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Frontier Pharma: Asthma Therapeutics-Cytokine and Kinase Targeted Small Molecules and mAbs Increase Pipeline Diversity and Dominate First-in-Class Innovation

Frontier Pharma: Asthma Therapeutics-Cytokine and Kinase Targeted Small Molecules and mAbs Increase Pipeline Diversity and Dominate First-in-Class Innovation


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Executive Summary

Frontier Pharma: Asthma Therapeutics-Cytokine and Kinase Targeted Small Molecules and mAbs Increase Pipeline Diversity and Dominate First-in-Class Innovation

Summary

Asthma is a chronic condition affecting the respiratory system, with disease occurrence linked to both genetic and environmental factors. It has significant global incidence and there is currently no cure. Pharmacotherapeutic intervention aims to provide patients with an increased level of disease control and reduce the severity of symptoms, and a number of inhalational therapeutic options are available. Current asthma treatment options are able to provide the majority of patients with a sufficient level of disease control. Additionally, scientific advancements through the development of combination and add-on therapeutics have provided patients with treatments that allow for a greater level of disease control. However, unmet need remains, in the form of patients that do not respond well to current therapeutics or therapeutic combinations. This group of patients accounts for the vast majority of global healthcare costs associated with asthma. Pipeline product development aims to improve upon current therapeutic options and provide options for satisfactory disease control to patients with unmet needs. This is reflected in the high number of products in development, with 287 pipeline products, accounting for just over a third of products within the broader respiratory therapy area pipeline. There are a total of 93 first-in-class pipeline products in development for asthma, representing a substantial 44% of the 212 pipeline products for which there is a disclosed molecular target. A number of these first-in-class pipeline programs appear to have significant potential to strengthen the asthma treatment landscape-as well as representing promising commercial opportunities. A large number of first-in-class products in the current asthma pipeline have not previously been involved in licensing or co-development deals. This highlights the significant opportunities in the asthma pipeline, and the many possibilities for high-risk, high-reward investment.

Scope

Analysis of innovation in the asthma market in the context of the overall pipeline and current market landscape-also includes analysis of the deals landscape surrounding first-in-class products in asthma, and highlights opportunities for in-licensing

A brief introduction to asthma, including symptoms, pathophysiology, and an overview of pharmacotherapy

The changing molecular target landscape between the market and the pipeline, and particular focal points of innovation in the pipeline

Comprehensive review of the pipeline for first-in-class therapies, analyzed on the basis of stage of development, molecule type and molecular target

Identification and assessment of first-in-class molecular targets, with a particular focus on early-stage programs for which clinical utility has yet to be evaluated, as well as literature reviews on novel molecular targets

Assessment of the licensing and co-development deal landscape for asthma therapies, and benchmarking of deals involving first-in-class versus non-first-in-class-products

Reasons To Buy

Understand the current clinical and commercial landscape by considering disease pathogenesis, diagnosis, prognosis, and the treatment strategies currently available.

Visualize the composition of the asthma market in terms of the dominant classes of therapies. Unmet needs are highlighted to allow a competitive understanding of current gaps in the market.

Analyze the asthma pipeline and stratify pipeline therapies by stage of development, molecule type and molecular target. There are signs in the pipeline that the industry is seeking novel approaches to meet unmet needs within asthma.

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

Identify commercial opportunities in the asthma deals landscape by analyzing trends in licensing and co-development deals and assessing asthma therapies that are not yet involved in deals, and may be potential investment opportunities.

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 Biologics and mAbs Growing in Prominence in Asthma Treatment 5

2.2 Market Landscape to Grow in Diversity over Coming Years 5

2.3 Cytokine and Kinase Targeted Small Molecules and mAbs Dominate First-in-Class Innovation 5

2.4 Deals Landscape Offers Significant Investment Opportunities for First-in-Class Products 5

3 The Case for Innovation in the Asthma Market 6

3.1 Growing Number of 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 Changes in Clinical and Commercial Environment to be More Favorable to Products Targeting Niche Patient Populations and Indications 8

3.5 Sustained Innovation 8

3.6 GBI Research Report Guidance 9

4 Clinical and Commercial Landscape 10

4.1 Disease Overview 10

4.2 Epidemiology 10

4.3 Etiology 11

4.4 Pathophysiology 11

4.5 Disease Symptoms 12

4.6 Diagnosis 12

4.6.1 Disease Prgnosis 13

4.6.2 Assessment of Disease Severity 13

4.7 Treatment 15

4.7.1 Quick-Relief Medication 15

4.7.2 ICSs for the Maintenance Treatment of Asthma 16

4.7.3 ICS/LABA Combination Therapy for the Maintenance Treatment of Asthma 16

4.7.4 Add-on Therapies to ICS or ICS/LABA Therapies for the Maintenance Treatment of Asthma 17

4.7.5 Treatment Algorithm 18

4.8 Overview of Marketed Products 21

4.9 Current Unmet Need in the Asthma Market 22

5 Assessment of Pipeline Product Innovation 23

5.1 Asthma Pipeline by Molecule Type, Stage of Development and Molecular Target 23

5.2 Comparative Distribution of Programs between the Asthma Market and Pipeline by Molecular Target 29

5.3 First-in-Class Pipeline Programs Targeting Novel Molecular Targets 29

6 Signaling Network and Innovation Alignment 33

6.1 Complexity of Signaling Networks in Asthma 33

6.2 First-in-Class Matrix Assessment 33

7 First-in-Class Target Evaluation 36

7.1 Pipeline Programs Targeting Calcium Release Activated Calcium Channel Protein 1 36

7.1.1 Overview of Pipeline Programs Targeting Calcium Release Activated Calcium Channel Protein 1 37

7.2 Pipeline Programs Targeting CXC Chemokine Receptors 37

7.2.1 Overview of Pipeline Programs Targeting CXC Chemokine Receptors 38

7.3 Pipeline Programs Targeting Spleen Tyrosine Kinase 38

7.3.1 Overview of Pipeline Programs Targeting Spleen Tyrosine Kinase 39

7.4 Pipeline Programs Targeting Compliment Component 5a Receptor 1 40

7.4.1 Overview of Pipeline Programs Targeting Compliment Component 5a Receptor 1 40

7.5 Pipeline Programs Targeting Interleukin-33 41

7.5.1 Overview of Pipeline Programs Targeting Interleukin-33 41

7.6 Pipeline Programs Targeting CC Chemokine Receptor Type 3 42

7.6.1 Overview of Pipeline Programs Targeting CC Chemokine Receptor Type 3 42

7.7 Pipeline Programs Targeting Antigen Presenting Glycoprotein CD1d 43

7.7.1 Overview of Pipeline Programs Targeting Antigen Presenting Glycoprotein CD1d 44

7.8 Pipeline Programs Targeting Interleukin 4 Receptor Subunit Alpha 44

7.8.1 Overview of Pipeline Programs Targeting Interleukin 4 Receptor Subunit Alpha 45

7.9 Conclusion 45

8 Deals and Strategic Consolidations 46

8.1 Industry-Wide First-in-Class Deals 46

8.2 Asthma Deals Landscape 47

8.3 Licensing Deals 48

8.3.1 Molecule Type 50

8.3.2 Molecular Target 50

8.4 Co-development Deals 52

8.4.1 Molecule Type 53

8.4.2 Molecular Target 53

8.5 Pipeline Products without Prior Licensing or Co-Development Deal Involvement 55

9 Appendix 57

9.1 References 57

9.2 Abbreviations 59

9.3 Primary Research 60

9.4 Contact Us 61

9.5 Disclaimer 61

1.2 List of Figures

Figure 1: Overall Pharmaceutical Industry, Innovation Trends in Product Approvals, Number of Product Approvals by FDA and Five-Year Moving Average of Products Approvals (%), 1987-2014 6

Figure 2:Overall Pharmaceutical Industry, First-in-Class and Non-First-in-Class Products, Sales Performance After Marketing Approval, 2006-2013 ($m) 7

Figure 3:Asthma Therapeutics Market, Global, Marketed Product Overview, 2016 22

Figure 4:Pharmaceutical Market, Global, Developmental Pipeline Overview, 2016 23

Figure 5: Asthma Therapeutics Market, Global, Pipeline by Stage of Development and Molecule Type, 2016 24

Figure 6: Asthma Therapeutics Market, Global, Pipeline by Molecular Target and Cytokine/Cytokine Receptor Subcategory, 2016 25

Figure 7: Asthma Therapeutics Market, Global, Pipeline by Molecular Target Subcategories, 2016 28

Figure 8: Asthma Therapeutics Market, Global, Molecular Target Category Comparison, Pipeline and Marketed Products, 2016 29

Figure 9: Asthma Therapeutics Market, Global, Molecular Target Family Comparison, Pipeline First-in-Class and Established Molecular Targets, 2016 30

Figure 10: Asthma Therapeutics Market, Global, Percentage of First-in-Class Products in Pipeline by Stage of Development (%), 2016 31

Figure 11: Asthma Therapeutics Market, Global, Percentage of First-in-Class Products in Pipeline by Molecular Target Family (%), 2016 31

Figure 12: Asthma Therapeutics Market, Global, First-in-Class Molecular Targets in Pipeline Development, 2016 32

Figure 13: Asthma Therapeutics Market, Global, First-in-Class Molecular Target Analysis Matrix, 2016 34

Figure 14: Asthma Therapeutics Market, Global, Pipeline Programs Targeting Calcium Release Activated Calcium Channel Protein 1, 2016 37

Figure 15: Asthma Therapeutics Market, Global, Pipeline Programs Targeting CXC Chemokine Receptors, 2016 38

Figure 16: Asthma Therapeutics Market, Global, Pipeline Programs Targeting Spleen Tyrosine Kinase, 2016 40

Figure 17: Asthma Therapeutics Market, Global, Pipeline Programs Targeting Compliment Component 5a Receptor 1, 2016 41

Figure 18: Asthma Therapeutics Market, Global, Pipeline Programs Targeting Interleukin-33, 2016 42

Figure 19: Asthma Therapeutics Market, Global, Pipeline Programs Targeting CC Chemokine Receptor Type-3, 2016 43

Figure 20: Asthma Therapeutics Market, Global, Pipeline Programs Targeting Antigen Presenting Glycoprotein CD1d, 2016 44

Figure 21: Asthma Therapeutics Market, Global, Pipeline Programs Targeting Interleukin 4 Receptor Subunit Alpha, 2016 45

Figure 22: Pharmaceutical Market, Global, Industry-Wide Deals by Stage of Development, 2006-2014 46

Figure 23: Pharmaceutical Market, Global, Industry Licensing Deal Values by Stage of Development, 2006-2014 47

Figure 24: Asthma Therapeutics Market, Global, Licensing Deals by Region and Value, 2006-2016 49

Figure 25: Asthma Therapeutics Market, Global, Licensing Deals by Stage of Development, 2006-2016 50

Figure 26: Asthma Therapeutics Market, Global, Licensing Deals by Molecule Type, 2006-2016 50

Figure 27: Asthma Therapeutics Market, Global, Licensing Deals by Molecular Target, 2006-2016 51

Figure 28: Asthma Therapeutics Market, Global, Licensing Deals Valued Above $100m, 2006-2016 51

Figure 29: Asthma Therapeutics Market, Global, Co-Development Deals by Region and Value, 2006-2016 52

Figure 30: Asthma Therapeutics Market, Global, Co-Development Deals by Stage of Development, 2006-2016 53

Figure 31: Asthma Therapeutics Market, Global, Co-Development Deals by Molecule Type, 2006-2016 53

Figure 32: Asthma Therapeutics Market, Global, Co-Development Deals by Molecular Target, 2006-2016 54

Figure 33: Asthma Therapeutics Market, Global, Co-Development Deals Valued Above $100m, 2006-2016 54

Figure 34: Asthma Therapeutics Market, Global, First-in-class Programs in Active Development Involved in Previous Deals, 2016 55

Figure 35: Asthma Therapeutics Market, Global, First-in-class Programs in Active Development Without Recorded Prior Deal Involvement, 2016 56

1.1 List of Tables

Table 1: Asthma Therapeutics Market, Global, Classification of Asthma Severity in Children Aged 0-4 14

Table 2: Asthma Therapeutics Market, Global, Classification of Asthma Severity in Children Aged 5-11 14

Table 3: Asthma Therapeutics Market, Global, Classification of Asthma Severity in Youths ?12 Years of Age and Adults 15

Table 4: Asthma Therapeutics Market, Global, Management of Chronic Asthma 19

Table 5: Asthma Therapeutics Market, Global, Management of Chronic Asthma 20

Table 6: Asthma Therapeutics Market, Global, Management of Acute Asthma 21

Table 7: Asthma Therapeutics Market, Global, Data for Calcium Release Activated Calcium Channel Protein 1 as a Molecular Target 37

Table 8: Asthma Therapeutics Market, Global, Data for CXC Chemokine Receptors as Molecular Targets, 2016 38

Table 9: Asthma Therapeutics Market, Global, Data for Spleen Tyrosine Kinase as a Molecular Target, 2016 39

Table 10:Asthma Therapeutics Market, Global, Data for Compliment Component 5a Receptor 1 as a Molecular Target, 2016 40

Table 11: Asthma Therapeutics Market, Global, Data for Interleukin-33 as a Molecular Target, 2016 41

Table 12:Asthma Therapeutics Market, Global, Data for CC Chemokine Receptor Type-3 as a Molecular Target, 2016 42

Table 13:Asthma Therapeutics Market, Global, Data for Antigen Presenting Glycoprotein CD1d as a Molecular Target, 2016 43

Table 14: Asthma Therapeutics Market, Global, Data for Interleukin 4 Receptor Subunit Alpha as a Molecular Target, 2016 45

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