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DOMAIN EXPERT ENGAGEMENTS

Number of executives repeatedly engaged by snail & email outreach*

POOL + OUTREACH

6406

Interactions with Platform & by Email *

INTERACTIONS

1025

Unique # Participated *

PARTICIPANTS

192

Responses Validated *

VALIDATIONS

42

* Platform engagements are dynamic. Stats are published quarterly.


  •  CODE

  •  PAGES

  •  DATE

  •  PRICE

    $

  •  DATA EXHIBITS

    125


TABLE OF CONTENTS


   Pages :    | $

   Study Reliability and Reporting Limitations.....I-1  
   Disclaimers.....I-2
Data Interpretation & Reporting Level.....I-2
  
   Product Definition and Scope of Study.....I-3
Hepatitis C Virus.....I-3
  
   Outlook .....II-1
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).....II-1
1$300
   Pegylated Alpha Interferon Plus Ribavirin – The Standard Therapy for HCV.....II-2
Table 2: HCV Treatment Market in the US (2007, 2008): Number of Patients Undergoing Treatment with PEG-IFN and Ribavirin Drugs.....II-2
Protease Inhibitors (PIs) - Way Above Others in HCV Pipeline.....II-2
Protease Inhibitor Drugs in Pipeline by Company and Development Stage.....II-2
1$300
   SCH 900518 – Schering’s Next-Generation Protease Inhibitor.....II-3
Telaprevir (VX-950) – The Most Promising Pipeline HCV Protease Inhibitor.....II-3
1$100
   Telaprevir, in Combination with Ribavirin and Pegylated Interferon, Shortens
  Therapy Duration.....II-4
Boceprevir – Schering’s PI Class Lead Candidate.....II-4
Comparison Between VX-950 and SCH 503034.....II-4
1$100
   Telaprevir and Boceprevir – A Comparison.....II-5
Polymerase Inhibitors (PLIs) – Adding More Teeth to HCV Pipeline.....II-5
Viral Polymerases.....II-5
1$100
   Polymerase Inhibitor Drugs in Pipeline by Company, Category, and Development
  Stage.....II-6
1$100
   Comparison of Antiviral Properties in Select Polymerase Inhibitor Drugs.....II-7
R7128 – A Promising PLI Class Drug.....II-7
Development of PLIs Remains a Challenge for HCV Researchers.....II-7
Industry in Search of Novel STAT-C Drugs.....II-7
1$100
   Non-Interferon Combination Therapies Gain Traction.....II-8
Specific Antiviral Activity of Select HCV Drug Classes.....II-8
Select NS5A Inhibitors, Entry Inhibitors, and Thiazolides in Pipeline by Company and
  Development Stage.....II-8
1$100
   Researchers Show Continuous Appetite for Immunomodulators and Other Classes.....II-9
Oral Interferon Makes Treatment Easier.....II-9
Immunomodulators in Pipeline by Company, and Development Stage.....II-9
Alpha Interferons and Ribavirin – Continue to Stay in HCV Market.....II-9
1$100
   Interferon-based Drugs in Pipeline by Company and Development Stage.....II-10
Table 3: HCV Treatment Market in Europe (2007): Percentage of Patients Treated with Interferon Drugs in Select Countries (includes corresponding Graph/Chart).....II-10
Albuferon – Rising Above the Standards.....II-10
1$300
   Viramidine – Next-Generation Ribavirin Drug.....II-11
PEG-Interferon ? (lambda): A Type III Interferon.....II-11
Adjuvant Therapies to Compete with Mainline Therapies.....II-11
1$100
   Cyclophilin Analogs and Fibrosis/Inflammation Inhibitors in Pipeline by
  Company.....II-12
Vaccine Development Remains at Low Scale.....II-12
HCV Therapeutic Vaccines in Pipeline by Company, and Development Stage.....II-12
High Mutation Rates Keep HCV Elusive.....II-12
1$100
   Genotype I – Least Responsive and Most Common Variant of HCV.....II-13
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).....II-13
1$300
   Decisive Factors For Success of New HCV Therapeutics.....II-14
Novel HCV Therapies: Challenges Ahead.....II-14
HCV Treatment Costs to Escalate.....II-14
1$300
   Table 5: HCV Treatment Market: Cost Structure for Years 2007 through 2016 and Beyond (includes corresponding Graph/Chart).....II-15
Roche & Schering – Dominant Players in HCV Therapeutics Market.....II-15
HCV Drugs from Roche & Schering.....II-15
1$100
   Partnerships in R&D Become Order of the Day.....II-16
Select Partnership Deals in HCV Drug Development Programs.....II-16
1$100
   Market Drivers/Constraints.....II-17
Treatment-Experienced Patients – A Potential Opportunity for Developers.....II-17
Education Campaigns to Magnify Patient Diagnosis Rates.....II-17
Stigmatization and Discrimination – Major Hurdles for HCV Treatment.....II-17
1$100
   Treatment with Current Therapies Plagued by Side Effects.....II-18
Side Effects Associated with HCV Treatment Therapies.....II-18
1$100
   Hemolytic Anemia – A Key Side Effect with Ribavirin.....II-19
Epidemiology.....II-19
Quick Facts about HCV Infection.....II-19
1$300
   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.....II-20

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).....II-20
Low-Treatment Rates vis-à-vis Patient Population.....II-20
1$300
   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).....II-21

Table 9: HCV Prevalence in Europe (2006): Number of Reported and Un-diagnosed Cases of HCV Infection in Select Countries (includes corresponding Graph/Chart).....II-21
1$300
   The Effect of Race Factor.....II-22
Factors Influencing HCV Treatment Market.....II-22
Drivers.....II-22
Bottle Necks.....II-22
1$100
   Approved Drugs for HCV Treatment.....II-23
Interferons – The Backbone of HCV Treatment.....II-23
Intron® A.....II-23
Roferon A.....II-23
Infergen.....II-23
PEG-Intron®.....II-23
Pegasys.....II-23
1$100
   FDA Approval of Interferons for Use as Monotherapy in Chronic Hepatitis C
  Treatment.....II-24
Ribavirin – Antiviral Drug for HCV Treatment.....II-24
Rebetol®.....II-24
Copegus.....II-24
1$300
   Table 10: Global HCV Therapeutics Market: Annual Sales of Select Interferons & Ribavirins offered by Major Players - Roche and Schering for the Years 2003 through 2008 (In US$ Million) (includes corresponding Graph/Chart).....II-25
Drugs in Pipeline for HCV Treatment.....II-25
BI-201335 – A Protease Inhibitor.....II-25
ITMN-191 (R7227) - An Oral HCV NS3/4A Protease Inhibitor.....II-25
1$100
   IDX184 – A Polymerase Inhibitor.....II-26
PSI-7851 – An Analog Polymerase Inhibitor.....II-26
A-831 & A-832: NS5A Inhibitors in Pipeline.....II-26
ITX5061 - HCV Entry Inhibitor.....II-26
1$100
   Debio 025 – A Cyclophilin Inhibitor.....II-27
ANA773 - A TLR9 Agonist.....II-27
SPC3649 (LNA-antimiRTM-122): microRNA in Pipeline.....II-27
1$100
   Bavituximab – A Potent Anti-Phospholipid Antibody.....II-28
Celgosivir (MX- 3253) - A Glucosidase I Inhibitor.....II-28
PF-03491390 – A Caspase Inhibitor.....II-28
1$100
   Taribavirin - A Nucleoside Analogue Inhibitor.....II-29
Select HCV Drugs Under Pipeline (Phase III/Phase II) by Company.....II-29
1$100
   Select HCV Drugs Under Pipeline (Phase I) by Company.....II-301$100
   Select HCV Drugs in Pre-Clinical/Research Stage by Company.....II-311$100
   Select HCV Drugs with Cancelled Clinical Studies by Company.....II-32
1$100
   Hepatitis A Virus.....II-33
Hepatitis B Virus.....II-33
Hepatitis C Virus.....II-33
History.....II-33
Structure.....II-33
1$100
   Components of HCV Genome.....II-34
NS4B – A Hydrophobic Protein.....II-34
Life Cycle.....II-34
1$100
   Genotypes.....II-35
Prevalence of HCV Genotypes in Select Geographic Regions.....II-35
Table 11: Percentage Breakdown of Viral Load Levels (High and Low) in Common Genotypes.....II-35
Physicochemical and Morphology Properties.....II-35
1$300
   Transmission of HCV.....II-36
Injection Drugs.....II-36
Sexual Contact.....II-36
Tattoos and Body Piercing.....II-36
Contaminated Medical Equipment.....II-36
1$100
   Occupational Risks.....II-37
Personal Care Goods.....II-37
Mother-to-Baby.....II-37
Blood and Blood Products.....II-37
Transmission of Hepatitis Virus.....II-37
1$100
   HCV Risk Groups.....II-38
Types of Infection.....II-38
Chart: HCV Infection Outcome.....II-38
Acute Hepatitis C.....II-38
1$100
   Figure: Natural History of Hepatitis C.....II-39
Chronic Hepatitis C.....II-39
Damage to Liver.....II-39
1$100
   Stages and Symptoms.....II-40
Stages in Chronic HCV Condition.....II-40
1$100
   Symptoms of Liver Disease in Chronic HCV Condition.....II-41
Common Symptoms.....II-41
Uncommon Symptoms (Indications of Severe Liver Disease).....II-41
Complications Due to Chronic HCV Infection.....II-41
1$100
   HCV Intensifies Risk of Lymphoma.....II-42
Diagnosis.....II-42
Tests to Confirm HCV Presence.....II-42
Antibody Tests.....II-42
1$100
   ELISA.....II-43
RIBA.....II-43
HCV RNA Test.....II-43
1$100
   Other Test Types.....II-44
ALT Tests.....II-44
Genotype Tests.....II-44
Liver Biopsy.....II-44
Treatment for HCV Infection.....II-44
Monotherapy.....II-44
1$100
   Brief Description of Approved Drugs for Monotherapy Treatment.....II-45
Comparison of Response of Interferon Based Drugs in Chronic Hepatitis C
  Treatment.....II-45
Interferons – An Overview.....II-45
1$100
   Interferons Working Mechanism.....II-46
Interferon Types.....II-46
1$100
   Combination Therapy.....II-47
Table 12: Approved Drugs for HCV Combination Therapy.....II-47
1$300
   Table 13: Major Side Effects Associated with Pegasys + Copegus, and Pegasys (includes corresponding Graph/Chart).....II-48

Table 14: Effectiveness of PEG-Intron, Pegasys, and PEG-Intron + Ribavirin in HCV Treatment Therapy (includes corresponding Graph/Chart).....II-48
1$300
   Table 15: Data for 20-Year Risks and Other Related Aspects in HCV Patients (Treated and Untreated Patients).....II-49
Alternative Therapies.....II-49
Vaccine.....II-49
Liver Transplantation.....II-49
1$100
   Treatment Costs.....II-50
Types of Treatment Responses.....II-50
Sustained Response.....II-50
Relapsing (Transient) Response.....II-50
Breakthrough Response.....II-50
Null Response.....II-50
1$100
   Monitoring Tests.....II-51
Laboratory tests.....II-51
Medical Examinations.....II-51
Prevention.....II-51
1$100
   HBV-HCV Coinfection.....II-52
Treatment Options for HBV-HCV Coinfected Patients.....II-52
1$100
   United States.....II-53
Table 16: HCV Infection in the US: Number of Infected People for the Years 2006, 2007 and 2008 (in '000s) (includes corresponding Graph/Chart).....II-53

Table 17: 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).....II-53
1$300
   HCV Infection – Ethnicity.....II-54
Table 18: HCV Prevalence in the US (1999-2002): Prevalence Rate by Age and Race (includes corresponding Graph/Chart).....II-54
African-Americans React Poorly to Treatment.....II-54
1$300
   Genotype 1 – The Most Prevalent HCV Strain.....II-55
Table 19: HCV Prevalence in the US (2005): Prevalence by Genotype (In %).....II-55
Falling HCV Incidences in the US.....II-55
Table 20: Acute HCV Infection Incidences in the US for the Years 1996 through 2007 (includes corresponding Graph/Chart).....II-55
1$300
   Table 21: US HCV Market (2006): Incidence of Acute Hepatitis C by Age Group and Gender (includes corresponding Graph/Chart).....II-56
HCV in Children.....II-56
1$100
   Unresolved Factors.....II-57
Treatment Options.....II-57
US Scientists Develop Monoclonal Antibody to Neutralize HCV.....II-57
Canada.....II-57
1$100
   Australia.....II-58
Table 22: Modes of HCV Infection Transmission in Australia (includes corresponding Graph/Chart).....II-58
1$300
   Table 23: Hepatitis C Infection in Australia (2000): Rate of Incidence by Age Group and Gender (includes corresponding Graph/Chart).....II-59
China.....II-59
1$100
   India.....II-60
Egypt.....II-60
1$100
   France.....II-61
The Netherlands.....II-61
Table 24: HCV Infection Prevalence in Risk Groups in the Netherlands.....II-61
Brazil.....II-61
Sportspersons Expose to HCV Risks.....II-61
1$300
   Central and Eastern Europe.....II-62
HCV Prevalence Rate Higher in Injection Drug Users.....II-62
Alarming Rates of HIV/HCV Co-Infection.....II-62
1$300
   Table 25: 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).....II-63
Testing and Counseling Structure Poorly Developed.....II-63
1$100
   Depleted Testing Schemes for Prisoners.....II-64
Scarcity Prevails at Health Care Providers and Governments As Well.....II-64
Practical Availability of PEG-IFN Remains Limited.....II-64
Dearth in Political Commitment.....II-64
1$100
   HCV Diagnostic Tests and Treatment in Select CEE Countries.....II-65
Bulgaria.....II-65
Czech Republic.....II-65
Hungary.....II-65
Romania.....II-65
Russia.....II-65
1$100
   Ukraine.....II-66
Availability of Testing Protocols for HCV in Select CEE Countries.....II-66
1$100
   Pharmasset Initiates Phase Ib Clinical Study of PSI-7851 in Chronic HCV
  Patients.....II-67
Chugai Initiates Phase I Trial for NA 808 HCV Drug.....II-67
Aethlon Medical Releases Positive Clinical Data with Aethlon Hemopurifier®.....II-67
Schering-Plough Receives FDA Approval for HCV Drug in Children.....II-67
1$100
   Human Genome Reveals Data on Phase III Clinical Trial on Albuferon.....II-68
Canopus Initiates Phase II Clinical Trial for Hepatitis C Drug - CB5300.....II-68
Vertex to Initiate Phase III Trial of Telaprevir.....II-68
Amarillo and CytoPharm to Initiate Phase II Study of Novel Oral Interferon.....II-68
Biolex Releases Locteron® Phase IIa Trial Results.....II-68
1$100
   Schering-Plough Releases Details of Boceprevir Phase II Study.....II-69
Progenics Focuses on HCV Entry Inhibitors.....II-69
1$100
   ZymoGenetics Reveals Phase Ib Results of IL-29.....II-70
Phenomix Begins Phase Ia Study of PHX1766.....II-70
Inovio and Tripep Release Additional Interim Results for ChronVac-C®.....II-70
1$100
   InterMune Starts Clinical Study of ITMN-191.....II-71
Roche and Associates Commence Clinical Trial of All-Oral Dual-Antiviral
  Therapy.....II-71
GlobeImmune Announces Phase II Clinical Trials with GI-5005.....II-71
1$100
   Human Genome Gets Encouraging Interim Results with Albuferon.....II-72
Intarcia Releases Study Results of Omega Interferon.....II-72
Nautilus Biotech Commences Phase I Study for Belerofon®.....II-72
1$100
   Migenix Announces Phase II Proof-of-Concept Study Results of Celgosivir.....II-73
Pharmasset Begins Multiple Dose-Escalating Study of R7128.....II-73
Transgene Commences Phase I Trial of TG4040.....II-73
Debiopharm Releases Phase Ib Results of Debio 025.....II-73
1$100
   Nabi Biopharmaceuticals Starts Proof-Of-Concept Trial for Civacir.....II-74
Peregrine Announces Positive Results for Bavituximab.....II-74
Jenken to Commence Phase II Trial of JBK-122.....II-74
1$100
   Pevion Biotech Initiates Phase I Study of Hepatitis C Vaccine.....II-75
Intercell Releases Phase II Findings of IC41.....II-75
1$100
   Roche Acquires Genentech.....II-76
Schering-Plough to Merge with Merck.....II-76
Valeant Enters into Agreement with Schering-Plough for HCV Drug – Taribavirin.....II-76
ImQuest and Arisyn Receive Grant for Developing Novel HCV Therapeutic Agent.....II-76
1$100
   Virco Signs an Agreement with Siemens Healthcare.....II-77
Indian Government Issues Patent to Roche’s HCV Drug – Pegasys.....II-77
Vertex Takes Over HCV and HIV Drug Development Company, ViroChem.....II-77
InterMune Wins US Patent for HCV Drug - ITMN-191.....II-77
BMS Collaborates with ZymoGenetics for Developing HCV Drug.....II-77
Quest Diagnostics Develops New Quantitative Test for HCV.....II-77
1$100
   Three Rivers Acquires Infergen®.....II-78
International Consolidated Cos Takes Over China Gene.....II-78
Hologic Signs Definitive Deal to Acquire Third Wave.....II-78
1$100
   GlaxoSmithKline Inks Deal to Take Over Genelabs.....II-79
Biolex Signs Deal to Purchase OctoPlus’ Stake in Locteron®.....II-79
OraSure and Schering-Plough Form Global Alliance.....II-79
Tacere and Oncolys Sign Licensing Agreement.....II-79
1$100
   Beckman Wins HCV Diagnostics Rights from Siemens Healthcare.....II-80
Anadys Secures FDA Fast Track Designation for its Lead Drug Candidate.....II-80
Roche Bags European Commission Approval for Combination Therapy.....II-80
Roche Receives European Commission Approval for Shortened Hepatitis C Therapy.....II-80
iTherX Establishes Advisory Board for Hepatitis C Advanced Therapeutics.....II-80
1$100
   SciClone Terminates Zadaxin®.....II-81
Tacere Therapeutics Signs Agreement with Pfizer for RNAi Hepatitis C Drug.....II-81
OraSure Technologies Files PMA Application for OraQuickÒ HCV Test.....II-81
GENOVAC Develops New Therapy for HCV.....II-81
AstraZeneca Acquires Arrow Therapeutics.....II-81
1$100
   Cubist Takes Over Illumigen.....II-82
China Medical to Take Over Beijing Bio-Ekon.....II-82
Schering-Plough Collaborates with OraSure.....II-82
Pro-Pharmaceuticals to Collaborate with Digna Biotech.....II-82
1$100
   Medivir and Tibotec Establish Collaboration Deal.....II-83
VGX Extends Collaboration with University of Pennsylvania.....II-83
Presidio Wins Exclusive License to Novel HCV Technology.....II-83
Roche Inks Licensing Deal with Novartis and Ortho-Clinical.....II-83
Peregrine Opens Subsidiary in China.....II-83
InterMune Completes Production Milestone.....II-83
1$100
   Arrow Expands Hepatitis C Pipeline.....II-84
Roche Wins Japanese Approval for Combination Therapy.....II-84
Schering-Plough Bags European Commission Approval for Combination Therapy.....II-84
Abbott Bags FDA Approval for Screening Test.....II-84
Abbott Bags Canadian Approval for Viral Load Tests.....II-84
Worldwide Biotech Bags Chinese FDA Approval for HCV Diagnostic Kit.....II-84
1$100
   Tibotec Applies to European Regulator to Initiate Phase I Trials.....II-85
Roche Submits Application for Novel Hepatitis C to with FDA.....II-85
Anadys Discontinues ANA975.....II-85
Cerus Bags NIH Funding for HCV Vaccine Program.....II-85
1$100
   Abbott Diagnostics (USA).....II-86
Achillion Pharmaceuticals, Inc. (USA).....II-86
Anadys Pharmaceuticals, Inc. (USA).....II-86
Boehringer Ingelheim GmbH (Germany).....II-86
1$100
   Bristol-Myers Squibb Company (USA).....II-87
F. Hoffmann-La Roche Ltd. (Switzerland).....II-87
1$100
   GlaxoSmithKline plc (UK).....II-881$100
   Hayashibara Biochemical Labs, Inc. (Japan).....II-89
HemispheRx Biopharma, Inc. (USA).....II-89
Human Genome Sciences (USA).....II-89
1$100
   Idenix Pharmaceuticals, Inc. (USA).....II-90
Innogenetics NV (Belgium).....II-90
InterMune, Inc. (USA).....II-90
1$100
   Intarcia Therapeutics, Inc. (USA).....II-91
Medivir AB (Sweden).....II-91
1$100
   Merck & Co., Inc. (USA).....II-92
Novartis AG (Switzerland).....II-92
Chiron Corporation (USA).....II-92
1$100
   Pfizer, Inc. (USA).....II-93
Schering-Plough Corporation (USA).....II-93
1$100
   Tibotec Pharmaceuticals Ltd. (Ireland).....II-94
Tripep AB (Sweden).....II-94
Toray Industries, Inc. (Japan).....II-94
1$100
   Valeant Pharmaceuticals International (USA).....II-95
Vertex Pharmaceuticals, Inc. (USA).....II-95
1$100
    
 
 


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