Commercial Insight: Psoriasis - Intellectual property drives growth

Commercial Insight: Psoriasis - Intellectual property drives growth

Introduction

The launch of new brands in both biologic and topical treatments in 2009 is shaking up the psoriasis market. Stelara (ustekinumab; Johnson & Johnson) is eagerly anticipated by dermatologists, and Datamonitor forecast strong uptake. However, the threat of biosimilars looms over all biologic therapies.

Scope

*Analysis of the current and future market dynamics in psoriasis across the US, France, Germany, Italy, Spain the UK and Japan

*Assessment of biologic, vitamin derivative, topical corticosteroid and immunomodulator classes

*Psoriasis-specific forecast data for indication scrutiny, but total brand data also included to put sales in context for brand and company

*Scenario forecasts for go/no-go on biosimilar legislation and the impact of possible additional cost containment measures

Highlights

The biologics created $1.4 billion in psoriasis sales in 2008 across the seven major markets, contributing 55% of the $2.5billion psoriasis market. However, the economic downturn resulted in a plateau in biologic sales in psoriasis in 2008. Following a double digit CAGR over the last 4 years, it will slow to 3.4% from 2008 to 2018.

Leo Pharma's Dovobet (calcipotriol + betamethasone) brand dominates the topical class, reaching nearly $0.5billion over the next 10 years. Other molecules are attempting to break into this domain. Galderma's Vectical (calcitriol) launched in February 2009 in the US, but intellectual property challenges are predicted to dampen its potential.

The withdrawal of Genentech/Merck Serono's Raptiva (efalizumab) in Q1 2009 is predicted to benefit both Abbott's Humira (adalimumab) and Johnson & Johnson's Stelara (ustekinumab), but safety will be even more key to regulators now. Dermatologists are particularly eager to use Stelara, and peak psoriasis sales reach $600m in the seven major markets.

Reasons to Purchase

*Assess the impact of the economic downturn on psoriasis, which is vulnerable to cost-saving behavior compared to other autoimmune disorders

*Assess the impact of new brands on the market and consider the value to volume ratio for the key classes

*See how psoriasis contributes to total brand sales and company portfolios

ABOUT DATAMONITOR HEALTHCARE 2
About the Immunology & Inflammation therapy analysis team 2
CHAPTER 1 EXECUTIVE SUMMARY 3
Strategic scoping and focus 3
Datamonitor insight into the disease market 3
Related reports 5
Upcoming related reports 5
CHAPTER 2 MARKET DEFINITION 7
Market definition for this report 7
Biologic therapies 7
Systemic immunomodulators 7
Topical corticosteroids 8
Topical vitamin derivatives 8
Other 9
Indication split methodology 9
Diagnosis value based on retail data only 10
Country coverage 11
CHAPTER 3 MARKET OVERVIEW 12
Seven major markets 12
Current and future market overview 12
Biologic and topical vitamin derivative launches spurred psoriasis market growth in 2005-08 12
Seven major psoriasis market will grow from $2.5 billion in 2008 to $3.5 billion in 2018 18
Volume analysis shows topical therapies create the cornerstone of treatment 19
US 27
Current and future market assessment 27
US sales jumped between 2005 and 2007, but leveled off by 2007-08 27
US will continue to be the largest of the seven major markets for psoriasis 28
Opportunities and threats 33
Opportunities 33
Threats 34
Japan 36
Current and future market assessment 36
Japanese psoriasis market growth has been slowed by government price cuts 36
Biologics and vitamin derivatives will drive psoriasis sales in Japan in 2018 39
Opportunities and threats 41
Opportunities 41
Threats 41
Five major European markets (5EU) 44
Current and future market assessment 44
Opportunities and threats 50
Opportunities 50
Threats 50
European trends 52
Germany, Italy: topical vitamin derivative license expiries loom 52
UK: NICE guidance slows uptake of biologics for psoriasis 54
Rest of the world snapshot 56
Current market assessment 56
CHAPTER 4 BRAND DYNAMICS 60
Overview of competitive landscape 60
Patient acquisition process 62
Introduction 62
Patient care path 62
Points of influence in the patient care path 64
Initial therapy recommendation is a key point of influence in psoriasis 64
Topical treatment efficacy depends heavily on patient compliance 65
Specialists are more likely to initiate systemic therapy for psoriasis 66
Drivers of brand choice 67
Disease modification and long-term efficacy drive prescribing 67
Efficacy and safety are important to all classes 70
Perceived safety motivates topical vitamin derivative usage 72
Speed of action governs the prescribing decision for steroids 73
US pricing and reimbursement status for leading brands 74
Trends in marketing strategies 76
Marketing strategy for leading brands 76
Sponsorship/disease awareness campaigns 78
Direct-to-consumer advertising 79
Overview of biologics in psoriasis 81
The anti-TNF class dominates biological therapy for psoriasis 81
More data are required to elucidate biologics' long-term safety in psoriasis 82
Enbrel (etanercept; Amgen, Pfizer/Wyeth, Takeda) 85
Drug profile 85
Product positioning 86
Enbrel leads the market, but cost-driven prescribing may constrain its efficacy 86
Prescribers perceive Enbrel as a safer option in biological psoriasis therapy 89
First pediatric psoriasis indication stands to enhance Enbrel's position 90
In 2005, Enbrel overstepped its labeling in DTC advertising 91
Breaking news regarding continuous treatment and an autoinjector in Europe 92
SWOT analysis 95
Brand forecast to 2018 96
Humira (adalimumab; Abbott, Eisai) 97
Drug profile 98
Product positioning 99
Humira's efficacy in psoriasis has helped it gain a foothold quickly 99
Humira appears set to challenge Enbrel's lead in psoriasis 100
Humira's market share expands with additional country and pediatric approvals 101
In 2008, a Humira psoriasis journal advertisement hit a wrong note with the FDA 101
SWOT analysis 105
Brand forecast to 2018 106
Remicade (infliximab; Centocor Ortho Biotech, Merck/Schering-Plough and Mitsubishi Tanabe) 108
Drug profile 109
Product positioning 109
Remicade relies on a long history of use in diverse indications 109
Remicade defends its position at second/third-line 112
SWOT analysis 114
Brand forecast to 2018 116
Raptiva (efalizumab; Genentech, Merck Serono) 118
Drug profile 119
The aftermath of Raptiva's withdrawal 120
Raptiva was condemned on safety grounds 120
Humira is set to sweep share from Raptiva by virtue of its efficacy and dosing 121
Stelara (ustekinumab; Centocor Ortho Biotech, Janssen-Cilag) 123
Drug profile 124
Product positioning 124
Compared to Enbrel, Stelara shines in terms of efficacy 124
Dosing frequency distinguishes Stelara from marketed biologics 126
SWOT analysis 128
Brand forecast to 2018 130
Dovonex (calcipotriol; Leo Pharma, Warner Chilcott, Intendis Torii and Teikoku Medix) 131
Drug profile 132
Product positioning 133
Leo Pharma's response to generic competition has sparked controversy 133
Licensing agreements complicate Dovonex's market presence in Europe 134
SWOT analysis 135
Brand forecast to 2018 137
Dovobet (calcipotriol/betamethasone; Leo Pharma, Warner Chilcott, Intendis) 139
Drug profile 140
Product positioning 141
Dovobet is a reformulation with lifecycle management implications 141
SWOT analysis 142
Brand forecast to 2018 143
Silkis/Vectical (calcitriol; Galderma) 144
Drug profile 145
Product positioning 145
Silkis/Vectical marketing pushes brand as an "attachment to your regimen" in the US 145
Silkis US formulation patent will not defend the brand for long 150
SWOT analysis 150
Brand forecast to 2018 151
Additional brands 153
Olux/Olux-E (clobetasol; Stiefel/GlaxoSmithKline) 153
Olux brand proposition: patient preference for the VersaFoam vehicle 156
Olux/Olux-E Complete: competitive strategy in a combination pack 157
Brand forecast to 2018 160
Clobex (clobetasol propionate; Galderma) 161
The Clobex brand value proposition is based on innovation 162
Combining clobetasol and calcitriol in a novel formulation could drive success 163
Brand forecast to 2018 164
Soriatane/Neotigason (acitretin; Roche, Actavis, Stiefel/GlaxoSmithKline) 165
Patents expired but generics not launched, side effects continue to be limiting 166
Brand Forecasts to 2018 166
CHAPTER 5 KEY DEVELOPERS 168
Strategic overview 168
Recent strategic partnerships and deals 169
Pfizer and Wyeth 170
GlaxoSmithKline and Stiefel 171
Merck and Schering-Plough 171
Company strategies in psoriasis 173
Big Pharma-backed biologics create a competitive atmosphere, but psoriasis is not the top earner 173
Abbott 175
Amgen and Wyeth 176
Johnson & Johnson and Schering-Plough 177
Topical treatments employ a number of strategies to varying success 180
Leo Pharma's Dovobet shows profitability of fixed dose combinations 181
Ointment remains the most used formulation, but foams command a higher price 182
Prodrugs and molecular variations offer limited innovation 183
CHAPTER 6 CASE STUDIES 185
Potential impact of biosimilars in the US 185
Base case: biosimilar impact from 2014 186
Scenario A: price cuts to innovative biologics but no biosimilars in the next 10 years 188
Scenario B: 20% price cut and moratorium on price increases from 2014 with biosimilars launch in 2018 189
Scenario C: biosimilars launch in 2018, without interim action by US payers 191
BIBLIOGRAPHY 193
Journal papers 193
Others 195
Conference papers 195
Websites 195
Other sources 196
Datamonitor reports 197
APPENDIX A 198
Data definitions, limitations and assumptions 198
Standard units 198
Lining out of branded products in the forecast versus 'all others' 198
Diagnosis values for topical products 198
Assumptions regarding biosimilars 199
Derivation of sales forecasts and pricing trends 199
Forecast methodology 200
APPENDIX B 201
Contributing experts 201
Report methodology 201
About Datamonitor 202
About Datamonitor Healthcare 202
About the Disease analysis team 203
Disclaimer 204
List of Tables
Table 1: Dermatologist breakdown by region for IMS Prescribing Insights data, 2008 11
Table 2: Sales and growth of drug classes and brands for psoriasis in the seven major markets, 2008-2018 16
Table 3: Key events impacting the psoriasis market, 2009-2018 18
Table 4: Psoriasis volume and volume growth for the major drug classes for psoriasis in the seven major markets, 2008-2018 21
Table 5: Sales forecasts for psoriasis in the seven major markets ($m), 2008-2018 24
Table 6: Sales and growth of drug classes and brands for psoriasis in the US, 2008-2018 28
Table 7: Sales forecasts for psoriasis in the US ($m), 2008-2018 30
Table 8: Summary of opportunities and threats in the psoriasis market in the US, 2009 36
Table 9: Sales and growth of drug classes and brands for psoriasis in Japan, 2008-2018 37
Table 10: Sales forecasts for psoriasis in Japan ($m), 2008-2018 39
Table 11: Summary of opportunities and threats in the psoriasis market in Japan, 2009 44
Table 12: Sales and growth of drug classes and brands for psoriasis in the five major EU markets, 2008-2018 46
Table 13: Sales forecasts for psoriasis in the five major EU markets ($m), 2008-2018 48
Table 14: Summary of opportunities and threats for psoriasis in the five major European markets, 2009 51
Table 15: Comparison of leading branded drug sales ($m) for psoriasis in the seven major markets and the rest of the world (ROW), 2008 59
Table 16: Leading branded drug sales for psoriasis in the seven major markets, by class ($m), 2008-2018 61
Table 17: Dermatologists surveyed regarding psoriasis, 2008 68
Table 18: Comparison of PASI 50, -75 and -90 scores among the biologic brands 72
Table 19: Comparative importance of factors affecting dermatologists' prescribing decisions for topical vitamin derivatives by country, points out of 100, 2008 73
Table 20: Representative formulary tier status in the US for leading brands in psoriasis, 2009 75
Table 21: Marketing strategies employed by the companies behind the top two biologics for psoriasis, 2009 76
Table 22: Tuberculosis post-marketing data for TNF inhibitors (rheumatoid arthritis), 2008 84
Table 23: Enbrel - drug profile, 2009 86
Table 24: Comparative efficacy of Enbrel (etanercept) and Raptiva (efalizumab) in psoriasis, 2004 87
Table 25: Comparative cost per QALY of Enbrel (etanercept) and Raptiva (efalizumab) in psoriasis in the UK, 2004 88
Table 26: Humira (adalimumab) - drug profile, 2009 99
Table 27: Selected recent Humira (adalimumab) trials in psoriasis, 2009 104
Table 28: Remicade - drug profile, 2009 109
Table 29: Selected recent Remicade (infliximab) trials in psoriasis, 2009 113
Table 30: Raptiva (efalizumab) - drug profile, 2009 119
Table 31: Stelara (ustekinumab) - drug profile, 2009 124
Table 32: Projected pricing for Stelara (ustekinumab) based on relative pricing of Humira compared to Germany, 2009 ($/SU) 128
Table 33: Dovonex (calcipotriol) - drug profile, 2008 132
Table 34: Dovobet (calcipotriol/betamethasone) - drug profile, 2009 140
Table 35: Silkis/Vectical (calcitriol) - drug profile, 2009 145
Table 36: Olux (clobetasol) - drug profile, 2009 154
Table 37: Olux-E/Olux-E Complete (clobetasol) - drug profile, 2009 155
Table 38: Clobex (clobetasol propionate) - drug profile, 2009 161
Table 39: Soriatane/Neotigason (acitretin) - drug profile, 2009 165
Table 40: Leading companies in the seven major market for psoriasis-specific sales, 2008-2018 169
Table 41: Comparative price ($ per patient year) of topical treatments by formulation, 2008 183
Table 42: Potential scenarios for US biosimilar entry 186
Table 43: Base case forecast impact of biosimilars by country 187
List of Figures
Figure 1: Psoriasis sales by drug class in the seven major markets ($m), 2005-08 13
Figure 2: Key events impacting the psoriasis market, 2005-09 14
Figure 3: Psoriasis-specific value ($m) and volume (SU/dose/year) by class, 2008 and 2018 23
Figure 4: Psoriasis sales by drug class in the US ($m), 2005-08 28
Figure 5: Psoriasis sales by drug class in Japan ($m), 2005-08 37
Figure 6: Price per standard unit ($/SU) for Remicade (infliximab) in Japan, Q1 2007-Q2 2008 42
Figure 7: Psoriasis sales by drug class in the five major EU markets ($m), 2005-08 45
Figure 8: Effect of expiration of distribution agreement between Schering (now Intendis) and Leo Pharma on the Psorcutan Beta and Dovobet brands of calcipotriol/betamethasone topical combinations for psoriasis in Germany ($m), 2005-2018f 53
Figure 9: Effect of expiration of distribution agreement between Schering (now Intendis) and Leo Pharma on the Token (Psorcutan Beta) and Dovobet brands of calcipotriol/betamethasone topical combinations for psoriasis in Italy ($m), 2005-2018f 54
Figure 10: Psoriasis sales ($m) and growth of biologics in the five major EU markets, 2005-08 55
Figure 11: Global psoriasis sales breakdown, 2008 57
Figure 12: Annual estimated psoriasis sales outside the seven major markets, 2005-08 58
Figure 13: Psoriasis patient path 63
Figure 14: Mean non-pharmacological and pharmacological treatment rates in psoriasis across the seven major markets, 2008 65
Figure 15: Drivers of brand choice for psoriasis, 2009 69
Figure 16: Comparative importance of factors affecting dermatologist prescribing decisions by class across the seven major markets, 2008 71
Figure 17: Screenshot of Humira of patient assistance program targeting all patients 77
Figure 18: Screenshot of Enbrel patient assistance program targeting all patients 78
Figure 19: Screenshot of LeAnn Rimes' story, www.stophiding.org 79
Figure 20: Screenshot of advertising information, www.psoriasis.org 80
Figure 21: Biologics launch dates, by indication, across the seven major markets, 1998-2009 82
Figure 22: Enbrel (etanercept) SWOT analysis, 2009 95
Figure 23: Enbrel (etanercept) psoriasis sales by country across the seven major markets ($m), 2008-2018 96
Figure 24: Abbott Humira advertisement in American Academy of Dermatology Post-Meeting News, 2008 102
Figure 25: Humira (adalimumab): SWOT analysis, 2009 105
Figure 26: Humira (adalimumab) psoriasis sales by country across the seven major markets ($m), 2008-2018 106
Figure 27: Remicade SWOT analysis, 2009 115
Figure 28: Remicade (infliximab) psoriasis sales by country across the seven major markets ($m), 2008-2018 116
Figure 29: Datamonitor estimated biologic market share, 2008 and 2010 122
Figure 30: Apotheke.de screenshot showing the price of Stelara 127
Figure 31: Stelara (ustekinumab) SWOT analysis, 2009 129
Figure 32: Stelara (ustekinumab) psoriasis sales by country, across the seven major markets ($m), 2008-2018 130
Figure 33: Dovonex (calcipotriol) SWOT analysis 136
Figure 34: Dovonex (calcipotriol) psoriasis sales by country across the seven major markets ($m), 2008-2018 137
Figure 35: Dovobet (calcipotriol/betamethasone) SWOT analysis, 2009 142
Figure 36: Dovobet (calcipotriol/betamethasone) psoriasis sales by country in the US and 5EU ($m), 2008-2018 143
Figure 37: Vectical brand website with "Choose Vectical" rationale, Galderma US, 2009 146
Figure 38: Vectical trial comparisons, Vectical brand website, Galderma US, 2009 147
Figure 39: Splash page, Vectical brand website, Galderma US, 2009 148
Figure 40: Vectical brand website outlining regime Galderma USA, 2009 149
Figure 41: Silkis/Vectical (calcitriol) SWOT analysis, 2009 151
Figure 42: Silkis/Vectical (calcitriol) psoriasis sales in the US and 5EU ($m), 2008-2018 152
Figure 43: Olux brand website, Stiefel Laboratories, 2009 157
Figure 44: Olux/Olux-E (clobetasol) psoriasis sales by country, in the US, UK and Italy ($m), 2008-2018 160
Figure 45: Clobex (clobetasol) psoriasis sales by country in the US and 5EU ($m), 2008-2018 164
Figure 46: Soriatane/Neotigason (acitretin) psoriasis sales by country in the US and 5EU ($m), 2008-2018 167
Figure 47: Pfizer and Wyeth's company-reported global prescription sales and Datamonitor forecasts split by therapy area ($m), 2002-2014 170
Figure 48: Merck and Schering-Plough's company-reported global prescription sales and Datamonitor forecasts split by therapy area ($m),, 2002-2014 172
Figure 49: Psoriasis-specific sales for key biologic brands, in the seven major markets ($m), 2008-2018 174
Figure 50: Proportion of total brand sales attributed to psoriasis for key biologic brands in the seven major markets ($m), 2008 and 2018 175
Figure 51: Importance of Humira within Abbott portfolio, company-reported global sales and Datamonitor forecast, ($ billion), 2008-2014 176
Figure 52: Importance of Enbrel within the Wyeth and Amgen portfolios, company-reported global sales and Datamonitor forecast, ($ billion), 2008-2014 177
Figure 53: Importance of Remicade within the Schering-Plough and Johnson & Johnson portfolios, company-reported global sales and Datamonitor forecast, ($ billion), 2009-2014 179
Figure 54: Psoriasis-specific sales split by delivery method across the seven major markets ($m), 2004-08 180
Figure 55: Successful uptake of Dovobet showing some switch from Dovonex in the seven major markets ($m), 2005-08 181
Figure 56: Topical vitamin derivatives and corticosteroids by formulation in the seven major markets ($m), 2005-2018 182
Figure 57: Vitamin D analog structures 184
Figure 58: US psoriasis-specific biologic sales ($m), 2008-2018 187
Figure 59: Remicade price cut and recovery in Japan ($/SU), 2008 188
Figure 60: Scenario A: US psoriasis-specific sales ($m), 2008-2018 189
Figure 61: Scenario B: US psoriasis-specific sales ($m), 2008-2018 190
Figure 62: Scenario C: US psoriasis-specific sales ($m), 2008-2018 191