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Commercial and Pipeline Perspectives: Rheumatoid Arthritis - Novel Biologics Drive Innovation in the Global RA MarketPublished by: Datamonitor Published: Jun. 23, 2004 - 230 Pages Table of ContentsTABLE 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 AbstractIntroductionEnbrel (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. Pfizer's COX-2 portfolio will out-perform Merck's, 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 Amgen's 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 Get Full Details About This Report >> |
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