Psoriasis - Anti-TNF's lead another indication
Scope
Report Highlights
Reasons to Purchase
Table of Contents
- ABOUT DATAMONITOR HEALTHCARE - page 2
- About the Immune Disorders and Inflammation (IDI) pharmaceutical analysis team - page 2
- CHAPTER 1 EXECUTIVE SUMMARY - page 3
- Objective of the analysis - page 3
- Datamonitor insight into the psoriasis market - page 3
- CHAPTER 2 MARKET DEFINITION AND OVERVIEW - page 14
- Strategic scoping and focus - page 14
- Current market situation - page 14
- Abbott's top-line driven by Humira's expansion into additional indications - page 19
- Psoriasis definition for this report - page 20
- Psoriasis ICD10 definition - page 21
- Current treatment and brands included in forecast definition - page 21
- Biologics - page 22
- Corticosteroids - page 24
- Vitamin derivatives - page 24
- Vitamin D analogue Dovenex dominates but patent expiry looms - page 24
- Retinoids or vitamin A derivatives also provide a steroid alternative - page 25
- Immunosuppressants - page 25
- Other topical treatments - page 25
- Unmet needs and treatment challenges - page 26
- In a market driven by product switching, long-term efficacy and safety is elusive - page 26
- Efficacy is the key prescribing influence according to Datamonitor survey - page 26
- Flaring nature of psoriasis and rebound caused by some therapies make this disease difficult to deal with - page 27
- The PASI score is the most often used but is it the best primary endpoint? - page 28
- PASI definition - page 28
- PASI not used in everyday practice - page 29
- Trials for combinations needed to reflect the 'real life' use of psoriasis therapies - page 31
- In a market driven by product switching, long-term efficacy and safety is elusive - page 26
- CHAPTER 3 EPIDEMIOLOGY AND PATIENT NUMBERS - page 32
- Psoriasis definitions and diagnostics - page 32
- Diagnostic criteria - page 33
- Numerous measures of disease severity and quality of life are used for psoriasis, but the PASI is currently the most common in trials - page 34
- Diagnostic criteria - page 33
- Epidemiology of psoriasis - page 36
- US - page 37
- Japan - page 37
- Europe - page 37
- France - page 38
- Germany - page 38
- Italy - page 39
- Spain - page 39
- UK - page 39
- Psoriasis definitions and diagnostics - page 32
- CHAPTER 4 FORECAST ANALYSIS OF MARKETED PRODUCTS - page 40
- Regulatory action - page 40
- NICE appraisal for Enbrel and Raptiva is limiting but positive - page 40
- Topical immunomodulator cancer warning - page 42
- Elidel and Protopic hit by cancer warnings in US - page 42
- Brand specific events - page 44
- Amgen/Wyeth plans numerous post-market trials for Enbrel (etanercept) to compete with pipeline launches - page 44
- Numerous Phase IV clinical trials in psoriatic disorders show Amgen/Wyeths attempts to persuade physicians not to switch to Remicade or Humira - page 47
- Amevive (alefacept) brought by Astellas and launch in Japan predicted - page 48
- Astellas' ASAP and AWARE programs increase confidence in Amevive's new marketing partnership - page 50
- Raptiva (efalizumab) moves down the treatment algorithm - page 51
- Company reported versus IMS variation in sales for Raptiva - page 52
- Humira easy injection - page 54
- Dovobet launches in the US - page 54
- Amgen/Wyeth plans numerous post-market trials for Enbrel (etanercept) to compete with pipeline launches - page 44
- Patent expiry - page 56
- Dovonex patent expiry - page 56
- Zorac patent expiry - page 59
- Elocon continued generic erosion - page 61
- US shows high generic erosion but EU yet to be impacted - page 61
- Data definitions, limitations and assumptions - page 62
- Derivation of Sales Forecasts and Pricing Trends - page 62
- Dosing assumptions - page 63
- Pricing assumptions and analysis - page 64
- Standard Units - page 64
- Japanese Market Data - page 65
- Derivation of Sales Forecasts and Pricing Trends - page 62
- Forecast methodology - page 65
- Regulatory action - page 40
- CHAPTER 5 LATE STAGE PIPELINE - page 66
- Key classes in the pipeline - page 66
- Delivery methods - page 67
- Phase III and Pre-registration pipeline candidates - page 68
- Phase II - page 69
- Phase I - page 72
- Pipeline company and clinical overview - page 74
- Forecast launch dates - page 78
- Remicade - page 79
- Forecast and assumptions - page 80
- Marketing and patient potential - page 81
- Current maintenance data shows a fall in efficacy over time possibly due to infliximab antibody formation - page 81
- Future trials will add value but competition is high - page 82
- Clinical trial overview - page 82
- Earlier psoriatic arthritis studies show a similar response - page 84
- Humira - page 84
- Forecast and assumptions - page 85
- Patient and marketing potential - page 87
- New manufacturing plant will allow for expected expansion of total brand - page 87
- Off label use is anticipated to be a predictor of good uptake - page 87
- Overview of clinical trials - page 88
- CHAMPION study data presented in October 2006 - page 88
- Efficacy in psoriatic arthritis demonstrated in 2005 - page 90
- ISA247 - page 90
- Forecast and assumptions - page 91
- Price premium expected if side-effect advantage proven - page 91
- Patient and marketing potential - page 92
- Nephrotoxicity key side-effect to watch out for - page 92
- ISA247 is a good "in license" candidate - page 93
- Clinical trial overview - page 94
- Forecast and assumptions - page 91
- CNTO-1275 - page 96
- Forecast and assumptions - page 97
- Patient and marketing potential - page 97
- CNTO-1275 dosing regime promising in some and niches opportunities exist - page 97
- Centocor's patient assistance program and biologic experience will help - page 98
- Clinical trial overview - page 98
- Phase II data presented at the 2006 AAD meeting - page 98
- BG-12 (dimethyl fumerate) - page 100
- Forecast and assumptions - page 101
- Patient and marketing potential - page 102
- Comparison with existing Fumaderm - page 103
- Clinical trial overview - page 104
- Cimzia (certolizumab pegol) - page 105
- Forecast and assumptions - page 106
- Patient and market potential - page 108
- Less favorable dosing regime in psoriasis trial - page 109
- Clinical trial overview - page 109
- Other pipeline products - page 111
- ABT-874 - page 111
- Psoraxine - page 111
- AVT-02 - page 112
- Asord (becocalcidol) - page 112
- CC-10004 - page 113
- MM-093 - page 114
- Recently discontinued - page 114
- Onercept - page 114
- Key classes in the pipeline - page 66
- CHAPTER 6 COMMERCIAL IMPACT AND LIFECYCLE MANAGEMENT: CASE STUDIES - page 116
- Introduction - page 116
- Case study one: Psoriatic arthritis - page 116
- Epidemiology studies show psoriasis to be much more common than psoriatic arthritis - page 117
- Impact on Enbrel's sales of approvals in psoriasis and psoriatic arthritis - page 118
- The US shows clear correlation between uptake in psoriasis and psoriatic arthritis - page 119
- Psoriasis definition includes arthropathic arthritis in Datamonitor's forecast - page 121
- Case study two: Patient segmentation and product differentiation in the psoriasis market - page 122
- Mild patients treated by primary care physicians using topical therapies is a large but difficult to capture segment - page 122
- Remicade used in patients requiring fast efficacy - page 123
- Enbrel and Humira used in less severe more independent patients - page 125
- How will novel mechanisms distinguish themselves in the market? - page 126
- APPENDIX A - MARKET DATA AND MAJOR BRAND KEY FACTS - page 128
- Summary psoriasis market data - page 128
- Biologics market data - page 129
- Topical treatments - page 134
- Immunosuppressant key brands - page 136
- APPENDIX B - MARKET FORECAST DATA - page 137
- US Forecast - page 137
- Five major European countries forecast - page 139
- Japanese forecast - page 141
- BIBLIOGRAPHY - page 142
- Opinion Leaders - page 146
- Report methodology - page 147
- About Datamonitor - page 148
- About Datamonitor Healthcare - page 148
- About the IDI analysis team - page 149
- Disclaimer - page 150
- List of Tables
- Table 1: Key players in the psoriasis market - page 16
- Table 2: Overview of common treatment classes - page 22
- Table 3: Features that have been considered in different classifications of psoriasis - page 33
- Table 4: Measures of disease severity and quality of life - page 35
- Table 5: Psoriasis prevalence in the seven major markets, 2006 - page 36
- Table 6: Raptiva forecast for psoriasis indication, 2005-2015, $m - page 53
- Table 7: US price for Dovobet - page 55
- Table 8: Marketing agreements for Dovonex - page 57
- Table 9: Estimation of Standard units per month for key brands - page 63
- Table 10: Clinical pipeline delivery methods - page 67
- Table 11: Phase III and Pre-registration psoriasis pipeline candidates, 2006 - page 68
- Table 12: Phase II psoriasis pipeline candidates, 2006 - page 69
- Table 13: Phase I psoriasis pipeline candidates, 2006 - page 72
- Table 14: Company assessment factors - page 75
- Table 15: Clinical assessment factors - page 76
- Table 16: Efficacy comparison of key systemic psoriasis therapies - page 77
- Table 17: Estimated launch dates across the three major markets - page 78
- Table 18: Remicade forecast for psoriatic conditions, $, 000s - page 81
- Table 19: Humira sales in psoriatic conditions, $, 000s - page 86
- Table 20: ISA247 forecast for psoriasis, $, 000s - page 92
- Table 21: CNTO-1275 forecast in psoriasis, $, 000s - page 97
- Table 22: BG-12 forecast in the psoriasis indication, $, 000s - page 102
- Table 23: Expected launches for Cimzia in autoimmune indications - page 107
- Table 24: Cimzia forecast for psoriatic conditions, $, 000s - page 107
- Table 25: Autoimmune prevalence studies - page 118
- Table 26: Summary market data - page 128
- Table 27: Enbrel: key facts - page 129
- Table 28: Remicade: key facts - page 130
- Table 29: Humira: key facts - page 131
- Table 30: Amevive: key facts - page 132
- Table 31: Raptiva: key facts - page 133
- Table 32: Dovonex: key facts - page 134
- Table 33: Elocon: key facts - page 135
- Table 34: Neoral/Sandimmun: key facts - page 136
- Table 35: Forecasts for psoriasis in the US to 2015 ($m) - page 137
- Table 36: Forecasts for psoriasis in the M5EU to 2015 ($m) - page 139
- Table 37: Forecasts for psoriasis in Japan to 2015 ($m) - page 141
- List of Figures
- Figure 1: Performance of the US, 5 major EU combined and Japanese OA markets from 2004-2005 - page 15
- Figure 2: Sales for psoriatic conditions in the seven major markets, $m, 2005 - page 16
- Figure 3: Performance of top ten brands in psoriatic conditions in the seven major markets, 2004-2005 - page 18
- Figure 4: Growth drivers and resistors by product, 2005-11 - page 20
- Figure 5: Mechanisms for biologic therapies in psoriasis - page 23
- Figure 6: Factors influencing physician decisions, by drug class - page 26
- Figure 7: Percentage of physicians using the PASI score - page 29
- Figure 8: Effect of cancer warning on Protopic and Elidel sales, including off-label psoriasis use - page 43
- Figure 9: Enbrel forecast for psoriatic conditions, 2005-2015, $m - page 45
- Figure 10: Amevive forecast in psoriasis, 2005-2015, $m - page 50
- Figure 11: Raptiva heavily impacted by biologic launches in the next six years - page 52
- Figure 12: The Humira pen injection device - page 54
- Figure 13: Dovobet launch in US and contrasting sales in five major EU markets, 2005 -2015 - page 56
- Figure 14: Forecast impact of Dovonex patent expiry, 2005-2015, $m - page 59
- Figure 15: Zorac forecast patent expiry, 2005-2015, $m - page 60
- Figure 16: Elocon generic erosion in the US and EU, $m - page 62
- Figure 17: Overview of key pipeline mechanisms - page 66
- Figure 18: Company and clinical scores - page 74
- Figure 19: Remicade comparative clinical and company scores - page 79
- Figure 20: Humira comparative clinical and company scores - page 85
- Figure 21: Preliminary results of Humira's Phase III study in psoriasis - page 88
- Figure 22: Phase II Humira results, 12 to 60 weeks - page 89
- Figure 23: ISA247 comparative clinical and company scores - page 91
- Figure 24: Results of 24 week Phase III clinical trial of ISA247 in moderate to severe plaque psoriasis patients - page 95
- Figure 25: CNTO-1275 comparative clinical and company scores - page 96
- Figure 26: BG-12 comparative clinical and company scores - page 100
- Figure 27: Cimzia comparative clinical and company scores - page 106
- Figure 28: Preliminary results of Cimzia's Phase II trial in psoriasis at week 12 - page 110
- Figure 29: Enbrel prescriptions for psoriasis and psoriatic arthritis, US, 2002-2005 - page 119
- Figure 30: Enbrel prescriptions for psoriasis and psoriatic arthritis, EU, 2002-2005 - page 120
- Figure 31: Breakdown of physician-managed psoriasis population by disease severity in the seven major markets, 2004 - page 122
- Figure 32: Remicade brand perception and awareness - page 124
- Figure 33: Enbrel brand perception and awareness - page 125
- Figure 34: Raptiva mechanism explanation - page 126
- Figure 35: Example of clear explanation of a complex mechanism for novel biologic therapy in autoimmune disease - page 127
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