Table of Contents
- ABOUT DATAMONITOR HEALTHCARE
- About the Disease pharmaceutical analysis team
- CHAPTER 1 EXECUTIVE SUMMARY
- Scope of the analysis
- Datamonitor insight into the rheumatoid arthritis market
- Key metrics
- Datamonitor Pipeline Assessment Summary
- CHAPTER 2 PIPELINE OVERVIEW AND DYNAMICS
- Pipeline overview
- Key companies involved in the rheumatoid arthritis pipeline
- Roche and partners
- Mutually beneficial partnerships
- Key R&D company strategies
- Small molecules - is it feasible?
- CHAPTER 3 RHEUMATOID ARTHRITIS - MARKET POTENTIAL
- Definition of rheumatoid arthritis
- Epidemiology of rheumatoid arthritis
- Segmentation of rheumatoid arthritis
- Mild, moderate and severe patients
- Early active rheumatoid arthritis
- Anti-TNF failure population
- Patient potential for anti-TNF failure drugs
- Current market overview
- Unmet needs in rheumatoid arthritis
- Environmental unmet need
- Cost and reimbursement is a barrier to extensive use of some DMARDs
- Clinical trial design
- Clinical unmet need
- Disease modification and side effects are the most important factors
to prescribing physicians
- Predicting response
- CHAPTER 4 R&D APPROACH
- Classification of pipeline products
- Cytokine T cell targets
- Interleukins
- TNF inhibitors
- Co-stimulatory pathways
- Cytokine B cell targets
- CD20
- Other B-cell mechanisms
- Small molecules
- Clinical trial design
- Non-responder clinical trials
- What is remission?
- Clinical trial endpoints in RA
- American College of Rheumatology (ACR) measures are the most common
endpoints
- Disease Activity Scale
- Tender Joint Count and Swollen Joint Count
- Quality of Life questionnaires
- HAQ
- Medical Outcome Short Form 36 (SF-36) Health Survey
- Disease progression
- CHAPTER 5 BIOLOGIC LATE-STAGE DRUG ANALYSIS AND FORECASTS
- Overview for the biologic class
- Biologic pipeline summary
- Comparative forecasts
- Definition of current comparator therapy
- Orencia (abatacept)
- Drug overview
- Clinical trial data
- More two-year data for abatacept
- A rare head-to-head trial with infliximab
- Data in JIA
- Patient potential
- Marketing factors
- Satisfaction of unmet needs
- Forecasts to 2016
- Datamonitor drug assessment summary
- Actemra (tocilizumab)
- Drug overview
- Clinical trial data
- Results on three key trials presented at the ACR Annual Meeting 2006
- Press release Phase III data
- Radiographic progression targeted at ACR
- European trial has more realistic results
- Tocilizumab in JIA
- Patient potential
- Marketing factors
- Satisfaction of unmet needs
- Forecasts to 2016
- Datamonitor drug assessment summary
- Ocrelizumab (rhuMab 2H7)
- Profile
- Clinical trial data
- Patient potential
- Marketing potential
- Satisfaction of unmet needs
- Forecasts to 2016
- Datamonitor drug assessment summary
- Cimzia (certolizumab)
- Drug overview
- Clinical trial data
- Positive signals but still no fully published data on Cimzia
- Phase IIb results
- Patient potential
- Marketing factors
- Satisfaction of unmet needs
- Forecasts to 2016
- Datamonitor drug assessment summary
- Golimumab
- Drug overview
- Clinical trial data
- Patient potential
- Smart trial design segments the RA population
- Marketing factors
- Satisfaction of unmet needs
- Forecasts to 2016
- Datamonitor drug assessment summary
- Atacicept (TACI-Ig)
- Drug overview
- Clinical trial data
- Patient potential
- SLE offers a higher unmet need than RA but a difficult route to
approval
- Marketing factors
- Clinical development partnerships boost atacicept' s commercial
viability
- Satisfaction of unmet need
- Forecast to 2016
- Ofatumumab (HuMax-CD20)
- Drug overview
- Clinical trials data
- Patient potential
- NHL as primary indication creates more direct competition with
Rituxan/MabThera
- Market potential
- Genmab' s alliances add commercial value
- Satisfaction of unmet needs
- Forecast to 2016
- Datamonitor drug assessment summary
- AMG 714 (HuMax Il-15)
- Drug overview
- Clinical trial data
- Patient potential
- Marketing factors
- Satisfaction of unmet needs
- Forecasts to 2016
- Other drugs in the biologic DMARD class
- Late-stage development compounds recently discontinued
- Cell adhesion molecule inhibitors
- CHAPTER 6 SMALL MOLECULE LATE-STAGE DRUG ANALYSIS AND FORECASTS
- Overview for the small molecules
- Small molecule pipeline summary
- Definition of current comparator
- Careram (iguratimod, T-614)
- Drug overview
- Clinical trial data
- Patient potential
- Increased liver enzymes create concern
- Lack of disease modifying effects
- Market factors
- Launch in Japan is more likely than in the US or EU
- ACR50 scores lacking in the latest data making clinical efficacy
difficult to compare
- Satisfaction of unmet needs
- Forecasts to 2016
- CF101
- Drug overview
- Clinical trial data
- Patient potential
- Marketing factors
- Satisfaction of unmet need
- Forecast to 2016
- CP-690550
- Overview
- Clinical trial data
- Patient potential
- Marketing factors
- Satisfaction of unmet need
- Forecast to 2016
- Other small molecules
- VX-702
- AT-001 (dnaJP1)
- R-788
- ABN-912
- RhuDex
- Apilimod mesylate (STA-5326)
- SCIO-469
- MLN-3897
- Late-stage development compounds recently discontinued
- Apratastat (TMI-005, APS)
- MK-0812
- CHAPTER 7 INNOVATIVE EARLY-STAGE PROJECTS
- Preclinical and discovery compounds
- BIBLIOGRAPHY
- APPENDIX A
- Methodology
- Datamonitor forecast methodology
- IMS Assumptions
- Product forecasts
- Definition of a standard unit
- Datamonitor drug assessment summary
- Contributing experts
- Report methodology
- APPENDIX B
- About Datamonitor
- About Datamonitor Healthcare
- Datamonitor Healthcare' s therapy area capabilities
- About the Disease analysis team
- Disclaimer
- List of Tables
- Table 1: Prevalence of RA in 2007
- Table 2: Products in late-phase development for rheumatoid arthritis,
2007
- Table 3: Roche' s recently launched and pipeline RA products, 2007
- Table 4: Prevalence of rheumatoid arthritis in the seven major
markets, 2007
- Table 5: RA prevalence applied to growing population rates in the
seven major markets, 2006-2016
- Table 6: Epidemiology studies into rheumatoid arthritis, 1955-2005
- Table 7: Point prevalence of rheumatoid arthritis by age and sex per
100 patients in Norfolk, UK study, 2002
- Table 8: CAGR for over-60 population in the seven major markets,
2005-2015
- Table 9: Rheumatoid arthritis disease severity as a percentage of
total diagnosed RA population in the seven major markets (%), 2006
- Table 10: Physician-estimated proportion of patients defined as having
early active rheumatoid arthritis in the seven major markets, 2006
- Table 11: Estimation of anti-TNF failure patient population in the
seven major markets, 2006-2016
- Table 12: Interleukin targeting products in the rheumatoid arthritis
pipeline, 2007
- Table 13: TNF products in the pipeline for rheumatoid arthritis, 2007
- Table 14: Approved biologic TNF inhibitors in rheumatoid arthritis
across the seven major markets, 2007
- Table 15: CD20 targets in human clinical trials for rheumatoid
arthritis,, 2007
- Table 16: Other B-cell targeting therapies in human clinical trials,
2007
- Table 17: Oral p38 MAP kinase targets in clinical trials for
rheumatoid arthritis, 2007
- Table 18: CCR2 targets in human trials in rheumatoid arthritis, 2007
- Table 19: CCR1 targets in human trials for rheumatoid arthritis in the
US, 2007
- Table 20: Key trial data presented in prescribing information and used
for approval of Enbrel and Remicade
- Table 21: Key biologic products in the late-stage pipeline for
rheumatoid arthritis, 2007
- Table 22: Sales forecasts for biologic drugs in rheumatoid arthritis
across the seven major markets, 2007-2016
- Table 23: Enbrel clinical efficacy, study IV from prescribing
information
- Table 24: Enbrel: key facts
- Table 25: Orencia: prescribing information
- Table 26: Published key Phase III abatacept studies, 2007
- Table 27: Percentage of ACR responders during the open-label period of
the ATTAIN trial in patients who were originally randomized to abatacept
(ITT and as-observed analysis)
- Table 28: Mean percentage improvement from baseline through 2 years in
the ASSURE Trial
- Table 29: Abatacept: safety summary
- Table 30: Results of abatacept versus infliximab
- Table 31: Cost comparison from Abatacept monograph from US Dept of
Veterans Affairs, 2006
- Table 32: Orencia: satisfaction of unmet needs
- Table 33: Percentage of patients in ITT analysis reaching ACR70 when
receiving 8mg/kg of tocilizumab or placebo
- Table 34: Percentage of patients in ITT analysis reaching DAS28
remission when receiving 8mg/kg of tocilizumab or placebo
- Table 35: Actemra preliminary Phase III results
- Table 36: Actemra: satisfaction of unmet needs
- Table 37: Results of ocrelizumab' s Phase I/II ACTION study, at week 24
- Table 38: Ocrelizumab: satisfaction of unmet needs
- Table 39: Cimzia Phase IIb trial results at week 12, 2001
- Table 40: Cimzia: satisfaction of unmet needs
- Table 41: ACR20/50/70 and DAS28 assessments at weeks 16 and 52 for all
treatment arms
- Table 42: Golimumab: satisfaction of unmet needs
- Table 43: Atacicept: satisfaction of unmet need
- Table 44: Patient baseline demographics for Phase II trial for
HuMax-CD20 in rheumatoid arthritis
- Table 45: Ofatumumab 24-week clinical response rates per dose group
for Phase II trial for HuMax-CD20 in rheumatoid arthritis, % of patients
- Table 46: Ofatumumab: satisfaction of unmet needs
- Table 47: AMG 714 Phase II ACR20 results at weeks 12, 14 and 16
- Table 48: AMG 714: satisfaction of unmet need
- Table 49: Forecast sales for small molecule disease modifying agents
in development for rheumatoid arthritis across the seven major markets
($m), 2007-2016
- Table 50: Small molecule agents in the pipeline for rheumatoid
arthritis, 2007
- Table 51: Careram: satisfaction of unmet need
- Table 52: CF101 satisfaction of unmet need
- Table 53: CP-690550: Phase II trial-week 6 responses
- Table 55: CP-690550: Phase II trial - numbers withdrawn
- Table 54: CP-690550: satisfaction of unmet need
- Table 55: Preclinical and discovery RA projects in the seven major
markets, 2007
- Table 56: ICD10 codes used to define an RA diagnosis
- Table 58: Datamonitor drug assessment tool - factors and weightings
- List of Figures
- Figure 1: Total RA sales and SUs in the seven major markets by region,
2003-06
- Figure 2: Datamonitor drug assessment summary for RA
- Figure 3: Breakdown of rheumatoid arthritis clinical projects by
phase, 2007
- Figure 4: Rheumatoid arthritis pipeline broken down by mechanism, 2007
- Figure 5: Pipeline broken down by administration method and molecule
type, 2007
- Figure 6: Likely sites of action of the major novel drugs on the RA
market, 2007
- Figure 7: Percentage of patients on biologics switching or terminating
therapy, and key reasons, 2006
- Figure 8: Total RA sales and SUs in the seven major markets by region,
2003-06
- Figure 9: The top rheumatoid arthritis products/molecules in the seven
major markets market, 2005-06
- Figure 10: Importance of challenges facing the rheumatoid arthritis
market, 2006
- Figure 11: Average influence on prescribing decision: weightings
assigned by surveyed physicians to key attributes for biologic and
traditional DMARDs
- Figure 12: Normal and rheumatoid joint comparison
- Figure 13: Suggested mechanism for B cell activation in rheumatoid
arthritis
- Figure 14: Breakdown of small molecules in human clinical trials for
RA by mechanism, 2007
- Figure 15: Swollen and tender joint count assessment
- Figure 16: Datamonitor drug assessment summary of biologic disease
modifying drugs in late-stage development for rheumatoid arthritis,
2007-2016
- Figure 17: Sales forecasts for biologic drugs in rheumatoid arthritis
across the seven major markets, 2007-2016
- Figure 18: Orencia' s novel mechanism
- Figure 19: Bristol-Myers Squibb' s strategy for Orencia, February 2007
- Figure 20: Orencia' s forecast revenues in rheumatoid arthritis across
the seven major markets ($m), 2007-2016
- Figure 21: Datamonitor drug assessment summary for Orencia in
late-stage development for rheumatoid arthritis
- Figure 22: Actemra' s forecast revenues in rheumatoid arthritis across
the seven major markets ($m), 2007-2016
- Figure 23: Datamonitor drug assessment summary for Actemra in
late-stage development for rheumatoid arthritis
- Figure 24: Results of ocrelizumab' s Phase I/II ACTION study, at week 24
- Figure 25: Ocrelizumab' s forecast revenues in rheumatoid arthritis
across the seven major markets ($m), 2007-2016
- Figure 26: Datamonitor drug assessment summary for Ocrelizumab in
late-stage development for rheumatoid arthritis
- Figure 27: Cimzia' s forecast revenues in rheumatoid arthritis across
the seven major markets ($m), 2007-2016
- Figure 28: Datamonitor drug assessment summary for Cimzia in
late-stage development for rheumatoid arthritis
- Figure 29: Golimumab' s forecast revenues in rheumatoid arthritis
across the seven major markets ($m), 2007-2016
- Figure 30: Datamonitor drug assessment summary for golimumab in
late-stage development for rheumatoid arthritis
- Figure 31: Atacicept: mechanism of action
- Figure 32: Ofatumumab' s forecast revenues in rheumatoid arthritis
across the seven major markets ($m), 2007-2016
- Figure 33: Datamonitor drug assessment summary for ofatumumab in
late-stage development for rheumatoid arthritis
- Figure 34: Datamonitor drug assessment summary of small molecule
disease modifying agents in late-stage development for rheumatoid arthritis
- Figure 35: Careram' s forecast revenues in rheumatoid arthritis in
Japan only ($m), 2007-2016
- Figure 36: CF101 preliminary Phase IIa results at 12 weeks
- Figure 37: CP-690550' s forecast revenues in rheumatoid arthritis
across the seven major markets ($m), 2007-2016
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