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Frontier Pharma: Hepatitis C - Diverse Range of First-in-Class Host-Targeting and Direct-Acting Antivirals Offer Potential in Difficult-to-Treat Populations

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Frontier Pharma: Hepatitis C - Diverse Range of First-in-Class Host-Targeting and Direct-Acting Antivirals Offer Potential in Difficult-to-Treat Populations


Hepatitis C is a blood-borne...
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Frontier Pharma: Hepatitis C - Diverse Range of First-in-Class Host-Targeting and Direct-Acting Antivirals Offer Potential in Difficult-to-Treat Populations


Hepatitis C is a blood-borne viral infection characterized by chronic inflammation of the liver. Although patients may be asymptomatic for a number of years or decades, chronic HCV infection can lead to liver fibrosis (formation of scar tissue) and ultimately liver cirrhosis, in which permanent fibrotic scar tissue replaces healthy liver cells. In severe cases, cirrhosis may lead to liver failure and death. In addition, hepatitis C patients are at an increased risk of developing liver cancer.

Hepatitis C has a high global prevalence, with the number of people living with the disease estimated at 130-170 million worldwide. Before the arrival of direct-acting antivirals (DAA) in 2011, the gold-standard of hepatitis C therapy consisted of the host-targeting drugs pegylated interferon-_ and ribavirin, which were associated with significant side effects.

After nearly a decade of minimal progress in the development of hepatitis C therapies, the treatment landscape of hepatitis C has evolved substantially in recent years. This has resulted in an increasingly competitive market landscape, and several oral regimens that combine DAAs from different nonstructural (NS) HCV protein families - NS5B polymerase inhibitors, NS5A replication complex inhibitors and NS3/4A protease inhibitors - have already been licensed. These new combination therapies have been highly commercially successful and are now regarded as the gold-standard within the treatment algorithm.

Despite the entry of these new therapies, there is a subgroup of patients that do not respond to current treatments, or relapse. In addition, HCV resistance to DAAs may also be a cause for concern, as the development of selection pressure by the host immune system in combination with DAA therapy may lead to outgrowth of resistant viruses. As such, the rationale for investment in first-in-class innovation remains strong.

First-in-class products account for a relatively small proportion of the hepatitis C pipeline. However, in comparison with historical hepatitis C trends, which saw virtually no first-in-class products approved over a large period up until 2011, the presence of a modest number of these products is promising. The first-in-class targets identified show considerable diversity, and the high number of novel pathways targeted by first-in-class products provides evidence of enhanced divergence in hepatitis C first-in-class innovation in recent years.


The escalating hepatitis C public healthcare need has resulted in a competitive market landscape
- What is the pathophysiology of hepatitis C?
- What are the common co-morbidities and complications?
- How has the emergence of new drug classes in the past decade impacted the treatment algorithm?
- What are the most significant unmet needs within the market?
The hepatitis C pipeline is relatively large and innovative
- Which molecule types and molecular targets are most prominent within the pipeline?
- Which first-in-class targets are most promising?
- How does the ratio of first-in-class targets to first-in-class products differ by stage of development and molecular target class?
The hepatitis C deals landscape is highly active
- Do hepatitis C products attract high deal values?
- Which molecule types and molecular targets dominate the deals landscape?
- Which first-in-class pipeline products have no prior involvement in licensing or co-development deals?

Reasons to buy

This report will allow you to -
- Appreciate the current clinical and commercial landscapes by considering disease pathogenesis, etiology, epidemiology, symptoms, co-morbidities and complications, and treatment options and algorithms.
- Visualize the composition of the hepatitis C market in terms of dominant classes of therapies. Key unmet needs are identified to allow a competitive understanding of gaps in the market.
- Recognize innovative pipeline trends by analyzing therapies by stage of development, molecule type and molecular target.
- Assess the therapeutic potential of first-in-class targets. Using a proprietary matrix tailored to hepatitis C, all first-in-class targets in the hepatitis C pipeline have been assessed and ranked according to clinical potential. Promising early-stage targets have been further reviewed in greater detail.
- Consider first-in-class pipeline products with no prior involvement in licensing and co-development deals that may represent potential investment opportunities.'

Additional Information

Additional Information

Publisher name GBI Research.
Format PDF
Page count 65
Publication date 9 Dec 2016
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 5
2.1 Unmet Needs Remain in Hepatitis C Market 5
2.2 Pipeline Dominated by Direct-Acting Antivirals with Small Number of First-in-Class Products 5
2.3 Diverse Range of Host-Targeting and Direct-Acting Antivirals in First-in-Class Pipeline 5
3 The Case for Innovation 6
3.1 Growing Opportunities for Biologic Products 7
3.2 Diversification of Molecular Targets 7
3.3 Innovative First-in-Class Development Remains Attractive 7
3.4 Regulatory and Reimbursement Policy Shifts Favor First-in-Class Product Innovation 8
3.5 Sustained Innovation 8
3.6 GBI Research Report Guidance 9
4 Clinical and Commercial Landscape 10
4.1 Disease Overview 10
4.2 Disease Symptoms 10
4.3 Epidemiology 10
4.4 Etiology and Risk Factors 11
4.5 Pathophysiology 12
4.6 Disease Progression 14
4.6.1 Acute Stage 14
4.6.2 Chronic Stage 14
4.6.3 End Stage 15
4.6.4 Factors Affecting Progression 15
4.7 Co-morbidities and Complications 15
4.8 Diagnosis 15
4.9 Treatment Options and Treatment Algorithm 16
4.9.1 Treatment Options 16
4.9.2 Treatment Algorithm 18
4.10 Overview of Marketed Products in Hepatitis C 20
4.10.1 Molecule Type and Molecular Target Analysis 20
5 Assessment of Pipeline Product Innovation 21
5.1 Pipeline by Stage of Development, Molecule Type and Molecular Target 21
5.2 Comparative Distribution of Programs between the Hepatitis C Market and Pipeline by Therapeutic Target Family 23
5.3 First-in-Class Programs Targeting Novel Molecular Targets 24
6 Signaling Network, Disease Causation and Innovation Alignment 33
6.1 Complexity of Signaling Networks in Hepatitis C 33
6.2 Signaling Pathways and First-in-Class Molecular Target Integration 34
6.3 First-in-Class Matrix Assessment 34
7 First-in-Class Target Evaluation 37
7.1 Viral Targets 37
7.1.1 Pipeline Programs Targeting HCV P7 37
7.1.2 Pipeline Programs Targeting HCV Envelope Proteins E1 and E2 38
7.1.3 Pipeline Programs Targeting HCV NS4B 40
7.2 Host Targets 41
7.2.1 Pipeline Programs Targeting MicroRNA 122 41
7.2.2 Pipeline Programs Targeting Toll-like Receptor 3 43
7.2.3 Pipeline Programs Targeting Claudin 1 43
7.2.4 Pipeline Programs Targeting Serine C-Palmitoyltransferase 45
7.2.5 Pipeline Programs Targeting Type III Phosphatidylinositol 4-Kinase Beta 45
7.2.6 Pipeline Programs Targeting Caspases 46
8 Strategic Consolidations 50
8.1 Industry-Wide First-in-Class Deals 50
8.2 Licensing Deals 51
8.3 Co-development Deals 54
8.4 First-in-Class Programs Not Involved in Licensing or Co-development Deals 57
9 Appendix 59
9.1 References 59
9.2 Abbreviations 63
9.3 Research Methodology 64
9.4 Secondary Research 64
9.4.1 Market Analysis 64
9.4.2 Pipeline Analysis 64
9.4.3 First-in-Class Matrix Assessment 65
9.4.4 First-in-Class Target Profiles 65
9.4.5 Licensing and Co-Development Deals 65
9.5 Contact Us 65
9.6 Disclaimer 65


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