Datamonitor forecasts the inflammatory bowel disease market to become increasingly competitive with the anticipated launch of seven new products, spanning five drug classes from 2010 to 2019.

Dallas, TX -- (SBWire) -- 08/10/2010 -- ReportsandReports announce it will carry Pipeline Insight: Inflammatory Bowel Disease - Varied drug targets to broaden future therapy options Market Research Report in its Store.

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Datamonitor forecasts the inflammatory bowel disease market to become increasingly competitive with the anticipated launch of seven new products, spanning five drug classes from 2010 to 2019. These therapies are forecast to inject over $1 billion into a market projected to reach up to $5.7 billion by 2019 and offer more therapy choice to specific patient groups.

Scope

• Segmentation and analysis of products across all stages of the IBD pipeline with in-depth discussion of key Phase II and III pipeline therapies
• Insight and analysis of market potential including robust epidemiology forecasts, and a review of key opinion leader requirements for new products
• Ten-year indication-specific forecasts of seven pipeline products, with a comparison of their relative clinical and commercial attractiveness
• Review of unmet needs based on key opinion leader interviews and a focus on innovative early-stage drug development and assessment of future treatment

Highlights

Datamonitor identified 108 products across all stages of development, but these treatments vary immensely by target. The diversity of the pipeline will broaden future therapy choice for specific patient groups, such as TNF-failure patients and the mild to moderate group.

Opinion leaders cite the re-randomization of patients responding to initial treatment in Crohn's disease trials as an effective design. In ulcerative colitis assessing induction and maintenance treatment in separate studies of new drugs will play a significant role in drug labeling, particularly for the European Medicines Agency.

Two key late-stage pipeline drugs show particular clinical and commercial potential. Simponi (golimumab) is viewed positively by opinion leaders for ulcerative colitis. In Crohn's disease, chemokine antagonist GSK1605786 (Traficet-EN) is anticipated to reach the market by 2017 and could potentially threaten biologics as a maintenance agent.

Reasons to Purchase

• Understand the recent advances in the inflammatory bowel disease pipeline and gain insight into leading gastroenterologist opinion
• Access sales forecasts for late-stage pipeline products and understand new product positioning through analysis of clinical and commercial factors
• Evaluate the unmet needs in both Crohn's disease and ulcerative colitis and the challenges faced in clinical trial development

Table of Content
Overview 1
Catalyst 1
Summary 1
About Datamonitor Healthcare 2
About the Immunology & Inflammation pharmaceutical analysis team 2
Executive Summary 3
Strategic scoping and focus 3
Datamonitor insight into the disease market 3
Related reports 5
Upcoming related reports 5
Table of Contents 6

1. Pipeline Overview and Dynamics 7
Key findings 7
Pipeline overview 8
Diverse late-stage pipeline for inflammatory bowel disease 8
Companies remain interested in inflammatory bowel disease, particularly ulcerative colitis 10
Limited number of candidates have made it to Phase III 11
Interleukin and TNF inhibitors are most commonly targeted, while development focuses on oral delivery 12
Comparative forecasts 14
Datamonitor pipeline assessment summary 16
Key companies involved in the inflammatory bowel disease pipeline 17
Centocor Ortho Biotech 17
Cosmo Pharmaceuticals 18
GlaxoSmithKline 18

2. Epidemiology 20
Key findings 20
Definition 21
Crohn's disease 21
Ulcerative colitis 21
ICD-10 codes used to define the inflammatory bowel disease indications 21
Patient segmentation by anatomical location 22
Ulcerative colitis 23
Crohn's disease 23
Patient segmentation according to disease severity 25
Crohn's disease 25
Mild-to-moderate Crohn's disease 25
Moderate-to-severe Crohn's disease 25
Fistulizing Crohn's disease 25
Severe fulminant Crohn's disease 26
Remission in Crohn's disease 26
Ulcerative colitis 26
Mild ulcerative colitis 26
Moderate ulcerative colitis 26
Severe ulcerative colitis 26
Fulminant ulcerative colitis 27
Remission 27
Segmentation of patients by severity useful for directing therapy, but is not clearcut 28
Disease definition and diagnosis criteria used in epidemiology analysis 28
Crohn's disease 29
Ulcerative colitis 29
Global variation and historical trends 30
Risk factors 33
Genetics 33
Environmental factors 34
Smoking 34
Epidemiologic forecasting of IBD 35
Sources of epidemiologic data 35
Description of methods 35
Japan 36
US 36
European markets 36
Epidemiological results 38
Current prevalent cases and future trends of Crohn's disease 38
Current prevalent cases and future trends of ulcerative colitis 41
Discussion 44
Strengths of Datamonitor's epidemiologic projections 45
Conclusions 45
Rest of the world 46

3. Current Market Overview 47
Key Findings 47
Current treatment options 48
Topical and oral 5-aminosalicylates (5-ASAs) 48
Corticosteroids 49
Immunomodulators 49
Biologics 50
Antibiotics 50
Antidiarrheal and fluid replacement 50
Leading treatments for inflammatory bowel disease 50
Current gold standard and comparator therapies 52
5-aminosalicylates remain the gold-standard therapy in ulcerative colitis 52
Gold-standard in Crohn's disease is less clearcut 53
Comparator drug 54
Remicade (infliximab) is the comparator therapy in both Crohn's disease and ulcerative colitis
Current market overview 55
Unmet needs in Crohn's disease and ulcerative colitis 58
Crohn's disease 58
Effective agents for maintaining remission without immunosuppression 58
Drugs needed for mild Crohn's disease population 59
Safer oral therapies as an alternative to expensive biologics 59
Effective treatments for fistulizing Crohn's disease 59
Predicting response to therapy 60
Better activity measurements in clinical trials 60
Ulcerative colitis 61
Powerful, well-tolerated agents for inducing remission quickly and an oral maintenance agent are most wanted 61
Drug therapies for refractory patient population 61
Disease-modifying drugs 62
Simple blood test to indicate disease activity 62
Target product profile versus current level of attainment 62
Efficacy 64
Crohn's disease 64
Ulcerative colitis 65
Safety 66
Formulation 66
Cost 67

4. R&D Approach 68
Key findings 68
Clinical trial design in Crohn's disease 69
Changes in inflammatory bowel disease clinical trial design have been two-fold over the last decade 69
Crohn's disease trial design remains a work in progress, but aided by several recently published guidelines 70
Indices that reflect inflammation are needed in modern Crohn's disease trial design 72
Time point to assess the effectiveness of drugs in clinical trials 72
Randomization of patients from onset of trial with induction and maintenance endpoint deemed less effective 73
ACT, PRECiSE-2 and CHARM trials set a precedent for modern Phase III Crohn's disease trials 74
Clinical trial design in ulcerative colitis 75
Ulcerative colitis clinical development guidelines for European approval 75
Indices in clinical trials of ulcerative colitis 76
Remicade's ACT clinical trial set the precedent for modern ulcerative colitis trial design 76

5. Pipeline Analysis & Forecasts: TNF inhibitors 78
Key findings 78
Overview for TNF inhibitors 79
Pipeline summary 79
Simponi (golimumab; Centocor Ortho Biotech/Merck & Co./Mitsubishi Tanabe) 79
Drug overview 79
Drug profile 80
Clinical trial data 80
SWOT analysis 82
Datamonitor drug assessment summary for Simponi 83
Clinical and commercial attractiveness 85
Potential to switch patients from Remicade to Simponi 85
Simponi targets only the moderate to severe ulcerative colitis subgroup 87
Company experience boosts commercial attractiveness, but arbitration between Johnson & Johnson and Schering-Plough is concerning 87
Satisfaction of unmet needs 87
Forecasts to 2019 89
TNF-kinoid (debio0512; Neovacs) 91
Key early-stage and preclinical compounds in TNF inhibitors 91

6. Pipeline Analysis & Forecasts: Corticosteroids 93
Key findings 93
Overview for corticosteroids 94
Pipeline summary 94
Budesonide MMX (Cosmo/Ferring/Santarus) 94
Drug overview 94
Drug profile 95
Clinical trial data 95
Phase III studies 95
SWOT analysis 98
Datamonitor drug assessment summary for Budesonide MMX 99
Clinical and commercial attractiveness 101
MMX delivery system sets Budesonide MMX apart from other corticosteroids 101
Potential for Budesonide MMX as first-line ulcerative colitis therapy, but more data needed 103
Commercial potential for Budesonide MMX in the European market 103
Satisfaction of unmet needs 104
Forecasts to 2019 105
Other drugs in the corticosteroid class 108
COLAL-PRED (prednisolone sodium metasulfobenzoate) 108
Key preclinical compound in corticosteroids 110

7. Pipeline Analysis & Forecasts: Integrin inhibitors 111
Key findings 111
Overview for integrin inhibitors 112
Pipeline summary 112
Comparative forecasts 112
Vedolizumab (MLN0002; (Takeda/Millennium Pharmaceuticals) 114
Drug overview 114
Drug profile 114
Clinical trial data 115
Phase III studies: GEMINI studies 115
SWOT analysis 118
Datamonitor drug assessment summary for vedolizumab 118
Clinical and commercial attractiveness 120
Targeting both Crohn's disease and ulcerative colitis boosts patient potential 120
Safety profile negatively impacts on clinical attractiveness 122
Takeda has available resources, but lacks experience in inflammatory bowel disease 122
Satisfaction of unmet needs 122
Forecasts to 2019 125
AJM300 (Ajinomoto) 128
Drug overview 128
Drug profile 128
Clinical trial data 128
SWOT analysis 130
Datamonitor drug assessment summary for AJM300 130
Clinical and commercial attractiveness 132
Large patient potential as both Crohn's disease and ulcerative colitis are targeted 132
Ajinomoto gaining inflammatory bowel disease market experience 134
Satisfaction of unmet needs 134
Forecasts to 2019 136
Key early-stage and preclinical compounds in integrin inhibitors 138

8. Pipeline Analysis & Forecasts: Other cytokine targets 139
Key findings 139
Overview for cytokine targets 140
Pipeline summary 140
Comparative forecasts 140
Stelara (ustekinumab; Centocor Ortho Biotech/Janssen-Cilag) 142
Drug overview 142
Drug profile 142
Clinical trial data 143
SWOT analysis 145
Datamonitor drug assessment summary for Stelara (ustekinumab) 146
Clinical and commercial attractiveness 148
Formulation strategy remains unclear 148
Potential for ustekinumab in anti-TNF failure or biologics setting 149
Company experience in the autoimmune area 149
Satisfaction of unmet needs 150
Forecasts to 2019 151
GSK1605786 (formerly Traficet-EN, CCX282; ChemoCentryx/GlaxoSmithKline) 153
Drug overview 153
Drug profile 154
Clinical data 154
PROTECT-1: maintenance phase of trial shows positive data 155
PROTECT-1: induction phase of study 157
Phase II trial data 159
SWOT analysis 159
Datamonitor drug assessment summary for GSK1605786 (Traficet-EN) 160
Clinical and commercial attractiveness 162
Positive Phase II/III shows more definitive data on remission but dosing issues need to be resolved 162
Commercial potential boosted by GlaxoSmithKline's resources, but the company lacks IBD experience 164
First-in-class for Crohn's disease as an alternative to immunosuppressants 164
ChemoCentryx is also developing CCX025, a potential back-up to GSK1605786 164
Potential for future indication expansion into ulcerative colitis 164
Satisfaction of unmet needs 164
Forecasts to 2019 165
ABT-874 (briakinumab; Abbott) 167
AIN457 (Novartis) 169
AG011 (ActoGeniX) 169
STA5326 (apilimod mesylate; Synta Pharmaceuticals) 170
MDX-1100 (Bristol Myers Squibb) 170
Late-stage development compounds recently discontinued 171
Simulect (Basiliximab BSX; Cerimon Pharmaceuticals) 171
Rebif (interferon-beta-1a; Merck Serono) 171
Key early-stage and preclinical compounds in other cytokine targets 172

9. Pipeline Analysis & Forecasts: Others 173
Key findings 173
Overview for other drugs 173
Pipeline summary 173
LMW Heparin MMX (CB-01-05-MMX, parnaparin sodium; Cosmo Pharmaceuticals) 175
Drug overview 175
Drug profile 176
Clinical trial data 176
SWOT analysis 178
Datamonitor drug assessment summary for LMW Heparin MMX 179
Clinical and commercial attractiveness 181
Large patient potential as LMW Heparin MMX targets mild-to-moderate ulcerative colitis 181
Cosmo has some market experience in ulcerative colitis 182
Promising initial clinical data support clinical attractiveness 182
Satisfaction of unmet needs 182
Forecasts to 2019 184
Prochymal (Osiris Therapeutics/Genzyme) 185
Drug overview 185
Drug profile 186
Clinical trial data 186
Phase III Crohn's disease study enrollment discontinued, but strong partnership with Genzyme
Alicaforsen sodium (AP1431, AP1451, AP1007; Atlantic Healthcare) 189
Drug overview 189
Clinical data 190
Other drugs 190
Tasocitinib (CP-690550; Pfizer) 190
Tetomilast (OPC6535; Otsuka Pharmaceuticals) 193
LT-02 (Lipid Therapeutics) 194
HMPL004 (Hutchison MediPharma) 195
Dersalazine sodium (UR-12715; Palau Pharma) 196
Late-stage development compounds recently discontinued 196
Orencia (abatacept; Bristol-Myers Squibb) 196
Drug overview 196
Drug profile 197
Clinical trial data 197
Phase III Crohn's disease study 197
Phase III ulcerative colitis study 200
Clinical program of abatacept for inflammatory bowel disease comes to an end 202
Visilizumab (HuM291; PDL BioPharma) 202
Key early-stage compounds in others 203

10. Innovative Early-Stage Approaches 206
Key findings 206
Overview of early-stage innovative projects 207
Toll-like receptors- promising preclinical target 207
Interleukin 6 - preclinical models suggest potential in inflammatory bowel disease 208
Targeting IL-6 five or more years away in inflammatory bowel disease 210
Interleukin 10 -potential target for inflammatory bowel disease 211
Early-stage inflammatory bowel disease pipeline is diverse 211
The future of treatment in inflammatory bowel disease 211
Bibliography 214
Journals 214
Websites 224
Datamonitor reports 230
APPENDIX 231
Methodology 231
Datamonitor forecast methodology 231
Product forecasts 231
Derivation of sales forecasts and pricing trends 231
Exchange rates 231
Definition of a standard unit 232
Datamonitor drug assessment scorecard 232
Contributing experts 233
About Datamonitor 234
About Datamonitor Healthcare 234
About the Disease analysis team 234
Datamonitor consulting 235
Disclaimer 237

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