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Pipeline and Commercial Insight: Hepatitis C - High unmet need drives rapid innovation

Published by: Datamonitor

Published: Dec. 18, 2008 - 177 Pages


Table of Contents


ABOUT DATAMONITOR HEALTHCARE
About the Infectious Diseases and Respiratory pharmaceutical analysis team
CHAPTER 1 EXECUTIVE SUMMARY
Datamonitor insight into the hepatitis C market
Key metrics
Datamonitor Pipeline Assessment Summary
Contributing experts
Related reports
CHAPTER 2 PIPELINE OVERVIEW AND DYNAMICS
Current market overview
Pegylated interferon alpha in combination with ribavirin is current standard of care
The history of hepatitis C virus therapy from interferon monotherapy to pegylated interferon plus ribavirin combination therapy
Standard interferon monotherapy was initially used to treat hepatitis C virus
Ribavirin enhances the effects of interferons but is associated with anemia
Pegylation of standard interferon reduced the dosing frequency
The hepatitis C pipeline is highly active
The hepatitis C virus pipeline consists of compounds with different mechanisms of action
Datamonitor expects the hepatitis C virus market to increase to $4.5 billion by 2017
Key companies involved in the hepatitis C virus pipeline
Roche
Schering Plough
Vertex
CHAPTER 3 DISEASE OVERVIEW - PATIENT POTENTIAL
Definition of hepatitis C virus
Hepatitis C virus escapes immune surveillance by the host, causing chronic infection
Chronic hepatitis C virus infection silently progresses to liver cirrhosis and cancer over prolonged periods of time
Significantly higher hepatitis C virus prevalence is found in intravenous drug users and patients who received blood transfusions before the 1990s
Immigration from areas of high prevalence is having a growing impact
The number of patients developing chronic hepatitis C will increase over the coming years
Management of hepatitis C virus
Segmentation of hepatitis C virus
Patients can be stratified according to hepatitis C virus genotype
The distribution of hepatitis C virus genotypes varies by geography and route of transmission
Genotype 1 is the most difficult to treat
There are different types of response to therapy
Epidemiology of hepatitis C virus
Estimating prevalence
US
Japan
Europe
France
Germany
Italy
Spain
UK
The HCV market has significant unmet needs
High efficacy in genotype 1 patients and non-responders remains the greatest unmet need
Improvements in tolerability and dosing may lead to better treatment outcomes
Shortened duration of treatment
Drugs efficacious in patients who do not respond or show intolerance to interferon
Effective therapies for hepatitis C patients of non-Caucasian ethnicity (African-American, Asian)
Drugs efficacious in HCV/HIV co-infection
CHAPTER 4 R&D APPROACH
Classification of pipeline products
Interferons
Small molecule antivirals
Immunomodulators
Therapeutic vaccines
Clinical trial design in hepatitis C virus
Future hepatitis C virus therapy falls into three distinct categories
Add on therapy currently appears to be the most promising strategy
Interferon and ribavirin replacement is unlikely
Sustained virological response is the most frequently used endpoint
Early virological response and rapid virological response are strong predictors of sustained virological response and are increasingly being used
Patients are stratified according to genotype and response to therapy
Clinical trials for novel agents are focusing on genotype 1 patients
The non-responder population is also attractive given the high unmet need
Late-stage trials involve comparison with current standard of care
Reducing the duration of treatment
Implications of new drug launches on clinical trial design
CHAPTER 5 INTERFERONS LATE-STAGE DRUG ANALYSIS & FORECASTS
Overview of the interferon class
Pipeline summary
Comparative forecasts
Pegylated interferon (peginterferon) combined with ribavirin is the current gold standard
Peginterferon therapy is associated with a high incidence of side effects and limited efficacy in genotype 1 patients
Albuferon (Novartis/Human Genome Sciences)
Drug overview
Clinical trial data
Phase III studies
Phase IIb studies
Phase II studies
Marketing factors
Patient potential
Satisfaction of unmet needs
Forecasts to 2017
Locteron (Biolex)
Drug overview
Clinical trial data
Phase IIb - SELECT 2 trial
Phase IIa - SELECT-1 trial
Phase IIa - PLUS trial
Marketing factors
Patient potential
Satisfaction of unmet needs
Forecasts to 2017
IFNalpha-2b XL (Flamel Technologies)
Drug overview
Clinical trial data
Phase II studies
Datamonitor comments
Other drugs in the interferons class
Omega-interferon (Intarcia)
CHAPTER 6 SMALL MOLECULE ANTIVIRALS LATE-STAGE DRUG ANALYSIS AND FORECASTS
Overview for the small molecule antivirals class
Resistance to new hepatitis C virus antivirals is an emerging issue
Pipeline summary
Comparative forecasts
Hepatitis C virus NS5B polymerase inhibitors
Pipeline overview
R7128 (Roche and Pharmasset)
Drug overview
Key clinical trials
Datamonitor comments
Forecasts to 2017
GS-9190 (Gilead)
VCH-916
PF-868554
Hepatitis C virus NS3/4A protease inhibitors
Pipeline overview
Telaprevir (Vertex and Tibotec)
Drug overview
Key clinical trials
Marketing factors
Patient potential
Satisfaction of unmet needs
Forecasts to 2017
Boceprevir
Drug overview
Key clinical trials
Marketing factors
Patient potential
Satisfaction of unmet needs
Forecasts to 2017
Protease inhibitors in early stage development
TMC435350 (Tibotec/Johnson & Johnson)
Key clinical trials
Datamonitor comments
R7227/ITMN-191 (Roche and InterMune)
Key clinical trials
Datamonitor comments
BI 201335
Other small molecule antivirals
Pipeline overview
Taribavirin (Valeant Pharmaceuticals)
Key clinical trials
Datamonitor comments
Forecasts to 2017
BMS-790052 (Bristol Myers Squibb)
CHAPTER 7 IMMUNOMODULATORS (NON-INTERFERON) LATE-STAGE DRUG ANALYSIS
Pipeline overview
Product profiles
Zadaxin (SciClone Pharmaceuticals)
SCV-07 (SciClone Pharmaceuticals)
Bavituximab (Peregrine Pharmaceuticals)
Civacir (Nabi Biopharmaceuticals)
Alinia (Romark Laboratories)
IPH 1101 (Innate Pharma)
CYT 107 (Cytheris)
CHAPTER 8 THERAPEUTIC VACCINES LATE STAGE DRUG ANALYSIS
Overview for the therapeutic vaccines class
Pipeline overview
IC41 (Intercell and Novartis)
Key clinical trial data
Phase II monotherapy study
Phase II combination study
Datamonitor comments
GI-5005 (GlobeImmune)
Drug overview
Key clinical trials
Phase II
Phase Ib
Datamonitor comments
ChronVac-C (Tripep and Inovio)
Drug overview
CHAPTER 9 HOST ENZYME INHIBITORS
Pipeline overview
Celgosivir (MX-3253; Migenix)
Debio-025 (Debiopharm)
NIM-811 (Novartis)
BIBLIOGRAPHY
Journals
Websites
Others
Datamonitor reports
APPENDIX
Methodology
Product forecasts
Definition of a standard unit (only use if ForeSight model used to forecast)
Forecasts for new drug classes (telaprevir, boceprevir, R-7128)
Pricing assumptions
Calculation of volume
Contributing experts
About Datamonitor
About Datamonitor Healthcare
Datamonitor Healthcare's therapy area capabilities
About the Disease analysis team
Key therapy team members
Holger Rovini, Lead Analyst, Infectious Diseases and Respiratory
Disclaimer
List of Tables
Table 1: Key parameters of HCV for the seven major markets
Table 2: Forecast key pipeline products in HCV in 2017 ($m)
Table 3: Overview of products in Phase I-III development
Table 4: Overview of hepatitis C virus pipeline drugs included in Datamonitor's forecasts, 2008
Table 5: Prevalence of Hepatitis C in Spain
Table 6: Estimated number of HIV/HCV co-infected patients by country in the seven major markets, 2008
Table 7: Overview of classes in development for hepatitis C virus, 2008
Table 8: Hepatitis C virus pipeline overview for the interferon class, 2008
Table 9: Overview of the result from the IDEAL study
Table 10: Resistant mutations associated with virus inhibitors
Table 11: Overview of small molecule antivirals in development
Table 12: Hepatitis C virus pipeline overview - NS5B polymerase inhibitors, 20072008
Table 13: Hepatitis C virus pipeline overview - NS3/4A protease inhibitors, 20072008
Table 14: PROVE-1 response rates for Telaprevir in hepatitis C virus
Table 15: PROVE-2 final analysis for Telaprevir in hepatitis C virus
Table 16: SVR12 rates for telaprevir-based 24 week regimen (group 1) in hepatitis C virus
Table 17: Interim results from the C208 study for Telaprevir in hepatitis C virus
Table 18: Adverse event-related discontinuations and virological breakthroughs by treatment arm for Telaprevir in hepatitis C virus in the C208 study
Table 19: Sustained virological response rates from SPRINT-1 study by treatment arm for boceprevir in hepatitis C virus
Table 20: Comparison of boceprevir and telaprevir SVR rates
Table 21: Hepatitis C virus pipeline overview -other small molecule antivirals, 20072008
Table 22: Taribavirin Phase IIb efficacy and safety data in hepatitis C virus
Table 23: Hepatitis C virus pipeline overview - immunomodulators (non-interferon), 20072008
Table 24: Hepatitis C virus pipeline overview - therapeutic vaccines, 2007
Table 25: HCV pipeline overview - host enzyme inhibitors, 2008
Table 26: Diagnostic split for US interferon and ribavirin sales
Table 27: Datamonitor drug assessment parameters
List of Figures
Figure 1: Datamonitor drug assessment summary of therapies in late stage development for HCV, 2008
Figure 2: Hepatitis C virus sales by region in the US, Japan and the 5EU, 2004-07
Figure 3: Evolution of chronic HCV therapy in the US since the launch of Intron A in 1991
Figure 4: Improvement in sustained virological response rates from monotherapy to combination therapy
Figure 5: Hepatitis C pipeline overview by drug class and phase, 2008
Figure 6: HCV pipeline overview
Figure 7: Estimated US launch dates of forecasted pipeline drugs for hepatitis C virus, 2008
Figure 8: HCV sales 2007-2017 by region
Figure 9: HCV sales or marketed drugs versus new drugs 2007-2017
Figure 10: Interferon sales 2003-2007
Figure 11: Market share of interferons in 2007
Figure 12: Interferon and ribavirin sales 2004-2007
Figure 13: The hepatitis C virus genome
Figure 14: Hepatitis C virus disease progression
Figure 15: Genotype distribution of hepatitis C virus across Europe, 2007
Figure 16: Hepatitis C virus - patient classification by response to treatment
Figure 17: Incidence of hepatitis C virus in the US, 1982-2006
Figure 18: Age-specific prevalence of anti-HCV antibodies in first-time blood donors in eight districts of Japan
Figure 19: Unmet needs in hepatitis C virus, 2008
Figure 20: Datamonitor drug assessment summary of pipeline interferon therapies in development for HCV, 2008
Figure 21: Sales forecasts for marketed and new interferon therapies across the seven major markets 2007-2017
Figure 22: Phase IIb trial design for Albuferon in hepatitis C virus
Figure 23: Albuferon sales across the seven major markets 2007-2017
Figure 24: Locteron Phase IIa study design in hepatitis C virus
Figure 25: Locteron sales across the seven major markets 2007-2017
Figure 26: -IFNalpha-2b XL Phase IIa study design in hepatitis C virus
Figure 27: Overview of key hepatitis C virus targets
Figure 28: Datamonitor drug assessment summary of pipeline small molecule antiviral therapies in development for HCV, 2008
Figure 29: Small molecule antiviral drug sales across the seven major markets 2007-2017
Figure 30: R7128 Phase I Part 3 trial design
Figure 31: R-7128 sales across the seven major markets 2007
Figure 32: Telaprevir Phase III study in treatment-naïve hepatitis C virus patients
Figure 33: Overview of the REALIZE trial design for Telaprevir in hepatitis C virus
Figure 34: Overview of PROVE-1 study for Telaprevir in hepatitis C virus
Figure 35: Overview of PROVE-2 study for Telaprevir in hepatitis C virus
Figure 36: Telaprevir sales across the seven major markets 2007-2017
Figure 37: Overview of the SPRINT-1 trial for boceprevir in hepatitis C virus
Figure 38: Overview of telaprevir and boceprevir response rates
Figure 39: Boceprevir sales across the seven major markets 2007-2017
Figure 40: Overview of the OPERA-1 trial for TMC435350 in treatment-naïve patients with hepatitis C virus
Figure 41: VISER-1 design overview for taribavirin in hepatitis C virus
Figure 42: Phase IIb design overview for taribavirin in hepatitis C virus
Figure 43: Taribavirin sales across the seven major markets 2007-2017
Figure 44: Overview of pricing methodology for boceprevir and telaprevir
Figure 45: Overview of pricing methodology for R-7128
Figure 46: Overview of methodology used to derive volume for telaprevir
Figure 47: Overview of methodology used to derive volume for R-7128
Figure 48: Datamonitor drug assessment summary of pipeline molecular targeted therapies in development for hematological malignancies, 2007

Abstract

Introduction

The Hepatitis C market was worth $2.3 billion in 2007, declining at a CAGR of -2.8% from 2004-2007. Despite this recent slump, Datamonitor forecasts sales to grow to $4.5 billion by 2017, driven primarily by the launch of the new protease inhibitors. The US and EU will remain the largest markets, generating $1.9 billion and $1.7 billion respectively in 2017. Scope
  • An overview of the current Hepatitis C market and its key players


  • In-depth analysis of Phase II and III clinical development compounds and comprehensive overview of Phase I drugs


  • Epidemiological dynamics of Hepatitis C in the six major markets are discussed along with unmet needs


  • 10 year sales forecasts for marketed and six pipeline drugs
Highlights

Given its large patient potential and significant unmet needs, the Hepatitis C market has attracted considerable interest from companies with a strong presence in infectious diseases. The HCV pipeline is therefore very active and consists of drugs with various mechanisms of action.

Several strategies are being explored in clinical trials, including add-on therapy to the current standard of care, interferon replacement and ribavirin replacement. Of these Datamonitor believes that add-on therapy will be the most successful in the medium term.

The two most advanced pipeline candidates are Schering Plough's boceprevir and Vertex's telaprevir. Both drugs have demonstrated comparable efficacy benefits when combined with current standard of care. Datamonitor expects telaprevir to gain higher market share due to its ability to cut short the overall duration of therapy in genotype 1 patients. Reasons to Purchase
  • Understand current and future Hepatitis C market dynamics


  • Gain insight into the unmet needs of HCV patients and the extent to which pipeline drugs are addressing these issues


  • Evaluate the Hepatitis C market forecast for existing and key pipeline drugs to 2018
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