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Xeljanz (Ulcerative Colitis) - Forecast and Market Analysis to 2022

Summary

During the forecast period from 2012-2022, the growth of the UC market will be driven largely by the entry of Johnson & Johnson’s (J&J’s) Simponi and Takeda’s Entyvio, which will lead to an increase in the overall number of patients being treated with biologics in the US, 5EU, Japan, and Canada. Another key event affecting the UC market is the anticipated launch of biosimilars, given that the patent expiry of the UC blockbusters, Remicade and Humira are set to expire in the US in 2018 and 2016, respectively.

Pfizer developed Xeljanz (tofacitinib, formerly known as tasocitinib), an oral, small-molecule JAK inhibitor, for the treatment of RA, and as a potential treatment for psoriasis, psoriatic arthritis, ankylosing spondylitis, CD, and UC. Xeljanz is a potential first-in-class product for UC, being one of the most advanced JAK inhibitors in the pipeline.

Scope

- Overview of Ulcerative Colitis, including epidemiology, etiology, symptoms, diagnosis, pathology and treatment guidelines as well as an overview on the competitive landscape.
- Detailed information on Xeljanz including product description, safety and efficacy profiles as well as a SWOT analysis.
- Sales forecast for Xeljanz for the top eight countries from 2012 to 2022.
- Sales information covered for the US, France, Germany, Italy, Spain, the UK, Japan and Canada.

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 Ulcerative Colitis
- 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 performance
- Obtain sales forecast for Xeljanz from 2012-2022 in the top eight countries (the US, France, Germany, Italy, Spain, the UK, Japan and Canada)

Table Of Contents

Xeljanz (Ulcerative Colitis) - Forecast and Market Analysis to 2022
1 Table of Contents

2 Introduction 8
2.1 Catalyst 8
2.2 Related Reports 8
2.3 Upcoming Related Reports 10
3 Disease Overview 11
3.1 Etiology and Pathophysiology 11
3.1.1 Etiology 11
3.1.2 Pathophysiology 13
3.2 Symptoms 15
3.2.1 Quality of Life 15
4 Disease Management 17
4.1 Diagnosis and Treatment Overview 17
4.1.1 Diagnosis 17
4.1.2 Treatment Guidelines and Leading Prescribed Drugs 20
4.1.3 Clinical Practice 22
5 Competitive Assessment 26
5.1 Overview 26
5.2 Strategic Competitor Assessment 27
6 Opportunity and Unmet Need 29
6.1 Overview 29
6.2 Unmet Needs 30
6.2.1 Curative Therapy for Severe UC Patients 30
6.2.2 Diagnostic Markers for Disease Severity 30
6.2.3 Personalized Therapy 31
6.2.4 A Replacement for Steroids 31
6.2.5 Novel Oral Drug Formulations 32
6.2.6 Preventative Medicine for Lowering the Associated Colorectal Cancer Risk 33
6.2.7 Improved Management of Infectious Adverse Events 33
6.3 Unmet Needs Gap Analysis 34
6.4 Disease Severity and Colorectal Cancer Biomarker-Based Prognostic Tools 35
6.5 Predictors of Medically-Refractory Disease 36
7 Pipeline Assessment 37
7.1 Overview 37
7.2 Promising Drugs in Clinical Development 37
8 Xeljanz (tofacitinib) 39
8.1 Overview 39
8.2 Efficacy 40
8.3 Safety 41
8.4 Dosing and Formulation 43
8.5 Potential Clinical Positioning 43
8.6 Potential Commercial Positioning 43
8.7 Pricing and Reimbursement 43
8.8 SWOT Analysis 44
8.9 Forecast 44
9 Appendix 46
9.1 Bibliography 46
9.2 Abbreviations 48
9.3 Methodology 52
9.4 Forecasting Methodology 52
9.4.1 Diagnosed UC Patients 52
9.4.2 Percent Drug-Treated Patients 53
9.4.3 General Pricing Assumptions 53
9.4.4 Generic Erosion 54
9.4.5 Pricing of Pipeline Agents 54
9.5 Physicians and Specialists Included in This Study 55
9.6 Primary Research - Prescriber Survey 56
9.7 About the Authors 57
9.7.1 Author 57
9.8 About GlobalData 58
9.9 Disclaimer 58

1.1 List of Tables

Table 1: Genetic Factors That Confer a Predisposition to UC 13
Table 2: Typical Symptoms of UC 15
Table 3: Truelove and Witts UC Severity Index 19
Table 4: UCDAI 20
Table 5: Treatment Guidelines for UC Used in the 10MM 21
Table 6: Most Commonly Prescribed Drugs for UC by Class in the 10MM, 2013 22
Table 7: Leading Treatments for UC, 2014 28
Table 8: Overall Unmet Needs - Current Level of Attainment 29
Table 9: Corticosteroid Long-Term Side Effects 32
Table 10: Clinical Unmet Needs in UC - Gap Analysis, 2013 35
Table 11: Prognostic Markers in UC 36
Table 12: UC - Pre-Registration and Phase III Pipeline, 2014 37
Table 13: Comparison of Therapeutic Classes in Development for UC, 2014 38
Table 14: Product Profile - Xeljanz 39
Table 15: Results of Phase IIa Trial of Xeljanz in the Induction of Remission in UC 41
Table 16: Most Common Adverse Events in the Phase IIa Trial of Xeljanz 42
Table 17: Xeljanz SWOT Analysis, 2014 44
Table 18: Global Sales Forecasts ($m) for Xeljanz, 2012-2022 45
Table 19: Physicians Surveyed, By Country 56

1.2 List of Figures

Figure 1: Cellular Mechanisms Involved in the Pathogenesis of UC 14
Figure 2: UC Disease Management Flowchart 25
Figure 3: Competitive Assessment of Late-Stage Pipeline Agents UC, 2012-2022 38

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