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Introduction

Biologic therapies have had a major impact on the psoriasis market since the first such agent was approved by the FDA in 2003. In the moderate-to-severe psoriasis market, biologic agents alone totaled over $900 million in 2006. The psoriasis market is currently dominated by two classes of biologic agents: TNF-alpha inhibitors (Amgen/Wyeth/Takeda' s Enbrel and Centocor/Schering-Plough/Tanabe' s Remicade) and T-cell modulators (Genentech/Merck Serono' s Raptiva, Astellas Pharmaceutical' s Amevive). Several new agents are set to enter the market during the 2005-2010 such as Abbott Laboratories/Eisai' s Humira, a fully-human TNF-alpha inhibitor with highly competitive efficacy, Centocor' s CNTO-1275, the first interleukin inhibitor in the psoriasis market, and Isotechnika' s voclosporine, a small-molecule analogue of cyclosporine with reportedly a much better safety profile. The launch of these drugs will impact both currently available therapies and expand the share of patients treated with branded agents.

Questions Answered in This Report

• Enbrel is the undisputed leader of the moderate-to-severe psoriasis market because dermatologists are comfortable with the agent' s safety profile and efficacy, patients have responded well to the therapy, and third-party payers have granted the drug more favorable reimbursement than its peers. How have Amgen and Wyeth secured such a dominant market share for Enbrel? What strategies have shown success in the psoriasis market?
• Dermatologists have been cautious in their uptake of biologic agents due to concerns over potential safety risks and the high cost of the drugs. Amevive, the first biologic to market, was sold by Biogen Idec to Astellas Pharmaceuticals in 2006 due to disappointing sales. What do physicians identify as the key attributes of currently marketed agents? What are the perceived advantages and/or disadvantages of emerging therapies versus available therapies?
• On April 2, 2007, Abbott Laboratories filed regulatory submissions with the FDA and EMEA seeking approval for the company' s monoclonal antibody Humira in the moderate-to-severe psoriasis indication. What is Abbott doing to position Humira in the psoriasis market in advance of its anticipated approval? How will Enbrel and other agents be affected by Humira' s launch and uptake?
• TNF-alpha inhibitors currently are the gold-standard for psoriasis therapy; however, Centocor' s highly anticipated IL-12/IL-23 inhibitor CNTO-1275 has the potential to radically change the market on the strength of hitherto unseen efficacy. Other companies also have agents in their pipelines with novel mechanisms of action. What products are being developed in the major competitors' pipelines? How will CNTO-1275 perform if it is approved to treat psoriasis?
• Psoriasis is part of a broader set of chronic autoimmune and inflammatory conditions with similar pathophysiologies such as rheumatoid arthritis and inflammatory bowel disease. These diseases can be best treated with biologic agents and some pharmaceutical companies are increasingly organizing therapeutic areas around this opportunity. How does psoriasis fit into the wider autoimmune and inflammatory therapeutic areas of companies in the market? What strategies are being pursued to achieve success in this treatment area?

• Markets Covered: United States, France, Germany, Italy, Spain, United Kingdom, and Japan.
• Competitive Analysis: Detailed discussion of major competitors including Amgen, Wyeth, Genentech, Merck Serono, Centocor, Schering-Plough, Abbot Laboratories, and Astellas Pharmaceuticals in addition to the emerging competitor Isotechnika. Included is an analysis of each company' s autoimmune and inflammatory product portfolio, strategic positioning, and development pipeline. The report features an in-depth discussion of leading brands including approval history, sales and market position, SWOT analysis, and on-going life cycle management initiatives.
• Physician Perception of Key Brands: Analysis of physician perceptions of the psoriasis market based on a custom survey of over 50 US-based dermatologists. The survey is brand-focused and examines physician perceptions of key competitors, brand attributes, and uptake of emerging agents.
• Epidemiology: Total prevalent and diagnosed cases for each of the major markets are presented in an annualized forecast from 2005 to 2010.
• Market Forecast: Annualized sales forecasts for branded agents presented by region, drug class, molecule, and brand for 2005 to 2010, including the uptake of new agents.

Table of Contents

Table of Exhibits

• Market Summary
• Competitive Landscape
• Brand Overview
• Physician Perspectives

• Scope of Report
• Primary Research Methodology

• Psoriasis Background
• Prevalence and Diagnosis
  • Major Markets Statistics and Key Findings
  • US Statistics and Key Findings
  • Europe Statistics and Key Findings
  • Japan Statistics and Key Findings
• Prescribers
  • General Prescriber Trends
  • Key Drivers of Prescriber Decisions
• Reimbursement Issues
• Treatment Dynamics
  • Existing Therapies
  • Emerging Therapies

• Overview of Competitive Landscape
• Promotional Spending
• Survey Results: Physician Perceptions
  • Perceptions of Competitors in the Psoriasis Market
  • Perceptions of Brands in the Psoriasis Market

• Enbrel
  • Development and Commercial Overview
  • Current Positioning
  • Enbrel Competitive Analysis
  • Key Brand Strategies
    • Current Strategy in the Psoriasis Market
    • Lifecycle management and future strategy
  • Future Positioning
  • Amgen
    • Inflammatory Disease Product Portfolio
    • Goals and Vision in Inflammatory Disease
    • Current Positioning
    • Market Strategy
    • Outlook
  • Wyeth
    • Inflammatory Disease Product Portfolio
    • Goals and Vision in Inflammatory Disease
    • Current Positioning
    • Market Strategy
    • Outlook
• Raptiva
  • Development and Commercial Overview
  • Current Positioning
  • Raptiva Competitive Analysis
  • Key Brand Strategies
    • Current Strategy in the Psoriasis Market
    • Lifecycle Management and Future Strategy
  • Future Positioning
  • Genentech
    • Immunology Product Portfolio
    • Goals and Vision in Immunology
    • Current Positioning
    • Market Strategy
    • Outlook
  • Merck Serono
    • Autoimmune & Inflammatory Product Portfolio
    • Goals and Vision in Autoimmune & Inflammatory Disease
    • Current Positioning
    • Market Strategy
    • Outlook
• Remicade
  • Development and Commercial Overview
  • Current Positioning
  • Remicade Competitive Analysis
  • Key Brand Strategies
    • Current Strategy in the Psoriasis Market
    • Lifecycle Management and Future Strategy
  • Future Positioning
  • Centocor
    • Immune-Mediated Inflammatory Disorder Product Pipeline
    • Goals and Vision in Inflammatory Disease
    • Current Positioning
    • Market Strategy
    • Outlook
  • Schering-Plough
    • Inflammation Product Portfolio
    • Goals and Vision in Inflammatory Disease
    • Current Positioning
    • Market Strategy
    • Outlook
• Humira
  • Development and Commercial Overview
  • Current Positioning
  • Humira Competitive Analysis
  • Key Brand Strategies
    • Current Strategy in the Psoriasis Market
    • Lifecycle Management and Future Strategy
  • Future Positioning
  • Abbott Laboratories
    • Immunology Product Portfolio
    • Goals and Vision in Immunology
    • Current Positioning
    • Market Strategy
    • Outlook
• Amevive
  • Development and Commercial Overview
  • Current Positioning
  • Amevive Competitive Analysis
  • Key Brand Strategies
    • Biogen/Biogen Idec' s Strategies for Amevive
    • Astellas Pharma' s Strategies for Amevive
  • Future Positioning
  • Astellas Pharma
    • Dermatology Product Portfolio
    • Current Positioning and Market Strategy
    • Outlook

• CNTO-1275
  • Overview
  • CNTO-1275 Competitive Analysis
  • Key Brand Strategies
  • Future Positioning
• Voclosporine (ISA-247)
  • Overview
  • Voclosporine Competitive Analysis
  • Key Brand Strategies
  • Isotechnika

• Drug Sales by Region
• Drug Sales by Class

Acronyms and Abbreviations

Bibliography

Methodology

• Epidemiological Forecast Methodology
• Market Forecast Methodology
• Competitive Analysis Methodology

• Exhibit ES-1: Key Parameters of the Psoriasis Market
• Exhibit ES-2: Psoriasis Branded Market, ($US), Major Markets, 2005- 2010
• Exhibit ES-3: Psoriasis Market Competitive Position, 2005 and 2010
• Exhibit ES-4: Psoriasis Brand Sales ($US), by Brand, as a Percent of Total, 2005 and 2010
• Exhibit ES-5: Dermatologist Rankings of Companies in Psoriasis Treatment
• Exhibit ES-6: Humira in Dermatologist' s Line of Therapy

• Exhibit 1-1: Surveyed Physicians' Years of Practice
• Exhibit 1-2: Surveyed Physicians' Patients per Month
• Exhibit 1-3: Surveyed Physicians' Geographic Distribution

• Exhibit 2-1: Drug Classes Used in the Treatment of Psoriasis
• Exhibit 2-2: Prevalent and Diagnosed Psoriasis Cases, Major Markets
• Exhibit 2-3: Prevalent and Diagnosed Psoriasis Cases, US
• Exhibit 2-4: Prevalent and Diagnosed Psoriasis Cases, Europe
• Exhibit 2-5: Prevalent and Diagnosed Psoriasis Cases, Europe, Continued
• Exhibit 2-6: Prevalent and Diagnosed Psoriasis Cases, Japan
• Exhibit 2-7: Dermatologist Information Channels Used in Psoriasis Treatment
• Exhibit 2-8: End Points Used in Clinical Trials for Psoriasis, 2007
• Exhibit 2-9: Biologic Agents in the Psoriasis Market, 2006
• Exhibit 2-10: Approved Indications for Biologic Therapies in Current Psoriasis Treatment
• Exhibit 2-11: Timeline of Recent Approvals in the Psoriasis Market, 1998- 2007

• Exhibit 3-1: Psoriasis Market Competitive Position, 2005 and 2010
• Exhibit 3-2: Market for Biologic Psoriasis Therapies, by Company, 2005-2010
• Exhibit 3-3: Psoriasis Market Share, by Competitor, as a % of Total, 2005
• Exhibit 3-4: Psoriasis Market Share, by Competitor, as a % of Total, 2010
• Exhibit 3-5: Promotional Spending, by Brand, as a % of Total Spending for All Indications of Biologic Agents in Psoriasis, 2004- 2006
• Exhibit 3-6: Promotional Spending, by Competitor, as a % of Total Spending for All
• Indications of Biologic Agents in Psoriasis, 2004- 2006 [Tabular Format]
• Exhibit 3-7: Promotional Spending, by Competitor, as a % of Total Spending for All
• Indications of Biologic Agents in Psoriasis, 2004- 2006 [Graphical Format]
• Exhibit 3-8: Dermatologist Perceptions of Psoriasis Market Competitors, 2007
• Exhibit 3-9: Dermatologist Rankings of Best Company in the Psoriasis Market, 2007
• Exhibit 3-10: Dermatologist Efficacy Rankings, by Brand, 2007
• Exhibit 3-11: Dermatologist Safety Rankings, by Brand, 2007
• Exhibit 3-12: Dermatologist Convenience Rankings, by Brand, 2007
• Exhibit 3-13: Dermatologist Reimbursement Rankings, by Brand, 2007
• Exhibit 3-14: Dermatologist-Reported Rankings of Biologic Therapies in Psoriasis, 2005 versus 2007
• Exhibit 3-15: Dermatologist Efficacy Rankings, Detail, 2007
• Exhibit 3-16: Dermatologist Safety Rankings, Detail, 2007
• Exhibit 3-17: Dermatologist Safety Rankings, Detail (continued), 2007
• Exhibit 3-18: Dermatologist Convenience Rankings, Detail, 2007

• Exhibit 4-1: Established Brands in the Psoriasis Market, 2006 and 2010
• Exhibit 4-2: Timeline of Notable Milestones in Enbrel' s Development for Psoriasis
• Exhibit 4-3: Enbrel' s Rank Among Biologic Therapies in Psoriasis Treatment
• Exhibit 4-4: Predominant Reasons for Discontinuing Enbrel Therapy, Cumulative Rankings, 2007
• Exhibit 4-5: Enbrel' s Rank among Biologic Therapies for Psoriasis, by Key Efficacy and Safety Attributes
• Exhibit 4-6: Enbrel' s Rank among Biologic Therapies for Psoriasis, by Key Convenience Attributes
• Exhibit 4-7: Enbrel' s Rank among Biologic Therapies for Psoriasis, by Long-term Safety Data
• Exhibit 4-8: Dermatologist Rankings of TNF-α Inhibitor Efficacy in Psoriasis
• Exhibit 4-9: Summary of Key Clinical Trials Supporting Enbrel' s Psoriasis Approvals
• Exhibit 4-10: Select Ongoing Phase III Clinical Trials for Enbrel in Psoriasis
• Exhibit 4-11: Select Ongoing Phase IV Clinical Trials for Enbrel in Psoriasis
• Exhibit 4-12: Enbrel Psoriasis Revenue ($US), by Country, 2005- 2010
• Exhibit 4-13: Enbrel Psoriasis Revenue ($US), by Country, 2005- 2010
• Exhibit 4-14: Price to Treat per Day ($US), Enbrel, by Country, 2006
• Exhibit 4-15: Amgen' s Pharmaceutical Product Revenue, by Brand, 2006
• Exhibit 4-16: Summary of Amgen' s Inflammatory Disease Product Portfolio
• Exhibit 4-17: Physician-Reported Rankings of Amgen/Wyeth
• Exhibit 4-18: Enbrel Revenue ($US), by Company and Region, 2005- 2010 [Graphical Format]
• Exhibit 4-19: Enbrel Revenue ($US), by Company and Region, 2005- 2010 [Tabular Format]
• Exhibit 4-20: Wyeth' s Pharmaceutical Product Revenue, with Enbrel Revenue Allocation, 2006
• Exhibit 4-21: Summary of Wyeth' s Inflammatory Disease Product Portfolio
• Exhibit 4-22: Wyeth' s Enbrel Psoriasis Revenue ($US), by Country, 2005- 2010, [Graphical Format]
• Exhibit 4-23: Wyeth' s Enbrel Psoriasis Revenue ($US), by Country, 2005- 2010, [Tabular Format]
• Exhibit 4-24: Important Milestones in Raptiva' s Development for Psoriasis
• Exhibit 4-25: Raptiva' s Rank Among Biologic Therapies in Psoriasis Treatment
• Exhibit 4-26: Raptiva' s Rank Among Biologic Agents, by Efficacy and Safety Attributes
• Exhibit 4-27: Raptiva' s Rank Among Biologic Agents in terms of Continuous Monitoring Requirements
• Exhibit 4-28: Predominant Reasons for Discontinuing Raptiva Therapy
• Exhibit 4-29: Clinical trials cited by the FDA in Raptiva' s approval using predominantly XOMA-produced drugs
• Exhibit 4-30: Clinical Trials Cited by the FDA in Raptiva' s Approval Using Genentech- Produced Raptiva
• Exhibit 4-31: Raptiva Psoriasis Revenue ($US), by Country, 2005- 2010
• Exhibit 4-32: Raptiva Psoriasis Revenue ($US), by Country, 2005- 2010
• Exhibit 4-33: Price to Treat per Day ($US), Raptiva, by Country, 2006
• Exhibit 4-34: Genentech Product Revenue and Growth, 2006
• Exhibit 4-35: Summary of Genentech' s Immunology Product Portfolio
• Exhibit 4-36: Merck Serono' s Products and Revenue
• Exhibit 4-37: Summary of Merck Serono' s Autoimmune & Inflammatory Product Portfolio
• Exhibit 4-38: Timeline of Notable Milestones in Remicade' s Development for Psoriasis
• Exhibit 4-39: Remicade' s Revenue Rank in Marketed Biologic Agents, by Indication
• Exhibit 4-40: Remicade' s Rank Among Biologic Therapies in Psoriasis Treatment, 2007
• Exhibit 4-41: Remicade' s Rank Among Biologic Therapies in Psoriasis Treatment, by Efficacy and Safety Attributes, 2007
• Exhibit 4-42: Remicade' s Rank Among Biologic Therapies in Psoriasis Treatment, by Efficacy and Safety Attributes, 2007
• Exhibit 4-43: Remicade' s Safety Rank Among Biologic Agents
• Exhibit 4-44: Summary of Key Clinical Trials Supporting Remicade' s Psoriasis Approvals
• Exhibit 4-45: Select Ongoing or Unreported Phase III Clinical Trials for Remicade in Psoriasis
• Exhibit 4-46: Remicade Psoriasis Revenue ($US), by Country, 2005- 2010
• Exhibit 4-47: Remicade Psoriasis Revenue ($US), by Country, 2005- 2010
• Exhibit 4-48: Price to Treat per Day ($US), Remicade, by Country, 2006
• Exhibit 4-49: Summary of Centocor and J&J' s IMID Product Portfolio
• Exhibit 4-50: Centocor' s Psoriasis Revenue ($US), by Country and Brand, 2005- 2010
• Exhibit 4-51: Schering-Plough' s Pharmaceutical Revenue, 2006
• Exhibit 4-52: Summary of Schering-Plough' s Inflammation Product Portfolio
• Exhibit 4-53: Important Milestones in Humira' s Development for Psoriasis
• Exhibit 4-54: Humira' s Rank among Biologic Therapies for Psoriasis
• Exhibit 4-55: Humira' s Rank among Biologic Agents, by Dosing Attributes
• Exhibit 4-56: Humira versus Enbrel, Rank among Biologic Agents, by Long-Term Safety Data
• Exhibit 4-57: Humira' s Phase III Trials in Psoriasis
• Exhibit 4-58: Humira' s Current and Forecast Position in Dermatologist' s Line of Therapy for Moderate to severe Psoriasis
• Exhibit 4-59: Physician-Selected Patient Groups Appropriate for Humira Therapy following FDA Approval
• Exhibit 4-60: Humira vs. Enbrel, Rank among Biologic Agents, by Short-Term Efficacy
• Exhibit 4-61: Humira versus Enbrel, Rank among Biologic Agents, by Maintenance Efficacy
• Exhibit 4-62: Humira versus Enbrel, Rank among Biologic Agents, by Delivery Method
• Exhibit 4-63: Humira versus Enbrel, Rank among Biologic Agents, by Dosing Frequency
• Exhibit 4-64: Humira Psoriasis Revenue ($US), by Country, 2005- 2010
• Exhibit 4-65: Humira Psoriasis Revenue ($US), by Country, 2005- 2010
• Exhibit 4-66: Price to Treat per Day ($US), Humira, by Country, 2005
• Exhibit 4-67: Abbott' s Pharmaceutical Revenues, by Brand and Business Revenues, by Business Segment
• Exhibit 4-68: Summary of Abbott' s Immunology Product Portfolio
• Exhibit 4-69: Notable Milestones in Amevive' s Development for Psoriasis
• Exhibit 4-70: Amevive' s Rank among Biologic Therapies for Psoriasis, by General Attributes
• Exhibit 4-71: Amevive' s Rank among Biologic Therapies for Psoriasis, by Key Efficacy and Safety Attributes
• Exhibit 4-72: Amevive' s Rank among Biologic Therapies for Psoriasis, by Key Convenience and Reimbursement Attributes
• Exhibit 4-73: Amevive Psoriasis Revenue ($US), 2005- 2010
• Exhibit 4-74: Amevive Psoriasis Revenue ($US), 2005- 2010
• Exhibit 4-75: Astellas' North American Pharmaceutical Revenue as a % of Total Revenue
• Exhibit 4-76: Physician-Reported Rankings of Astellas Pharma

• Exhibit 5-1: CNTO-1275' s Efficacy Results in its Phase II Psoriasis Trial
• Exhibit 5-2: Ongoing Phase III Trials of CNTO-1275 in Psoriasis
• Exhibit 5-3: CNTO-1275' s Attributes Compared to Enbrel
• Exhibit 5-4: Price Per Treated Day of Branded Agents for Psoriasis in 2010
• Exhibit 5-5: Voclosporine' s Completed Phase II/III Clinical Trials in Psoriasis
• Exhibit 5-6: Isotechnika' s Strategic Alliances

• Exhibit 6-1: Psoriasis Branded Therapies Market ($US), Major Markets, 2005- 2010 (Tabular Format)
• Exhibit 6-2: Psoriasis Branded Therapies Market ($US), Major Markets, 2005- 2010 [Graphical Format]
• Exhibit 6-3: Psoriasis Branded Therapies Market ($US), by Country, 2005- 2010 [Graphical Format]
• Exhibit 6-4: Psoriasis Branded Therapies Market ($US), by Country, 2005- 2010 [Tabular Format]
• Exhibit 6-5: Psoriasis Branded Therapies Market ($US), by Drug Class, 2005- 2010