Pipeline Insight: Rheumatoid Arthritis and Osteoarthritis - Striving for Innovation Among Me-Toos

SUMMARY

INTRODUCTION

Driven by the globally aging population, the incidence of OA and RA will increase significantly over the next seven years. The efforts to findcures 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 OF THE REPORT

• 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, rituximab and CDP-870 are set to have the greatestcommercial impact.

The similarity between 2nd generation COX-II inhibitors, and the fact that there are no major patent expiries in the forecast window, will ensurethat Celebrex and Vioxx retain their dominance of the pain market, with lumiracoxib being the most promising pipeline NSAID for the treatment ofarthritis 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.Deficiencies in existing trials include choice of effective endpoint, clinical trial duration and comparator drug selection - improvement in any ofthese areas will offer new compounds an edge over the competition.

KEY REASONS TO BUY THIS REPORT

• Identify which pipeline compounds have the highest potential
• 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 trialdesign

TABLE OF CONTENTS

Overview

Introduction

DRIVERS AND TRENDS

PATIENT POTENTIAL

Understand the demographics and diagnosis rates that shape the potential drug-treated population:

• Evaluate the prevalence of OA and RA in each of 7 major markets
• Identify fastest growing patient populations
• Gain a greater understanding of unmet need in OA and RA

R&D APPROACH

Acquire knowledge of the major classes and clinical trial methodology in OA and RA

• Assess major areas in need of improvement in OA and RA clinical trial design through opinion leader recommendations
• Understand shortcomings of current clinical trials and backgrounds for each major drug class

ARTHRITIS PIPELINE ANALYSIS

Profit from an analysis of the major players in arthritis, their current strategies, and factors driving market growth

• Gage your company' s status in the arthritis market through case studies analyzing the strategies of all major players in OA and RA
• Learn which factors are driving growth in the market and which are hindering progress
• View datasets listing all of the key compounds expected to affect the DMARD and NSAID segment over the next 10 years

LATE STAGE DRUG ANALYSIS AND FORECASTS– DMARD CLASS

Gain deeper knowledge of all key DMARDs in phase II or above

• View clinical trial data and opinion leader comment on all key DMARDs expected to enter the market between now and 2007
• Assess future competitive threats through a comparative analysis of all key pipeline DMARDs
• Plan future strategies through forecasted growth of key pipeline DMARDs and the overall market between now and 2010

LATE STAGE DRUG ANALYSIS AND FORECASTS – NSAID CLASS

Understand which pipeline NSAIDs will have the greatest impact

• View clinical trial data and opinion leader comment on all key NSAIDs expected to enter the market between now and 2007
• Assess future competitive threats through a comparative analysis of all key pipeline NSAIDs
• Plan future strategies through forecasted growth of key pipeline NSAIDs and the overall market between now and 2010

INNOVATIVE EARLY STAGE PROJECTS

Assess which compounds in phase II or earlier affect the market most noticeably

• Gain in-depth knowledge of which early stage drugs have highest potential through opinion leader insight
• Understand which of these projects offer the greatest potential for marketing and licensing agreements

ACTION POINTS

Strategically designed clinical trials represent a key area which companies with pipeline OA and RA drugs can use to maximize potential of newcompounds. The highest levels of unmet need are found 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.

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' sCDP-870 are set to have the greatest impact and highest potential of dethroning the current market leaders, Enbrel and Remicade.

The clinical similarity between second 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 domination of the pain market for several years, with lumiracoxib being the most commerciallypromising pipeline NSAIDs for the treatment of arthritis and licofelone being slightly less promising.

The major unmet need in RA treatment is gaining a deeper understanding of the mechanisms causing the disease. A number of early stage DMARDs havemechanisms of action which are markedly different from the current anti-TNF and anti-IL compounds. The potential of many of these compounds in meetingthis unmet need is generating a great deal of excitement within the arthritis community and represents an ideal opportunity for marketing andlicensing agreements for those companies seeking to expand their presence in the RA market.

APPENDIX

• List all sources used in writing this analysis and provides biographies of opinion leaders consulted

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