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AIDS & HIV |
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Commercial Perspectives: HIV
Benchmarking Rapid Antiretroviral Uptake
Publication Date February 2005
Publisher Datamonitor
Product Type Report
Pages 181
ISBN Number not applicable
Product Code DAT287
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Summary
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 Buy
- 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
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Content
- Chapter 1 Executive Summary
- Scope of this report
- Datamonitor insight into the HIV market
- 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
- 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
- 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
- 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
- Key metrics
- Chapter 2 Benchmarking Protease Inhibitors
- Introduction
- Protease inhibitors: class overview
- Protease inhibitors - a summary
- Unmet needs within the PI class
- Product and pipeline overview
- Kaletra
- Reyataz
- Current market status
- Lexiva/Telzir
- Tipranavir
- TMC-114
- PI launch benchmarking
- Expanded access programs (EAPs)
- Kaletra
- Reyataz
- Tipranavir
- Summary of expanded access programs
- Key trials - design and findings
- Kaletra
- Reyataz
- Lexiva
- Dissemination of key clinical data
- Summary of Abbott's conference presence prior to, during and post Kaletra launch
- Summary of BMS's conference presence prior to, during and post Reyataz launch
- Summary of GSK's conference presence prior to, during and post Lexiva launch
- Conference presence
- Journal articles
- Dissemination of data - a summary
- Interaction with healthcare decision makers and influencers
- Sponsorship
- Key opinion leaders
- Patient advocacy groups
- Third party payors
- Corporate and social responsibility programs
- Overview of Abbott, BMS and GSK key HIV corporate and social responsibility undertakings
- The impact of corporate and social responsibility programs
- Chapter 3 Benchmarking Nrtis
- Class overview
- NRTIs - a summary
- Unmet needs within the NRTI class
- NRTI resistance
- Adverse effects and drug interactions
- Summary of key NRTI unmet needs
- Product and pipeline overview
- Viread
- Combination drugs
- NRTI launch benchmarking
- Expanded access programs
- Ziagen
- Viread
- Summary of expanded access programs
- Key trials - design and findings
- Viread
- Fixed-dose combinations
- Dissemination of key clinical data
- Summary of Gilead's conference presence prior to, during and post Viread launch
- Summary of GSK's conference presence prior to, during and post Epzicom launch
- Summary of Gilead's conference presence prior to, during and post Truvada launch
- Conference presence
- Journal articles
- Dissemination of data - a summary
- Interaction with healthcare decision makers and influencers
- Sponsorship
- Key opinion leaders
- Patient advocacy groups
- Cost of therapy
- Corporate and social responsibility programs
- Global Access Program
- Advancing Access Program
- Other programs and undertakings
- Chapter 4 Post-Launch Product Positioning And Marketing
- Phase IIIb/IV trial design
- Kaletra
- Reyataz
- Lexiva
- Viread
- Summary of Phase IIIb/IV trials
- Marketing communication - highlighting the key product attributes
- Kaletra
- Reyataz
- Lexiva
- Viread
- Epzicom
- Truvada
- Sales force efficiency
- Global versus regional marketing - is the HIV community big enough to be segmented?
- Portfolio synergies
- Lifecycle management - maintaining strong sales
- Managing the pill burden
- Reformulation
- Appendix A Bibliography
- Journal articles and abstracts
- Conferences
- Press releases
- Websites
- Miscellaneous sources
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