PharmaPoint: Rheumatoid Arthritis - United States Drug Forecast and Market Analysis Event-Driven Update

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PharmaPoint: Rheumatoid Arthritis - United States Drug Forecast
and Market Analysis Event-Driven Update
Published on November 2012

Report Summary

PharmaPoint: Rheumatoid Arthritis - United States Drug Forecast and Market Analysis Event-Driven Update

Summary

GlobalData has released its new Country report, 'PharmaPoint: Rheumatoid Arthritis - United States Drug Forecast and Market
Analysis Event-Driven Update'. The RA market is currently very dynamic, with the November 6, 2012 FDA approval of Pfizer's Xeljanz
(tofacitinib) and novel oral therapies awaiting approval such as: Eli Lilly's anti-BAFF, tabalumab and JAK1,2 inhibitor, baricitinib, and
Rigel/AZ's SYK inhibitor, fostamatinib. These compounds will challenge the current biologics in the attempt to dislodge the stronghold
of the TNF inhibitors, if their safety and efficacy profiles are proven once they enter the market.

US physicians surveyed for this report state that they may follow guidelines such as ACR, but also follow their own clinical experience
to treat patients. In the US, about 75% of patient referrals come from Primary Care Physicians (PCPs). Also, most patients who are
referred present with signs and symptoms of moderate to severe RA. People seeking treatment are generally in the 55 and older age
group. Within this age group, females outnumber men by a small margin.

Scope

- Overview of RA, including epidemiology, etiology, symptoms, diagnosis, pathology and treatment guidelines as well as an overview
on the competitive landscape.
- Detailed information on the key drugs in the United States including product description, safety and efficacy profiles as well as a
SWOT analysis.
- Sales forecast for the top drugs in United States from 2011 to 2022.
- Analysis of the impact of key events as well the drivers and restraints affecting the United States rheumatoid arthritis market.

Reasons to buy

- Understand and capitalize by identifying products that are most likely to ensure a robust return
- Stay ahead of the competition by understanding the changing competitive landscape for rheumatoid arthritis
- Effectively plan your M&A and partnership strategies by identifying drugs with the most promising sales potential
- Make more informed business decisions from insightful and in-depth analysis of rheumatoid arthritis drug performance in the United
States
- Obtain sales forecast from 2011-2022 in the United States

Table of Content

1 Table of Contents
1 Table of Contents 4

PharmaPoint: Rheumatoid Arthritis - United States Drug Forecast and Market Analysis Event-Driven Update (From Slideshare) Page 1/7


1.1 List of Tables 6
1.2 List of Figures 8
2 Introduction 9
2.1 Catalyst 9
2.2 Related Reports 10
3 Disease Overview 12
3.1 Etiology and Pathophysiology 12
3.1.1 Etiology 12
3.1.2 Pathophysiology 12
3.1.3 Prognosis 15
3.1.4 Quality of Life 15
3.2 Symptoms 16
4 Disease Management 17
4.1 Treatment Overview 20
4.2 US 24
4.2.1 Diagnosis 24
4.2.2 Clinical Practice 24
5 Competitive Assessment 26
5.1 Overview 26
5.2 Strategic Competitor Assessment 26
5.3 Product Profiles - Major Brands 28
5.3.1 Enbrel (etanercept) 28
5.3.2 Humira (adalimumab) 34
5.3.3 Remicade (infliximab) 37
5.3.4 Simponi (golimumab) 41
5.3.5 Cimzia (certolizumab pegol) 45
5.3.6 Orencia (abatacept) 49
5.3.7 Actemra/RoActemra (tocilizumab) 53
5.3.8 Rituxan/MabThera (rituximab) 57
5.3.9 Methotrexate Sodium (numerous generic names) 60
5.3.10 DMARDs 63
6 Opportunity and Unmet Need 64
6.1 Overview 64
6.2 Unmet Needs 65
6.2.1 More rheumatologists in the field and physician knowledge of the disease 65
6.2.2 More cost-effective therapies through oral formulation and biosimilars 65
6.2.3 The development of predictive tests and discovery of biomarkers 66
6.2.4 The discovery of curative therapies 66
6.2.5 Improved drug safety and efficacy profiles 66
6.3 Gap Analysis 67
6.4 Opportunities 68
6.4.1 Predictive tools for diagnosis and treatment 68
6.4.2 Target specificity 68
7 Pipeline Assessment 69
7.1 Overview 69
7.2 Promising Drugs in Clinical Development 70
7.2.1 Tofacitinib (CP-690550) 72
7.2.2 Tabalumab (LY2127399) 79



7.2.3 Fostamatinib (previously R788) 82
7.2.4 RAVAX 86
7.2.5 Secukinumab (AIN457) 90
7.2.6 Masitinib (AB101) 94
7.2.7 Baricitinib (formerly LY3009104/INCB28050) 98
7.2.8 Sarilumab (REGN88/SAR153191) 102
7.2.9 Sirukumab (CNTO 136) 105
8 Market Outlook 108
8.1 United States 108
8.1.1 Forecast 108
8.1.2 Key Events 110
8.1.3 Drivers and Barriers 111
9 Appendix 113
9.1 Abbreviations 113
9.2 Bibliography 115
9.3 Methodology 125
9.4 Forecasting Methodology 125
9.4.1 Diagnosed Rheumatoid Arthritis Patients 125
9.4.2 Percent Drug-treated Patients 126
9.4.3 Drugs Included in Each Therapeutic Class 126
9.4.4 Launch and Patent Expiry Dates 127
9.4.5 General Pricing Assumptions 127
9.4.6 Individual Drug Assumptions 128
9.4.7 Generic Erosion 134
9.4.8 Pricing of Pipeline agents 134
9.5 Physicians and Specialists Included in this Study 135
9.6 Primary Research - Prescriber Survey 135
9.7 About the Authors 136
9.7.1 Analysts 136
9.7.2 Global Head of Healthcare 137
9.8 About GlobalData 138
9.9 Contact Us 138
9.10 Disclaimer 138

List of Tables

1.1 List of Tables
Table 1: Symptoms of Rheumatoid Arthritis 16
Table 2: Treatment Guidelines for Rheumatoid Arthritis 20
Table 3: Top Three Biologics Prescribed for Moderate-Severe Rheumatoid Arthritis by Market 23
Table 4: Treatment Guidelines for Rheumatoid Arthritis 27
Table 5: Product Profile - Enbrel 29
Table 6: 10 year Open-label Safety and Efficacy Trial of Enbrel: Efficacy Results at 11 years for Completers 30
Table 7: 10 year Open-label Safety and Efficacy Trial of Enbrel: Safety Results Overall 31
Table 8: Enbrel SWOT Analysis, 2012 33
Table 9: Product Profile - Humira 34



Table 10: Humira SWOT Analysis, 2012 36
Table 11: Product Profile - Remicade 38
Table 12: Remicade SWOT Analysis, 2012 40
Table 13: Product Profile - Simponi 42
Table 14: Simponi SWOT Analysis, 2012 44
Table 15: Product Profile - Cimzia 46
Table 16: Cimzia SWOT Analysis, 2012 48
Table 17: Product Profile - Orencia 50
Table 18: Orencia SWOT Analysis, 2012 52
Table 19: Product Profile - Actemra/RoActemra 54
Table 20: Actemra/RoActemra SWOT Analysis, 2012 56
Table 21: Product Profile - Rituxan 58
Table 22: Rituxan SWOT Analysis, 2012 59
Table 23: Product Profile - Methotrexate 61
Table 24: Methotrexate SWOT Analysis, 2012 62
Table 25: Summary of Minor Therapeutic Classes, 2012 63
Table 26: Overall Unmet Needs - Current Level of Attainment 64
Table 27: Clinical Unmet Needs - Gap Analysis, 2012 67
Table 28: Rheumatoid Arthritis - Phase Pipeline, 2012 70
Table 29: Comparison of Therapeutic Classes in Development for RA, 2012 71
Table 30: Product Profile - Tofacitinib 73
Table 31: Clinical Trial Locations by Country for Tofacitinib 73
Table 32: ORAL Standard ACR 20 Responses for Tofacitinib vs. Placebo vs. Humira at Month 6 74
Table 33: ORAL Step ACR 20, 50, 70 Responses for Tofacitinib vs. Placebo at Month Six 74
Table 34: Efficacy Issues Regarding Tofacitinib Determined by FDA Advisory Panel, May 2012 75
Table 35: Safety Issues Regarding Tofacitinib Determined by FDA Advisory Panel, May 2012 76
Table 36: Tofacitinib Clinical Trial Mortalities as of September 29, 2011 77
Table 37: Tofacitinib SWOT Analysis, 2012 78
Table 38: Product Profile - Tabalumab 79
Table 39: ACR Responses and DAS28 Scores for Tabalumab vs. Placebo at Week 16 80
Table 40: Tabalumab SWOT Analysis, 2012 81
Table 41: Product Profile - Fostamatinib 82
Table 42: ACR Responses and DAS28 Scores for Fostamatinib vs. Placebo at Month Three 83
Table 43: Fostamatinib SWOT Analysis, 2012 85
Table 44: Product Profile - RAVAX 86
Table 45: RAVAX SWOT Analysis, 2012 89
Table 46: Product Profile - Secukinumab 90
Table 47: Secondary Endpoint Results for Secukinumab vs. Placebo at Weeks 24 and 52 91
Table 48: Secukinumab SWOT Analysis, 2012 93
Table 49: Product Profile - Masitinib 94
Table 50: ACR Responses for Masitinib in the ITT Population (12 Weeks) 95
Table 51: ACR Responses for Masitinib in the ITT Population (12-82 Weeks) 95
Table 52: Masitinib SWOT Analysis, 2012 97
Table 53: Product Profile - Baricitinib 98
Table 54: ACR Responses for Baricitinib + MTX vs. Placebo + MTX at Week 12 99
Table 55: Safety of 4 and 8mg Baricitinib at Week 12 100
Table 56: Laboratory Values of 4 and 8mg Baricitinib at Week 12 100
Table 57: Baricitinib SWOT Analysis, 2012 101



Table 58: Product Profile - Sarilumab 102
Table 59: MOBILITY Study Results for Sarilumab at Week 12 103
Table 60: Sarilumab SWOT Analysis, 2012 104
Table 61: Product Profile - Sirukumab 105
Table 62: Sirukumab SWOT Analysis, 2012 107
Table 63: Sales Forecasts ($m) for Rheumatoid Arthritis in the United States 109
Table 64: Key Events Impacting Sales for Rheumatoid Arthritis in the United States, 2012 110
Table 65: Rheumatoid Arthritis Market - Drivers and Barriers in the United States, 2012 111
Table 66: Key Launch Dates 127
Table 67: Key Patent Expiries 127
Table 68: Physicians Surveyed, By Country 135

List of Figures

1.2 List of Figures
Figure 1: Healthy and Arthritic Joint with Rheumatoid Arthritis 12
Figure 2: Rheumatoid Arthritis Biologic Drug Targets 14
Figure 3: Diagnosis Criteria for Rheumatoid Arthritis Based on 2010 ACR/EULAR Criteria Point System 18
Figure 4: Severity of Rheumatoid Arthritis 19
Figure 5: Biologic Treatment Flow Based on Updated 2012 ACR Treatment Recommendations* 22
Figure 6: Competitive Assessment of Late-Stage Pipeline Agents in RA, 2012-2022 70
Figure 7: Sales for Rheumatoid Arthritis in the United States by Drug Class 110


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PharmaPoint: Rheumatoid Arthritis - United States Drug Forecast and Market Analysis Event-Driven Update