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Frontier Pharma - Rheumatoid Arthritis: Identifying and Commercializing First-in-Class Innovation

GBI Research
Published Date » 2013-10-30
No. Of Pages » 112

GBI Research has released a new pharmaceutical report, “Frontier Pharma: Rheumatoid Arthritis Identifying and Commercializing First-in-Class Innovation”. This highly competitive market is saturated with multiple targeted monoclonal Antibody (mAb) therapies and small molecules, yet more of these treatments are expected to enter the market over the next few years. Despite this, the current developmental pipeline is highly innovative beyond these me-too products and incremental innovations and promises a number of first-in-class products across all stages. These new developments are driven by improvements in the understanding of signaling pathways and underlying disease mechanisms of Rheumatoid Arthritis (RA). These highly innovative products are expected to increase the diversity of available products, in terms of mechanism of action over the coming decade and are likely to have a significant impact on the dynamics of the clinical and commercial landscape.

The market is also characterized by high activity in licensing and co-development deals. In particular, there is sustained commercial interest in pipeline biologic therapies with a range of molecular targets. There is also considerable interest in small molecule inhibitors of intracellular kinases despite their clinical performances not being as well established as biologics or mAbs.

Scope

  • The report analyzes the RA pipeline and strategic alliance landscape with particular emphasis on first-in-class programs.
  • A brief introduction to RA, including symptoms, pathophysiology, and an overview of the pharmacotherapy
  • Highlights of the changing molecular target landscape between marketed and pipeline products with particular focus on innovation
  • A comprehensive review of first-in-class pipeline therapies; the pipeline is analyzed by Phase distribution, molecule type, molecular target, and administration route
  • Identification and assessment of first-in-class molecular targets highlighting early-stage programs with clinical utility that has yet to be evaluated, as well as an in-depth literature review of novel molecular targets
  • Assessment of the licensing and co-development deals for RA therapeutics

Reasons to buy

  • The report will assist business development strategies of companies who wish to develop RA therapies with improved benefits to existing treatments. In addition, this report will be of interest to companies seeking to expand pipeline portfolios through licensing agreements and co-development deals allowing them to 
  • Understand the overall focal shifts in therapeutic molecular targets of RA treatments
  • Identify first-in-class product development and understand the therapeutic and commercial prospects of first-in-class developmental programs based on available animal model data
  • Assess the value of products benchmarked against licensed and co-developed therapeutic programs 
  • Spot first-in-class programs that are potentially available for licensing and co-development deals
Table of Contents

1 Table of Contents
1 Table of Contents 5
1.1 List of Tables 6
1.2 List of Figures 7

2 Introduction 8
2.1 The Case for Innovation 8
2.1.1 Growing Opportunities for Biologic Products 8
2.1.2 Diversification of Molecular Targets 8
2.1.3 Innovative First-in-class Product Developments Remain Attractive 9
2.1.4 Changes in the Clinical and Commercial Environment to be More Favorable to Products Targeting Niche Patient Populations and Niche Indications 9
2.1.5 Sustained Innovation 10

3 Clinical and Commercial Landscape 11
3.1 Disease Overview 11
3.1.1 Disease Symptoms 12
3.1.2 Environmental Factors and Genetic Predisposition 12
3.1.3 Disease Pathophysiology 12
3.1.4 Pharmacotherapy Algorithm 13
3.2 Overview of Marketed Products for Rheumatoid Arthritis 14
3.3 Molecular Type Analysis 15
3.4 Molecular Target Analysis 16
3.4.1 Intracellular Therapeutic Targets 16
3.4.2 Membrane Therapeutic Targets 17
3.4.3 Extracellular Targets 17
3.5 Innovative Products in the RA Market 17
3.6 Efficacy and Safety of Marketed Products 20
3.7 Current Unmet Needs 22

4 Assessment of Pipeline Product Innovation 23
4.1 Rheumatoid Arthritis Pipeline by Molecule Type, Phase and Therapeutic Targets 23
4.2 Frequently Targeted Intracellular Kinases 25
4.2.1 p38 Kinase 25
4.2.2 MAPK 25
4.2.3 JAK 25
4.2.4 Spleen Tyrosine Kinase (Syk) 25
4.3 Frequently Targeted Cytokines and Receptors 26
4.3.1 TNF-α 26
4.3.2 Toll-Like Receptors 26
4.3.3 B Lymphocyte Stimulator 26
4.4 Efficacy and Safety of Pipeline Products 27
4.5 Comparative Distribution of Programs between the RA Market and Pipeline by Therapeutic Target Family 29
4.6 First-in-class Pipeline Programs Targeting Novel Molecule Targets 31

5 First-in-Class Target and Pipeline Program Evaluation 37
5.1 Cytokines and Receptors 37
5.1.1 Pipeline Programs which Target HMGB-1 37
5.1.2 Pipeline Programs which Target IL-10 Receptor 42
5.1.3 Pipeline Programs which Target HSP 60 46
5.1.4 Pipeline Programs which Target Interleukins 15 and 16 49
5.1.5 Pipeline programs which Target Macrophage Migration Inhibitory Factor (MIF) 52
5.2 Integrins 55
5.2.1 Pipeline Programs which Target Cadherin-11 55
5.2.2 Pipeline Programs which Target α1β1 Integrin (Very Late Antigen-1) 56
5.2.3 Pipeline Programs which Target Vascular Adhesion Protein-1 (VAP-1) 58
5.3 Proteases 59
5.3.1 Pipeline Programs which Target Cathepsin S 59
5.4 Nuclear Receptors 61
5.4.1 Pipeline Programs which Target RAR-Related Orphan Receptor (ROR) 61
5.4.2 Pipeline Programs which Target Nuclear Receptor Related 1 Protein 63
5.5 Intracellular Kinases 64
5.5.1 Pipeline Programs which Target Interleukin 1 Receptor Associated Kinase 4 64
5.6 Ion Channels 66
5.6.1 Pipeline Programs which Target Calcium Release Activated Channels 66
5.7 Others 68
5.7.1 Pipeline Programs which Target F1F0 ATP Synthase 68
5.7.2 Pipeline Programs which Target Immunoproteosome Subunit 7 (IMP7) 69
5.8 Conclusion 71

6 Deals and Strategic Consolidations 73
6.1 Licensing Deals 73
6.2 Co-development Deals 86
6.3 First-in-Class Programs which have not been involved in Licensing or Co-Development Deals 98

7 Appendix 99
7.1 Abbreviations 99
7.2 Methodology 102
7.3 References 102
7.4 References for Figures 5 and 8 109
7.5 Contact Us 111
7.6 Disclaimer 112

List of Tables


Table 1: Pipeline, Global, First-in-class, High Mobility Box Protein-1 Inhibitors 39
Table 2: Pipeline, Global, First-in-class IL-10 Receptor 44
Table 3: Overview of Pipeline, Global, First-in-class IL-10 Receptor Activator 46
Table 4: Pipeline, Global, First-in-class Inhibitors of HSP60 48
Table 5: Overview of Pipeline, Global, First-in-class Inhibitors of HSP60 49
Table 6: Pipeline, Global, First-in-class Inhibitors of IL-15 50
Table 7: Pipeline, Global, First-in-class Inhibitors of MIF 54
Table 8: Pipeline, Global, First-in-class Inhibitors of Very Late Antigen-1 57
Table 9: Overview of Pipeline, Global, First-in-class Inhibitors of Very Late Antigen-1 57
Table 10: Pipeline, Global, First-in-class Modulators of Cathepsin S 60
Table 11: Pipeline, Global, First-in-class Modulators of NURR-1 63
Table 12: Pipeline, Global, First-in-class modulators of Interleukin-1 Associated Kinase 4 65
Table 13: Pipeline, Global, First-in-class Modulators of Immunoproteosome Subunit 7 70
Table 14: Overview of Pipeline, Global, First-in-class Modulators of Immunoproteosome Subunit 7 71
Table 15: References for Figures 5 and 8 109

List of Figures


Figure 1: American College of Rheumatology Treatment Guidelines. 2012 14
Figure 2: Rheumatoid Arthritis, Global, Marketed Products, Part 1 15
Figure 3: Rheumatoid Arthritis, Global, Marketed Products, Part 2 16
Figure 4: Rheumatoid Arthritis, Global, Innovative Marketed Products 19
Figure 5: Rheumatoid Arthritis, Global, Marketed Products, Comparative Efficacy and Safety 21
Figure 6: Rheumatoid Arthritis, Global, Pipeline by Molecule Type, Phase and Therapeutic Targets 24
Figure 7: Rheumatoid Arthritis, Global, Pipeline 27
Figure 8: Rheumatoid Arthritis, Global, Pipeline Products, Comparative Efficacy and Safety 28
Figure 9: Rheumatoid Arthritis, Global, Pipeline and Marketed Products 30
Figure 10: Rheumatoid Arthritis, Global, Pipeline, First-in-class Products 32
Figure 11: Rheumatoid Arthritis, Global, Pipeline, First-in-class Products in the RA Pipeline, Part-1 34
Figure 12: Rheumatoid Arthritis, Global, Pipeline, First-in-class Products in the RA Pipeline, Part-2 35
Figure 13: Pipeline, Global, First-in-class High Mobility Box Protein-1 Inhibitors 41
Figure 14: Pipeline, Global, First-in-class Inhibitors of IL-15 52
Figure 15: Pipeline, Global, First-in-class Inhibitors of MIF 55
Figure 16: Pipeline, Global, First-in-class Inhibitors Cadherin-11 56
Figure 17: Pipeline, Global, First-in-class Inhibitors of Vascular Adhesion Protein-1 58
Figure 18: Pipeline, Global, First-in-class Inhibitors of Cathepsin S 61
Figure 19: Pipeline, Global, First-in-class Modulators of RAR-related Orphan Receptors 62
Figure 20: Pipeline, Global, First-in-class Modulators of Interleukin 1 Associated Kinase 4 66
Figure 21: Pipeline, Global, First-in-class modulators of Calcium Release Activated Channels 67
Figure 22: Pipeline, Global, First-in-class Modulators of F1F0 ATP Synthase 68
Figure 23: Rheumatoid Arthritis, Global, Licensing Agreements, 2006–September 2013, (A) 73
Figure 24: Rheumatoid Arthritis, Global, Licensing Agreements, 2006–September 2013,(B) 75
Figure 25: Rheumatoid Arthritis, Global, Licensing Agreements, 2006–September 2013, (C) 76
Figure 26: Rheumatoid Arthritis, Global, Licensing Agreements, 2006–September 2013, (D) 78
Figure 27: Rheumatoid Arthritis, Global, Licensing Agreements, 2006–September 2013, (E) 79
Figure 28: Rheumatoid Arthritis, Global, Licensing Agreements, 2006–September 2013, (F) 81
Figure 29: Rheumatoid Arthritis, Global, Licensing Agreements, First-in-class Programs, 2006 -September 2013, (A) 82
Figure 30: Rheumatoid Arthritis, Global, Licensing Agreements, First-in-class Programs, 2006–September 2013, (B) 83
Figure 31: Rheumatoid Arthritis, Global, Licensing Agreements, First-in-class Programs, 2006–September 2013, (C) 84
Figure 32: Rheumatoid Arthritis, Global, Licensing Agreements, First-in-class Programs, 2006–September 2013, (D) 85
Figure 33: Rheumatoid Arthritis, Global, Co-development Deals, 2006–September 2013, (A) 86
Figure 34: Rheumatoid Arthritis, Global, Co-development Deals, 2006–September 2013, (B) 88
Figure 35: Rheumatoid Arthritis, Global, Co-development Deals, 2006–September 2013, (C) 89
Figure 36: Rheumatoid Arthritis, Global, Co-development Deals, 2006–September 2013, (D) 91
Figure 37: Rheumatoid Arthritis, Global, Co-development Deals, 2006–September 2013, (E) 92
Figure 38: Rheumatoid Arthritis, Global, Co-development Deals, 2006–September 2013, (F) 93
Figure 39: Rheumatoid Arthritis, Global, Co-development Deals, September First-in-class Programs, 2006–September 2013, (A) 94
Figure 40: Rheumatoid Arthritis, Global, Co-development Deals, September First-in-class Programs, 2006–September 2013, (B) 95
Figure 41: Rheumatoid Arthritis, Global, Co-development Deals, 2006-2013 (September), First-in-class Programs,(C) 96
Figure 42: Rheumatoid Arthritis, Global, Co-development Deals, 2006-2013 (September), First-in-class Programs, (D) 97
Figure 43: Rheumatoid Arthritis, Global, First-in-class Programs with no Recorded Prior Deal Involvement, 2006–2013 98

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