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Commercial and Pipeline Perspectives: Rheumatoid Arthritis - Novel Biologics Drive Innovation in the Global RA Market


Description: Introduction
Enbrel (etanercept) and Remicade (infliximab) dominate the US and European RA markets, accounting for more than 80% of value sales; in Japan Remicade competes with sales of traditional DMARDs. Market success could rely on finding new inflammatory indications. Pfizers COX-2 portfolio will out-perform Mercks, as side-effect issues and product approval delays hit Vioxx and Arcoxia, respectively.

Scope
The RA market is defined for the purposes of this report as the ATC4 classes M1C0, M1A1, M1A3, L4A0 (Remicade and Prograf only), L1X3 (Rituxan only)
The ten year forecast is based on four years of IMS sales data, extrapolated using a dampened time series methodology and adjusted for market events
The forecast is split into the major markets: US, Japan, France, Germany, Italy, Spain and UK; with Global and European regional totals also provided
Pipeline, late phase, DMARD and NSAID therapies are profiled in detail using a new, enhanced, quantitative SWOT benchmarking framework
Highlights
Approval in additional indications will lessen the impact on Remicade (infliximab) of new biologic DMARD launches, commencing in 2006. Late-phase pipeline candidates are beginning trials for non-core indications before launch in the core indication to maximize revenues over the lifecycle of the compound.

CDP 870, Rituxan and CTLA4-Ig are the most commercially promising pipeline DMARDs. Sales are predicted to follow the exponential growth curves of Enbrel (etanercept) and Remicade (infliximab) with long take-up phases. Current late-stage candidates address the unmet need of dosing frequency, but an opportunity remains for an effective oral DMARD.

Prospects for Amgens portfolio remain strong, but continued success depends on the impact of patent expiry. Biogeneric erosion of Enbrel, the first biologic DMARD to go off patent in the US, in 2009, would force Amgen to push new candidates, such as Humax IL-15, currently in Phase II, to fill the revenue gap left by under-performing Kineret.

Reasons to Purchase
Follow the commercial success of Remicade use the PowerPoint presentation to share key market insight
Identify market potential for pipeline products access country-specific sales forecasts for the 7 major markets in an interactive Excel database
Plan lifecycle management strategies to achieve market success understand the key events that will shape the sector


Contents: TABLE OF CONTENTS
ABOUT DATAMONITOR HEALTHCARE 2
About the immune disorders and inflammation pharmaceutical analysis team 2
CHAPTER 1 EXECUTIVE SUMMARY 3
Objective of the analysis 3
Datamonitor insight into the RA market 3
CHAPTER 2 PATIENT POTENTIAL 11
Definition of arthritis 12
Epidemiology of RA 12
Key studies and reviews 13
Limitations, assumptions, and caveats 16
Diagnosis criteria 16
Point vs. cumulative prevalence 16
Data inadequacies 16
Race 17
RA patient population 18
US RA population holding steady at 1% 18
Europe varies widely by country 19
Japan: less RA patients than the UK 21
Are RA rates declining? 21
Unmet needs 23
CHAPTER 3 CURRENT RA TREATMENTS 27
Medicare analysis 28
Medicare Prescription Drug Improvement and Modernization Act of 2003 (DIMA) 28
DMARD class 32
Enbrel (etanercept) analysis 32
Remicade (infliximab) analysis 36
Kineret (anakinra) analysis 40
Arava (leflunomide) analysis 44
Humira (adalimumab) analysis 47
NSAID class 51
Celebrex (celecoxib) analysis 52
Bextra (valdecoxib) analysis 55
Vioxx (rofecoxib) analysis 58
Mobic (meloxicam) analysis 61
CHAPTER 4 RA CASE STUDIES 64
Pipeline overview 65
The RA product lifecycle 68
Amgen case study 68
Launch strategy and market penetration 73
Enbrel and Remicade 73
Celebrex and Vioxx 76
Strategic partnership 79
Cross-indication approvals 83
CHAPTER 5 DMARD LATE-STAGE DRUG ANALYSIS & FORECASTS 86
Clinical trial endpoints in arthritis 87
ACR values 87
Pain scales 87
Clinical trial design 88
Overview for DMARDs 92
Pipeline summary 92
Comparative positioning of pipeline drugs 94
Methodology of SWOT analysis 96
Definition of current DMARD comparator therapy 100
Pricing forecasts 104
Country roll out assumptions 104
MRA (atlizumab) 105
Prograf (tacrolimus) 110
CDP 870 (certolizumab pegol) 116
CTLA4-Ig (abatacept) 120
Rituxan (rituximab) 125
Eculizumab (Mab C5) 131
IL-1 Trap 135
Pegunercept (PEG-sTNF-R1) 139
HuMax IL-15 (AMG 714) 143
ISIS 104838 (IDEC 151) 147
Clenoliximab 151
Other drugs in DMARD class 154
MLN 1202 157
DPC 333 (BMS 561392) 160
AGIX 4207 162
SCIO-469 164
Vitaxin 167
AP 001 169
Late-stage development compounds recently discontinued 172
Pralnacasan 173
Raptiva 174
CHAPTER 6 NSAID LATE-STAGE DRUG ANALYSIS AND FORECASTS 175
Definition of current NSAID comparator therapy 177
Forecast pricing 180
Prexige (lumiracoxib) 181
Arcoxia (etoricoxib) 184
T-614 (iguratimod) 188
Other NSAID drugs in development 192
CHAPTER 7 INNOVATIVE EARLY-STAGE PROJECTS 193
Phase I projects 194
Preclinical projects 197
Preclinical projects and research platforms requiring partners 200
APPENDIX A 201
Contributing experts 201
Transcripts 201
Dr G Weissmann 201
Dr A R Poole 209
Prof D Isenberg 215
Bibliography 222
Epidemiology 222
Clinical trial data 223
Other 225
Report methodology 225
Japanese market data 225
Regional launch dates for new products 225
Standard units 225
Pricing forecasts 226
APPENDIX B 227
About Datamonitor 227
About Datamonitor Healthcare 227
Datamonitor Healthcare’s research and analysis methodologies 228
About the IDI analysis team 228
Disclaimer 230





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