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Pipeline Insight: Systemic Lupus Erythematosus - Turning a corner in drug development
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Introduction
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Datamonitor estimates 2008 SLE sales of $1.1 billion in the seven major markets. After 50 years without a new drug approval, serious unmet needs persist. Numerous drug candidates have failed to progress beyond Phase III, but innovation in development has led to recent success. Datamonitor forecasts four late-stage pipeline products, which could inject $2.9 billion into the SLE market by 2019.
Scope
*Segmentation and analysis of the SLE pipeline with in-depth discussion and assessment of key late-stage and recently discontinued drug candidates
*Interactive patient-based forecasts of 4 late-stage pipeline candidates, with a comparison of their relative clinical and commercial attractiveness
*Insight and analysis of market potential including commercial opportunity, epidemiology and discussion of unmet needs
*Focus on R&D trends with recommendations on late-stage development and assessments of past drug failures
Highlights
Considerable unmet needs remain in SLE, creating significant market opportunity. Late-stage pipeline products offer the potential to address these needs, mainly by reducing side effects. As a result, the SLE market is set to experience strong growth, with four new product launches forecast to create sales of $2.9 billion by 2019.
With Phase III success, Benlysta (belimumab) is set to reach the market first and experience rapid uptake, with peak sales of $1.9 billion by 2013. However market potential will remain for pipeline products through both further patient penetration and patient switching. Competition is forecast to decrease Benlysta's sales to $1.1 billion by 2019.
After years of failed SLE trials, the lessons learned are being applied. Recent trial design Highlights a shift in thinking, moving from use of solo disease activity indices, to utilization of a composite responder index. Initial results are encouraging, representing a significant advancement in development, but careful interpretation is required.
Reasons to Purchase
*Gain insight into the recent advances and failures in the SLE pipeline and understand the trends driving development
*Access 10 year patient based forecasts of four late-stage pipeline products and key off-label products in SLE, with interactive assumptions
*Understand the unmet needs in SLE and challenges faced in drug development, plus how each can be addressed
Overview 1
Catalyst 1
Summary 1
ABOUT DATAMONITOR HEALTHCARE 2
About the Immunology & Inflammation pharmaceutical analysis team 2
Executive Summary 3
Strategic scoping and focus 3
Datamonitor insight into the disease market 3
Datamonitor pipeline assessment summary 4
Related reports 5
TABLE OF CONTENTS 6
Chapter 1. Pipeline Overview and Dynamics 7
Key findings 7
Pipeline overview 8
Comparative forecasts 11
Datamonitor pipeline assessment summary 13
Key companies involved in the systemic lupus erythematosus (SLE) pipeline 14
Chapter 2. Systemic Lupus Erythematosus (SLE) - Market Potential 16
Key findings 16
Definition 17
Patient segmentation 19
Patient segmentation poses a challenge 19
Severity and flares 19
Organ involvement 21
Gender and age 23
Epidemiology 24
Seven major markets 24
Lupus effects less than 1% of the population in the seven major markets 24
Robust epidemiology studies selected from a literature review 26
Limitations, assumptions and caveats 28
Diagnostic criteria 28
Representative sample 29
US 29
Japan 30
France 31
Germany 31
Italy 31
Spain 31
UK 32
Race and ethnicity 32
Black populations are at the greatest risk for SLE 33
Race dynamics expected to impact SLE prevalence in the long term 35
Little change in SLE prevalent population predicted for the next 10 years 35
Mild and moderate SLE is more prevalent than severe SLE 37
Rest of the world 38
Patterns in SLE prevalence are seen across regions 41
Large SLE patient potential in emerging markets 41
Unmet need in systemic lupus erythematosus (SLE) 43
Room for improvement in efficacy 45
Side effects remain high 45
Steroid-sparing treatments highly anticipated 46
Biomarkers could help support research and development 46
Target product profile versus current level of attainment 47
Chapter 3. Current treatment options 50
Current treatment options 51
Corticosteroids are the foundation of SLE therapy 51
Immunosuppressants are primarily used for major organ involvement 52
Antimalarials are used to treat SLE across a broad spectrum of disease involvement 52
Cytotoxic agents target neuropsychiatric and renal involvement 53
NSAIDS treat milder inflammation and pain 53
Uptake of biologics highest for patients with lupus nephritis 54
Gold standard and comparator therapies 54
Off-label treatments are the gold standard therapies for SLE 54
Current market overview 55
Patient numbers are used to estimate market size 55
Rituxan/MabThera (rituximab, Biogen Idec/Roche/Zenyaku Kogyo) 60
Drug overview 60
Drug profile 61
SWOT analysis 61
Clinical trial data 62
Clinical attractiveness 67
Commercial attractiveness 68
Datamonitor drug assessment score card for Rituxan/MabThera 68
Forecasts to 2019 70
CellCept (mycophenolate mofetil, Roche/Vifor Pharma) 72
Drug overview 72
Drug profile 73
SWOT analysis 73
Clinical trial data 74
Clinical attractiveness 76
Commercial attractiveness 77
Datamonitor drug assessment score card for CellCept 77
Forecasts to 2019 79
Orencia (abatacept, Bristol-Myers Squibb) 81
Drug overview 81
Drug profile 82
SWOT analysis 82
Clinical trial data 83
Clinical and commercial attractiveness 87
Datamonitor drug assessment score card for Orencia 87
Forecasts to 2019 89
Chapter 4. R&D Approach 91
Key findings 91
Clinical trial design in systemic lupus erythematosus (SLE) 92
Regulatory guidance is limited 92
Similarities can be seen in recent trial designs 92
Standard of care 95
Endpoints 95
Variations in disease activity create a challenge 95
Systemic Lupus Erythematosus Disease Activity Index (SLEDAI) 96
The British Isles Lupus Assessment Group (BILAG) 97
European Consensus Lupus Activity Measure (ECLAM) 98
Systemic Lupus Erythematosus Activity Index (SLAM) 98
Movement towards composite endpoints 99
Quality of life (QoL) measures used as secondary endpoints 100
Steroid-sparing effects 100
Chapter 5. Pipeline Analysis & Forecasts: Immunosuppressants 101
Key findings 101
Overview for immunosuppressants 102
Pipeline summary 102
Lupuzor (IPP2011-01, ImmuPharma/Cephalon) 104
Drug overview 104
Drug profile 105
SWOT analysis 105
Clinical trial data 106
Clinical attractiveness 109
Commercial attractiveness 110
Datamonitor drug assessment score card for Lupuzor 111
Forecasts to 2019 112
Late-stage development compounds recently discontinued 114
Prestara (prasterone, GlaxoSmithKline) 114
Drug overview 114
Drug profile 114
SWOT analysis 115
Clinical trial data 115
Clinical and commercial attractiveness 117
After multiple Phase III attempts, La Jolla accepts defeat for Riquent (abetimus) 117
Teva's edratide joins the lupus graveyard after reaching Phase II 118
Chapter 6. Pipeline Analysis & Forecasts: B-Cell Therapy 119
Key findings 119
Overview for B cell therapies 120
Pipeline summary 120
Comparative forecasts 122
Benlysta (belimumab, Human Genome Sciences/GlaxoSmithKline) 124
Drug overview 124
Drug profile 125
SWOT analysis 125
Clinical trial data 126
Clinical attractiveness 133
Commercial attractiveness 134
Datamonitor drug assessment score card for Benlysta 135
Forecasts to 2019 137
Atacicept (TAC-Ig, ZymoGenetics/Merck Serono) 139
Drug overview 139
Drug profile 140
SWOT analysis 140
Clinical trial data 141
Clinical attractiveness 145
Commercial attractiveness 146
Datamonitor drug assessment score card for atacicept 146
Forecasts to 2019 148
Epratuzumab (Immunomedics/ UCB) 150
Drug overview 150
Drug profile 151
SWOT analysis 151
Clinical trial data 152
Clinical attractiveness 154
Commercial attractiveness 155
Datamonitor drug assessment score card for epratuzumab 155
Forecasts to 2019 157
Late-stage development compounds recently discontinued 159
Ocrelizumab (Roche/Biogen Idec/Chugai) 159
Drug overview 159
Drug profile 160
SWOT analysis 160
Clinical trial data 161
Clinical attractiveness 164
Commercial attractiveness 165
Chapter 7. Innovative Early-Stage Approaches 166
Key findings 166
Biologics make up the majority of the early-stage pipeline 167
Interferon inhibitors moving through the pipeline 170
Cluster of Differentiation (CD) drug candidates seen in all phases of development 172
The future of treatment in systemic lupus erythematosus (SLE) 172
Targeted therapies to reduce dependence on steroids 172
Identification of biomarkers will aid in development and treatment 173
Bibliography 174
Journals 174
Books 181
Websites 181
Datamonitor reports 187
APPENDIX 188
Methodology 188
Datamonitor market sizing methodology 188
Definition of a standard unit 190
Product forecasts 190
Datamonitor drug assessment scorecard 192
Contributing experts 193
About Datamonitor 194
About Datamonitor Healthcare 194
About the Disease analysis team 194
Datamonitor consulting 195
Disclaimer 197
LIST OF TABLES
Table 1: Products in clinical development for systemic lupus erythematosus (SLE), 2010 10
Table 2: Sales forecasts for systemic lupus erythematosus (SLE) pipeline products in the US and five major EU markets, 2010-2019 ($m) 13
Table 3: American College of Rheumatology (ACR) classification criteria for systemic lupus erythematosus (SLE), 1997 update 18
Table 4: Percentage of systemic lupus erythematosus (SLE) patients with different involvements in Okinawa, Japan, 1972-1991 23
Table 5: Systemic lupus erythematosus (SLE) prevalence in the US and UK, split by age, 2010 24
Table 6: Systemic lupus erythematosus (SLE) population, split by gender across the seven major markets, 2010 26
Table 7: Literature survey on systemic lupus erythematosus (SLE) epidemiology in the seven major markets, 2010 27
Table 8: Systemic lupus erythematosus (SLE) population, split by race/ethnicity and gender in selected parts the US and the UK, 2010 34
Table 9: Race dynamics in the US, (%), 2010-2050 35
Table 10: Estimated systemic lupus erythematosus (SLE) prevalent population (000s) by gender in the seven major markets, 2010-19 36
Table 11: Systemic lupus erythematosus (SLE) population in the seven major markets, by disease severity and country, 2010 38
Table 12: Key systemic lupus erythematosus (SLE) prevalence studies in the rest of the world, 1985-2010 40
Table 13: The estimated systemic lupus erythematosus (SLE) prevalent population in the emerging markets of China, India and Mexico, 2010 42
Table 14: Minimum acceptable product profile (MAPP) and target product profile (TPP) versus comparators, 2010 49
Table 15: Leading classes and treatments for systemic lupus erythematosus (SLE) , 2010 51
Table 16: Estimated systemic lupus erythematosus (SLE) sales in the seven major markets, by drug class, 2008 ($m) 59
Table 17: Rituxan/MabThera - drug profile, 2010 61
Table 18: Overview of small-scale studies involving Rituxan/MabThera (rituximab) for lupus indications 63
Table 19: Datamonitor's drug assessment score card for Rituxan/MabThera, 2010 70
Table 20: Sales forecast for Rituxan/MabThera for systemic lupus erythematosus (SLE) in the US and five major EU markets, 2008-2019 ($m) 72
Table 21: CellCept - drug profile, 2010 73
Table 22: Datamonitor's drug assessment score card for CellCept, 2010 79
Table 23: Sales forecast for CellCept and generic mycophenolate mofetil for systemic lupus erythematosus (SLE) in the US and five major EU markets, 2008-2019 ($m) 81
Table 24: Orencia - drug profile, 2010 82
Table 25: Datamonitor's drug assessment score card for Orencia, 2010 89
Table 26: Late-stage trial design for systemic lupus erythematosus (SLE) and lupus nephritis drug candidates, 2010 93
Table 27: Primary (P) and secondary (S) clinical trial endpoints for systemic lupus erythematosus (SLE) drug candidates, 2010 94
Table 28: Main characteristics of disease activity indices in systemic lupus erythematosus (SLE), 2010 96
Table 29: Immunosuppressants in late-stage development for systemic lupus erythematosus (SLE), 2010 104
Table 30: Lupuzor - drug profile, 2010 105
Table 31: Datamonitor's drug assessment score card for Lupuzor, 2010 112
Table 32: Sales forecast for Lupuzor for systemic lupus erythematosus (SLE) in the US and five major EU markets, 2010-19 ($m) 113
Table 33: Prestara (prasterone) - drug profile, 2010 114
Table 34: B cell targets in late-stage development for systemic lupus erythematosus (SLE), 2010 122
Table 35: Sales forecasts B cell therapies in development for systemic lupus erythematosus (SLE) in the US and five major EU markets, 2010-19 124
Table 36: Benlysta - drug profile, 2010 125
Table 37: Datamonitor's drug assessment score card for Benlysta, 2010 137
Table 38: Sales forecast for Benlysta for systemic lupus erythematosus (SLE) in the US and five major EU markets, 2010-19 ($m) 139
Table 39: Atacicept - drug profile, 2010 140
Table 40: Datamonitor's drug assessment score card for atacicept, 2010 148
Table 41: Sales forecast for atacicept for systemic lupus erythematosus (SLE) in the US and five major EU markets, 2010-19 ($m) 149
Table 42: Epratuzumab - drug profile, 2010 151
Table 43: Datamonitor's drug assessment score card for epratuzumab, 2010 157
Table 44: Sales forecast for Epratuzumab for systemic lupus erythematosus (SLE) in the US and five major EU markets, 2010-19 ($m) 158
Table 45: Ocrelizumab - drug profile, 2010 160
Table 46: Products in early-phase development for systemic lupus erythematosus (SLE), 2010 168
Table 47: Interferon inhibitors in early-stage development for systemic lupus erythematosus (SLE), 2010 171
Table 48: CD drug candidates in development for systemic lupus erythematosus (SLE), 2010 172
Table 49: Datamonitor's current market estimate assumptions by class, 2010 189
Table 50: Datamonitor's dosing assumptions by product, 2010 191
Table 51: Datamonitor's cost/patient/year assumptions for off-label products, 2010 191
Table 52: Datamonitor's cost/patient/year assumptions for pipeline products, 2010 192
Table 53: Datamonitor drug assessment parameters 193
List of Figures
Figure 1: Datamonitor drug assessment summary for therapies in development for systemic lupus erythematosus (SLE) in the US and five major EU markets, 2010 5
Figure 2: Late-stage systemic lupus erythematosus (SLE) products by class (n, %), 2010 8
Figure 3: Late-stage systemic lupus erythematosus (SLE) products by class and phase, 2010 9
Figure 4: US and EU Launch dates and probabilities of late-stage drug candidates for systemic lupus erythematosus (SLE), 2010 12
Figure 5: Datamonitor drug assessment summary for therapies in development for systemic lupus erythematosus (SLE) in the US and five major EU markets, 2010 14
Figure 6: Systemic lupus erythematosus (SLE) in the seven major markets split by disease severity (%), 2008 20
Figure 7: Mean number of disease flares in systemic lupus erythematosus patients seen per year, by disease severity in the seven major markets, 2008 21
Figure 8: Total systemic lupus erythematosus (SLE) population in the seven major markets, split by primary manifestation and disease severity, 2008 22
Figure 9: Systemic lupus erythematosus (SLE) population in the seven major markets (000s), 2010 25
Figure 10: Systemic lupus erythematosus (SLE) population in the seven major markets, by disease severity, 2010 37
Figure 11: Prevalence per 100,000 people of systemic lupus erythematosus (SLE) around the world from selected surveys, 2010 39
Figure 12: Key unmet needs for systemic lupus erythematosus (SLE), 2010 43
Figure 13: Priority ranking allocated by rheumatologists to challenges in systemic lupus erythematosus (SLE) management, 2008 44
Figure 14: SLE market sizing methodology, 2010 56
Figure 15: Estimated systemic lupus erythematosus (SLE) sales in the seven major markets, by drug class, 2008 57
Figure 16: Estimated systemic lupus erythematosus (SLE) sales in the seven major markets, 2008 58
Figure 17: Number of patients (000s) in the US and 5EU on current and pipeline products, 2010-19 60
Figure 18: Rituxan/MabThera (rituximab) - SWOT analysis for systemic lupus erythematosus (SLE), 2010 62
Figure 19: Rituxan/MabThera - EXPLORER Phase II/III trial results 64
Figure 20: Rituxan/MabThera - LUNAR Phase III trial results 66
Figure 21: Datamonitor's competitive positioning analysis of Rituxan/MabThera, 2010 69
Figure 22: Rituxan/MabThera's systemic lupus erythematosus (SLE) sales by country in the US and five major EU markets, 2008-2019 71
Figure 23: CellCept - SWOT analysis for systemic lupus erythematosus (SLE), 2010 74
Figure 24: CellCept- Phase III trial results 75
Figure 25: Datamonitor's competitive positioning analysis of CellCept, 2010 78
Figure 26: CellCept and generic mycophenolate mofetil's systemic lupus erythematosus (SLE) sales by country in the US and five major EU markets, 2008-2019 ($m) 80
Figure 27: Orencia - SWOT analysis for systemic lupus erythematosus (SLE), 2010 83
Figure 28: Orencia (abatacept) - Phase II trial results 84
Figure 29: Orencia (abatacept) - Phase II/III trial design 86
Figure 30: Datamonitor's competitive positioning analysis of Orencia, 2010 88
Figure 31: Datamonitor drug assessment summary for immunosuppressants in development for systemic lupus erythematosus (SLE), 2010 103
Figure 32: Lupuzor - SWOT analysis for systemic lupus erythematosus (SLE), 2010 106
Figure 33: Lupuzor - Phase IIb trial results 108
Figure 34: Datamonitor's competitive positioning analysis of Lupuzor, 2010 111
Figure 35: Lupuzor's systemic lupus erythematosus (SLE) sales by country in the US and five major EU markets, 2010-19 113
Figure 36: Prestara - SWOT analysis for systemic lupus erythematosus (SLE), 2010 115
Figure 37: Prestara - GL02-01 and GL03-01 Phase III trial results 116
Figure 38: Datamonitor drug assessment summary for B cell therapies in development for systemic lupus erythematosus (SLE), 2010 121
Figure 39: Sales forecasts B cell therapies in development for systemic lupus erythematosus (SLE) in the US and five major EU markets, 2010-19 123
Figure 40: Benlysta - SWOT analysis for systemic lupus erythematosus (SLE), 2010 126
Figure 41: Benlysta - BLISS-52 trial results 128
Figure 42: Benlysta - BLISS-76 trial results 130
Figure 43: Late-stage development timeline for Benlysta (belimumab, Human Genome Sciences/GlaxoSmithKline), 2010 132
Figure 44: Datamonitor's competitive positioning analysis of Benlysta, 2010 136
Figure 45: Benlysta's systemic lupus erythematosus (SLE) sales by country in the US and five major EU markets, 2010-19 138
Figure 46: Atacicept - SWOT analysis for systemic lupus erythematosus (SLE), 2010 141
Figure 47: Atacicept: Phase II/III trial design 142
Figure 48: Atacicept: Phase Ib trial results 144
Figure 49: Datamonitor's competitive positioning analysis of atacicept, 2010 147
Figure 50: Atacicept's systemic lupus erythematosus (SLE) sales by country in the US and five major EU markets, 2010-19 149
Figure 51: Epratuzumab - SWOT analysis for systemic lupus erythematosus (SLE), 2010 152
Figure 52: Epratuzumab - Phase IIb trial design, 2010 153
Figure 53: Datamonitor's competitive positioning analysis of epratuzumab, 2010 156
Figure 54: Epratuzumab's systemic lupus erythematosus (SLE) sales by country in the US and five major EU markets, 2010-19 158
Figure 55: Ocrelizumab - SWOT analysis for systemic lupus erythematosus (SLE), 2010 161
Figure 56: Ocrelizumab - BEGIN Phase III trial design 162
Figure 57: Ocrelizumab - BELONG Phase III trial design 163
Figure 58: Early-stage products for systemic lupus erythematosus (SLE) by type (n, %), 2010 169
Figure 59: Early-stage products in development for systemic lupus erythematosus (SLE) by phase, 2010 170
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