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Published by: Datamonitor
Published: Apr. 2, 2003 - 185 Pages
Table of Contents
CHAPTER 1 EXECUTIVE SUMMARY
Scope of the analysis
Datamonitor insight into the arthritis R&D pipeline
Key metrics
CHAPTER 2 PATIENT POTENTIAL
Definition of arthritis
Epidemiology of arthritis
Unmet needs in OA treatment
Unmet needs in RA treatment
Reliable predictive parameters for the clinical course of disease
Better patient management
Therapy to halt disease progression
CHAPTER 3 R&D APPROACH
Classification of pipeline products
Corticosteroids
NSAIDs
DMARDs
Opioids
Clinical trial design in arthritis
Effective endpoint selection
Clinical trial duration
Complexity of patient cohorts
Comparator drugs
Clinical trial endpoints in arthritis
ACR values
Pain scales
CHAPTER 4 ARTHRITIS PIPELINE ANALYSIS
Pipeline overview
Key drug delivery strategies in arthritis
Strategies for a successful launch in the arthritis market
Case study: Four major players and four different strategies for success in the
arthritis market
Pfizer/Pharmacia - Expanding upon an already dominant presence
Amgen: Sticking with what they do best
Merck: Second best is good enough for them but may not be for long
J&J: Standing Strong on One Great Product
Case study: Learning from the mistakes of previous market entrants
Arcoxia: Hindsight is 20:20 but it won’t increase profits
Prexige: Early planning expected to pay off big
Case study: Potent efficacy with potent side effects - how can uptake be
maximized?
Analysis of late stage drugs
Cost
Complex delivery regimens
Lack of long-term toxicity data
Long-term sustained disease remission
Marketing strength
Market drivers in arthritis
Trends in patient epidemiology
Patent expiries
Future drug launches
Treatment guidelines
NSAIDs
DMARDs
Drug lifecycle
Compliance 72
European DTC advertising 72
Market saturation 72
Market opportunities in arthritis 73
Forecast launches in arthritis from 2003-2010 74
CHAPTER 5 DMARD LATE-STAGE DRUG ANALYSIS &
FORECASTS
Overview for DMARDs
Pipeline summary
Definition of current DMARD comparator therapy
Enbrel (entanercept)
Prograf (tacrolimus)
Drug overview
Clinical trial data
Patient potential
Marketing factors
Satisfaction of unmet needs
SWOT analysis
Prograf comparative analysis to Enbrel
Efficacy
Disease Progression
Side Effects
Delivery
Cost
Marketing strength
Prograf forecasted sales
First year sales
CDP
Drug overview
Clinical trial data
Patient potential
Marketing factors
Satisfaction of unmet needs
SWOT analysis
CDP 870 comparative analysis to Enbrel
Efficacy
Disease Progression
Side Effects
Delivery
Cost
Marketing strength
CDP 870 forecasted sales
First year sales
CTLA4-Ig (BMS-188667)
Drug overview
Clinical trial data
Patient potential
Marketing factors
Satisfaction of unmet needs
SWOT analysis
CTLA-Ig comparative analysis to Enbrel
Efficacy
Disease Progression
Side Effects
Delivery
Cost
Marketing strength
CTLA4-Ig forecasted sales
First year sales
Rituximab
Drug Overview
Clinical trial data
Patient potential
Marketing factors
Satisfaction of unmet needs
SWOT analysis
Rituximab comparative analysis to Enbrel
Efficacy
Disease Progression
Side Effects
Delivery
Cost
Marketing strength
Rituximab forecasted sales
First year sales
HuMax-IL
Drug Overview
Clinical trial data
Patient potential
Marketing factors
Satisfaction of unmet needs
SWOT analysis
HuMax-IL comparative analysis to Enbrel
Efficacy
Disease Progression
Side Effects
Delivery
Cost
Marketing strength
HuMax-IL 15 forecasted sales
First year sales
Comparative analysis of DMARDs
Key DMARD R&D product forecasts summary table
Other late stage DMARDs
Clenoliximab
Drug overview
Clinical trial data
Patient potential
Marketing factors
Satisfaction of unmet needs
SWOT analysis
Eculizumab (5G1.1)
Drug overview
Clinical trial data
Patient potential
Marketing factors
Satisfaction of unmet needs
SWOT analysis
Onercept (Recombinant TNF binding protein)
Drug overview
Clinical trial data
Patient potential
Marketing factors
Satisfaction of unmet needs
SWOT analysis
DW-166HC
Drug overview
Clinical trial data
Patient potential
Marketing factors
Satisfaction of unmet needs
SWOT analysis
Pralnacasan
Drug Overview
Clinical trial data
Patient potential
Marketing factors
Satisfaction of unmet needs
SWOT analysis
Late-stage development DMARD compounds recently discontinued
HuMax-CD
Rebif (r-IFNB-1a)
DMARD with NSAID attributes
Iguratimod (T-614)
Drug overview
Clinical trial data
Patient potential
Marketing factors
Satisfaction of unmet needs
SWOT analysis
CHAPTER 6 NSAID LATE-STAGE DRUG ANALYSIS AND
FORECASTS
Comparison of key NSAIDs in development
Pipeline summary for NSAIDs
Definition of current NSAID comparator therapy
Celebrex (celecoxib)
Prexige (lumiracoxib)
Drug overview
Clinical trial data
Patient potential
Marketing factors
Satisfaction of unmet needs
SWOT analysis
Prexige (COX-189) forecasted sales
First year sales
Licofelone (ML 3000)
Drug overview
Clinical trial data
Patient potential
Marketing factors
Satisfaction of unmet needs
SWOT analysis
Licofelone (ML3000) forecasted sales
First year sales
NO-naproxen (AZD-3582)
Drug Overview
Clinical trial data
Patient potential
Marketing factors
Satisfaction of unmet needs
SWOT analysis
Comparative analysis of NSAIDs
Efficacy/GI Side Effects
CV Side Effects
Regimen
Marketing strength vs satisfaction of unmet need
NSAID R&D product forecasts summary
CHAPTER 7 INNOVATIVE EARLY-STAGE PROJECTS
Key early stage compounds in arthritis
RA-AnergiX
Drug overview
Clinical trial data
AnervaX.RA
Drug overview
Clinical trial data
Current Opinion
BMS-561392
Drug overview
Clinical trial data
Current Opinion
MRA
Drug Overview
Clinical Trial Data
Current Opinion
PEG-sTNF-RI
Drug overview
Clinical trial data
Current Opinion
AMD-3100
Drug overview
Clinical trial data
Current Opinion
SCIO-469
Drug overview
Clinical trial data
Current Opinion
Ro-320-1195
Drug overview
Current Opinion
JNK 2 inhibitors
Drug overview
Current Opinion
NF-kappa B modulators
Drug overview
Current Opinion
CCR antagonists
Drug overview
Current Opinion
Key research impacts on arthritis
APPENDIX A
Contributing experts
Professor T. Cawston
Professor D. Isenberg
Professor M. Matucci-Cerinic
Dr. P. Mease
Dr. A. R. Poole
Professor T Warner
Dr. Gerald Weissmann
List of tables
List of figures
Bibliography
Patient Potential
R& D Approach
Arthritis Pipeline Overview
Late Stage Drug Analysis
Report methodology
Introduction
Hypothesis formulation
Hypothesis testing
Ongoing information update
Product specific primary research
Data verification and quality control
APPENDIX B
About Datamonitor
About Datamonitor Healthcare
Datamonitor Healthcare’s therapy area capabilities
About Disease analysis team
Datamonitor Healthcare’s Consulting expertise
Datamonitor’s Therapeutic Consulting expertise
Key therapy team members
Simon Hemsworth, Director of Therapy Area Analysis
Simon Wright, Director of Arthritis
David Abramson, Therapeutic Lead Consultant
Disclaimer
DATASETS
Table 1: Key arthritis metrics, 2003-2010
Table 2: Forecast sales of key pipeline products in arthritis, $US (m), 2004-10
Table 3: Epidemiology overview of arthritis
Table 4: DMARD R&D pipeline, phase III compounds, 2003
Table 5: DMARD R&D pipeline, phase II compounds 2003
Table 6: DMARD R&D pipeline, phase I and discovery compounds 2003
Table 7: Anti-inflammatory R&D pipeline, 2003
Table 8: Analysis of DMARD arthritis pipeline by drug delivery technology, 2003
Table 9: Analysis of NSAID arthritis pipeline by drug delivery technology, 2003
Table 10: Key Product Launch Dates, 2003-10
Table 11: Late Stage DMARD Pipeline, 2003
Table 12: Enbrel Profile, 2003
Table 13: Tacrolimus Phase II trial results
Table 14: Global sales forecast for Prograf, 2003-2010
Table 15: Events table for Prograf in arthritis, 2004-10
Table 16: Global sales forecasts for CDP-870, 2005-2010
Table 17: Events table for CDP 870 in arthritis, 2005-10
Table 18: CTLA4-Ig Phase II trial results
Table 19: Global sales forecasts for CTLA4-Ig, 2005-2010
Table 20: Events Table for CTLA4-Ig in arthritis, 2005-10
Table 21: Rituximab interim phase II trial results
Table 22: Global sales forecast for Rituximab, 2005-2010
Table 23: Events Table for Rituximab in arthritis, 2005-10
Table 24: Global sales forecasts for HuMax-IL 15, 2007-2010
Table 25: Events Table for HuMax-IL 15 in arthritis, 2007-10
Table 26: Global sales forecasts in the arthritis DMARD market $ (million), 2001-10
Table 27: Eculizumab Treatment Regimen
Table 28: Discontinued R&D projects in DMARD Class, 2003
Table 29: Overview Table for Late Stage NSAIDs, 2003
Table 30: Celebrex Profile, 2002
Table 31: Global sales forecasts for Prexige, 2004-2010
Table 32: Events table for Prexige in arthritis, 2004-10
Table 33: Global sales forecasts for Licofelone, 2003-2010
Table 34: Events table for Licofelone in arthritis, 2004-10
Table 35: Global sales forecasts in the arthritis NSAID market $ (million), 2001-10
Table 36: Key compounds in early development for arthritis, 2004
AbstractIntroduction
Driven by the globally aging population, the incidence of OA and RA will increase significantly over the next seven years. The efforts to find cures for these diseases will increase as a direct result of this growing patient potential. The arthritis market will reach nearly $21bn by 2010, presenting abundant opportunity for the manufacturers of innovative and efficacious drugs to gain profits.
Scope
Analysis of clinical trial design in OA and RA, with opinion leader-driven recommendations for improvements in this area
Case studies examining the strategies of all of the major players in the OA and RA markets
Comparative analysis and forecasted sales for the key late stage DMARDs and NSAIDs
Opinion leader driven analysis of early stage (pre-clinical and phase I) pipeline OA and RA drugs
Report Highlights
Of the large number of late-stage DMARDs set to enter the market between 2003 and 2006, Genentech/IDEC/Roche’s rituximab and Celltech/Pfizer/Pharmacia’s CDP-870 are set to have the greatest impact and highest potential of dethroning the current market leaders, Enbrel and Remicade.
The similarity between 2nd generation COX-II inhibitors, and the fact that there are no major patent expiries in the forecast window, will ensure that Celebrex and Vioxx retain their dominance of the pain market, with lumiracoxib being the most promising pipeline NSAID for the treatment of arthritis and licofelone being slightly less promising.
Strategically designed clinical trials represent a key area which companies with pipeline OA and RA drugs can use to maximize potential. The highest levels of unmet need are in effective endpoint selection, clinical trial duration and comparator drug selection. Improvement in any of these areas will offer new compounds an edge over the competition.
Reasons to Purchase
Identify which pipeline compounds have the highest potential and which pose the least threat to current market leaders
Target R&D resources more effectively through a better understanding of unmet needs and the impact of important recent clinical trials
Enhance both your market entry and product defense strategies through opinion leader recommendations regarding unmet needs and clinical trial design
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