Frontier Pharma: Versatile Innovation in Immunology – Large Therapy Area Pipeline with a High Degree of Repositioning Potential

Immunology is a large therapy area characterized by disorders of the immune system – specifically an aberrant immune response against healthy tissues present in the body, leading to chronic or acute inflammation. Depending on the specific site affected, this can lead to various types of chronic pain and loss of mobility, and have a negative impact on quality of life.

This disease area has a total of 2,145 products in active development, trailing only oncology, infectious diseases and central nervous system disorders in terms of pipeline size. There are a total of 529 immunology pipeline products that act on first-in-class molecular targets, representing approximately 40% of the total immunology pipeline for which the molecular target was disclosed.

Due to a degree of crossover between immunology indications in terms of their underlying pathophysiology, it is not uncommon for products being developed for this therapy area to have developmental programs testing them across multiple indications.

Approximately one-fifth of first-in-class pipeline products are in development for two or more indications within the therapy area. This presents an opportunity for companies to develop innovative products across multiple immune disorders, and therefore reach a larger pool of patients than products developed for single indications.

Scope

– What are the key points of overlap in the pathophysiology of immune disorders?

– What is the current standard of treatment across these markets, and what lessons can be learned by companies seeking to innovate and build on these products?

– Which molecule types and molecular targets are most prominent within the pipeline?

– Which first-in-class targets are most promising?

– Do immunology products attract high deal values, and which specific product types are able to attract the highest values?

– Which molecule types and molecular targets dominate the deals landscape?

Reasons to buy

- Appreciate the current clinical and commercial landscapes by considering disease pathogenesis, etiology, epidemiology, symptoms, co-morbidities and complications, and treatment options.

- Identify leading products and companies within the market, as well as key unmet needs, in order to gain a competitive understanding of gaps in the market.

Review key pipeline trends by analyzing therapies by stage of development, molecule type and molecular target, and identify key trends regarding innovation within each segment.

- Assess the therapeutic potential of first-in-class targets. Using a proprietary matrix, all first-in-class targets in the immunology pipeline have been assessed and ranked according to clinical potential, and the most promising early-stage targets have been further reviewed in greater detail.

- Identify promising first-in-class pipeline assets that have had no prior involvement in licensing or co-development deals, and are therefore potentially suitable for in-licensing.

Table of Contents

1 Table of Contents

1 Table of Contents 2

1.1 List of Tables 3

1.2 List of Figures 3

2 Executive Summary 5

2.1 Large Therapy Area Characterized by a High Degree of Pathophysiological Crossover 5

2.2 Strong Pipeline Shows High Level of Versatile Innovation 5

2.3 Substantial Deal Making Activity Observed over the Past Decade 5

3 The Case for Innovation in the Immunology Market 6

3.1 Growing Opportunities for Biologic Products 7

3.2 Diversification of Molecular Targets 7

3.3 Innovative First-in-Class Product Developments Remain Attractive 7

3.4 Regulatory and Reimbursement Policy Shifts Favor First-in-Class Product Innovation 8

3.5 Sustained Innovation 8

4 Introduction 9

4.1 Therapy Area Introduction 9

4.2 Symptoms 9

4.3 Etiology and Pathophysiology 9

4.3.1 Innate Immunity 9

4.3.2 Adaptive Immunity 10

4.3.3 The Role of Cytokines 11

4.3.4 Autoimmunity 11

4.3.5 Etiologic Factors for Autoimmunity and Allergies 12

4.3.6 Conclusion 12

4.4 Co-morbidities and Complications 13

4.5 Epidemiology 13

4.6 Treatment 14

4.6.1 Non-Biologic Disease-Modifying Anti-Rheumatic Drugs 15

4.6.2 Glucocorticoids 15

4.6.3 Biologics and Targeted Therapies 15

5 Pipeline Landscape Assessment 17

5.1 Overview 17

5.2 Pipeline Development Landscape 18

5.3 Molecular Targets in the Pipeline 19

5.4 Comparative Distribution of Programs between the Oncology Market and Pipeline by Therapeutic Target Family 20

5.5 First-in-Class and Versatile Pipeline Programs 21

5.6 First-in-Class Immunology Products by Phase, Molecule Type and Molecular Target 23

5.7 Versatility of First-in-Class Pipeline Products 26

6 Immunology Signaling Network, Disease Causation and Innovation Alignment 35

6.1 Complexity of Signaling Networks 35

6.2 Signaling Pathways and First-in-Class Molecular Target Integration 35

6.3 First-in-Class Matrix Assessment 35

7 First-in-Class Target and Pipeline Program Evaluation 40

7.1 Pipeline Programs Targeting Toll-Like Receptors 3, 6 and 8 40

7.2 Pipeline Programs Targeting Spleen Tyrosine Kinase 44

7.3 Pipeline Programs Targeting IL-7R 46

7.4 Pipeline Programs Targeting C-C Chemokine Receptor Type 6 47

7.5 Pipeline Programs Targeting P2RX7 48

7.6 Pipeline Programs Targeting ITK 50

7.7 Pipeline Programs Targeting IRAK4 51

7.8 Pipeline Programs Targeting Orai1 52

7.9 Pipeline Programs Targeting Tumor Necrosis Factor Receptor Superfamily Member 5 54

7.10 Conclusion 55

8 Strategic Consolidations 56

8.1 Industry-Wide First-in-Class Deals 56

8.2 Licensing Deals 57

8.2.1 Deals by Region, Year and Value 58

8.2.2 Deals by Stage of Development and Value 59

8.2.3 Deals by Molecule Type and Value 60

8.2.4 Deals by Molecular Target and Value 61

8.3 Co-development Deals 62

8.3.1 Deals by Region, Year and Value 62

8.3.2 Deals by Stage of Development and Value 64

8.3.3 Deals by Molecule Type and Value 65

8.3.4 Deals by Molecular Target and Value 66

8.4 List of First-in-Class Pipeline Products with and Without Prior Deal Involvement 67

9 Appendix 72

9.1 Abbreviations 72

9.2 References 72

9.3 Research Methodology 78

9.3.1 Data integrity 78

9.3.2 Innovative and meaningful analytical techniques and frameworks 78

9.3.3 Evidence based analysis and insight 78

9.4 Secondary Research 79

9.4.1 Market Analysis 79

9.4.2 Pipeline Analysis 79

9.4.3 Licensing and Co-development Deals 80

9.5 Contact Us 80

9.6 Disclaimer 80

List of Tables

1.1 List of Tables

Table 1: Versatile Innovation in Immunology, Global, Epidemiology of Inflammatory Immunological Disorders, 2015 13

Table 2: Versatile Innovation in Immunology, Global, Toll-Like Receptors and their Known Ligands, 2016 40

Table 3: Versatile Innovation in Immunology, Global, Key Features of TLR3, 2016 42

Table 4: Versatile Innovation in Immunology, Global, Key Features of TLR6, 2016 42

Table 5 Versatile Innovation in Immunology, Global, Key Features of TLR8, 2016 43

Table 6: Versatile Innovation in Immunology, Global, Key Features of Syk, 2016 45

Table 7: Versatile Innovation in Immunology, Global, Key Features of IL-7R, 2016 46

Table 8: Versatile Innovation in Immunology, Global, Key Features of C-C Chemokine Receptor Type 6, 2016 48

Table 9: Versatile Innovation in Immunology, Global, Key Features of P2RX7, 2016 49

Table 10: Versatile Innovation in Immunology, Global, Key Features of ITK, 2016 51

Table 11: Versatile Innovation in Immunology, Global, Key Features of IRAK4, 2016 52

Table 12: Versatile Innovation in Immunology, Global, Key Features of Orai1, 2016 53

Table 13: Versatile Innovation in Immunology, Global, Key Features of Tumor Necrosis Factor Receptor Superfamily Member 5 , 2016 55

List of Figures

1.2 List of Figures

Figure 1: Versatile Innovation in Immunology, US, Innovation Trends in Product Approvals, 1987–2014 6

Figure 2: Versatile Innovation in Immunology, US, Sales Performance of First-in-Class and Non-First-in-Class Products Post Marketing Approval, 2006–2013 8

Figure 3: Versatile Innovation in Immunology, Global, Overall Pharmaceutical Industry Pipeline by Therapy Area and Breakdown of Immunology Pipeline by Indication, 2016 17

Figure 4: Versatile Innovation in Immunology, Global, Pipeline for Immunology by Stage of Development and Molecule Type, 2016 18

Figure 5: Versatile Innovation in Immunology, Global, Pipeline for Immunology by Molecular Target, 2016 20

Figure 6: Versatile Innovation in Immunology, Global, Pipeline and Marketed Products for Immunology by Molecular Target Category, 2016 21

Figure 7: Versatile Innovation in Immunology, Global, Overall Pharmaceutical Industry First-in-Class Pipeline by Therapy Area and Breakdown of Immunology First-in-Class Pipeline by Indication, 2016 22

Figure 8: Versatile Innovation in Immunology Therapeutics Market, Global, First-in-Class Pipeline for Immunology by Stage of Development and Molecule Type, 2016 23

Figure 9: Versatile Innovation in Immunology, Global, First-in-Class Pipeline for Immunology by Molecular Target, 2016 24

Figure 10: Versatile Innovation in Immunology, Global, Pipeline for Immunology by First-in-Class Status and Molecular Target Class, 2016 25

Figure 11: Versatile Innovation in Immunology, Global, Distribution of First-in-Class and Established Products by Stage of Development (%), 2016 26

Figure 12: Versatile Innovation in Immunology, Global, Distribution of First-in-Class and Established Products by Molecular Target Class (%), 2016 26

Figure 13: Versatile Innovation in Immunology, Global, First-in-Class Immunology Pipeline Products by Number of Indications, 2016 26

Figure 14: Versatile Innovation in Immunology, Global, Pipeline for Key Immunology Indications by Molecular Target, 2016 27

Figure 15: Versatile Innovation in Immunology, Global, Versatile Pipeline for Immunology by Stage of Development and Molecule Type, 2016 28

Figure 16: Versatile Innovation in Immunology, Global, Versatile First-in-Class Pipeline Immunology by Molecular Target, 2015 29

Figure 17: Versatile Innovation in Immunology, Global, First-in-Class Pipeline for Immunology by Versatile Status and Molecular Target Class, 2016 30

Figure 18: Versatile Innovation in Immunology, Global, First-in-class Pipeline for Immunology Indications (Part 1), 2016 31

Figure 19: Versatile Innovation in Immunology, Global, First-in-class Pipeline for Immunology Indications (Part 2), 2016 32

Figure 20: Versatile Innovation in Immunology, Global, First-in-class Pipeline for Immunology Indications (Part 3), 2016 33

Figure 21: Versatile Innovation in Immunology, Global, First-in-class Pipeline for Immunology Indications (Part 4), 2016 34

Figure 22: Versatile Innovation in Immunology, Global, First-in-Class Matrix, 2016 (part 1) 37

Figure 23: Versatile Innovation in Immunology, Global, First-in-Class Matrix, 2016 (part 2) 38

Figure 24: Versatile Innovation in Immunology, Global, First-in-Class Matrix, 2016 (part 3) 39

Figure 25: Versatile Innovation in Immunology, Global, Pipeline Programs Targeting TLR3, 2016 43

Figure 26: Versatile Innovation in Immunology, Global, Pipeline Programs Targeting TLR6, 2016 43

Figure 27: Versatile Innovation in Immunology, Global, Pipeline Programs Targeting TLR8, 2016 43

Figure 28: Versatile Innovation in Immunology, Global, Pipeline Programs Targeting Syk, 2016 45

Figure 29: Versatile Innovation in Immunology, Global, Pipeline Programs Targeting IL-7R, 2016 47

Figure 30: Versatile Innovation in Immunology, Global, Pipeline Programs Targeting C-C Chemokine Receptor Type 6, 2016 48

Figure 31: Versatile Innovation in Immunology, Global, Pipeline Programs Targeting P2RX7, 2016 50

Figure 32: Versatile Innovation in Immunology, Global, Pipeline Programs Targeting ITK, 2016 51

Figure 33: Versatile Innovation in Immunology, Global, Pipeline Programs Targeting IRAK4, 2016 52

Figure 34: Versatile Innovation in Immunology, Global, Pipeline Programs Targeting Orai1, 2016 54

Figure 35: Versatile Innovation in Immunology, Global, Pipeline Programs Targeting Tumor necrosis factor receptor superfamily member 5 , 2016 55

Figure 36: Versatile Innovation in Immunology, Global, Licensing Deals by Stage of Development, 2006–2015 56

Figure 37: Versatile Innovation in Immunology, Global, Industry-Wide Licensing Deals by Deal Value, Upfront Payment Value, Stage of Development and First-in-Class Status ($m), 2006–2015 57

Figure 38: Versatile Innovation in Immunology, Global, Licensing Deals by Region, Value and Year, 2006–2016 58

Figure 39: Versatile Innovation immunology, Global, Licensing Deals by Stage of Development, Deal Value and Upfront Payment Value, 2006–2016 59

Figure 40: Versatile Innovation in Immunology, Global, Licensing Deals by Molecule Type, 2006–2016 60

Figure 41: Immunology, Global, Licensing Deals by Molecular Target, 2006–2016 61

Figure 42: Versatile Innovation in Immunology, Global, Licensing Deals Valued Above $100m, 2006–2016 62

Figure 43: Versatile Innovation in Immunology, Global, Co-development Deals by Region, Value and Year, 2006–2016 63

Figure 44: Immunology, Global, Co-development Deals by Stage of Development, Deal Value and Upfront Payment Value, 2006–2016 64

Figure 45: Versatile Innovation in Immunology, Global, Co-development Deals by Molecule Type, 2006–2016 65

Figure 46: Versatile Innovation in Immunology, Global, Co-development Deals by Molecular Target, 2006–2016 66

Figure 47: Versatile Innovation in Immunology, Global, Co-development Deals Valued Above $100m, 2006–2016 67

Figure 48: Versatile Innovation in Immunology, Global, List of First-in-Class Pipeline Products with and Without Prior Deal Involvement, 2016 68

Figure 49: Versatile Innovation in Immunology, Global, List of First-in-Class Pipeline Products with and Without Prior Deal Involvement, 2016 69

Figure 50: Versatile Innovation in Immunology, Global, List of First-in-Class Pipeline Products with and Without Prior Deal Involvement, 2016 70

Figure 51: Versatile Innovation in Immunology, Global, List of First-in-Class Pipeline Products with and Without Prior Deal Involvement, 2016 71

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