Pipeline <strong>and</strong> Commercial Perspectives: <strong>Psoriasis</strong> <strong>and</strong> <strong>Atopic</strong> <strong>Dermatitis</strong>DMHC1935Summary of contentsDRIVERS AND TRENDSThe launch of Amevive, Biogen's novel therapeutic protein, marks thestart of a biologics revolution in the treatment of psoriasis, which willsee at least four biologics available for psoriasis in the US in the nextthree years. These biologics will compete closely in the market forpsoriasis systemics, with each offering unique advantages <strong>and</strong>disadvantages to patients <strong>and</strong> physicians. The new biologics facestrong challenges to physician <strong>and</strong> patient uptake, including cost,reimbursement, <strong>and</strong> mode of administration issues. In the atopicdermatitis market, Fujisawa with Protopic <strong>and</strong> Novartis with Elidel arestruggling for ascendancy in the topical immunomodulators sector,where Novartis' marketing might is now challenged byGlaxoSmithKline's co-promotion of Protopic in the key US market.ATOPIC DERMATITIS COMMERCIAL ANALYSISCase studies <strong>and</strong> comparisons• Overview• Fujisawa: Protopic• Novartis: ElidelPSORIASIS LATE STAGE DRUG ANALYSIS AND FORECASTSKey developmental products <strong>and</strong> their potential market impact• Profiles of drugs in development or in registration• Assessment of market potential• Forecasts to 2011LIST OF TABLES• Reimbursement is the key issue in the success of biologics.Marketers of biologics must learn from the experiences of Amevive<strong>and</strong> commit considerable resources to securing reimbursement.• <strong>Datamonitor</strong> has identified 14 patent licensing relationshipsaffecting Amevive, Raptiva, Enbrel, Remicade, <strong>and</strong> Humira; six arecurrently disputed. Enbrel is more exposed than competitors, withfive patent licensing agreements, only one of which is disputed.Royalties paid on licenses can be substantial, but the need for bigpharma to supplement development pipelines through in licensingmakes it important that larger companies do not alienate thebiotech sector by involving smaller partners <strong>and</strong> patent licensors inlengthy <strong>and</strong> expensive legal action.• Novartis' promotion of Elidel has relied on a strategy of"consumerization": an integrated marketing campaign haspromoted the drug to PCPs, pediatricians, <strong>and</strong> patients. Fujisawahas enlisted GlaxoSmithKline to transform Protopic into a"consumerized" product.EXECUTIVE SUMMARY<strong>Datamonitor</strong> insight into the psoriasis <strong>and</strong> atopic dermatitis markets:key findings <strong>and</strong> strategic recommendationsPSORIASIS PATIENT POTENTIALDefining the market• Disease definitions• Epidemiological issuesPSORIASIS R&D APPROACHRecommendations for R&D success• Key clinical trial end-points in psoriasis• <strong>Psoriasis</strong> disease scoring systems• Clinical trial design <strong>and</strong> recruitment strategiesTable 1: Key parameters of the psoriasis marketTable 2: Global sales forecasts for psoriasis only, 2003-11Table 3: Prevalence of psoriasis by countryTable 4: Global Protopic sales ($m) <strong>and</strong> growth (%), 1999-2003Table 5: Global Protopic sales by region ($m), 1999-2003Table 6: Global Protopic sales by region ($m), Q1 2003Table 7: Global Protopic sales by region (%), 1999-2003Table 8: Global Elidel sales by quarter ($m), 2002-Q2 2003Table 9: Protopic <strong>and</strong> Elidel launch dates by territoryTable 10: Protopic <strong>and</strong> Elidel atopic dermatitis indications byterritoryTable 11: Protopic <strong>and</strong> Elidel development status by regionTable 12: Protopic <strong>and</strong> Elidel development status by stage <strong>and</strong>forecast filing <strong>and</strong> launch datesTable 13: Key biologics in late-stage R&D for psoriasis, 2003Table 14: Global sales forecasts for Amevive, 2003-11Table 15: Factors impacting revenues of Amevive, 2003-11Table 16: Global sales forecasts for Raptiva, 2003-11Table 17: Factors impacting on revenues of Raptiva, 2004-11Table 18: Global sales forecasts for Enbrel for psoriasis only,2003-11Table 19: Factors impacting on revenues of Enbrel for psoriasisonly, 2004-11Table 20: Global sales forecasts for Remicade for psoriasis only,2006-11Table 21: Factors impacting on revenues of Remicade for psoriasisonly, 2006-11Table 22: Global sales forecasts for psoriasis, 2003-11Table 23: Exchange rates to the US dollar used in this analysisTable 24: Years as stated in this analysis <strong>and</strong> Fujisawa years“...What people are not comfortable with is taking on financial risk withbuying drugs…They are not used to having an AR out to Biogen...”· US clinical opinion leader
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