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Frontier Pharma: Breast Cancer - First-in-Class Innovation Clustered Around Growth Factor Signalling Processes

Summary

The breast cancer pipeline is the largest in the pharmaceutical industry, with 1,050 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. The degree and proportion of breakthrough innovations in this pipeline is exceptional – GBI Research analysis identified 333 first-in-class programs in the breast cancer pipeline, acting on 251 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 products will reach the market over the coming decade and, will have the opportunity to transform the clinical and commercial landscape.

Potential driving factors behind this market include a very large and growing patient pool, a well-established disease market with a number of strong unmet needs, and the strong understanding of the disease pathophysiology that has developed over the last decade, facilitating the development of novel compounds that may fill the unmet needs.

Some 289 first-in-class products that are currently in development have not yet been involved in licensing or co-development deals, meaning 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.

Scope

- The report analyzes innovation in breast cancer, in the context of the overall pipeline and current market landscape. In addition, it analyzes the deals landscape surrounding first-in-class products in breast cancer, and pinpoints opportunities for in-licensing.
- A brief introduction to breast cancer, including symptoms, pathophysiology, and an overview of pharmacotherapy and treatment algorithms.
- 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 breast cancer 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, including a comprehensive study of disease pathogenesis, diagnosis, prognosis and the available treatment options available at each stage of diagnosis.
- Visualize the composition of the breast cancer market in terms of dominant molecule types and targets, highlighting what the current unmet needs are and how they can be addressed. This knowledge allows a competitive understanding of the gaps in the current market.
- Analyze the breast cancer pipeline, stratified by stage of development, molecule type and molecular target.
- 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 breast cancer deals landscape by analyzing trends in licensing and co-development deals, and producing a list of breast cancer therapies that are not yet involved in deals and may be potential investment opportunities.

Table Of Contents

Frontier Pharma: Breast Cancer - First-in-Class Innovation Clustered Around Growth Factor Signalling Processes
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 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 Clinical and Commercial Environment to be More Favorable to Products Targeting Niche Patient Populations and Indications 5
3.5 Sustained Innovation 6
3.6 Report Guidance 6
4 Clinical and Commercial Landscape 8
4.1 Disease Overview 8
4.2 Epidemiology 8
4.3 Disease Symptoms 9
4.4 Etiology 9
4.4.1 Age and Gender 9
4.4.2 Genetic Makeup 9
4.4.3 Environmental 10
4.5 Pathophysiology 10
4.5.1 Tumor Initiation and Aberrant Cell Proliferation and Survival 10
4.5.2 Tumor Metabolic Shift 11
4.5.3 Tumor Progression, Micro-environment Alteration and Angiogenesis 12
4.5.4 Cancer Stem Cells 13
4.6 Diagnosis 13
4.7 Prognosis and Disease Staging 14
4.7.1 Classification 15
4.8 Introduction to Breast Cancer Treatments 16
4.9 Surgery and Radiation Therapy 17
4.10 Overview of Marketed Products for Breast Cancer 17
4.10.1 Chemotherapy 18
4.10.2 Hormonal Therapies 19
4.10.3 Targeted Therapies 19
4.11 Treatment Algorithm 21
4.12 Current Unmet Need in Breast Cancer Market 23
5 Assessment of Pipeline Product Innovation 25
5.1 Breast Cancer Pipeline by Phase, Molecule Type and Molecular Target 25
5.2 First-in-Class Pipeline Programs 29
6 Signaling Network, Disease Causation and Innovation Alignment 36
6.1 The Complexity of Signaling Networks in Oncology 36
6.2 Signaling Pathways, Disease-Causing Mutations and First-in-Class Molecular Target Integration 37
6.3 First-in-Class Target Matrix Assessment 37
7 First-in-Class Target Evaluation 41
7.1 Pipeline Programs which Target FGFR 3 and 4 41
7.2 Pipeline Programs which Target HER3 42
7.3 Pipeline Programs which Target PDK1 44
7.4 Pipeline Programs which Target Akt 1, 2 and 3 45
7.5 Pipeline Programs which Target PI3K-alpha 48
7.6 Conclusion 50
8 Deals and Strategic Consolidations 51
8.1 Industry-Wide First-in-Class Deals 51
8.2 Breast Cancer Deals Landscape 52
8.3 Licensing Deals 53
8.3.1 Molecule Type 55
8.3.2 Molecular Target 56
8.4 Co-development Deals 59
8.4.1 Molecule Type 60
8.4.2 Molecular Target 61
8.5 First-In-Class Molecules not Involved in Licensing or Co-development Deals 63
9 Appendix 66
9.1 Abbreviations 66
9.2 References 66
9.3 Contact Us 79
9.4 Disclaimer 79

1.1 List of Tables
Table 1: Tumor, regional lymph Node and Metastasis Staging, 2010-2013 14
Table 2: US, Disease Stage at Diagnosis and Five-year Relative Survival (%), 2013 14
Table 3: Breast Cancer Histopathological and Molecular Classification 15
Table 4: Key Features and Pipeline Activity of FGFR3 41
Table 5: Key Features and Pipeline Activity of FGFR4 42
Table 6: Pipeline Programs Targeting FGFR4 42
Table 7: Key Features and Pipeline Activity of HER3 43
Table 8: Key Features and Pipeline Activity of PDPK1 44
Table 9: Key Features and Pipeline Activity of Akt1 46
Table 10: Key Features and Pipeline Activity of Akt2 46
Table 11: Key Features and Pipeline Activity of Akt3 47
Table 12: Key Features and Pipeline Activity of PI3K-alpha 48

1.2 List of Figures
Figure 1: Marketed Product Overview 18
Figure 2: Treatment Algorithm for Cancer Diagnosed at Stages I to III 22
Figure 3: Treatment Algorithm for Cancer Diagnosed at Stage IV 23
Figure 4: Developmental Pipeline Overview 26
Figure 5: Developmental Pipeline Molecular Target Categories 28
Figure 6: Molecular Target Category Comparison, Pipeline and Marketed Products 29
Figure 7: Molecular Target Category Comparison, Pipeline First-in-Class and Established Molecular Targets 31
Figure 8: First-in-Class Products in the Breast Cancer Pipeline, Part 1 32
Figure 9: First-in-Class Products in the Breast Cancer Pipeline, Part 2 33
Figure 10: First-in-Class Products in the Breast Cancer Pipeline, Part 3 34
Figure 11: First-in-Class Products in the Breast Cancer Pipeline, Part 4 35
Figure 12: First-in-Class Molecular Target Analysis Matrix 38
Figure 13: First-in-Class Molecular Target Analysis Matrix 39
Figure 14: First-in-Class Molecular Target Analysis Matrix 40
Figure 15: Pipeline Programs Targeting FGFR3 42
Figure 16: Pipeline Programs Targeting HER3 43
Figure 17: Pipeline Programs Targeting PDK1 44
Figure 18: Pipeline Programs Targeting Akt1 47
Figure 19: Pipeline Programs Targeting Akt2 47
Figure 20: Pipeline Programs Targeting Akt3 48
Figure 21: Pipeline Programs Targeting PI3K 49
Figure 22: Industry-Wide Deals by Stage of Development, 2006-2014 51
Figure 23: Industry Licensing Deal Values by Stage of Development ($m), 2006-2014 52
Figure 24: Global, Licensing Deals by Region and Value, 2006-2014 54
Figure 25: Global, Licensing Deals by Stage and Value, 2006-2014 55
Figure 26: Licensing Deals by Molecule Type, 2006-2014 56
Figure 27: Licensing Deals by Molecular Target, 2006-2014 56
Figure 28: Licensing Deals, 2006-2014 57
Figure 29: Licensing Deals, 2006-2014 58
Figure 30: Co-Development Deals, 2006-2014 59
Figure 31: Co-Development Deals, 2006-2014 60
Figure 32: Co-Development Deals by Molecule Type, 2006-2014 61
Figure 33: Co-Development Deals by Molecular Target, 2006-2014 61
Figure 34: Co-Development Deals, 2006-2014 62
Figure 35: First-in-Class Programs with no Prior Deal Involvement, Part 1 63
Figure 36: First-in-Class Programs with no Prior Deal Involvement, Part 2 64
Figure 37: First-in-Class Programs with no Prior Deal Involvement, Part 3 65

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