Monoclonal Antibodies Report Part II: Companies - Holding mAbs in portfolio promises protection against the looming 2011-12 patent cliff

About the PharmaVitae team 3
Scope of the report 4
CHAPTER 1 EXECUTIVE SUMMARY 5
Key findings 5
Total market outlook 5
Monoclonal antibody market outlook 6
Introduction to the PharmaVitae universe 8
Prescription pharmaceutical market performance, 2006-12 10
Generic competition and the ’patent cliff’ - the key driver of market growth 11
Balance of launch and expiry products in the prescription pharmaceutical market, 2006-12 11
The majority of expiry driven sales decline occurs over the ’patent cliff’ 13
Prescription pharmaceutical sales by molecule type, 2006-12 14
Generic competition and the ’patent cliff’ - an exclusive burden on small molecules 15
Absolute annual sales growth by molecule type, 2006-12 16
Sales growth rate by molecule type, 2006-12 17
mAb market performance 2006-12 18
mAbs are the most attractive product segment in the prescription pharmaceutical market, 2006-12 19
Contrasting fortunes - Roche versus Pfizer 20
mAb market penetration - insulation from the ’patent cliff’ 21
Which companies have the mAbs? 25
Established mAb players 27
The role of Big Pharma 28
The ’Big 5’ products 32
Genentech & Roche 34
Johnson & Johnson 38
Abbott 41
Strategies of the four incumbent players 42
Emerging mAb players 44
Emergent biotech players have gained scale 45
The need to circumvent the ’Big 5’ products 45
Direct head-to-head competition 47
Position as complementary therapy to incumbent mAb 47
Access patients who are refractory to gold-standard therapy 48
Biogen IDEC 52
Amgen 54
Novartis 56
UCB Pharma 57
CHAPTER 2 MAB COMPANY ANALYSIS 62
Key findings 62
The monoclonal antibody business model 64
mAb technology providers 65
Early-stage mAb developers 66
Late-stage mAb developers 67
Fully-integrated companies 68
Case study: PDL BioPharma 70
mAb alliance network 73
Early-stage alliances 73
Late-stage alliances 74
mAb driven M&A activity 75
Key players in the mAb market 79
Historical mAb company landscape 82
Forecast mAb company landscape 84
mAb sales dependency 87
Therapeutic focus 91
Oncology mAb market 92
AIID mAb market 95
Other mAb market 97
Technology focus 99
Pipeline focus 103
Emerging mAb technology providers 106
Private company overview 106
mAb company profiles 111
CHAPTER 3 ROCHE/GENENTECH 113
Introduction 113
Genentech partnership gives Roche mAb market superiority 113
Global licensing of Genentech products 114
The emergence of an oncology giant 115
mAb SWOT 116
mAb alliances 120
Financial position 122
Historical sales performance 123
Forecast sales performance 126
mAb portfolio 130
Avastin (bevacizumab) 131
Overview 131
Current market assessment 131
Future market assessment 132
Rituxan (rituximab) 132
Overview 132
Current market assessment 133
Future market assessment 134
Herceptin (trastuzumab) 134
Overview 134
Current market assessment 135
Future market assessment 135
Lucentis (ranibizumab) 136
Overview 136
Current market assessment 137
Future market assessment 138
Xolair (omalizumab) 138
Overview 138
Current market assessment 139
Future market assessment 140
Raptiva (efalizumab) 141
Overview 141
Current market assessment 141
Future market assessment 143
Actemra (tocilizumab) 143
Overview 143
Current market assessment 144
Future market assessment 145
Zenapax (daclizumab) 145
Overview 145
Current market assessment 146
Future market assessment 146
mAb pipeline 147
CHAPTER 4 JOHNSON & JOHNSON 149
Introduction 149
Acquisition of Centocor central to J&J’s antibody presence 149
mAb SWOT 152
mAb alliances 153
Financial position 154
Historical sales performance 155
Forecast sales performance 157
mAb portfolio 160
Remicade (infliximab) 161
Overview 161
Current market assessment 161
Future market assessment 163
Reopro (abciximab) 163
Current market assessment 164
Future market assessment 164
mAb pipeline 165
Golimumab 166
Overview 166
Future market assessment 166
CHAPTER 5 ABBOTT LABORATORIES 168
Introduction 168
In-licensing strategy secures Abbott’s mAb position 168
Humira central to Abbott’s growth in the wake of core genericization 169
mAb alliances 171
Financial position 172
Historical sales performance 173
Forecast sales performance 175
mAb portfolio 178
Humira (adalimumab) 178
Overview 178
Current market assessment 180
Future market assessment 181
Synagis (palivizumab) 182
Overview 182
Current market assessment 183
Future market assessment 183
mAb pipeline 183
Numax (motavizumab) 184
Overview 184
Future market assessment 186
CHAPTER 6 UCB PHARMA 187
Introduction 187
Celltech innovation to drive long-term opportunity 188
Cimzia central to UCB’s medium-term accruement from Celltech acquisition 189
mAb SWOT 190
mAb alliances 191
Financial position 192
Historical sales performance 193
Forecast sales performance 194
mAb pipeline 197
Cimzia (certolizumab pegol) 198
Overview 198
Future market assessment 198
LymphoCide (epratuzumab) 199
Overview 199
Future market assessment 200
CHAPTER 7 BIOGEN IDEC 201
Introduction 201
mAb platform supported by manufacturing and development infrastructure 201
Tysabri central to medium-term growth potential 203
mAb SWOT 204
mAb alliances 205
Financial position 206
Historical sales performance 207
Forecast sales performance 208
mAb portfolio 211
Tysabri (natalizumab) 212
Overview 212
Current market assessment 213
Future market assessment 214
Rituxan (rituximab) 214
mAb pipeline 215
Galiximab (anti-CD80) 216
Lumiliximab (anti-CD23) 217
Daclizumab (anti-CD25) 217
Volociximab (anti-AAB1) 218
CHAPTER 8 AMGEN 219
Introduction 219
Abgenix integration diversifies Amgen’s robust molecule focus 219
mAb SWOT 221
mAb alliances 222
Financial position 223
Historical sales performance 224
Forecast sales performance 225
mAb portfolio 229
Vectibix (panitumumab) 229
Overview 229
Current market assessment 230
Future market assessment 230
mAb pipeline 231
Denosumab 233
Overview 233
Future market assessment 233
AMG 531 (anti-MGDF) 234
Overview 234
Future market assessment 234
CHAPTER 9 NOVARTIS 235
Introduction 235
Externalization pursuits provide Novartis with mAb opportunity 235
mAb SWOT 237
mAb alliances 238
Financial position 239
Historical sales performance 240
Forecast sales performance 242
mAb portfolio 245
Xolair (omalizumab) 245
Lucentis (ranibizumab) 245
mAb pipeline 246
Mycograb (efungumab) 247
Future market assessment 248
CHAPTER 10 MEDIMMUNE 249
Introduction 249
mAb SWOT 251
mAb alliances 252
Financial position 253
Historical sales performance 254
Forecast sales performance 256
mAb portfolio 259
Synagis (palivizumab) 259
Overview 259
Current market assessment 259
Future market assessment 260
mAb pipeline 260
Numax (motavizumab) 262
Overview 262
Future market assessment 262
CHAPTER 11 APPENDIX 263
References 263
Abbreviations 263
List of Tables
Table 1: PharmaVitae company coverage by peer set 8
Table 2: Forecast sales by molecule type ($m), 2006-12 14
Table 3: mAb market overview, sales ($m), 2003-12 25
Table 4: Sales ($m) of ’top 4’ mAb players in 2003, 2006 and 2012 27
Table 5: Key examples of mAb-fuelled M&A 75
Table 6: mAb market overview, sales ($m), 2003-12 79
Table 7: Oncology mAb market sales ($m) by company, 2006 and 2012 92
Table 8: AIID mAb landscape, sales ($m), 2006 and 2012 95
Table 9: Other TAs mAb landscape, sales ($m), 2006 and 2012 97
Table 10: Technology presence by company, marketed mAbs in 2012 101
Table 11: mAb pipeline by company, preclinical to launched 103
Table 12: Private mAb company landscape 107
Table 13: mAb company profiles, sales ($m) 111
Table 14: Roche/Genentech’s operating revenue/cost analysis ($m), 2003-06 122
Table 15: Roche/Genentech’s historical performance, sales ($m), 2003-06 123
Table 16: Roche/Genentech’s forecast performance, sales ($m), 2006-12 126
Table 17: Roche/Genentech marketed mAb portfolio 130
Table 18: Roche/Genentech’s mAb pipeline (Phase I-III) 147
Table 19: J&J’s operating revenue/cost analysis ($m), 2003-06 154
Table 20: J&J’s historical performance, sales ($m), 2003-06 155
Table 21: J&J’s forecast performance, sales ($m), 2006-12 157
Table 22: J&J’s mAb portfolio 161
Table 23: J&J’s mAb pipeline 165
Table 24: Abbott’s operating revenue/cost analysis ($m), 2003-06 172
Table 25: Abbott’s historical performance, sales ($m), 2003-06 173
Table 26: Abbott’s forecast performance, sales ($m), 2006-12 175
Table 27: Abbott’s mAb portfolio 178
Table 28: Abbott’s mAb pipeline 183
Table 29: UCB’s operating revenue/cost analysis ($m), 2003-06 192
Table 30: UCB’s historical performance, sales ($m), 2003-06 193
Table 31: UCB’s forecast performance, sales ($m), 2006-12 194
Table 32: UCB’s mAb pipeline 197
Table 33: Biogen Idec’s operating revenue/cost analysis ($m), 2003-06 206
Table 34: Biogen Idec’s historical performance, sales ($m), 2003-06 207
Table 35: Biogen Idec’s forecast performance, sales ($m), 2006-12 208
Table 36: Biogen Idec’s marketed mAb portfolio 212
Table 37: Biogen Idec’s mAb pipeline 215
Table 38: Amgen’s operating revenue/cost analysis ($m), 2003-06 223
Table 39: Amgen’s historical performance, sales ($m), 2003-06 224
Table 40: Amgen’s forecast performance, sales ($m), 2006-12 225
Table 41: Amgen’s marketed mAb portfolio 229
Table 42: Amgen’s mAb pipeline 231
Table 43: Novartis’s operating revenue/cost analysis ($m), 2003-06 239
Table 44: Novartis’s historical performance, sales ($m), 2003-06 240
Table 45: Novartis’s forecast performance, sales ($m), 2006-12 242
Table 46: Novartis’s mAb portfolio 245
Table 47: Novartis’s mAb pipeline 246
Table 48: MedImmune’s operating revenue/cost analysis ($m), 2003-06 253
Table 49: MedImmune’s historical performance, sales ($m), 2003-06 254
Table 50: MedImmune’s forecast performance, sales ($m), 2006-12 256
Table 51: Abbott’s mAb portfolio 259
Table 52: MedImmune’s mAb pipeline 260
List of Figures
Figure 1: Pharmaceutical market performance, sales ($m) and year-on-year growth (%), 2006-12 10
Figure 2: Sales growth by launch, core & expiry (ethical sales $m), 2006-12 12
Figure 3: Expiry portfolio, year-on-year change in annual sales ($m), 2006-12 13
Figure 4: Forecast sales by molecule type ($m), 2006-12 15
Figure 5: Change in annual sales ($m) by molecule type, 2006-12 16
Figure 6: Sales compound annual growth rate (CAGR) by molecule type, 2006-12 17
Figure 7: mAb market outlook, sales ($m) and year-on-year growth (%), 2006-12 18
Figure 8: Top five PV growth drivers & resistors, sales ($m), 2006-12 21
Figure 9: Absolute growth by company, sales ($m), 2011-12 23
Figure 10: Percentage growth by molecule type, 2011-12 24
Figure 11: mAb sales by company, 2006-12 (US$m) 26
Figure 12: The established mAb players - absolute annual sales growth ($m), 2006-12 28
Figure 13: Dominance of the ’Big 5’ mAb products - The ’big 5’ mAbs have held over 70% of mAb sales since 2003 and are forecast to retain this market dominance until 2012 33
Figure 14: Genentech/Roche absolute sales growth by molecule type, ($m) 2006-12 34
Figure 15: J&J’s absolute growth by molecule type, sales ($m), 2006-12 38
Figure 16: Abbott’s absolute growth by molecule type, sales ($m), 2006-12 41
Figure 17: The emerging mAb players - absolute annual sales growth ($m), 2006-12 44
Figure 18: Dominance of oncology and AIID in mAb market - mAb absolute annual sales growth ($m), 2006-12 46
Figure 19: Biogen IDEC’s absolute growth by molecule type, sales ($m), 2006-12 52
Figure 20: Amgen’s absolute growth by molecule type, sales ($m), 2006-12 54
Figure 21: Novartis’s absolute growth by molecule type, sales ($m), 2006-12 56
Figure 22: UCB’s absolute growth by molecule type, sales ($m), 2006-12 57
Figure 23: mAb company evolution 65
Figure 24: Examples of company placement across the mAb business model 70
Figure 25: Major factors motivating mAb-fuelled acquisition 78
Figure 26: mAb sales by company ($m), 2003, 2006 and 2012 81
Figure 27: mAb sales by company ($m), 2003-06 82
Figure 28: Absolute mAb sales growth ($m), 2003-06 83
Figure 29: mAb market outlook ($m), 2006-12 84
Figure 30: mAb sales by company ($m), 2006-12 85
Figure 31: Absolute mAb sales growth ($m), 2006-12 86
Figure 32: mAb sales dependency (%), 2006 88
Figure 33: mAb sales dependency (%), 2012 89
Figure 34: mAb landscape by therapy area, 2006-12 91
Figure 35: Oncology mAb landscape, 2006 and 2012 94
Figure 36: AIID mAb landscape, 2006-12 97
Figure 37: Other mAb landscape, 2006-12 99
Figure 38: Technology presence by company, marketed mAbs in 2012 102
Figure 39: mAb programs by company, preclinical to launched 104
Figure 40: No. of commercial and institutional collaborations, circle size corresponds to no. of mAb programs 109
Figure 41: SWOT analysis of Roche/Genentech 116
Figure 42: Genentech (and Roche) major mAb alliances 120
Figure 43: Roche/Genentech mAb vs. non-mAb sales ($m), 2003-06 125
Figure 44: Roche/Genentech mAb vs. non-mAb sales ($m), 2006-12 127
Figure 45: Roche/Genentech consolidated mAb product sales ($m), ~ 2006-12 128
Figure 46: J&J’s SWOT analysis 152
Figure 47: J&J’s major mAb alliances, past and present 153
Figure 48: J&J’s mAb vs. non-mAb sales ($m), 2003-06 156
Figure 49: J&J’s mAb vs. non-mAb sales ($m), 2006-12 159
Figure 50: J&J’s mAb product sales ($m), 2006-12 160
Figure 51: Abbott’s mAb SWOT analysis 170
Figure 52: Abbott’s major mAb alliances, past and present 171
Figure 53: Abbott’s mAb vs. non-mAb sales ($m), 2003-06 174
Figure 54: Abbott’s mAb vs. non-mAb sales ($m), 2006-12 176
Figure 55: Abbott’s mAb product sales ($m), 2006-12 177
Figure 56: UCB’s SWOT analysis 190
Figure 57: UCB’s major mAb alliances, past and present 191
Figure 58: UCB’s mAb vs. non-mAb sales ($m), 2006-12 195
Figure 59: UCB’s mAb product sales ($m), 2006-12 196
Figure 60: Biogen Idec’s SWOT analysis 204
Figure 61: Biogen Idec’s major mAb alliances, past and present 205
Figure 62: Biogen Idec’s mAb vs. non-mAb sales ($m), 2006-12 210
Figure 63: Biogen Idec’s mAb product sales ($m), 2006-12 211
Figure 64: Amgen’s SWOT analysis 221
Figure 65: Amgen’s major mAb alliances, past and present 222
Figure 66: Amgen’s mAb vs. non-mAb sales ($m), 2006-12 226
Figure 67: Amgen’s mAb product sales ($m), 2006-12 227
Figure 68: Novartis’s SWOT analysis 237
Figure 69: Novartis’s major mAb alliances, past and present 238
Figure 70: Novartis’s mAb vs. non-mAb sales ($m), 2003-06 241
Figure 71: Novartis’s mAb vs. non-mAb sales ($m), 2006-12 243
Figure 72: Novartis’s mAb product sales ($m), 2006-12 244
Figure 73: MedImmune’s SWOT analysis 251
Figure 74: MedImmune’s major mAb alliances, past and present 252
Figure 75: MedImmune’s mAb vs. non-mAb sales ($m), 2003-06 255
Figure 76: MedImmune’s mAb vs. non-mAb sales ($m), 2006-12 257
Figure 77: MedImmune’s mAb product sales ($m), 2006-12 258