Commercial and Pipeline Insight: Psoriasis - Anti-TNF’s lead another indication
Pages: 150
Publisher: Datamonitor
Date Published: December 2006
Format: PDF, Slide-Pack
Price: $15200
Overview
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
Table of Contents
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
