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Follow on Google News | "R&D Trends: Psoriasis - Pipeline outlook following withdrawal of key regulatory filing" PublishedNew Healthcare market report from Datamonitor: "R&D Trends: Psoriasis - Pipeline outlook following withdrawal of key regulatory filing"
Datamonitor identified 128 products in development, with a notable focus on interleukin (IL) targets. 2009 market entrant Stelara, an IL-12/23 inhibitor is fuelling interest in IL therapies. Stelara (ustekinumab) Features and benefits * Enhance understanding of the competitive landscape and potential future market dynamics with an in depth analysis of the psoriasis pipeline * Benchmark novel and existing therapies using the ideal target product profiles identified by Datamonitor and access leading dermatologist opinion * Support R&D decision making by evaluating psoriasis clinical trial designs that have set a precedent, as well as analysis of discontinued projects Highlights Interleukins are key targets for late and early-stage programs. If IL selectivity leads to better efficacy and safety, new drugs would gain backing from physicians. However, cardiac risks may be an issue, as shown by briakinumab. In the current risk-adverse regulatory environment clinical trial designers should consider how to dispel these fears. The Psoriasis Area and Severity Index (PASI) remains the gold standard tool for efficacy, due to historic use and ease of benchmarking new and existing therapies. Phase III trials like Stelara versus Enbrel lead dermatologists to speculate that regulatory agencies will desire analyses from direct comparator trials in future drug approval. Drug attrition rates are high in psoriasis, with a mix of commercial and clinical reasons behind this. Established brands and generics seems to deter companies from pursuing some topical agents, while the higher dose of biologics often required to show meaningful efficacy in psoriasis compared to say rheumatoid arthritis creates further challenges. ------------------------------------------------------------ Full Report Details at - http://www.fastmr.com/ ------------------------------------------------------------ Your key questions answered * What do key opinion leaders think is the ideal target product profile in psoriasis? * Which innovative therapeutic approaches do leading dermatologists believe are the most promising for small molecules and biologics? * How will biomarkers and comorbidities play a role in the future treatment of psoriasis? * What is the breakdown by delivery methods for candidates being developed for this chronic skin disorder? Report Table of Contents: Executive Summary Strategic scoping and focus Datamonitor key findings Related reports OVERVIEW Catalyst Summary CLINICAL PIPELINE OVERVIEW The psoriasis pipeline is extensive, but appears to have a high attrition rate There is an increased focus on targeting interleukins and kinases in the psoriasis pipeline Topical delivery remains dominant in the psoriasis pipeline, but there is a growing focus on oral drugs Late-stage development compounds recently discontinued LEO 80190 (calcipotriol plus hydrocortisone; NYC 0462 (Nycomed) LY-2525623 (Eli Lilly) Teplizumab (MGA031; MacroGenics/ NN8226 (anti-IL-20; R348 (Rigel) TA-5493 (Mitsubishi Tanabe) TARGET PRODUCT PROFILE Comparator 1: Enbrel (etanercept; Comparator 2: Dovonex (calcipotriol; Comparator 3: Methotrexate Target product profile versus current level of attainment CLINICAL TRIAL DESIGN IN PSORIASIS Preclinical studies Clinical trials Introduction Clinical endpoints Future developments in clinical trial design Active comparator studies Measuring treatment efficacy with PASI and PGA will remain over the next five years Assessing improvements in comorbidities, especially psoriatic arthritis as a secondary outcome measure INNOVATIVE EARLY-STAGE APPROACHES Physicians believe interleukin inhibition is the most promising approach for new biologics Physicians believe Janus kinase inhibition is a promising approach for small molecules Phosphodiesterase 4 inhibition Select cluster of differentiation targets are in the pipeline, but physicians remain cautious of this approach THE FUTURE OF TREATMENT IN PSORIASIS Selecting treatments based on the presence of comorbidities, especially psoriatic arthritis Biomarkers to identify clinical subtypes in psoriasis Dermatologists anticipate a rise in moderate-to- BIBLIOGRAPHY Journal papers Websites Datamonitor reports APPENDIX A Physician research methodology The survey questionnaire APPENDIX B Contributing experts Report methodology About Datamonitor The Datamonitor Group is a world-leading provider of premium global business information, delivering independent data, analysis and opinion across the Automotive, Consumer Markets, Energy & Utilities, Financial Services, Logistics & Express, Pharmaceutical & Healthcare, Retail, Technology and Telecoms industries. Datamonitor's market intelligence products and services ensure that you will achieve your desired commercial goals by giving you the insight you need to best respond to your competitive environment. View more research from Datamonitor at http://www.fastmr.com/ About Fast Market Research Fast Market Research is an online aggregator and distributor of market research and business information. We represent the world's top research publishers and analysts and provide quick and easy access to the best competitive intelligence available. For more information about these or related research reports, please visit our website at http://www.fastmr.com or call us at 1.800.844.8156. # # # Fast Market Research is an online aggregator and distributor of market research and business information. We represent the world's top research publishers and analysts and provide quick and easy access to the best competitive intelligence available. End
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