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


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GBI Research

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Large and Diverse Pipeline

The liver cancer pipeline contains 238 products in active development, approximately 47% of which are first-in-class. The percentage of the pipeline devoted to innovative products is considerably larger than both the industry and oncology average, which is a promising sign for novel therapeutics reaching the liver cancer market.

The contrast between the market and pipeline is vast. Analysis showed that the market contains 70 products, the majority of which are generic formulations of chemotherapies that are not frequently used in treatment, particularly in advanced-stage patients. Nexavar (sorafenib) is the dominant therapeutic on the market, and is also the only targeted therapy that is in regular use for advanced-stage liver cancer patients. However, pipeline analysis revealed that targeted therapies aimed at the underlying oncogenic signaling pathways are under much greater focus in the pipeline than in the market. The success of targeted therapies across the oncology market as a whole implies that the diversity and innovation in the pipeline is a promising sign, with products currently in development having the potential to transform and improve the relatively open liver cancer market.

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

The liver cancer pipeline is showing signs of adapting to the increasing understanding of aberrant signaling pathways and causes of liver cancer. A large portion of pipeline products target components of known dysfunctional signaling pathways, such as Wnt/ß–catenin signaling, which is commonly mutated in liver cancer tumor samples. By aligning the treatment with specific disease-causing features, the damaging off-target cytotoxic effects of treatment can be reduced, resulting in safer and more efficacious therapies.

GBI Research’s analysis identified substantial variation in the alignment of first-in-class products to underlying dysfunctional signaling at protein and genetic level. The first-in-class products were compared in an in-depth analysis using various parameters to measure the potential of each target, with the most promising targets being further substantiated by published clinical and scientific evidence. Results of the analysis suggested that first-in-class status is not a feature that, in its own right, will create a successful product. However, there are a large number of first-in-class products backed by clinical and Preclinical data that are exciting future prospects for the liver cancer market.

Analysis of Patent Data

The report features an analysis of granted patent applications in the liver cancer market, which was used as an indication of innovation at the earliest stage of product development. Patent analysis provides an insight into the pre-developmental landscape, and identifies long-term future trends within a disease market. In liver cancer, the trend in patent applications in terms of predominant molecular targets reflects the pipeline landscape, suggesting that liver cancer therapeutics will continue to target key oncogenic signaling pathways in the long term.

The frequency at which companies apply for patents within the market helps to identify companies that are trying to establish themselves or increase their liver cancer market share. This information identifies not only potential competitors, but also companies that may seek strategic partnerships to enter drug development.

First-in-Class Products in Licensing and Co-Development Deals

The deals landscape for liver cancer has been relatively active in recent years, with 62 licensing deals and 23 co-development deals between 2006 and 2014. However, the number pertaining to first-in-class products is very low.

A comparative analysis of the deals revealed that first-in-class products have the potential to command substantially higher deal values than non-first-in-class products, which is a reflection of their market potential and importance. A total of 68 first-in-class products that are currently in development have not yet been entered into a licensing or co-development deal. In a transforming market that will favor innovative, targeted therapies with a strong clinical record, there are numerous opportunities for strategic alliances to bolster a first-in-class portfolio or fund clinical development. Although not all are aligned to disease-causing signaling pathways, many are supported by robust scientific and clinical data, making them attractive prospects as both therapeutics and investment opportunities.

Scope

The report includes:

  • A brief introduction to liver cancer, including symptoms, pathophysiology, and an overview of pharmacotherapy and treatment algorithms
  • Coverage of the changing molecular target landscape and particular points of innovation in the pipeline
  • A comprehensive review of the pipeline for first-in-class therapies, analyzed by stage of development, molecule type and molecular target
  • Analysis of patent trends and patent families in liver cancer
  • 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 of novel molecular targets
  • Industry-wide analysis of first-in-class deals compared to non-first-in-class deals
  • An assessment of the licensing and co-development deal landscape for liver cancer therapies, and benchmarking of deals comparing first-in-class and non-first-in-class-products

Reasons To Buy

The report will enable business development and enable marketing executives to strategize their product launches by allowing them to:

  • Understand the focal shifts in molecular targets in the liver cancer pipeline
  • Understand the distribution of pipeline programs by phase of development, molecule type and molecular target
  • Understand the patent trends in liver cancer and what this means for long-term innovation
  • Access a scientific and clinical analysis of first-in-class developmental programs for liver cancer, benchmarked against non-first-in-class targets
  • Assess the valuations of licensed and co-developed liver cancer treatments
  • Access a list of the first-in-class therapies potentially open to deal-making opportunities

1 Table of Contents
1.1 List of Tables
1.2 List of Figures

2 Executive Summary
2.1 Unmet Needs and Limited Market Drive an Innovative Pipeline
2.2 Targeted Therapies Segment to Expand over the Coming Decade
2.3 Active Deals Landscape Reflects the Dynamic Pipeline

3 The Case for Innovation
3.1 Growing Opportunities for Biologic Products
3.2 Diversification of Molecular Targets
3.3 Innovative First-in-class Product Developments Remain Attractive
3.4 Regulatory and Reimbursement Policy Shifts Favor First-in-Class Product Innovation
3.5 Sustained Innovation
3.6 GBI Research Report Guidance

4 Clinical and Commercial Landscape
4.1 Disease Overview
4.2 Symptoms
4.3 Epidemiology and Etiology
4.4 Pathophysiology
4.4.1 Hepatocellular Carcinoma
4.4.2 Cholangiocarcinoma
4.4.3 Conclusion
4.5 Diagnosis
4.5.1 Clinical Presentation
4.5.2 Alpha-Fetoprotein
4.5.3 Diagnostic Imaging and Scans
4.5.4 Screening
4.5.5 Biopsy
4.5.6 Classification
4.6 Treatment Options
4.7 Treatment Algorithm
4.7.1 First Line
4.8 Overview of Marketed Products for Liver Cancer
4.8.1 Molecular Type and Target Analysis
4.8.2 Innovative Products in the Liver Cancer Market
4.8.3 Unmet Needs

5 Assessment of Pipeline Product Innovation
5.1 Liver Cancer Pipeline by Molecule Type, Phase and Therapeutic Target
5.2 Comparative Distribution of Programs between the Liver Cancer Market and Pipeline by Therapeutic Target Family
5.3 First-in-Class Pipeline Programs Targeting Novel Molecular Targets

6 Liver Cancer Patent Family Analysis

7 Signaling Network, Disease Causation and Innovation Alignment
7.1 The Complexity of Signaling Networks in Oncology
7.2 Signaling Pathways Disease-Causing Mutations and First-in-Class Molecular Target Integration
7.3 First-in-Class Target Matrix Assessment

8 First-in-Class Target Evaluation
8.1 Pipeline Programs Targeting ß-Catenin
8.2 Pipeline Programs Targeting FGFR4
8.3 Pipeline Programs Targeting GPR55
8.4 Pipeline Programs Targeting Protein Disulfide Isomerase
8.5 Pipeline Programs Targeting Telomerase
8.6 Pipeline Programs Targeting Delta-Like 1 Homolog
8.7 Pipeline Programs Targeting eIF5A
8.8 Pipeline Programs Targeting FAK
8.9 Pipeline Programs Targeting TGFß Receptor
8.10 Conclusion

9 Deals and Strategic Consolidations
9.1 Industry-wide First-in-Class Deals
9.2 Liver Cancer Deals Landscape
9.3 Licensing Deals
9.3.1 Molecule Types
9.3.2 Mechanism of Action
9.4 Co-Development Deals
9.4.1 Molecule Types
9.4.2 Mechanism of Action
9.5 First-In-Class Programs Not Involved in Licensing or Co-Development Deals

10 Appendix
10.1 References
10.2 Abbreviations
10.3 Contact Us
10.4 Disclaimer

Table 1: Liver Cancer, Organizations Frequently Applying for Chemical Entity Patent Families, (2008–2012)

Figure 1: Innovation Trends in Product Approvals
Figure 2: Sales Performance of First-in-Class and Non-First-in-Class Product Post Marketing Approval
Figure 3: Overview of Marketed Products
Figure 4: Overview of Pipeline Products
Figure 5: Breakdown of Pipeline Molecular Targets
Figure 6: Pipeline Molecular Targets by Stage of Development
Figure 7: Molecular Target Category Comparison, Pipeline and Marketed Products
Figure 8: Molecular Target Category Comparison, Pipeline First-in-Class and Established Molecular Targets
Figure 9: List of First-in-Class Pipeline Products (Part 1)
Figure 10: List of First-in-Class Pipeline Products (Part 2)
Figure 11: Liver Cancer, US and EU, Patent Families Filed and Granted by Year, 2008–2012
Figure 12: Liver Cancer, US and EU, Granted Patent Families by Molecular Target, 2008–2012
Figure 13: Liver Cancer, US and EU, Granted Patent Families by Molecular Target Family, 2008–2012
Figure 14: Liver Cancer, US and EU, Molecular Targets Identified in Patents (Part 1), 2008–2012
Figure 15: Liver Cancer, US and EU, Molecular Targets Identified in Patents (Part 2), 2008–2012
Figure 16: Signaling Networks of Functional Families in Liver Cancer
Figure 17: Target Matrix Assessment (Part 1)
Figure 18: Target Matrix Assessment (Part 2)
Figure 19: Target Matrix Assessment (Part 3)
Figure 20: Target Matrix Assessment (Part 4)
Figure 21: Target Matrix Assessment (Part 5)
Figure 22: Data and Evidence for ß-Catenin as a Therapeutic Target
Figure 23: Pipeline Products Targeting ß-Catenin
Figure 24: Data and Evidence for FGFR4 as a Therapeutic Target
Figure 25: Pipeline Products Targeting FGFR4
Figure 26: Data and Evidence for GPR55 as a Therapeutic Target
Figure 27: Pipeline Products Targeting GPR55
Figure 28: Data and Evidence for PDI as a Therapeutic Target
Figure 29: Pipeline Products Targeting PDI
Figure 30: Data and Evidence for Telomerase as a Therapeutic Target
Figure 31: Pipeline Products Targeting Telomerase
Figure 32: Data and Evidence for DLK1 as a Therapeutic Target
Figure 33: Pipeline Products Targeting DLK1
Figure 34: Data and Evidence for eIF5A as a Therapeutic Target
Figure 35: Pipeline Products Targeting eIF5A
Figure 36: Data and Evidence for FAK as a Therapeutic Target
Figure 37: Pipeline Products Targeting FAK
Figure 38: Data and Evidence for TGFßR1 as a Therapeutic Target
Figure 39: Pipeline Products Targeting TGFßR1
Figure 40: Industry Wide Deals by Stage of Development, 2006–2014
Figure 41: Industry Licensing Deal Values by Stage of Development, 2006–2014
Figure 42: Licensing Agreements, 2006–2014
Figure 43: Licensing Agreements by Phase, 2006–2014
Figure 44: Licensing Agreements by Territory, 2006–2014
Figure 45: Licensing Agreements by Molecule Type, 2006–2014
Figure 46: Licensing Agreements by Molecular Target, 2006–2014
Figure 47: Co-development Agreements, 2006–2014
Figure 48: Co-development Agreements by Territory, 2006–2014
Figure 49: Co-development Agreements by Molecule Type, 2006–2014
Figure 50: Co-development Agreements by Molecular Target, 2006–2014
Figure 51: List of First-in-Class Pipeline Products Not Involved in Deals (Part 1)
Figure 52: List of First-in-Class Pipeline Products Not Involved in Deals (Part 2)