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Reportlinker Adds Pipeline Insight: Systemic Lupus Erythematosus - Turning a corner in drug development

Wednesday, April 7, 2010 Research News J E 4
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NEW YORK, April 6 Reportlinker.com announces that a new market research report is available in its catalogue:

Pipeline Insight: Systemic Lupus Erythematosus - Turning a corner in drug development

http://www.reportlinker.com/p0184962/Pipeline-Insight-Systemic-Lupus-Erythematosus---Turning-a-corner-in-drug-development.html

Introduction

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

To order this report:

Drug Discovery and Development Industry: Pipeline Insight: Systemic Lupus Erythematosus - Turning a corner in drug development

More Market Research Report

Check our Company Profile, SWOT and Revenue Analysis!

Contact: Nicolas Bombourg Reportlinker Email: nbo@reportlinker.com US: (805)652-2626 Intl: +1 805-652-2626

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