Pipeline Insight: HIV - The Age of Convenience

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IntroductionThree 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-na

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Pipeline Insight: HIV - The Age of Convenience

  1. 1. Find Industry reports, Company profilesReportLinker and Market Statistics >> Get this Report Now by email!Pipeline Insight: HIV - The Age of ConveniencePublished on October 2009 Report SummaryIntroductionThree new partnerships are reshaping the competitive environment in HIV. Most notably, Tibotec/Johnson & Johnson is linking upwith Gilead to combine their Phase III drug rilpivirine with Truvada to create a new gold standard fixed dose combination fortreatment-naïve patients. Addressing Atriplas 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 theprolonged use of HAART*Sales forecasts over the next 10 years for the each of the late-stage drugsHighlightsAdvances in antiretroviral therapy have addressed the two big unmet medical needs, resistance and safety. Convenience is the newfrontier, pointing towards a bright future for cross-class fixed-dose combination, notably Gileads Quad Pill and Gileads and Johnson& Johnsons Truvada/rilpivirine combination.Gileads two new cross-class fixed dose combinations offer only moderate medical progress, but their added convenience comparedwith single ingredient formulations will cement the companys market leadership and reduce the market opportunity forsingle-ingredient formulations.Abbotts monopoly in protease inhibitor boosting agents is nearing its end. At least three companies have pharmacokinetic enhancerswith potentially improved safety profiles in clinical development, hopefully enabling the creation of more co-formulated brandsReasons to Purchase*Understand the constantly evolving market dynamics of antiretroviral drugs in view of corporate alliances, co-formulations andgeneric 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 otherfactorsPipeline Insight: HIV - The Age of Convenience Page 1/11
  2. 2. Find Industry reports, Company profilesReportLinker and Market Statistics Table of ContentOverview 1Catalyst 1Summary 1ABOUT DATAMONITOR HEALTHCARE 2About the Disease pharmaceutical analysis team 2Executive Summary 3Strategic scoping and focus 3Datamonitor insight into the disease market 3Related reports 5Table of Contents 61. Pipeline Overview and Dynamics 7Key findings 7Pipeline overview 8Comparative forecasts - cross-class fixed-dose combinations to dominate 11Datamonitor Pipeline Assessment Summary 13Key companies involved in the HIV market 14Gilead set to remain the HIV market leader 14Key companies involved in the HIV pipeline 16Key R&D company strategies - collaborations and cross-class combinations 21GlaxoSmithKline and Pfizer HIV merger 21Gilead and Tibotec/Johnson & Johnson 24Merck and Schering-Plough 262. HIV - Market Potential 28Key findings 28Definition 29Patient segmentation 29Treatment-naïve patients 29Treatment-experienced patients 29Epidemiology 30Seven major markets 30The US has the highest prevalence of HIV infection among the seven major markets 30Men who have sex with men remain the most affected group 33Increasing diagnosis rates contributing to rise in HIV incidence in the US 35Antiretroviral therapy has increased life expectancy and is driving the rise in HIV/AIDS prevalence 36Immigration from areas of high prevalence contributing to the increasing incidence in Europe 37Rest of the world 38Brazil 39China 40India 40Russian Federation 41South Africa 41Current treatment options 41Nucleoside reverse transcriptase inhibitors 41Non-nucleoside reverse transcriptase inhibitors 42Pipeline Insight: HIV - The Age of Convenience Page 2/11
  3. 3. Find Industry reports, Company profilesReportLinker and Market StatisticsProtease inhibitors 42Entry inhibitors 42Integrase inhibitors 42Cross-class combinations 42Current gold standard and comparator therapies 44Atripla is widely accepted as the gold standard of HIV therapy 44Choice of comparator differs for individual drug classes and treatment populations 45Current market overview 46Atripla will surpass Truvada in 2009 47Reyataz displaces Kaletra as leading protease inhibitor 47Despite being the fifth best-selling antiretroviral, Epzicom sales lag behind Truvada 47Unmet needs in HIV 48The increasing number of treatment-experienced patients achieving undetectable levels suggests efficacy is not an unmet needanymore 48Resistance remains an issue for first-line NNRTIs and the integrase inhibitors 49Although antiretroviral tolerability has improved considerably it remains an issue for some drug classes 49Issue of pill burden eliminated by availability of simplified treatments 50Cost 50Current level of attainment vs. target product profile 513. R&D Approach 57Key findings 57Clinical trial design in HIV 58Superiority trial design 58Non-inferiority trial design 59Dose comparison trial design 60Choice of control arms 60Background regimens 60Duration of studies 61Clinical trial endpoints 61Early trials were based on hard clinical endpoints, such as progression to AIDS or death 61The availability of HIV viral load diagnostics hugely benefited clinical trials 61Improved understanding of HIV and the advent of HAART have changed endpoints significantly 62Reduction in viral load 62CD4 elevation 63Activity against resistant virus-a must for most of the HIV pipeline 63Quality of life considerations 634. Pipeline Analysis & Forecasts: Nucleoside Reverse Transcriptase Inhibitors 64Key findings 64Overview for nucleoside reverse transcriptase inhibitors 65Pipeline summary 65Comparative forecasts 66Apricitabine (Avexa) 67Drug overview 67Clinical trial data 68Phase III 68Phase II studies 69Clinical and commercial attractiveness 71Positioning in treatment experienced patients will limit uptake 71Commercialization of apricitabine may prove difficult without a suitable partner 72SWOT analysis 73Pipeline Insight: HIV - The Age of Convenience Page 3/11
  4. 4. Find Industry reports, Company profilesReportLinker and Market StatisticsDatamonitor drug assessment score card for apricitabine 73Satisfaction of unmet needs 75Resistance 75Toxicity 75Target product profile 75Forecasts to 2018 76Other drugs in the nucleoside reverse transcriptase class 77Elvucitabine 77Amdoxovir 784. Pipeline Analysis & Forecasts: Protease Inhibitors 79Key findings 79Overview for the protease inhibitor class 80Key early-stage compounds in the protease inhibitor class 80Pipeline summary 80Marketed protease inhibitors are highly potent and have improved dosing 81Tibotec/Johnson & Johnson developing a co-formulation of Prezista and an investigational pharmacokinetic enhancer 81PPL-100 was previously the most promising among the remaining compounds 815. Pipeline Analysis & Forecasts: Non-Nucleoside Reverse Transcriptase Inhibitors 82Key findings 82Overview for the non-nucleoside reverse transcriptase class 83Pipeline summary 83Comparative forecasts 84Rilpivirine 85Drug overview 85Clinical trial data 86Phase III studies in naïve patients 86Phase II studies confirm efficacy in naïve patients 88Clinical and commercial attractiveness 91High efficacy, simplified dosing and reduced CNS toxicity favor use in first line but questions over QTc prolongation remain 91Tibotec is an established player in the HIV market 92SWOT analysis 93Datamonitor drug assessment score card for rilpivirine 93Satisfaction of unmet needs 94Resistance 94Toxicity 95Target product profile 95Forecasts to 2018 96Other drugs in the non-nucleoside reverse transcriptase class 97RDEA806 (Ardea Biosciences) 98Drug overview 98Clinical trial data 98Datamonitor drug assessment score card for RDEA806 99IDX899 (GlaxoSmithKline/Idenix Pharmaceuticals) 100Drug overview 100Clinical trial data 100Datamonitor drug assessment score card for RDEA806 101Lersivirine (Pfizer) 101Drug overview 101Clinical trial data 102Datamonitor drug assessment score card for lersivirine 103Pipeline Insight: HIV - The Age of Convenience Page 4/11
  5. 5. Find Industry reports, Company profilesReportLinker and Market StatisticsClinical and commercial attractiveness 103Ardeas partnering efforts may delay development of RDEA806 104IDX899 and lersivirine form part of the combined GlaxoSmithKline and Pfizer pipeline 104Forecasts to 2018 104Key early-stage compounds in the non-nucleoside reverse transcriptase class 1056. Pipeline Analysis & Forecasts: Entry Inhibitors 107Key findings 107Overview for the entry inhibitors 108Pipeline summary 109Comparative forecasts 111Vicriviroc (Schering-Plough) 112Drug overview 112Clinical trial data 113Phase III studies in experienced patients 113Phase II/III studies in naïve patients 114Phase II studies VICTOR-E1 and A5211 115Clinical and commercial attractiveness 119Positioning in naïve patients is crucial for CCR5 inhibitors 119Once-daily dosing is an advantageous in first line but ritonavir boosting may carry additional side effects 119Merck & Co and Schering-Plough merger may improve the outlook for vicriviroc 120SWOT analysis 120Datamonitor drug assessment score card for vicriviroc 121Satisfaction of unmet needs 122Target product profile 122Forecasts to 2018 123PRO-140 (Progenics) 124Drug overview 124Clinical trial data 124Phase II intravenous formulation study 124Phase IIa subcutaneous formulation study 125Clinical attractiveness 125Early data for PRO-140 look promising but its mode of administration will restrict its use 125Commercialization of PRO-140 will be difficult without a suitable partner 126SWOT analysis 126Datamonitor drug assessment score card for PRO-140 127Satisfaction of unmet needs 128Forecasts to 2018 128Other drugs in the entry inhibitor class 129Ibalizumab 130PF-232798 131Key early-stage compounds in the entry inhibitor class 1317. Pipeline Analysis & Forecasts: Integrase inhibitors 132Key findings 132Overview for the integrase inhibitor class 133Pipeline summary 133Comparative forecasts 134Elvitegravir (Gilead Sciences) 134Drug overview 134Clinical trial data 135Phase III trials against raltegravir are underway 135Pipeline Insight: HIV - The Age of Convenience Page 5/11
  6. 6. Find Industry reports, Company profilesReportLinker and Market StatisticsPhase II studies confirmed efficacy in experienced patients 136Clinical and commercial attractiveness 137Low efficacy rates observed in Phase II studies reduce elvitegravirs clinical attractiveness 137Elvitegravir as a standalone product is unlikely to generate significant revenue for Gilead 137SWOT analysis 137Datamonitor drug assessment score card for elvitegravir 138Satisfaction of unmet needs 139Forecasts to 2018 140Other drugs in the integrase inhibitor class 140S/GSK1349572 and S/GSK1265744 (GSK/Shionogi Pharmaceuticals) 141Key early-stage compounds in the integrase inhibitor class 1428. Pipeline Analysis & Forecasts: Cross-Class Fixed-Dose Combinations 143Key findings 143Overview for the cross-class fixed-dose combinations class 144Pipeline summary 144Comparative forecasts 146Truvada/rilpivirine (Gilead and Tibotec/Johnson & Johnson) 147Drug overview 147Clinical trial data 148Phase III 148Clinical and commercial attractiveness 148Rilpivirine has demonstrated good efficacy and tolerability in naïve patients 148Gilead and Tibotec/Johnson & Johnson can rely on their combined expertise to establish Truvada/rilpivirine in first line 149SWOT analysis 149Datamonitor drug assessment score card for Truvada/rilpivirine 150Satisfaction of unmet needs 151Target product profile 151Forecasts to 2018 151Quad Pill (Gilead Sciences) 152Drug overview 152Clinical trial data 153Phase II 153Phase I 153Clinical and commercial attractiveness 154Co-formulation with Truvada increases the commercial attractiveness of elvitegravir 154Truvada/rilpivirine co-formulation may restrict use of the Quad Pill to later lines of therapy 154SWOT analysis 155Datamonitor drug assessment score card for cross-class fixed-dose combinations 155Satisfaction of unmet needs 156Forecasts to 2018 1579. Innovative Early-Stage Approaches 159Key findings 159Pharmacokinetic enhancers 160GS-9350 (Gilead Sciences) 160SPI-452 (Sequoia Pharmaceuticals) 161PF3716539 (Pfizer/GlaxoSmithKline) 161Microbicides and pre-exposure prophylaxis 162PRO2000 Gel (Endo Pharmaceuticals) 162Tenofovir gel (Gilead Sciences) 162The future of HIV treatment 163Pipeline Insight: HIV - The Age of Convenience Page 6/11
  7. 7. Find Industry reports, Company profilesReportLinker and Market StatisticsEarly initiation of therapy 163Nucleoside-sparing approaches have safety benefits but lack the simplicity of cross-class combinations 164Bibliography 167Journal papers 167Websites 168Others 170Datamonitor reports 175APPENDIX 176Methodology 176Datamonitor forecast methodology 176Epidemiology forecasts 176Product forecasts 176Definition of a standard unit (only use if ForeSight model used to forecast) 176Datamonitor drug assessment scorecard 177Contributing experts 178About Datamonitor 179About Datamonitor Healthcare 179About the Disease analysis team 180Datamonitor consulting 180Disclaimer 180List of TablesTable 1: Products in clinical development for the treatment of HIV infection, 2009 9Table 2: Sales forecast for pipeline products for the treatment of HIV infection in the US and five major European markets ($m),2009-18 12Table 3: Leading companies in the HIV market, 2008-18 15Table 4: Gilead Sciences portfolio assessment for HIV, 2009 17Table 5: GlaxoSmithKlines portfolio assessment for HIV, 2009 19Table 6: Pfizers portfolio assessment for HIV, 2009 20Table 7: GlaxoSmithKline and Pfizer combined marketed portfolio, 2009 22Table 8: GlaxoSmithKline and Pfizer combined pipeline, 2009 23Table 9: Prevalence of HIV infection in the seven major markets, 2007 30Table 10: Mortality rates and life expectancy of HIV patients, stratified by CD4 count, 2008 36Table 11: HIV incidence, prevalence and mortality from AIDS, by region, 2007 39Table 12: Leading treatments for HIV infection, 2009 43Table 13: Atripla - drug profile, 2009 45Table 14: Target product profile for NRTIs 52Table 15: Target product profile for NNRTIs 53Table 16: Target product profile for the Integrase inhibitors 54Table 17: Target product profile for the entry inhibitors 55Table 18: Target product profile for cross class combinations 56Table 19: Key products in the R&D pipeline for the NRTI class, 2009 66Table 20: Sales forecasts for NRTIs in the US and five major European markets ($m), 2009-19 67Table 21: Apricitabine - drug profile, 2009 68Table 22: Overview of 48-week efficacy data from AVX-201 71Table 23: Ability of apricitabine to meet unmet needs 76Table 24: Sales forecasts for apricitabine in the US and 5EU ($m), 2009-18 76Table 25: Impacting factors on the revenues of apricitabine, 2009-18 77Table 26: Other drugs in the nucleoside reverse transcriptase class, 2009 77Table 27: Key products in the early-stage R&D pipeline for the protease inhibitor class, 2009 80Table 28: Key products in the R&D pipeline for non-nucleoside reverse transcriptase inhibitors, 2009 84Pipeline Insight: HIV - The Age of Convenience Page 7/11
  8. 8. Find Industry reports, Company profilesReportLinker and Market StatisticsTable 29: Sales forecasts for non-nucleoside reverse transcriptase inhibitors in the US and 5EU ($m), 2009-18 85Table 30: Rilpivirine - drug profile, 2009 86Table 31: A comparison of 48 and 96-week Phase IIb rilpivirine efficacy data, 2009 90Table 32: An overview of safety findings from the rilpivirine Phase IIb study 91Table 33: Ability of rilpivirine to meet unmet needs 95Table 34: Sales forecasts for rilpivirine n the US and 5EU ($m), 2009-18 96Table 35: Impacting factors on the revenues of rilpivirine, 2009-18 97Table 36: Other NNRTIs in clinical development, 2009 97Table 37: RDEA806 - drug profile, 2009 98Table 38: Overview of Phase IIa efficacy data 99Table 39: IDX899 - drug profile, 2009 100Table 40: Overview of IDX899 Phase IIa efficacy data 101Table 41: Lersivirine - drug profile, 2009 102Table 42: Combined sales forecasts for RDEA806, lersivirine and IDX899 in the US and 5EU, 2009-18 ($m) 105Table 43: Impacting factors on the revenues of RDEA806, IDX899 and lersivirine, 2009-18 105Table 44: Key products in the early-stage R&D pipeline for the non-nucleoside reverse transcriptase class, 2009 106Table 45: Key products in the late-stage R&D pipeline for entry inhibitors, 2009 111Table 46: Sales forecasts for the entry inhibitors in the US and five major European markets, 2009-18 112Table 47: Vicriviroc - drug profile, 2009 113Table 48: Overview of 48-week VICTOR-E1 efficacy data 116Table 49: Overview of safety data from the VICTOR-E1 study 117Table 50: Ability of vicriviroc to meet unmet needs 122Table 51: Sales forecasts for vicriviroc in the US and five major European markets ($m), 2009-18 123Table 52: Impacting factors on the revenues of vicriviroc 123Table 53: PRO-140 - drug profile, 2009 124Table 54: Sales forecasts for PRO-140 in the US and 5EU ($m), 2009-18 129Table 55: Impacting factors on the revenues of PRO-140, 2009 129Table 56: Key products in the early-stage R&D pipeline for the entry inhibitors class, 2009 130Table 57: Key products in the early-stage R&D pipeline for the entry inhibitors class, 2009 131Table 58: Key products in the late-stage R&D pipeline for the integrase inhibitors class, 2009 133Table 59: Sales forecasts for integrase inhibitors in the US and five major European markets, 2008-18 ($m) 134Table 60: Elvitegravir - drug profile, 2009 135Table 61: Sales forecasts for elvitegravir in the US and five major European markets ($m), 2009-18 140Table 62: Other integrase inhibitors in development 141Table 63: Key products in the early-stage R&D pipeline for the integrase inhibitor class, 2009 142Table 64: Key cross-class combinations in the late-stage R&D pipeline, 2009 146Table 65: Sales forecasts for cross-class combinations in the US and five major European markets ($m), 2008-18 147Table 66: Truvada/rilpivirine - drug profile, 2009 148Table 67: Ability of Truvada/rilpivirine to meet unmet needs 151Table 68: Sales forecasts for Truvada/rilpivirine in the US and five major European markets ($m), 2009-18 152Table 69: Impacting factors on the revenues of Truvada/rilpivirine, 2009-18 152Table 70: Quad Pill - drug profile, 2009 153Table 71: Sales forecasts for the Quad Pill in the US and five major European markets, 2009-18 ($m) 157Table 72: Impacting factors on the revenues of the Quad Pill, 2009-18 158Table 73: Datamonitor drug assessment parameters 177List of FiguresFigure 1: HIV pipeline activity by class, 2009 11Figure 2: Datamonitor drug assessment summary for antiretroviral therapies in development for HIV infection, 2009 14Figure 3: HIV market share by company, 2008 16Figure 4: Estimated number of people living with HIV in the US, 5EU and Japan, 1997-2007 31Pipeline Insight: HIV - The Age of Convenience Page 8/11
  9. 9. Find Industry reports, Company profilesReportLinker and Market StatisticsFigure 5: Estimated number of people living with HIV in the five major European markets, 1997-2007 32Figure 6: Number of newly reported HIV infections and AIDS cases in Japan, 1985-2006 33Figure 7: Estimated Numbers of HIV/AIDS cases among adults and adolescents, by transmission category, 1994-2007 34Figure 8: Number of reported HIV infections by transmission mode, origin and year of notification in the EU/EFTA, 2003-07 35Figure 9: Death rates from HIV infection during pre- and post-HAART era, 1990-2003 37Figure 10: Estimated number of adults (15-59 years) living with HIV (both diagnosed and undiagnosed) in the UK, 2007 38Figure 11: Antiretroviral sales in the US and five major European markets ($m), 2005-08 46Figure 12: Overview of the raltegravir BENCHMRK study 59Figure 13: Overview of the Phase III study for apricitabine 69Figure 14: Overview of the Phase IIb study for apricitabine 70Figure 15: Apricitabine SWOT analysis 73Figure 16: Datamonitors competitive positioning analysis of apricitabine, 2009 74Figure 17: Overview of the rilpivirine Phase III THRIVE study 87Figure 18: Overview of the rilpivirine Phase III ECHO study 88Figure 19: Overview of the rilpivirine Phase IIb study 89Figure 20: Rilpivirine SWOT analysis, 2009 93Figure 21: Datamonitors competitive positioning analysis of rilpivirine, 2009 94Figure 22: HIV mechanism of entry into host cell 109Figure 23: Datamonitor drug assessment summary for products in development for entry inhibitors, 2009 110Figure 24: Overview of the vicriviroc VICTOR-E3 and VICTOR-E4 studies 114Figure 25: Overview of the vicriviroc VICTOR-E1 study 115Figure 26: Overview of the vicriviroc A5211 study 118Figure 27: Vicriviroc SWOT analysis 120Figure 28: Datamonitors competitive positioning analysis of vicriviroc, 2009 121Figure 29: PRO-140 SWOT analysis, 2009 127Figure 30: Datamonitors competitive positioning analysis of PRO-140, 2009 128Figure 31: Overview of the Phase III program for elvitegravir 136Figure 32: Elvitegravir SWOT analysis, 2009 138Figure 33: Datamonitors competitive positioning analysis of elvitegravir, 2009 139Figure 34: Datamonitors competitive positioning analysis of fixed-dose combinations, 2009 145Figure 35: Truvada/rilpivirine SWOT analysis, 2009 149Figure 36: Datamonitors competitive positioning analysis of Truvada/rilpivirine, 2009 150Figure 37: Quad Pill SWOT analysis, 2009 155Figure 38: Datamonitors competitive positioning analysis of the Quad Pill, 2009 156Figure 39: Datamonitor drug assessment summary of pipeline molecular targeted therapies in development for hematologicalmalignancies, 2007 178Pipeline Insight: HIV - The Age of Convenience Page 9/11
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