HIV - Benchmarking Rapid Antiretroviral Uptake
Scope
Report Highlights
Reasons to Purchase
Table of Contents
- ABOUT DATAMONITOR HEALTHCARE - page 2
- About the Infectious Disease pharmaceutical analysis team - page 2
- CHAPTER 1 EXECUTIVE SUMMARY - page 3
- Scope of this report - page 3
- Datamonitor insight into the HIV market - page 4
- Historically, HIV antiretrovirals have differed markedly in their speed of market uptake. Now, to win market share in an already mature market, newly launched products need not only a superior profile but also a first-class pre-launch program. Datamonitor analysis has dissected four interdependent pre-launch activities known to influence uptake and compliment company operational sales strategies - page 5
- While costly, Expanded Access Programs (EAPs) can be an effective way of disseminating awareness of the clinical benefit of a new HIV antiretroviral. However, as regulatory stringency increases, possibly to counter commercial motive, a company might only operate an EAP if their new product significantly enhances the HIV standard of care - page 7
- Although large international conferences foster the gathering of HIV patient and doctor communities, it is becoming clear they are of more use to commercial marketing attendees than those seeking objective scientific analysis. Despite this view, Datamonitor's analysis would suggest Gilead is a good example of maintaining strong scientific outflow to support its products, notably Viread. When questioned, HIV key opinion leaders generally preferred advisory boards as a learning interface - page 9
- According to Datamonitor's expert panel, HIV antiretroviral Phase III trial design is considered to be generally poor. Few recent studies are considered pivotal, especially within the PI class. Often poor comparators, irrelevant backgrounds and unusual dosing regimens signal an overall 'risk averse' strategy. In the NRTI class, again Gilead's Viread has bucked this trend - page 11
- Key metrics - page 13
- CHAPTER 2 BENCHMARKING PROTEASE INHIBITORS - page 21
- Introduction - page 21
- Protease inhibitors: class overview - page 23
- Protease inhibitors - a summary - page 25
- Unmet needs within the PI class - page 28
- Product and pipeline overview - page 30
- Kaletra - page 30
- Reyataz - page 33
- Current market status - page 34
- Lexiva/Telzir - page 35
- Tipranavir - page 37
- TMC-114 - page 38
- PI launch benchmarking - page 39
- Expanded access programs (EAPs) - page 39
- Kaletra - page 41
- Reyataz - page 41
- Tipranavir - page 42
- Summary of expanded access programs - page 43
- Key trials - design and findings - page 46
- Kaletra - page 46
- Reyataz - page 48
- Lexiva - page 52
- Dissemination of key clinical data - page 57
- Summary of Abbott's conference presence prior to, during and post Kaletra launch - page 57
- Summary of BMS's conference presence prior to, during and post Reyataz launch - page 59
- Summary of GSK's conference presence prior to, during and post Lexiva launch - page 60
- Conference presence - page 61
- Journal articles - page 68
- Dissemination of data - a summary - page 71
- Interaction with healthcare decision makers and influencers - page 75
- Sponsorship - page 75
- Key opinion leaders - page 78
- Patient advocacy groups - page 80
- Third party payors - page 81
- Corporate and social responsibility programs - page 85
- Overview of Abbott, BMS and GSK key HIV corporate and social responsibility undertakings - page 85
- The impact of corporate and social responsibility programs - page 88
- Expanded access programs (EAPs) - page 39
- CHAPTER 3 BENCHMARKING NRTIS - page 92
- Class overview - page 92
- NRTIs - a summary - page 94
- Unmet needs within the NRTI class - page 97
- NRTI resistance - page 97
- Adverse effects and drug interactions - page 99
- Summary of key NRTI unmet needs - page 101
- Product and pipeline overview - page 102
- Viread - page 102
- Combination drugs - page 105
- NRTI launch benchmarking - page 106
- Expanded access programs - page 106
- Ziagen - page 107
- Viread - page 108
- Summary of expanded access programs - page 109
- Key trials - design and findings - page 110
- Viread - page 110
- Fixed-dose combinations - page 114
- Dissemination of key clinical data - page 117
- Summary of Gilead's conference presence prior to, during and post Viread launch - page 117
- Summary of GSK's conference presence prior to, during and post Epzicom launch - page 119
- Summary of Gilead's conference presence prior to, during and post Truvada launch - page 120
- Conference presence - page 120
- Journal articles - page 127
- Dissemination of data - a summary - page 129
- Interaction with healthcare decision makers and influencers - page 130
- Sponsorship - page 130
- Key opinion leaders - page 131
- Patient advocacy groups - page 132
- Cost of therapy - page 134
- Corporate and social responsibility programs - page 139
- Global Access Program - page 139
- Advancing Access Program - page 139
- Other programs and undertakings - page 140
- Expanded access programs - page 106
- Class overview - page 92
- CHAPTER 4 POST-LAUNCH PRODUCT POSITIONING AND MARKETING - page 141
- Phase IIIb/IV trial design - page 141
- Kaletra - page 141
- Reyataz - page 143
- Lexiva - page 145
- Viread - page 146
- Summary of Phase IIIb/IV trials - page 147
- Marketing communication - highlighting the key product attributes - page 148
- Kaletra - page 149
- Reyataz - page 150
- Lexiva - page 151
- Viread - page 152
- Epzicom - page 154
- Truvada - page 155
- Sales force efficiency - page 157
- Global versus regional marketing - is the HIV community big enough to be segmented? - page 157
- Portfolio synergies - page 158
- Lifecycle management - maintaining strong sales - page 161
- Managing the pill burden - page 161
- Reformulation - page 164
- Phase IIIb/IV trial design - page 141
- APPENDIX A BIBLIOGRAPHY - page 168
- Journal articles and abstracts - page 168
- Conferences - page 177
- Press releases - page 178
- Websites - page 180
- Miscellaneous sources - page 180
- List of Tables
- Table 1: Forecast protease inhibitor sales in the seven major markets, 2004-14 - page 26
- Table 2: Benchmarking marketed and pipeline protease inhibitors - page 27
- Table 3: Summary of major Kaletra clinical studies - page 31
- Table 4: Summary of major Reyataz clinical studies - page 34
- Table 5: Summary of major Lexiva clinical studies - page 37
- Table 6: Summary of protease inhibitor EAPs - page 40
- Table 7: Summary of selected opinion leader comments on Reyataz trials - page 51
- Table 8: Summary of selected opinion leader comments on Lexiva trials - page 56
- Table 9: Summary of major Kaletra conference publications - page 58
- Table 10: Summary of major Reyataz conference publications - page 59
- Table 11: Summary of major Lexiva conference publications - page 60
- Table 12: Overview of the BMS abstracts at the ICAAC and CROI meetings prior to the drug launch - page 62
- Table 13: Overview of the Abbott abstracts at key HIV and ID meetings prior to drug launch - page 64
- Table 14: Overview of the GSK abstracts at key HIV and ID meetings prior to drug launch - page 66
- Table 15: Summary of recent Abbott HIV corporate responsibility undertakings - page 86
- Table 16: Summary of recent BMS HIV corporate responsibility undertakings - page 87
- Table 17: Summary of recent GSK HIV corporate responsibility undertakings - page 88
- Table 18: Forecast NRTI sales in the seven major markets, 2004-14 - page 95
- Table 19: Overview of selected marketed NRTIs - page 96
- Table 20: Typical adverse effects and drug interactions of selected NRTIs - page 100
- Table 21: Summary of recent NRTI EAPs - page 107
- Table 22: Efficacy of a tenofovir containing regime compared to one containing stavudine in treatment-naïve patients - page 111
- Table 23: Summary of selected opinion leader comments on Viread trials - page 114
- Table 24: Summary of key studies involving Epzicom - page 115
- Table 25: Summary of major Gilead Viread conference presentations - page 118
- Table 26: Summary of major GSK Epzicom conference presentations - page 119
- Table 27: Summary of major Gilead Truvada conference presentations - page 120
- Table 28: Overview of the Gilead abstracts at the ICAAC and CROI meetings prior to the launch of Viread - page 121
- Table 29: Overview of the GSK abstracts at the ICAAC and IAS meetings prior to the launch of Epzicom - page 124
- Table 30: Overview of the Gilead abstracts at the ICAAC and IAS meetings prior to the launch of Truvada - page 125
- Table 31: Overview of abstracts presented by Gilead on TDF/3TC at key meetings prior to the launch of Truvada - page 126
- Table 32: Estimated price per day of selected NRTIs in the US and UK - page 135
- List of Figures
- Figure 1: Antiretroviral market share (sales value), 1999 and 2003 - page 13
- Figure 2: Global analysis of new protease inhibitor uptake - page 14
- Figure 3: Antiretroviral market share (sales value), 1999 and 2003 - page 22
- Figure 4: Sales summary of marketed protease inhibitors, 2003 - page 24
- Figure 5: Global analysis of new protease inhibitor uptake - page 25
- Figure 6: Summary of key unmet needs in the PI class - page 29
- Figure 7: Timing and phasing of key protease inhibitor EAPs - page 45
- Figure 8: Opinion leader ratings of the level of influence regarding the dissemination of data through selected conferences - page 67
- Figure 9: Key Abbott Kaletra pre-launch data dissemination activities - page 72
- Figure 10: Key BMS's Reyataz pre-launch data dissemination activities - page 73
- Figure 11: Key GSK Lexiva pre-launch data dissemination activities - page 74
- Figure 12: Reyataz advertising on 'thebody.com' website - page 76
- Figure 13: 'Medical advocates' home page - page 77
- Figure 14: Selected HIV companies involvement in corporate and social responsibility programs - page 89
- Figure 15: Sales summary of marketed NRTIs, 2003 - page 93
- Figure 16: Analysis of new NRTI uptake - page 94
- Figure 17: Summary of key unmet needs in the NRTI class - page 102
- Figure 18: Timing and phasing of the Ziagen and Viread EAPs - page 109
- Figure 19: Key Gilead Viread pre-launch data dissemination activities - page 129
- Figure 20: Price of Trizivir, Combivir and the individual components in the UK and US - page 137
- Figure 21: Expected price of Truvada, Epzicom and the individual components in the US - page 138
- Figure 22: Kaletra website - page 149
- Figure 23: Lexiva website - page 151
- Figure 24: Viread website - page 153
- Figure 25: Epzicom website - page 154
- Figure 26: Preliminary Epzicom advert - page 155
- Figure 27: Truvada website - page 156
- Figure 28: Truvada advertisement - page 157
- Figure 29: Selected products in HIV players' portfolios used in HIV/AIDS associated disorders - page 160
- Figure 30: Total pill burden associated with each antiretroviral drugs - page 162
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