Hepatitis C Virus And Therapeutics

Table of Contents

I. INTRODUCTION, METHODOLOGY & PRODUCT DEFINITIONS

• Study Reliability and Reporting Limitations
• Disclaimers
• Data Interpretation & Reporting Level
• Product Definition and Scope of Study
• Hepatitis C Virus

II. EXECUTIVE SUMMARY

1. Industry Overview

• Market Outlook
• Table 1: World Recent Past, Current and Future Analysis for Hepatitis C Virus Therapeutics Market - Annual Sales Figures in US$ Million for the Years 2006 through 2015 (includes corresponding Graph/Chart)
• Market Overview
• Pegylated Alpha Interferon Plus Ribavirin - The Standard Therapy
• Approved Drugs for HCV Combination Therapy
• Table 2: HCV Treatment Market in the US (2007-2010): Number of Patients Undergoing Treatment with PEG-IFN and Ribavirin Drugs (includes corresponding Graph/Chart)
• Alpha Interferons and Ribavirin are Here to Stay
• Interferon-based Drugs in Pipeline by Company and Development Stage
• Table 3: HCV Treatment Market in Europe (2007): Percentage of Patients Treated with Interferon Drugs in Select Countries (includes corresponding Graph/Chart)
• Albuferon - Rising Above the Standards
• Viramidine - Next-Generation Ribavirin Drug
• High Mutation Rates Keep HCV Elusive
• Genotype I - Least Responsive and Most Common Variant of HCV
• Table 4: Distribution of Genotypes: As a Percentage of Total Infected Population in Select Pharmaceutical Markets - USA, France, Germany, Italy, Spain, and Global (includes corresponding Graph/Chart)
• Protease Inhibitors (PIs) - Way Above Others
• Protease Inhibitor Drugs in Pipeline by Company and Development Stage
• SCH 900518 - Schering' s Next-Generation Protease Inhibitor
• Telaprevir (VX-950) - The Most Promising Pipeline HCV Protease Inhibitor
• Boceprevir - Schering' s PI Class Lead Candidate
• Comparison Between Telaprevir and Boceprevir
• Telaprevir and Boceprevir - A Comparison
• Polymerase Inhibitors (PLIs) - Adding More Teeth to HCV Pipeline
• Viral Polymerases
• Polymerase Inhibitor Drugs in Pipeline by Company, Category, and Development Stage
• Comparison of Antiviral Properties in Select Polymerase Inhibitor Drugs
• R7128 - A Promising PLI Class Drug
• Development of PLIs Remains a Challenge for HCV Researchers
• Industry in Search of Novel STAT-C Drugs
• Specific Antiviral Activity of Select HCV Drug Classes
• Select NS5A Inhibitors, Entry Inhibitors, and Thiazolides in Pipeline by Company and Development Stage
• Researchers Show Continued Appetite for Immunomodulators and Other Classes
• Immunomodulators in Pipeline by Company, and Development Stage
• Adjuvant Therapies to Compete with Mainline Therapies
• Cyclophilin Analogs and Fibrosis/Inflammation Inhibitors in Pipeline by Company
• Vaccine Development Remains at Low Scale
• HCV Vaccines in Pipeline by Company, and Development Stage
• Decisive Factors For Success of New HCV Therapeutics
• HCV Treatment Costs to Escalate
• Table 5: HCV Treatment Market: Cost Structure for Years 2007 through 2016 and Beyond (includes corresponding Graph/Chart)
• Roche & Schering - Dominant Players in HCV Therapeutics Market
• HCV Drugs from Roche & Schering
• Partnerships in R&D Become Order of the Day
• Select Partnership Deals in HCV Drug Development Programs
• Market Drivers/Constraints
• Treatment-Experienced Patients - A Potential Opportunity for Developers
• Education Campaigns to Magnify Patient Diagnosis Rates
• Stigmatization and Discrimination - Major Hurdles for HCV Treatment
• Treatment with Current Therapies Plagued by Side Effects
• Side Effects Associated with HCV Treatment Therapies
• Hemolytic Anemia - A Key Side Effect with Ribavirin
• Epidemiology
• Quick Facts about HCV Infection
• Table 6: Recent Estimates for HCV Infected Population in Millions By Region - Far East Asia, South East Asia, East Mediterranean, West Europe, Africa, South America, USA, Canada, and Australia
• Table 7: Global HCV Market (2006): Prevalence and Incidence Rate of HCV Infected Population by Select Country - Australia, Canada, China, New Zealand, and Switzerland (includes corresponding Graph/Chart)
• Low-Treatment Rates vis-a-vis Patient Population
• Table 8: HCV Epidemiology in Major Pharmaceutical Markets: Patients in Thousands Collectively in the US, France, Germany, Italy, Spain and the UK (includes corresponding Graph/Chart)
• Table 9: HCV Prevalence in Europe (2006): Number of Total, Reported and Un-diagnosed Cases of HCV Infection in Select Countries (includes corresponding Graph/Chart)
• Factors Influencing HCV Treatment Market
• Drivers
• Bottle Necks

2. HCV Medication - Approved & Pipeline Drugs

• Approved Drugs for HCV Treatment
• Interferons - The Backbone of HCV Treatment
• FDA Approval of Interferons for Use as Monotherapy in Chronic Hepatitis C Treatment
• Ribavirin - Antiviral Drug for HCV Treatment
• Table 10: Global HCV Therapeutics Market: Annual Sales of Select Interferons & Ribavirins offered by Major Players - Roche and Schering for the Years 2003 through 2008 (In US$ Million) (includes corresponding Graph/Chart)
• Drugs in Pipeline for HCV Treatment
• Select HCV Drugs Under Pipeline (Phase III/Phase II) by Company
• Select HCV Drugs Under Pipeline (Phase I) by Company
• Select HCV Drugs in Pre-Clinical/Research Stage by Company
• Select HCV Drugs with Cancelled Clinical Studies by Company

3. Hepatitis C Virus - An Overview

• Hepatitis A Virus
• Hepatitis B Virus
• Hepatitis C Virus
• History
• Structure
• Components of HCV Genome
• Life Cycle
• Genotypes
• Prevalence of HCV Genotypes in Select Geographic Regions
• Table 11: Percentage Breakdown of Viral Load Levels (High and Low) in Common Genotypes
• Physicochemical and Morphology Properties
• Transmission of HCV
• Injection Drugs
• Sexual Contact
• Tattoos and Body Piercing
• Contaminated Medical Equipment
• Occupational Risks
• Personal Care Goods
• Mother-to-Baby
• Blood and Blood Products
• Transmission of Hepatitis Virus
• HCV Risk Groups
• Types of Infection
• Chart: HCV Infection Outcome
• Acute Hepatitis C
• Figure: Natural History of Hepatitis C
• Chronic Hepatitis C
• Stages and Symptoms
• Stages in Chronic HCV Condition
• Symptoms of Liver Disease in Chronic HCV Condition
• Complications Due to Chronic HCV Infection
• Diagnosis
• Tests to Confirm HCV Presence
• HCV IgG Antibody Test
• HCV RNA Test
• HCV Core Antigen EIA
• Genotype Tests
• Liver Biopsy
• Treatment for HCV Infection
• Monotherapy
• Brief Description of Approved Drugs for Monotherapy Treatment
• Comparison of Response of Interferon Based Drugs in Chronic Hepatitis C Treatment
• Combination Therapy
• Table 12: Major Side Effects Associated with HCV Treatment with Pegasys + Copegus Combination Therapy and Pegasys Monotherapy (includes corresponding Graph/Chart)
• Table 13: Comparison Between PEG-Intron and Pegasys in Monotherapy and Combination Therapy in HCV Treatment (includes corresponding Graph/Chart)
• Table 14: Data for 20-Year Risks and Other Related Aspects in Treatment Given and Untreated HCV Patients
• Alternative Therapies
• Vaccine
• Liver Transplantation
• Treatment Costs
• Types of Treatment Responses
• Sustained Response
• Relapsing (Transient) Response
• Breakthrough Response
• Null Response
• Monitoring Tests
• Laboratory tests
• Medical Examinations
• Prevention

4. Regional Perspective

• United States
• Table 15: HCV Infection in the US: Number of Infected People for the Years 2006, 2007 and 2008 (in ' 000s) (includes corresponding Graph/Chart)
• Table 16: HCV Infection in the US (2007): Percentage Breakdown of Infection Sources by Medium- Injection Drugs, Sexual Contact, Transfusions, Occupation - Related Exposure, and Others and Unknown (includes corresponding Graph/Chart)
• HCV Infection - Ethnicity
• Table 17: HCV Prevalence in the US (1999-2002): Prevalence Rate by Age and Race (includes corresponding Graph/Chart)
• African-Americans React Poorly to Treatment
• Genotype 1 - The Most Prevalent HCV Strain
• Table 18: HCV Prevalence in the US (2005): Prevalence by Genotype (In %)
• Falling HCV Incidences in the US
• Table 19: Acute HCV Infection Incidences in the US for the Years 1996 through 2007 (includes corresponding Graph/Chart)
• Table 20: US HCV Market (2006): Incidence of Acute Hepatitis C by Age Group and Gender (includes corresponding Graph/Chart)
• Canada
• Australia
• Table 21: Modes of HCV Infection Transmission in Australia (includes corresponding Graph/Chart)
• Table 22: Hepatitis C Infection in Australia (2000): Rate of Incidence by Age Group and Gender (includes corresponding Graph/Chart)
• India
• Egypt
• France
• The Netherlands
• Table 23: HCV Infection Prevalence in Risk Groups in the Netherlands
• Central and Eastern Europe
• HCV Prevalence Rate Higher in Injection Drug Users
• Alarming Rates of HIV/HCV Co-Infection
• Table 24: HIV/HCV Co-Infection in CEE (2005): Number of HIV Patients and Percentage of HIV Patients infected with HCV in Select CEE Countries (includes corresponding Graph/Chart)
• Testing and Counseling Structure Poorly Developed
• Depleted Testing Schemes for Prisoners
• Scarcity Prevails at Health Care Providers and Governments As Well
• Practical Availability of PEG-IFN Remains Limited
• Dearth in Political Commitment
• HCV Diagnostic Tests and Treatment in Select CEE Countries
• Bulgaria
• Czech Republic
• Hungary
• Romania
• Russia
• Ukraine
• Availability of Testing Protocols for HCV in Select CEE Countries

5. Drug Approvals & Clinical Trials

• Vertex to Initiate Phase III Trial of Telaprevir
• Amarillo and CytoPharm to Initiate Phase II Study of Novel Oral Interferon
• Biolex Releases Locteron(r) Phase IIa Trial Results
• Schering-Plough Releases Details of Boceprevir Phase II Study
• Progenics Releases Pre-Clinical Results of PRO 206
• ZymoGenetics Reveals Phase Ib Results of IL-29
• Phenomix Begins Phase Ia Study of PHX1766
• Inovio and Tripep Release Additional Interim Results for ChronVac-C(r)
• InterMune Starts Clinical Study of ITMN-191
• Roche and Associates Commence Clinical Trial of All-Oral Dual-Antiviral Therapy
• GlobeImmune Announces Phase II Clinical Trials with GI-5005
• Human Genome Gets Encouraging Interim Results with Albuferon
• Intarcia Releases Study Results of Omega Interferon
• Nautilus Biotech Commences Phase I Study for Belerofon(r)
• Migenix Announces Phase II Proof-of-Concept Study Results of Celgosivir
• Pharmasset Begins Multiple Dose-Escalating Study of R7128
• Transgene Commences Phase I Trial of TG4040
• Debiopharm Releases Phase Ib Results of Debio 025
• Nabi Biopharmaceuticals Starts Proof-Of-Concept Trial for Civacir
• Peregrine Announces Positive Results for Bavituximab
• Jenken to Commence Phase II Trial of JBK-122
• Pevion Biotech Initiates Phase I Study of Hepatitis C Vaccine
• Intercell Releases Phase II Findings of IC41

6. Recent Industry Activity

• Three Rivers Acquires Infergen(r)
• International Consolidated Cos Takes Over China Gene
• Hologic Signs Definitive Deal to Acquire Third Wave
• GlaxoSmithKline Inks Deal to Take Over Genelabs
• Biolex Signs Deal to Purchase OctoPlus' Stake in Locteron(r)
• OraSure and Schering-Plough Form Global Alliance
• Tacere and Oncolys Sign Licensing Agreement
• Beckman Wins HCV Diagnostics Rights from Siemens Healthcare
• Anadys Secures FDA Fast Track Designation for its Lead Drug Candidate
• Roche Bags European Commission Approval for Combination Therapy
• Roche Receives European Commission Approval for Shortened Hepatitis C Therapy
• iTherX Establishes Advisory Board for Hepatitis C Advanced Therapeutics
• SciClone Terminates Zadaxin(r)
• AstraZeneca Acquires Arrow Therapeutics
• Cubist Takes Over Illumigen
• China Medical to Take Over Beijing Bio-Ekon
• Schering-Plough Collaborates with OraSure
• Pro-Pharmaceuticals to Collaborate with Digna Biotech
• Medivir and Tibotec Establish Collaboration Deal
• VGX Extends Collaboration with University of Pennsylvania
• Presidio Wins Exclusive License to Novel HCV Technology
• Roche Inks Licensing Deal with Novartis and Ortho-Clinical
• Peregrine Opens Subsidiary in China
• InterMune Completes Production Milestone
• Arrow Expands Hepatitis C Pipeline
• Roche Wins Japanese Approval for Combination Therapy
• Schering-Plough Bags European Commission Approval for Combination Therapy
• Abbott Bags FDA Approval for Screening Test
• Abbott Bags Canadian Approval for Viral Load Tests
• Phynova Bags FDA Approval for IND Application
• Worldwide Biotech Bags Chinese FDA Approval for HCV Diagnostic Kit
• Tibotec Applies to European Regulator to Initiate Phase I Trials
• Roche Submits Application for Novel Hepatitis C to with FDA
• Anadys Discontinues ANA975
• Cerus Bags NIH Funding for HCV Vaccine Program

7. Focus on Select Global Players

• Abbott Diagnostics (USA)
• Achillion Pharmaceuticals, Inc. (USA)
• Anadys Pharmaceuticals, Inc. (USA)
• Boehringer Ingelheim GmbH (Germany)
• Bristol-Myers Squibb Company (USA)
• F. Hoffmann-La Roche Ltd. (Switzerland)
  • GlaxoSmithKline plc (UK)
  • Hayashibara Biochemical Labs, Inc. (Japan)
  • HemispheRx Biopharma, Inc. (USA)
  • Human Genome Sciences (USA)
  • Idenix Pharmaceuticals, Inc. (USA)
  • Innogenetics NV (Belgium)
  • InterMune, Inc. (USA)
  • Intarcia Therapeutics, Inc. (USA)
  • Medivir AB (Sweden)
  • Merck & Co., Inc. (USA)
  • Novartis AG (Switzerland)
  • Chiron Corporation (USA)
  • Pfizer, Inc. (USA)
  • Schering-Plough Corporation (USA)
  • Tibotec Pharmaceuticals Ltd. (Ireland)
  • Tripep AB (Sweden)
  • Toray Industries, Inc. (Japan)
  • Valeant Pharmaceuticals International (USA)
  • Vertex Pharmaceuticals, Inc. (USA)

COMPETITIVE LANDSCAPE