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Pipeline Insight: Inflammatory Bowel Disease - Varied drug targets to broaden future therapy options
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245 Pages | |||||||||||
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Introduction
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 .....
Introduction 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 [Studien Infos ausblenden] |
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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 List of Tables Table 1: Late-stage pipeline products in development for inflammatory bowel disease (IBD) 2010 9 Table 2: Sales forecast for pipeline products in inflammatory bowel disease (IBD) in the seven major markets ($m), 2010-19 15 Table 3: Centocor Ortho Biotech: key marketed drugs and R&D pipeline for inflammatory bowel disease (IBD), 2010 18 Table 4: Cosmo Pharmaceuticals: key marketed drugs and R&D pipeline for inflammatory bowel disease (IBD), 2010 18 Table 5: GlaxoSmithKline: key marketed drugs and R&D pipeline for inflammatory bowel disease (IBD), 2010 19 Table 6: Datamonitor's definition of Crohn's disease 22 Table 7: Datamonitor's definition of ulcerative colitis 22 Table 8: Montreal classification for ulcerative colitis covering extent and anatomy, 2005 23 Table 9: Montreal classification for Crohn's disease covering parameters and classification, 2005 24 Table 10: Crohn's disease population-based prevalence studies conducted the EU, US and Japan 37 Table 11: Ulcerative colitis population-based prevalence studies conducted the EU, US and Japan 38 Table 12: Total prevalent Crohn's disease cases in the seven major markets, 2009-2019 39 Table 13: Total prevalent ulcerative colitis cases in the seven major markets, 2009-2019 42 Table 14: Datamonitor's estimated prevalence of inflammatory bowel disease in BRICT, 2010 46 Table 15: Leading treatments for inflammatory bowel disease (IBD), 2010 51 Table 16: Remicade (infliximab) - drug profile, 2010 55 Table 17: Ability of current comparator Remicade to meet unmet needs in inflammatory bowel disease (IBD), 2010 63 Table 18: Summary of activity indices used for ulcerative colitis clinical trials 76 Table 19: Key TNF inhibitors in the late-stage inflammatory bowel disease (IBD) R&D pipeline, 2010 79 Table 20: Simponi (golimumab) - drug profile, 2010 80 Table 21: Datamonitor's drug assessment score card for Simponi (golimumab), 2010 85 Table 22: Simponi versus TNF inhibitor comparator therapy Remicade in ulcerative colitis - minimum acceptable product profile (MAPP) and target product profile (TPP), 2010 88 Table 23: Impacting factors on the revenues of Simponi, 2010-19 89 Table 24: Sales forecasts for Simponi (golimumab, ) in ulcerative colitis in the US and five major EU markets ($m), 2010-19 91 Table 25: Key TNF inhibitors in early-stage inflammatory bowel disease (IBD) R&D pipeline, 2010 92 Table 26: Key corticosteroids in the late-stage inflammatory bowel disease (IBD) R&D pipeline, 2010 94 Table 27: Budesonide MMX - drug profile, 2010 95 Table 28: Budesonide MMX: Phase III trials in ulcerative colitis, 2010 96 Table 29: Datamonitor's drug assessment score card for Budesonide MMX, 2010 101 Table 30: Budesonide MMX versus TNF inhibitor comparator therapy Remicade in ulcerative colitis - minimum acceptable product profile (MAPP) and target product profile (TPP), 2010 105 Table 31: Impacting factors on the revenues of Budesonide MMX, 2010-19 106 Table 32: Sales forecasts for Budesonide MMX in ulcerative colitis in the US and five major EU markets ($m), 2010-19 108 Table 33: Key Integrin inhibitors in the late-stage inflammatory bowel disease (IBD) R&D pipeline, 2010 112 Table 34: Vedolizumab - drug profile, 2010 114 Table 35: Vedolizumab (MLN0002) - Phase III GEMINI studies 115 Table 36: Datamonitor's drug assessment score card for Vedolizumab (MLN0002), 2010 120 Table 37: Vedolizumab versus TNF inhibitor comparator therapy Remicade in Crohn's disease - minimum acceptable product profile (MAPP) and target product profile (TPP), 2010 123 Table 38: Vedolizumab versus TNF inhibitor comparator therapy Remicade in ulcerative colitis - minimum acceptable product profile (MAPP) and target product profile (TPP), 2010 124 Table 39: Impacting factors on the revenues of vedolizumab, 2010-19 125 Table 40: Sales forecasts for vedolizumab in inflammatory bowel disease (IBD) in the US and five major EU markets ($m), 2010-19 127 Table 41: AJM300 - drug profile, 2010 128 Table 42: Datamonitor's drug assessment score card for AJM300, 2010 132 Table 43: AJM300 versus TNF inhibitor comparator therapy Remicade in Crohn's disease - minimum acceptable product profile (MAPP) and target product profile (TPP), 2010 135 Table 44: Impacting factors on the revenues of AJM300, 2010-19 136 Table 45: Sales forecasts for AJM300 in inflammatory bowel disease (IBD) in Japan ($m), 2010-19 137 Table 46: Key Integrin inhibitors in the early-stage inflammatory bowel disease (IBD) R&D pipeline, 2010, 2010 138 Table 47: Key other cytokine targets in the late-stage inflammatory bowel disease (IBD) R&D pipeline, 2010 140 Table 48: Stelara (ustekinumab) - drug profile, 2010 142 Table 49: Datamonitor's drug assessment score card for Stelara (ustekinumab), 2010 148 Table 50: Stelara versus TNF inhibitor comparator therapy Remicade in Crohn's disease - minimum acceptable product profile (MAPP) and target product profile (TPP), 2010 151 Table 51: Impacting factors on the revenues of Stelara, 2010-19 152 Table 52: Sales forecasts for Stelara (ustekinumab) in Crohn's disease in the US and five major EU markets ($m), 2010-19 153 Table 53: GSK1605786 (Traficet-EN, CCX282) - drug profile, 2010 154 Table 54: Datamonitor's drug assessment score card for GSK1605786 (Traficet-EN, CCX282), 2010 162 Table 55: GSK1605786 versus TNF inhibitor comparator therapy Remicade in Crohn's disease - minimum acceptable product profile (MAPP) and target product profile (TPP), 2010 165 Table 56: Impacting factors on the revenues of GSK1605786, 2010-19 166 Table 57: Sales forecasts for GSK1605786 (Traficet-EN) in Crohn's disease in the US and five major EU markets ($m), 2010-19 167 Table 58: Key other cytokine targets in the early-stage inflammatory bowel disease (IBD) R&D pipeline, 2010 172 Table 59: Key other agents in the late-stage inflammatory bowel disease (IBD) R&D pipeline, 2010 174 Table 60: LMW Heparin MMX - drug profile, 2010 176 Table 61: Datamonitor's drug assessment score card for LMW Heparin MMX, 2010 181 Table 62: LMW Heparin MMX versus TNF inhibitor comparator therapy Remicade in inflammatory bowel disease - minimum acceptable product profile (MAPP) and target product profile (TPP), 2010 183 Table 63: Impacting factors on the revenues of LMW Heparin MMX, 2010-19 184 Table 64: Sales forecasts for LMW Heparin MMX in ulcerative colitis in the US and five major EU markets ($m), 2010-19 185 Table 65: Prochymal - drug profile, 2010 186 Table 66: Orencia - drug profile, 2010 197 Table 67: Key other agents in the early-stage inflammatory bowel disease (IBD) R&D pipeline, 2010 204 Table 68: Key interleukin-6 products in early-stage inflammatory bowel disease (IBD) R&D pipeline, 2010 211 Table 69: Key interleukin-10 products in early-stage inflammatory bowel disease (IBD) R&D pipeline, 2010 211 Table 70: Datamonitor drug assessment parameters 233 List of Figures Figure 59: Methodology for forecasting price to remove impact of currency fluctuations on future trend 232 [Inhaltsverzeichnis ausblenden] |
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