Pipeline Insight: HIV - Extending treatment options

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Publication Date: 2006-09-12

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More people than ever are living with HIV and AIDS in North America and Western Europe. Over the next five years, a great variety of new HIV drugs are expected to reach the market early stage therapies will be simplified by new products that will transform the market. For those with few treatment options left, new pipeline products will redefine late stage therapy.

Scope

Discussion of the epidemiology dynamics of HIV in the seven major markets, as well as the changing unmet needs that result

Assessment of late-phase clinical development compounds, competitors, and opinion leader comments on trial design

Forecasted sales of drugs in the antiretroviral market for the next 10 years

Examination of the emerging drug classes including Entry Inhibitors and Integrase Inhibitors

Report Highlights
The increased use of antiretroviral agents has been accompanied by a rise in resistance to these drugs. Resistance generally falls into two categories: natural and acquired. The factors surrounding the development of HIV resistance are interrelated and include poor drug compliance, pharmacological factors, and direct molecular drug resistance.

Atripla, approved in the US in July 2006, has been one of the greatest developments in HIV therapy. A combination of two class leaders, Truvada and Sustiva, the triple pill is the first to combine the components of HAART into a single pill formulation taken once daily. Datamonitor forecasts it to reach peak sales in excess of $2 billion.

Integrase inhibitors MK-0518 and GS-9137 look to be the most promising candidates in the EI and others pipeline. Of the two, MK-0518 is the most advanced and looks set to dominate the salvage market.

Reasons to Purchase

Understand key drivers in the antiretroviral market and predict the future performance of key compounds

Explore the changing unmet needs of patients and clinical endpoints used in current trial design

Evaluate forecasts for the antiretroviral market to 2015, taking into account key launch dates, patent expiries and generic incursion

ABOUT DATAMONITOR HEALTHCARE - page 2
- About the Infectious Diseases & Respiratory pharmaceutical analysis team - page 2
CHAPTER 1 EXECUTIVE SUMMARY - page 3
- Scope of the analysis - page 3
- Contributing experts - page 4
- Datamonitor insight into the HIV market - page 4
  - In the main line HIV treatments, Truvada-containing regimes have taken over from Combivir as the new gold standard for the NRTI class and patient simplicity will be greatly improved with the launch of Atripla - page 4
  - The NNRTI analogs are dominated by Sustiva and physicians have few choices when drug resistance develops - page 5
  - Despite a large number of available products, two PIs have over half the class market share. The role of PIs in salvage therapy is being redefined by Prezista and Aptivus, yet a gold standard here has not yet emerged - page 5
  - Entry Inhibitors (EIs), integrase inhibitors and other new drug classes represent a major opportunity for new product development but are initially targeting the small salvage market - page 6
CHAPTER 2 PATIENT POTENTIAL - page 16
- Definition of HIV - page 16
- Epidemiology of HIV - page 17
  - Growing epidemics are underway in Eastern Europe, Central Asia and India - page 19
  - More people than ever are living with HIV and AIDS in the USA and Western Europe - page 20
  - Increased HIV diagnosis is driven by immigration, a rise in risky behavior, more convenient diagnostics and broader testing guidelines - page 23
    - Immigration from areas of high prevalence means the need for antiretroviral therapy in the seven major markets will continue to grow - page 24
    - Improved HIV tests and changes in CDC HIV testing guidelines should increase the HIV diagnosis and treatment rates and might reduce HIV transmission - page 26
    - The perception that HIV is a manageable condition and not a 'death sentence' has led to a rise in risky behavior, particularly among the younger age groups - page 27
    - The increased number of women becoming infected is driven by heterosexual intercourse - page 28
    - Concentration of HIV infections among Africa Americans and Hispanic Americans - page 30
  - Increased occurrence of HIV drug resistance in treatment-naïve patients is affecting front-line treatment strategies - page 30
- Treatment efficacy remains the primary unmet medical need - page 33
- Side effects and drug resistance are key unmet medical needs in individual drug classes - page 39
  - Drug resistance is a problem in most HIV drug classes - but for different reasons - page 40
  - Despite good efficacy, PIs are plagued by drug interactions, resistance and side effects - page 43
  - 'Pill burden' is no longer an unmet need across the antiretroviral drug classes - page 45
  - No one issue stands out with NRTIs; new drugs must be good 'all round' - page 46
  - Entry Inhibitors have commanded a premium price; this has made physicians wary of this drug class - page 46
CHAPTER 3 R&D APPROACH - page 47
- Overview of HIV drug classes - page 48
  - Nucleoside analogs (NRTIs), the oldest HIV drug class, have a mature market dynamic and physicians may choose between many available products - page 49
  - Non-nucleoside analogs (NNRTIs) are dominated by Sustiva and physicians have few choices when drug resistance develops - page 52
  - Despite a large number of available products, two Protease Inhibitors (PIs) take over half the class market share - page 53
  - Entry Inhibitors (EIs) and other new drug classes represent a major opportunity for new product development but are targeted to the small salvage market when first launched - page 55
- Clinical trial endpoints are shifting in response to the newer unmet needs in HIV - page 56
  - Early trials were based on 'hard' clinical endpoints, such as progression to AIDS or death - page 56
  - 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 - page 57
    - Reduction in viral load - page 58
    - CD4 Elevation - page 58
    - Efficacy Equivalence - page 59
  - With improved understanding of HIV and the advent of HAART therapy, endpoints have changed significantly - page 59
    - Activity against resistant virus - a must for most of the HIV pipeline - page 60
    - Quality of life considerations - page 60
CHAPTER 4 HIV PIPELINE ANALYSIS - page 62
- Pipeline overview - page 62
- A collaboration between Gilead and BMS has produced Atripla, the first of its kind - page 63
- Tibotec's highly anticipated pipeline products set to generate significant revenues for J&J - page 64
- GSK currently dominates the HIV market but with only one pipeline product its market share will be drastically reduced by 2016 - page 65
CHAPTER 5 NRTI LATE-STAGE DRUG ANALYSIS & FORECASTS - page 68
- Fixed dose combinations dominate the NRTI market - page 68
  - Truvada-containing regimes replace Combivir as the new gold standard - page 70
  - Once-daily Atripla eliminates the issue of pill burden and is forecast to become the first HIV blockbuster - page 73
- Pipeline products attempt to tackle drug resistance - page 75
  - Multi-nucleoside resistance - page 78
- Development of new drugs has been slow - page 79
- Elvucitabine - page 81
  - Clinical trial data - page 82
  - Datamonitor analysis - page 83
- Racivir - page 85
  - Clinical trial data - page 86
  - Datamonitor analysis - page 86
- AVX-754 - page 88
  - Clinical trial data - page 88
  - Datamonitor analysis - page 90
- MIV-210 - page 91
  - Clinical trial data - page 91
  - Datamonitor analysis - page 92
- Amdoxovir - page 93
  - Clinical trial data - page 93
  - Datamonitor analysis - page 95
- Late-stage development compounds recently discontinued - page 96
  - Reverset - page 96
CHAPTER 6 NNRTI LATE-STAGE DRUG ANALYSIS AND FORECASTS - page 98
- The NNRTIs are recommended for first-line therapy, but can only be used for a limited time before class resistance develops - page 98
  - Sustiva maintains its grip on the market and its gold-standard status - page 99
- Class-wide resistance is the primary unmet need for the NNRTIs and its prevalence is growing in treatment-naïve patients - page 102
- Pipeline NNRTIs are addressing the greatest unmet need for this class - page 105
- TMC125 - page 106
  - Clinical trial data - page 109
  - Datamonitor analysis - page 110
- TMC278 - page 112
  - Clinical trial data - page 113
  - Datamonitor analysis - page 114
- BILR355 - page 116
  - Clinical trial data - page 117
  - Datamonitor analysis - page 117
- Innovative Early-Stage Project - page 120
  - Calanolide A - page 120
- Late-stage development compounds recently discontinued - page 120
  - Capravirine - page 120
  - GW-695634 - page 121
  - MIV-150 - page 121
CHAPTER 7 PI LATE-STAGE DRUG ANALYSIS AND FORECASTS - page 122
- Overview of current PI Market - page 122
  - Boosting with ritonavir improves pharmacokinetics, increases efficacy and is now standard practice; Abbott's ownership of ritonavir gives it a competitive advantage in the PI market - page 123
  - Kaletra - the gold standard in the PI class - is now available in once-daily, temperature-stable tablets without food restrictions - page 125
  - The competitive pressure from Reyataz is strong - page 126
- Current developmental compounds tackle resistance but not side effects or drug-drug interactions - page 128
- Aptivus (tipranavir) - page 132
  - Clinical trial data - page 133
  - Datamonitor analysis - page 136
- Prezista (TMC114) - page 138
  - Clinical trial data - page 139
  - Datamonitor analysis - page 141
- Brecanavir - page 144
  - Clinical trial data - page 146
  - Datamonitor analysis - page 146
- Innovative early-stage projects - page 149
  - PPL-100 - page 149
CHAPTER 8 EI AND OTHER LATE-STAGE DRUG ANALYSIS AND FORECASTS - page 151
- Overview of current EI Market - page 151
  - There is no gold standard treatment in the EI drug class; Fuzeon sales are limited to the salvage market - page 153
  - Roche and Trimeris aim for once weekly needle-free T-20 to increase patient tolerability - page 155
  - Fuzeon boosts efficacy of other products - page 156
- The EI and others pipeline encompasses a wide range of products, with a variety of targets and mechanisms of action under investigation - page 158
  - CCR5 and CXCR4 receptors have become important antiretroviral targets as the two main co-receptors essential for HIV entry into uninfected cells - page 159
- CCR5 Inhibitors - poor results from most pipeline compounds have tarnished the reputation of this class - page 161
  - Vicriviroc - page 162
    - Clinical trial data - page 162
    - Datamonitor analysis - page 163
  - Maraviroc - page 165
    - Clinical trial data - page 168
    - Datamonitor analysis - page 169
- CXCR4 inhibitors - page 171
  - AMD070 - page 171
    - Clinical trial data - page 173
    - Datamonitor analysis - page 174
- Attachment inhibitors - page 176
  - TNX-355 - page 176
    - Clinical trial data - page 178
    - Datamonitor analysis - page 179
- Integrase Inhibitors - page 182
  - MK-0518 - page 182
    - Clinical trial data - page 185
    - Datamonitor analysis - page 186
  - GS-9137 - page 189
    - Clinical trial data - page 190
    - Datamonitor analysis - page 191
- Maturation Inhibitors - page 193
  - Bevirimat (PA-457) - page 193
    - Clinical trial data - page 196
    - Datamonitor analysis - page 197
- Innovative Early-Stage Projects - page 199
  - PRO-140 - page 199
  - TRI-999 and TRI-1144 - page 200
APPENDIX A - page 201
- Methodology - page 201
  - Datamonitor forecast methodology. - page 201
    - Epidemiology forecasts - page 201
    - Product forecasts - page 201
    - Definition of a standard unit - page 201
    - Estimation of launch dates - page 202
  - Datamonitor drug assessment summary - page 204
- Contributing experts - page 204
- Bibliography and Press Releases - page 204
- Frequently Used Websites - page 215
- Company websites - page 216
APPENDIX B - page 218
- About Datamonitor - page 218
  - About Datamonitor Healthcare - page 218
- Datamonitor Healthcare's therapy area capabilities - page 219
  - About the Infectious disease analysis team - page 220
  - Key therapy team members - page 221
    - Mansi Shah, Analyst, Infectious Diseases - page 221
    - Morris Paterson, Senior Analyst, Infectious Diseases - page 221
  - Disclaimer - page 222

List of Tables
Table 1: Regional HIV and AIDS overview, 2005 - page 19
Table 2: DHHS and BHIVA HIV treatment guidelines - page 35
Table 3: DHHS and BHIVA HIV recommended treatment combinations - page 37
Table 4: Overview of the HIV pipeline by company, 2006 - page 63
Table 5: Overview of number of marketed drugs and developmental drugs for key HIV companies, 2006 - page 66
Table 6: Overview of currently marketed NRTIs in the six major markets, 2006 - page 69
Table 7: Overview of NRTI drug pipeline, 2006 - page 81
Table 8: Key clinical trials of Elvucitabine - page 82
Table 9: Overview of Phase II trial of Elvucitabine - page 83
Table 10: Key clinical trials of AVX-754 - page 89
Table 11: Overview of current Phase IIb trial of AVX-754 - page 90
Table 12: Key clinical trials of MIV-210 - page 92
Table 13: Key clinical trials of Amdoxovir - page 94
Table 14: Overview of current Phase II trial of Amdoxovir - page 95
Table 15: Overview of currently marketed NNRTIs, 2006 - page 99
Table 16: Overview of NNRTI drug pipeline, 2006 - page 105
Table 17: Key clinical trials of TMC125 - page 109
Table 18: Key clinical trials of TMC278 - page 113
Table 19: Overview of current Phase IIb trial of TMC278 - page 114
Table 20: Key clinical trials of BILR355 - page 117
Table 21: Overview of currently marketed Protease Inhibitors, 2006 - page 124
Table 22: Overview of PI drug pipeline and recently launched PIs and pipeline products, 2006 - page 132
Table 23: RESIST 1 & 2 trial summary - page 134
Table 24: Key ongoing clinical trials for Prezista, 2006 - page 139
Table 25: Previous trials of Prezista - page 140
Table 26: Key clinical trials of Brecanavir - page 146
Table 27: Key clinical trials of Maraviroc - page 168
Table 28: Key clinical trials of AMD070 - page 173
Table 29: Overview of the XACT trial - page 174
Table 30: Key clinical trials of TNX-355 - page 178
Table 31: Overview of Phase II trial of TNX-355 - page 179
Table 32: Results from MK-0518 head-to-head trial with Sustiva - page 183
Table 33: Key clinical trials of MK-0518 - page 185
Table 34: Overview of MK-0518 Phase II trial - page 186
Table 35: Overview of MK-0518 Phase II trial - page 186
Table 36: Key clinical trials of GS-9137 - page 190
Table 37: Overview of the Phase I/II study evaluating GS-9137 - page 191
Table 38: Key clinical trials of PA-457 - page 196
Table 39: Overview of Phase IIa study evaluating Bevirimat - page 197
Table 40: Average development timeline of HIV NMEs - page 202
Table 41: Estimated launch dates for the US and EU - page 202

List of Figures
Figure 1: Global HIV epidemic, 1990-2005 - page 18
Figure 2: HIV prevalence in the seven major markets, 2003 and 2005 - page 21
Figure 3: Annual HIV incidence, US, Germany and UK, 1995-2003 - page 22
Figure 4: HIV-infected individuals accessing treatment in the UK, 1995-2004 - page 23
Figure 5: HIV incidence by transmission group in Western Europe, 1994-2004 - page 24
Figure 6: HIV acquired through heterosexual contact in the UK, 1995-2004 - page 25
Figure 7: Increased ratio of women infected in the seven major markets, 2001 and 2005 - page 29
Figure 8: Drug resistance by class in newly diagnosed HIV-positive cases in the US, 1995-2004 - page 31
Figure 9: Drug resistance by class in newly diagnosed HIV-positive cases in the UK, 1996/97-2002/03 - page 32
Figure 10: Comparison of clinical trials evaluating three drug combinations - page 36
Figure 11: Drivers of switching from first- to second-line antiretroviral therapy - page 39
Figure 12: Unmet medical needs in individual HIV drug classes, 2006 - page 40
Figure 13: Underlying causes of HIV drug resistance - page 42
Figure 14: Improving outcomes with evolving antiretroviral regimens, 1986-2006 - page 48
Figure 15: HIV virus lifecycle - page 49
Figure 16: US quarterly sales of HIV drug classes, 2002-05 - page 50
Figure 17: Market share within each antiretroviral drug class in the six major markets, 2005 - page 52
Figure 18: Overview of HIV drug development pipeline, 2006 - page 62
Figure 19: HIV market share by company, 2005 and 2016 - page 67
Figure 20: Forecast antiretroviral sales by company, 2016 - page 67
Figure 21: US quarterly sales of currently marketed NRTIs, 2002-2005 - page 71
Figure 22: Atripla sales forecast, 2006-2016 - page 75
Figure 23: Mutations in the reverse transcriptase gene associated with resistance to NRTIs - page 77
Figure 24: Prevalence of major drug resistance mutations (IAS-USA definitions) in patients failing HAART - page 78
Figure 25: Levels of unmet needs in the NRTI class, 2006 - page 80
Figure 26: Elvucitabine sales forecast, 2006-2016 - page 85
Figure 27: Racivir sales forecast, 2006-2016 - page 87
Figure 28: AVX-754 sales forecast, 2006-2016 - page 91
Figure 29: MIV-210 sales forecast, 2006-2016 - page 93
Figure 30: Amdoxovir sales forecast, 2006-2016 - page 96
Figure 31: Mutations in the reverse transcriptase gene associated with resistance to NNRTIs - page 102
Figure 32: Level of unmet needs in the NNRTI class, 2006 - page 104
Figure 33: Activity of NNRTIs against resistance causing mutations - page 106
Figure 34: SWOT analysis for TMC125 - page 111
Figure 35: TMC125 sales forecast, 2006-2016 - page 111
Figure 36: SWOT analysis for TMC278 - page 115
Figure 37: TMC278 sales forecast, 2006-2016 - page 115
Figure 38: SWOT analysis for BILR-355 - page 119
Figure 39: BILR355 sales forecast, 2006-2016 - page 119
Figure 40: Unmet needs in the Protease Inhibitor class, 2006 - page 129
Figure 41: Mutations in the protease gene associated with resistance to PIs - page 131
Figure 42: SWOT Analysis for Aptivus - page 137
Figure 43: Aptivus sales forecast, 2006-2016 - page 138
Figure 44: SWOT Analysis for Prezista - page 143
Figure 45: Prezista sales forecast, 2006-2016 - page 144
Figure 46: SWOT analysis for Brecanavir - page 148
Figure 47: Brecanavir sales forecast, 2006-2016 - page 149
Figure 48: HIV host cell entry mechanism - page 152
Figure 49: Molecular structure of Fuzeon - page 154
Figure 50: Unmet needs across the Entry Inhibitors and others class, 2006 - page 158
Figure 51: HIV infection of target cells takes place via chemokine receptors - page 160
Figure 52: Prevalence of CCR5-, CXCR4-using and dual-tropic HIV strains - page 160
Figure 53: SWOT analysis for Vicriviroc - page 164
Figure 54: Vicriviroc sales forecast, 2006-2016 - page 165
Figure 55: SWOT analysis for Maraviroc, 2006 - page 170
Figure 56: Maraviroc sales forecast, 2006-2016 - page 171
Figure 57: SWOT analysis for AMD070 - page 175
Figure 58: AMD070 sales forecast, 2006-2016 - page 175
Figure 59: SWOT analysis for TNX355 - page 181
Figure 60: TNX355 sales forecast, 2006-2016 - page 181
Figure 61: SWOT analysis for MK-0518, 2006 - page 188
Figure 62: MK-0518 sales forecast, 2006-2016 - page 189
Figure 63: SWOT analysis for GS-9137 - page 192
Figure 64: GS-9137 sales forecast, 2006-2016 - page 192
Figure 65: SWOT analysis for Bevirimat - page 198
Figure 66: Bevirimat (PA-457) sales forecast, 2006-2016 - page 199

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Pipeline Insight: HIV - Extending treatment options

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