Commercial and Pipeline Insight: Psoriasis

Anti-TNF's lead another indication

Publication Date	December 2006
Publisher	Datamonitor
Product Type	Report
Pages	150
ISBN Number	not applicable
Product Code	DAT03290

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Summary

Introduction

There is no cure for psoriasis, which profoundly affects sufferers quality of life, physical and social functioning. There is a particular unmet need for effective long-term therapies for psoriasis. Prevalence is the highest of the autoimmune diseases at 16 million in 2006, but this is deceptive in terms of market size, as the treated and severe patient populations are comparatively small.

Scope

Psoriasis specific ten year forecasts, contrasted against estimated total brand sales for key products
Sales and volume estimates, by indication from 2005-2015, for the US, combined five major EU markets and Japan
Analysis of late-stage pipeline products for psoriasis
Discussion of key events that affect the sales and volume of key brands

Highlights

The disappointment of initial biologics in psoriasis and the fact that a higher dose tends to be required from biologics to achieve efficacy can be off-putting to companies. However, Enbrel's success, with an estimated $933 m in sales in the seven major markets for psoriatic conditions in 2005, shows that this market is not to be neglected.

In a market driven by product switching, long term safety and efficacy is elusive. Year long trial data as exemplified by market leading biologics, is key and should be applied to all psoriasis products, be they biologic, traditional systemic or topical therapies.

Approval in psoriatic arthritis appears to add force to uptake in psoriasis but is not a key indication in itself. Novel therapeutics expanding from rheumatology indications should consider this strategy, but Enbrel has paved the way for anti-TNF therapies to launch directly in psoriasis.

Reasons to Purchase

Compare psoriasis forecasts with total brand sales for key existing products
Estimate the size of the psoriasis market to 2015
Benchmark late-stage pipeline products against the market leader

Content

Chapter 1 Executive Summary
- Objective of the analysis
- Datamonitor insight into the psoriasis market
Chapter 2 Market Definition And Overview
- Strategic scoping and focus
- Current market situation
- Abbott's top-line driven by Humira's expansion into additional indications
- Psoriasis definition for this report
- Psoriasis ICD10 definition
- Current treatment and brands included in forecast definition
- Biologics
- Corticosteroids
- Vitamin derivatives
- Vitamin D analogue Dovenex dominates but patent expiry looms
- Retinoids or vitamin A derivatives also provide a steroid alternative
- Immunosuppressants
- Other topical treatments
- Unmet needs and treatment challenges
- In a market driven by product switching, long-term efficacy and safety is elusive
- Efficacy is the key prescribing influence according to Datamonitor survey
- Flaring nature of psoriasis and rebound caused by some therapies make this disease difficult to deal with
- The PASI score is the most often used but is it the best primary endpoint?
- PASI definition
- PASI not used in everyday practice
- Trials for combinations needed to reflect the 'real life' use of psoriasis therapies
Chapter 3 Epidemiology And Patient Numbers
- Psoriasis definitions and diagnostics
- Diagnostic criteria
- Numerous measures of disease severity and quality of life are used for psoriasis, but the PASI is currently the most common in trials
- Epidemiology of psoriasis
- US
- Japan
- Europe
- France
- Germany
- Italy
- Spain
- UK
Chapter 4 Forecast Analysis Of Marketed Products
- Regulatory action
- NICE appraisal for Enbrel and Raptiva is limiting but positive
- Topical immunomodulator cancer warning
- Elidel and Protopic hit by cancer warnings in US
- Brand specific events
- Amgen/Wyeth plans numerous post-market trials for Enbrel (etanercept) to compete with pipeline launches
- Numerous Phase IV clinical trials in psoriatic disorders show Amgen/Wyeths attempts to persuade physicians not to switch to Remicade or Humira
- Amevive (alefacept) brought by Astellas and launch in Japan predicted
- Astellas' ASAP and AWARE programs increase confidence in Amevive's new marketing partnership
- Raptiva (efalizumab) moves down the treatment algorithm
- Company reported versus IMS variation in sales for Raptiva
- Humira easy injection
- Dovobet launches in the US
- Patent expiry
- Dovonex patent expiry
- Zorac patent expiry
- Elocon continued generic erosion
- US shows high generic erosion but EU yet to be impacted
- Data definitions, limitations and assumptions
- Derivation of Sales Forecasts and Pricing Trends
- Dosing assumptions
- Pricing assumptions and analysis
- Standard Units
- Japanese Market Data
- Forecast methodology
Chapter 5 Late Stage Pipeline
- Key classes in the pipeline
- Delivery methods
- Phase III and Pre-registration pipeline candidates
- Phase II
- Phase I
- Pipeline company and clinical overview
- Forecast launch dates
- Remicade
- Forecast and assumptions
- Marketing and patient potential
- Current maintenance data shows a fall in efficacy over time possibly due to infliximab antibody formation
- Future trials will add value but competition is high
- Clinical trial overview
- Earlier psoriatic arthritis studies show a similar response
- Humira
- Forecast and assumptions
- Patient and marketing potential
- New manufacturing plant will allow for expected expansion of total brand
- Off label use is anticipated to be a predictor of good uptake
- Overview of clinical trials
- CHAMPION study data presented in October 2006
- Efficacy in psoriatic arthritis demonstrated in 2005
- ISA247
- Forecast and assumptions
- Price premium expected if side-effect advantage proven
- Patient and marketing potential
- Nephrotoxicity key side-effect to watch out for
- ISA247 is a good "in license" candidate
- Clinical trial overview
Cnto-1275
- Forecast and assumptions
- Patient and marketing potential
Cnto-1275 Dosing Regime Promising In Some And Niches Opportunities Exist
- Centocor's patient assistance program and biologic experience will help
- Clinical trial overview
- Phase II data presented at the 2006 AAD meeting
- BG-12 (dimethyl fumerate)
- Forecast and assumptions
- Patient and marketing potential
- Comparison with existing Fumaderm
- Clinical trial overview
- Cimzia (certolizumab pegol)
- Forecast and assumptions
- Patient and market potential
- Less favorable dosing regime in psoriasis trial
- Clinical trial overview
- Other pipeline products
- ABT-874
- Psoraxine
- AVT-02
- Asord (becocalcidol)
Cc-10004
- MM-093
- Recently discontinued
- Onercept
Chapter 6 Commercial Impact And Lifecycle Management: Case Studies
- Introduction
- Case study one: Psoriatic arthritis
- Epidemiology studies show psoriasis to be much more common than psoriatic arthritis
- Impact on Enbrel's sales of approvals in psoriasis and psoriatic arthritis
- The US shows clear correlation between uptake in psoriasis and psoriatic arthritis
- Psoriasis definition includes arthropathic arthritis in Datamonitor's forecast
- Case study two: Patient segmentation and product differentiation in the psoriasis market
- Mild patients treated by primary care physicians using topical therapies is a large but difficult to capture segment
- Remicade used in patients requiring fast efficacy
- Enbrel and Humira used in less severe more independent patients
- How will novel mechanisms distinguish themselves in the market?
Appendix A  Market Data And Major Brand Key Facts
- Summary psoriasis market data
- Biologics market data
- Topical treatments
- Immunosuppressant key brands
Appendix B  Market Forecast Data
- US Forecast
- Five major European countries forecast
- Japanese forecast
Bibliography
- Opinion Leaders
- Report methodology
- About Datamonitor
- About Datamonitor Healthcare
- About the IDI analysis team
- Disclaimer