Therapeutic Class Overview : Psoriasis Plaque Psoriasis & Psoriatic Arthritis - Novel Oral Drugs And Biologics To Change Future Treatment Paradigm

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1 Brochure More information from Therapeutic Class Overview : Psoriasis Plaque Psoriasis & Psoriatic Arthritis - Novel Oral Drugs And Biologics To Change Future Treatment Paradigm Description: Over the last decades, therapeutic options for Plaque Psoriasis (PsO) and Psoriatic Arthritis (PsA) have expanded considerably and improved patients' pain, function, and quality of life. Approved biologics fill in a critical unmet need of limited efficacy of DMARDs; however, as in most cases one drug does not fit the bill for all the patients. The lack of targeted immune therapies other than TNF-a inhibitors in Psoriasis signals opportunities for drug developers to bring agents to market that offer treatment alternatives (Anti-IL-17, IL-13, JAK, PDE4 inhibitors, etc). Pfizer launched the first oral Rheumatoid Arthritis (RA) drug Xeljanz (tofacitinib/ CP-690,550, JAK 1/3 inhibitor) in 2012 for pts with moderately to severely active RA who are inadequate responder or intolerant to Methotrexate (MTX) at a price almost at par with biologics. In the last couple of years, the face of healthcare has been changing due to challenges quality and its affordability and accessibility to the providers and patients. The authors believe there is an ample room for an efficacious affordable therapy to tap the mild to moderate RA pts population where biologics have not made a dent and expect few potential launches in (OTEZLA apremilast, Xeljanz tofacitinib) and onwards. In this report, the authors highlight the novel targets oral, injectables, and topical drugs in the pipeline for the treatment of Psoriasis, compare their clinical trials data, and their commercial potential! Contents: Executive Summary Unmet Need in Psoriasis Limitations of Anti-TNFs Scope for Entrants with Better Efficacy and Safety Profiles Specific Unmet Need and Emerging Therapies Plaque Psoriasis Psoriatic Arthritis Pipeline Biologics Products IL-12 and IL-23 inhibitors Stelara tildrakizumab (MK-3222/ SCH ) Guselkumab (CNTO 1959) Fezakinumab (ILV-094) Interleukin-17 (IL-17) and Receptor (IL-17RA) Secukinumab Ixekizumab (LY ) Brodalumab (AMG 827) Other Targets Cimzia Itolizumab Tregalizumab Pipeline Oral Treatment Targeting JAK-STATs Tofacitinib LY INCB39110 ASP015K GSK Approved/ Marketed Products 3 A. Psoriasis' Pipeline: Small Molecules Oral/ Injectable B. Psoriasis' Pipeline: Topical

2 Psoriasis' Pipeline: Biologics Select Late- & Mid-Stage Pipeline: Plaque Psoriasis Select Late- & Mid-Stage Pipeline: Psoriatic Arthritis Ixekizumab: Phase III Clinical Trial Designs Brodalumab: Phase III Clinical Trial Designs Clinical Data Comparison: Plaque Psoriasis Biologics A. Tofacitinib: PASI Improvement from Baseline B. Tofacitinib: Improvement in Quality-of-Life (QOL)Measures Other Targets in Clinical Development for RA Genes Associated with Psoriasis Susceptibility Competitive Landscape: Plaque Psoriasis Competitive Landscape: Psoriatic Arthritis FIGURES PFE's Xeljanz Launch vs. Other Recent RA Launches The Structure and Function of the Cytokines IL-12 And IL-23 Clinical Data: ACCEPT Head-To-Head Trial with Enbrel MK-3222Neutralizes IL-23, Specifically Immunology and Immunotherapeutic Targets of Psoriasis IL-17-Induced Signaling Pathways Ixekizumab: Clinical Response (PASI And week 20 Itolizumab Value Proposition with Marketed Products Regulation of JAK STAT Signaling INCB39110: Response Rate - Exploratory Efficacy Analyses ASP015K Changes from Baseline in PASI at Day 42 PDE Inhibitors Crosstalk AEB071 PASI 75 Reductions Compared with Baseline DRM02 Novel Mechanism of Action DLX105 PhIa Results (PASI Day 14) Psoriasis Treatment Ladder (Schematic) US Psoriasis Market Estimation Proposed Schema of the Evolution of A Psoriatic Lesion Distribution of Psoriasis Severity Use of Therapies Depending on the Disease Severity Targeted Therapy Classification Based on Pathogenesis Comparison of GRAPPA and AAD Treatment Guidelines Fig. # Title Pg. No. PFE's Xeljanz Launch vs. Other Recent RA Launches The Structure and Function of the Cytokines IL-12 And IL-23 Clinical Data: ACCEPT Head-To-Head Trial with Enbrel MK-3222Neutralizes IL-23, Specifiably Immunology and Immunotherapeutic Targets of Psoriasis IL-17-Induced Signaling Pathways Ixekizumab: Clinical Response (PASI And week Itolizumab Value Proposition with Marketed Products Regulation of JAK STAT Signaling INCB39110: Response Rate - Exploratory Efficacy Analyses ASP015K Changes from Baseline in PASI at Day 42 PDE Inhibitors Crosstalk AEB071 PASI 75 Reductions Compared with Baseline DRM02 Novel Mechanism of Action DLX105 PhIa Results (PASI Day 14) Psoriasis Treatment Ladder (Schematic) US Psoriasis Market Estimation Proposed Schema of the Evolution of A Psoriatic Lesion Distribution of Psoriasis Severity Use of Therapies Depending on the Disease Severity Targeted Therapy Classification Based on Pathogenesis Comparison of GRAPPA and AAD Treatment Guidelines

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