Pipeline Insight: HIV - Novel NNRTIs address crucial unmet need
Scope
Report Highlights
Reasons to Purchase
Table of Contents
- ABOUT DATAMONITOR HEALTHCARE - page 2
- About the Infectious Disease and Respiratory pharmaceutical analysis team - page 2
- CHAPTER 1 EXECUTIVE SUMMARY - page 3
- Scope of the analysis - page 3
- Datamonitor insight into the HIV market - page 4
- Key metrics - page 7
- Datamonitor Pipeline Assessment Summary - page 8
- Related reports - page 9
- CHAPTER 2 PIPELINE OVERVIEW AND DYNAMICS - page 11
- HIV pipeline overview - page 11
- Growth in the HIV market will be driven by launch of new compounds and classes from 2007 onwards - page 13
- Key companies involved in the HIV pipeline - page 16
- GSK set to lose significant market share - page 16
- Gilead's fixed dose combinations dominating initial therapy - page 19
- Merck's promising pipeline will strengthen its presence in HIV - page 22
- Tibotec positioning compounds across all lines of therapy - page 23
- Key R&D company strategies - page 24
- Major players in HIV are also developing their drugs for HBV as a secondary indication - page 24
- HIV pipeline overview - page 11
- CHAPTER 3 HIV - MARKET POTENTIAL - page 27
- Definition of disease HIV - page 27
- Segmentation of HIV - page 27
- Treatment-naïve patients - page 27
- Treatment-experienced patients - page 28
- Epidemiology of HIV - page 28
- HIV prevalence in US and Western Europe increasing - page 30
- MSM remains the predominant transmission group in the US - page 31
- Immigration from areas of high prevalence driving the increase in number of HIV-infected patients in Western Europe - page 34
- Prolonged life expectancy from HAART - page 37
- Awareness campaigns increasing diagnosis rates in the US but not enough emphasis on testing in Western Europe - page 37
- Unmet needs in HIV - page 38
- Efficacy is generally not an issue for most classes - page 40
- Resistance remains a key unmet need for the NRTIs and NNRTIs - page 42
- Side effects are particularly problematic for PIs - page 43
- Issue of pill burden eliminated by availability of simplified treatments - page 44
- PIs are more commonly associated with drug-drug interactions - page 45
- Cost is currently not an issue but likely to be problem in the future - page 45
- CHAPTER 4 R&D APPROACH - page 47
- Antiretroviral drug classes - page 47
- NRTIs are the oldest class of drugs and form the backbone of HAART regimens - page 48
- NNRTIs are generally used in first-line but are prone to resistance - page 50
- Despite the availability of several PIs, two members dominate this class - page 52
- Selzentry and Isentress are latest additions to the entry inhibitors and others class - page 54
- Entry inhibitors - page 54
- Integrase inhibitors - page 56
- First cross class combination - Atripla - page 56
- Clinical trials in HIV - page 57
- Clinical trial endpoints - page 58
- Early trials were based on 'hard' clinical endpoints, such as progression to AIDS or death - page 58
- The availability of HIV viral load diagnostics enabled trials to measure the direct effect on the virus, use 'soft' clinical endpoints and reduced the length of trials - page 59
- Reduction in viral load - page 60
- CD4 elevation - page 60
- Efficacy equivalence - page 61
- With improved understanding of HIV and the advent of HAART therapy, endpoints have changed significantly - page 61
- Activity against resistant virus - a must for most of the HIV pipeline - page 61
- Quality of life considerations - page 62
- Clinical trial endpoints - page 58
- Antiretroviral drug classes - page 47
- CHAPTER 5 NUCLEOSIDE REVERSE TRANSCRIPTASE INHBITORS LATE-STAGE DRUG ANALYSIS & FORECASTS - page 64
- Overview for NRTIs - page 64
- Pipeline summary - page 64
- Comparative forecasts - page 66
- Definition of current comparator therapy - page 68
- NRTI gold standard - Truvada - page 68
- Apricitabine - page 73
- Drug overview - page 73
- Clinical trial data - page 73
- Satisfaction of unmet needs - page 74
- Resistance - page 74
- Toxicity - page 75
- Patient potential - page 75
- Marketing factors - page 75
- Forecasts to 2016 - page 76
- Datamonitor drug assessment summary - page 77
- Elvucitabine - page 78
- Drug overview - page 78
- Clinical trial data - page 79
- Satisfaction of unmet needs - page 80
- Resistance - page 80
- Toxicity - page 81
- Patient potential - page 81
- Marketing factors - page 82
- Forecasts to 2016 - page 82
- Datamonitor drug assessment study - page 83
- Racivir - page 84
- Drug overview - page 84
- Clinical trial data - page 84
- Satisfaction of unmet needs - page 85
- Resistance - page 85
- Toxicity - page 86
- Patient potential - page 86
- Marketing factors - page 86
- Forecasts to 2016 - page 87
- Datamonitor drug assessment study - page 88
- Other drugs in the NRTI class - page 89
- MIV-210 - page 89
- Amdoxovir - page 89
- Overview for NRTIs - page 64
- CHAPTER 6 NON-NUCLEOSIDE REVERSE TRANSCRIPTASE INHIBITORS LATE-STAGE DRUG ANALYSIS AND FORECASTS - page 91
- Overview for the NNRTI class - page 91
- Pipeline summary - page 91
- Comparative forecasts - page 93
- Definition of current comparator therapy - page 95
- NNRTI 'gold-standard': Sustiva - page 95
- Etravirine - page 99
- Drug overview - page 99
- Clinical trial data - page 99
- Satisfaction of unmet needs - page 101
- Resistance - page 101
- Patient potential - page 102
- Marketing factors - page 103
- Forecasts to 2016 - page 103
- Datamonitor drug assessment study - page 104
- Rilpivirine - page 105
- Drug overview - page 105
- Clinical trial data - page 106
- Satisfaction of unmet needs - page 108
- Resistance - page 108
- Patient potential - page 108
- Marketing factors - page 109
- Forecasts to 2016 - page 109
- Datamonitor drug assessment study - page 110
- Other drugs in development from the NNRTI class - page 110
- UK 453,061 - page 111
- RDEA806 - page 112
- IDX-899 - page 113
- Overview for the NNRTI class - page 91
- CHAPTER 7 PROTEASE INHIBITORS LATE STAGE DRUG ANALYSIS AND FORECASTS - page 115
- Overview for the PI class - page 115
- Pipeline summary - page 115
- Definition of current comparator therapy - page 116
- PI gold-standard Kaletra - page 116
- Competitive pressure from Reyataz and Prezista - page 118
- PIs in early stage development - page 121
- MK-8122 - page 121
- GS-8374 - page 123
- SPI-256 - page 123
- Late-stage development compounds recently discontinued - page 124
- Brecanavir - page 124
- Overview for the PI class - page 115
- CHAPTER 8 EIS AND OTHERS LATE STAGE DRUG ANALYSIS AND FORECASTS - page 125
- Overview for the EI & others class - page 125
- Pipeline summary - page 125
- Comparative forecasts - page 125
- Definition of current comparator therapy - page 126
- Fuzeon - page 126
- Selzentry/Celsentri - page 127
- Drug assessment study for entry inhibitors - page 132
- Isentress - page 133
- Compounds in late-stage development - page 137
- Elvitegravir - page 138
- Drug overview - page 138
- Clinical trial data - page 138
- Patient potential - page 139
- Marketing factors - page 140
- Forecasts to 2016 - page 141
- Elvitegravir - page 138
- Vicriviroc - page 142
- Drug overview - page 142
- Clinical trial data - page 142
- Patient potential - page 144
- Marketing factors - page 144
- Forecasts to 2016 - page 145
- Drug assessment study - page 145
- Bevirimat - page 146
- Drug overview - page 146
- Clinical trial data - page 147
- Patient potential - page 149
- Marketing factors - page 150
- Forecasts to 2016 - page 150
- Other drugs in the EI and others class - page 151
- PRO-140 - page 151
- Ibalizumab (TNX-355) - page 152
- INCB9471 - page 153
- MK-2048 - page 154
- Vivecon (MPC-9055) - page 154
- Overview for the EI & others class - page 125
- APPENDIX A - page 156
- Bibliography - page 156
- Journal articles and conference abstracts - page 156
- Websites - page 165
- Methodology - page 167
- Datamonitor forecast methodology - page 167
- Epidemiology forecasts - page 167
- Product forecasts - page 167
- Definition of a standard unit (only use if ForeSight model used to forecast) - page 167
- Datamonitor forecast methodology - page 167
- Contributing experts - page 170
- Bibliography - page 156
- APPENDIX B - page 172
- About Datamonitor - page 172
- About Datamonitor Healthcare - page 172
- Datamonitor Healthcare's therapy area capabilities - page 173
- About the Disease analysis team - page 174
- Key therapy team members - page 175
- Holger Rovini, Lead Analyst, Infectious Disease and Respiratory - page 175
- Disclaimer - page 176
- About Datamonitor - page 172
- List of Tables
- Table 1: Key parameters of HIV for the sixmajor markets - page 7
- Table 2: HIV pipeline overview, 2007 - page 12
- Table 3: Overview of GSK's HIV portfolio, 2007 - page 17
- Table 4: Overview of Gilead's HIV portfolio, 2007 - page 20
- Table 5: Overview of the NRTIs, 2007 - page 50
- Table 6: Overview of the NNRTIs, 2007 - page 51
- Table 7: Overview of currently marketed PIs, 2007 - page 53
- Table 8: Key NRTI products in late-stage R&D pipeline for HIV, 2007 - page 64
- Table 9: Sales forecasts for pipeline NRTIs across the six major markets, 2006 -2015 - page 67
- Table 10: Gilead's Truvada - page 68
- Table 11: Key NNRTI products in late-stage R&D pipeline for HIV, 2007 - page 92
- Table 12: Sales forecasts for pipeline NNRTIs across the six major markets, 2007-2015 - page 94
- Table 13: BMS's Sustiva - page 96
- Table 14: Key PI products in early-stage R&D pipeline for HIV, 2007 - page 116
- Table 15: Abbott's Kaletra - page 117
- Table 16: Key EI and others products in late-stage R&D pipeline for HIV, 2007 - page 125
- Table 17: Datamonitor drug assessment parameters - page 169
- List of Figures
- Figure 1: Datamonitor drug assessment summary of pipeline drugs in late stage development for HIV, 2007 - page 8
- Figure 2: Number of compounds in late-stage development for HIV by class, 2007 - page 13
- Figure 3: Antiretroviral sales forecasts, six major markets, 2006-2016 - page 14
- Figure 4: HIV market share by company, 2003-06 - page 18
- Figure 5: Sales forecasts for Gilead products, six major markets, 2006-2016 - page 21
- Figure 6: Gilead HIV market share, 2006 and 2016 - page 22
- Figure 7: Sales forecasts for Prezista, etravirine and rilpivirine, six major markets, 2006-2016 - page 24
- Figure 8: Adults and children estimated to be living with HIV, 2007 - page 29
- Figure 9: Estimated number of people living with HIV globally, 1990-2007 - page 29
- Figure 10: Estimated number of people newly infected with HIV globally, 1990-2007 - page 30
- Figure 11: HIV diagnoses by exposure category, United Kingdom: 1981-2005 - page 32
- Figure 12: Number of newly diagnosed cases of HIV infection by transmission group and year of report in Western Europe (13 countries), 1999-2006 - page 33
- Figure 13: UK HIV diagnoses by the two main routes of transmission, 1997 -2004 - page 35
- Figure 14: HIV infections in the UK by the region they were acquired from, 2006 - page 36
- Figure 15: HIV lifecycle - page 39
- Figure 16: Unmet needs for HIV drugs by class - page 40
- Figure 17: Overview of sales of HIV treatments by drug class, 2002-06 - page 47
- Figure 18: HIV mechanism of entry into host cell - page 55
- Figure 19: Datamonitor drug assessment summary of pipeline NRTIs - page 66
- Figure 20: Sales forecasts for pipeline NRTIs across the six major markets, 2006-2016 - page 67
- Figure 21: Sales of Truvada. Epzicom and Combivir 2002-2006 - page 72
- Figure 22: Sales forecasts for apricitabine across the six major markets to 2016 - page 77
- Figure 23: Datamonitor's competitive positioning analysis of apricitabine, 2007 - page 78
- Figure 24: Sales forecasts for elvucitabine across the six major markets to 2016 - page 82
- Figure 25: Datamonitor's competitive positioning analysis of elvucitabine, 2007 - page 83
- Figure 26: Sales forecasts for racivir across the six major markets to 2016 - page 87
- Figure 27: Datamonitor's competitive positioning analysis of racivir, 2007 - page 88
- Figure 28: Datamonitor drug assessment summary of pipeline NNRTIs - page 93
- Figure 29: Sales forecasts for pipeline NNRTIs across the six major markets, 2006-2016 - page 94
- Figure 30: Sales of Sustiva Viramune and Rescriptor 2002-2006 - page 97
- Figure 31: DUET studies - page 100
- Figure 32: Sales forecasts for etravirine across the six major markets to 2016 - page 104
- Figure 33: Datamonitor's competitive positioning analysis of etravirine, 2007 - page 105
- Figure 34: Phase II program for rilpivirine - page 107
- Figure 35: Sales forecasts for rilpivirine across the six major markets to 2016 - page 109
- Figure 36: Datamonitor's competitive positioning analysis of rilpivirine, 2007 - page 110
- Figure 37: Sales of PIs 2002-2006 - page 118
- Figure 38: Sales forecasts for developmental and recently introduced EIs and others drugs, 6MM, 2006-2016 - page 126
- Figure 39: Overview of sales of Fuzeon in the US and Canada, 2003-06 - page 127
- Figure 40: MOTIVATE trials - page 128
- Figure 41: MOTIVATE trial results - page 129
- Figure 42: MERIT study - page 130
- Figure 43: Sales forecasts for Selzentry across the six major markets to 2016 - page 132
- Figure 44: Datamonitor drug assessment summary of pipeline entry inhibitors - page 133
- Figure 45: BENCHMARK trials - page 134
- Figure 46: TRIO study - page 136
- Figure 47: Sales forecasts for Isentress across the six major markets to 2016 - page 137
- Figure 48: Sales forecasts for elvitegravir across the six major markets to 2016 - page 141
- Figure 49: Sales forecasts for vicriviroc across the six major markets to 2016 - page 145
- Figure 50: Datamonitor's competitive positioning analysis of rilpivirine, 2007 - page 146
- Figure 51: Sales forecasts for bevirimat across the six major markets to 2016 - page 151
- Figure 52: Datamonitor drug assessment summary of pipeline molecular targeted therapies in development for hematological malignancies, 2007 - page 170
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