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- FDA' s recommendations for SLE drug development remain as draft guidance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
- 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
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