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

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Globally, liver cancer is the sixth most common cancer, but its poor prognosis makes it the second leading cause of cancer-related death (Globocan, 2012). Currently, the range of therapies is limited; the market consisted entirely of chemotherapies for many years, and only recently have targeted therapies begun to emerge.

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The liver cancer market is segmented in terms of its needs. Early-stage patients have access to curative therapies such as surgical resection, and therefore have a relatively positive outlook. However, at at the opposite end of the spectrum patients that are diagnosed in later stages who represent the majority of the patient population are not eligible for surgery, and have a very poor prognosis in spite of the approvals of targeted therapies such as Nexavar (sorafenib) and Stivarga (regorafenib).

In stark contrast to the relatively limited market landscape, which contains just 86 products, the liver cancer pipeline is large, diverse and highly innovative. The pipeline has 423 products in active development, with diversity of both molecule type and mechanism of action. Of these, 122 are first-in-class, and act on 109 distinct first-in-class molecular targets. These products span a very wide range of molecular target types including cancer immunotherapies, receptor tyrosine kinases, targeted cytotoxic agents and kinase inhibitors, far exceeding the scope of products present in the chemotherapy-dominated market.

Scope

- The 423 products in active development, of which 122 are first-in-class and therefore act on completely novel targets, far exceed the scope of the current market. How will pipeline innovation affect the future liver cancer market?
- There are 109 distinct first-in-class molecular targets currently being studied. Which of these hold the greatest potential to improve future disease treatment with regard to their molecular target?
- The majority of first-in-class products in development are cancer immunotherapies. Which of these are the most promising, and how does the ratio of first-in-class targets to first-in-class products differ by stage of development and molecular target class?
- A significant number of first-in-class products have been identified with some prior involvement in deals. How do deal frequency and value compare between target families and molecule types, and which first-in-class programs have not yet been involved in a licensing or co-development deal?

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Reasons to buy

- Understand the current clinical and commercial landscape. The report includes a comprehensive study of disease pathogenesis, diagnosis, prognosis and the treatment options available.
- Visualize the composition of the liver 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 gaps in the market.
- Analyze the liver cancer pipeline and stratify by stage of development, molecule type and molecular target. There are strong signs in the pipeline that the industry is seeking novel approaches to treating liver cancer subtypes such as hepatocellular carcinoma and cholangiocarcinoma.
- Assess the therapeutic potential of first-in-class targets. Using a proprietary molecular target matrix, first-in-class products have been assessed and ranked according to clinical potential.
- Identify commercial opportunities in the liver cancer deals landscape by analyzing trends in licensing and co-development deals, and producing a list of first-in-class therapies with no prior involvement in licensing or co-development deals."

Table of Contents

1 Table of Contents1 Table of Contents 2
1.1 List of Tables 3
1.2 List of Figures 3

2 Executive Summary 4
2.1 High Unmet Need and a Limited Number of Marketed Options 4
2.2 Large, Diverse and Highly Innovative Pipeline 4
2.3 Active Deals Landscape Reflects the Dynamic Pipeline 4

3 The Case for Innovation 5
3.1 Growing Opportunities for Biologic Products 6
3.2 Diversification of Molecular Targets 6
3.3 Innovative First-in-Class Product Developments Remain Attractive 7
3.4 Regulatory and Reimbursement Policy Shifts Favor First-in-Class Product Innovation 7
3.5 Sustained Innovation 8
3.6 GBI Research Report Guidance 8

4 Clinical and Commercial Landscape 9
4.1 Disease Overview 9
4.2 Symptoms 9
4.3 Diagnosis 10
4.3.1 Clinical Presentation 10
4.3.2 Alpha-Fetoprotein 10
4.3.3 Diagnostic Imaging and Scans 10
4.3.4 Screening 10
4.3.5 Biopsy 11
4.3.6 Staging, Classification and Prognosis 11
4.4 Epidemiology and Etiology 11
4.5 Pathophysiology 13
4.6 Risk Factors and Co-Morbidities 17
4.7 Treatment Options 17
4.8 Treatment Algorithm 18
4.9 Overview of Marketed Products for Liver Cancer 19
4.9.1 Innovative Products in the Liver Cancer Market 20
4.9.2 Unmet Needs 21

5 Assessment of Pipeline Product Innovation 22
5.1 Liver Cancer Pipeline by Molecule Type, Phase and Therapeutic Target 22
5.2 Comparative Distribution of Programs between the Liver Cancer Market and Pipeline by Therapeutic Target Family 26
5.3 First-in-Class Pipeline Programs 26

6 Signaling Network, Disease Causation and Innovation Alignment 34
6.1 The Complexity of Signaling Networks in Oncology 34
6.2 Signaling Pathways Disease-Causing Mutations and First-in-Class Molecular Target Integration 35
6.3 First-in-Class Target Matrix Assessment 35

7 First-in-Class Target Evaluation 38
7.1 Pipeline Programs Targeting PIK3CA, PIK3CB and PIK3CG 38
7.2 Pipeline Programs Targeting Protein Kinase C Delta 39
7.3 Pipeline Programs Targeting AKT1 40
7.4 Pipeline Programs Targeting HER3/ERBB3 42
7.5 Pipeline Programs Targeting ROR1 43
7.6 Pipeline Programs Targeting PRKACA fusions 44
7.7 Pipeline Programs Targeting Frizzled 2 44
7.8 Pipeline Programs Targeting CDK1 and 2 45
7.9 Pipeline Programs Targeting PTK2/FAK 46
7.10 Conclusion 47

Continued...

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