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Frontier Pharma: Versatile Innovation in Oncology-Identifying and Commercializing Versatile First-in-Class Innovation

Frontier Pharma: Versatile Innovation in Oncology-Identifying and Commercializing Versatile First-in-Class Innovation


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Executive Summary

Frontier Pharma: Versatile Innovation in Oncology-Identifying and Commercializing Versatile First-in-Class Innovation

The oncology therapy area comprises a large and diverse range of indications, encompassing virtually all sites and tissues in the human body. These indications are the leading cause of death in economically developed countries and the second-leading cause of death in developing countries and present a major global health burden. Across the pharmaceutical industry as a whole, the oncology pipeline is far larger than any other therapy area, with 6,484 products in active development across all oncology indications, and 2,084 first-in-class products in development across all stages.

Due to a degree of crossover between oncology 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. Some 473 first-in-class pipeline products are in concurrent development for two or more of the top 20 cancer sites ranked by incidence. The most promising versatile first-in-class molecular targets predominantly consist of receptor tyrosine kinases and their downstream signal transduction kinases, although a number of other cancer-related processes such as DNA repair, cancer immunosurveillance and apoptotic pathways are also targeted.

Scope

With 6,484 products in active development across all oncology indications, this is the largest therapy area pipeline by a considerable margin.

-What factors are driving this high level of R&D activity?

-Which indications have the highest concentration of pipeline products?

Although the unmet need varies between and within indications, this need is primarily for improved overall survival rates in patients, particularly those at the late stage of the disease.

-Which first-in-class molecular targets appear able to best address the key unmet needs within oncology?

The variation in molecule type has shifted away from small molecules, the dominance of which has decreased from 94% across marketed products to 49% across the pipeline.

-What are the dynamics of the remaining 51% of the pipeline?

-How does this reflect the need for novel targeted therapies?

There has been a significant shift towards inhibitors of receptor tyrosine kinases, their ligands and signal transduction proteins, as well as drugs targeted against cancer antigens.

-What is the scientific rationale behind these targets?

-Across which indications are they being developed?

-How successful have drugs against these targets been?

A number of versatile first-in-class targets appear to be particularly promising, including HER3, FGFR3, telomerase reverse transcriptase, and others.

-Why are these targets considered to be particularly promising?

-Why are these targets being developed across such a wide range of indications?

Reasons To Buy

Understand the current clinical and commercial landscape by considering disease pathogenesis, diagnosis, prognosis, and the treatment options across the key oncology indications

Acquire a detailed understanding of the 20 most common oncology indications by incidence, pinpointing the unmet needs for each indication

Assess the market for oncology in terms of the molecular targets that are approved across multiple indications and the predominant molecule types and targets

Analyze the oncology pipeline and stratify by stage of development, molecule type, molecular target, and first-in-class status

Understand the level of versatility across the pipeline and within each molecular target. Assess the pipeline activity of each versatile first-in-class product and the indications that they are in development for

Analyze the therapeutic potential and developmental footprint of versatile first-in-class targets and understand which are the most promising. Understand which targets are being developed in each indication, for how many pipeline products, and how well they align with the underlying pathophysiology of cancer

Identify commercial opportunities in the oncology deals landscape by analyzing trends in licensing and co-development deals for versatile first-in-class products

Identify versatile first-in-class pipeline products that have not been previously involved in licensing or co-development deals and are thus more likely to be available for in-licensing or co-development

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 A Large Therapy Area with Varying Unmet Needs Across Indications 5

2.2 A Large Pipeline with a High Degree of First-in-Class Innovation 5

2.3 A Number of Highly Promising First-in-Class Versatile Oncology Pipeline Targets 5

3 The Case for Innovation in the Oncology 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

3.6 Report Guidance 9

4 Clinical and Commercial Landscape 10

4.1 Therapy Area Overview 10

4.1.1 Epidemiology 10

4.1.2 Etiology 14

4.1.3 Pathophysiology 15

4.1.4 Diagnosis 21

4.1.5 Prognosis and Disease Staging 22

4.2 Treatment Options 24

4.2.1 Surgery and Radiation Therapy 24

4.2.2 Chemotherapy 27

4.2.3 Hormonal Therapies 28

4.2.4 Targeted Therapies 29

4.3 Overview of Marketed Products for Oncology 30

4.4 Current Unmet Needs across the Oncology Markets 32

5 Assessment of Pipeline Product Innovation 34

5.1 Oncology Pipeline by Phase, Molecule Type and Molecular Target 35

5.2 Comparative Distribution of Programs between the Oncology Market and Pipeline by Therapeutic Target Family 38

5.3 First-in-Class and Versatile Pipeline Programs 38

5.3.1 First-in-Class Oncology Products by Phase, Molecule Type and Molecular Target 40

5.3.2 Versatility of First-in-Class Pipeline Products 43

6 Signaling Pathways, Disease-Causing Mutations and Versatile First-in-Class Molecular Target Integration 54

6.1 The Complexity of Signaling Networks in Oncology 54

6.2 Signaling Pathways, Disease-Causing Mutations and Versatile First-in-Class Molecular Target Integration 54

6.3 Versatile First-in-Class Target Matrix Assessment 56

7 Versatile First-in-Class Target Assessment 62

7.1 Pipeline Programs that Target Fibroblast Growth Factor Receptor-3 62

7.2 Pipeline Programs that Target Human Epidermal Growth Factor Receptors-3 and -4 65

7.3 Pipeline Programs that Target Phosphoinositide 3-Kinase Alpha 68

7.4 Pipeline Programs that Target Akt1, 2 and 3 71

7.5 Pipeline Programs that Target Telomerase Reverse Transcriptase 75

7.6 Pipeline Programs that Target Heat Shock Protein 90 77

7.7 Pipeline Programs that Target Focal Adhesion Kinase 80

7.8 Pipeline Programs that Target DNA-Dependent Protein Kinase 82

7.9 Pipeline Programs that Target Programmed Death Ligand-1 83

7.10 Conclusion 86

8 Deals and Strategic Consolidations 87

8.1 Industry-Wide First-in-Class Deals 87

8.2 Licensing Deals 88

8.3 Co-development Deals 95

9 Appendix 100

9.1 Abbreviations 100

9.2 References 100

9.2.1 Main 100

9.3 Contact Us 108

9.4 Disclaimer 108

1.1 List of Tables

Table 1: Epidemiology by Top 20 Most Common Cancer Sites, 2012 11

Table 2: Epidemiology by Top 20 Most Common Cancer Sites, 2012 12

Table 3: Epidemiology by Top 20 Most Common Cancer Sites, 2012 13

Table 4: Epidemiology by Top 20 Most Common Cancer Sites, 2012 14

Table 5: TNM Staging, 2015 22

Table 6: Karnofsky Scores and Equivalent ECOG Staging, 2015 24

Table 7: Optimal and Actual Radiation Therapy Usage Rates in US, 1995-2000 26

Table 8: Optimal and Actual Chemotherapy Usage Rates in Australia, 2010 28

Table 9: Optimal and Actual Chemotherapy Usage Rates in the US, 2008 28

Table 10: Frequency of Mutations in Components in PI3K Alpha Catalytic Isoform, by Cancer Type 70

Table 11: Frequency of Mutations in Components in Akt Proteins, by Cancer Type 72

1.2 List of Figures

Figure 1: Innovation Trends in Product Approvals, 1987-2013 6

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

Figure 3: Relative Survival Rates for the Top 20 Cancers by Site, 2014 23

Figure 4: Molecule Types and Molecular Targets of Marketed Products for Oncology, 2015 31

Figure 5: Molecular Targets of Versatile Marketed Product for Oncology, 2015 32

Figure 6: Summary of Five-Year Survival Rate, Incidence and Mortality by Site, 2012 33

Figure 7: Pipeline Products by Therapy Area and Pipeline Oncology Products by Tumor Site, 2015 34

Figure 8: Developmental Pipeline Overview 36

Figure 9: Developmental Pipeline Overview by Molecular Target 37

Figure 10: Molecular Target Category Comparison, Pipeline and Marketed Products, 2015 38

Figure 11: First-in-Class Pipeline by Therapy Area and Site, 2015 39

Figure 12: Summary of Incidence, Mortality, Mortality Rates and Pipeline Activity by Tumor Site, 2015 40

Figure 13: Overview of First-in-Class Oncology Products, 2015 41

Figure 14: Overview of First-in-Class Oncology Products, 2015 42

Figure 15: Versatility of First-in-Class Oncology Pipeline Products 43

Figure 16: Versatility of First-in-Class Oncology Pipeline Products, as Inferred by Molecular Target 43

Figure 17: Versatility of First-in-Class Oncology Pipeline Products and Potential Additional Indications 44

Figure 18: Overview of Highly Versatile First-in-Class Pipeline Oncology Products, 2015 45

Figure 19: Overview of Highly Versatile First-in-Class Pipeline Oncology Products by Molecular Target, 2015 47

Figure 20: Molecular Target Category Comparison, Pipeline First-in-Class and Established Molecular Targets 48

Figure 21: Versatile First-in-Class Products in Oncology Pipeline, Part 1, 2015 50

Figure 22: Versatile First-in-Class Products in Oncology Pipeline, Part 2, 2015 51

Figure 23: Versatile First-in-Class Products in Oncology Pipeline, Part 3, 2015 52

Figure 24: Versatile First-in-Class Products in Oncology Pipeline, Part 4, 2015 53

Figure 25: Signaling Networks of Functional Families in Oncology, Part 1 55

Figure 26: Signaling Networks of Functional Families in Oncology, Part 2 56

Figure 27: Versatile First-in-Class Molecular Target Analysis Matrix, Part 1 58

Figure 28: Versatile First-in-Class Molecular Target Analysis Matrix, Part 2 59

Figure 29: Versatile First-in-Class Molecular Target Analysis Matrix, Part 3 60

Figure 30: Pipeline Programs Targeting Fibroblast Growth Factor Receptor-3 64

Figure 31: Pipeline Programs Targeting Human Epidermal Growth Factor Receptor-3 67

Figure 32: Pipeline Programs Targeting Human Epidermal Growth Factor Receptor-4 68

Figure 33: Pipeline Programs Targeting Phosphoinositide 3-Kinase Alpha 71

Figure 34: Pipeline Programs Targeting Akt-1 73

Figure 35: Pipeline Programs Targeting Akt-2 74

Figure 36: Pipeline Programs Targeting Akt-3 74

Figure 37: Pipeline Programs Targeting Telomerase Reverse Transcriptase 76

Figure 38: Pipeline Programs Targeting Heat Shock Protein 90 79

Figure 39: Pipeline Programs Targeting Focal Adhesion Kinase 81

Figure 40: Pipeline Programs Targeting DNA-Dependent Protein Kinase 83

Figure 41: Pipeline Program Targeting Programmed Death Ligand-1 85

Figure 42: Industry-Wide Deals by Stage of Development, 2006-2014 87

Figure 43: Industry Licensing Deal Values by Stage of Development (USD m), 2006-2014 88

Figure 44: Licensing Deals for Versatile Pipeline Oncology First-in-Class Products, 2006-2014 89

Figure 45: Regional Network of Licensing Deals for Versatile Pipeline Oncology First-in-Class Products, 2006-2015 90

Figure 46: Licensing Deals for Versatile Pipeline Oncology First-in-Class Products by Molecule Type, 2006-2015 91

Figure 47: Licensing Deals for Versatile Pipeline Oncology First-in-Class Products by Molecular Target, 2006-2015 92

Figure 48: Licensing Deals for Versatile Pipeline Oncology First-in-Class Products, 2006-2015, Part 1 93

Figure 49: Licensing Deals for Versatile Pipeline Oncology First-in-Class Products, 2006-2015, Part 2 94

Figure 50: Co-development Deals for Versatile Pipeline Oncology First-in-Class Products, 2006-2014 95

Figure 51: Regional Network of Co-development Deals for Versatile Pipeline Oncology First-in-Class Products, 2006-2015 96

Figure 52: Co-development Deals for Versatile Pipeline Oncology First-in-Class Products by Molecule Type, 2006-2015 97

Figure 53: Co-development Deals for Versatile Pipeline Oncology First-in-Class Products by Molecular Target, 2006-2015 98

Figure 54: Co-development Deals for Versatile Pipeline Oncology First-in-Class Products, 2006-2015 99

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