Printer Friendly Printed from http://www.researchandmarkets.com/reports/452390 Stakeholder Opinion: Atopic Dermatitis - A High Level of Unmet Need Creates Market Opportunities Description: Atopic dermatitis is a skin disorder characterized by intense itch, dry skin and redness. Often considered a benign disease, it actually impacts very negatively on quality of life, sometimes more than psoriasis and diabetes. Through opinion leader interviews, we have identified a high level of unmet need in atopic dermatitis treatment and believe that a number of market opportunities exist Scope of this title: Understand opinion leaders views on hot issues in the atopic dermatitis market Assess the key unmet medical needs and identify specific opportunities in the atopic dermatitis market Examine epidemiological data for the prevalence of atopic dermatitis in the seven major markets (US, Japan, France, Germany, Italy, Spain, UK) Explore the current atopic dermatitis pipeline and identify leading products in development Highlights of this title: About 40 million patients suffer from atopic dermatitis in the seven major markets. There is a high level of unmet need and market opportunities exist for safer systemic therapies and effective drugs for itch. However, high drug cost will be a significant barrier to entry to the market and companies must also increase focus on patient education. Future entrants to the atopic dermatitis market will benefit from the strategies used by Novartis for Elidel such as a rapid global rollout and broad marketing campaign. Approval across all possible patient segments will ensure greatest sales potential. Choice of topical formulation is another important issue that companies must address. The late stage atopic dermatitis pipeline is empty and lacks innovation. In contrast, there are a number of Phase II products looking to fill the gap in the market for effective non-steroidal therapies, left by Protopic and Elidel. Despite a need for systemic therapies, we expect the overall demand for topical therapies will remain high. Reasons to order your copy: Review available treatments and understand major treatment controversies such as the safety of topical calcineurin inhibitors. Identify opportunities in the atopic dermatitis market and learn which strategies should be considered for success of future market entrants. Gain insight into the direction of future research for atopic dermatitis and learn what opinion leaders think of current pipeline products. Contents: About the Immune Disorders and Inflammation (IDI) pharmaceutical analysis team 2 Chapter 1. Executive summary 3 Scope of the report 3 Objective of the analysis 3 Our insight into the atopic dermatitis market 4 Chapter 2. Introduction and epidemiology 12 Classification of atopic dermatitis 12 Atopic dermatitis is a chronic, relapsing skin disease and has many clinical features 12 Atopic dermatitis occurs in three distinct clinical phases: infantile, childhood and adult 14 Segmenting the AD population 15 Assessing disease severity in AD can be problematic 15 Patients are segmentated according to mild, moderate and severe atopic dermatitis 15 There is no single way of assessing disease severity 16 Will there ever be a single standardized index to assess disease severity? 17 Atopic dermatitis significantly affects quality of life 18 Pathophysiology of atopic dermatitis 19 There is an acute and chronic phase involved in the pathogenesis of atopic dermatitis 19 Atopic dermatitis is driven by T cells and specific cytokines 20 Phosphodiesterase IV hyperactivity is thought to be a feature of atopic dermatitis 20 Epidemiology of atopic dermatitis 21 Atopic dermatitis has both genetic and environmental risk factors 21 Family history remains the strongest predictor for the development of atopic dermatitis 21 Environmental factors play a major role in atopic dermatitis 21 Atopic dermatitis affects females slightly more than males 22 The prevalence of atopic dermatitis has risen in the past three decades 22 Comparing epidemiological studies is a challenge 22 There are around 40 million patients with atopic dermatitis in the seven major markets 26 US 27 Japan 29 Europe 30 Chapter 3. Unmet needs 34 Introduction 34 Unmet medical needs in atopic dermatitis 34 Patient education is seen as critical by opinion leaders 34 Standardized treatment regimens and patient education will help improve compliance 36 How can pharmaceutical companies help with patient education? 37 Tackling the itch: more drugs are needed to specifically target pruritus 40 Lack of treatment options for severe atopic dermatitis 43 Preventative strategies will become increasingly important 44 There is another unmet need for less expensive therapies 46 Providing therapies for the infant population 47 Identifying the processes involved in lichenification 49 Summary of unmet needs 51 Chapter 4. Current treatments for atopic dermatitis 52 Treatment overview 52 Our definition of atopic dermatitis 54 Size of the atopic dermatitis market 54 Non-pharmacological therapy 56 Combination of behavioral modification techniques with topical therapies reduces scratching associated with atopic dermatitis 56 UV phototherapy can be an effective treatment option but is limited to adult sufferers or severe cases of atopic dermatitis 56 Emollients reduce the symptoms of dry skin and can reduce the need for topical corticosteroid treatment 57 Pharmacological therapy 57 Topical corticosteroids remain the cornerstone of treatment for atopic dermatitis 57 The arrival of topical calcineurin inhibitors represented a significant advance in the treatment options for atopic dermatitis 59 Combination of topical therapies can accelerate remission of atopic dermatitis and helps to lessen the risk of side effects 61 Antihistamines are used to treat pruritus but their efficacy remains questionable 62 Tricyclic antidepressants, such as doxepin hydrochloride, can be prescribed to promote restful sleep and tackle pruritus 63 Systemic and topical antibiotics are prescribed in order to counteract secondary bacterial infections associated with atopic dermatitis 64 Systemic corticosteroids should be avoided unless they are required for acute flare-ups in severe atopic dermatitis 65 A number of immunosuppresive drugs, including cyclosporin A and mycophenolate mofetil, are used off-label to treat atopic dermatitis 65 Chapter 5. Treatment controversies 69 Patients phobia of corticostoids can lead to non-compliance and ultimately to treatment failure 69 The long-term safety of topical calcineurin inhibitors has been questioned 70 The FDA imposed a black box warning for Protopic and Elidel 70 The black box warning was based on theoretical risk and not on clinical evidence 70 The FDAs decision limits the availability of TCIs and pushes patients back on to topical corticosteroids or on to more harmful systemic drugs 72 Safety concerns and black box warning have impacted on the sales of Elidel and Protopic in the US, 5EU and Japan 73 In Europe, the EMEA reviewed the safety data of Protopic and Elidel and concluded the benefits outweigh the risks 76 Most clinical trials to date suggest a favorable safety profile for topical calcineurin inhibitors 77 An oral formulation of pimecrolimus has been discontinued by Novartis 80 Cost of topical calcineurin inhibitors is high 81 In general TCIs are 20 times more expensive than corticosteroids 81 Topical calcineurin inhibitors cost nearly twice as much in the US than in the UK 82 Cream versus ointment: what type of topical formulation is most appropriate for atopic dermatitis? 84 In the US and 5EU, creams are the most popular formulation of topcial corticosteroid, however, ointments are more popular in Japan 84 Ointments are more effective than creams, but creams are preferred for cosmetic reasons 86 Pressure foam preparations are becoming more popular for dermatoses 87 Novartis was looking to expand the Elidel product range with an ointment formulation 90 Protopic cream is in late-stage clinical development 91 Marketing strategies for topical calcineurin inhibitors 91 Fujisawa and GSK joined forces to co-promote Protopic in the US in light of increased competition from Novartis Elidel 91 Protopic and the Eczema Beast 94 Despite being the second topical calcineurin inhibitor to market, sales of Elidel were double those of Protopic within two years after launch 95 Novartis signed co-marketing agreements with Esteve in Spain and 3M in Germany for pimecrolimus 98 Protopic and Elidel are prescribed off-label in a number of dermatological diseases 98 Around 40% of Elidel and Protopic sales are for off-label indications 98 The psoriasis market is an attractive prospect but current safety fears may limit potential 100 Chapter 6. Pipeline drugs 102 The atopic dermatitis pipeline lacks innovative drugs in Phase III 102 There are only two drugs in Phase III development for atopic dermatitis 102 The majority of drugs in development for atopic dermatitis are topically administered 108 Biologics used in psoriasis are undergoing clinical trials for atopic dermatitis 109 Raptiva (efalizumab) is being evaluated as an alternative to systemic immunosuppressive agents in severe atopic dermatitis 109 The immunopharmacological effects of Rituxan/MabThera (rituximab) in atopic dermatitis are being investigated in a Phase I study 112 Amevive (alefacept), the first biologic developed for psoriasis, is in Phase II for atopic dermatitis 113 Is there potential for other psoriasis therapies to expand into the atopic dermatitis indication? 113 High cost of biologicals may be an issue with in atopic dermatitis as it is in psoriasis 114 Histamine may not be a justifiable target for pharmacological intervention 115 Topical patch will be interesting for localized disease but not for widely affected areas 116 Protease inhibitors will have a place in the treatment of atopic dermatitis but remain in Phase II development 116 With a promising portfolio, which includes Sabarep for atopic dermatitis, York Pharma aims to be a force in the field of dermatology 117 Arrivas and ProMetics topical rAAT gel may require reformulation for atopic dermatitis 118 Cytos Biotechnology are aiming to provide a more effective immunotherapy than those that are currently available 119 Early-stage treatments for atopic dermatitis are directed against a variety of targets 120 Cytokines and NF-KappaB modulators 121 Topical PDE IV inhibitors 122 Chapter 7. Appendix 124 Contributing experts 124 Market Profile: Protopic (tacrolimus) and Elidel (pimecrolimus) 125 Methodology 126 Calculation of 2006 sales figures 126 Our definition of vitiligo, psoriasis, seborrheic dermatitis and contact dermatitis 126 Bibliography 128 Journal articles 128 Websites 134 Our reports 137 About Us 138 About We Healthcare 138 Our Healthcares research and analysis methodologies 139 Our Healthcares therapy area capabilities 139 Disclaimer List of Tables Table 1: Clinical features of atopic dermatitis 13 Table 2: Criteria for the diagnosis of atopic dermatitis 14 Table 3: Prevalence studies for atopic dermatitis in the seven major markets, 1994-2004 24 Table 4: Our estimation of the atopic dermatitis population (000s) in the seven major markets, 2007 26 Table 5: Estimated AD population in the US, 2007 29 Table 6: Estimated AD population in Japan, 2007 30 Table 7: Estimated AD population in France, 2007 31 Table 8: Estimated AD population in Germany, 2007 32 Table 9: Estimated AD population in the UK, 2007 32 Table 10: Estimated AD population in Spain, 2007 33 Table 11: Estimated AD population in Italy, 2007 33 Table 12: Examples of available therapies for atopic dermatitis, 2007 53 Table 13: Our definition of atopic dermatitis according to ICD10 code 54 Table 14: Key facts: topical calcineurin inhibitors for atopic dermatitis, 2007 60 Table 15: Antihistamines used in the management of atopic dermatitis 63 Table 16: Cost of Protopic (tacrolimus) and Elidel (pimecrolimus) in the UK, 2007 81 Table 17: Cost of Protopic (tacrolimus) and Elidel (pimecrolimus) in the US 82 Table 18: Pipeline products in all stages of development for atopic dermatitis, 2007 103 Table 19: Market profile: Protopic (tacrolimus) and Elidel (pimecrolimus), 2007 125 Table 20: Our definition of vitiligo, psoriasis, seborrheic dermatitis and contact dermatitis according to ICD10 codes List of Figures Figure 1: Pathogenesis of atopic dermatitis 19 Figure 2: Our estimation of the atopic dermatitis population (000s) in the seven major markets, 2007 27 Figure 3: Rationale behind the development of antipruritic drugs for AD 42 Figure 4: Summary of unmet medical needs in the atopic dermatitis market, 2007 51 Figure 5: The atopic dermatitis market, 2005 55 Figure 6: Common topical corticosteroids used to treat atopic dermatitis grouped by strength 59 Figure 7: The mechanism of action of topical calcineurin inhibitors 60 Figure 8: Topical treatment paradigm for atopic dermatitis 61 Figure 9: The FDA black box warning that appears as part of the label change for Protopic and Elidel, January 2006 71 Figure 10: AD-specific sales of Protopic (tacrolimus) in the US, 5EU and Japan ($m), 2005-06 73 Figure 11: AD-specific sales of Elidel (pimecrolimus) in the US and 4EU ($m), 2005-06 75 Figure 12: Year-on-year sales growth of Protopic and Elidel in the seven major markets (%), 2003-06 76 Figure 13: Sales of topical corticosteroids for all therapeutic indications categorized by formulation ($m), 2005 85 Figure 14: Sales of pressure foam corticosteroids in the US and 5EU by brand for all therapeutic indications ($m), 2005-06 88 Figure 15: Total promotional spend for Elidel and Protopic in the US only ($m), 2003 93 Figure 16: Astellas DTC campaign for Protopic featured the Eczema Beast 94 Figure 17: Example of DTC advertising for Novartis Elidel 97 Figure 18: Elidel and Protopic sales in the seven major markets for atopic dermatitis and off-label indications ($m), 2005 99 Figure 19: Pipeline drugs for atopic dermatitis categorized by phase of development, 2007 102 Figure 20: Pipeline drugs for atopic dermatitis categorized by method of administration, 2007 109 Figure 21: Molecular targets for therapies in Phase I and preclinical development for atopic dermatitis, 2007 120 Ordering: Order Online - visit http://www.researchandmarkets.com/reports/452390 Order by Fax - using the order form below Order By Post - print the order form below and send to Research and Markets, Guinness Centre, Taylors Lane, Dublin 8, Ireland. 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