Pipeline Insight: Inflammatory Bowel Disease - Varied drug targets to broaden future therapy options
Datamonitor, July 2010, Pages: 245
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
Overview
Catalyst
Summary
Executive Summary
Strategic scoping and focus
Datamonitor insight into the disease market
Related reports
Upcoming related reports
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
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