Commercial And Pipeline Insight: Hepatitis B

Published by: Datamonitor

Published: Oct. 31, 2007 - 241 Pages

Table of Contents

ABOUT DATAMONITOR HEALTHCARE

About the Infectious Diseases pharmaceutical analysis team

CHAPTER 1 EXECUTIVE SUMMARY

Objective of the analysis

Datamonitor insight into the disease market

Contributing experts

Key metrics

Datamonitor Pipeline Assessment Summary

Related reports

Upcoming related reports

CHAPTER 2 HEPATITIS B - DISEASE BACKGROUND

Summary

Epidemiology

Virus

Structure

Lifecycle

Transmission

Risk groups

Symptoms and disease progression

Acute HBV infection

Chronic HBV infection

Diagnosis

CHAPTER 3 MARKET DEFINITION AND OVERVIEW

Summary

Market definition for this report

Current market situation

Sales and volume use in HBV are increasing steadily

Key events - Five new drug approvals since 1999 have increased treatment diversity

Country market analysis - US is leading the field, while market growth is strongest in the EU5

US: New antivirals experience a good uptake in a diverse market

Japan: Lamivudine takes over from interferon alfa-2b

EU5: Strong growth driven by adefovir

Market drivers and restrictors - Disease awareness as the key factor

Lack of awareness leads to low diagnosis and treatment rates for HBV infections

Segmentation of Hepatitis B

HBV prevalence is highest in adults aged >25 years of age

Men represent a higher percentage of HBV patients than women

Sex between men accounts for an increasing percentage of HBV cases

Immigrants account for the vast majority of infections

HIV-HBV co-infected patients constitute a significant target population

Unmet needs in hepatitis B

A cure for hepatitis B is the key clinical unmet need

The increasing level of HBV drug resistance is creating a need for novel therapeutics

Combination therapy approaches are needed for second- and third-line therapy

Market forecast

The HBV market is set to grow to $1.2 billion by 2012, but will stagnate afterwards

Genericization will start in 2010, but its impact will remain limited

The US will remain leader in sales, whereas Japan will show high growth in volume use

CHAPTER 4 PREVENTION AND TREATMENT

Summary

Vaccines

HBV vaccination is recommended in more and more countries

Plasma-derived vaccines have been replaced by safer, recombinant products

Currently available vaccines provide strong protection

HBV vaccination is widely regarded as safe

Coverage in most of the 7MM is high

Currently marketed Hep B vaccines include single-antigen as well as combination vaccines

HBV pharmacotherapy

Serum levels of ALT and HBV DNA are the key factors for treatment initiation

Suppression of HBV replication is the key endpoint in chronic hepatitis B (CHB) therapy

Currently marketed drugs are split into interferons and antivirals

Choice of first-line treatment depends on multiple factors

Interferons

Antivirals

CHAPTER 5 KEY PLAYERS IN THE HEPATITIS B MARKET

Summary

Gilead and Bristol-Myers Squibb will dominate the HBV market, whereas GSK and Schering-Plough will lose share

GSK - vaccines as future revenue drivers?

Current position

Strategic development

Outlook

Gilead - New hope in tenofovir

Current position

Strategic development

Outlook

Bristol-Myers Squibb - the one-product franchise

Current position

Strategic development

Outlook

Novartis - a new entrant with ambitions

Current position

Strategic development

Outlook

Roche - flying on the wings of Pegasys

Current position

Strategic development

Outlook

Schering-Plough - gloomy prospects

Current position

Strategic development

Outlook

CHAPTER 6 FORECASTING ANALYSIS

New product launches

Patent expiries

Data definitions, limitations and assumptions

Standard units

Japanese market data

Forecasts

Forecast methodology

CHAPTER 7 HBV PIPELINE: CLASS OVERVIEW AND R&D APPROACH

Summary

Pipeline overview: The immune system is the key target for future HBV drugs

Clinical trial design in hepatitis B

Vaccines

Therapeutics

CHAPTER 8 HBV VACCINES: LATE-STAGE PIPELINE ANALYSIS

Summary

Overview for prophylactic HBV vaccines

Pipeline summary

Definition of current comparator therapy

Engerix-B

Key improvement opportunities

Heplisav

Vaccine overview

Clinical trial data

Patient potential

Marketing factors

Satisfaction of unmet needs

Datamonitor vaccine assessment summary

Other late-stage HBV vaccine candidates

Sci-B-Vac (SciGen)

Supervax (Dynavax)

Overview for therapeutic HBV vaccines

Pipeline overview

Hepatitis B Therapeutic Vaccine (Emergent BioSolutions)

Hi-8 Hepatitis B Vaccine (Oxford BioMedica)

CHAPTER 9 HBV THERAPEUTICS: LATE-STAGE PIPELINE ANALYSIS AND FORECAST

Summary

Overview for HBV therapeutics

Pipeline summary

Assessment of clinical and commercial attractiveness

Comparative forecasts

Definition of current comparator therapy

Tenofovir/emtricitabine

Drug overview

Clinical trial data

Trials investigating tenofovir as monotherapy in CHB patients

Trials investigating tenofovir in combination with emtricitabine in CHB patients

Trials investigating tenofovir with and without emtricitabine in HIV-HBV co-infected patients

Patient potential

Marketing factors

Satisfaction of unmet needs

Forecasts to 2016

Datamonitor drug assessment summary

Clevudine

Drug overview

Clinical trial data

The Korean Phase III trials - more data needed on long-term efficacy

Patient potential

Marketing factors

Satisfaction of unmet needs

Forecasts to 2016

Datamonitor drug assessment summary

Other HBV therapeutics in late-stage development

Valtorcitabine (Novartis/Idenix)

EHT899 (Enzo Biochem Inc)

Nitazoxanide (Romark Laboratories LC)

Elvucitabine (Achillion Pharmaceuticals)

Immunitin/HE2000 (Hollis-Eden Pharmaceuticals)

Late-stage development compounds recently discontinued

Pradefovir (Metabasis Therapeutics/Valeant/Schering-Plough)

CHAPTER 10 COMBINATION THERAPIES

Summary

Combination therapy would prove a valuable alternative in resistant patients and potentially increase the chance of eradicating the virus

Combinations between two antivirals

Lamivudine plus adefovir dipivoxil - no benefits in efficacy, but in decelerating resistance development

Combinations with telbivudine - potential benefits with tenofovir, adefovir or valtorcitabine?

Tenofovir plus emtricitabine - extending Truvada's success in HIV?

Others - focus on entecavir plus nucleotides

Combinations between one interferon and one antiviral

Combinations with peginterferon alfa-2a - building on the success in HCV treatment?

Combinations with interferon alfa-2b - no added value in efficacy shown for lamivudine and ribavirin

BIBLIOGRAPHY

Literature

APPENDIX A - MARKET FORECAST DATA

Seven major markets

EU5

US

Japan

France

Germany

Italy

Spain

UK

APPENDIX B

Methodology

Datamonitor forecast methodology

Epidemiology forecasts

Product forecasts

Definition of a standard unit

Datamonitor drug assessment summary

About Datamonitor

About Datamonitor Healthcare

Datamonitor Healthcare's therapy area capabilities

About the Infectious Diseases analysis team

Key therapy team members

Holger Rovini, Head of Respiratory and Infectious Diseases

Hedwig Kresse, Analyst, Infectious Diseases

Disclaimer

List of Tables

Table 1: Key parameters of Hepatitis B for the seven major markets, 2006-2016

Table 2: Forecast key products in Hepatitis B; 7MM, 2006-2016 ($m)

Table 3: HBV nomenclature - viral and host-derived serum markers

Table 4: HBV serology - diagnosis results

Table 5: HBV - prevalence, diagnosis and treatment rates across the 7MM, 2004

Table 6: Hep B vaccines - key products, 2007

Table 7: Currently marketed HBV drugs

Table 8: Factors influencing the choice of first-line therapy for HBV

Table 9: HBV treatment options - comparison of resistances, mode of administration, safety profile and duration of treatment

Table 10: HBV therapy with interferons - factors indicating the likelihood of response

Table 11: Intron A: product profile

Table 12: Events impacting sales forecast for Intron-A, 2006-2016

Table 13: Pegasys: product profile

Table 14: Events impacting sales forecast for Pegasys, 2006-2016

Table 15: Mechanism of currently marketed antivirals, 2007

Table 16: Zeffix: product profile

Table 17: Events impacting sales forecast for Zeffix; 2006-2016

Table 18: Hepsera: product profile

Table 19: Events impacting sales forecast for Hepsera; 2006-2016

Table 20: Baraclude: product profile

Table 21: Events impacting sales forecast for Baraclude 2006-2016

Table 22: Tyzeka: product profile

Table 23: Events impacting sales forecast for Tyzeka, 2006-2016

Table 24: Key players in the hepatitis B market, 2007

Table 25: Datamonitor's launch dates for HBV therapeutics in the 7MM, 2007-2016

Table 26: Patent expiry dates for HBV therapeutics in the 7MM, 2007-2016

Table 27: Number of key hepatitis B pipeline candidates by class and phase of development, September 2007

Table 28: HBV prophylactic vaccines pipeline - overview, September 2007

Table 29: Engerix-B - vaccine profile

Table 30: Heplisav - vaccine profile

Table 31: Heplisav - key Phase III clinical trials, 2007

Table 32: Heplisav - key Phase II clinical trials, 2007

Table 33: HBV therapeutic vaccines pipeline - overview, September 2007

Table 34: HBV therapy - clinical pipeline overview, 2007

Table 35: HBV therapy - preclinical pipeline overview, 2007

Table 36: Entecavir - comparative profile

Table 37: Tenofovir - product profile

Table 38: Tenofovir - clinical trials for monotherapy, 2007

Table 39: Tenofovir - trials for HBV therapy with tenofovir plus emtricitabine (Truvada)

Table 40: Tenofovir - Trials for HIV/HBV co-infection

Table 41: Impacting factors on the revenues of tenofovir, 2006-2016

Table 42: Clevudine - drug profile

Table 43: Clevudine - terminated clinical trials in Korea

Table 44: Clevudine - ongoing clinical trials

Table 45: Impacting factors on the revenues of clevudine, 2006-2016

Table 46: Recently discontinued HBV therapeutics, 2007

Table 47: Combination therapies - clinical trials for lamivudine + adefovir dipivoxil

Table 48: Combination therapies - clinical trials for combinations involving telbivudine

Table 49: Combination therapies - other clinical trials

Table 50: Combination therapies - clinical trials based on peginterferon alfa-2a

Table 51: Combination therapies - clinical trials based on interferon alfa-2b

Table 52: Seven major market Hepatitis B drug sales ($000s) forecasts, 2006-2016

Table 53: EU5 Hepatitis B drug sales ($000s) forecasts, 2006-2016

Table 54: US Hepatitis B drug sales ($000s) forecasts, 2006-2016

Table 55: Japan Hepatitis B drug sales ($000s) forecasts, 2006-2016

Table 56: France Hepatitis B drug sales ($000s) forecasts, 2006-2016

Table 57: Germany Hepatitis B drug sales ($000s) forecasts, 2006-2016

Table 58: Italy Hepatitis B drug sales ($000s) forecasts, 2006-2016

Table 59: Spain Hepatitis B drug sales ($000s) forecasts, 2006-2016

Table 60: UK Hepatitis B drug sales ($000s) forecasts, 2006-2016

Table 61: Datamonitor drug assessment parameters

List of Figures

Figure 1: Datamonitor drug assessment summary of pipeline drugs in development for chronic hepatitis B, 2007

Figure 2: Global HBV prevalence, 2005

Figure 3: HBV - prevalence and mortality, 2004

Figure 4: HBV - impact of vaccination on case numbers, US, 1978-2006

Figure 5: HBV - key structural elements

Figure 6: HBV - lifecycle

Figure 7: HBV - routes of transmission

Figure 8: HBV - major routes of transmission across the seven major markets, 2004

Figure 9: Hepatitis B - course of disease

Figure 10: HBV - risk of chronic HBV carriage by age of infection

Figure 11: HBV disease progression - factors triggering development of cirrhosis

Figure 12: HBV serology - development of ALT and HBV DNA levels over the course of HBV infection

Figure 13: HBV therapeutics market sales value across the 7MM by class and molecule, 2003-06

Figure 14: HBV therapeutics market volume across the 7MM by class and molecule, 2003-06

Figure 15: Key events impacting the HBV therapeutics market, 1999-2006

Figure 16: Performance of the US, EU5 and Japan HBV therapeutics markets, 2006

Figure 17: US HBV market - overview of sales and volume use, 2003-06

Figure 18: Japanese HBV market - overview of sales and volume use; 2003-06

Figure 19: EU5 HBV market - overview of sales and volume use, 2003-06

Figure 20: HBV market - drivers and restrictors, 2007

Figure 21: Key target groups for HBV therapy

Figure 22: Incidence of acute hepatitis B by age group, US, 1990-2005

Figure 23: Incidence of acute HBV infection by sex, US, 2005

Figure 24: Trends in selected epidemiologic characteristics in patients with acute HBV infection, US 1999-2005

Figure 25: Unmet needs in hepatitis B

Figure 26: HBV market - sales and volume use forecast across the, 7MM by molecule, 2006-2016

Figure 27: Impact of genericization on sales and volume use of HBV drugs, 7MM, 2006-2016

Figure 28: HBV therapeutics - sales and volume use forecast by country, 7MM, 2006-2016

Figure 29: Hepatitis B vaccination - geographical spread of vaccination introduction and coverage, 2005

Figure 30: Hepatitis B vaccination - recommendations across the 7MM, 2007

Figure 31: HBV vaccination - coverage rates, 2007

Figure 32: Chronic HBV - treatment algorithms

Figure 33: HBV treatment options - comparison of efficacy in HBeAg+ and HBeAg- patients, 2007

Figure 34: HBV - cost of treatment in the US, 2006

Figure 35: Interferon therapy - SWOT analysis, 2007

Figure 36: Intron-A (interferon alfa 2b) sales in the 7MM for HBV, 2003-06

Figure 37: Intron-A: sales forecast for HBV, 7MM, 2006-2016

Figure 38: Pegasys (peginterferon alfa 2a) - 7MM HBV sales 2003-06

Figure 39: Pegasys - sales forecast in HBV, 7MM, 2006-2016

Figure 40: Antiviral therapy - SWOT analysis, 2007

Figure 41: Zeffix (lamivudine) - 7MM sales 2003-06

Figure 42: Zeffix - sales forecast in HBV, 7MM, 2006-2016

Figure 43: Hepsera (adefovir dipivoxil) - 7MM sales in HBV, 2003-06

Figure 44: Hepsera - sales forecast in HBV, 7MM, 2006-2016

Figure 45: Baraclude (entecavir) - 7MM sales in HBV, 2003-06

Figure 46: Baraclude - sales forecast, 7MM, 2006-2016

Figure 47: Tyzeka (telbivudine) - 7MM sales, 2003-06

Figure 48: Tyzeka - sales forecast, 7MM, 2006-2016

Figure 49: HBV drugmakers - portfolio focus

Figure 50: Sales forecast for the HBV drugs market by company - 7MM, 2006-2016

Figure 51: HBV drugs market by company market share, 2006, 2011 and 2016

Figure 52: GSK - HBV antiviral revenues by country, 7MM, 2003-07

Figure 53: GSK - HBV vaccines portfolio, 2007

Figure 54: GSK - timeline of HBV product approvals, 1993-2007

Figure 55: Gilead - strategic development of HBV portfolio, 2007

Figure 56: Bristol-Myers Squibb - strategic development of Baraclude (entecavir)

Figure 57: Novartis - strategic development of HBV portfolio, 2007

Figure 58: HBV pipeline - key focal points of development, 2007

Figure 59: Engerix-B - efficacy in different age groups

Figure 60: Heplisav - results of Phase III trial, (Asia, 2005-07)

Figure 61: Heplisav - results of Phase II/III trial (Singapore, 2005)

Figure 62: Heplisav - strategic assessment

Figure 63: Datamonitor drug assessment summary of HBV therapeutics late-stage pipeline, 2007

Figure 64: Sales forecasts for HBV therapeutics pipeline, 7MM, 2006-2016

Figure 65: Tenofovir (HBV) - sales forecast in 7MM by country, 2006-2016

Figure 66: Datamonitor's competitive positioning analysis of tenofovir, 2007

Figure 67: Clevudine - HBV DNA reduction in Phase III trial in HBeAg+ patients

Figure 68: Clevudine - HBV DNA reduction in Phase III trial in HBeAg- patients

Figure 69: Clevudine - sales forecast in HBV for the 7MM by country, 2006-2016

Figure 70: Clevudine - impact of genericization, 7MM, 2006-2016

Figure 71: Datamonitor's competitive positioning analysis of clevudine, 2007

Abstract

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