Pipeline Insight: Hepatitis C - Small Molecules, Big Revolution?

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Publication Date: 2005-04-26

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Less than 50% of chronically infected hepatitis C patients do not benefit from the current standard of care, pegylated interferon plus ribavirin. In the short-term, the treatment landscape is likely to be enriched by interferon or ribavirin replacement drugs providing incremental benefit. In the longer term, specific HCV antivirals might demonstrate greater efficacy in difficult-to-treat patients.

Scope

Overview of HCV pipeline with coverage of polymerase inhibitors, protease inhibitors along with newer generation ribavirin and long acting interferons

Opinion leader appraisal of HCV clinical trial design, comparators and endpoint definition

Detailed analysis of new product first year market share and peak sales forecasts

Expert outlook on evolution of HCV therapy and discussion of opposing views

Report Highlights
The HCV market in 2004 is estimated at $2 billion with a larger proportion of sales generated by the pegylated interferons such as Pegasys and PEG-Intron.

Datamonitor delineates 3 defined growth phases in the period 2004-2013 which will contribute to increased pegylated interferon uptake.

Incremental benefits afforded by viramidine and possibly, Albuferon are the only conceivable changes to HCV therapy within this decade.

Reasons to Purchase

Gain the latest understanding on the long term outlook for HCV treatments

Assess the long-term impact of new small molecules on pegylated interferon uptake

Quantify present and future split between antiviral and immunomodulator segments

ABOUT DATAMONITOR HEALTHCARE - page 2
- About the Infectious Disease pharmaceutical analysis team - page 2
CHAPTER 1 EXECUTIVE SUMMARY - page 3
- Scope of the analysis - page 3
- Datamonitor insight into the Hepatitis C market - page 4
CHAPTER 2 PIPELINE DYNAMICS - page 19
- The changing hepatitis C market - minor changes in the short-term, potential new treatment paradigm in the long-term - page 19
  - Pipeline overview - page 19
  - With most pipeline drugs in early phases of clinical development, new drug launches are expected to cluster in the period 2011-2013 - page 20
  - Pegylated interferon and ribavirin replacement drugs in the short term, small molecule antivirals in the long term - page 21
- The value of the HCV pharmaceutical market is expected to double between 2004-2012 - page 22
  - Factors of both clinical and commercial nature are expected to fuel the future growth of the HCV market - page 22
  - As a consequence of their early stage in clinical development, new drugs are expected to account for only one-third of total sales in 2013 - page 24
- New players are expected to enter a market traditionally dominated by Schering-Plough and Roche - page 25
  - Although several new players are expected to enter the HCV market, the two members of the traditional duopoly are expected to hold their positions - page 25
  - In-licensing could provide the opportunity for companies lacking an HCV antivirals portfolio to enter a rapidly growing infectious disease market - page 26
CHAPTER 3 PATIENT POTENTIAL - page 27
- Due to the silent nature and slow disease progression of chronic HCV infection, the pool of chronically infected patients seeking treatment is expected to peak within the next 10-20 years - page 27
  - Globally, 170-200m people are believed to be chronically infected with HCV - page 27
    - Japan and the US account for 75% of hepatitis C patients in the seven major markets - page 30
    - While past infections occurred through contaminated blood, present infections occur predominantly due to the use of shared needles - page 31
  - Chronic HCV infection silently progresses to liver cirrhosis and cancer over prolonged periods of time - page 33
    - The number of CHC patients seeking treatment is expected to peak within the next 10-20 years - page 35
- HCV genotype 1, liver transplant and HIV-coinfected patients are the key patient populations requiring improved treatment options - page 35
  - HCV genotype 1 mono-infected patients constitute the majority of both the naïve and treatment-experienced chronic HCV patient pool - page 35
    - Nonresponders and relapsers, most of whom are infected with HCV genotype 1, are accumulating due to the lack of alternative therapies - page 36
  - The high incidence of post-transplant HCV reinfection has created an important niche market - page 37
  - Due to the prolongation of life expectancy associated with HAART therapy, HIV/HCV coinfection is becoming an increasingly important indication - page 38
- Clinical limitations associated with the current standard of care have led to suboptimal diagnosis and treatment rates - page 40
  - Peg-IFN alfa plus RBV combination therapy is current standard of care but not gold standard - page 41
    - Both therapy components have individual limitations - page 42
  - Due to the immaturity of the HCV pharmaceutical market, new product development might increase both diagnosis and treatment rates - page 43
- The key unmet needs are HCV genotype 1 infection, non-response to current therapy and improved drug tolerability - page 45
  - HCV genotype 1 infection is the most common but also the least responsive to available therapy - page 46
    - Up to 90% of nonresponders are infected with HCV genotype 1 - page 47
  - Increased drug tolerability-related issues are also key to increasing market uptake - page 47
CHAPTER 4 R&D APPROACH - page 49
- HCV protease inhibitors are perceived as the most promising antivirals in the HCV pipeline, but interferon and ribavirin replacement drugs are closer to approval - page 49
  - The highly active HCV pipeline is driven by several different drug classes and sub-classes - page 49
  - Strategies for HCV drug development focus on 'add-on' therapy or replacement of either component of the current standard of care and pave the way for a potential new treatment paradigm - page 52
    - Developmental drug strategies - page 53
  - Specific HCV antivirals are not expected to reach the market before the end of the decade - page 56
    - Late discovery and drug research patents have slowed the development of HCV-specific small molecule antivirals - page 57
- Current clinical trial design requires careful evaluation of various trial components - page 57
  - Comparison against Peg-IFN plus ribavirin is a must, although, in some cases, valuable data can also be gained from a placebo arm - page 58
  - Treatment remains sub-optimal for HCV genotype 1-infected patients, leading to a large pool of nonresponders that is now increasingly being enrolled in clinical trials - page 59
    - Lack of differentiation between male and female coinfected patients also a factor - page 61
- The achievement of a sustained virological response (SVR) is the key endpoint in both HCV clinical trials and therapy - page 61
  - Since HCV therapy leads to durable viral suppression, the key goal of HCV therapy is the reduction of the HCV viral load to undetectable levels - page 61
    - The achievement of an early virological response is often a prognostic factor for the achievement of a sustained virological response - page 63
    - Additional endpoints include the incidence of anemia for ribavirin replacement drug viramidine and the histological and biochemical response - page 63
CHAPTER 5 IMMUNOMODULATORS (NON-INTERFERON) - page 65
- The immunomodulator pipeline is relatively active, with companies focusing on 'add-on' therapy, IFN replacement or reinfection following liver transplant - page 65
  - Pipeline summary - page 66
- The low success rate associated with Peg-IFN plus RBV retreatment has led to the development of 'add-on' therapies for HCV nonresponders - page 67
  - The immune enhancer Zadaxin has shown efficacy in HCV nonresponders when added to the current standard of care - page 67
    - Profile - page 67
    - Key clinical trial overview - page 68
    - Datamonitor analysis - page 70
  - Ceplene, an antioxidant and immunomodulant, is in development as 'add-on' therapy for HCV nonresponders - page 72
    - Profile - page 72
    - Key clinical trial overview - page 73
    - Datamonitor analysis - page 74
- IFN alfa-inducing drugs with improved tolerability have the potential to replace Peg-IFN alfa - page 76
  - Isatoribine (ANA245) and its oral prodrugs, ANA971 and ANA975 are being developed for potential IFN replacement or 'add-on' therapy - page 76
    - Profile - page 76
    - Key clinical trial overview - page 76
    - Datamonitor analysis - page 78
  - Actilon (CPG 10101) induces endogenous IFN alfa but only targets patients relapsing from, or intolerant to, previous IFN-based therapy - page 79
    - Profile - page 79
    - Datamonitor analysis - page 81
- Therapeutic HCV vaccines have been finding their niche in the growing pool of nonresponders to IFN-based therapy - page 82
  - InnoVac-C improves liver histology in HCV genotype 1-infected nonresponders with active liver disease - page 82
    - Profile - page 82
    - Datamonitor analysis - page 83
  - Intercell's HCV therapeutic vaccine - from the nonresponder & relapser niche to treatment-naïve patients - page 84
    - Profile - page 84
    - Key clinical trial overview - page 84
    - Datamonitor analysis - page 85
  - Chiron is developing several HCV vaccines, including one for nonresponders - page 86
    - Profiles - page 86
    - Datamonitor analysis - page 87
- The increase in HCV post-liver transplant patients has created a niche for products that address HCV reinfection - page 87
  - HepeX-C - a dual human monoclonal antibody therapy to prevent HCV reinfection post transplant - page 87
    - Profile - page 87
    - Key clinical trial overview - page 89
    - Trial results - page 90
    - Datamonitor analysis - page 91
  - Civacir - a preparation of human polyclonal antibodies - has received orphan drug status for the prevention of HCV reinfection in liver transplant patients - page 93
    - Profile - page 93
    - Datamonitor analysis - page 93
  - Late-stage development compounds potentially discontinued recently - page 94
    - EHC-18, broad-spectrum immunomodulator for HCV infection and HCV-related hepatocellular carcinoma - page 94
    - FK778, an immunomodulator in development for HCV nonresponders - page 95
- Comparative class forecasts - page 96
CHAPTER 6 INTERFERONS - page 97
- Unmodified interferons were the gold standard for HCV until they were displaced from their pedestal by pegylated interferons - page 97
  - Interferons have a non-specific, broad antiviral activity - page 98
    - The mechanism of IFN alfa against HCV infection has not been elucidated - page 98
  - Standard interferons were first in class but have poor efficacy as monotherapy - page 99
    - Although the longer-acting pegylated IFNs improved IFN efficacy... - page 99
    - ...it was primarily the addition of RBV that significantly boosted the IFN-based treatment response - page 100
- Few companies have attempted to replace Peg-IFN, with main drivers in this class including more favorable dosing, delivery and tolerability, and further efficacy against HCV genotype 1 - page 100
  - Pipeline summary - page 101
- Long-acting interferons requiring less frequent dosing might challenge pegylated interferons for first-line therapy - page 102
  - Due to its improved bioavailability, Albuferon is undergoing clinical trials in naïve patients of all genotypes - page 102
    - Profile - page 102
    - Key clinical trial overview - page 103
    - Datamonitor analysis - page 106
  - Omega interferon - progress on improved delivery system justifies testing in naïve patients for Peg-IFN replacement - page 108
    - Profile - page 108
    - Key clinical trial overview - page 108
    - Datamonitor analysis - page 110
  - Other interferons - page 112
    - Viragen seeks to expand Multiferon use from second- to first-line therapy and enter the US market - page 112
    - IFN-beta 1 for Asian nonresponders and relapsers - page 113
  - Strategic issues have led to the discontinuation of two developmental compounds - page 115
    - PEG-Alfacon-1 - seeking a partner for future development - page 115
    - As part of a strategic decision, Viragen abandoned development of Omniferon in favor of Multiferon - page 115
- Comparative class forecasts - page 116
CHAPTER 7 SMALL MOLECULE ANTIVIRALS - page 117
- Most specific HCV antivirals are at early stages of clinical development, therefore, their potential efficacy is surrounded by uncertainty - page 117
  - Pipeline summary - page 119
- RBV dose reduction due to drug-related anemia has led to the development of second-generation ribavirin with reduced toxicity - page 119
  - Several factors of predominantly clinical nature preclude the wider use of ribavirin - page 119
    - RBV has no effect when administered on its own - page 119
    - RBV's four hypothetical mechanisms of action - page 120
    - Dose-limiting anemia leads to dose-reduction or supplementation with growth factors - page 120
    - For several years, Schering-Plough dominated the HCV ribavirin market - page 121
    - Fierce generic competition since loss of patent protection in 2003 - page 121
  - Viramidine, a ribavirin prodrug, has significant potential to replace ribavirin based on its favorable toxicity profile - page 122
    - Profile - page 122
    - Key clinical trial overview - page 122
    - Datamonitor analysis - page 125
- The lack of efficacy of the current standard of care in the growing pool of genotype 1-infected patients has triggered the race for specific HCV inhibitors - page 129
  - BILN 2061 provided proof-of-concept for HCV protease inhibitors, but development has been suspended due to toxicity - page 129
    - Profile - page 129
    - Clinical trials showed an early and potent decrease in HCV viral load in genotype 1-infected patients - page 130
- HCV NS5B polymerase inhibitors follow the rationale used for the HBV and HIV reverse transcriptase inhibitors and have the potential to revolutionize HCV therapy - page 130
  - Rationale for HCV NS5B polymerase inhibitors - page 130
    - Inhibition of the NS5B polymerase specifically blocks HCV replication at an early stage - page 130
    - The RdRp can be targeted with both active and allosteric site inhibitors - page 131
    - The rationale for RdRp inhibitors is similar to that of HBV and HIV RT inhibitors - page 131
  - Valopicitabine (NM283) - potential for ribavirin replacement - page 131
    - Profile - page 131
    - Key clinical trial overview - page 132
    - Datamonitor analysis - page 134
  - Other HCV polymerase inhibitors - page 136
    - JTK-003 - ongoing Phase II trials but little published data - page 136
    - ViroPharma's HCV-086 and HCV-796 - page 137
- Despite being the most promising class among HCV antivirals, the development of HVC NS3 protease inhibitors has taken off slowly - page 139
  - Rationale for HCV NS3 protease inhibitors - page 139
    - The NS3 protease is essential for viral replication - page 140
    - The HCV protease as a drug target: ideal in theory, difficult in practice - page 141
    - Since viral resistance to PIs might develop, combination treatment-initially with Peg-IFN alfa-could be the preferred strategy - page 142
  - VX-950 - potential to become first-in-class HCV PI - page 142
    - Profile - page 142
    - Key clinical trial overview - page 144
    - Datamonitor analysis - page 144
  - Other HCV protease inhibitors - page 146
    - Little data available for Schering-Plough's SCH 6 and SCH7 - page 146
  - Other small molecule antivirals with unknown function - page 147
    - KPE02003002 - page 147
    - UT 231B - page 148
- Discontinued small molecule antivirals - page 150
  - Most small molecule antivirals are discontinued due to the lack of activity in the clinic - page 150
    - BILN 2061 - unexpected cardiac toxicity - page 151
    - VP-50406 - poor antiviral activity - page 151
    - R803 - insignificant effects in Phase I/II clinical trial despite potent anti-HCV activity in vitro led to the removal of the drug from Rigel's pipeline - page 152
    - Levovirin - lack of antiviral activity - page 153
    - JTK-109 - discontinued for unknown reasons - page 153
    - R1479 - discontinued for unknown reasons - page 153
- Comparative class forecasts - page 154
CHAPTER 8 HOST ENZYME INHIBITORS - page 155
- Limited R&D attention has been paid to the inhibition of host enzyme inhibitors, with only three compounds in this class currently undergoing Phase II trials - page 155
  - Pipeline summary - page 155
- Host enzyme inhibitors are in development for 'add-on' therapy in patients who fail to respond to the current standard of care - page 156
  - IMPDH inhibitor merimepodib (VX-497) for 'add-on' therapy in nonresponders - page 156
    - Profile - page 156
    - Key clinical trial overview - page 157
    - Datamonitor analysis - page 159
  - Caspase inhibitor IDN-6556 is primarily being developed to prevent liver damage in nonresponders - page 161
    - Profile - page 161
    - Key clinical trial overview - page 162
    - Datamonitor analysis - page 163
  - Other host enzyme inhibitors - page 165
    - Alfa-glucosidase inhibitor Celgosivir - potential as monotherapy but ultimately to be positioned as 'add-on' therapy - page 165
- Comparative class forecasts - page 168
CHAPTER 9 OPINION LEADER TRANSCRIPTS - page 169
- Discussion guide - page 169
  - Section 1 - Unmet needs - page 169
  - Section 2 - Clinical trial design - page 170
  - Section 3 - Developmental drug profile and assessment - page 171
  - Section 4 - Future of HCV therapy - page 175
- Opinion leader 1 - page 176
  - Section 1 - Unmet needs - page 176
  - Section 2 - Clinical trial design - page 177
  - Section 3 - Developmental drug profile and assessment - page 178
  - Section 4 - Future of HCV therapy - page 185
- Opinion leader 2 - page 187
  - Section 1 - Unmet needs - page 187
  - Section 2 - Clinical trial design - page 189
  - Section 3 - Developmental drug profile and assessment - page 191
  - Section 4 - Future of HCV therapy - page 196
- Opinion leader 3 - page 200
  - Section 1 - Unmet needs - page 200
  - Section 2 - Clinical trial design - page 201
  - Section 3 - Developmental drug profile and assessment - page 202
  - Section 4 - Future of HCV therapy - page 206
- Opinion leader 4 - page 208
  - Section 1 - Unmet needs - page 208
  - Section 2 - Clinical trial design - page 209
  - Section 3 - Developmental drug profile and assessment - page 211
  - Section 4 - Future of HCV therapy - page 217
APPENDIX A - page 221
- Bibliography - page 221
  - Epidemiology - page 221
  - Journal articles - page 221
  - Conference abstracts - page 225
  - Useful websites - page 228
  - Power Point Presentations - page 228
  - Press releases - page 228
  - Datamonitor reports - page 232
  - Miscellaneous - page 232
- Report methodology - page 233
APPENDIX B - page 234
- About Datamonitor - page 234
  - About Datamonitor Healthcare - page 234
- Datamonitor Healthcare's therapy area capabilities - page 235
  - About the Infectious Disease analysis team - page 236
  - Disclaimer - page 237

List of Tables
Table 1: HCV pipeline overview - page 19
Table 2: Total HCV market sakes forecasts, 2005-2013, US, EU and Pacific Rim - page 24
Table 3: Deaths caused by HCV infection, by geographical area, 2002 - page 28
Table 4: Reported HCV cases in England and Wales, 2003 - page 29
Table 5: HCV prevalence and total patient population in the seven major markets, 2004 - page 31
Table 6: Geographical distribution of HCV genotypes - page 33
Table 7: Relative distribution of HCV genotypes in the West - page 36
Table 8: HIV mono-infected and HIV/HCV coinfected populations in the seven major markets, 2003 - page 39
Table 9: Interferons and ribavirin are the only marketed HCV antivirals - page 41
Table 10: Historically, HCV therapy has failed to address patients interferon-resistant HCV-genotypes 1 and 4 - page 42
Table 11: Estimated HCV genotype 1-infected CHC patient -population - page 46
Table 12: Mode of action of developmental immunomodulators (non-IFN) - page 50
Table 13: Mode of action of developmental interferons - page 50
Table 14: Mode of action of developmental small molecule antivirals - page 51
Table 15: Mode of action of developmental host enzyme inhibitors - page 51
Table 16: Several developmental drugs are specifically enrolling genotype 1-infected patients and nonresponders - page 60
Table 17: The four key endpoints used for clinical trials involving CHC patients with compensated liver disease - page 62
Table 18: Pipeline overview for immunomodulators (non-IFN) - page 66
Table 19: In a pilot trial, Zadaxin plus Peg-IFN alfa-2a plus RBV triple combination therapy led to a significant virologic response in HCV genotype 1 infected nonresponders - page 68
Table 20: In a Phase II trial, Ceplene was found to be effective in reducing the HCV viral load and normalizing ALT levels in naïve patients when used with IFN alfa - page 73
Table 21: Phase II trial design for the study of Ceplene in nonresponders - page 74
Table 22: Isatoribine's proof-of-concept Phase Ib trial - page 77
Table 23: In two Phase I studies, Actilon has demonstrated a good safety and tolerability profile and led to HCV RNA reductions in HCV relapsers of and patients intolerant to previous IFN alfa therapy - page 80
Table 24: Intercell's Phase II European multicenter trial in HCV nonresponders and relapsers showed the induction of a significant T cell response - page 85
Table 25: Phase I and II clinical trials for HepeX-C monotherapy (AbXTL68) pave the way for dual antibody therapy - page 90
Table 26: Suspended or discontinued late-stage drugs - page 94
Table 27: Relative proportion of standard and pegylated interferon being prescribed to chronic hepatitis C versus chronic hepatitis B patients, seven major markets, 2004 - page 98
Table 28: Pipeline overview for interferons - page 101
Table 29: The mean half-life of Albuferon alpha is significantly higher than that of the Peg-IFNs, supporting less frequent dosing - page 103
Table 30: In a Phase I/II study, Albuferon alfa monotherapy demonstrated antiviral activity when administered as monotherapy to genotype 1 nonresponders - page 103
Table 31: Preliminary results at treatment day 28 for 38 patients enrolled in the Canada-based Phase II trial showed that Albuferon monotherapy significantly reduced the viral load - page 106
Table 32: In a European Phase II trial, omega IFN was effective in all genotypes in treatment-naïve patients, although genotype 1-infected patients required a higher dose - page 109
Table 33: Omega IFN is currently undergoing a Phase II clinical trial in Russia involving HCV genotype 1-infected, treatment-naïve patients - page 110
Table 34: Suspended or discontinued interferons - page 115
Table 35: Pipeline overview for small molecule antivirals - page 119
Table 36: In a Phase I/II double-blind, randomized trial, NM283 led to consistent reductions of HCV RNA - page 132
Table 37: VX-950's developmental history - page 143
Table 38: VX-950 Phase Ib trial design - page 144
Table 39: UT-231B Phase II clinical trial design - page 149
Table 40: Discontinued small molecule HCV antivirals - page 151
Table 41: Host enzyme inhibitors in development for HCV - page 155
Table 42: IDN-6556 Phase II clinical trials overview - page 163
Table 43: Phase IIa clinical trial design of Celgosivir monotherapy - page 166

List of Figures
Figure 1: HCV pipeline, by phase of clinical development and drug class - page 21
Figure 2: Estimated launch dates for developmental HCV drugs - page 22
Figure 3: HCV market sales forecasts by class, 2003-2015, US, EU and Pacific Rim - page 23
Figure 4: Anticipated long-term impact of novel HCV products on marketed HCV products - page 25
Figure 5: Geographic distribution of HCV prevalence - page 27
Figure 6: Prevalence of HCV infection by age and gender, US, 1988-94 - page 28
Figure 7: Reported HCV incidence in England and Wales, 1993-2003 - page 30
Figure 8: Most patients infected with HCV progress to chronic HCV (CHC) infection, which can lead to liver cirrhosis and cancer within 20-50 years - page 34
Figure 9: Proportion of CHC patients receiving each line of therapy in the seven major markets, 2004 - page 37
Figure 10: HCV diagnosis rates, seven major markets, 2004 - page 44
Figure 11: HCV treatment rates, seven major markets, 2004 - page 44
Figure 12: Key clinical HCV unmet needs - page 46
Figure 13: Drug developers follow four major strategies for HCV developmental drugs - page 52
Figure 14: One of the ongoing Phase III trials studies the efficacy of Zadaxin + Peg-IFN alfa-2a + RBV triple combination in genotype 1-infected nonresponders - page 69
Figure 15: SciClone has enrolled patients for two multicenter, randomized double-blinded Phase III studies for Zadaxin in combination with Peg-IFN alfa-2a in HCV nonresponders - page 70
Figure 16: Zadaxin sales forecasts, 2005-2013 - page 72
Figure 17: Ceplene sales forecasts, 2005-2013 - page 75
Figure 18: Isatoribine sales forecasts, 2005-2013 - page 79
Figure 19: Actilon sales forecasts, 2005-2013 - page 82
Figure 20: HepeX-C sales forecasts, 2005-2013 - page 92
Figure 21: Civacir sales forecasts, 2005-2013 - page 94
Figure 22: Immunomodulators (non-interferon) comparative sales forecasts, 2005-2013 - page 96
Figure 23: Two Phase II trials are assessing Albuferon either as monotherapy in treatment-naïve patients (Canada study) or as combination therapy with RBV in nonresponders (US study) - page 105
Figure 24: Albuferon sales forecasts, 2005-2013 - page 107
Figure 25: Omega interferon sales forecasts, 2005-2013 - page 111
Figure 26: Multiferon sales forecasts, 2005-2013 - page 113
Figure 27: Interferon beta sales forecasts, 2005-2013 - page 114
Figure 28: Interferon comparative sales forecasts, 2005-2013 - page 116
Figure 29: In a comparative, US Phase II trial involving mainly genotype 1-infected CHV patients, viramidine showed similar antiviral efficacy to RBV but significantly less anemia - page 123
Figure 30: 12-week interim data of viramidine's Phase II trials highlighted that the accumulation of viramidine in both plasma and RBCs was lower than that of RBV - page 124
Figure 31: Two global viramidine Phase III trials, VISER1 and VISER2, have completed patient enrollment - page 125
Figure 32: Initially, viramidine us likely to be the alternative to adding erythropoietin to Peg-IFN alfa plus RBV therapy - page 127
Figure 33: Viramidine sales forecasts, 2005-2015 - page 128
Figure 34: Interim data from a Phase IIa trial show that combination therapy of NM283 and Peg-IFN significantly reduces the HCV viral load - page 133
Figure 35: Valopicitabine sales forecasts, 2005-2013 - page 135
Figure 36: JTK-003 sales forecasts, 2005-2013 - page 137
Figure 37: HCV-086 sales forecasts, 2005-2013 - page 138
Figure 38: The HCV NS3-encoded serine protease cleaves the non-structural HCV proteins - page 141
Figure 39: VX-950 sales forecasts, 2005-2013 - page 146
Figure 40: KPE02003002 sales forecasts, 2005-2013 - page 148
Figure 41: UT 231B sales forecasts, 2005-2013 - page 150
Figure 42: Small molecule antivirals comparative sales forecasts, 2005-2013 - page 154
Figure 43: In a randomized, placebo-controlled European Phase IIa trial in genotype 1 nonresponders, addition of MMPD to the standard of care improved treatment success - page 157
Figure 44: In the double-blind, placebo-controlled randomized METRO (Phase II) trial, MMPD is assessed in HCV nonresponders as triple combination with the current standard of care - page 158
Figure 45: Merimepodib sales forecasts, 2005-2013 - page 160
Figure 46: An estimated 1,5m patients in the seven major markets are likely to progress to liver cirrhosis and could potentially benefit from IDN-6556 therapy - page 165
Figure 47: Celgosivir sales forecasts, 2005-2013 - page 167
Figure 48: Host enzyme inhibitors comparative sales forecasts, 2005-2013 - page 168

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Pipeline Insight: Hepatitis C - Small Molecules, Big Revolution?

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