Pipeline Insight: Disease Modification in Rheumatoid Arthritis
Competition for the anti-TNF failure patient population increases
Pages: 222
Publisher: Datamonitor
Date Published: April 2007
Format: PDF
Price: $11400
Overview
Introduction
The treatment of Rheumatoid Arthritis (RA) has been rapidly evolving over the last decade. The success of the next wave of novel RA therapies depends on their ability to address the key issue of cost effectiveness, as the patient population for anti-TNF’s is reaching a maximum and competition moves to anti-TNF failure patients.
Scope
- Detailed pipeline analysis for key products in a specific rheumatoid arthritis indication, plus drug sales forecasts to 2016
- Overview of patient potential, segmentation by indication and unmet needs in rheumatoid arthritis across the seven major markets
- Benchmarking of key clinical and company attractiveness of the late-phase pipeline products
- Comprehensive and up-to-date clinical trial information
Highlights
The anti-TNF failure segment will be an area of increased competition over the next five years, as new products avoid direct confrontation with the established anti-TNF’s. This population will increase as more patients use biologics and cycle through the anti-TNF’s, but there are a finite number of eligible patients, especially if prices remain high. The race is on between the Roche/Genentech/Biogen Idec and the Genmab/GSK partnerships to launch a CD20-inhibiting monoclonal antibody to follow, and build upon, the success shown by Rituxan/MabThera (rituximab) in the RA indication. At present Roche with ocrelizumab have a slight, but uncertain, advantage. The majority (58%) of projects in human clinical trials are in Phase II development showing the positive growth potential in the RA disease area. However, a large proportion are small molecule, orally available products, which have in the past shown a high attrition rate in Phase II.
Reasons to Purchase
- Understand why pricing restraint is necessary for the continued exponential uptake and commercial growth of the biologic DMARDs
- Quantify the future size and potential of the market for novel treatments in the rheumatoid arthritis indication
- Use analysis of the common molecular targets under investigation to find gaps in the market for your product
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
MAP kinase
Chemokines
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
Total Sharp Score
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
US
EU
Japan
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
US
EU
Japan
Datamonitor drug assessment summary
Ocrelizumab (rhuMab 2H7)
Profile
Clinical trial data
The ACTION study results
Patient potential
Marketing potential
Satisfaction of unmet needs
Forecasts to 2016
US
EU
Japan
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
US
EU
Japan
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
US
EU
Japan
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
US
EU
Japan
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
TRU-015
Denosumab
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
US and EU
Japan
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
US
EU
Japan
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
Webpages
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
