Commercial Insight: Disease Modification in Rheumatoid Arthritis - Market awaits game changing therapies and strategies

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1 Brochure More information from Commercial Insight: Disease Modification in Rheumatoid Arthritis - Market awaits game changing therapies and strategies Description: In 2009, TNF inhibitors were the dominant drug class in terms of sales. However, there is growing use of non -TNF biologics at earlier lines of treatment, and this trend will continue over the next decade. With the first Phase III data from tasocitinib (CP-690,550; Pfizer) reaffirming efficacy with no new safety signals, novel oral small molecules could revolutionize the treatment of RA.Gain insight into the RA market potential utilizing robust 10-year IMS- and patient-based forecasts, enabling commercial opportunity assessment Scope of the report: - Assess the future competitive landscape, with in-depth profiles of the leading marketed biologics - Evaluate future patient numbers and brand dynamics by line of therapy - Enhance understanding of future product potential, with key opinion leader views of late stage agents in the pipeline, such as tasocitinib and FosD New product launches, brand reformulations and further biologic uptake will grow the RA market to over $13bn in Using a patient-based approach, Datamonitor speculates that the RA market for biologics will double from 2009 to reach over 1million patients in 2019, translating to a value that could surpass $15bn.Datamonitor anticipates non-tnf biologics will be used more frequently at earlier lines of therapy. Bristol-Myers Squibb and Roche, which market Orencia (abatacept) and Actemra (tocilizumab), respectively, are attempting to change the game, with subcutaneous formulations and head-to-head studies against Humira (adalimumab; Abbott, Eisai).Tasocitinib (CP-690,550; Pfizer) demonstrated efficacy with no new safety signals in its first set of Phase III data. Despite ongoing debate over annual cost and positioning, rheumatologists believe tasocitinib has the potential to be a paradigm changing drug, and will achieve blockbuster status in the forecast period, reaching $1.3bn by 2019.What is the anticipated uptake of Cimzia (certolizumab) and Simponi (golimumab) and can these displace sales of the entrenched TNF brands? Key questions answered: - How will first-, second-, third- and fourth-line and above biologic brand dynamics change in the RA market across the 10-year forecast period? - What is the potential market impact from Pfizer s tasocitinib, how will it be priced and how will rheumatologists position the novel small molecule? - What impact will subcutaneous Orencia and Actemra have, and will these formulations help to propel non- TNFs further up the treatment algorithm? - Who were the top company players in the rheumatoid arthritis market in 2009 and how will the landscape change to 2019? Contents: Executive Summary Strategic scoping and focus Datamonitor insight into the rheumatoid arthritis market Related reports OVERVIEW Catalyst Summary MARKET DEFINITION Market definition for this report A7E0 intestinal anti-inflammatory drugs L1B0 antimetabolites L1X3 antineoplastic MAbs L4A0 immunosuppressive agents M1C0 specific antirheumatic agents ICD-10 codes used to define the rheumatoid arthritis market MARKET OVERVIEW

2 Seven major markets Current and future market overview US Japan Five major European markets France Germany Italy Spain UK Rest of the world snapshot Current market assessment Brand Dynamics Overview of competitive landscape Leading marketed products for rheumatoid arthritis 2010 pipeline update Pipeline overview Summary of discontinued products B-cell therapies dropped from late-stage clinical developmentrituxan/mabthera (rituximab) remains the only B-cell targeted therapy available for the treatment of rheumatoid arthritis. With two notable pipeline candidates dropped from late-stage clinical development during the course of 2010, coupled with the increased competition among biologics players and future market landscape and new entrants, Datamonitor questions the clinical and commercial need for additional B-cell/CD20 targeted therapies. GlaxoSmithKline and Genmab recently announced that they were to cease development of the intravenous formulation of Arzerra (ofatumumab) in rheumatoid arthritis, but would instead focus on a subcutaneous (SC) formulation for multiple sclerosis and autoimmune indications. However, the companies have not yet formally announced their intentions to proceed with SC Arzerra in rheumatoid arthritis, with development in this indication under review. Ocrelizumab (Genentech/Roche, Biogen Idec)Genentech, with its partners Biogen Idec, Roche, and Chugai, was developing ocrelizumab, a second-generation fully human anti-cd20 monoclonal antibody for the potential treatment of rheumatoid arthritis. However, the companies announced in May 2010 that they would cease development of the drug in rheumatoid arthritis ( TRU-015 (Pfizer, Trubion) Patient acquisition process Introduction Patient care path Drivers of brand choice Disease modification remains the most important driver of brand choice US formulary tier status for leading brandstier status in Trends in marketing strategies Marketing strategy for leading brands Marketing messages from ACR 2010Datamonitor attended the American College of Rheumatology (ACR) Scientific Meeting 2010, in Atlanta. Tumor necrosis factor inhibitors Enbrel (etanercept; Amgen/Pfizer/Takeda) Remicade (infliximab; Centocor Ortho Biotech/Johnson & Johnson/Merck & Co./Mitsubishi Tanabe)Drug profile Humira (adalimumab; Abbott/Eisai)Drug profile Cimzia (certolizumab; UCB/Otsuka Pharmaceuticals)Drug profile Simponi (golimumab; Centocor Ortho Biotech/Merck & Co./Mitsubishi Tanabe/Janssen Pharmaceuticals)Drug profile

3 Other mechanisms Actemra/RoActemra, IV and SC (tocilizumab; Chugai/Roche) Rituxan/MabThera (rituximab; Genentech/Biogen Idec/Roche/Chugai)Drug profile Orencia, IV and SC (abatacept; Bristol-Myers Squibb)Drug profile Select pipeline drugs Tasocitinib (CP-690,550; Pfizer) FosD (fostamatinib disodium R788; AstraZeneca/Rigel Pharmaceuticals) Arzerra (ofatumumab; Genmab/GlaxoSmithKline) KEY DEVELOPERS Strategic overview Trends in corporate strategy Subcutaneous and intravenous formulations Genmab and GlaxoSmithKline decide to focus on subcutaneous Arzerra Recent strategic partnerships/deals Increased licensing activity over the past 12 months Pfizer Corporate strategy Rheumatoid arthritis portfolio assessment Roche/Genentech Corporate strategy Rheumatoid arthritis portfolio assessment Bristol-Myers Squibb Corporate strategy Rheumatoid arthritis portfolio assessment Novartis Novartis plans AIN457 Phase III trials in 2011, despite not meeting primary endpoint at Phase IIb CASE STUDIES Case study: patient-based model for biologics in rheumatoid arthritis, 2009 Introduction Rheumatoid arthritis biologics market set to exceed 1 million patients by Forecast methodology: overview BIBLIOGRAPHY Market definition Market overview Websites Other Brand dynamics Websites Other Key developers Websites Case studies APPENDIX A MARKET ASSUMPTIONS Forecasting assumptions New product launches Pricing Data definitions, limitations and assumptions Standard Units Derivation of sales forecasts and pricing trends Exchange rates Country group definitions Derivation of sales forecasts and pricing trends Forecast methodology APPENDIX B

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