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Commercial and Pipeline Insight: Psoriasis - Anti-TNF's lead another indicationPublished by: Datamonitor Published: Dec. 21, 2006 - 150 Pages Table of ContentsCHAPTER 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 AbstractIntroductionThere 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
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
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