Pipeline Insight: HIV - The Age of Convenience

Published by: Datamonitor

Published: Oct. 2, 2009 - 180 Pages

Table of Contents

Overview

Catalyst

Summary

ABOUT DATAMONITOR HEALTHCARE

About the Disease pharmaceutical analysis team

Executive Summary

Strategic scoping and focus

Datamonitor insight into the disease market

Related reports

Table of Contents

1. Pipeline Overview and Dynamics

Key findings

Pipeline overview

Comparative forecasts - cross-class fixed-dose combinations to dominate

Datamonitor Pipeline Assessment Summary

Key companies involved in the HIV market

Gilead set to remain the HIV market leader

Key companies involved in the HIV pipeline

Key R&D company strategies - collaborations and cross-class combinations

GlaxoSmithKline and Pfizer HIV merger

Gilead and Tibotec/Johnson & Johnson

Merck and Schering-Plough

2. HIV - Market Potential

Key findings

Definition

Patient segmentation

Treatment-naïve patients

Treatment-experienced patients

Epidemiology

Seven major markets

The US has the highest prevalence of HIV infection among the seven major markets

Men who have sex with men remain the most affected group

Increasing diagnosis rates contributing to rise in HIV incidence in the US

Antiretroviral therapy has increased life expectancy and is driving the rise in HIV/AIDS prevalence

Immigration from areas of high prevalence contributing to the increasing incidence in Europe

Rest of the world

Brazil

China

India

Russian Federation

South Africa

Current treatment options

Nucleoside reverse transcriptase inhibitors

Non-nucleoside reverse transcriptase inhibitors

Protease inhibitors

Entry inhibitors

Integrase inhibitors

Cross-class combinations

Current gold standard and comparator therapies

Atripla is widely accepted as the gold standard of HIV therapy

Choice of comparator differs for individual drug classes and treatment populations

Current market overview

Atripla will surpass Truvada in 2009

Reyataz displaces Kaletra as leading protease inhibitor

Despite being the fifth best-selling antiretroviral, Epzicom sales lag behind Truvada

Unmet needs in HIV

The increasing number of treatment-experienced patients achieving undetectable levels suggests efficacy is not an unmet need anymore

Resistance remains an issue for first-line NNRTIs and the integrase inhibitors

Although antiretroviral tolerability has improved considerably it remains an issue for some drug classes

Issue of pill burden eliminated by availability of simplified treatments

Cost

Current level of attainment vs. target product profile

3. R&D Approach

Key findings

Clinical trial design in HIV

Superiority trial design

Non-inferiority trial design

Dose comparison trial design

Choice of control arms

Background regimens

Duration of studies

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 hugely benefited clinical trials

Improved understanding of HIV and the advent of HAART have changed endpoints significantly

Reduction in viral load

CD4 elevation

Activity against resistant virus-a must for most of the HIV pipeline

Quality of life considerations

4. Pipeline Analysis & Forecasts: Nucleoside Reverse Transcriptase Inhibitors

Key findings

Overview for nucleoside reverse transcriptase inhibitors

Pipeline summary

Comparative forecasts

Apricitabine (Avexa)

Drug overview

Clinical trial data

Phase III

Phase II studies

Clinical and commercial attractiveness

Positioning in treatment experienced patients will limit uptake

Commercialization of apricitabine may prove difficult without a suitable partner

SWOT analysis

Datamonitor drug assessment score card for apricitabine

Satisfaction of unmet needs

Resistance

Toxicity

Target product profile

Forecasts to 2018

Other drugs in the nucleoside reverse transcriptase class

Elvucitabine

Amdoxovir

4. Pipeline Analysis & Forecasts: Protease Inhibitors

Key findings

Overview for the protease inhibitor class

Key early-stage compounds in the protease inhibitor class

Pipeline summary

Marketed protease inhibitors are highly potent and have improved dosing

Tibotec/Johnson & Johnson developing a co-formulation of Prezista and an investigational pharmacokinetic enhancer

PPL-100 was previously the most promising among the remaining compounds

5. Pipeline Analysis & Forecasts: Non-Nucleoside Reverse Transcriptase Inhibitors

Key findings

Overview for the non-nucleoside reverse transcriptase class

Pipeline summary

Comparative forecasts

Rilpivirine

Drug overview

Clinical trial data

Phase III studies in naïve patients

Phase II studies confirm efficacy in naïve patients

Clinical and commercial attractiveness

High efficacy, simplified dosing and reduced CNS toxicity favor use in first line but questions over QTc prolongation remain

Tibotec is an established player in the HIV market

SWOT analysis

Datamonitor drug assessment score card for rilpivirine

Satisfaction of unmet needs

Resistance

Toxicity

Target product profile

Forecasts to 2018

Other drugs in the non-nucleoside reverse transcriptase class

RDEA806 (Ardea Biosciences)

Drug overview

Clinical trial data

Datamonitor drug assessment score card for RDEA806

IDX899 (GlaxoSmithKline/Idenix Pharmaceuticals)

Drug overview

Clinical trial data

Datamonitor drug assessment score card for RDEA806

Lersivirine (Pfizer)

Drug overview

Clinical trial data

Datamonitor drug assessment score card for lersivirine

Clinical and commercial attractiveness

Ardea's partnering efforts may delay development of RDEA806

IDX899 and lersivirine form part of the combined GlaxoSmithKline and Pfizer pipeline

Forecasts to 2018

Key early-stage compounds in the non-nucleoside reverse transcriptase class

6. Pipeline Analysis & Forecasts: Entry Inhibitors

Key findings

Overview for the entry inhibitors

Pipeline summary

Comparative forecasts

Vicriviroc (Schering-Plough)

Drug overview

Clinical trial data

Phase III studies in experienced patients

Phase II/III studies in naïve patients

Phase II studies VICTOR-E1 and A5211

Clinical and commercial attractiveness

Positioning in naïve patients is crucial for CCR5 inhibitors

Once-daily dosing is an advantageous in first line but ritonavir boosting may carry additional side effects

Merck & Co and Schering-Plough merger may improve the outlook for vicriviroc

SWOT analysis

Datamonitor drug assessment score card for vicriviroc

Satisfaction of unmet needs

Target product profile

Forecasts to 2018

PRO-140 (Progenics)

Drug overview

Clinical trial data

Phase II intravenous formulation study

Phase IIa subcutaneous formulation study

Clinical attractiveness

Early data for PRO-140 look promising but its mode of administration will restrict its use

Commercialization of PRO-140 will be difficult without a suitable partner

SWOT analysis

Datamonitor drug assessment score card for PRO-140

Satisfaction of unmet needs

Forecasts to 2018

Other drugs in the entry inhibitor class

Ibalizumab

PF-232798

Key early-stage compounds in the entry inhibitor class

7. Pipeline Analysis & Forecasts: Integrase inhibitors

Key findings

Overview for the integrase inhibitor class

Pipeline summary

Comparative forecasts

Elvitegravir (Gilead Sciences)

Drug overview

Clinical trial data

Phase III trials against raltegravir are underway

Phase II studies confirmed efficacy in experienced patients

Clinical and commercial attractiveness

Low efficacy rates observed in Phase II studies reduce elvitegravir's clinical attractiveness

Elvitegravir as a standalone product is unlikely to generate significant revenue for Gilead

SWOT analysis

Datamonitor drug assessment score card for elvitegravir

Satisfaction of unmet needs

Forecasts to 2018

Other drugs in the integrase inhibitor class

S/GSK1349572 and S/GSK1265744 (GSK/Shionogi Pharmaceuticals)

Key early-stage compounds in the integrase inhibitor class

8. Pipeline Analysis & Forecasts: Cross-Class Fixed-Dose Combinations

Key findings

Overview for the cross-class fixed-dose combinations class

Pipeline summary

Comparative forecasts

Truvada/rilpivirine (Gilead and Tibotec/Johnson & Johnson)

Drug overview

Clinical trial data

Phase III

Clinical and commercial attractiveness

Rilpivirine has demonstrated good efficacy and tolerability in naïve patients

Gilead and Tibotec/Johnson & Johnson can rely on their combined expertise to establish Truvada/rilpivirine in first line

SWOT analysis

Datamonitor drug assessment score card for Truvada/rilpivirine

Satisfaction of unmet needs

Target product profile

Forecasts to 2018

Quad Pill (Gilead Sciences)

Drug overview

Clinical trial data

Phase II

Phase I

Clinical and commercial attractiveness

Co-formulation with Truvada increases the commercial attractiveness of elvitegravir

Truvada/rilpivirine co-formulation may restrict use of the Quad Pill to later lines of therapy

SWOT analysis

Datamonitor drug assessment score card for cross-class fixed-dose combinations

Satisfaction of unmet needs

Forecasts to 2018

9. Innovative Early-Stage Approaches

Key findings

Pharmacokinetic enhancers

GS-9350 (Gilead Sciences)

SPI-452 (Sequoia Pharmaceuticals)

PF3716539 (Pfizer/GlaxoSmithKline)

Microbicides and pre-exposure prophylaxis

PRO2000 Gel (Endo Pharmaceuticals)

Tenofovir gel (Gilead Sciences)

The future of HIV treatment

Early initiation of therapy

Nucleoside-sparing approaches have safety benefits but lack the simplicity of cross-class combinations

Bibliography

Journal papers

Websites

Others

Datamonitor reports

APPENDIX

Methodology

Datamonitor forecast methodology

Epidemiology forecasts

Product forecasts

Definition of a standard unit (only use if ForeSight model used to forecast)

Datamonitor drug assessment scorecard

Contributing experts

About Datamonitor

About Datamonitor Healthcare

About the Disease analysis team

Datamonitor consulting

Disclaimer

List of Tables

Table 1: Products in clinical development for the treatment of HIV infection, 2009

Table 2: Sales forecast for pipeline products for the treatment of HIV infection in the US and five major European markets ($m), 2009-18

Table 3: Leading companies in the HIV market, 2008-18

Table 4: Gilead Sciences' portfolio assessment for HIV, 2009

Table 5: GlaxoSmithKline's portfolio assessment for HIV, 2009

Table 6: Pfizer's portfolio assessment for HIV, 2009

Table 7: GlaxoSmithKline and Pfizer combined marketed portfolio, 2009

Table 8: GlaxoSmithKline and Pfizer combined pipeline, 2009

Table 9: Prevalence of HIV infection in the seven major markets, 2007

Table 10: Mortality rates and life expectancy of HIV patients, stratified by CD4 count, 2008

Table 11: HIV incidence, prevalence and mortality from AIDS, by region, 2007

Table 12: Leading treatments for HIV infection, 2009

Table 13: Atripla - drug profile, 2009

Table 14: Target product profile for NRTIs

Table 15: Target product profile for NNRTIs

Table 16: Target product profile for the Integrase inhibitors

Table 17: Target product profile for the entry inhibitors

Table 18: Target product profile for cross class combinations

Table 19: Key products in the R&D pipeline for the NRTI class, 2009

Table 20: Sales forecasts for NRTIs in the US and five major European markets ($m), 2009-19

Table 21: Apricitabine - drug profile, 2009

Table 22: Overview of 48-week efficacy data from AVX-201

Table 23: Ability of apricitabine to meet unmet needs

Table 24: Sales forecasts for apricitabine in the US and 5EU ($m), 2009-18

Table 25: Impacting factors on the revenues of apricitabine, 2009-18

Table 26: Other drugs in the nucleoside reverse transcriptase class, 2009

Table 27: Key products in the early-stage R&D pipeline for the protease inhibitor class, 2009

Table 28: Key products in the R&D pipeline for non-nucleoside reverse transcriptase inhibitors, 2009

Table 29: Sales forecasts for non-nucleoside reverse transcriptase inhibitors in the US and 5EU ($m), 2009-18

Table 30: Rilpivirine - drug profile, 2009

Table 31: A comparison of 48 and 96-week Phase IIb rilpivirine efficacy data, 2009

Table 32: An overview of safety findings from the rilpivirine Phase IIb study

Table 33: Ability of rilpivirine to meet unmet needs

Table 34: Sales forecasts for rilpivirine n the US and 5EU ($m), 2009-18

Table 35: Impacting factors on the revenues of rilpivirine, 2009-18

Table 36: Other NNRTIs in clinical development, 2009

Table 37: RDEA806 - drug profile, 2009

Table 38: Overview of Phase IIa efficacy data

Table 39: IDX899 - drug profile, 2009

Table 40: Overview of IDX899 Phase IIa efficacy data

Table 41: Lersivirine - drug profile, 2009

Table 42: Combined sales forecasts for RDEA806, lersivirine and IDX899 in the US and 5EU, 2009-18 ($m)

Table 43: Impacting factors on the revenues of RDEA806, IDX899 and lersivirine, 2009-18

Table 44: Key products in the early-stage R&D pipeline for the non-nucleoside reverse transcriptase class, 2009

Table 45: Key products in the late-stage R&D pipeline for entry inhibitors, 2009

Table 46: Sales forecasts for the entry inhibitors in the US and five major European markets, 2009-18

Table 47: Vicriviroc - drug profile, 2009

Table 48: Overview of 48-week VICTOR-E1 efficacy data

Table 49: Overview of safety data from the VICTOR-E1 study

Table 50: Ability of vicriviroc to meet unmet needs

Table 51: Sales forecasts for vicriviroc in the US and five major European markets ($m), 2009-18

Table 52: Impacting factors on the revenues of vicriviroc

Table 53: PRO-140 - drug profile, 2009

Table 54: Sales forecasts for PRO-140 in the US and 5EU ($m), 2009-18

Table 55: Impacting factors on the revenues of PRO-140, 2009

Table 56: Key products in the early-stage R&D pipeline for the entry inhibitors class, 2009

Table 57: Key products in the early-stage R&D pipeline for the entry inhibitors class, 2009

Table 58: Key products in the late-stage R&D pipeline for the integrase inhibitors class, 2009

Table 59: Sales forecasts for integrase inhibitors in the US and five major European markets, 2008-18 ($m)

Table 60: Elvitegravir - drug profile, 2009

Table 61: Sales forecasts for elvitegravir in the US and five major European markets ($m), 2009-18

Table 62: Other integrase inhibitors in development

Table 63: Key products in the early-stage R&D pipeline for the integrase inhibitor class, 2009

Table 64: Key cross-class combinations in the late-stage R&D pipeline, 2009

Table 65: Sales forecasts for cross-class combinations in the US and five major European markets ($m), 2008-18

Table 66: Truvada/rilpivirine - drug profile, 2009

Table 67: Ability of Truvada/rilpivirine to meet unmet needs

Table 68: Sales forecasts for Truvada/rilpivirine in the US and five major European markets ($m), 2009-18

Table 69: Impacting factors on the revenues of Truvada/rilpivirine, 2009-18

Table 70: Quad Pill - drug profile, 2009

Table 71: Sales forecasts for the Quad Pill in the US and five major European markets, 2009-18 ($m)

Table 72: Impacting factors on the revenues of the Quad Pill, 2009-18

Table 73: Datamonitor drug assessment parameters

List of Figures

Figure 1: HIV pipeline activity by class, 2009

Figure 2: Datamonitor drug assessment summary for antiretroviral therapies in development for HIV infection, 2009

Figure 3: HIV market share by company, 2008

Figure 4: Estimated number of people living with HIV in the US, 5EU and Japan, 1997-2007

Figure 5: Estimated number of people living with HIV in the five major European markets, 1997-2007

Figure 6: Number of newly reported HIV infections and AIDS cases in Japan, 1985-2006

Figure 7: Estimated Numbers of HIV/AIDS cases among adults and adolescents, by transmission category, 1994-2007

Figure 8: Number of reported HIV infections by transmission mode, origin and year of notification in the EU/EFTA, 2003-07

Figure 9: Death rates from HIV infection during pre- and post-HAART era, 1990-2003

Figure 10: Estimated number of adults (15-59 years) living with HIV (both diagnosed and undiagnosed) in the UK, 2007

Figure 11: Antiretroviral sales in the US and five major European markets ($m), 2005-08

Figure 12: Overview of the raltegravir BENCHMRK study

Figure 13: Overview of the Phase III study for apricitabine

Figure 14: Overview of the Phase IIb study for apricitabine

Figure 15: Apricitabine SWOT analysis

Figure 16: Datamonitor's competitive positioning analysis of apricitabine, 2009

Figure 17: Overview of the rilpivirine Phase III THRIVE study

Figure 18: Overview of the rilpivirine Phase III ECHO study

Figure 19: Overview of the rilpivirine Phase IIb study

Figure 20: Rilpivirine SWOT analysis, 2009

Figure 21: Datamonitor's competitive positioning analysis of rilpivirine, 2009

Figure 22: HIV mechanism of entry into host cell

Figure 23: Datamonitor drug assessment summary for products in development for entry inhibitors, 2009

Figure 24: Overview of the vicriviroc VICTOR-E3 and VICTOR-E4 studies

Figure 25: Overview of the vicriviroc VICTOR-E1 study

Figure 26: Overview of the vicriviroc A5211 study

Figure 27: Vicriviroc SWOT analysis

Figure 28: Datamonitor's competitive positioning analysis of vicriviroc, 2009

Figure 29: PRO-140 SWOT analysis, 2009

Figure 30: Datamonitor's competitive positioning analysis of PRO-140, 2009

Figure 31: Overview of the Phase III program for elvitegravir

Figure 32: Elvitegravir SWOT analysis, 2009

Figure 33: Datamonitor's competitive positioning analysis of elvitegravir, 2009

Figure 34: Datamonitor's competitive positioning analysis of fixed-dose combinations, 2009

Figure 35: Truvada/rilpivirine SWOT analysis, 2009

Figure 36: Datamonitor's competitive positioning analysis of Truvada/rilpivirine, 2009

Figure 37: Quad Pill SWOT analysis, 2009

Figure 38: Datamonitor's competitive positioning analysis of the Quad Pill, 2009

Figure 39: Datamonitor drug assessment summary of pipeline molecular targeted therapies in development for hematological malignancies, 2007

Abstract

Introduction

Three new partnerships are reshaping the competitive environment in HIV. Most notably, Tibotec/Johnson & Johnson is linking up with Gilead to combine their Phase III drug rilpivirine with Truvada to create a new gold standard fixed dose combination for treatment-naïve patients. Addressing Atripla's shortcomings, Datamonitor expects this product to dominate the market.

Scope

• In-depth analysis of Phase II and III clinical development compounds and comprehensive overview of Phase I drugs
• An overview of the key companies involved in the HIV pipeline, including an analysis of the new corporate alliances
• 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

Advances in antiretroviral therapy have addressed the two big unmet medical needs, resistance and safety. Convenience is the new frontier, pointing towards a bright future for cross-class fixed-dose combination, notably Gilead's Quad Pill and Gilead's and Johnson & Johnson's Truvada/rilpivirine combination.

Gilead's two new cross-class fixed dose combinations offer only moderate medical progress, but their added convenience compared with single ingredient formulations will cement the company's market leadership and reduce the market opportunity for single-ingredient formulations.

Abbott's monopoly in protease inhibitor boosting agents is nearing its end. At least three companies have pharmacokinetic enhancers with potentially improved safety profiles in clinical development, hopefully enabling the creation of more co-formulated brands

Reasons to Purchase

• Understand the constantly evolving market dynamics of antiretroviral drugs in view of corporate alliances, co-formulations and generic entry
• Learn about 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 2018, taking into account key launch dates, patent expirations and other factors

Please note: this is delivered as a Zip file.

Get Full Details About This Report >>

About MarketResearch.com
MarketResearch.com is an online aggregator selling over 250,000 market research reports, company profiles and country profiles from over 650 research firms. Our reports will provide you with the critical business and competitive intelligence you need for strategic planning and marketing research. Coverage includes the US, UK, Europe, Asia and global markets.