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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 billion into a market projected to reach up to .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

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 54

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 188

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

Unfortunately the video is me when I was first diagnosed at age 15, I am now 46 years of age. Looking back at this video I cannot believe how frightened that young girl was and it’s hard for me to watch even to this day. Guess what? Not only do I have Parkinson’s Disease, I also have MS. I can’t understand what is up with this? I guess it could be worse. I’m not here to whine or complain and I most definately DO NOT want ANYONE feeling sorry for me. I am here because I feel and have felt it is long past time the government and pharmaceutical houses do something productive besides managing to get away with distributing drugs that are not (in my opinion) suitable to be distributed to those who suffer day in and day out with this illness. It is a most unforgiving illness and the medicines are archaic. If you or a loved one has PD I can recommend a wonderful hospital with doctors who surpassed all my expectations (and I have seen too many neurologists to list). Contact me if you would like the information. You may reach me at: tlrothwell@gmail.com or you can google Tammy Rothwell. Look, anyone living in communities that have any type of insecticides spred in their air that might eventually enter the water table is vulnerable. If you carry the PD gene, it is a very good possibility you could pass that on to your child, or even (which might be the case with me) is a dormant gene from a virus from many years ago quite similar to the H1 virus of today. Scary? You’re darned right …
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