New Study Reveals Hepatitis B Therapeutics in Major Developed Markets to 2021 | Researchmoz.us

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Hepatitis B is an infectious liver disease caused by the Hepatitis B Virus (HBV) and characterized by acute or chronic inflammation of the liver. Despite its status as a vaccine-preventable disease, it remains a serious global health concern. Incidence tends to be higher in countries with a significant number of migrants from medium and high-prevalence countries. Approximately 350 million people worldwide are infected with chronic hepatitis B, which causes significant morbidity and mortality. Around 780,000 patients die from hepatitis B each year, of which 650,000 deaths are due to complications such as cirrhosis and liver cancer. Despite this, diagnosis and treatment rates are poor, stemming from its asymptomatic nature.

Globally, the hepatitis B therapeutics market is served moderately well by the available products, of which Baraclude and Viread are the most frequently prescribed. However, both have received black-box warnings from the US Food and Drug Administration (FDA), meaning that the market has a high level of unmet need.

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Scope

- The current hepatitis B market contains mainly nucleoside analog reverse transcriptase inhibitors, nucleotide analogs, and interferons.
- Will these drugs continue to dominate hepatitis B treatment?
- With 81 active pipeline molecules, most of the investigational drug candidates are small molecules and vaccines, comprising 64% of the pipeline.
- What are the most prominent small molecules and vaccines in the pipeline?
- Do the pipeline molecules offer advantages over commercially proven mechanisms?
- Analysis of clinical trials since 2006 has identified a high rate of attrition in hepatitis B products.
- How do failure rates vary by product stage of development, molecule type, and mechanism of action?
- How do other factors such as average trial duration and trial size influence the costs and risks associated with product development?
- Over the 2014

Table of Contents

1 Table of Contents 51.1 List of Tables 7
1.2 List of Figures 8

2 Introduction 9
2.1 Classification 9
2.2 Pathophysiology 9
2.3 Etiology 11
2.4 Symptoms 12
2.5 Diagnosis 12
2.6 Epidemiology 13
2.7 Treatment and Management 15
2.8 Prognosis 16
2.9 Co-infection 17
2.9.1 HBV-HIV Co-infection 17
2.9.2 HBV-HDV Co-infection 17
2.9.3 HBV–HCV Co-infection 17

3 Marketed Products 18
3.1 Viread 18
3.1.1 Study 0102 18
3.1.2 Study 0103 18
3.2 Entecavir 19
3.2.1 Nucleoside-Inhibitor-Naive Subjects with Compensated Liver Disease (Studies AI463022 and AI463027) 20
3.2.2 Lamivudine-Refractory Subjects with Compensated Liver Disease (Study AI463026) 21
3.3 Pegasys (peg interferon a-2a) 23
3.4 Adefovir dipivoxil 25
3.4.1 Study 437 (HBeAg-Positive Chronic Hepatitis B Patients) 25
3.4.2 Study 438 (HBeAg-Negative Chronic Hepatitis B Patients) 25
3.4.3 Adefovir Treatment beyond 48 Weeks 27
3.4.4 Study 435 (Pre- and Post-liver Transplantation Subjects) 27
3.4.5 Study 461 (Clinical Evidence of Lamivudine Resistance Patients) 27
3.5 Tyzeka per Sebivo 28
3.5.1 NV-02B-007 GLOBE Trial 28
3.5.2 HBeAg-Positive Subjects 28
3.5.3 HBeAg-Negative Subjects 28
3.6 Comparative Efficacy and Safety 30

4 Pipeline Analysis 32
4.1 Overall Pipeline 32
4.2 Pipeline Analysis of Therapeutic Vaccines 33
4.3 Clinical Trials 35
4.3.1 Failure Rate 35
4.3.2 Failure Rate by Molecule Type 36
4.3.3 Failure Rate by Mechanism of Action 37
4.3.4 Patient Enrollment and Clinical Trial Size by Molecule Type 38
4.3.5 Duration 39
4.4 Competitive Clinical Trials Metrics Analysis 41
4.5 Promising Drug Candidates in Pipeline 41
4.5.1 GS-7340 (tenofovir alafenamide fumarate) 41
4.6 Therapeutic Vaccines in Pipeline 42
4.6.1 GS-4774 Therapeutic Vaccine with Oral Antiviral Treatment 42
4.6.2 ABX203 Therapeutic Vaccine with Nucleos(t)ide Analogs against HBeAg-Negative Chronic Hepatitis B 42
4.6.3 HB-110E Therapeutic DNA Vaccine 42
4.6.4 Therapeutic (Synthesized Peptide) HBV Vaccine (ePA-44) 43
4.6.5 INO-1800 with or without INO-9112 in Entecavir/Tenofovir-Treated HBeAg-Positive Chronic Hepatitis B Patients 44
4.6.6 TG1050 Therapeutic Vaccine 45

5 Market Forecast to 2021 46
5.1 Geographical Markets 46
5.2 Global Market 46
5.3 North America 47
5.3.1 Treatment Usage Patterns 47
5.3.2 Annual Cost of Therapy 48
5.3.3 Market Size 49
5.4 Top Five EU Markets 50
5.4.1 Treatment Usage Patterns 50
5.4.2 Annual Cost of Therapy 51
5.4.3 Market Size 52
5.5 Japan 53
5.5.1 Treatment Usage Patterns 53
5.5.2 Annual Cost of Therapy 54
5.5.3 Market Size 55
5.6 Drivers and Barriers in the Disease Market 55
5.6.1 Drivers 55
5.6.2 Barriers 56

6 Deals and Strategic Consolidations 58
6.1 Licensing Deals 58
6.1.1 OnCore Enters into Licensing Agreement with NeuroVive 61
6.1.2 Dynavax Enters into Licensing Agreement with Merck for Heplisav 61
6.1.3 Ligand Enters into Licensing Agreement with Chiva for Pradefovir and MB01733 61
6.2 Co-development Deals 61

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