Hepatitis C Virus And Therapeutics


April 1, 2009
466 Pages - SKU: GJOB2271642
License type:
Table of Contents Related Reports
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 Analysisfor Hepatitis C Virus Therapeutics Market - AnnualSales Figures in US$ Million for the Years 2006through 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 UndergoingTreatment with PEG-IFN and Ribavirin Drugs(includes corresponding Graph/Chart)
Alpha Interferons and Ribavirin are Here to Stay
Interferon-based Drugs in Pipeline by Companyand Development Stage
Table 3: HCV Treatment Market in Europe (2007): Percentage of Patients Treated with InterferonDrugs in Select Countries (includescorresponding Graph/Chart)
Albuferon - Rising Above the Standards
Viramidine - Next-Generation Ribavirin Drug
High Mutation Rates Keep HCV Elusive
Genotype I - Least Responsive and Most CommonVariant of HCV
Table 4: Distribution of Genotypes: As a Percentage of Total Infected Population in Select PharmaceuticalMarkets - USA, France, Germany, Italy, Spain, andGlobal (includes corresponding Graph/Chart)
Protease Inhibitors (PIs) - Way Above Others
Protease Inhibitor Drugs in Pipeline by Companyand Development Stage
SCH 900518 - Schering’s Next-GenerationProtease Inhibitor
Telaprevir (VX-950) - The Most PromisingPipeline 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 Teethto HCV Pipeline
Viral Polymerases
Polymerase Inhibitor Drugs in Pipeline by Company,Category, and Development Stage
Comparison of Antiviral Properties in SelectPolymerase Inhibitor Drugs
R7128 - A Promising PLI Class Drug
Development of PLIs Remains a Challenge forHCV Researchers
Industry in Search of Novel STAT-C Drugs
Specific Antiviral Activity of Select HCV DrugClasses
Select NS5A Inhibitors, Entry Inhibitors, andThiazolides in Pipeline by Company andDevelopment Stage
Researchers Show Continued Appetite forImmunomodulators and Other Classes
Immunomodulators in Pipeline by Company,and Development Stage
Adjuvant Therapies to Compete with MainlineTherapies
Cyclophilin Analogs and Fibrosis/InflammationInhibitors in Pipeline by Company
Vaccine Development Remains at Low Scale
HCV Vaccines in Pipeline by Company, andDevelopment Stage
Decisive Factors For Success of New HCVTherapeutics
HCV Treatment Costs to Escalate
Table 5: HCV Treatment Market: Cost Structurefor Years 2007 through 2016 and Beyond(includes corresponding Graph/Chart)
Roche & Schering - Dominant Players in HCVTherapeutics Market
HCV Drugs from Roche & Schering
Partnerships in R&D Become Order of the Day
Select Partnership Deals in HCV Drug DevelopmentPrograms
Market Drivers/Constraints
Treatment-Experienced Patients - A PotentialOpportunity for Developers
Education Campaigns to Magnify PatientDiagnosis Rates
Stigmatization and Discrimination - Major Hurdlesfor HCV Treatment
Treatment with Current Therapies Plagued bySide Effects
Side Effects Associated with HCV TreatmentTherapies
Hemolytic Anemia - A Key Side Effect withRibavirin
Epidemiology
Quick Facts about HCV Infection
Table 6: Recent Estimates for HCV Infected Populationin 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): Prevalenceand Incidence Rate of HCV Infected Populationby Select Country - Australia, Canada, China,New Zealand, and Switzerland (includescorresponding Graph/Chart)
Low-Treatment Rates vis-à-vis Patient Population
Table 8: HCV Epidemiology in Major Pharmaceutical Markets: Patients in Thousands Collectively inthe US, France, Germany, Italy, Spain andthe UK (includes corresponding Graph/Chart)


Table 9: HCV Prevalence in Europe (2006): Numberof Total, Reported and Un-diagnosed Cases ofHCV Infection in Select Countries (includescorresponding 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 asMonotherapy in Chronic Hepatitis C Treatment
Ribavirin - Antiviral Drug for HCV Treatment
Table 10: Global HCV Therapeutics Market: AnnualSales of Select Interferons & Ribavirins offered byMajor Players - Roche and Schering forthe 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 Stageby Company
Select HCV Drugs with Cancelled Clinical Studiesby 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 SelectGeographic Regions
Table 11: Percentage Breakdown of Viral LoadLevels (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 ChronicHCV 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 forMonotherapy Treatment
Comparison of Response of Interferon BasedDrugs in Chronic Hepatitis C Treatment
Combination Therapy
Table 12: Major Side Effects Associated withHCV Treatment with Pegasys + CopegusCombination Therapy and Pegasys Monotherapy (includes corresponding Graph/Chart)


Table 13: Comparison Between PEG-Intron andPegasys in Monotherapy and CombinationTherapy in HCV Treatment (includes corresponding Graph/Chart)


Table 14: Data for 20-Year Risks and OtherRelated Aspects in Treatment Given andUntreated 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 InfectedPeople 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- InjectionDrugs, 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 (includescorresponding 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 USfor the Years 1996 through 2007 (includescorresponding Graph/Chart)


Table 20: US HCV Market (2006): Incidence ofAcute Hepatitis C by Age Group and Gender(includes corresponding Graph/Chart)
Canada
Australia
Table 21: Modes of HCV Infection Transmission inAustralia (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 Groupsin 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 ofHIV Patients infected with HCV inSelect CEE Countries (includescorresponding Graph/Chart)
Testing and Counseling Structure Poorly Developed
Depleted Testing Schemes for Prisoners
Scarcity Prevails at Health Care Providers andGovernments As Well
Practical Availability of PEG-IFN Remains Limited
Dearth in Political Commitment
HCV Diagnostic Tests and Treatment in SelectCEE Countries
Bulgaria
Czech Republic
Hungary
Romania
Russia
Ukraine
Availability of Testing Protocols for HCV inSelect CEE Countries
5.Drug Approvals & Clinical Trials
Vertex to Initiate Phase III Trial of Telaprevir
Amarillo and CytoPharm to Initiate Phase II Studyof Novel Oral Interferon
Biolex Releases Locteron® Phase IIa Trial Results
Schering-Plough Releases Details of BoceprevirPhase 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 Resultsfor ChronVac-C®
InterMune Starts Clinical Study of ITMN-191
Roche and Associates Commence Clinical Trialof All-Oral Dual-Antiviral Therapy
GlobeImmune Announces Phase II Clinical Trialswith GI-5005
Human Genome Gets Encouraging Interim Resultswith Albuferon
Intarcia Releases Study Results of Omega Interferon
Nautilus Biotech Commences Phase I Study forBelerofon®
Migenix Announces Phase II Proof-of-ConceptStudy Results of Celgosivir
Pharmasset Begins Multiple Dose-Escalating Studyof R7128
Transgene Commences Phase I Trial of TG4040
Debiopharm Releases Phase Ib Results of Debio 025
Nabi Biopharmaceuticals Starts Proof-Of-Concept Trialfor Civacir
Peregrine Announces Positive Results for Bavituximab
Jenken to Commence Phase II Trial of JBK-122
Pevion Biotech Initiates Phase I Study ofHepatitis C Vaccine
Intercell Releases Phase II Findings of IC41
6.Recent Industry Activity
Three Rivers Acquires Infergen®
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’ Stakein Locteron®
OraSure and Schering-Plough Form Global Alliance
Tacere and Oncolys Sign Licensing Agreement
Beckman Wins HCV Diagnostics Rights fromSiemens Healthcare
Anadys Secures FDA Fast Track Designation forits Lead Drug Candidate
Roche Bags European Commission Approval forCombination Therapy
Roche Receives European Commission Approvalfor Shortened Hepatitis C Therapy
iTherX Establishes Advisory Board for Hepatitis CAdvanced Therapeutics
SciClone Terminates Zadaxin®
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 ofPennsylvania
Presidio Wins Exclusive License to NovelHCV Technology
Roche Inks Licensing Deal with Novartis andOrtho-Clinical
Peregrine Opens Subsidiary in China
InterMune Completes Production Milestone
Arrow Expands Hepatitis C Pipeline
Roche Wins Japanese Approval for CombinationTherapy
Schering-Plough Bags European CommissionApproval 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 Approvalfor HCV Diagnostic Kit
Tibotec Applies to European Regulator to InitiatePhase I Trials
Roche Submits Application for Novel Hepatitis Cto 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)
III. COMPETITIVE LANDSCAPE
Total Companies Profiled: 123 (including Divisions/Subsidiaries - 127 )
Region/Country Players
The United States
Canada
Japan
Europe
France
Germany
The United Kingdom
Italy
Spain
Rest of Europe
Asia-Pacific (Excluding Japan)
Middle East
 
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