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

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


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Executive Summary

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

Large and Innovative Pipeline

Analysis has confirmed the asthma pipeline to be highly active, with 252 products in active development across all stages. The range of mechanisms of action employed by these compounds is also highly diverse, especially in comparison to the existing market landscape. More pertinently, the degree and proportion of breakthrough innovations is significant. GBI Research analysis identified 59 first-in-class programs in the asthma pipeline, acting on 43 first-in-class molecular targets, accounting for 23% of all products with a disclosed molecular target and reflective of the high degree of innovation in this indication. This has far-reaching strategic implications for all market participants, as, despite the high clinical trial attrition rate, it is highly likely that many of the first-in-class technologies will reach the market over the coming decade and may transform the clinical and commercial landscape.

Biologics Growing in Prominence in Asthma Treatment

While the current asthma market is almost exclusively dominated by small molecules, which account for approximately 99% (the exception being Xolair), the current asthma pipeline includes 64 biologics, accounting for 24%. Small molecules amount to 178 compounds, equating to 66%.

This highlights both the commercial and clinical appeal of developing drugs of this class, and follows trends seen in other therapy areas, particularly oncology. Xolair (omalizumab), a recombinant humanized anti-IgE monoclonal Antibody (mAb), was the first humanized therapeutic mAb to be indicated for asthma. It was approved by the FDA in 2003 as an add-on therapy for adults and adolescents aged 12 and over, with moderate-to-severe allergic asthma and symptoms not adequately controlled with Inhaled Corticosteroids (ICS).

Xolair is also the only targeted therapy indicated for the treatment of a specific asthma phenotype. Its launch therefore addressed a significant unmet need for personalized therapy in asthma. Approximately 60% of asthmatics have allergic asthma, and may therefore benefit from Xolair treatment. However, only a minority of these patients has moderate-to-severe disease that is inadequately controlled with standard-of-care therapies, and is therefore eligible for treatment. Despite this, the drug has achieved blockbuster status, and although this can be attributed to a high Annual Cost of Therapy (ACoT), it is also reflective of how innovative drug development that targets unmet clinical needs can result in strong commercial outcomes. Indeed, drug developers are now looking to follow this example by developing highly specific biologics aimed at specific patient sub-types with the hope of benefiting previously underserved patients and generating strong revenues. Notable examples are mepolizumab, reslizumab, lebrikizumab and dupilumab, all of which target Interleukins (IL) heavily implicated in the inflammatory response.

A Deals Landscape with Numerous Investment Opportunities

Analysis has confirmed that 52 of the 59 first-in-class products have not been involved in a licensing or co-development deal. Although a number act on targets that are not yet strongly substantiated in terms of their therapeutic potential in asthma in clinical studies, many are supported by promising in vivo and in vitro preclinical evidence, and as such are highly promising asthma therapies. Indeed, breakthrough innovations are highly desirable as an investment option.

However, many deals involving first-in-class products were in early-stage development, whereas advance-in-class and addition-to-class product deals were typically made in late-stage development, indicating significant differentiation. These findings have significant strategic implications for both biotech companies seeking to out-license products and firms with an interest in in-licensing first-in-class products with strong clinical and commercial prospects.

Scope

The report analyzes innovation in asthma in the context of the overall pipeline and the current market landscape. In addition, it analyzes the deals landscape surrounding first-in-class products in asthma, and pinpoints opportunities for in-licensing. The report covers and includes

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

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

Comprehensive review of the pipeline for first-in-class therapies, analyzed by 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 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 deal landscape for asthma therapies and benchmarking of deals involving first-in-class versus non-first-in-class-products

Reasons To Buy

The report will assist business development and enable marketing executives to strategize their product launches, by allowing them to

Understand the focal shifts in molecular targets in the asthma pipeline

Understand the distribution of pipeline programs by phase of development, molecule type and molecular target

Access a scientific and clinical analysis of first-in-class developmental programs for asthma, benchmarked against non-first-in-class targets

Access a list of the first-in-class therapies potentially open to deal-making 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 4

2.1 Biologics Growing in Prominence in Asthma Treatment 4

2.2 Market Landscape to Grow in Diversity over Coming Years 4

2.3 Deals Landscape Offers Significant Investment Opportunities for First-in-Class Products 4

3 The Case for Innovation in Asthma 5

3.1 Growing Number of Opportunities for Biologic Products 6

3.2 Diversification of Molecular Targets 6

3.3 Innovative First-in-Class Product Developments Remain Attractive 6

3.4 Regulatory and Reimbursement Policy Shifts Favor First-in-Class Product Innovation 7

3.5 Sustained Innovation 7

3.6 GBI Research Report Guidance 8

4 Clinical and Commercial Landscape 9

4.1 Disease Overview 9

4.1.1 Epidemiology 9

4.1.2 Etiology 10

4.1.3 Disease Pathophysiology 10

4.1.4 Disease Symptoms 11

4.1.5 Diagnosis 11

4.1.6 Assessment of Disease Severity 12

4.1.7 Treatment 14

4.1.8 Treatment Algorithm 14

4.2 Overview of Marketed Products 16

4.2.1 Quick-Relief Medication 17

4.2.2 ICSs for the Maintenance Treatment of Asthma 17

4.2.3 ICS/LABA Combination Therapy for the Maintenance Treatment of Asthma 18

4.2.4 Add-on Therapy to ICS or ICS/LABA Therapies for the Maintenance Treatment of Asthma 19

4.2.5 Conclusion 20

5 Assessment of Pipeline Product Innovation 21

5.1 Asthma Pipeline by Phase, Molecule Type and Therapeutic Target 21

5.2 Comparative Distribution of Programs between the Asthma Market and Pipeline by Molecular Target 26

5.3 First-in-Class Pipeline Programs Targeting Novel Molecule Targets 26

6 Signaling Network, Disease Causation and Innovation Alignment 31

6.1 The Complexity of Signaling Networks in Asthma 31

6.2 Signaling Pathways, Disease-Causing Mutations and First-in-Class Molecular Target Integration 32

6.3 First-in-Class Target Matrix Assessment 34

7 First-in-Class Target and Pipeline Program Evaluation 36

7.1 Pipeline Programs Targeting Leukotriene A4 Hydrolase 36

7.2 Pipeline Programs Targeting P-selectin 38

7.3 Pipeline Programs Targeting Spleen Tyrosine Kinase 39

7.4 Pipeline Programs Targeting Prostaglandin D2 Receptor 2 41

7.5 Pipeline Programs Targeting OX40 Ligand 43

7.6 Pipeline Programs Targeting Interleukin-33 44

7.7 Pipeline Programs Targeting Interleukin-10 45

7.8 Pipeline Programs Targeting Mast Stem Cell Growth Factor Receptor 47

7.9 Pipeline Programs Targeting Bradykinin B1 Receptor 48

7.10 Conclusion 49

8 Deals and Strategic Consolidations 51

8.1 Industry-Wide First-in-Class Deals 51

8.2 Licensing Deals 53

8.3 Co-development Deals 57

8.4 First-in-Class Programs not Involved in Licensing or Co-Development Deals 59

9 Appendix 62

9.1 References 62

9.2 Abbreviations 66

9.2.1 Expert Panel Validation 67

9.3 Contact Us 67

9.4 Disclaimer 67

1.1 List of Tables

Table 1: Asthma Therapeutics Market, Global, Classification of Asthma Severity in Children of 0-4 Years of Age 12

Table 2: Asthma Therapeutics Market, Global, Classification of Asthma Severity in Children of 5-11 Years of Age 13

Table 3: Asthma Therapeutics Market, Global, Classification of Asthma Severity in Youths ?12 Years of Age and Adults 13

Table 4: Management of Chronic Asthma 15

Table 5: Management of Acute Asthma 16

1.2 List of Figures

Figure 1: Innovation Trends in Product Approvals 5

Figure 2: Sales Performance of First-in-Class and Non-First-in-Class Product Post Marketing Approval 7

Figure 3: Asthma, Global Pipeline Overview 22

Figure 4: Asthma, Molecular Target Classes of Pipeline Products 23

Figure 5: Asthma, Molecular Targets 25

Figure 6: Asthma, Molecular Target Category Comparison, Pipeline and Marketed Products 26

Figure 7: Asthma, Comparative Pipeline 27

Figure 8: Asthma, First-in-Class Products in the Asthma Pipeline 29

Figure 9: Signaling Networks of Functional Families in Asthma-Part 1 33

Figure 10: Signaling Networks of Functional Families in Asthma-Part 2 34

Figure 11: First-in-Class Molecular Target Analysis Matrix 35

Figure 12: Leukotriene A4 Hydrolase as a Therapeutic Target 37

Figure 13: Pipeline Programs Targeting Leukotriene A4 Hydrolase 38

Figure 14: P-selectin as a Therapeutic Target 39

Figure 15: Pipeline Programs Targeting P-Selectin 39

Figure 16: Spleen Tyrosine Kinase as a Therapeutic Target 40

Figure 17: Pipeline Programs Targeting Spleen Tyrosine Kinase 41

Figure 18: Prostaglandin D2 Receptor 2 as a Therapeutic Target 42

Figure 19: Pipeline Programs Targeting Prostaglandin D2 Receptor 2 43

Figure 20: OX40 Ligand as a Therapeutic Target 44

Figure 21: Pipeline Programs Targeting OX40 Ligand 44

Figure 22: Interleukin-33 as a Therapeutic Target 45

Figure 23: Pipeline Programs Targeting Interleukin-33 45

Figure 24: Interleukin-10 as a Therapeutic Target 46

Figure 25: Pipeline Programs Targeting Interleukin-10 47

Figure 26: Mast stem Cell Growth Factor Receptor as a Therapeutic Target 48

Figure 27: Pipeline Programs Targeting Mast Stem Cell Growth Factor Receptor 48

Figure 28: Bradykinin B1 Receptor as a Therapeutic Target 49

Figure 29: Pipeline Programs Targeting Bradykinin B1 Receptor 49

Figure 30: Industry-Wide Deals by Stage of Development, 2006-2014 51

Figure 31: Industry-wide Deals by Stage of Development, 2006-2014 52

Figure 32: Asthma, Licensing Deals by Region, 2006-2015 53

Figure 33: Asthma, Licensing Deals, 2006-2015 55

Figure 34: Asthma, First-in-Class and Non-First-in-Class Comparison, 2006-2015 56

Figure 35: Asthma, Licensing Deals by Mechanism of Action, 2006-2015 56

Figure 36: Asthma, Co-development Deals by Region, 2006-2015 57

Figure 37: Asthma, Co-development Deals, 2006-2015 58

Figure 38: Asthma, Co-development Deals by Mechanism of Action, 2004-2015 59

Figure 39: Asthma, First-in-class Programs with no Recorded Prior Deal Involvement, 2006-2015 60

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