Xeljanz (tofacitinib) (Rheumatoid Arthritis) Forecast and Market Analysis

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Xeljanz (tofacitinib) (Rheumatoid Arthritis) Forecast and Market
Analysis
Published on November 2012

Report Summary

Xeljanz (tofacitinib) (Rheumatoid Arthritis) Forecast and Market Analysis

Summary

GlobalData has released its new PharmaPoint Drug Evaluation report, Xeljanz (tofacitinib) (Rheumatoid Arthritis) Forecast and Market
Analysis. 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.

Pfizer has developed Xeljanz (tofacitinib;formerly known as tasocitinib), an oral, small-molecule inhibitor of JAK3 kinase for the
treatment of RA, psoriasis, psoriatic arthritis, ankylosing spondylitis, Crohn's disease, ulcerative colitis, transplant rejection, and dry
eye syndrome. Xeljanz (tofacitinib) is the most advanced kinase inhibitor in development for RA and is a first-in-class product. Xeljanz
(tofacitinib) targets the JAK pathway, thus disrupting the intracellular signal pathway through which cytokines regulate immune
responses.

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 Xeljanz (tofacitinib) including product description, safety and efficacy profiles as well as a SWOT analysis.
- Sales forecast for Xeljanz (tofacitinib) for the top eight countries from 2011 to 2022.
- Sales information covered for the US, France, Germany, the UK, Italy, Spain, Japan and Australia.

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 Xeljanz (tofacitinib) performance
- Obtain sales forecast for Xeljanz (tofacitinib) from 2011 to 2022 in (the US, France, Germany, the UK, Italy, Spain, Japan and
Australia)

Table of Content

1 Table of Contents
1 Table of Contents 4

Xeljanz (tofacitinib) (Rheumatoid Arthritis) Forecast and Market Analysis (From Slideshare) Page 1/6


1.1 List of Tables 6
1.2 List of Figures 6
2 Introduction 7
2.1 Catalyst 7
2.2 Related Reports 8
3 Disease Overview 10
3.1 Etiology and Pathophysiology 10
3.1.1 Etiology 10
3.1.2 Pathophysiology 10
3.1.3 Prognosis 13
3.1.4 Quality of Life 13
3.2 Symptoms 14
4 Disease Management 15
4.1 Overview 15
4.2 Diagnosis 15
4.3 Treatment 17
5 Competitive Assessment 21
5.1 Overview 21
5.2 Strategic Competitor Assessment 21
6 Opportunity and Unmet Need 23
6.1 Overview 23
6.2 Unmet Needs 24
6.2.1 More rheumatologists in the field and physician knowledge of the disease 24
6.2.2 More cost-effective therapies through oral formulation and biosimilars 24
6.2.3 The development of predictive tests and discovery of biomarkers 25
6.2.4 The discovery of curative therapies 25
6.2.5 Improved drug safety and efficacy profiles 25
6.3 Gap Analysis 26
6.4 Opportunities 27
6.4.1 Predictive tools for diagnosis and treatment 27
6.4.2 Target specificity 27
7 Pipeline Assessment 28
7.1 Overview 28
7.2 Promising Drugs in Clinical Development 29
8 Xeljanz (tofacitinib) 31
8.1 Overview 31
8.2 Efficacy 32
8.3 Safety 34
8.4 Dosing and Formulation 36
8.5 Potential Clinical Positioning 36
8.6 Potential Commercial Positioning 36
8.7 Pricing and Reimbursement 36
8.8 SWOT Analysis 37
8.9 Forecast 37
9 Appendix 39
9.1 Abbreviations 39
9.2 Bibliography 41
9.3 Methodology 46



9.4 Forecasting Methodology 46
9.4.1 Diagnosed Rheumatoid Arthritis Patients 46
9.4.2 Percent Drug-treated Patients 46
9.4.3 General Pricing Assumptions 47
9.4.4 Pricing of Pipeline agents 48
9.5 Physicians and Specialists Included in this Study 48
9.6 Primary Research - Prescriber Survey 49
9.7 About the Authors 49
9.7.1 Analysts 49
9.7.2 Global Head of Healthcare 50
9.8 About GlobalData 50
9.9 Contact Us 51
9.10 Disclaimer 51

List of Tables

1.1 List of Tables
Table 1: Symptoms of Rheumatoid Arthritis 14
Table 2: Treatment Guidelines for Rheumatoid Arthritis 18
Table 3: Top Three Biologics Prescribed for Moderate-Severe Rheumatoid Arthritis by Market 20
Table 4: Treatment Guidelines for Rheumatoid Arthritis 22
Table 5: Overall Unmet Needs - Current Level of Attainment 23
Table 6: Clinical Unmet Needs - Gap Analysis, 2012 27
Table 7: Rheumatoid Arthritis - Phase Pipeline, 2012 29
Table 8: Comparison of Therapeutic Classes in Development for RA, 2012 30
Table 9: Product Profile - Xeljanz (tofacitinib) 32
Table 10: Clinical Trial Locations by Country for Xeljanz (tofacitinib) 32
Table 11: ORAL Standard ACR 20 Responses for Xeljanz (tofacitinib) vs. Placebo vs. Humira at Month 6 33
Table 12: ORAL Step ACR 20, 50, 70 Responses for Xeljanz (tofacitinib) vs. Placebo at Month Six 33
Table 13: Efficacy Issues Regarding Xeljanz (tofacitinib) Determined by FDA Advisory Panel, May 2012 34
Table 14: Safety Issues Regarding Xeljanz (tofacitinib) Determined by FDA Advisory Panel, May 2012 35
Table 15: Xeljanz (tofacitinib) Clinical Trial Mortalities as of September 29, 2011 35
Table 16: Xeljanz (tofacitinib) SWOT Analysis, 2012 37
Table 17: Global Sales Forecasts ($m) for Xeljanz (tofacitinib) 38
Table 18: Physicians Surveyed, By Country 49

List of Figures

1.2 List of Figures
Figure 1: Healthy and Arthritic Joint with Rheumatoid Arthritis 10
Figure 2: Rheumatoid Arthritis Biologic Drug Targets 12
Figure 3: Diagnosis Criteria for Rheumatoid Arthritis Based on 2010 ACR/EULAR Criteria Point System 16
Figure 4: Severity of Rheumatoid Arthritis 17
Figure 5: Biologic Treatment Flow Based on Updated 2012 ACR Treatment Recommendations* 19



Figure 6: Competitive Assessment of Late-Stage Pipeline Agents in RA, 2012-2022 29


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Xeljanz (tofacitinib) (Rheumatoid Arthritis) Forecast and Market Analysis

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