HIV - Simplicity And Survival

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HIV - Simplicity And Survival
Description: Despite accounting for only 1% of global pharmaceutical sales, HIV antiretrovirals have experienced rapid growth between 2000-2004, accounting for $6.6 billion in global sales. Enthusiasm for new once daily FDCs and PIs such as Reyataz has rendered the market for first-line naïve patients a battleground where simplicity wins. Even older flagship products such as Combivir are now under threat. Scope - Examination of drivers and resistors to prescription of new FDCs - pricing analysis and opinion leader perception of short and long term toxicities - Coverage of FDA approval of Boehringer Ingelheims Aptivus (tipranavir) - future lessons for clinical studies in highly treatment experienced patients - Assessment of the impact of generic antiretrovirals - case analysis of generic didanosine, FDA tentative approval of NNRTIs, efavirenz and nevirapine - In-depth regional sales forecasts of marketed and pipeline drugs from 2005 to 2015 with full event analysis Highlights Our opinion leader research has revealed that in the majority of Western markets the major route of HIV transmission is changing. Most reported increased presentation of individuals believed to have been infected by heterosexual contact. In countries such as France, immigrants from SubSaharan Africa continue to dominate new diagnoses. In 2004, the global market for HIV antiretrovirals was valued at $6.6 billion with the US accounting for around 70% of value. In Europe, France is the largest market valued at around $600m. Despite an increase in commercial value, most markets apart from the UK have experienced a decline in standard unit volume driven by uptake of FDC products. Boehringer Ingelheims FDA approval for Aptivus (tipranavir) raises the PI class to nine members. Despite challenges during clinical development, testing in a highly experienced population and 24weeks data using a surrogate for efficacy, tipranavirs approval signals a high need for additional agents to Fuzeon (enfuvirtide) in this patient group. Reasons to Purchase - Assess the value and volume dynamics of HIV antiretrovirals on a regional level with a 5 year retrospective view - Understand the pending impact of patent expiries and generic incursion on the antiretrovirals market, including product-specific case studies - Obtain full global, country, class and product-specific forecasts of currently marketed and pipeline antiretrovirals from 2005 to 2015

Contents: CHAPTER 1 3. Objective of the analysis 3 Insight into the HIV market 3

CHAPTER 2 MARKET DEFINITION AND OVERVIEW 14. Market definition for this report 14 Current market situation 14 Class overview 18 Nucleoside reverse transcriptase inhibitors 19 Non-nucleoside reverse transcriptase inhibitors 21 Protease inhibitors 23 Entry inhibitors 26 Strategic scoping and focus 27 The emerging markets 29 CHAPTER 3 COUNTRY MARKET ASSESSMENTS 31. Current and future opportunities and threats in the HIV market 31 Global opportunities and threats 31 Opportunities 31 Threats 41 US: opportunities and threats 48 Market overview 48 Opportunities 50 Threats 52 Japan: opportunities and threats 57 Market overview 57 Opportunities 59 Threats 65 France: opportunities and threats 68 Market overview 68 Opportunities 70 Threats 72 Germany: opportunities and threats 75 Market overview 75 Opportunities 77 Threats 78 Italy: opportunities and threats 81 Market overview 81 Opportunities 83 Threats 86 Spain: opportunities and threats 87 Market overview 87 Opportunities 88 Threats 91 UK: opportunities and threats 92 Market overview 92 Opportunities 94 Threats 97 Summary of environmental issues affecting the antiretroviral market size 101 CHAPTER 4 FORECAST ANALYSIS 102. Assumptions and events 102 Events not included 102 Global events 102 Increase in the number of patients receiving antiretroviral therapy 102 Pricing adjustments 103 Product-specific events 103 Launch of new combination drugs – tenofovir/emtricitabine (Truvada) and lamivudine/abacavir (Epzicom) 103 Antiretroviral patent expiries 105 Launch of new drugs with activity against resistant strains of HIV 114 Launch of new entry inhibitors and mABs 117 Limitations of data 120

Standard units 120 Japanese market data 120 Regional launch dates for new products 121 Forecasts 121 CHAPTER 5 COMMERCIAL IMPACT AND LIFECYCLE MANAGEMENT: CASE STUDIES 122. Introduction 122 Fixed-dose combinations – the future of NRTI therapy? 122 Fixed-dose combinations – an overview 122 Convenience and simplicity drive FDC uptake 124 FDC prescription practices 126 NRTI FDC clinical trials – the three go head-to-head 128 The need for data – is bioequivalence enough? 133 Generic incursion – are FDCs adequate protection? 133 The cost of FDCs – what price for convenience? 134 FDCs – the future of antiretroviral therapy? 137 NRTIs – will the backbone be fixed? 137 PI fixed dose combinations – generic ritonavir may open the way for new FDCs 138 Cross class fixed-dose combinations – could HAART be reduced to a single pill? 140 Once-daily dosing 142 Once-daily dosing – a double-edged sword for HIV therapy? 143 Few products now require more than twice daily dosing 147 Aptivus (tipranavir, TPV) – Boehringer pulls it through 150 Open label trial design leads to differences in analyses 151 Safety concerns and required follow-up 154 Lessons for HIV trials in “heavily treatment experienced patients” 156 Commercial outlook for BI’s HIV portfolio 158 Guideline changes for nevirapine 158 Aptivus – a Fuzeon-like product? 160 Generics and patent expiries 163 Generic impact is likely to vary considerably 165 Older products are not expected to raise generic interest 166 Those hardest hit will be the most widely prescribed products – Epivir, Viread, Sustiva and Kaletra 167 APPENDIX A – MARKET DATA AND MAJOR BRAND KEY FACTS 169 NRTI market data 169 PI market data 182 NNRTI market data 192 Others market data 195 APPENDIX B 196 Bibliography 196 Journal articles and conference abstracts 196 Press releases 202 General 202 EU 203 France 204 Italy 204 Japan 204 Spain 205 UK 206 US 207 Conferences 209 Websites 210 Organizations 212 Miscellaneous 213 Report methodology 215 LIST OF TABLES Table 1: Overview of the NRTIs 20 Table 2: Overview of the NNRTIs 22 Table 3: Overview of the PIs 24 Table 4: HIV/AIDS prevalence, incidence and death rates by region, 2004 29

Table 5: HIV/AIDS prevalence and diagnosis rates in the seven major markets, 2004* 34 Table 6: Exposure category of HIV infections diagnosed in the US and UK, 1999 to 2003 35 Table 7: Patent expiries of antiretrovirals, 2005–15 41 Table 8: US antiretroviral market, 2000–04 48 Table 9: Pacific Rim antiretroviral market, 2000–04 57 Table 10: French antiretroviral market, 2000–04 69 Table 11: German antiretroviral market, 2000–04 75 Table 12: Italian antiretroviral market, 2000–04 82 Table 13: Spanish antiretroviral market, 2000–04 87 Table 14: UK antiretroviral market, 2000–04 93 Table 15: An overview of selected pipeline products included in the HIV market forecasts 115 Table 16: Comparison of Combivir, Epzicom & Truvada 129 Table 17: Key products in late-stage R&D pipeline for NRTIs 137 Table 18: Boosted PI regimes 139 Table 19: Key antiretroviral combinations, not currently available in the seven major markets, 2005 141 Table 20: Once-daily ARVs currently available (in US) 144 Table 21: Patient populations for the tipranavir RESIST trials 153 Table 22: Tipranavir post-marketing studies, as requested by the FDA 156 Table 23: Patent expiries of antiretrovirals, 2005–15 163 Table 24: Combivir: key facts 169 Table 25: Viread: key facts 170 Table 26: Trizivir: key facts 171 Table 27: Epivir: key facts 172 Table 28: Zerit: key facts 173 Table 29: Ziagen: key facts 174 Table 30: Videx EC: key facts 175 Table 31: Videx: key facts 176 Table 32: Retrovir: key facts 177 Table 33: Truvada: key facts 178 Table 34: Emtriva: key facts 179 Table 35: Epzicom: key facts 180 Table 36: Hivid: key facts 181 Table 37: Kaletra: key facts 182 Table 38: Reyataz: key facts 183 Table 39: Viracept: key facts 184 Table 40: Norvir: key facts 185 Table 41: Crixivan: key facts 186 Table 42: Lexiva: key facts 187 Table 43: Invirase: key facts 188 Table 44: Fortovase: key facts 189 Table 45: Agenerase: key facts 190 Table 46: Sustiva: key facts 192 Table 47: Viramune: key facts 193 Table 48: Rescriptor: key facts 194 Table 49: Fuzeon: key facts 195


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