Research details developments in the Frontier Pharma: Breast Cancer – Identifying and Commercializing First-in-Class Innovation

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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.

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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.

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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

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

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