Pipeline Insight: HIV - The Age of Convenience

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Pipeline Insight: HIV - The Age of Convenience
Published on October 2009

Report Summary

Introduction

Three new partnerships are reshaping the competitive environment in HIV. Most notably, Tibotec/Johnson & Johnson is linking up
with Gilead to combine their Phase III drug rilpivirine with Truvada to create a new gold standard fixed dose combination for
treatment-naïve patients. Addressing Atripla's shortcomings, Datamonitor expects this product to dominate the market.

Scope

*In-depth analysis of Phase II and III clinical development compounds and comprehensive overview of Phase I drugs

*An overview of the key companies involved in the HIV pipeline, including an analysis of the new corporate alliances

*The epidemiology dynamics of HIV in the six major markets are discussed along with unmet needs that have evolved from the
prolonged use of HAART

*Sales forecasts over the next 10 years for the each of the late-stage drugs

Highlights

Advances in antiretroviral therapy have addressed the two big unmet medical needs, resistance and safety. Convenience is the new
frontier, pointing towards a bright future for cross-class fixed-dose combination, notably Gilead's Quad Pill and Gilead's and Johnson
& Johnson's Truvada/rilpivirine combination.

Gilead's two new cross-class fixed dose combinations offer only moderate medical progress, but their added convenience compared
with single ingredient formulations will cement the company's market leadership and reduce the market opportunity for
single-ingredient formulations.

Abbott's monopoly in protease inhibitor boosting agents is nearing its end. At least three companies have pharmacokinetic enhancers
with potentially improved safety profiles in clinical development, hopefully enabling the creation of more co-formulated brands

Reasons to Purchase

*Understand the constantly evolving market dynamics of antiretroviral drugs in view of corporate alliances, co-formulations and
generic entry

*Learn about the changing unmet needs of patients and the extent to which pipeline drugs are addressing these issues

*Evaluate the forecast of key pipeline antiretroviral drugs to 2018, taking into account key launch dates, patent expirations and other
factors

Pipeline Insight: HIV - The Age of Convenience Page 1/11


Table of Content

Overview 1
Catalyst 1
Summary 1
ABOUT DATAMONITOR HEALTHCARE 2
About the Disease pharmaceutical analysis team 2
Executive Summary 3
Strategic scoping and focus 3
Datamonitor insight into the disease market 3
Related reports 5
Table of Contents 6
1. Pipeline Overview and Dynamics 7
Key findings 7
Pipeline overview 8
Comparative forecasts - cross-class fixed-dose combinations to dominate 11
Datamonitor Pipeline Assessment Summary 13
Key companies involved in the HIV market 14
Gilead set to remain the HIV market leader 14
Key companies involved in the HIV pipeline 16
Key R&D company strategies - collaborations and cross-class combinations 21
GlaxoSmithKline and Pfizer HIV merger 21
Gilead and Tibotec/Johnson & Johnson 24
Merck and Schering-Plough 26
2. HIV - Market Potential 28
Key findings 28
Definition 29
Patient segmentation 29
Treatment-naïve patients 29
Treatment-experienced patients 29
Epidemiology 30
Seven major markets 30
The US has the highest prevalence of HIV infection among the seven major markets 30
Men who have sex with men remain the most affected group 33
Increasing diagnosis rates contributing to rise in HIV incidence in the US 35
Antiretroviral therapy has increased life expectancy and is driving the rise in HIV/AIDS prevalence 36
Immigration from areas of high prevalence contributing to the increasing incidence in Europe 37
Rest of the world 38
Brazil 39
China 40
India 40
Russian Federation 41
South Africa 41
Current treatment options 41
Nucleoside reverse transcriptase inhibitors 41
Non-nucleoside reverse transcriptase inhibitors 42



Protease inhibitors 42
Entry inhibitors 42
Integrase inhibitors 42
Cross-class combinations 42
Current gold standard and comparator therapies 44
Atripla is widely accepted as the gold standard of HIV therapy 44
Choice of comparator differs for individual drug classes and treatment populations 45
Current market overview 46
Atripla will surpass Truvada in 2009 47
Reyataz displaces Kaletra as leading protease inhibitor 47
Despite being the fifth best-selling antiretroviral, Epzicom sales lag behind Truvada 47
Unmet needs in HIV 48
The increasing number of treatment-experienced patients achieving undetectable levels suggests efficacy is not an unmet need
anymore 48
Resistance remains an issue for first-line NNRTIs and the integrase inhibitors 49
Although antiretroviral tolerability has improved considerably it remains an issue for some drug classes 49
Issue of pill burden eliminated by availability of simplified treatments 50
Cost 50
Current level of attainment vs. target product profile 51
3. R&D Approach 57
Key findings 57
Clinical trial design in HIV 58
Superiority trial design 58
Non-inferiority trial design 59
Dose comparison trial design 60
Choice of control arms 60
Background regimens 60
Duration of studies 61
Clinical trial endpoints 61
Early trials were based on 'hard' clinical endpoints, such as progression to AIDS or death 61
The availability of HIV viral load diagnostics hugely benefited clinical trials 61
Improved understanding of HIV and the advent of HAART have changed endpoints significantly 62
Reduction in viral load 62
CD4 elevation 63
Activity against resistant virus-a must for most of the HIV pipeline 63
Quality of life considerations 63
4. Pipeline Analysis & Forecasts: Nucleoside Reverse Transcriptase Inhibitors 64
Key findings 64
Overview for nucleoside reverse transcriptase inhibitors 65
Pipeline summary 65
Comparative forecasts 66
Apricitabine (Avexa) 67
Drug overview 67
Clinical trial data 68
Phase III 68
Phase II studies 69
Clinical and commercial attractiveness 71
Positioning in treatment experienced patients will limit uptake 71
Commercialization of apricitabine may prove difficult without a suitable partner 72
SWOT analysis 73



Datamonitor drug assessment score card for apricitabine 73
Satisfaction of unmet needs 75
Resistance 75
Toxicity 75
Target product profile 75
Forecasts to 2018 76
Other drugs in the nucleoside reverse transcriptase class 77
Elvucitabine 77
Amdoxovir 78
4. Pipeline Analysis & Forecasts: Protease Inhibitors 79
Key findings 79
Overview for the protease inhibitor class 80
Key early-stage compounds in the protease inhibitor class 80
Pipeline summary 80
Marketed protease inhibitors are highly potent and have improved dosing 81
Tibotec/Johnson & Johnson developing a co-formulation of Prezista and an investigational pharmacokinetic enhancer 81
PPL-100 was previously the most promising among the remaining compounds 81
5. Pipeline Analysis & Forecasts: Non-Nucleoside Reverse Transcriptase Inhibitors 82
Key findings 82
Overview for the non-nucleoside reverse transcriptase class 83
Pipeline summary 83
Rilpivirine 85
Drug overview 85
Phase III studies in naïve patients 86
Phase II studies confirm efficacy in naïve patients 88
High efficacy, simplified dosing and reduced CNS toxicity favor use in first line but questions over QTc prolongation remain 91
Tibotec is an established player in the HIV market 92
SWOT analysis 93
Datamonitor drug assessment score card for rilpivirine 93
Resistance 94
Toxicity 95
Other drugs in the non-nucleoside reverse transcriptase class 97
RDEA806 (Ardea Biosciences) 98
Drug overview 98
Datamonitor drug assessment score card for RDEA806 99
IDX899 (GlaxoSmithKline/Idenix Pharmaceuticals) 100
Drug overview 100
Datamonitor drug assessment score card for RDEA806 101
Lersivirine (Pfizer) 101
Drug overview 101
Datamonitor drug assessment score card for lersivirine 103



Ardea's partnering efforts may delay development of RDEA806 104
IDX899 and lersivirine form part of the combined GlaxoSmithKline and Pfizer pipeline 104
Key early-stage compounds in the non-nucleoside reverse transcriptase class 105
6. Pipeline Analysis & Forecasts: Entry Inhibitors 107
Key findings 107
Overview for the entry inhibitors 108
Pipeline summary 109
Vicriviroc (Schering-Plough) 112
Drug overview 112
Phase III studies in experienced patients 113
Phase II/III studies in naïve patients 114
Phase II studies VICTOR-E1 and A5211 115
Positioning in naïve patients is crucial for CCR5 inhibitors 119
Once-daily dosing is an advantageous in first line but ritonavir boosting may carry additional side effects 119
Merck & Co and Schering-Plough merger may improve the outlook for vicriviroc 120
SWOT analysis 120
Datamonitor drug assessment score card for vicriviroc 121
PRO-140 (Progenics) 124
Drug overview 124
Phase II intravenous formulation study 124
Phase IIa subcutaneous formulation study 125
Clinical attractiveness 125
Early data for PRO-140 look promising but its mode of administration will restrict its use 125
Commercialization of PRO-140 will be difficult without a suitable partner 126
SWOT analysis 126
Datamonitor drug assessment score card for PRO-140 127
Other drugs in the entry inhibitor class 129
Ibalizumab 130
PF-232798 131
Key early-stage compounds in the entry inhibitor class 131
7. Pipeline Analysis & Forecasts: Integrase inhibitors 132
Key findings 132
Overview for the integrase inhibitor class 133
Elvitegravir (Gilead Sciences) 134
Drug overview 134
Phase III trials against raltegravir are underway 135



Phase II studies confirmed efficacy in experienced patients 136
Low efficacy rates observed in Phase II studies reduce elvitegravir's clinical attractiveness 137
Elvitegravir as a standalone product is unlikely to generate significant revenue for Gilead 137
SWOT analysis 137
Datamonitor drug assessment score card for elvitegravir 138
Other drugs in the integrase inhibitor class 140
S/GSK1349572 and S/GSK1265744 (GSK/Shionogi Pharmaceuticals) 141
Key early-stage compounds in the integrase inhibitor class 142
8. Pipeline Analysis & Forecasts: Cross-Class Fixed-Dose Combinations 143
Key findings 143
Overview for the cross-class fixed-dose combinations class 144
Truvada/rilpivirine (Gilead and Tibotec/Johnson & Johnson) 147
Drug overview 147
Phase III 148
Rilpivirine has demonstrated good efficacy and tolerability in naïve patients 148
Gilead and Tibotec/Johnson & Johnson can rely on their combined expertise to establish Truvada/rilpivirine in first line 149
SWOT analysis 149
Datamonitor drug assessment score card for Truvada/rilpivirine 150
Quad Pill (Gilead Sciences) 152
Drug overview 152
Phase II 153
Phase I 153
Co-formulation with Truvada increases the commercial attractiveness of elvitegravir 154
Truvada/rilpivirine co-formulation may restrict use of the Quad Pill to later lines of therapy 154
SWOT analysis 155
Datamonitor drug assessment score card for cross-class fixed-dose combinations 155
9. Innovative Early-Stage Approaches 159
Key findings 159
Pharmacokinetic enhancers 160
GS-9350 (Gilead Sciences) 160
SPI-452 (Sequoia Pharmaceuticals) 161
PF3716539 (Pfizer/GlaxoSmithKline) 161
Microbicides and pre-exposure prophylaxis 162
PRO2000 Gel (Endo Pharmaceuticals) 162
Tenofovir gel (Gilead Sciences) 162
The future of HIV treatment 163



Early initiation of therapy 163
Nucleoside-sparing approaches have safety benefits but lack the simplicity of cross-class combinations 164
Bibliography 167
Journal papers 167
Websites 168
Others 170
Datamonitor reports 175
APPENDIX 176
Methodology 176
Datamonitor forecast methodology 176
Epidemiology forecasts 176
Product forecasts 176
Definition of a standard unit (only use if ForeSight model used to forecast) 176
Datamonitor drug assessment scorecard 177
Contributing experts 178
About Datamonitor 179
About Datamonitor Healthcare 179
About the Disease analysis team 180
Datamonitor consulting 180
Disclaimer 180
List of Tables
Table 1: Products in clinical development for the treatment of HIV infection, 2009 9
Table 2: Sales forecast for pipeline products for the treatment of HIV infection in the US and five major European markets ($m),
2009-18 12
Table 3: Leading companies in the HIV market, 2008-18 15
Table 4: Gilead Sciences' portfolio assessment for HIV, 2009 17
Table 5: GlaxoSmithKline's portfolio assessment for HIV, 2009 19
Table 6: Pfizer's portfolio assessment for HIV, 2009 20
Table 7: GlaxoSmithKline and Pfizer combined marketed portfolio, 2009 22
Table 8: GlaxoSmithKline and Pfizer combined pipeline, 2009 23
Table 9: Prevalence of HIV infection in the seven major markets, 2007 30
Table 10: Mortality rates and life expectancy of HIV patients, stratified by CD4 count, 2008 36
Table 11: HIV incidence, prevalence and mortality from AIDS, by region, 2007 39
Table 12: Leading treatments for HIV infection, 2009 43
Table 13: Atripla - drug profile, 2009 45
Table 14: Target product profile for NRTIs 52
Table 15: Target product profile for NNRTIs 53
Table 16: Target product profile for the Integrase inhibitors 54
Table 17: Target product profile for the entry inhibitors 55
Table 18: Target product profile for cross class combinations 56
Table 19: Key products in the R&D pipeline for the NRTI class, 2009 66
Table 20: Sales forecasts for NRTIs in the US and five major European markets ($m), 2009-19 67
Table 21: Apricitabine - drug profile, 2009 68
Table 22: Overview of 48-week efficacy data from AVX-201 71
Table 23: Ability of apricitabine to meet unmet needs 76
Table 24: Sales forecasts for apricitabine in the US and 5EU ($m), 2009-18 76
Table 25: Impacting factors on the revenues of apricitabine, 2009-18 77
Table 26: Other drugs in the nucleoside reverse transcriptase class, 2009 77
Table 27: Key products in the early-stage R&D pipeline for the protease inhibitor class, 2009 80
Table 28: Key products in the R&D pipeline for non-nucleoside reverse transcriptase inhibitors, 2009 84



Table 29: Sales forecasts for non-nucleoside reverse transcriptase inhibitors in the US and 5EU ($m), 2009-18 85
Table 30: Rilpivirine - drug profile, 2009 86
Table 31: A comparison of 48 and 96-week Phase IIb rilpivirine efficacy data, 2009 90
Table 32: An overview of safety findings from the rilpivirine Phase IIb study 91
Table 33: Ability of rilpivirine to meet unmet needs 95
Table 34: Sales forecasts for rilpivirine n the US and 5EU ($m), 2009-18 96
Table 35: Impacting factors on the revenues of rilpivirine, 2009-18 97
Table 36: Other NNRTIs in clinical development, 2009 97
Table 37: RDEA806 - drug profile, 2009 98
Table 38: Overview of Phase IIa efficacy data 99
Table 39: IDX899 - drug profile, 2009 100
Table 40: Overview of IDX899 Phase IIa efficacy data 101
Table 41: Lersivirine - drug profile, 2009 102
Table 42: Combined sales forecasts for RDEA806, lersivirine and IDX899 in the US and 5EU, 2009-18 ($m) 105
Table 43: Impacting factors on the revenues of RDEA806, IDX899 and lersivirine, 2009-18 105
Table 44: Key products in the early-stage R&D pipeline for the non-nucleoside reverse transcriptase class, 2009 106
Table 45: Key products in the late-stage R&D pipeline for entry inhibitors, 2009 111
Table 46: Sales forecasts for the entry inhibitors in the US and five major European markets, 2009-18 112
Table 47: Vicriviroc - drug profile, 2009 113
Table 48: Overview of 48-week VICTOR-E1 efficacy data 116
Table 49: Overview of safety data from the VICTOR-E1 study 117
Table 50: Ability of vicriviroc to meet unmet needs 122
Table 51: Sales forecasts for vicriviroc in the US and five major European markets ($m), 2009-18 123
Table 52: Impacting factors on the revenues of vicriviroc 123
Table 53: PRO-140 - drug profile, 2009 124
Table 54: Sales forecasts for PRO-140 in the US and 5EU ($m), 2009-18 129
Table 55: Impacting factors on the revenues of PRO-140, 2009 129
Table 56: Key products in the early-stage R&D pipeline for the entry inhibitors class, 2009 130
Table 57: Key products in the early-stage R&D pipeline for the entry inhibitors class, 2009 131
Table 58: Key products in the late-stage R&D pipeline for the integrase inhibitors class, 2009 133
Table 59: Sales forecasts for integrase inhibitors in the US and five major European markets, 2008-18 ($m) 134
Table 60: Elvitegravir - drug profile, 2009 135
Table 61: Sales forecasts for elvitegravir in the US and five major European markets ($m), 2009-18 140
Table 62: Other integrase inhibitors in development 141
Table 63: Key products in the early-stage R&D pipeline for the integrase inhibitor class, 2009 142
Table 64: Key cross-class combinations in the late-stage R&D pipeline, 2009 146
Table 65: Sales forecasts for cross-class combinations in the US and five major European markets ($m), 2008-18 147
Table 66: Truvada/rilpivirine - drug profile, 2009 148
Table 67: Ability of Truvada/rilpivirine to meet unmet needs 151
Table 68: Sales forecasts for Truvada/rilpivirine in the US and five major European markets ($m), 2009-18 152
Table 69: Impacting factors on the revenues of Truvada/rilpivirine, 2009-18 152
Table 70: Quad Pill - drug profile, 2009 153
Table 71: Sales forecasts for the Quad Pill in the US and five major European markets, 2009-18 ($m) 157
Table 72: Impacting factors on the revenues of the Quad Pill, 2009-18 158
Table 73: Datamonitor drug assessment parameters 177
List of Figures
Figure 1: HIV pipeline activity by class, 2009 11
Figure 2: Datamonitor drug assessment summary for antiretroviral therapies in development for HIV infection, 2009 14
Figure 3: HIV market share by company, 2008 16
Figure 4: Estimated number of people living with HIV in the US, 5EU and Japan, 1997-2007 31



Figure 5: Estimated number of people living with HIV in the five major European markets, 1997-2007 32
Figure 6: Number of newly reported HIV infections and AIDS cases in Japan, 1985-2006 33
Figure 7: Estimated Numbers of HIV/AIDS cases among adults and adolescents, by transmission category, 1994-2007 34
Figure 8: Number of reported HIV infections by transmission mode, origin and year of notification in the EU/EFTA, 2003-07 35
Figure 9: Death rates from HIV infection during pre- and post-HAART era, 1990-2003 37
Figure 10: Estimated number of adults (15-59 years) living with HIV (both diagnosed and undiagnosed) in the UK, 2007 38
Figure 11: Antiretroviral sales in the US and five major European markets ($m), 2005-08 46
Figure 12: Overview of the raltegravir BENCHMRK study 59
Figure 13: Overview of the Phase III study for apricitabine 69
Figure 14: Overview of the Phase IIb study for apricitabine 70
Figure 15: Apricitabine SWOT analysis 73
Figure 16: Datamonitor's competitive positioning analysis of apricitabine, 2009 74
Figure 17: Overview of the rilpivirine Phase III THRIVE study 87
Figure 18: Overview of the rilpivirine Phase III ECHO study 88
Figure 19: Overview of the rilpivirine Phase IIb study 89
Figure 20: Rilpivirine SWOT analysis, 2009 93
Figure 21: Datamonitor's competitive positioning analysis of rilpivirine, 2009 94
Figure 22: HIV mechanism of entry into host cell 109
Figure 23: Datamonitor drug assessment summary for products in development for entry inhibitors, 2009 110
Figure 24: Overview of the vicriviroc VICTOR-E3 and VICTOR-E4 studies 114
Figure 25: Overview of the vicriviroc VICTOR-E1 study 115
Figure 26: Overview of the vicriviroc A5211 study 118
Figure 27: Vicriviroc SWOT analysis 120
Figure 28: Datamonitor's competitive positioning analysis of vicriviroc, 2009 121
Figure 29: PRO-140 SWOT analysis, 2009 127
Figure 30: Datamonitor's competitive positioning analysis of PRO-140, 2009 128
Figure 31: Overview of the Phase III program for elvitegravir 136
Figure 32: Elvitegravir SWOT analysis, 2009 138
Figure 33: Datamonitor's competitive positioning analysis of elvitegravir, 2009 139
Figure 34: Datamonitor's competitive positioning analysis of fixed-dose combinations, 2009 145
Figure 35: Truvada/rilpivirine SWOT analysis, 2009 149
Figure 36: Datamonitor's competitive positioning analysis of Truvada/rilpivirine, 2009 150
Figure 37: Quad Pill SWOT analysis, 2009 155
Figure 38: Datamonitor's competitive positioning analysis of the Quad Pill, 2009 156
Figure 39: Datamonitor drug assessment summary of pipeline molecular targeted therapies in development for hematological
malignancies, 2007 178



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Pipeline Insight: HIV - The Age of Convenience

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Pipeline Insight: HIV - The Age of Convenience