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Kappaproct (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.

InDeX Pharmaceuticals is a biopharmaceutical company that focuses on the discovery and development of immunological treatments for diseases with a high unmet need. The company is dedicated to developing personalized treatments and diagnostic assays that will allow physicians to predict which patient populations will respond to specific biologics. InDeX developed Kappaproct with the goal of addressing a significant unmet need in severe UC patients, which is the lack of an effective treatment.

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 Kappaproct including product description, safety and efficacy profiles as well as a SWOT analysis.
- Sales forecast for Kappaproct for the top five countries from 2012 to 2022.
- Sales information covered for France, Germany, Italy, Spain and the UK.

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 Kappaproct performance
- Obtain sales forecast for Kappaproct from 2012-2022 in the top five countries (France, Germany, Italy, Spain and the UK)

Table Of Contents

Kappaproct (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 Kappaproct (DIMS 0150) 40
8.1 Overview 40
8.2 Efficacy 41
8.3 Safety 42
8.4 Dosing and Formulation 42
8.5 Potential Clinical Positioning 42
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 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 - Kappaproct 41
Table 15: Results of Phase IIb Trial of Kappaproct in the Induction of Remission in UC 42
Table 16: Kappaproct SWOT Analysis, 2014 44
Table 17: Global Sales Forecasts ($m) for Kappaproct, 2012-2022 45
Table 18: Physicians Surveyed, By Country 56

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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