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Introduction
 
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.
 

 
Scope
 
Review of expanded access programs, including numbers, location, length of time and range of participants
 
Detailed examination of late-phase trials, including an assessment of comparators and comments from opinion leaders on trial design
 
Insight into Company strategies for pre-launch dissemination of data, including conference attendance, journal articles and physician interaction
 
Analysis of post-launch product positioning and marketing strategies, using case studies, and their applicability for the future
 
Highlights
 
As the HIV market moves towards maturity, promotion and marketing efforts are becoming increasingly important in ensuring rapid market penetration. An analysis of recent product launches provides case-studies for companies looking to launch new antiretrovirals and highlights the need for coherent product development and launch strategies.
 

 
Within HIV clinical practice, it is becoming recognized that EAPs are considered the 'true launch' of a new product, and successful programs are thought to have contributed greatly to the success of Kaletra, Reyataz and Viread. The larger EAPs, run for longer periods of time, have raised 'real-life experience'.
 

 
Datamonitor's opinion leader research placed most emphasis on the late stage clinical trial design. Those Phase III clinical trials which used up-to-date comparator drugs, were sufficiently powered and did not contain any inherent protocol biases in terms of administration and patient eligibility, were the most favored by the expert community.
 

 
Reasons to Purchase
 
Understand patient segmentation relevant to pipeline products and validate internal forecasts/market potential for these products
 
Analyze the competitive environment at the time of product launch to ensure maximum rapid uptake of new antiretrovirals
 
Devise a coherent and comprehensive drug development and launch program to ensure lasting product commerical success

TABLE OF CONTENTS
 
CHAPTER 1 EXECUTIVE SUMMARY 3
 
Scope of this report 3
 
Datamonitor insight into the HIV market 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 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 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 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 11
 
Key metrics 13
 
CHAPTER 2 BENCHMARKING PROTEASE INHIBITORS 21
 
Introduction 21
 
Protease inhibitors: class overview 23
 
Protease inhibitors – a summary 25
 
Unmet needs within the PI class 28
 
Product and pipeline overview 30
 
Kaletra 30
 
Reyataz 33
 
Current market status 34
 
Lexiva/Telzir 35
 
Tipranavir 37
 
TMC-114 38
 
PI launch benchmarking 39
 
Expanded access programs (EAPs) 39
 
Kaletra 41
 
Reyataz 41
 
Tipranavir 42
 
Summary of expanded access programs 43
 
Key trials – design and findings 46
 
Kaletra 46
 
Reyataz 48
 
Lexiva 52
 
Dissemination of key clinical data 57
 
Summary of Abbott’s conference presence prior to, during and post Kaletra launch 57
 
Summary of BMS’s conference presence prior to, during and post Reyataz launch 59
 
Summary of GSK’s conference presence prior to, during and post Lexiva launch 60
 
Conference presence 61
 
Journal articles 68
 
Dissemination of data – a summary 71
 
Interaction with healthcare decision makers and influencers 75
 
Sponsorship 75
 
Key opinion leaders 78
 
Patient advocacy groups 80
 
Third party payors 81
 
Corporate and social responsibility programs 85
 
Overview of Abbott, BMS and GSK key HIV corporate and social responsibility undertakings 85
 
The impact of corporate and social responsibility programs 88
 
CHAPTER 3 BENCHMARKING NRTIS 92
 
Class overview 92
 
NRTIs – a summary 94
 
Unmet needs within the NRTI class 97
 
NRTI resistance 97
 
Adverse effects and drug interactions 99
 
Summary of key NRTI unmet needs 101
 
Product and pipeline overview 102
 
Viread 102
 
Combination drugs 105
 
NRTI launch benchmarking 106
 
Expanded access programs 106
 
Ziagen 107
 
Viread 108
 
Summary of expanded access programs 109
 
Key trials – design and findings 110
 
Viread 110
 
Fixed-dose combinations 114
 
Dissemination of key clinical data 117
 
Summary of Gilead’s conference presence prior to, during and post Viread launch 117
 
Summary of GSK’s conference presence prior to, during and post Epzicom launch 119
 
Summary of Gilead’s conference presence prior to, during and post Truvada launch 120
 
Conference presence 120
 
Journal articles 127
 
Dissemination of data – a summary 129
 
Interaction with healthcare decision makers and influencers 130
 
Sponsorship 130
 
Key opinion leaders 131
 
Patient advocacy groups 132
 
Cost of therapy 134
 
Corporate and social responsibility programs 139
 
Global Access Program 139
 
Advancing Access Program 139
 
Other programs and undertakings 140
 
CHAPTER 4 POST-LAUNCH PRODUCT POSITIONING AND MARKETING 141
 
Phase IIIb/IV trial design 141
 
Kaletra 141
 
Reyataz 143
 
Lexiva 145
 
Viread 146
 
Summary of Phase IIIb/IV trials 147
 
Marketing communication – highlighting the key product attributes 148
 
Kaletra 149
 
Reyataz 150
 
Lexiva 151
 
Viread 152
 
Epzicom 154
 
Truvada 155
 
Sales force efficiency 157
 
Global versus regional marketing – is the HIV community big enough to be segmented? 157
 
Portfolio synergies 158
 
Lifecycle management – maintaining strong sales 161
 
Managing the pill burden 161
 
Reformulation 164
 
APPENDIX A BIBLIOGRAPHY 168
 
Journal articles and abstracts 168
 
Conferences 177
 
Press releases 178
 
Websites 180
 
Miscellaneous sources 180