Colazal & Giazo (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.

Colazal is an aminosalicylate prodrug. This means that its active ingredient, balsalazide disodium, contains an azo bond that can only be processed by bacterial azo reductases in the colon. Following its metabolism by the colonic commensal bacteria, mesalamine is released into and is restricted to the colon area, preventing the active ingredient from being systemically absorbed. Giazo is an aminosalicylate prodrug. This means that its active ingredient, balsalazide disodium, contains an azo bond that can only be processed by bacterial azo reductases in the colon. Following metabolism by the colonic commensal bacteria, mesalamine is released into and is restricted to the colon area, preventing the active ingredient from being systemically absorbed.

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 Colazal & Giazo including product description, safety and efficacy profiles as well as a SWOT analysis.
– Sales forecast for Colazal & Giazo for the top three countries from 2012 to 2022.
– Sales information covered for the US, Italy, 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 Colazal & Giazo performance
– Obtain sales forecast for Colazal & Giazo from 2012-2022 in the top three countries (the US, Italy, and the UK.)

1 Table of Contents
1 Table of Contents 6
1.1 List of Tables 8
1.2 List of Figures 9
2 Introduction 10
2.1 Catalyst 10
2.2 Related Reports 11
2.3 Upcoming Related Reports 12
3 Disease Overview 13
3.1 Etiology and Pathophysiology 13
3.1.1 Etiology 13
3.1.2 Pathophysiology 15
3.2 Symptoms 17
3.2.1 Quality of Life 17
4 Disease Management 19
4.1 Diagnosis and Treatment Overview 19
4.1.1 Diagnosis 19
4.1.2 Treatment Guidelines and Leading Prescribed Drugs 22
4.1.3 Clinical Practice 24
5 Competitive Assessment 28
5.1 Overview 28
5.2 Strategic Competitor Assessment 29
6 Colazal & Giazo (balsazide disodium) 31
6.1 Overview 31
6.1.1 Colazal 31
6.1.2 Giazo 31
6.2 Efficacy 32
6.2.1 Colazal 32
6.2.2 Giazo 32
6.3 Safety 33
6.3.1 Colazal 33
6.3.2 Giazo 33
6.4 SWOT Analysis 33
6.4.1 Colazal 33
6.4.2 Giazo 34
6.5 Forecast 35
6.5.1 Colazal 35
6.5.2 Giazo 36
7 Appendix 38
7.1 Bibliography 38
7.2 Abbreviations 39
7.3 Methodology 42
7.4 Forecasting Methodology 42
7.4.1 Diagnosed UC Patients 42
7.4.2 Percent Drug-Treated Patients 43
7.4.3 General Pricing Assumptions 43
7.4.4 Individual Drug Assumptions 44
7.4.5 Generic Erosion 44
7.5 Physicians and Specialists Included in This Study 45
7.6 Primary Research - Prescriber Survey 46
7.7 About the Authors 47
7.7.1 Author 47
7.7.2 Global Head of Healthcare 48
7.8 About GlobalData 49
7.9 Disclaimer 49

1.1 List of Tables
Table 1: Genetic Factors That Confer a Predisposition to UC 15
Table 2: Typical Symptoms of UC 17
Table 3: Truelove and Witts UC Severity Index 21
Table 4: UCDAI 22
Table 5: Treatment Guidelines for UC Used in the 10MM 23
Table 6: Most Commonly Prescribed Drugs for UC by Class in the 10MM, 2013 24
Table 7: Leading Treatments for UC, 2014 30
Table 8: Product Profile - Colazal 31
Table 9: Product Profile - Giazo 32
Table 10: Colazal SWOT Analysis, 2014 34
Table 11: Giazo SWOT Analysis, 2014 35
Table 12: Global Sales Forecasts ($m) for Colazal, 2012-2022 36
Table 13: Global Sales Forecasts ($m) for Giazo, 2012-2022 37
Table 14: Annual Cost of Therapy for 5-ASAs ($) 44
Table 15: Physicians Surveyed, By Country 46

1.2 List of Figures
Figure 1: Cellular Mechanisms Involved in the Pathogenesis of UC 16
Figure 2: UC Disease Management Flowchart 27