Stakeholder Opinions: Systemic Lupus Erythematosus - Market set to enter era of biologic therapies

Table of Contents

• ABOUT DATAMONITOR HEALTHCARE
  • About the Immunology and Inflammation (I&I) pharmaceutical analysis team
• CHAPTER 1 EXECUTIVE SUMMARY
  • Datamonitor insight into the systemic lupus erythematosus market
  • Contributing experts
  • Related reports
  • Upcoming reports
• CHAPTER 2 EPIDEMIOLOGY
  • Lupus affects less than 1% of the population in the seven major markets
  • US
    • Datamonitor estimates a conservative SLE patient population in the US
    • Prevalence of lupus in Canada is similar to the US
    • Race and ethnic segmentation influence SLE in the US
      • Race is an important mediator of disease activity in SLE
      • Estimated SLE prevalent population in the US can be split by race
  • Japan
  • EU
    • UK
      • Lupus population split by sex in the UK
      • Lupus population split by race in the UK
    • UK prevalence rates can be applied to Germany
    • Prevalence rates from Spain can be applied to France
    • Italy
      • Lupus population split by sex in Italy
    • Spain
      • Lupus population split by sex in Spain
  • The SLE prevalent population will experience minimal growth over the next decade in the seven major markets
  • Countries of emerging markets represent a large SLE patient population
• CHAPTER 3 SLE MARKET
  • Drug approvals
    • Prograf (tacrolimus) approved for lupus nephritis in Japan
  • Clinical trial design
    • FDA' s recommendations for SLE drug development remain as draft guidance
    • Key challenges in clinical trials for SLE
  • Global opportunities and threats
    • Opportunities
      • High demand for products and level of unmet need provide a significant opportunity in the SLE market
      • Steroid-sparing therapies with improved side-effect profiles are needed
      • Understanding pathogenesis of SLE will help drive drug development
      • Potential for early use of biologics exists in SLE
      • Significant patient population in the emerging markets
    • Threats
      • Comparatively smaller patient population in the seven major markets
      • Lack of clarity from regulatory agencies
      • Difficulty and/or delay in diagnosis
      • Cost to healthcare systems of expensive therapies
      • Potential threat from biosimilars
  • Estimation of the size of the off-label SLE market in 2007
    • Estimation of Rituxan/MabThera costs for the treatment of SLE
      • Cost of Rituxan/MabThera in the seven major markets
      • Size of the SLE population receiving off-label Rituxan/MabThera
    • Diagnosis Value to establish retail sales of key brands
• CHAPTER 4 PIPELINE DRUGS AND KEY TRIALS
  • Majority of pipeline drugs are being developed for SLE specifically
  • Promising drug candidates in Phase III development
  • Competitive landscape of the late-stage pipeline
    • Estimation of Phase III product launch dates
    • Commercial versus clinical attractiveness of late-stage products
  • Immunosuppressants
    • Prestara/Aslera (prasterone)
      • After two failed Phase III studies, Genelabs secures SPA
      • Strong competition from targeted therapies drives Genelabs to search for late-stage development partner
      • Prestara: Strengths and weaknesses
    • Riquent (abetimus sodium)
      • La Jolla pushes on with another Phase III trial
      • Riquent: Strengths and weaknesses
  • B-cell therapy
    • Atacicept (TAC-Ig)
      • Phase Ib data confirm atacicept' s mechanism of action in SLE patients
      • Merck Serono partnership strengthens atacicept' s commercial potential
      • Atacicept has entered Phase II/III clinical trials for SLE and lupus nephritis
      • Atacicept: Strengths and weaknesses
    • Rituxan/MabThera (rituximab)
      • Rituxan is already prescribed off-label for SLE
      • Rituxan looks set to achieve first to market status
      • Small studies demonstrate efficacy of Rituxan in SLE
      • FDA raised safety concerns over the use of Rituxan in SLE patients
      • Rituxan/MabThera: Strengths and weaknesses
    • Ocrelizumab
      • Second generation humanized anti-CD20 MAb being developed for SLE
      • Potential for cannibalization of Rituxan/MabThera sales by ocrelizumab
      • Genentech and Biogen Idec embroiled in arbitration over ocrelizumab, which could affect its progress towards commercialization
      • Phase III clinical trials for ocrelizumab in SLE have been initiated
      • Ocrelizumab: Strengths and weaknesses
    • LymphoStat-B (belimumab)
      • Efficacy of belimumab has been demonstrated in Phase II trials by multiple disease activity indices in seropositive SLE patients
      • Phase III trials for belimumab
      • LymphoStat-B: Strengths and weaknesses
    • Epratuzumab
      • Phase III trials have resumed for SLE after regulatory agencies put clinical trials on hold
      • Epratuzumab: Strengths and weaknesses
  • Other cytokines suppression
    • Orencia (abatacept, CTLA4-Ig)
      • Orencia: Strengths and weaknesses
    • Actemra (tocilizumab)
    • Anti-TNF therapy: is there a place in the treatment of SLE?
      • Remicade (infliximab)
      • Enbrel (etanercept)
  • Recently discontinued drugs
    • CellCept (mycophenolate mofetil)
      • CellCept used off-label for systemic lupus erythematosus and is the standard of care in many patients
      • Development of CellCept for lupus nephritis on hold as trial fails to show superiority over Cytoxan
  • Drugs in development for cutaneous lupus erythematosus
    • CNTO-136
    • ASF-1096
    • TRX-1
• CHAPTER 5 BIBLIOGRAPHY
  • References
  • Websites
  • Datamonitor reports
• APPENDIX
  • Contributing experts
  • About Datamonitor
    • About Datamonitor Healthcare
    • Datamonitor Healthcare' s research and analysis methodologies
    • Datamonitor Healthcare' s therapy area capabilities
  • Disclaimer
  • List of Tables
    • Table 1: SLE population, split by sex, across the seven major markets, 2008
    • Table 2: Key prevalence and incidence studies of systemic lupus erythematosus, 1976-2008
    • Table 3: Estimate of persons with definite systemic lupus erythematosus in the US, split by race and sex, 2005
    • Table 4: Prevalence estimates of systemic lupus erythematosus in California and Pennsylvania, 2000
    • Table 5: Estimation of the systemic lupus erythematosus population in the US using prevalence figures reported by Chakravarty et al.
    • Table 6: Estimate of the systemic lupus erythematosus prevalent population in Canada, 2008
    • Table 7: Systemic lupus erythematosus prevalent population, split by race, in the US, 2008
    • Table 8: Systemic lupus erythematosus prevalent population, split by race, in the UK, 2008
    • Table 9: The estimated systemic lupus erythematosus prevalent population, split by sex, in the seven major markets, 2008-2018
    • Table 10: The estimated systemic lupus erythematosus prevalent population in the emerging markets of China, India and Mexico, 2008
    • Table 11: Phase III trial results for Prograf (tacrolimus) in lupus nephritis
    • Table 12: Cost of Rituxan/MabThera in the major 5EU markets and the US for the treatment of systemic lupus erythematosus
    • Table 13: Estimation of the off-label sales of Rituxan/MabThera in the treatment of systemic lupus erythematosus, 2008
    • Table 14: Datamonitor' s definition of systemic lupus erythematosus
    • Table 15: Estimated sales of the main drugs used in the treatment of systemic lupus erythematosus in the seven major markets, ($000s), 2007
    • Table 16: Products in development for lupus indications, 2008
    • Table 17: Summary of Phase III clinical trials for Prestara (prasterone), 1994-2004
    • Table 18: Overview of small-scale studies involving Rituxan/MabThera (rituximab) for lupus indications
    • Table 19: Overview of the Phase III clinical trial of ocrelizumab for systemic lupus erythematosus, 2008
    • Table 20: LymphoStat-B (belimumab): Key abstracts from ACR/ARHP Scientific Meetings 2006-07
    • Table 21: LymphoStat-B: Key clinical trials for lupus indications, 2008
    • Table 22: Orencia (abatacept): Key clinical trials for lupus indications, 2008
  • List of Figures
    • Figure 1: Potential strategies for improved clinical trial design or systemic lupus erythematosus
    • Figure 2: Opportunities and threats in the systemic lupus erythematosus market, 2008
    • Figure 3: Summary of the method used to estimate the sales of Rituxan/MabThera for systemic lupus erythematosus in the 6MM, 2008
    • Figure 4: Number of pipeline drugs in development split by lupus indication, 2008
    • Figure 5: Number of pipeline drugs in development for lupus erythematosus indications split by clinical phase, 2008
    • Figure 6: Timeline for estimated Phase III product launches for systemic lupus erythematosus, 2008-2016
    • Figure 7: Commercial and clinical assessment of key late-stage pipeline therapies for systemic lupus erythematosus, 2008
    • Figure 8: Prestara: Strengths and weaknesses for SLE, 2008
    • Figure 9: Riquent: Strengths and weaknesses for SLE, 2008
    • Figure 10: Atacicept: Strengths and weaknesses for SLE, 2008
    • Figure 11: Historical time line of approval of Rituxan for rheumatoid arthritis and estimation of approval timing for SLE indication
    • Figure 12: Rituxan/MabThera: Strengths and weaknesses for SLE, 2008
    • Figure 13: Ocrelizumab: Strengths and weaknesses for SLE, 2008
    • Figure 14: LymphoStat-B: Strengths and weaknesses for SLE, 2008
    • Figure 15: Epratuzumab: Strengths and weaknesses for SLE, 2008
    • Figure 16: Orencia: Strengths and weaknesses for SLE, 2008