Hepatitis C Virus And Therapeutics - A Global Update of Market Trends & Opportunities

1.METHODOLOGY
Study Reliability and Reporting Limitations
Disclaimers
Quantitative Techniques & Reporting Level
2.GLOBAL MARKET OVERVIEW AND OUTLOOK
Pegylated Alpha Interferon Plus Ribavirin – The Standard Therapy
Approved Drugs for HCV Combination Therapy
Alpha Interferons and Ribavirin are Here to Stay
Interferon-based Drugs in Pipeline by Company and Development Stage
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
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
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
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 DrugDevelopment 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
Hemolytic Anemia – A Key Side Effect with Ribavirin
Epidemiology
Quick Facts about HCV Infection
Low-Treatment Rates vis-à-vis Patient Population
Factors Influencing HCV Treatment Market
Drivers
Bottle Necks
3.HCV MEDICATION - APPROVED & PIPELINE DRUGS
Approved Drugs for HCV Treatment
Interferons – The Backbone of HCV Treatment
Intron® A
Roferon A
Infergen
PEG-Intron®
Pegasys
FDA Approval of Interferons for Use as Monotherapy in Chronic Hepatitis C Treatment
Ribavirin – Antiviral Drug for HCV Treatment
Rebetol®
Copegus
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
4.PRODUCT FACTS
Hepatitis C Virus
5.REGIONAL PERSPECTIVE
United States
HCV Infection – Ethnicity
African-Americans React Poorly to Treatment
Genotype 1 – The Most Prevalent HCV Strain
Falling HCV Incidences in the US
Canada
Australia
India
Egypt
France
The Netherlands
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
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
6.CORPORATE DEVELOPMENTS
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’ Stake in Locteron®
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®
Vertex to Initiate Phase III Trial of Telaprevir
Amarillo and CytoPharm to Initiate Phase II Study of Novel Oral Interferon
Biolex Releases Locteron® 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®
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
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
Human Genome Gets Encouraging Interim Results with Albuferon
Intarcia Releases Study Results of Omega Interferon
Nautilus Biotech Commences Phase I Study for Belerofon®
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
7.MAJOR 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)
ExhibitsTable 1: Global Hepatitis C Virus Therapeutics Market: 2007-2015 (Sales in US$ Million)
Table 2: Prevalence and Incidence Rate of HCV Infected Population by Select Country in the World –
Table 3: Annual Sales of Select Interferons & Ribavirins offered by Major Players in the Global HCV Therapeutics Market – 2008 (In US$ Million)
Table 4: HCV Infection in the US: Number of Infected People for the Year 2008 (in '000s)
Table 5: Percentage Breakdown of Infection Sources by Medium in the US HCV Market –
Table 6: HCV Prevalence by Genotype in the US – 2005 (In %)
Table 7: Market Shares of HCV Infection Transmission Modes in AustraliaCompanies Profiled