Pipeline Insight: Inflammatory Bowel Disease - Varied drug targets to broaden future therapy options

Pipeline Insight: Inflammatory Bowel Disease - Varied drug targets to broaden future therapy options published by Datamonitor in July, 2010. This report consists of Pages: 245 and the price starts from US $ 11400.

Introduction

Abstract

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

Table of Contents

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

1. Pipeline Overview and Dynamics

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

2. Epidemiology

• Key findings
• Definition
• Crohn' s disease
• Ulcerative colitis
• ICD-10 codes used to define the inflammatory bowel disease indications
• Patient segmentation by anatomical location
• Ulcerative colitis
• Crohn' s disease
• Patient segmentation according to disease severity
• Crohn' s disease
• Mild-to-moderate Crohn' s disease
• Moderate-to-severe Crohn' s disease
• Fistulizing Crohn' s disease
• Severe fulminant Crohn' s disease
• Remission in Crohn' s disease
• Ulcerative colitis
• Mild ulcerative colitis
• Moderate ulcerative colitis
• Severe ulcerative colitis
• Fulminant ulcerative colitis
• Remission
• Segmentation of patients by severity useful for directing therapy, but is not clearcut
• Disease definition and diagnosis criteria used in epidemiology analysis
• Crohn' s disease
• Ulcerative colitis
• Global variation and historical trends
• Risk factors
• Genetics
• Environmental factors
• Smoking
• Epidemiologic forecasting of IBD
• Sources of epidemiologic data
• Description of methods
• Japan
• US
• European markets
• Epidemiological results
• Current prevalent cases and future trends of Crohn' s disease
• Current prevalent cases and future trends of ulcerative colitis
• Discussion
• Strengths of Datamonitor' s epidemiologic projections
• Conclusions
• Rest of the world

3. Current Market Overview

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

4. R&D Approach

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

5. Pipeline Analysis & Forecasts: TNF inhibitors

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

6. Pipeline Analysis & Forecasts: Corticosteroids

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

7. Pipeline Analysis & Forecasts: Integrin inhibitors

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

8. Pipeline Analysis & Forecasts: Other cytokine targets

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

9. Pipeline Analysis & Forecasts: Others

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

10. Innovative Early-Stage Approaches

• Key findings
• Overview of early-stage innovative projects
• Toll-like receptors- promising preclinical target
• Interleukin 6 - preclinical models suggest potential in inflammatory bowel disease
• Targeting IL-6 five or more years away in inflammatory bowel disease
• Interleukin 10 -potential target for inflammatory bowel disease
• Early-stage inflammatory bowel disease pipeline is diverse
• The future of treatment in inflammatory bowel disease
• Bibliography
• Journals
• Websites
• Datamonitor reports

APPENDIX

• Methodology
• Datamonitor forecast methodology
• Product forecasts
• Derivation of sales forecasts and pricing trends
• Exchange rates
• Definition of a standard unit
• Datamonitor drug assessment scorecard
• Contributing experts
• About Datamonitor
• About Datamonitor Healthcare
• About the Disease analysis team
• Datamonitor consulting
• Disclaimer

List of Tables

• Table 1: Late-stage pipeline products in development for inflammatory bowel disease (IBD) 2010
• Table 2: Sales forecast for pipeline products in inflammatory bowel disease (IBD) in the seven major markets ($m), 2010-19
• Table 3: Centocor Ortho Biotech: key marketed drugs and R&D pipeline for inflammatory bowel disease (IBD), 2010
• Table 4: Cosmo Pharmaceuticals: key marketed drugs and R&D pipeline for inflammatory bowel disease (IBD), 2010
• Table 5: GlaxoSmithKline: key marketed drugs and R&D pipeline for inflammatory bowel disease (IBD), 2010
• Table 6: Datamonitor' s definition of Crohn' s disease
• Table 7: Datamonitor' s definition of ulcerative colitis
• Table 8: Montreal classification for ulcerative colitis covering extent and anatomy, 2005
• Table 9: Montreal classification for Crohn' s disease covering parameters and classification, 2005
• Table 10: Crohn' s disease population-based prevalence studies conducted the EU, US and Japan
• Table 11: Ulcerative colitis population-based prevalence studies conducted the EU, US and Japan
• Table 12: Total prevalent Crohn' s disease cases in the seven major markets, 2009-2019
• Table 13: Total prevalent ulcerative colitis cases in the seven major markets, 2009-2019
• Table 14: Datamonitor' s estimated prevalence of inflammatory bowel disease in BRICT, 2010
• Table 15: Leading treatments for inflammatory bowel disease (IBD), 2010
• Table 16: Remicade (infliximab) - drug profile, 2010
• Table 17: Ability of current comparator Remicade to meet unmet needs in inflammatory bowel disease (IBD), 2010
• Table 18: Summary of activity indices used for ulcerative colitis clinical trials
• Table 19: Key TNF inhibitors in the late-stage inflammatory bowel disease (IBD) R&D pipeline, 2010
• Table 20: Simponi (golimumab) - drug profile, 2010
• Table 21: Datamonitor' s drug assessment score card for Simponi (golimumab), 2010
• Table 22: Simponi versus TNF inhibitor comparator therapy Remicade in ulcerative colitis - minimum acceptable product profile (MAPP) and target product profile (TPP), 2010
• Table 23: Impacting factors on the revenues of Simponi, 2010-19
• Table 24: Sales forecasts for Simponi (golimumab, ) in ulcerative colitis in the US and five major EU markets ($m), 2010-19
• Table 25: Key TNF inhibitors in early-stage inflammatory bowel disease (IBD) R&D pipeline, 2010
• Table 26: Key corticosteroids in the late-stage inflammatory bowel disease (IBD) R&D pipeline, 2010
• Table 27: Budesonide MMX - drug profile, 2010
• Table 28: Budesonide MMX: Phase III trials in ulcerative colitis, 2010
• Table 29: Datamonitor' s drug assessment score card for Budesonide MMX, 2010
• Table 30: Budesonide MMX versus TNF inhibitor comparator therapy Remicade in ulcerative colitis - minimum acceptable product profile (MAPP) and target product profile (TPP), 2010
• Table 31: Impacting factors on the revenues of Budesonide MMX, 2010-19
• Table 32: Sales forecasts for Budesonide MMX in ulcerative colitis in the US and five major EU markets ($m), 2010-19
• Table 33: Key Integrin inhibitors in the late-stage inflammatory bowel disease (IBD) R&D pipeline, 2010
• Table 34: Vedolizumab - drug profile, 2010
• Table 35: Vedolizumab (MLN0002) - Phase III GEMINI studies
• Table 36: Datamonitor' s drug assessment score card for Vedolizumab (MLN0002), 2010
• Table 37: Vedolizumab versus TNF inhibitor comparator therapy Remicade in Crohn' s disease - minimum acceptable product profile (MAPP) and target product profile (TPP), 2010
• Table 38: Vedolizumab versus TNF inhibitor comparator therapy Remicade in ulcerative colitis - minimum acceptable product profile (MAPP) and target product profile (TPP), 2010
• Table 39: Impacting factors on the revenues of vedolizumab, 2010-19
• Table 40: Sales forecasts for vedolizumab in inflammatory bowel disease (IBD) in the US and five major EU markets ($m), 2010-19
• Table 41: AJM300 - drug profile, 2010
• Table 42: Datamonitor' s drug assessment score card for AJM300, 2010
• Table 43: AJM300 versus TNF inhibitor comparator therapy Remicade in Crohn' s disease - minimum acceptable product profile (MAPP) and target product profile (TPP), 2010
• Table 44: Impacting factors on the revenues of AJM300, 2010-19
• Table 45: Sales forecasts for AJM300 in inflammatory bowel disease (IBD) in Japan ($m), 2010-19
• Table 46: Key Integrin inhibitors in the early-stage inflammatory bowel disease (IBD) R&D pipeline, 2010, 2010
• Table 47: Key other cytokine targets in the late-stage inflammatory bowel disease (IBD) R&D pipeline, 2010
• Table 48: Stelara (ustekinumab) - drug profile, 2010
• Table 49: Datamonitor' s drug assessment score card for Stelara (ustekinumab), 2010
• Table 50: Stelara versus TNF inhibitor comparator therapy Remicade in Crohn' s disease - minimum acceptable product profile (MAPP) and target product profile (TPP), 2010
• Table 51: Impacting factors on the revenues of Stelara, 2010-19
• Table 52: Sales forecasts for Stelara (ustekinumab) in Crohn' s disease in the US and five major EU markets ($m), 2010-19
• Table 53: GSK1605786 (Traficet-EN, CCX282) - drug profile, 2010
• Table 54: Datamonitor' s drug assessment score card for GSK1605786 (Traficet-EN, CCX282), 2010
• Table 55: GSK1605786 versus TNF inhibitor comparator therapy Remicade in Crohn' s disease - minimum acceptable product profile (MAPP) and target product profile (TPP), 2010
• Table 56: Impacting factors on the revenues of GSK1605786, 2010-19
• Table 57: Sales forecasts for GSK1605786 (Traficet-EN) in Crohn' s disease in the US and five major EU markets ($m), 2010-19
• Table 58: Key other cytokine targets in the early-stage inflammatory bowel disease (IBD) R&D pipeline, 2010
• Table 59: Key other agents in the late-stage inflammatory bowel disease (IBD) R&D pipeline, 2010
• Table 60: LMW Heparin MMX - drug profile, 2010
• Table 61: Datamonitor' s drug assessment score card for LMW Heparin MMX, 2010
• Table 62: LMW Heparin MMX versus TNF inhibitor comparator therapy Remicade in inflammatory bowel disease - minimum acceptable product profile (MAPP) and target product profile (TPP), 2010
• Table 63: Impacting factors on the revenues of LMW Heparin MMX, 2010-19
• Table 64: Sales forecasts for LMW Heparin MMX in ulcerative colitis in the US and five major EU markets ($m), 2010-19
• Table 65: Prochymal - drug profile, 2010
• Table 66: Orencia - drug profile, 2010
• Table 67: Key other agents in the early-stage inflammatory bowel disease (IBD) R&D pipeline, 2010
• Table 68: Key interleukin-6 products in early-stage inflammatory bowel disease (IBD) R&D pipeline, 2010
• Table 69: Key interleukin-10 products in early-stage inflammatory bowel disease (IBD) R&D pipeline, 2010
• Table 70: Datamonitor drug assessment parameters

List of Figures

• Figure 59: Methodology for forecasting price to remove impact of currency fluctuations on future trend

Related Reports