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Entyvio (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.

Takeda Pharmaceuticals developed Entyvio for the treatment of moderate to severe CD and UC. Takeda’s subsidiary, Millennium Pharmaceuticals, sponsored the Entyvio clinical trials, GEMINI I, GEMINI II, and GEMINI III, as well as the ongoing GEMINI LTS trial. Entyvio has been studied in 2,700 patients in nearly 40 countries, making it the largest Phase III clinical trial program ever conducted evaluating both CD and UC patients.

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 Entyvio including product description, safety and efficacy profiles as well as a SWOT analysis.
- Sales forecast for Entyvio 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 Entyvio performance
- Obtain sales forecast for Entyvio from 2012-2022 in the top eight countries (the US, France, Germany, Italy, Spain, the UK Japan and Canada)

Table Of Contents

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

2 Introduction 9
2.1 Catalyst 9
2.2 Related Reports 9
2.3 Upcoming Related Reports 11
3 Disease Overview 12
3.1 Etiology and Pathophysiology 12
3.1.1 Etiology 12
3.1.2 Pathophysiology 14
3.2 Symptoms 16
3.2.1 Quality of Life 16
4 Disease Management 18
4.1 Diagnosis and Treatment Overview 18
4.1.1 Diagnosis 18
4.1.2 Treatment Guidelines and Leading Prescribed Drugs 21
4.1.3 Clinical Practice 23
5 Competitive Assessment 27
5.1 Overview 27
5.2 Strategic Competitor Assessment 28
6 Opportunity and Unmet Need 30
6.1 Overview 30
6.2 Unmet Needs 31
6.2.1 Curative Therapy for Severe UC Patients 31
6.2.2 Diagnostic Markers for Disease Severity 31
6.2.3 Personalized Therapy 32
6.2.4 A Replacement for Steroids 32
6.2.5 Novel Oral Drug Formulations 33
6.2.6 Preventative Medicine for Lowering the Associated Colorectal Cancer Risk 34
6.2.7 Improved Management of Infectious Adverse Events 34
6.3 Unmet Needs Gap Analysis 35
6.4 Disease Severity and Colorectal Cancer Biomarker-Based Prognostic Tools 36
6.5 Predictors of Medically-Refractory Disease 37
7 Pipeline Assessment 38
7.1 Overview 38
7.2 Promising Drugs in Clinical Development 38
8 Entyvio (vedolizumab) 40
8.1 Overview 40
8.2 Efficacy 42
8.3 Safety 44
8.4 Dosing and Formulation 46
8.5 Potential Clinical Positioning 46
8.6 Potential Commercial Positioning 47
8.7 Pricing and Reimbursement 48
8.8 SWOT Analysis 49
8.9 Forecast 49
9 Appendix 51
9.1 Bibliography 51
9.2 Abbreviations 53
9.3 Methodology 57
9.4 Forecasting Methodology 57
9.4.1 Diagnosed UC Patients 57
9.4.2 Percent Drug-Treated Patients 58
9.4.3 General Pricing Assumptions 58
9.4.4 Generic Erosion 59
9.4.5 Pricing of Pipeline Agents 59
9.5 Physicians and Specialists Included in This Study 60
9.6 Primary Research - Prescriber Survey 61
9.7 About the Authors 62
9.7.1 Author 62
9.8 About GlobalData 63
9.9 Disclaimer 63

1.1 List of Tables

Table 1: Genetic Factors That Confer a Predisposition to UC 14
Table 2: Typical Symptoms of UC 16
Table 3: Truelove and Witts UC Severity Index 20
Table 4: UCDAI 21
Table 5: Treatment Guidelines for UC Used in the 10MM 22
Table 6: Most Commonly Prescribed Drugs for UC by Class in the 10MM, 2013 23
Table 7: Leading Treatments for UC, 2014 29
Table 8: Overall Unmet Needs - Current Level of Attainment 30
Table 9: Corticosteroid Long-Term Side Effects 33
Table 10: Clinical Unmet Needs in UC - Gap Analysis, 2013 36
Table 11: Prognostic Markers in UC 37
Table 12: UC - Pre-Registration and Phase III Pipeline, 2014 38
Table 13: Comparison of Therapeutic Classes in Development for UC, 2014 39
Table 14: Product Profile - Entyvio 42
Table 15: Results of the GEMINI I Trial, Efficacy of Vedolizumab in the Induction of Remission in UC 43
Table 16: Results of the GEMINI I Trial, Efficacy of Vedolizumab in the Maintenance of Remission in UC 44
Table 17: Most Common Adverse Events with Vedolizumab in the GEMINI I Study 45
Table 18: Entyvio SWOT Analysis, 2014 49
Table 19: Global Sales Forecasts ($m) for Entyvio, 2012-2022 50
Table 20: Physicians Surveyed, By Country 61

1.2 List of Figures

Figure 1: Cellular Mechanisms Involved in the Pathogenesis of UC 15
Figure 2: UC Disease Management Flowchart 26
Figure 3: Competitive Assessment of Late-Stage Pipeline Agents UC, 2012-2022 39

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