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Pipeline Insight: HIV - Novel NNRTIs address crucial unmet need

Published by: Datamonitor

Published: Dec. 19, 2007 - 184 Pages


Table of Contents


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


Abstract

Introduction

Treatment of HIV has come a long way since the discovery of the virus. Although no real cure has been found yet, the last few decades have seen the introduction of many classes of drugs that suppress the replication of the virus. As therapeutics have improved dramatically in terms of efficacy, safety and convenience, the bar for new drugs has been raised considerably.

Scope

In-depth analysis of Phase II and III clinical development compounds and comprehensive overview of Phase I drugs Overview of the key companies involved in the HIV pipeline 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

Class drug resistance represents a major problem for the NNRTIs. The two late stage compounds, developed by Tibotec/J&J, address this issue. etravirine is the more advanced of the two, but rilpivirine convenient dosing schedule makes it the commercially more promising candidate. New NRTIs in development have not generated much excitement in the HIV community since most of these compounds, including Avexa's apricitabine, Achillion's elvucitabine and Pharmasset's Racivir. have only made slow progress over the last few years. Historically, emerging drug resistance may have signaled overall treatment failure and hastened the onset of AIDS. While newer classes of drugs will enable patients with complex drug resistance to continue with successful antiretroviral therapy, exactly how they will be incorporated into traditional HAART regimens remains unclear at this stage.

Reasons to Purchase

Understand the constantly evolving market dynamics of antiretroviral drugs Understand 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 2016, taking into account key launch dates, adressing of unmet needs and other factors.


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