Frontier Pharma: Melanoma Therapeutics – Cytokine and Multiple Targeted Small Molecules and mAbs Dominate Pipeline and First-in-Class Innovation

Melanoma is a type of cancer that begins in the melanocytes, often in moles or other pigmented tissues. It most commonly affects the skin, as cutaneous melanoma; however it can also affect other pigmented tissues, such as the eye or intestines, as extracutaneous melanoma. It is the deadliest form of skin cancer and remains one of the most aggressive and treatment-resistant human cancers.

Global prevalence of the disease has risen significantly in the past several decades, primarily due to an increase in exposure to UV light and/or sunlight. This has resulted in an increase in developmental interest with regard to improving disease management, particularly in the advanced metastatic setting.

The emergence over the past decade of novel targeted therapies and therapies that manipulate the immune response has improved treatment options for patients. These new drug classes have been highly commercially successful with blockbuster products that are now well established within the treatment algorithm.

In spite of these developments, there are still significant unmet needs for both cutaneous and extracutaneous melanoma, and the rationale for investment in first-in-class innovation remains strong. First-in-class products account for a considerable proportion of the melanoma pipeline, which is substantially larger than the current market.

Scope

Rising global prevalence and unmet need have resulted in an increase in developmental interest

– What is the pathophysiology of melanoma?

– How has the emergence of new drug classes in the past decade impacted the treatment algorithm?

– What are the most significant unmet needs within the market?

The melanoma pipeline is large and innovative in comparison with the current market

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

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

– How does the ratio of first-in-class targets to first-in-class products differ by stage of development and molecular target class?

– Do melanoma products attract high deal values?

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

– Which first-in-class pipeline products have no prior involvement in licensing or co-development deals?

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 melanoma 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 melanoma 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 melanoma.

- 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 novel targets have been further reviewed in greater detail.

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

Table of Contents

1 Table of Contents

1 Table of Contents 2

1.1 List of Tables 4

1.2 List of Figures 4

2 Executive Summary 6

2.1 Unmet Need Remains Despite Significant Advances in Therapy Options 6

2.2 Moderately Sized but Innovative Pipeline 6

2.3 Deals Landscape Offers Significant Investment Opportunities for First-in-Class Products 6

3 The Case for Innovation in the Melanoma Market 7

3.1 Growing Number of Opportunities for Biologic Products 8

3.2 Diversification of Molecular Targets 8

3.3 Innovative First-in-Class Product Developments Remain Attractive 8

3.4 Regulatory and Reimbursement Policy Shifts Favor First-in-Class Product Innovation 9

3.5 Sustained Innovation 9

3.6 GBI Research Report Guidance 10

4 Clinical and Commercial Landscape 11

4.1 Disease Overview 11

4.2 Types of Melanoma 11

4.3 Disease Symptoms 13

4.3.1 Cutaneous Melanoma 13

4.3.2 Ocular Melanoma 13

4.3.3 Mucosal Melanoma 13

4.3.4 Melanoma of the Internal Organs and Soft Tissue 13

4.3.5 Advanced Melanoma 13

4.4 Diagnosis 14

4.4.1 Cutaneous Melanoma 14

4.4.2 Ocular Melanoma 14

4.4.3 Mucosal Melanoma 14

4.5 Etiology 15

4.5.1 Phenotypic Characteristics 15

4.5.2 Exposure to Ultraviolet Radiation 16

4.5.3 Inherited Genetic Factors 16

4.5.4 Non-inherited Genetic factors 17

4.5.5 Xeroderma Pigmentosum 17

4.5.6 Parkinson’s Disease 18

4.6 Pathophysiology 18

4.6.1 Cutaneous Melanoma 18

4.6.2 Ocular Melanoma 18

4.6.3 Mucosal Melanoma 19

4.6.4 Underlying Molecular Pathways 19

4.7 Epidemiology 20

4.7.1 Cutaneous Melanoma 20

4.7.2 Ocular Melanoma 21

4.7.3 Mucosal Melanoma 21

4.8 Treatment 21

4.8.1 Surgery 22

4.8.2 Radiation Therapy 22

4.8.3 Pharmacotherapy 23

4.9 Overview of Marketed Products 24

4.10 Current Unmet Need in the Melanoma Market 25

5 Assessment of Pipeline Product Innovation 27

5.1 Melanoma Pipeline by Molecule Type, Stage of Development and Molecular Target 27

5.2 Comparative Distribution of Programs between the Melanoma Market and Pipeline by Molecular Target 31

5.3 First-in-Class Pipeline Programs Targeting Novel Molecular Targets 31

6 Signaling Network and Innovation Alignment 39

6.1 Complexity of Signaling Networks in Melanoma 39

6.2 Signaling Pathways, Disease-Causing Mutations and First-in-Class Molecular Target Integration 39

6.3 First-in-Class Matrix Assessment 40

7 First-in-Class Target Evaluation 43

7.1 Pipeline Programs Targeting Insulin Receptor Substrate 2 43

7.1.1 Overview of Pipeline Programs Targeting Insulin Receptor Substrate 2 44

7.2 Pipeline Programs Targeting RAC Serine/Threonine Protein Kinase Alpha, Beta and Gamma 44

7.2.1 Overview of Pipeline Programs Targeting RAC Serine/Threonine Protein Kinase 47

7.3 Pipeline Programs Targeting Thrombospondin-1 47

7.3.1 Overview of Pipeline Programs Targeting Thrombospondin-1 48

7.4 Pipeline Programs Targeting Phosphatidylinositol-4, 5-Bisphosphate 3-Kinase Catalytic Subunit Beta Isoform 49

7.4.1 Overview of Pipeline Programs Targeting Phosphatidylinositol-4, 5-bisphosphate 3-kinase catalytic subunit beta isoform 50

7.5 Pipeline Programs Targeting e3 Ubiquitin Protein Ligase Mdm2 51

7.5.1 Overview of Pipeline Programs Targeting e3 Ubiquitin Protein Ligase Mdm2 52

7.6 Pipeline Programs Targeting Receptor Tyrosine Protein Kinase HER3 53

7.6.1 Overview of Pipeline Programs Targeting Receptor Tyrosine Protein Kinase HER3 54

7.7 Pipeline Programs Targeting Neurogenic Locus Notch Homolog Protein (NOTCH)1, 2, 3 and 4 54

7.7.1 Overview of Pipeline Programs Targeting Neurogenic Locus Notch Homolog Protein 1, 2, 3 and 4 56

7.8 Pipeline Programs Targeting Telomerase Reverse Transcriptase 56

7.8.1 Overview of Pipeline Programs Targeting Telomerase Reverse Transcriptase 58

7.9 Conclusion 58

8 Deals and Strategic Consolidations 59

8.1 Industry-Wide First-in-Class Deals 59

8.2 Melanoma Deals Landscape 60

8.3 Licensing Deals 60

8.3.1 Deals by Region, Deal Value and Year 60

8.3.2 Deals by stage of development and deal value 62

8.3.3 Molecule Type 62

8.3.4 Molecular Target 63

8.4 Co-development Deals 64

8.4.1 Deals by region, deal value and year 64

8.4.2 Deals by Stage of Development and Value 66

8.4.3 Molecule Type 66

8.4.4 Molecular Target 67

8.5 First-in-Class Programs Not Involved in Licensing or Co-development Deals 68

9 Appendix 73

9.1 Abbreviations 73

9.2 References 74

9.3 Research Methodology 79

9.3.1 Data integrity 80

9.3.2 Innovative and meaningful analytical techniques and frameworks 80

9.3.3 Evidence based analysis and insight 80

9.4 Secondary Research 80

9.4.1 Market Analysis 80

9.4.2 Pipeline Analysis 80

9.5 Contact Us 81

9.6 Disclaimer 81

List of Tables

1.1 List of Tables

Table 1:Melanoma Drug Market, Global, Classification of Melanoma, 2016 12

Table 2: Melanoma Therapeutics Market, Data for IRS2 as a Molecular Target, 2016 44

Table 3: Melanoma Therapeutics Market, Data for AKT as a Molecular Target, 2016 46

Table 4: Melanoma Therapeutics Market, Data for THBS1 as a Molecular Target, 2016 48

Table 5: Melanoma Therapeutics Market, Data for PIK3CB as a Molecular Target, 2016 50

Table 6: Melanoma Therapeutics Market, Data for MDM2 as a Molecular Target, 2016 52

Table 7: Melanoma Therapeutics Market, Data for ERBB3 as a Molecular Target, 2016 54

Table 8: Melanoma Therapeutics Market, Data for NOTCH1, 2, 3 and 4 as Molecular Targets, 2016 56

Table 9: Melanoma Therapeutics Market, Data for TERT as a Molecular Target, 2016 57

List of Figures

1.2 List of Figures

Figure 1: Melanoma Drug Market, US, Overall Pharmaceutical Industry, Innovation Trends in Product Approvals, Number of Product Approvals by FDA and Five-Year Moving Average of Products Approvals (%), 1987-2016 7

Figure 2: Melanoma Drug Market, Global, Sales Performance After Marketing Approval of First-in-Class and Non-First-in-Class Products, 2006-2013 ($m) 9

Figure 3: Melanoma Drug Market, Global, Marketed Products Overview, 2016 25

Figure 4: Melanoma Drug Market, Global, Pharmaceutical Pipeline Overview, 2016 27

Figure 5:Melanoma Drug Market, Global, Pipeline by Stage of Development and Molecule Type, 2016 28

Figure 6: Melanoma Drug Market, Global, Pipeline by Biologic Sub-class, 2016 29

Figure 7: Melanoma Therapeutics Market, Global, Pipeline by Molecular Target, 2016 29

Figure 8: Melanoma Therapeutics Market, Global, Pipeline Breakdown of Cytokine Signaling and Kinase Molecular Target Subcategories, 2016 30

Figure 9: Melanoma Drug Market, Global, Molecular Target Category Comparison of Pipeline and Marketed Products, 2016 31

Figure 10: Melanoma Drug Market, Global, Pipeline First-in-Class and Established Molecular Targets by Molecular Target Family, 2016 33

Figure 11: Melanoma Drug Market, Global, Percentage Distribution of First-in-Class Products in Pipeline by Stage of Development (%), 2016 34

Figure 12: Melanoma Drug Market, Global, Distribution of First-in-Class Products in Pipeline by Molecular Target (%), 2016 34

Figure 13: Melanoma Drug Market, Global, All Pipeline Products, 2016 (Part 1) 35

Figure 14: Melanoma Drug Market, Global, All Pipeline Products, 2016 (Part 2) 36

Figure 15: Melanoma Drug Market, Global, All Pipeline Products, 2016 (Part 3) 37

Figure 16: Melanoma Drug Market, Global, All Pipeline Products, 2016 (Part 4) 38

Figure 17: Melanoma Drug Market, Global, First-in-Class Molecular Target Analysis Matrix, 2016 (Part 1) 41

Figure 18: Melanoma Drug Market, Global, First-in-Class Molecular Target Analysis Matrix, 2016 (Part 2) 42

Figure 19: Melanoma Therapeutics Market, Pipeline Programs Targeting IRS2, 2016 44

Figure 20: Melanoma Therapeutics Market, Pipeline Programs Targeting AKT, 2016 47

Figure 21: Melanoma Therapeutics Market, Pipeline Programs Targeting THBS1, 2016 48

Figure 22: Melanoma Therapeutics Market, Pipeline Programs Targeting PIK3CB, 2016 50

Figure 23: Melanoma Therapeutics Market, Pipeline Programs Targeting MDM2, 2016 52

Figure 24: Melanoma Therapeutics Market, Pipeline Programs Targeting ERBB3, 2016 54

Figure 25: Melanoma Therapeutics Market, Pipeline Programs Targeting NOTCH1, 2, 3 and 4, 2016 56

Figure 26: Melanoma Therapeutics Market, Pipeline Programs Targeting TERT, 2016 58

Figure 27: Pharmaceutical Market, Global, Industry-Wide Deals by Stage of Development, 2006-2014 59

Figure 28: Pharmaceutical Market, Global, Industry Licensing Deal Values by Stage of Development, 2006-2014 60

Figure 29: Melanoma Therapeutics Market, Global, Licensing Deals by Region, Value and Year, 2006-2016 61

Figure 30: Melanoma Therapeutics Market, Global, Licensing Deals by Stage of Development, Deal Value and Upfront Payment Value, 2006-2016 62

Figure 31: Melanoma Therapeutics Market, Global, Licensing Deals by Molecule Type, 2006-2016 62

Figure 32: Melanoma Therapeutics Market, Global, Licensing Deals by Molecular Target, 2006-2016 63

Figure 33: Melanoma Therapeutics Market, Global, Licensing Deals Valued Above $100m, 2006-2016 64

Figure 34: Melanoma Drug Market, Global, Co-development Deals by Region, Value and Year, 2006-2016 65

Figure 35: Melanoma Therapeutics Market, Global, Co-development Deals by Stage of Development, Deal Value and Upfront Payment Value, 2006-2016 66

Figure 36: Melanoma Therapeutics Market, Global, Co-development Deals by Molecule Type, 2006-2016 66

Figure 37: Melanoma Therapeutics Market, Global, Co-development Deals by Molecular Target, 2006-2016 67

Figure 38: Melanoma Therapeutics Market, Global, Co-development Deals Valued Above $100m, 2006-2016 68

Figure 39: Melanoma Therapeutics Market, Global, First-in-Class Programs in Active Development Involved in Previous Deals, 2016 (Part 1) 68

Figure 40: Melanoma Therapeutics Market, Global, First-in-Class Programs in Active Development Involved in Previous Deals, 2016 (Part 2) 69

Figure 41: Melanoma Therapeutics Market, Global, First-in-class Programs in Active Development Without Recorded Prior Deal Involvement, 2016 (Part 1) 70

Figure 42: Melanoma Therapeutics Market, Global, First-in-class Programs in Active Development Without Recorded Prior Deal Involvement, 2016 (Part 2) 71

Figure 43: Melanoma Therapeutics Market, Global, First-in-class Programs in Active Development Without Recorded Prior Deal Involvement, 2016 (Part 3) 72

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