Contents:

TABLE OF CONTENTS CHAPTER 1 EXECUTIVE SUMMARY 3 Objective of the analysis 3 insight into the IBD market 3 CHAPTER 2 PATIENT POTENTIAL 11 Definition of IBD 12 CD 12 UC 13 Segmentation of the IBD population 15 CD 15 Mild to moderate 15 Moderate to severe 15 Severe fulminant disease 15 Remission 16 UC 16 Mild 16 Moderate 16 Severe 16 Epidemiology of the IBD population 17 Unmet needs in IBD 19 Efficacy 19 Side effects 20 Convenience 20 Products covered in this analysis 21 CHAPTER 3 R&D APPROACH 23 Classification of pipeline products 24 Clinical trial design and endpoints in IBD 25 Practical challenges in IBD trial design 25 CD trial design: a work in progress 25 Measuring efficacy in CD: indexes and beyond 26 CDAI for beginners 26 CDAI issues and debates 28 Additional endpoints 29 Improvements possible to CDAI gold standard 31 Using the CDAI: continuous index, or proportions of patients? 31 Placebo response in CD: trial design challenges and solutions for biologics 32 Efficacy endpoints in CD: how high is the bar? 33 Measuring efficacy in UC: indexes and beyond 34 DAI for beginners 34 DAI issues and debates 35 Placebo as active intervention in UC? 36 Diary keeping in UC: another active intervention? 37 CHAPTER 4 COMMERCIAL ANALYSIS 38 Remicade: localized strategies deliver outstanding growth in a tale of three companies 39 Profile 39 Drug overview 43 Marketing partners deliver global growth 49 Johnson & Johnson: relentless investment sustains growth 51 Schering-Plough: Remicade provides relief in troubled times 55 Tanabe: physician education to drive sales as epidemiology and market gaps define Remicade’s niche 59 Forecast assumptions 65 CHAPTER 5 LATE-STAGE DRUG ANALYSIS AND FORECASTS 70 Overview 71 Pipeline summary 71 Product assessment methodology 71 Prograf 77 Profile 77 Drug overview 77 Clinical trial data 80 Patient potential 82 Marketing factors 82 Satisfaction of unmet needs 83 Forecast assumptions 83 Humira 86 Profile 86 Drug overview 86 Clinical trial data 94 Patient potential 95 Marketing factors 95 Satisfaction of unmet needs 95 Forecast assumptions 97 Alicaforsen sodium 102 Profile 102 Drug overview 104 Clinical trial data 108 Patient potential 120 Marketing factors 120 Satisfaction of unmet needs 121 Forecast assumptions 122 CDP870 124 Profile 124 Drug overview 126 Clinical trial data 132 Patient potential 134 Marketing factors 134 Satisfaction of unmet needs 134 Forecast assumptions 136 OPC-6535 139 Profile 139 Drug overview 141 Clinical trial data 141 Patient potential 142 Marketing factors 142 Satisfaction of unmet needs 143 Forecast assumptions 144 Antegren 146 Profile 146 Drug overview 148 Clinical trial data 154 Patient potential 156 Marketing factors 157 Satisfaction of unmet needs 157 Forecast assumptions 158 COLAL-PRED 162 Profile 162 Drug overview 164 Clinical trial data 168 Patient potential 170 Marketing factors 170 Satisfaction of unmet needs 171 Forecast assumptions 172 Other drugs in IBD 175 CHAPTER 6 OPINION LEADER TRANSCRIPTS 177 Opinion leader interviews: methodology 177 Opinion leader interviews: biographies 177 Professor Anthony Axon (ATR Axon, Anthony Thomas Roger Axon, Tony Axon) 177 Professor Danial Baker 178 Professor Subrata Ghosh 178 Professor Tetsuya Mine 179 Opinion leader interviews: questions 180 Opinion leader interviews: answers 182 CHAPTER 7 APPENDIX 211 Report methodology 211 Japanese market data 211 Standard units 211 Pricing forecasts 211 Exchange rates and calendrical notes 212 Bibliography 213 Disclaimer 217