Frontier Pharma: Psoriasis - Identifying and Commercializing First-in-Class Innovation



GBI Research

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Psoriasis is a chronic, inflammatory disease triggered by deregulated Thymus-derived (T) cells, resulting inflammation and benign hyperplasia of keratinocytes within the skin. Manifestations of affected skin are red, thickened plaques with an overlying silver-white scale, which significantly impairs the patient’s physical and mental wellbeing. The primary cause of psoriasis is unknown, as are the mechanisms that lead to immune cells directing inflammatory responses towards the skin. Within the lucrative autoimmune market, the psoriasis market has grown considerably due to the repositioning of all three marketed Tumor Necrosis Factor (TNF) inhibitors: Humira (adalimumab) and Enbrel (etanercept) which were originally approved for rheumatoid arthritis, and also Remicade (infliximab), the first biologic to be approved for Crohn’s disease, an autoimmune disease which largely affects the gastrointestinal system.
Table of Contents

1 Table of Contents
1.1 List of Tables
1.2 List of Figures

2 The Case for Innovation
2.1 Growing Opportunities for Biologic Products
2.2 Diversification of Molecular Targets
2.3 Innovative First-in-Class Product Developments Remain Attractive
2.4 Changes in the Clinical and Commercial Environment Will be More Favorable to Products That Target Niche Indications and Patient Populations
2.5 Innovation in Psoriasis

3 Clinical and Commercial Landscape
3.1 Disease Introduction
3.2 Epidemiology
3.3 Etiology
3.3.1 Genetic Predisposition
3.3.2 Environmental Factors
3.4 Pathophysiology
3.4.1 Keratinocytes
3.4.2 Dendritic Cells
3.4.3 T-Cells
3.4.4 Angiogenesis
3.4.5 Growth Factors
3.5 Symptoms and Co-morbidities
3.5.1 Skin Manifestations
3.5.2 Psoriatic Arthritis
3.5.3 Uveitis
3.5.4 Cardiovascular Disease
3.5.5 Psychological Impact
3.6 Diagnosis of Psoriasis
3.6.1 Diagnosis of Psoriatic Arthritis
3.7 Treatment
3.7.1 Pharmacological Therapies
3.7.2 Topical Medications
3.7.3 Systemic Medications
3.7.4 Non-Pharmacological Therapies
3.7.5 Combination and Rotational Therapies
3.8 Overview of Marketed Products for Psoriasis
3.8.1 Oral Non-Biologic DMARDs
3.8.2 Off-Label Non-Biologic DMARDs
3.8.3 Biologics
3.8.4 Comparative Efficacy and Safety of Marketed Products
3.8.5 Unmet Need

4 Assessment of Psoriasis Pipeline and Innovation
4.1 Overview
4.2 Comparative Efficacy and Safety of Pipeline Programs
4.3 Comparative Distribution of Programs in the Psoriasis Market and Pipeline by Therapeutic Target Family
4.4 Comparative Distribution of Programs with First-in-Class and Established Molecular Targets
4.5 Pipeline Programs Targeting Established Molecular Targets
4.6 First-in-Class Pipeline Programs with Novel Molecular Targets

5 First-in-Class Target and Pipeline Program Evaluation
5.1 Cytokines and Receptors
5.1.1 Pipeline Programs Targeting Tumor Necrosis Factor Receptors
5.1.2 Pipeline Programs Targeting Interleukin-6
5.1.3 Pipeline Programs Targeting Interleukin-8
5.1.4 Pipeline Programs Targeting Interleukin-17
5.1.5 Pipeline Programs Targeting Interferon-?
5.2 B and T Cell Antigens
5.2.1 Pipeline Programs Targeting Cluster of Differentiation 4
5.2.2 Pipeline Programs Targeting Cluster of Differentiation 28
5.3 Intracellular Kinases
5.3.1 Pipeline Programs Targeting Interleukin-1 Receptor-Associated Kinase-4
5.4 Nuclear Receptors
5.4.1 Pipeline Programs Targeting Retinoic Acid Receptor-Related Orphan Receptor
5.5 Growth Factors
5.5.1 Pipeline Programs Targeting Transforming Growth Factor-ß Receptor
5.5.2 Pipeline Programs Targeting Insulin Receptor Substrate
5.6 Ion Channels
5.6.1 Pipeline Programs Targeting Calcium Release-Activated Calcium Channel
5.7 Integrins
5.7.1 Pipeline Programs Targeting Vascular Adhesion Protein-1
5.8 Other
5.8.1 Pipeline Programs Targeting F1F0-Adenosine Triphosphate Synthase
5.8.2 Pipeline Programs Targeting Cathepsin S
5.9 Conclusion

6 Deals and Strategic Consolidations
6.1 Licensing Agreements
6.2 Major Co-development Deals
6.3 First-in-Class Developmental Programs Not Involved in Co-Development or Licensing Deals

7 Appendix
7.1 Abbreviations
7.2 References
7.3 Methodology
7.4 Contact Us
7.5 Disclaimer
Table 1: Psoriasis Market, Global, First-in-Class Interferon-? Inhibitors, Pipeline Development
Table 2: Psoriasis Market, Global, First-in-Class F1F0-Adenosine Triphosphate Synthase Modulators, Pipeline Development
Table 3: Abbreviations
Figure 1: Psoriasis, Global, Treatment Algorithm
Figure 2: Psoriasis Market, Global, Comparative Safety and Efficacy, 2013 - 1
Figure 3: Psoriasis Market, Global, Comparative Safety and Efficacy, 2013 - 2
Figure 4: Psoriasis Market, Global, Pipeline Overview, 2013
Figure 5: Psoriasis Market, Global, Comparative Safety and Efficacy of Pipeline Products, 2013
Figure 6: Psoriasis, Global, Comparative Distribution of Marketed and pipeline Products by Target Family
Figure 7: Psoriasis Market, Global, Pipeline, Comparative Distribution of Programs by Established and First-in-Class Targets, 2013
Figure 8: soriasis Market, Global, Pipeline Products with Established Targets, 2013
Figure 9: Psoriasis Market, Global, Pipeline Products with First-in-Class Targets, 2013
Figure 10: Psoriasis Market, Global, First-in-Class Tumor Necrosis Factor-a Receptor Modulators, Pipeline Development
Figure 11: Psoriasis Market, Global, First-in-Class Interleukin-6 Inhibitors, Pipeline Development
Figure 12: Psoriasis Market, Global, First-in-Class Interleukin-8 Inhibitors, Pipeline Development
Figure 13: Psoriasis Market, Global, First-in-Class Interleukin-17 Inhibitors, Pipeline Development
Figure 14: Psoriasis Market, Global, First-in-Class Cluster of Differentiation 4 Modulators, Pipeline Development
Figure 15: Psoriasis Market, Global, First-in-Class Cluster of Differentiation 28 Modulators, Pipeline Development
Figure 16: Psoriasis Market, Global, First-in-Class Interleukin-1 Receptor Associated Kinase-4 Inhibitors, Pipeline Development
Figure 17: Psoriasis Market, Global, First-in-Class Retinoic Acid Receptor-Related Orphan Receptor Inhibitors, Pipeline Development
Figure 18: Psoriasis Market, Global, First-in-Class Transforming Growth Factor-ß Receptor Modulators, Pipeline Development
Figure 19: Psoriasis Market, Global, First-in-Class Insulin Receptor Substrate Modulators, Pipeline Development
Figure 20: Psoriasis Market, Global, First-in-Class Calcium Release-Activated Calcium Channel, Pipeline Development
Figure 21: Psoriasis Market, Global, First-in-Class Vascular Adhesion Protein-1 Inhibitors, Pipeline Development
Figure 22: Psoriasis Market, Global, First-in-Class Cathepsin S Inhibitors, Pipeline Development
Figure 23: Psoriasis Market, Global, Licensing Agreement Analysis 1, 2006–2014
Figure 24: Psoriasis Market, Global, Licensing Agreement Analysis 2, 2006–2014
Figure 25: Psoriasis Market, Global, Licensing Agreement Deal Analysis, 2006–2014
Figure 26: Psoriasis Market, Global, Co-Development Deal Analysis, 2006–2014 - 1
Figure 27: Psoriasis Market, Global, Co-Development Deal Analysis, 2006–2014 - 2
Figure 28: Psoriasis Market, Global, First-in-Class Programs with no Recorded Prior Deal Involvement, 2006–2014