Frontier Pharma: Head and Neck Cancer - Immunotherapies and Signal Transduction Inhibitors Dominate First-in-Class Innovation

  • ID: 4191094
  • Report
  • Region: Global
  • 78 Pages
  • GBI Research
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HNC Deals Landscape is Highly Active, with a Mean Value for Co-Development Deals of $496.6m Between 2006 and 2016, Which is Above the 2015 Industry Average of $346.8m, and a Mean Value for Licensing Deals of $198.6m, which is also Above the Industry Average of $198.6m

Head and neck cancer (HNC) is the sixth most common malignancy worldwide, and its incidence is rising (Lacko et al., 2014). It represents a number of cancers that are known collectively as HNCs, and which usually begin in the squamous cells that line the moist, mucosal surfaces inside the head and neck (Ridge et al., 2016).

This diverse group of tumors is frequently aggressive. It is found that the five-year overall survival (OS) was 62% for all HNC cases. In contrast, about 50% of diagnosed cancer patients survive their disease for 10 years or more, and 87% of women diagnosed with breast cancer survive their disease for five years or more (Cancer Research UK, 2017a; Cancer Research UK, 2017b). This reflects a large unmet need for this cancer, which often relapses and is often found in a metastatic stage.

The HNC pipeline has 340 products active across all stages of development. The range of mechanisms of action employed by these compounds is very diverse, especially in comparison with the existing market landscape, and matches the diversity of many of the other oncology indication pipelines. More pertinently, there is a large proportion of breakthrough innovation in this pipeline.

Despite risks associated with developing first-in-class products, they have still proven to be a highly desirable investment option. Indeed, the high level of deal-making activity within the head and neck cancer space is indicative of a strong willingness on the part of pharmaceutical companies to engage in strategic consolidations to mitigate some of the risks associated with drug development, such as the high attrition rates exhibited by oncology indications.

According to Adam Bradbury, research analyst, Factors driving the pipeline size include the limited efficacy of current treatments for refractory patients and a lack of approved targeted therapies in the market landscape, facilitating the development of novel compounds. These factors have far-reaching strategic implications for all market participants, as it is likely that numerous first-in-class products, many of which are supported by promising preclinical data, will reach the market over the coming decade, potentially transforming the clinical and commercial landscape.

The HNC deals landscape is highly active, with a mean value for co-development deals of $496.6m between 2006 and 2016, which is above the 2015 industry average of $346.8m, and a mean value for licensing deals of $198.6m, which is also above the industry average of $198.6m. Most deals involved drugs with established targets. However, some deals contained a variety of first-in-class products - although deal values were not always disclosed. Despite the risk that can be associated with first-in-class products, they have still been shown to be a highly desirable investment option. Risks are posed through identifying a new target, developing a therapeutic compound for that target and validating the target mechanism for disease intervention in HNC.

Scope

  • The report analyzes innovation in HNC in the context of the overall pipeline and current market landscape. It also analyzes the deals landscape surrounding first-in-class products, and pinpoints opportunities for in-licensing.
  • A brief introduction to HNC is provided, including symptoms, pathophysiology, and an overview of pharmacotherapy and treatment algorithms.
  • The changing molecular target landscape between the market and the pipeline is reviewed, including particular focal points of innovation in the pipeline.
  • A comprehensive review of the pipeline for first-in-class therapies, analyzed on the basis of stage of development, molecule type and molecular target is included.
  • First-in-class molecular targets are identified and assessed, 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.
  • An assessment is made of the licensing and co-development deal landscape for HNC therapies.

Reasons to buy

  • Understand the current clinical and commercial landscape, including a comprehensive study of disease pathogenesis, diagnosis, prognosis and the available treatment options.
  • Visualize the composition of the HNC market in terms of dominant molecule types and targets, highlighting what the current unmet needs are and how they can be addressed. This knowledge enables a competitive understanding of the gaps in the market.
  • Analyze the HNC 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 HNC deals landscape by analyzing trends in licensing and co-development deals.

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1 Executive Summary
1.1 High Unmet Need and Limited but Expanding Number of Marketed Options
1.2 Large but Highly Innovative Pipeline
1.3 Lucrative Deals Landscape, Mostly Involving Currently Established Targets

2 The Case for Innovation in the Head and Neck Cancer Market
2.1 Growing Opportunities for Biologic Products
2.2 Diversification of Molecular Targets
2.3 Innovative First-in-Class Product Developments Remain Attractive
2.4 Sustained Innovation
2.5 Report Guidance

3 Clinical and Commercial Landscape
3.1 Disease Overview
3.2 Disease Symptoms
3.3 Diagnosis
3.4 Etiology
3.4.1 Age, Ethnicity and Gender
3.4.2 Genetic Factors
3.4.3 Smoking, Alcohol and Environmental Factors
3.4.4 Viruses
3.5 Pathophysiology
3.5.1 Tumor Initiation and Aberrant Cell Proliferation and Survival
3.5.2 Tumor Metabolic Shift
3.5.3 Tumor Progression, Micro-environment Alteration, Angiogenesis and Metastasis
3.5.4 Cancer Stem Cells
3.6 Epidemiology
3.7 Prognosis
3.8 Head and Neck Cancer Treatment
3.8.1 Surgery and Radiation Therapy
3.8.2 Overview of Marketed Products for Head and Neck Cancer
3.8.3 Current Unmet Need in the Head and Neck Cancer Market

4 Assessment of Pipeline Product Innovation
4.1 Head and Neck Cancer Pipeline by Phase, Molecule Type and Molecular Target
4.2 First-in-Class Pipeline Programs

5 Signaling Network, Disease Causation and Innovation Alignment
5.1 The Complexity of Signaling Networks in Oncology
5.2 Signaling Pathways, Disease-Causing Mutations and First-in-Class Molecular Target Integration
5.3 First-in-Class Target Matrix Assessment

6 First-in-Class Target Evaluation
6.1 Pipeline Programs Targeting PIK3CA, PIK3CB and PIK3CG
6.2 Pipeline Programs Targeting HER3
6.3 Pipeline Programs Targeting ADAM17
6.4 Pipeline Programs Targeting Protein Kinase C Epsilon Type
6.5 Pipeline Programs Targeting AKT1, AKT2 and AKT3
6.6 Pipeline Programs Targeting HSP90AA1
6.7 Pipeline Programs Targeting Tyrosine-Protein Kinase SYK
6.8 Pipeline Programs Targeting Telomerase Reverse Transcriptase
6.9 Pipeline Programs Targeting Growth Factor Receptor-Bound Protein 2
6.10 Pipeline Programs Targeting Focal Adhesion Kinase
6.11 Conclusion

7 Deals and Strategic Consolidations
7.1 Industry-Wide First-in-Class Deals
7.2 Head and Neck Cancer Deals Landscape
7.3 Licensing Deals
7.3.1 Molecule Type
7.3.2 Molecular Target
7.4 Co-development Deals
7.4.1 Molecule Type
7.4.2 Molecular Target
7.5 List of Pipeline Products without Prior Licensing or Co-development Deal Involvement

8 Appendix
8.1 Abbreviations
8.2 References
8.3 Research Methodology
8.4 Secondary Research
8.4.1 Market Analysis
8.4.2 Pipeline Analysis
8.4.3 First-in-Class Matrix Assessment
8.4.4 First-in-Class Target Profiles
8.4.5 Licensing and Co-development Deals

List of Tables
Table 1: Symptoms of Head and Neck Cancer, 2017
Table 2: Symptoms of Head and Neck Cancer Metastasis, 2017
Table 3: Common Mutations in Head and Neck Cancer Metastasis, 2017
Table 4: Head and Neck Cancer, Key Features and Pipeline Activity of PIK3CA, PIK3CB and PIK3CG, 2017
Table 5: Head and Neck Cancer, Key Features and Pipeline Activity of HER3, 2017
Table 6: Head and Neck Cancers, Key Features and Pipeline Activity of ADAM17, 2017
Table 7: Head and Neck Cancer, Key Features and Pipeline Activity of Protein Kinase C Epsilon, 2017
Table 8: Head and Neck Cancer, Key Features and Pipeline Activity of AKT1, 2 and 3, 2017
Table 9: Head and Neck Cancer, Key Features and Pipeline Activity of HSP90, 2017
Table 10: Head and Neck Cancer, Key Features and Pipeline Activity of Tyrosine-Protein Kinase SYK, 2017
Table 11: Head and Neck Cancer, Key Features and Pipeline Activity of Telomerase Reverse Transcriptase, 2017
Table 12: Head and Neck Cancer, Key Features and Pipeline Activity of Growth Factor Receptor-Bound Protein 2, 2017
Table 13: Head and Neck Cancer, Key Features and Pipeline Activity of Focal Adhesion Kinase, 2017
Table 14: Abbreviations

List of Figures
Figure 1: Pharmaceutical Market, Global, Innovation Trends in Product Approvals, 1987-2016
Figure 2: Pharmaceutical Market, Global, Sales Performance of First-in-Class and Non-First-in-Class Products Post Marketing Approval, 2006-2013
Figure 3: Head and Neck Cancer, Marketed Product Overview by Molecule Type and Mechanism of Action, 2016
Figure 4: Head and Neck Cancer, Global, Overall Pharmaceutical Industry Pipeline by Therapy Area
Figure 5: Head and Neck Cancer, Developmental Pipeline Overview, 2017
Figure 6: Head and Neck Cancer, Developmental Pipeline by Molecular Target, 2017
Figure 7: Head and Neck Cancer, Molecular Target Category Comparison, Pipeline and Marketed Products, 2017
Figure 8: Head and Neck Cancer, Molecular Target Category Comparison, Pipeline First-in-Class and Established Molecular Targets
Figure 9: Head and Neck Cancer Drug Market, Global, Percentage Distribution of First-in-Class Products in Pipeline by Stage of Development (%), 2017
Figure 10: Head and Neck Cancer Drug Market, Global, Distribution of First-in-Class Products in Pipeline by Molecular Target (%), 2017
Figure 11: Head and Neck Cancer, First-in-Class Products in the HNC Pipeline Part 1, 2017
Figure 12: Head and Neck Cancer, First-in-Class Products in the HNC Pipeline Part 2, 2017
Figure 13: Head and Neck Cancer, First-in-Class Products in the HNC Pipeline Part 3, 2017
Figure 14: Head and Neck Cancer, First-in-Class Products in the HNC Pipeline Part 4 2017
Figure 15: Head and Neck Cancer, First-in-Class Molecular Target Analysis Matrix, 2017
Figure 16: Head and Neck Cancer, Pipeline Programs Targeting PIK3CA/PIK3CB/PIK3CG
Figure 17: Head and Neck Cancer, HER3 Targeting Products
Figure 18: Head and Neck Cancer, ADAM17 Targeting Products
Figure 19: Head and Neck Cancers, Protein Kinase C Epsilon Type Targeting Products
Figure 20: Head and Neck Cancer, AKT1/AKT2/AKT3 Targeting Products
Figure 21: Head and Neck Cancers, HSP90 Targeting Products
Figure 22: Head and Neck Cancer, Tyrosine-Protein Kinase SYK Targeting Products
Figure 23: Head and Neck Cancer, Telomerase Reverse Transcriptase Targeting Products
Figure 24: Head and Neck Cancer, Growth Factor Receptor-Bound Protein 2 Targeting Products
Figure 25: Head and Neck Cancer, Focal Adhesion Kinase 1 Targeting Products
Figure 26: Pharmaceutical Market, Global, Industry-Wide Deals by Stage of Development, 2006-2014
Figure 27: Pharmaceutical Market, Global, Industry Licensing Deal Values by Stage of Development, 2006-2014
Figure 28: Head and Neck Cancer, Global, Licensing Deals by Region and Value, 2006-2016
Figure 29: Head and Neck Cancer, Global, Licensing Deals by Stage and Value, 2006-2016
Figure 30: Head and Neck Cancer, Licensing Deals by Molecule Type, 2006-2016
Figure 31: Head and Neck Cancer, Licensing Deals by Molecular Target, 2006-2016
Figure 32: Head and Neck Cancer, Licensing Deals with Disclosed Values, 2006-2016
Figure 33: Head and Neck Cancer, Co-development Deals by Region and Value, 2006-2016
Figure 34: Head and Neck Cancer, Co-development Deals by Stage and Value, 2006-2016
Figure 35: Head and Neck Cancer, Co-development Deals by Molecule Type, 2006-2016
Figure 36: Head and Neck Cancer, Co-development Deals by Molecular Target, 2006-2016
Figure 37: Head and Neck Cancer, Co-development Deals with Disclosed Values, 2006-2016
Figure 38: Head and Neck Cancer, List of Pipeline Products With Prior Licensing or Co-development Deal Involvement, 2016
Figure 39: Head and Neck Cancer, List of Pipeline Products Without Prior Licensing or Co-development Deal Involvement, 2016

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