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Frontier Pharma: Breast Cancer - Identifying and Commercializing First-in-Class Innovation

Summary

Exceptionally Large and Innovative Pipeline

The breast cancer pipeline is the largest in the pharmaceutical industry with 815 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 in this pipeline is exceptional; GBI Research analysis identified 253 first-in-class programs in the breast cancer pipeline, acting on 176 first-in-class molecular targets. This accounts for some 39% of all products with a disclosed molecular target and is reflective of the high degree of innovation in this indication. This has far-reaching strategic implications for all market participants, as, despite the high attrition rate in breast cancer, it is highly likely many of the first-in-class technologies will reach the market over the coming decade and may transform the clinical and commercial landscape.

Alignment of First-in-Class Molecular Target with Disease Causation

One of the key trends in oncology and in breast cancer in particular over the last decade is the clinical and commercial impact of targeted therapies designed to target proteins in signaling pathways that are frequently mutated in a significant proportion of the patient population. By aligning the molecular targets for therapeutic intervention with disease causation and/or propagation, these therapies limit the systemic cytotoxic effects whilst inhibiting tumor-promoting signaling pathways. Such strategies thereby typically achieve superior efficacy and safety profiles.

Our proprietary analyses demonstrate significant levels of differentiation as to how well the first-in-class products and their respective molecular targets align to underlying gene and protein level mutations and dysfunction. More advanced analytics further substantiated these findings as strong levels of differentiation in the scientific and clinical rationale for first-in-class molecular targets emerged. Furthermore, clear frontrunners were identified by integrating analyses to assess the accessibility of molecular targets for therapeutic compounds, the size of the target patient population that would benefit from therapeutic intervention, and the expected positioning of the first-in-class products based on the molecular targets and mechanisms of action of currently marketed products.

These insights and a detailed review of the available evidence from scientific studies substantiate the perspective that first-in-class-product technology in its own right is not sufficient to offer a compelling scientific and clinical rationale. However, a range of products offer very significant scientific and clinical promise and could therefore result in a strong commercial proposition with the prospect of clinically and commercially transformative products in the future.

A Highly Active Deals Landscape with Numerous Investment Opportunities

The breast cancer deals landscape is highly dynamic, with both deal number and aggregate value exceeding industry benchmarks, reflecting the large and highly competitive marketed and pipeline product environments. Moreover, with 40 first-in-class products that are currently in development having been involved in a licensing or co-development deal, the capital being committed to breast cancer partnership deals is not limited to products with established mechanisms of action in the marketed product landscape. On the contrary, breakthrough innovations are highly desirable as an investment option. Analysis shows that the licensing deal values can exceed the mean and median deal values for licensing deals in Phase I, II and III, suggesting that premium deals can be achieved by smaller firms with the capacity to advance strong products to one of the clinical stages of development. However, most deals involving first-in-class products were either preclinical or Phase I development, whereas advance-in-class and addition-to-class product deals were typically made in Phases II and III, therefore showing 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.

With the remaining 213 first-in-class products that are currently in development having not yet been involved in a licensing or co-development deal, there are numerous opportunities for in-licensing or co-development in this indication, which already has a strong track record of breakthrough innovation yielding highly commercially and clinically successful therapies. Although many act on targets that are not yet strongly substantiated in terms of their therapeutic potential in breast cancer in clinical studies, there are many which are supported by very robust and promising in vivo and in vitro preclinical evidence, and as such are highly promising breast cancer therapies.

Scope

The report analyzes innovation in breast cancer, in the context of the overall pipeline and current market landscape. In addition, it analyzed the deals landscape surrounding first-in-class products in breast cancer, and pinpoints opportunities for in-licensing. The report covers and includes -
- A brief introduction to breast cancer, including symptoms, pathophysiology, and 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 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 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 breast cancer 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 -
- Understanding of the focal shifts in molecular targets in the breast cancer pipeline.
- Understanding of 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 breast cancer, benchmarked against non-first-in-class targets.
- Assess the valuations of licensed and co-developed breast cancer treatments.
- Access a list of the first-in-class therapies potentially open to deal-making opportunities.

Table Of Contents

Frontier Pharma: Breast Cancer - Identifying and Commercializing First-in-Class Innovation
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 Exceptionally Large and Innovative Pipeline 4
2.2 Alignment of First-in-Class Molecular Target with Disease Causation 4
2.3 A Highly Active Deals Landscape with Numerous Investment Opportunities 4
3 The Case for Innovation in the Breast Cancer Market 5
3.1 Growing Opportunities for Biologic Products 5
3.2 Diversification of Molecular Targets 5
3.3 Innovative First-in-Class Product Developments Remain Attractive 5
3.4 Changes in the Clinical and Commercial Environment to be More Favorable to Products Targeting Niche Patient Populations and Indications 6
3.5 Sustained Innovation 6
3.6 Report Guidance 6
4 Clinical and Commercial Landscape 8
4.1 Disease Overview 8
4.2 Disease Symptoms 8
4.3 Etiology 8
4.4 Pathophysiology 9
4.4.1 Tumor Initiation, and Aberrant Cell Proliferation and Survival 10
4.4.2 Tumor Metabolic Shift 11
4.4.3 Tumor Progression, Microenvironment Alteration and Angiogenesis 11
4.4.4 Cancer Stem Cells 12
4.5 Diagnosis 13
4.6 Prognosis and Disease Staging 13
4.6.1 Classification 14
4.7 Introduction to Breast Cancer Treatments 15
4.8 Surgery and Radiation Therapy 16
4.9 Overview of Marketed Products for Breast Cancer 16
4.9.1 Chemotherapy 17
4.9.2 Efficacy of Chemotherapy Regimens 18
4.9.3 Hormonal Therapies 20
4.9.4 Efficacy of Endocrine Therapies 20
4.9.5 Targeted Therapies 22
4.9.6 Efficacy of Targeted Therapies 23
4.10 Treatment Guidelines 26
4.11 Current Unmet Need in the Breast Cancer Market 29
5 Assessment of Pipeline Product Innovation 31
5.1 Breast Cancer Pipeline by Phase, Molecule Type and Molecular Target 31
5.2 First-in-Class Pipeline Programs 35
6 Signaling Network, Disease Causation and Innovation Alignment 40
6.1 The complexity of signaling networks in oncology 40
6.2 Signaling pathways, disease-causing mutations and first-in-class molecular target integration 41
6.3 First-in-Class Target Matrix Assessment 43
7 First-In-Class Target Evaluation 46
7.1 Pipeline Programs which Target Protein Kinase C Delta 46
7.2 Pipeline Programs which Target p53 47
7.3 Pipeline Programs which Target FGFR4 50
7.4 Pipeline Programs which Target Akt 1, 2 and 3 51
7.5 Pipeline Programs which Target HER3 54
7.6 Pipeline Programs which Target PI3K 56
7.7 Pipeline Programs which Target Murine Double Minute 2 58
7.8 Pipeline Programs which Target Growth factor receptor-bound protein 2 60
7.9 Pipeline Programs which Target Notch-1 61
7.10 Pipeline Programs which Target Signal Transducer and Activator of Transcription 3 63
7.11 Pipeline Programs which Target Cluster of Differentiation 44 65
7.12 Pipeline Programs which Target Protein Phosphatase 2A 66
7.13 Pipeline Programs which Target Heat Shock Protein 90 68
7.14 Pipeline Programs which Target Basigin (CD147) 70
7.15 Pipeline Programs which Target Rho-associated, Coiled-coil-containing Protein Kinase 1 71
7.16 Pipeline Programs which Target Creb 73
7.17 Pipeline Programs which Target Cyclin-Dependent Kinase 4 and Cyclin-Dependent Kinase 6 74
7.18 Pipeline Programs which Target Integrin ?V 77
7.19 Conclusion 79
8 Deals and Strategic Consolidations 81
8.1 Licensing Deals 81
8.1.1 Molecule Type 84
8.1.2 Mechanism of Action 86
8.2 Co-Development Deals 92
8.2.1 Molecule Type 94
8.2.2 Mechanism of Action 96
8.3 First-In-Class Molecules not Involved in Licensing or Co-Development Deals 100
9 Appendix 103
9.1 Abbreviations 103
9.2 References 103
9.3 References for Heat Map 115
9.4 Contact Us 116
9.5 Disclaimer 1161.1 List of Tables
Table 1: TNM Staging, 2010-2013 13
Table 2: US, Disease Stage at Diagnosis and Five-year Relative Survival (%), 2013 14
Table 3: Key Meta-Analyses for Chemotherapy Regimens 19
Table 4: Key Meta-Analyses for Endocrine Therapies 21
Table 5: Key Meta-Analyses for Targeted Therapies 26
Table 6: References for Heat Map (Figure 2) 1151.2 List of Figures
Figure 1: Marketed Product Overview 17
Figure 2: Heat Map for Targeted Therapies 25
Figure 3: Treatment Algorithm for Cancer Diagnosed at Stages I to III 27
Figure 4: Treatment Algorithm for Cancer Diagnosed at Stage IV 28
Figure 5: Developmental Pipeline Overview 32
Figure 6: Developmental Pipeline Molecular Target Categories 34
Figure 7: Molecular Target Category Comparison, Pipeline and Marketed Products 35
Figure 8: Molecular Target Category Comparison, Pipeline First-in-Class and Established Molecular Targets 37
Figure 9: First-in-Class Products in the Breast Cancer Pipeline, Part 1 38
Figure 10: First-in-Class Products in the Breast Cancer Pipeline, Part 2 39
Figure 11: Signaling Network, Disease Causation and Innovation Alignment Analysis 42
Figure 12: First-in-Class Molecular Target Analysis Matrix 44
Figure 13: First-in-Class Target Analysis Matrix (Part 2) 45
Figure 14: Data and Evidence for Protein Kinase C Delta as a Therapeutic Target 47
Figure 15: Pipeline Programs Targeting Protein Kinase C Delta 47
Figure 16: Data and Evidence for p53 as a Therapeutic Target 49
Figure 17: Pipeline Programs Targeting p53 49
Figure 18: Data and Evidence for FGFR4 as a Therapeutic Target 51
Figure 19: Pipeline Programs Targeting FGFR4 51
Figure 20: Data and Evidence for Akt as a Therapeutic Target 53
Figure 21: Pipeline Programs Targeting Akt, 2014 54
Figure 22: Data and Evidence for HER3 as a Therapeutic Target 55
Figure 23: Pipeline Programs Targeting HER3 56
Figure 24: Data and Evidence for PI3K as a Therapeutic Target 57
Figure 25: Pipeline Programs Targeting PI3K 57
Figure 26: Data and Evidence for Murine Double Minute 2 as a Therapeutic Target 59
Figure 27: Pipeline Programs Targeting Murine Double Minute 2 59
Figure 28: Data and Evidence for Grb2 as a Therapeutic Target 60
Figure 29: Pipeline Programs Targeting Grb2 61
Figure 30: Data and Evidence for Notch-1 as a Therapeutic Target 62
Figure 31: Pipeline Programs Targeting Notch-1 63
Figure 32: Data and Evidence for Signal Transducer and Activator of Transcription 3 as a Therapeutic Target 64
Figure 33: Pipeline Programs Targeting Signal Transducer and Activator of Transcription 3 65
Figure 34: Data and Evidence for CD44 as a Therapeutic Target 66
Figure 35: Pipeline Programs Targeting CD44 66
Figure 36: Data and Evidence for Protein Phosphatase 2A as a Therapeutic Target 67
Figure 37: Pipeline Programs Targeting Protein Phosphatase 2A 68
Figure 38: Data and Evidence for Heat Shock Protein 90 as a Therapeutic Target 69
Figure 39: Pipeline Programs Targeting Heat Shock Protein 90 70
Figure 40: Data and Evidence for Basigin (CD147) as a Therapeutic Target 71
Figure 41: Pipeline Programs Targeting Basigin (CD147), 2014 71
Figure 42: Data and Evidence for Rho-Associated, Coiled coil-containing Protein Kinase 1 as a Therapeutic Target 72
Figure 43: Pipeline Programs Targeting Rho-Associated, Coiled coil-containing Protein Kinase 1 73
Figure 44: Data and Evidence for Creb as a Therapeutic Target 74
Figure 45: Pipeline Programs Targeting Creb 74
Figure 46: Data and Evidence for Cyclin Dependent Kinase 4/6 as a Therapeutic Target 76
Figure 47: Pipeline Programs Targeting Cyclin Dependent Kinase 4/6 77
Figure 48: Data and Evidence for Integrin ?V as a Therapeutic Target 79
Figure 49: Pipeline Programs Targeting Integrin ?V 79
Figure 50: Global, Licensing Deals, 2006-2014 83
Figure 51: Network of Licensing Deals, 2006-2014 84
Figure 52: Licensing Deals by Molecule Type, 2006-2014 85
Figure 53: Upfront Payments by Molecule Type, 2006-2014 86
Figure 54: Licensing Deals by Mechanism of Action, 2006-2014 88
Figure 55: Upfront Payments by Mechanism of Action, 2006-2014 89
Figure 56: Licensing Deals, 2006-2014 90
Figure 57: Licensing Deals (Part 2), 2006-2014 91
Figure 58: Co-Development Deals, 2006-2014 93
Figure 59: Network of Co-Development Deals, 2006-2014 94
Figure 60: Co-Development Deals by Molecule Type, 2006-2014 95
Figure 61: Upfront Payments by Molecule Type, 2006-2014 96
Figure 62: Co-Development Deals by Mechanism of Action, 2006-2014 97
Figure 63: Upfront Payments by Mechanism of Action, 2006-2014 98
Figure 64: Co-Development Deals, 2006-2014 99
Figure 65: First-in-Class Programs with no Prior Deal Involvement 101
Figure 66: First-in-Class Programs with no Prior Deal Involvement (Part 2) 102

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