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

GBI Research
65 Pages - GBI10581
$6,995.00

Summary

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-α 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.

Scope

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.

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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

1.1 List of Tables
Table 1: Hepatitis C Therapeutics Market, Risk Factors for Fibrosis Progression, 2016 15
Table 2: Hepatitis C Therapeutics Market, Global, Characteristics of DAAs, 2016 17
Table 3: Hepatitis C Therapeutics Market, Global, Categories of Approved DAA Therapies in Hepatitis C, 2016 18
Table 4: Hepatitis C Therapeutics Market, Global, AASLD/IDSA Hepatitis C Treatment Guidelines, 2016 19
Table 5: Hepatitis C Therapeutics Market, Global, Key Features and Pipeline Activity of HCV P7, 2016 37
Table 6: Hepatitis C Therapeutics Market, Global, Pipeline Programs Targeting HCV P7, 2016 38
Table 7: Hepatitis C Therapeutics Market, Global, Key Features and Pipeline Activity of HCV Envelope Protein E1 and E2, 2016 38
Table 8: Hepatitis C Therapeutics Market, Global, Pipeline Programs Targeting HCV Envelope Protein E1 and E2, 2016 39
Table 9: Hepatitis C Therapeutics Market, Global, Key Features and Pipeline Activity of HCV Envelope Protein E2, 2016 39
Table 10: Hepatitis C Therapeutics Market, Global, Pipeline Programs Targeting HCV Envelope Protein E2, 2016 39
Table 11: Hepatitis C Therapeutics Market, Global, Key Features and Pipeline Activity of HCV NS4B, 2016 41
Table 12: Hepatitis C Therapeutics Market, Global, Pipeline Programs Targeting HCV NS4B, 2016 41
Table 13: Hepatitis C Therapeutics Market, Global, Key Features and Pipeline Activity of MicroRNA 122, 2016 42
Table 14: Hepatitis C Therapeutics Market, Global, Pipeline Programs Targeting MicroRNA 122, 2016 42
Table 15: Hepatitis C Therapeutics Market, Global, Key Features and Pipeline Activity of Toll-like Receptor 3, 2016 43
Table 16: Hepatitis C Therapeutics Market, Global, Pipeline Programs Targeting Toll-like Receptor 3, 2016 43
Table 17: Hepatitis C Therapeutics Market, Global, Key Features and Pipeline Activity of Claudin 1, 2016 44
Table 18: Hepatitis C Therapeutics Market, Global, Pipeline Programs Targeting Claudin 1, 2016 44
Table 19: Hepatitis C Therapeutics Market, Global, Key Features and Pipeline Activity of Serine C-Palmitoyltransferase, 2016 45
Table 20: Hepatitis C Therapeutics Market, Global, Pipeline Programs Targeting Serine C-Palmitoyltransferase, 2016 45
Table 21: Hepatitis C Therapeutics Market, Global, Key Features and Pipeline Activity of Type III Phosphatidylinositol 4-Kinase Beta, 2016 46
Table 22: Hepatitis C Therapeutics Market, Global, Pipeline Programs Targeting Type III Phosphatidylinositol 4-Kinase Beta, 2016 46
Table 23: Hepatitis C Therapeutics Market, Global, Key Features and Pipeline Activity of Caspase 1, 2016 47
Table 24: Hepatitis C Therapeutics Market, Global, Key Features and Pipeline Activity of Caspase 2, 2016 47
Table 25: Hepatitis C Therapeutics Market, Global, Key Features and Pipeline Activity of Caspase 3, 2016 47
Table 26: Hepatitis C Therapeutics Market, Global, Key Features and Pipeline Activity of Caspase 5, 2016 48
Table 27: Hepatitis C Therapeutics Market, Global, Key Features and Pipeline Activity of Caspase 6, 2016 48
Table 28: Hepatitis C Therapeutics Market, Global, Key Features and Pipeline Activity of Caspase 7, 2016 48
Table 29: Hepatitis C Therapeutics Market, Global, Key Features and Pipeline Activity of Caspase 8, 2016 48
Table 30: Hepatitis C Therapeutics Market, Global, Key Features and Pipeline Activity of Caspase 9, 2016 49
Table 31: Hepatitis C Therapeutics Market, Global, Pipeline Programs Targeting Caspases, 2016 49
Table 32: Abbreviations 63

1.2 List of Figures
Figure 1: Hepatitis C Therapeutics Market, US, Innovation Trends in Product Approvals, Number of Product Approvals by FDA and Five-Year Moving Average of Product Approvals, 1987-2014 6
Figure 2: Hepatitis C Therapeutics Market, Sales Performance of First-in-Class and Non-First-in-Class Products Post Marketing Approval ($m), 2006-2013 8
Figure 3: Hepatitis C Therapeutics Market, Major Markets, Hepatitis C Prevalent Population (million), 2015-2022 11
Figure 4: Hepatitis C Therapeutics Market, Major Markets, Hepatitis C Treatment Rate (‘000), 2015-2022 11
Figure 5: Hepatitis C Therapeutics Market, HCV Genomic RNA, 2016 13
Figure 6: Hepatitis C Therapeutics Market, Global, Marketed Products by Molecule Type and Molecular Target, 2016 20
Figure 7: Hepatitis C Therapeutics Market, Global, Pipeline by Stage of Development and Molecule Type, 2016 21
Figure 8: Hepatitis C Therapeutics Market, Global, Pipeline by Molecular Target and Stage of Development, 2016 23
Figure 9: Hepatitis C Therapeutics Market, Global, Distribution of Molecular Targets Across Pipeline and Marketed Products, 2016 24
Figure 10: Hepatitis C Therapeutics Market, Global, Distribution of Pipeline First-in-Class and Established Products, 2016 25
Figure 11: Hepatitis C Therapeutics Market, Global, Percentage Distribution of First-in-Class and Established Pipeline Products by Stage of Development (%), 2016 25
Figure 12: Hepatitis C Therapeutics Market, Global, Percentage Distribution of First-in-Class and Established Pipeline Products by Molecular Target (%), 2016 26
Figure 13: Hepatitis C Therapeutics Market, Global, Pipeline Products, 2016 (Part 1) 27
Figure 14: Hepatitis C Therapeutics Market, Global, Pipeline Products, 2016 (Part 2) 28
Figure 15: Hepatitis C Therapeutics Market, Global, Pipeline Products, 2016 (Part 3) 29
Figure 16: Hepatitis C Therapeutics Market, Global, Pipeline Products, 2016 (Part 4) 30
Figure 17: Hepatitis C Therapeutics Market, Global, Pipeline Products, 2016 (Part 5) 31
Figure 18: Hepatitis C Therapeutics Market, Global, Pipeline Products, 2016 (Part 6) 32
Figure 19: Hepatitis C Therapeutics Market, Global, First-in-Class Molecular Target for Host Factors Matrix Assessment, 2016 35
Figure 20: Hepatitis C Therapeutics Market, Global, First-in-Class Molecular Target for Viral Proteins Matrix Assessment, 2016 36
Figure 21: Hepatitis C Therapeutics Market, Global, Industry-Wide Deals by Stage of Development, 2006-2014 50
Figure 22: Hepatitis C Therapeutics Market, Global, Industry-Wide Licensing Deals by Deal Value ($m), Upfront Payment Value ($m) and Stage of Development, 2006-2014 51
Figure 23: Hepatitis C Therapeutics Market, Global, Licensing Deals by Region and Deal Value ($m), 2006-2016 52
Figure 24: Hepatitis C Therapeutics Market, Global, Disclosed and Undisclosed Licensing Deals by Year, Total Disclosed Deal Value ($m) and Total Upfront Payment Value ($m), 2006-2015 52
Figure 25: Hepatitis C Therapeutics Market, Global, Licensing Deals by Stage of Development, Deal Value ($m) and Upfront Payment Value ($m), 2006-2016 53
Figure 26: Hepatitis C Therapeutics Market, Frequency and Aggregate Deal Value of Licensing Deals by Molecule Type and Molecular Target, Global, 2006-2016 54
Figure 27: Hepatitis C Therapeutics Market, Global, Co-development Deals by Region and Deal Value ($m), 2006-2016 55
Figure 28: Hepatitis C Therapeutics Market, Global, Disclosed and Undisclosed Co-development Deals by Year, Total Disclosed Deal Value ($m) and Total Upfront Payment Value ($m), 2006-2015 55
Figure 29: Hepatitis C Therapeutics Market, Global, Co-development Deals by Stage of Development, Deal Value ($m) and Upfront Payment Value ($m), 2006-2016 56
Figure 30: Hepatitis C Therapeutics Market, Global, Frequency and Aggregate Deal Value of Co-development Deals by Molecule Type and Molecular Target, 2006-2016 57
Figure 31: Hepatitis C Therapeutics Market, Global, First-in-Class Programs with No Recorded Prior Deal Involvement, 2016 58
Figure 32: Hepatitis C Therapeutics Market, Global, First-in-Class Programs with Prior Deal Involvement, 2016 58

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