has been criticized for its complexity and lack of consistency.
Statutory guidelines are as follows:
x

Drugs new and generic drugs are approved under the Food, Drug
and Cosmetic Act and the Food and Drug Modernization Act. New
drug applications (NDAs) are filed under 505 (b)1, while
abbreviated new drug applications (ANDAs) for generics are filed
under 505 (j).

Biologics biopharmaceuticals are licensed under Section 351 of

the Public Health Service Act and in specific sections of the Food,
Drug and Cosmetic Act. To obtain marketing approval for a new
biologic, an applicant submits a biologics license application
(BLA).

Because of CDERs past history with biopharmaceuticals, having reviewed all the
biologics until CBERs inception and the agencies agreement in 1991, there remains a biologic
knowledge base at CDER. Alternatively, some biologic products are the result of recombinant
DNA technologys improved ability to manufacture drugs.
Most of the biologic products on the market were approved under a biological license
application and were regulated under the FDAs Center for Biologics Evaluation and Research.
However, in October 2003, the FDA switched many of the functions of CBER to CDER. The
consolidation of these review functions and personnel is expected to produce a more efficient
and effective review process for drugs and biologics by enhancing consistency and coordination
of the process.
The Center for Drug Evaluation and Research is now in charge of monoclonal antibodies
for in vivo use; cytokines, growth factors, enzymes, immunomodulators, and thrombolytic;
proteins intended for therapeutic use that are extracted from animals or microorganisms,
including recombinant versions, except clotting factors; and other non-vaccine therapeutic
immunotherapies. The Center for Biological Evaluation and Research continues to oversee gene
therapy, products composed of human or animal cells, or from physical parts of those cells,
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Three: Issues and Trends

36
Table 3-2

United States Population Trend Age 65+

(Thousands)

Year

U.S. Population 65+

Compound Annual Growth

Rate (CAGR%)

2005
2010
2015
2020
2025
2030
2035
2040
2045
2050
Source: U.S. Census Bureau International Database

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