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Pipeline Insight: Disease Modification in Rheumatoid Arthritis - New drug targets compete in crowded market
Pipeline Insight: Disease Modification in Rheumatoid Arthritis - New drug targets compete in crowded market
Pipeline Insight: Disease Modification in Rheumatoid Arthritis - New drug targets compete in crowded market
Pipeline Insight: Disease Modification in Rheumatoid Arthritis - New drug targets compete in crowded market
Pipeline Insight: Disease Modification in Rheumatoid Arthritis - New drug targets compete in crowded market
Pipeline Insight: Disease Modification in Rheumatoid Arthritis - New drug targets compete in crowded market
Pipeline Insight: Disease Modification in Rheumatoid Arthritis - New drug targets compete in crowded market
Pipeline Insight: Disease Modification in Rheumatoid Arthritis - New drug targets compete in crowded market
Pipeline Insight: Disease Modification in Rheumatoid Arthritis - New drug targets compete in crowded market
Pipeline Insight: Disease Modification in Rheumatoid Arthritis - New drug targets compete in crowded market
Pipeline Insight: Disease Modification in Rheumatoid Arthritis - New drug targets compete in crowded market
Pipeline Insight: Disease Modification in Rheumatoid Arthritis - New drug targets compete in crowded market
Pipeline Insight: Disease Modification in Rheumatoid Arthritis - New drug targets compete in crowded market
Pipeline Insight: Disease Modification in Rheumatoid Arthritis - New drug targets compete in crowded market
Pipeline Insight: Disease Modification in Rheumatoid Arthritis - New drug targets compete in crowded market
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Pipeline Insight: Disease Modification in Rheumatoid Arthritis - New drug targets compete in crowded market

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IntroductionDrugs with new mechanisms, in particular Pfizer's oral JAK inhibitor CP-690,550 and Chugai/Roche's Actemra (tocilizumab), will launch for rheumatoid arthritis and should offer advantages …

IntroductionDrugs with new mechanisms, in particular Pfizer's oral JAK inhibitor CP-690,550 and Chugai/Roche's Actemra (tocilizumab), will launch for rheumatoid arthritis and should offer advantages over current therapies, but do not come without some safety signals. Late-stage pipeline launches will be a major contributor to market growth from $7.4 billion in 2008 to $11.5 billion in 2018.Scope*In-depth analysis of Phase II and III disease modifying drug candidates in the rheumatoid arthritis pipeline*Segmentation and analysis of the current rheumatoid arthritis pipeline by developmental phase, drug class and company*Insight and analysis of market potential including commercial opportunity, epidemiology and discussion of unmet needs*Focus on innovative early-stage drug development with assessment of future treatment of rheumatoid arthritisHighlightsThe shift from Western regions to countries in Eastern Europe and South America is now a prominent feature of modern rheumatoid arthritis clinical trials. This has led to variability in placebo and drug responses resulting in higher failure rates. This will continue to be a difficult hurdle for drug development in rheumatoid arthritis.Pfizer's JAK inhibitor CP-690,550 blazes the trail for small molecule kinase inhibitors in rheumatoid arthritis. Despite efficacy being in line with biologics, product positioning, safety and cost are key debatable issues for uptake of this new drug upon launch in 2012. Datamonitor forecasts sales in the seven major markets of $0.9 billion in 2018.Pre-launch awareness, robust clinical data and marketing capability leads Datamonitor to believe Actemra (tocilizumab; Roche/Chugai) will have a significant impact on the market. Safety remains a question, but physicians are willing to deal with issues highlighted in clinical trials. Datamonitor expects Actemra to achieve blockbuster sales by 2015.Reasons to Purchase*Understand the major recent advances in the dynamic and constantly evolving rheumatoid arthritis pipeline*Evaluate the sales forecasts of key late-stage pipeline products to 2018 and understand new product positioning in this competitive market*Assess key opinion leaders' views on the most advanced pipeline products including Pfizer's JAK inhibitor CP-690,550

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  • 1. Find Industry reports, Company profilesReportLinker and Market Statistics >> Get this Report Now by email!Pipeline Insight: Disease Modification in Rheumatoid Arthritis - Newdrug targets compete in crowded marketPublished on October 2009 Report SummaryIntroductionDrugs with new mechanisms, in particular Pfizers oral JAK inhibitor CP-690,550 and Chugai/Roches Actemra (tocilizumab), willlaunch for rheumatoid arthritis and should offer advantages over current therapies, but do not come without some safety signals.Late-stage pipeline launches will be a major contributor to market growth from $7.4 billion in 2008 to $11.5 billion in 2018.Scope*In-depth analysis of Phase II and III disease modifying drug candidates in the rheumatoid arthritis pipeline*Segmentation and analysis of the current rheumatoid arthritis pipeline by developmental phase, drug class and company*Insight and analysis of market potential including commercial opportunity, epidemiology and discussion of unmet needs*Focus on innovative early-stage drug development with assessment of future treatment of rheumatoid arthritisHighlightsThe shift from Western regions to countries in Eastern Europe and South America is now a prominent feature of modern rheumatoidarthritis clinical trials. This has led to variability in placebo and drug responses resulting in higher failure rates. This will continue to bea difficult hurdle for drug development in rheumatoid arthritis.Pfizers JAK inhibitor CP-690,550 blazes the trail for small molecule kinase inhibitors in rheumatoid arthritis. Despite efficacy being inline with biologics, product positioning, safety and cost are key debatable issues for uptake of this new drug upon launch in 2012.Datamonitor forecasts sales in the seven major markets of $0.9 billion in 2018.Pre-launch awareness, robust clinical data and marketing capability leads Datamonitor to believe Actemra (tocilizumab;Roche/Chugai) will have a significant impact on the market. Safety remains a question, but physicians are willing to deal with issueshighlighted in clinical trials. Datamonitor expects Actemra to achieve blockbuster sales by 2015.Reasons to Purchase*Understand the major recent advances in the dynamic and constantly evolving rheumatoid arthritis pipeline*Evaluate the sales forecasts of key late-stage pipeline products to 2018 and understand new product positioning in this competitivemarket*Assess key opinion leaders views on the most advanced pipeline products including Pfizers JAK inhibitor CP-690,550Pipeline Insight: Disease Modification in Rheumatoid Arthritis - New drug targets compete in crowded market Page 1/15
  • 2. Find Industry reports, Company profilesReportLinker and Market Statistics Table of ContentOverview 1Catalyst 1Summary 1ABOUT DATAMONITOR HEALTHCARE 2About the Disease pharmaceutical analysis team 2Executive Summary 3Strategic scoping and focus 3Datamonitor insight into the disease market 3Related reports 4Upcoming related reports 5Table of Contents 61. Pipeline Overview and Dynamics 7Key findings 7Pipeline overview 8Extensive pipeline highlights commercial interest in rheumatoid arthritis 8Comparatively few products have made it to Phase III 10Comparative forecasts - pipeline products generate multi-billion dollar boost to the market 11Datamonitor pipeline assessment summary - Actemra/RoActemra will be well placed for market success 12Key companies involved in the rheumatoid arthritis pipeline 13Roche - Genentech acquisition solidifies its position as a major player in rheumatoid arthritis 13Pfizer - extensive pipeline with the most advanced kinase inhibitor for rheumatoid arthritis 14Bristol-Myers Squibb - looking beyond Orencia 15Key R&D company strategies 16Focus on oral, small molecule formulations 16Companies are going for dual subcutaneous and intravenous delivery formulations 172. Rheumatoid Arthritis - Market Potential 20Key findings 20Definition 21ICD-10 codes used to define the rheumatoid arthritis market 22Patient segmentation 23Early active rheumatoid arthritis 23Antibody positive rheumatoid arthritis 24TNF-failure patients 24Juvenile idiopathic arthritis 25Classification of juvenile idiopathic arthritis 25Treatment of juvenile idiopathic arthritis 26Epidemiology 27Seven major markets 27The incidence of rheumatoid arthritis is on the rise in the US 27Greater incidence of rheumatoid arthritis in females than males 28Datamonitor estimates there will be 4.4 million rheumatoid arthritis patients in the seven major markets in 2010 29Datamonitor estimates there are up to 177,000 juvenile idiopathic arthritis patients in the seven major markets 31Rest of the world 33Large patient population exists outside of the seven major markets 33Pipeline Insight: Disease Modification in Rheumatoid Arthritis - New drug targets compete in crowded market Page 2/15
  • 3. Find Industry reports, Company profilesReportLinker and Market StatisticsArthritis in Canada: An Ongoing Challenge, 2003 34Current treatment options 35Traditional DMARDs 35Anti-TNFs 35B cell therapies 36T cell co-stimulator modulators 36Current gold standard and comparator therapies 37Methotrexate remains the gold-standard for rheumatoid arthritis 37Comparator therapies 39Enbrel (etanercept; Amgen, Wyeth [now part of Pfizer]) 39Current market overview 40Minimal growth in seven major market rheumatoid arthritis sales between 2007 and 2008 40Anti-TNF sales were down in 2008, but alternative biologics experienced good uptake in 2007-08 41Orencia and Rituxan lead year-on-year growth from 2007 to 2008 42Unmet needs in rheumatoid arthritis 43Better clinical response 4430-40% of patients received most effective drugs still dont reach ACR20 44An add-on therapy for patients doing ok on biologic plus methotrexate 44Early diagnosis and early treatment 45Identifying patients who will respond to therapies 46Establish optimal treatment strategies for TNF-failure patients 47Oral, small molecules that fill the gap between DMARDs and biologics 47Understand the impact of combining therapies 48Treatments and strategies to stop the disease early then stop drug therapy 49Options for patients who fail all the biologics 49Current level of attainment vs. target product profile 49Efficacy 50Safety 50Formulation 51Cost 513. R&D Approach 53Key findings 53Clinical trial design in rheumatoid arthritis 54Shift towards patient recruitment from Eastern Europe and South America for clinical trials 54Trial design 55Background DMARD trials, add-on or step-up trials are becoming the standard 55DMARD-naïve trials 56Head-to-head trials - Bristol-Myers Squibb sets a new precedent 56Active controlled trials 59Newer biological agents tested in the anti-TNF-failure patient population 59Proof of concept trials 59Methotrexate (MTX) as an active comparator 60Open label run-in trials avoid use of placebo control, particularly in juvenile idiopathic arthritis 60Clinical trial endpoint measures 60American College of Rheumatology 20/50/70 scores 60Disease Activity Score 61Modified Disease Activity Score (DAS28) 61Disease Activity Score using C-reactive protein (CRP) 61EULAR scores 62Tender joint count and swollen joint count 62Pipeline Insight: Disease Modification in Rheumatoid Arthritis - New drug targets compete in crowded market Page 3/15
  • 4. Find Industry reports, Company profilesReportLinker and Market StatisticsRadiographic progression 62Quality of life questionnaires 62Productivity 63Other endpoints 634. Pipeline Analysis & Forecasts: TNF Inhibitors 64Key findings 64Overview for TNF inhibitors 65Pipeline summary 65Comparative forecasts 66Simponi (golimumab; Centocor Ortho Biotech/Schering-Plough/Mitsubishi Tanabe) 67Drug overview 67Drug profile 68Clinical trial data 68GO-FORWARD 68GO-BEFORE 69GO-AFTER 70Intravenous Simponi - study data presented at EULAR 2009 72SWOT analysis 75Datamonitor drug assessment score card for Simponi 76Clinical and commercial attractiveness 77Experienced companies add to commercial attractiveness, but arbitration between Johnson & Johnson and Schering-Plough is aconcern 77Simponi and first-generation anti-TNF Remicade will compete in the same rheumatoid arthritis populations 78Simponi positioned for use in multiple rheumatoid arthritis patient subgroups but in reality will fall behind established TNF inhibitors 78Improved dosing frequency will allow competition with other marketed TNF inhibitors 78Formulation strategy unclear, while intravenous formulation is held up over poor Phase III data 79Abbott sues Johnson & Johnson over subcutaneous Simponi 79Satisfaction of unmet needs 79Forecasts to 2018 80Cimzia (certolizumab; UCB, Otsuka Pharmaceuticals) 81Drug overview 82Drug profile 83Clinical trial data 83RAPID 1 83RAPID 2 84FAST4WARD 85SWOT analysis 86Datamonitor drug assessment score card for Cimzia 87Clinical and commercial attractiveness 88Cimzia is not sufficiently differentiated from the other anti-TNFs 88UCB has launched a prefilled syringe, but other anti-TNFs have easy-to-inject pen formulations 89Satisfaction of unmet needs 89Forecasts to 2018 90Other drugs in TNF inhibitor class 92ART621 (Domantis [GlaxoSmithKline]/Arana Therapeutics) 92Drug overview 92TNF alpha kinoid (Neovacs) 94Drug overview 94Late-stage development compounds recently discontinued 95SSR150106 95Pipeline Insight: Disease Modification in Rheumatoid Arthritis - New drug targets compete in crowded market Page 4/15
  • 5. Find Industry reports, Company profilesReportLinker and Market StatisticsKey early-stage and preclinical compounds in TNF inhibitors 965. Pipeline Analysis & Forecasts: B Cell Targets 97Key findings 97Overview for B Cell targets 98Pipeline summary 98Comparative forecasts 99Ocrelizumab (Genentech, Biogen Idec, Roche and Chugai) 100Drug overview 100Drug profile 101Clinical trial data 101Phase II ACTION study 101Phase III studies: STAGE, SCRIPT, FILM and FEATURE 102Japanese Phase III studies 103SWOT analysis 105Datamonitor drug assessment score card for ocrelizumab 106Clinical and commercial attractiveness 107Genentech and Roche are experienced players in the rheumatoid arthritis market 107Minimal Phase II clinical data, but demonstrated similar efficacy and safety to Rituxan/MabThera 108Active comparison with Remicade in single TNF failure patients 108Downside is that ocrelizumab is not really differentiated from Rituxan/MabThera 108Satisfaction of unmet needs 109Forecasts to 2018 110Arzerra (ofatumumab; Genmab, GlaxoSmithKline) 112Drug overview 112Drug profile 113Clinical trial data - Phase III 113Top-line trial data in methotrexate-failure patients 113Phase III trial program summary 114Clinical trial data - Phase II 114SWOT analysis 116Datamonitor drug assessment score card for Arzerra 116Clinical and commercial attractiveness 117Positive Phase III data emerging, but data in TNF-failures keenly awaited 117Not adequately differentiated from other B cell therapies Rituxan/MabThera or ocrelizumab 117Subcutaneous formulation is an advantage, but is 5 years away from market 118Satisfaction of unmet needs 118Forecasts to 2018 119Other drugs in B Cell targets class 121Atacicept (TACI-Ig; ZymoGenetics, Merck Serono) 121Benlysta (belimumab; Human Genome Sciences, GlaxoSmithKline) 122Drug overview 122Clinical trial data 123TRU-015 (Trubion Pharmaceuticals, Wyeth/Pfizer) 124Drug overview 124Clinical trial data 125LY2127399 127Drug overview 127Clinical trial data 128Veltuzumab (IMMU106; Immunomedics) 130B cell targets recently discontinued 130Pipeline Insight: Disease Modification in Rheumatoid Arthritis - New drug targets compete in crowded market Page 5/15
  • 6. Find Industry reports, Company profilesReportLinker and Market StatisticsBriobacept (BR3-Fc; Biogen Idec, Genentech) 130Key early-stage and preclinical compounds in B cell targets class 1316. Pipeline Analysis & Forecasts: Other Cytokine antagonists 132Key findings 132Overview for other cytokine antagonists 133Pipeline summary 133Actemra/RoActemra (tocilizumab; Chugai, Roche) 133Drug overview 134Drug profile 135Clinical trial data 135OPTION 135TOWARD 136RADIATE 137AMBITION 138LITHE 139SWOT analysis 140Datamonitor drug assessment score card for Actemra 141Clinical and commercial attractiveness 142Large Phase III program and excellent clinical efficacy enable Actemra to compete with Rituxan and Orencia, but also at first-line 142As a major player in the rheumatoid arthritis market, Roche adds considerable commercial weight to Actemra 143Currently similar dosing to Orencia, but the future may also bring subcutaneous delivery 144Safety signals may dampen uptake initially; REMS in place in the US 144Deaths related to Actemra intensify the long-term safety worries 145Satisfaction of unmet needs 146Forecasts to 2018 147Other drugs in cytokine antagonists 149Canakinumab (Ilaris, ACZ885; Novartis) 149Drug overview 149Clinical trial data - rheumatoid arthritis 150Clinical trial data - systemic juvenile idiopathic arthritis 151Iguratimod (T-164, Careram; Toyama Chemical; Eisai) 152Drug overview 152Clinical trial data 152Denosumab (AMG162; Amgen) 152Drug overview 152Clinical trial data 153AMG108 (Amgen) 154Drug overview 154Clinical trial data 155CNTO136 (Centocor Ortho Biotech) 155Drug overview 155Anti IL-17 antibody (LY2439821; Eli Lilly) 156Drug overview 156Clinical trial data 156K832 (Kowa Pharmaceuticals) 157Drug overview 157AIN457 (Novartis) 158Drug overview 158Clinical trial data 158Apilimod (STA5326; Synta Pharmaceuticals) 159Pipeline Insight: Disease Modification in Rheumatoid Arthritis - New drug targets compete in crowded market Page 6/15
  • 7. Find Industry reports, Company profilesReportLinker and Market StatisticsXOMA052 (Xoma) 160ALD-518 (Alder Biopharmaceuticals) 160Givinostat (ITF2357; Italfarmaco) 160Late-stage development compounds recently discontinued 161AZD5672 161MLN-3897 161LY2189102 161Key early-stage and preclinical compounds in cytokine antagonist class 1627. Pipeline Analysis & Forecasts: Kinase Inhibitors 163Key findings 163Overview for kinase inhibitors 164Pipeline summary 164Comparative forecasts 165CP-690,550 (Pfizer) 166Drug overview 166Drug profile 167Clinical trial design - Phase III 167Clinical trial design and data - Phase II 169Ongoing Phase II trials 169Completed Phase II trial summary 169A3921039 trial data 170A3921035 trial data 171CP-690,550 effects on pain, physical function and HRQoL - A3921035 and A3921025 trial data 172SWOT analysis 173Datamonitor drug assessment score card for CP-690,550 174Clinical and commercial attractiveness 175Large Phase III trial program will provide evidence of efficacy across every rheumatoid arthritis population 175Phase II data support efficacy and rapid action of CP-690,550 177Safety profile highlights some issues, but overall manageable 177Cost of CP-690,550 remains a major factor for consideration 178Satisfaction of unmet needs 179Forecasts to 2018 180R788 (Fostamatinib disodium; Rigel Pharmaceuticals) 182Drug overview 183Drug profile 183Clinical trial data - Phase II trial data mixed, but Datamonitor is positive 183TASKi3 183TASKi2 186TASKi1 188SWOT analysis 189Datamonitor drug assessment score card for R788 189Clinical and commercial attractiveness 190Datamonitor expects R788 will be positioned in DMARD or methotrexate failures 190Datamonitor sees benefit with oral drug, but some safety signals exist with R788 190Essential that Rigel finds partner quickly for R788 191Satisfaction of unmet needs 192Forecasts to 2018 193Other drugs in the kinase inhibitors class 195Masitinib (AB1010; AB Science) 195ARRY162 (ARRY-438162; Array BioPharma) 197Pipeline Insight: Disease Modification in Rheumatoid Arthritis - New drug targets compete in crowded market Page 7/15
  • 8. Find Industry reports, Company profilesReportLinker and Market StatisticsBMS-582949 (Pharmacopeia, Bristol-Myers Squibb) 199GW856553 (GlaxoSmithKline) 201INCB18424 (Incyte) 202INCB28050 (Incyte) 203PH797804 204Late-stage development compounds recently discontinued 206P38 MAP kinase inhibitors showing high attrition rate in rheumatoid arthritis 206VX702 (Vertex Pharmaceuticals) 206Talmapimod (SCIO469; Scios Inc/Johnson & Johnson) 207ARRY797 (ARRY-371797; Array BioPharma) 2088. Pipeline Analysis & Forecasts: Others 209Key findings 209Overview for Others 210Pipeline summary 210dnaJp1 (Adeona Pharmaceuticals) 210T-5224 (Toyama Chemical) 2124SC-101 (SC-12267; 4SC) 212BT061 (Biotest) 213CH1504 (Chelsea Therapeutics) 213Tranilast (Nuon Therapeutics) 214MDX-1100 (Medarex (Bristol-Myers Squibb) 215MM093 (GTC Biotherapeutics/Merrimack Pharmaceuticals) 215Rabeximod (Rob803; OxyPharma) 216PG760564 (Proctor & Gamble) 216RWJ-445380 (ALZA Corp, Johnson & Johnson) 216LX-2931 (LX-3305; Lexicon Pharmaceuticals) 217Fezakinumab (ILV-094; Wyeth [now Pfizer]) 218PI2301 (Peptimmune) 218Late-stage development compounds recently discontinued 218Recent high-profile discontinuations highlight P2X7 antagonism may not be successful target 218AZD9056 (AstraZeneca) 219CE-224535 (Pfizer) 219TAK783 (Takeda) 219Key early-stage and preclinical compounds in Others class 2209. Innovative Early-Stage Approaches 221Key findings 221Overview of early-stage innovative projects 222Kinase inhibitors represent a large proportion of the drugs in early phase development 222The anti-GM-CSF strategy: the next promising target 223Drug targeting GM-CSF could be the next blockbuster cytokine class 223Several GM-CSF-directed therapies looking to advance into Phase II for rheumatoid arthritis 224NFKappaB 225Chemokine receptor antagonists 226The future of treatment in rheumatoid arthritis 227Combining therapies will be commonplace in future treatment of rheumatoid arthritis 227Biomarkers to predict response to biologic therapy 228Bibliography 229Journals 229Websites 239Datamonitor reports 250Pipeline Insight: Disease Modification in Rheumatoid Arthritis - New drug targets compete in crowded market Page 8/15
  • 9. Find Industry reports, Company profilesReportLinker and Market StatisticsOther sources 250APPENDIX 251Methodology 251Datamonitor forecast methodology 251Product forecasts 251Exchange rates 251Definition of a standard unit 251Japan methodology 251Datamonitor drug assessment scorecard methodology 252Contributing experts 252About Datamonitor 254About Datamonitor Healthcare 254About the Disease analysis team 254Datamonitor consulting 255Disclaimer 256List of TablesTable 1: Late-phase pipeline products in development for rheumatoid arthritis, 2009 9Table 2: Sales forecasts for pipeline products in late-stage development in rheumatoid arthritis in the seven major markets ($m),2009-2018 12Table 3: Roches rheumatoid arthritis marketed and pipeline product portfolio, 2009 14Table 4: Pfizers rheumatoid arthritis pipeline portfolio, 2009 15Table 5: Bristol-Myers Squibbs rheumatoid arthritis pipeline portfolio, 2009 16Table 6: Pipeline products with both subcutaneous and intravenous formulations in potential development for rheumatoid arthritis,2009 19Table 7: Datamonitors definition of rheumatoid arthritis 22Table 8: Efficacy of common medication used to treat juvenile idiopathic arthritis, 2009 26Table 9: Marketed and pipeline products for juvenile idiopathic arthritis, 2009 27Table 10: Incidence rates (cases/1,000) of rheumatoid arthritis worldwide in studies based on ACR criteria, 1993-2002 29Table 11: Prevalence of rheumatoid arthritis across the seven major markets, 2010 30Table 12: Estimated total rheumatoid arthritis (RA) populations in each of the seven major markets, 2010-2020 31Table 13: Epidemiology studies into juvenile idiopathic arthritis (JIA), 1987-2007 32Table 14: Estimated juvenile idiopathic arthritis (JIA) prevalence and population across the seven major markets, 2010 33Table 15: Estimated juvenile idiopathic arthritis (JIA) population in the seven major markets, 2010-2020 33Table 16: Datamonitors estimated prevalence figures for rheumatoid arthritis in regions outside the seven major markets, 2009 34Table 17: Leading treatments for rheumatoid arthritis, 2009 37Table 18: Enbrel (etanercept) - Drug profile, 2009 40Table 19: Ability of current comparator Enbrel to meet unmet needs in rheumatoid arthritis, 2009 52Table 20: ACR scores in biologic-naïve versus TNF-failure rheumatoid arthritis patients 59Table 21: Key products in the late-stage R&D pipeline for TNF inhibitors for rheumatoid arthritis, 2009 65Table 22: Sales forecasts for new TNF inhibitors in rheumatoid arthritis in the seven major markets ($m), 2008-2018 67Table 23: Simponi - Drug profile, 2009 68Table 24: Simponi (golimumab): Efficacy results in patients previously receiving anti-TNFs for rheumatoid arthritis, 2009 72Table 25: Simponi (golimumab): efficacy data for intravenous Simponi (golimumab) at week 14, week 24 and week 48 in rheumatoidarthritis, 2009 74Table 26: Simponi versus TNF inhibitor comparator therapy Enbrel in rheumatoid arthritis - minimum acceptable product profile(MAPP) and target product profile (TPP), 2009 80Table 27: Simponi (golimumab): sales forecasts in the seven major markets ($m), 2009-2018 81Table 28: Cimzia - Drug profile, 2009 83Table 29: Cimzia versus TNF inhibitor comparator therapy Enbrel in rheumatoid arthritis - minimum acceptable product profile andtarget product profile, 2009 90Pipeline Insight: Disease Modification in Rheumatoid Arthritis - New drug targets compete in crowded market Page 9/15
  • 10. Find Industry reports, Company profilesReportLinker and Market StatisticsTable 30: Cimzia (certolizumab): sales forecasts for in the seven major markets ($m), 2009-2018 92Table 31: Neovacss kinoid active antibody therapy: advantages compared to standard monoclonal antibody therapy 95Table 32: Key products in the early-stage R&D pipeline for TNF inhibitors, 2009 96Table 33: Key products in the late-stage R&D pipeline for B Cell targets for rheumatoid arthritis, 2009 98Table 34: Sales forecasts for B cell therapies in the seven major markets ($m), 2009-2018 100Table 35: Ocrelizumab - Drug profile, 2009 101Table 36: Ocrelizumab: Phase III clinical trial program in rheumatoid arthritis, 2009 103Table 37: Ocrelizumab versus comparator therapy Enbrel in rheumatoid arthritis -minimum acceptable product profile and targetproduct profile, 2009 110Table 38: Ocrelizumab: sales forecasts in the seven major markets ($m), 2009-2018 112Table 39: Arzerra - Drug profile, 2009 113Table 40: Arzerra (ofatumumab): ongoing Phase III and Phase I/IIa trials in rheumatoid arthritis, 2009 114Table 41: Arzerra (ofatumumab): week 48 follow-up data for Phase II trial in DMARD-failure rheumatoid arthritis patients, 2008 115Table 42: Arzerra (ofatumumab) versus comparator therapy Enbrel in rheumatoid arthritis - minimum acceptable product profile andtarget product profile, 2009 119Table 43: Arzerra (ofatumumab): sales forecasts in the seven major markets ($m), 2009-2018 121Table 44: Atacicept (TACI-Ig); summary of Phase II clinical trials in rheumatoid arthritis, 2009 122Table 45: Key early-stage compounds targeting B cells in rheumatoid arthritis in 2009. 131Table 46: Key products in the late-stage R&D pipeline for cytokine antagonists for rheumatoid arthritis, 2009 133Table 47: Actemra/RoActemra - Drug profile, 2009 135Table 48: Actemra (tocilizumab) versus cytokine antagonist comparator therapy Enbrel - minimum acceptable product profile andtarget product profile, 2009 147Table 49: Actemra/RoActemra (tocilizumab): sales forecasts in the seven major markets ($m), 2008-2018 149Table 50: Denosumab (AMG162): MRI erosion score at 6 months and clinical efficacy scores at 12 months from the Phase II study inrheumatoid arthritis, 2008 154Table 51: AIN457: proof-of-concept study results in rheumatoid arthritis, 2009 159Table 52: Key early-stage and preclinical compounds in the cytokine antagonist class in development for rheumatoid arthritis, 2009162Table 53: Key products in the late-stage R&D kinase inhibitor pipeline for rheumatoid arthritis., 2009 164Table 54: Sales forecasts for kinase inhibitors in the seven major markets ($m), 2009-2018 166Table 55: CP-690,550 - Drug profile, 2009 167Table 56: CP-690,550: Summary of ongoing, recruiting Phase III rheumatoid arthritis trials, 2009 168Table 57: CP-690,550: summary of ongoing, recruiting Phase II rheumatoid arthritis trials , 2009 169Table 58: CP-690,550: Phase II clinical trial information for completed studies, 2009 170Table 59: CP-690,550: A3921035 and A3921025 trial data, 2009 173Table 60: CP-690,550 versus TNF inhibitor comparator therapy Enbrel in rheumatoid arthritis - minimum acceptable product profileand target product profile, 2009 180Table 61: CP-690,550: sales forecasts in the seven major markets ($m), 2009-2018 182Table 62: R788 - Drug profile, 2009 183Table 63: R788 versus comparator therapy Enbrel in rheumatoid arthritis, minimum acceptable product profile and target productprofile, 2009 193Table 64: R788: sales forecasts in the seven major markets ($m), 2009-2018 195Table 65: Masitinib (AB1010): Summary of efficacy outcomes at week 12 with subgroup analysis according to previous treatmentfailure, 2009 197Table 66: ARRY162: clinical trial efficacy results(ARRAY-162-201) - ACR20 scores at week 12 across geographic regions, 2009 198Table 67: ARRY162: clinical trial safety results ARRAY-162-201) - most common adverse events, 2009 199Table 68: GW856553: Completed Phase II trials in rheumatoid arthritis, 2008 202Table 69: SCIO469s Phase II trial results in rheumatoid arthritis, 2008 208Table 70: Key products in the late-stage R&D pipeline for Others for rheumatoid arthritis, 2009 210Table 71: 4SC-101: Phase IIa clinical trial data in rheumatoid arthritis patients who previously failed treatment with DMARDs, 2007Pipeline Insight: Disease Modification in Rheumatoid Arthritis - New drug targets compete in crowded market Page 10/15
  • 11. Find Industry reports, Company profilesReportLinker and Market Statistics213Table 72: Key early-stage products in the R&D pipeline for Others, 2009 220Table 73: Early-stage candidates targeting granulocyte-macrophage colony stimulating factor in development for rheumatoid arthritis,2009 225Table 74: NF-kappaB inhibitors in early-stage development for rheumatoid arthritis, 2009 226Table 75: Chemokine receptor antagonists in early-stage development for rheumatoid arthritis, 2009 227Table 76: Datamonitor drug assessment parameters 252List of FiguresFigure 1: Rheumatoid arthritis pipeline split by highest development phase and drug class, 2009 11Figure 2: Datamonitors pipeline assessment summary for rheumatoid arthritis, 2009 13Figure 3: Rheumatoid arthritis pipeline split by formulation, and type of molecule for oral products, 2009 17Figure 4: Datamonitors strategy for switching between intravenous and subcutaneous formulations in rheumatoid arthritis, 2009 18Figure 5: Datamonitors methodology for calculating rheumatoid arthritis specific sales from IMS total brand sales and volume data 23Figure 6: Datamonitors estimated number of rheumatoid arthritis patients receiving biologic therapy as anti-TNFs or alternativemechanisms in the seven major markets, 2007-2017 25Figure 7: Classification of juvenile idiopathic arthritis (JIA), 2009 26Figure 8: Age-adjusted incidence of rheumatoid arthritis in Rochester, Minnesota, 1955-2005 28Figure 9: Top 5 Rest of World countries with highest prevalent populations of rheumatoid arthritis, 2009-2019 35Figure 10: Rheumatoid arthritis-specific sales in the seven major markets, split by region ($ billion), 2004-08 41Figure 11: Rheumatoid arthritis-specific sales in the seven major markets, split by drug class ($ billion), 2004-08 42Figure 12: Performance of the top 10 brands/molecules and All Others in the seven major rheumatoid arthritis markets, 2004-08 43Figure 13: Key unmet needs in rheumatoid arthritis, 2009 44Figure 14: Orencia versus Humira head-to-head clinical trial design in rheumatoid arthritis (RA), 2009 58Figure 15: EULAR response criteria as defined by DAS28 62Figure 16: Datamonitor drug assessment summary for tumor necrosis factor (TNF) inhibitors in development for rheumatoid arthritis,2009 66Figure 17: Simponi (golimumab): GO-FORWARD: Clinical trial design and results at week 14 in rheumatoid arthritis (RA), 2008 69Figure 18: Simponi (golimumab): GO-BEFORE: Clinical trial design and results at week 24 in rheumatoid arthritis (RA), 2008 70Figure 19: Simponi (golimumab): GO-AFTER: Clinical trial design and results at week 14 in rheumatoid arthritis, 2008 71Figure 20: Simponi (golimumab): Phase III study design for intravenous dose in rheumatoid arthritis, 2009 73Figure 21: Simponi SWOT analysis, 2009 76Figure 22: Datamonitors competitive positioning analysis of Simponi (golimumab), 2009 77Figure 23: Cimzia (certolizumab): UCBs RAPID 1 trial in rheumatoid arthritis patients who failed methotrexate therapy, 2008 84Figure 24: Cimzia (certolizumab): UCBs RAPID 2 trial in rheumatoid arthritis patients who failed methotrexate therapy, 2009 85Figure 25: Cimzia (certolizumab): UCBs FAST4WARD trial as a monotherapy in rheumatoid arthritis patients who failed DMARDtherapy, 2009 86Figure 26: Cimzia SWOT analysis, 2009 87Figure 27: Datamonitors competitive positioning analysis of Cimzia (certolizumab), 2009 88Figure 28: ART621: Phase II clinical trial design in rheumatoid arthritis dose optimization study, 2009 93Figure 29: ART621: Phase II clinical trial design in rheumatoid arthritis dose ranging study, 2009 94Figure 30: Datamonitor drug assessment summary for B cell targets in development for rheumatoid arthritis, 2009 99Figure 31: Ocrelizumab: efficacy data from Phase II ACTION trial in rheumatoid arthritis, 2007 102Figure 32: Ocrelizumab: Phase III trial in Japanese rheumatoid arthritis patients who have failed therapy with anti-TNFs, 2009 104Figure 33: Ocrelizumab: Phase II trial in Japanese rheumatoid arthritis patients, 2009 105Figure 34: Ocrelizumab: SWOT analysis, 2009 106Figure 35: Datamonitors competitive positioning analysis of ocrelizumab, 2009 107Figure 36: Arzerra (ofatumumab): week 24 ACR scores in DMARD-failure rheumatoid arthritis patients, 2007 115Figure 37: Arzerra (ofatumumab): SWOT analysis, 2009 116Figure 38: Datamonitors competitive positioning analysis of Arzerra (ofatumumab), 2009 117Figure 39: Benlysta (belimumab): LBRA01 Phase II clinical trial design and summary of results for rheumatoid arthritis, 2005 124Pipeline Insight: Disease Modification in Rheumatoid Arthritis - New drug targets compete in crowded market Page 11/15
  • 12. Find Industry reports, Company profilesReportLinker and Market StatisticsFigure 40: TRU-015: Phase IIb Study Two clinical trial design for rheumatoid arthritis, 2009 125Figure 41: TRU-015: Phase IIb Study One clinical trial design summary and trial results for rheumatoid arthritis 126Figure 42: TRU-015: Phase IIb Study One - open label retreatment data with 800mg TRU-015 for rheumatoid arthritis 127Figure 43: LY2127399 (IV): trial design and results of first Phase II study (H9B-MC-BCDF) in rheumatoid arthritis, 2008 128Figure 44: LY2127399 (IV): trial design of Phase II study (H9B-MC-BCDG) in TNF-failure rheumatoid arthritis patients, 2009 129Figure 45: LY2127399 (SC): trial design of Phase II study (H9B-MC-BCDH) in patients with rheumatoid arthritis despite ongoingmethotrexate, 2009 130Figure 46: Actemra (tocilizumab): OPTION study design and results in rheumatoid arthritis, 2008 136Figure 47: Actemra (tocilizumab): TOWARD study design and results in rheumatoid arthritis, 2008 137Figure 48: Actemra (tocilizumab): RADIATE study design and results in rheumatoid arthritis, 2008 138Figure 49: Actemra (tocilizumab): AMBITION study design and results in rheumatoid arthritis, 2009 139Figure 50: Actemra (tocilizumab): LITHE study design and results in rheumatoid arthritis, 2008 140Figure 51: Actemra/RoActemra SWOT analysis, 2009 141Figure 52: Datamonitors competitive positioning analysis of Actemra (tocilizumab), 2009 142Figure 53: Canakinumab (ACZ885): Phase I/II clinical trial design and trial data for in rheumatoid arthritis, 2008 150Figure 54: Denosumab (AMG162): Phase II trial design for rheumatoid arthritis, 2008 153Figure 55: AMG108: Phase II clinical trial design and efficacy data in rheumatoid arthritis patients, 2009 155Figure 56: LY2439821: Phase II clinical trial design and efficacy data in rheumatoid arthritis, 2009 157Figure 57: ALD518: Clinical trial design of Phase II study in rheumatoid arthritis, 2009 160Figure 58: AZD5672: clinical trial design of Phase IIb proof-of-concept study of in rheumatoid arthritis, 2009 161Figure 59: Datamonitor drug assessment summary for kinase inhibitors in development for rheumatoid arthritis, 2009 165Figure 60: CP-690,550: Phase II (A3921039) trial of four doses, in combination with methotrexate, in Japanese rheumatoid arthritispatients with an inadequate response to methotrexate, 2009 171Figure 61: CP-690,550: 12-week interim data from Phase II (A3921035) trial in rheumatoid arthritis patients with an inadequateresponse to DMARDs, 2009 172Figure 62: CP-690,550:: SWOT analysis, 2009 174Figure 63: Datamonitors competitive positioning analysis of CP-690,550, 2009 175Figure 64: R788: TASKi3 Phase IIb clinical trial design and key results in rheumatoid arthritis, 2009 185Figure 65: R788: Time course for the ACR20 response for R788 and placebo in the TASKi3 trial in rheumatoid arthritis, 2009 186Figure 66: R788: TASKi2 Phase IIb clinical trial design and summary of results in rheumatoid arthritis, 2009 187Figure 67: R788: TASKi1 Phase IIa clinical trial design and summary of results in rheumatoid arthritis, 2008 188Figure 68: R788 SWOT analysis, 2009 189Figure 69: Datamonitors competitive positioning analysis of R788, 2009 190Figure 70: Masitinib (AB1010): Design of the ongoing Phase II (AB06010) trial in rheumatoid arthritis, 2009 196Figure 71: Masitinib (AB1010): Design of the completed Phase IIa (AB04012) trial in rheumatoid arthritis, 2006 196Figure 72: ARRY162: Phase II clinical trial (ARRAY-162-201) design in rheumatoid arthritis, 2009 198Figure 73: BMS-582949: Phase II clinical trial design in rheumatoid arthritis, 2009 200Figure 74: BMS-582949: Phase I trial design and results highlights, 2008 201Figure 75: INCB18424: Phase IIa clinical trial design in rheumatoid arthritis, 2008 203Figure 76: INCB28050: Phase II clinical trial design in rheumatoid arthritis, 2009 204Figure 77: PH797804: Phase II trial as a monotherapy in rheumatoid arthritis patients who failed DMARDs, 2008 205Figure 78: PH797804: Phase II trial (A6631005) as a combination therapy with methotrexate in rheumatoid arthritis, 2008 206Figure 79: VX702: Clinical trial design summary for Phase II trials in rheumatoid arthritis, 2009 207Figure 80: dnaJp1: Phase II clinical trial design for in rheumatoid arthritis, 2007 212Figure 81: CH1504: Phase II trial design showing efficacy and safety results in rheumatoid arthritis, 2009 214Figure 82: Tranilast: Nuon Therapeutics Phase II trial in combination with methotrexate in rheumatoid arthritis, 2009 215Figure 83: MM093: Phase II clinical trial design in rheumatoid arthritis, 2008 216Figure 84: RWJ-445380: Phase IIa clinical trial in active rheumatoid arthritis patients despite methotrexate, 2008 217Figure 85: LX-2931 (LX-3305): Phase II trial in rheumatoid arthritis, 2009 218Figure 86: TAK783: Phase II clinical trial design in rheumatoid arthritis, 2009 220Pipeline Insight: Disease Modification in Rheumatoid Arthritis - New drug targets compete in crowded market Page 12/15
  • 13. Find Industry reports, Company profilesReportLinker and Market StatisticsFigure 87: Early-stage projects, split by drug class, in development for rheumatoid arthritis, 2009 222Figure 88: Early phase kinase inhibitors in development for rheumatoid arthritis split by target, 2009 223Figure 89: Role of macrophages in model of rheumatoid arthritis pathogenesis 224Pipeline Insight: Disease Modification in Rheumatoid Arthritis - New drug targets compete in crowded market Page 13/15
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