GBI Research has released the pharma report: “Frontier Pharma: Psoriasis Identifying and Commercializing First-in-Class Innovation”, which identifies and assesses first-in-class innovation in the psoriasis development pipeline.

Over the last decade, a greater understanding of the underlying pathophysiology of psoriasis has increased emphasis on developing immuneomodulating therapies, as opposed to largely symptomatic treatments. This is currently reflected in a competitive market dominated by multiple disease-modifying biologic therapies (inhibitors of TNF-a and IL-12/IL-23) and generic small-molecule therapies. Despite this, there are significant unmet needs in the market, including safety concerns regarding immunomodulation. This is a particularly important issue for the long-term commercial and clinical success of psoriatic therapeutics, especially for emerging biologics. Another unmet need is ease of drug application, as biologic drug delivery is invasive and painful.

This allows for pipeline programs that offer a more refined approach to immunomodulation and ease of drug application to gain market share upon entry. In a pipeline of over 200 programs, approximately one third exhibits a novel mechanism of action. Innovative programs target a wide range of molecules implicated in immune signaling, such as cytokines and B and T cell antigens. Several promising first-in-class therapies can selectively modulate specific subsets of immune cells without compromising the entire immune system. In particular, biologics that target a subset of T cells, which are strongly implicated in autoimmune pathophysiology, could allow for specificity of immune suppression and thereby reduce adverse side effects. Based on clinical trials, IL-17-targeted therapies have demonstrated superiority over currently established therapies in achieving advanced clinical endpoints. Other agents which activate regulatory arms of the immune system have also shown promising clinical profiles. In addition, innovative programs that target molecules have only recently gained recognition of their therapeutic value in the treatment of psoriasis, including novel angiogenic proteins, signaling transduction proteins and novel nuclear receptors. Despite their recent implication in disease pathophysiology, many of these agents have also demonstrated clinical utility in the treatment of psoriasis and are likely to contribute to a diversified therapeutic landscape.

Scope

• A brief introduction to psoriasis, including symptoms, pathophysiology, and overview of pharmacotherapy
• The changing molecular target landscape between market and pipeline and particular focal points of innovation
• Overview of how innovative products are contributing to the pipeline and market for psoriasis
• Comprehensive review of the pipeline for first-in-class therapies, analyzed on the basis of phase distribution, molecule type, molecular target, and administration route
• Identification and assessment of first-in-class molecular targets with a particular focus on early-stage programs of which clinical utility has yet to be evaluated, as well as literature reviews on novel molecular targets
• Assessment of the licensing and co-development deals for psoriasis therapies

Reasons to buy

• Understanding of the focal shifts in molecular targets in the psoriasis pipeline
• Understanding of the distribution of pipeline programs by phase of development, molecule type and molecular target
• Scientific and clinical analysis of first-in-class developmental programs
• Assessment of the valuations of licensed and co-developed psoriasis treatments
• A list of the first-in-class therapies potentially open to deal-making opportunities.
• Analysis of financial valuations on licensed or co-developed first-in-class therapies and generics

Table of Contents

1 Table of Contents 4
1.1 List of Tables 6
1.2 List of Figures 6

2 The Case for Innovation 7
2.1 Growing Opportunities for Biologic Products 7
2.2 Diversification of Molecular Targets 7
2.3 Innovative First-in-Class Product Developments Remain Attractive 7
2.4 Changes in the Clinical and Commercial Environment Will be More Favorable to Products That Target Niche Indications and Patient Populations 8
2.5 Innovation in Psoriasis 8

3 Clinical and Commercial Landscape 9
3.1 Disease Introduction 9
3.2 Epidemiology 9
3.3 Etiology 10
3.3.1 Genetic Predisposition 10
3.3.2 Environmental Factors 10
3.4 Pathophysiology 10
3.4.1 Keratinocytes 10
3.4.2 Dendritic Cells 11
3.4.3 T-Cells 11
3.4.4 Angiogenesis 11
3.4.5 Growth Factors 11
3.5 Symptoms and Co-morbidities 12
3.5.1 Skin Manifestations 12
3.5.2 Psoriatic Arthritis 12
3.5.3 Uveitis 12
3.5.4 Cardiovascular Disease 12
3.5.5 Psychological Impact 12
3.6 Diagnosis of Psoriasis 13
3.6.1 Diagnosis of Psoriatic Arthritis 13
3.7 Treatment 13
3.7.1 Pharmacological Therapies 13
3.7.2 Topical Medications 13
3.7.3 Systemic Medications 14
3.7.4 Non-Pharmacological Therapies 14
3.7.5 Combination and Rotational Therapies 15
3.8 Overview of Marketed Products for Psoriasis 16
3.8.1 Oral Non-Biologic DMARDs 16
3.8.2 Off-Label Non-Biologic DMARDs 19
3.8.3 Biologics 19
3.8.4 Comparative Efficacy and Safety of Marketed Products 23
3.8.5 Unmet Need 26

4 Assessment of Psoriasis Pipeline and Innovation 27
4.1 Overview 27
4.2 Comparative Efficacy and Safety of Pipeline Programs 29
4.3 Comparative Distribution of Programs in the Psoriasis Market and Pipeline by Therapeutic Target Family 31
4.4 Comparative Distribution of Programs with First-in-Class and Established Molecular Targets 33
4.5 Pipeline Programs Targeting Established Molecular Targets 36
4.6 First-in-Class Pipeline Programs with Novel Molecular Targets 38

5 First-in-Class Target and Pipeline Program Evaluation 40
5.1 Cytokines and Receptors 40
5.1.1 Pipeline Programs Targeting Tumor Necrosis Factor Receptors 40
5.1.2 Pipeline Programs Targeting Interleukin-6 42
5.1.3 Pipeline Programs Targeting Interleukin-8 43
5.1.4 Pipeline Programs Targeting Interleukin-17 44
5.1.5 Pipeline Programs Targeting Interferon-γ 45
5.2 B and T Cell Antigens 46
5.2.1 Pipeline Programs Targeting Cluster of Differentiation 4 46
5.2.2 Pipeline Programs Targeting Cluster of Differentiation 28 47
5.3 Intracellular Kinases 48
5.3.1 Pipeline Programs Targeting Interleukin-1 Receptor-Associated Kinase-4 48
5.4 Nuclear Receptors 49
5.4.1 Pipeline Programs Targeting Retinoic Acid Receptor-Related Orphan Receptor 49
5.5 Growth Factors 51
5.5.1 Pipeline Programs Targeting Transforming Growth Factor-β Receptor 51
5.5.2 Pipeline Programs Targeting Insulin Receptor Substrate 52
5.6 Ion Channels 53
5.6.1 Pipeline Programs Targeting Calcium Release-Activated Calcium Channel 53
5.7 Integrins 54
5.7.1 Pipeline Programs Targeting Vascular Adhesion Protein-1 54
5.8 Other 55
5.8.1 Pipeline Programs Targeting F1F0-Adenosine Triphosphate Synthase 55
5.8.2 Pipeline Programs Targeting Cathepsin S 56
5.9 Conclusion 57

6 Deals and Strategic Consolidations 59
6.1 Licensing Agreements 59
6.2 Major Co-development Deals 62
6.3 First-in-Class Developmental Programs Not Involved in Co-Development or Licensing Deals 65

7 Appendix 66
7.1 Abbreviations 66
7.2 References 68
7.3 Methodology 76
7.4 Contact Us 76
7.5 Disclaimer 77

List of Tables

Table 1: Psoriasis Market, Global, First-in-Class Interferon-γ Inhibitors, Pipeline Development 46
Table 2: Psoriasis Market, Global, First-in-Class F1F0-Adenosine Triphosphate Synthase Modulators, Pipeline Development 56
Table 3: Abbreviations 66

List of Figures

Figure 1: Psoriasis, Global, Treatment Algorithm 15
Figure 2: Psoriasis Market, Global, Comparative Safety and Efficacy, 2013 - 1 24
Figure 3: Psoriasis Market, Global, Comparative Safety and Efficacy, 2013 - 2 25
Figure 4: Psoriasis Market, Global, Pipeline Overview, 2013 28
Figure 5: Psoriasis Market, Global, Comparative Safety and Efficacy of Pipeline Products, 2013 30
Figure 6: Psoriasis, Global, Comparative Distribution of Marketed and pipeline Products by Target Family 31
Figure 7: Psoriasis Market, Global, Pipeline, Comparative Distribution of Programs by Established and First-in-Class Targets, 2013 35
Figure 8: Psoriasis Market, Global, Pipeline Products with Established Targets, 2013 37
Figure 9: Psoriasis Market, Global, Pipeline Products with First-in-Class Targets, 2013 39
Figure 10: Psoriasis Market, Global, First-in-Class Tumor Necrosis Factor-α Receptor Modulators, Pipeline Development 41
Figure 11: Psoriasis Market, Global, First-in-Class Interleukin-6 Inhibitors, Pipeline Development 43
Figure 12: Psoriasis Market, Global, First-in-Class Interleukin-8 Inhibitors, Pipeline Development 44
Figure 13: Psoriasis Market, Global, First-in-Class Interleukin-17 Inhibitors, Pipeline Development 45
Figure 14: Psoriasis Market, Global, First-in-Class Cluster of Differentiation 4 Modulators, Pipeline Development 47
Figure 15: Psoriasis Market, Global, First-in-Class Cluster of Differentiation 28 Modulators, Pipeline Development 48
Figure 16: Psoriasis Market, Global, First-in-Class Interleukin-1 Receptor Associated Kinase-4 Inhibitors, Pipeline Development 49
Figure 17: Psoriasis Market, Global, First-in-Class Retinoic Acid Receptor-Related Orphan Receptor Inhibitors, Pipeline Development 50
Figure 18: Psoriasis Market, Global, First-in-Class Transforming Growth Factor-β Receptor Modulators, Pipeline Development 52
Figure 19: Psoriasis Market, Global, First-in-Class Insulin Receptor Substrate Modulators, Pipeline Development 53
Figure 20: Psoriasis Market, Global, First-in-Class Calcium Release-Activated Calcium Channel, Pipeline Development 54
Figure 21: Psoriasis Market, Global, First-in-Class Vascular Adhesion Protein-1 Inhibitors, Pipeline Development 55
Figure 22: Psoriasis Market, Global, First-in-Class Cathepsin S Inhibitors, Pipeline Development 57
Figure 23: Psoriasis Market, Global, Licensing Agreement Analysis 1, 2006–2014 59
Figure 24: Psoriasis Market, Global, Licensing Agreement Analysis 2, 2006–2014 60
Figure 25: Psoriasis Market, Global, Licensing Agreement Deal Analysis, 2006–2014 61
Figure 26: Psoriasis Market, Global, Co-Development Deal Analysis, 2006–2014 - 1 62
Figure 27: Psoriasis Market, Global, Co-Development Deal Analysis, 2006–2014 - 2 64
Figure 28: Psoriasis Market, Global, First-in-Class Programs with no Recorded Prior Deal Involvement, 2006–2014 65