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Pipeline Insight: HIV - Enter the New Generation InhibitorsPublished by: Datamonitor Published: Apr. 26, 2004 - 275 Pages Table of ContentsTABLE OF CONTENTS CHAPTER 1 EXECUTIVE SUMMARY 3 Scope of the analysis 3 Datamonitor insight into the HIV market 4 Datamonitor’s recent market analysis and survey of 32 HIV pipeline products (Phase I to Phase III) suggests that by 2012, global product sales could amount to just under $12 billion, approximately double the value recorded for 2003 ($5.76 billion). In the medium term (2003-2008), although 10 product launches are predicted, for the first time, four original NRTI antiretroviral products will also face patent expiry namely, Retrovir, Videx, Hivid and Zerit 4 Within the HIV pipeline surveyed, around a third of candidates (10 in number) are classified as entry inhibitors/others. Datamonitor predicts that in 2012, 16% of total sales revenue could be derived from these novel compounds. Candidates such as the CCR5 antagonists SCH-D, GW873140, UK-427, 857 and the CD4 inhibitors such as BMS-488043 presently appear safe and orally available, but more importantly, are being developed by major players 6 As well as novel HIV antiretrovirals, second generation NRTIs, NNRTIs and PIs are also being developed with a focus on efficacy against resistant HIV strains observed in patients failing first-line therapies. In addition, two new combination products, Ziagen/Epivir and Viread/Emtreva are predicted to contribute an additional $770 million in 2012 replacing revenue lost from GSK’s Combivir and Trizivir 7 Companies with no existing HIV market experience are currently developing more than half of the HIV pipeline with the greatest compound diversity. Despite this, Datamonitor predicts that only 30% of revenue ($3.5 billion) will be derived from these new players in 2012 should their clinical development plans be successful. Schering-Plough and Tibotec-Virco are the most noticeable new entrants 10 Key metrics 12 CHAPTER 2 PATIENT POTENTIAL 33 HIV - a general overview 33 Epidemiology of HIV 35 Regional breakdown 36 Case study: Western Europe 40 HIV ‘at-risk’ groups 42 IVDUs 42 Ethnic populations 43 MSM (men who have sex with men) 44 HBV/HIV co-morbid population 45 Vertical transmission 46 Treatment of HIV 46 First-line HIV therapy 50 Second-line HIV therapy 53 Third-line therapy 55 Salvage therapy 56 Unmet needs in HIV 58 Drug-induced resistance 60 Improving side effects 62 Lack of drug efficacy 63 High pill burden and dosing 64 Cost of therapy 65 CHAPTER 3 R&D APPROACH 67 Classification of pipeline products 67 Nucleoside reverse transcriptase inhibitors (NRTIs) 68 Non-nucleoside reverse transcriptase inhibitors (NNRTIs) 69 Protease inhibitors (PIs) 71 Entry inhibitors (EIs) 73 Clinical trial endpoints in HIV infections 74 Endpoint 1 - Suppression of HIV viral load 74 Endpoint 2 - Elevation of CD4 count 75 Endpoint 3 - Efficacy equivalency 75 Additional considerations 75 CHAPTER 4 HIV PIPELINE ANALYSIS 80 Pipeline overview 80 Companies involved in the HIV pipeline 83 GSK 85 Roche 86 Gilead 87 Bristol Myers Squibb (BMS) 88 Boehringer Ingelheim 89 CHAPTER 5 NUCLEOSIDE REVERSE TRANSCRIPTASE INHIBITORS 90 Overview of the NRTIs 90 Pipeline summary 90 Definition of current comparator therapy 91 Combivir 91 Elvucitabine (ACH-126,443/beta-L-Fd4C) 93 Profile 93 Clinical trial data 94 Trial 1 94 Author conclusions 95 Datamonitor comments 95 Trial II 96 Trial reference 96 Lead investigator 96 Study design 96 Results 97 Author conclusions 98 Datamonitor comments 98 Patient potential 98 Marketing factors 99 Satisfaction of unmet needs 100 Forecasts to 2012 101 MIV-310 (FLT/alovudine) 102 Profile 102 Clinical trial data 103 Trial reference 103 Study design 103 Results 104 Author conclusions 105 Datamonitor comments 105 Patient potential 105 Marketing factors 106 Satisfaction of unmet needs 106 Forecasts to 2012 107 Racivir (PSI5004) 108 Profile 108 Clinical trials 108 Trial reference 109 Study design 109 Results 110 Author conclusions 111 Datamonitor comments 111 Marketing factors 111 Satisfaction of unmet need 112 Forecasts to 2012 113 Reverset (DPC-817) 113 Profile 113 Clinical trials 114 Trial I 115 Trial reference 115 Study design 115 Results 115 Author conclusions 115 Trial II 116 Trial reference 116 Patient potential 117 Marketing factors 118 Satisfaction of unmet needs 118 Forecasts to 2012 119 SPD-754 (BCH-10618/52) 120 Profile 120 Clinical trials 121 Trial reference 1 121 Study design 121 Results 122 Author conclusions 123 Datamonitor comments 123 Patient potential 124 Marketing factors 124 Satisfaction of unmet needs 124 Forecasts to 2012 125 Comparative forecasts 126 Other NRTIs 127 GS-7340 127 Profile 127 Clinical trial data 127 Trial reference 128 Study design 128 Results 128 Author conclusions 128 Datamonitor comments 128 Patient potential 128 Marketing factors 129 Satisfaction of unmet needs 129 MIV-210 (FLG-204937) 130 Profile 130 Clinical trials 131 Trial reference 131 Study design 131 Results 131 Author conclusions 132 Datamonitor comments 132 Patient potential 133 Marketing factors 133 Satisfaction of unmet needs 133 Late-stage development compounds recently discontinued 134 Amdoxovir (DADP) 134 CHAPTER 6 NON-NUCLEOSIDE REVERSE TRANSCRIPTASE INHIBITORS 140 Overview of the NNRTIs 140 Pipeline summary 140 Definition of current comparator therapy 141 NNRTI ‘gold-standard’: Sustiva 141 Capravirine (AG 1549/S1153) 144 Profile 144 Clinical trial data 145 Trial I 146 Trial reference 146 Study design 146 Results 147 Author conclusions 148 Trial II 148 Study design 148 Results 149 Trial II b 149 Study design 150 Results 150 Author conclusions 150 Datamonitor comments 150 Patient potential 151 Marketing factors 152 Satisfaction of unmet needs 153 Forecasts to 2012 154 Calanolide A 155 Profile 155 Clinical trial data 156 Trial I 156 Trial reference 156 Study design 157 Results 157 Author conclusions 157 Trial II 157 Trial reference 157 Study design 157 Results 158 Author conclusions 158 Datamonitor comments 158 Patient potential 159 Marketing factors 159 Satisfaction of unmet needs 160 Forecasts to 2012 161 TMC-125 (etravirine) 162 Profile 162 Clinical trial data 162 Trial I reference 163 Trial II reference 163 Combined study rationale 164 Trial I study design 164 Results 164 Author conclusions 165 Trial II 166 Study design 166 Results 166 Author conclusions 167 Datamonitor comments 167 Patient potential 168 Marketing factors 169 Satisfaction of unmet needs 169 Forecasts to 2012 171 BILR-355 171 Profile 171 Comparative forecasts 173 Other drugs in the NNRTI class 173 GW695634 and GW678248 173 R-1495 (MV026048) 174 Late-stage development compounds recently discontinued 174 Emivirine (Coactinon/MKC-442) 174 Profile 174 TMC-120 176 Profile 176 Clinical trial data 176 CHAPTER 7 PROTEASE INHIBITORS 178 Overview of the protease inhibitor class 178 Pipeline summary 178 Definition of current comparator therapy 178 Kaletra 178 Tipranavir (PNU-140690) 181 Profile 181 Clinical trial data 182 Trial title 183 Trial reference 183 Study design 183 Results 183 Author conclusions 184 Patient potential 184 Marketing factors 185 Ritonavir boosting/dosing 187 Lipid profile 187 Dosing and pill burden 188 Satisfaction of unmet needs 189 Forecasts to 2012 190 TMC-114 191 Profile 191 Trial reference 192 Study design 192 Results 193 Author conclusions 194 Datamonitor comments 194 Patient potential 194 Marketing factors 195 Satisfaction of unmet needs 195 Forecasts to 2012 196 GW640385 (VX385) 197 Profile 197 Clinical trial summary 197 Trial reference 198 Study design 198 Results 199 Author conclusions 199 Datamonitor comments 199 Patient potential 200 Marketing factors 200 Satisfaction of unmet needs 200 Forecasts to 2012 201 RO-00334649 201 Profile 201 Clinical trial data 202 Trial reference 202 Study design 202 Results 203 Author conclusions 203 Datamonitor comments 203 Patient potential 203 Satisfaction of unmet needs 204 Forecasts to 2012 204 Comparative forecasts 205 Other drugs in the PI class 205 PL-100 205 Profile 205 Clinical trial data 206 GS9005 (GS4338) 206 Profile 206 CHAPTER 8 ENTRY INHIBITORS 208 Overview of the EIs 208 Pipeline summary 208 Definition of current comparator therapy 208 Fuzeon 208 SCH-D (SCH-417690) 211 Profile 211 Clinical trial data 212 Trial reference 212 Study design 212 Results 213 Author comments 213 Datamonitor comments 213 Patient potential 213 Marketing factors 215 Satisfaction of unmet needs 215 Forecasts to 2012 217 UK-427, 857 217 Profile 217 Clinical trial data 218 Trial I 218 Trial reference 218 Study design 218 Results 219 Author comments 220 Trial II 220 Trial reference 220 Study design 220 Results 221 Author comments 222 Datamonitor comments 222 Patient potential 222 Marketing factors 223 Satisfaction of unmet needs 223 Forecasts to 2012 224 GW-873140 225 Profile 225 Clinical trial data 226 Trial reference 226 Study design 226 Results 227 Author comments 228 Datamonitor comments 228 Patient potential 228 Marketing factors 229 Satisfaction of unmet needs 229 Forecasts to 2012 230 AMD-070 231 Profile 231 Clinical trial data 232 Patient potential 232 Marketing factors 233 Satisfaction of unmet needs 233 Forecasts to 2012 234 BMS-488043 235 Profile 235 Clinical trial data 236 Results 237 Author conclusions 237 Datamonitor comments 238 Patient potential 238 Marketing factors 238 Forecasts to 2012 240 Comparative forecasts 240 Other drugs in the entry inhibitor class 241 Viraldon (dextrin-2-sulphate/Emmelle) 241 Profile 241 Clinical trial data 242 Key clinical trials 242 Results 244 Author conclusions 244 Datamonitor comments 245 Patient potential 245 Marketing factors 245 Satisfaction of unmet needs 246 Forecasts to 2012 247 TNX-355 247 Profile 247 Clinical trial data 249 Key clinical trial 249 Trial reference 249 Study design 250 Results 250 Author conclusions 251 Datamonitor comments 252 Patient potential 252 Marketing factors 252 Satisfaction of unmet needs 253 PRO-542 254 Profile 254 Clinical trial data 255 Key clinical trials 256 Trial I 256 Trial reference 256 Study design 256 Results 256 Author comments 256 Trial II 257 Trial reference 257 Study design 257 Results 257 Author comments 257 Datamonitor comments 258 Patient potential 258 Marketing factors 259 Satisfaction of unmet needs 260 Comparative forecasts 261 Late-stage development compounds recently discontinued 261 T-1249 261 Profile 261 Clinical trial data 263 APPENDIX A 264 Contributing experts 264 Bibliography 264 Websites 269 Expected US launch dates of Pipeline HIV products 270 Report methodology 271 APPENDIX B 272 About Datamonitor 272 About Datamonitor Healthcare 272 Datamonitor Healthcare’s research and analysis methodologies 273 Datamonitor Healthcare’s therapy area capabilities 273 Key therapy team members 274 John Savopoulos, Lead Analyst, Infectious Diseases 274 Disclaimer 275 AbstractIntroductionCurrently there is a range of marketed antiretrovirals for the treatment of HIV, the majority of which were launched between the years 1990 to 2000. These are slowly being replaced by products with lower pill burden, higher potency and less incidence of adverse side effects. Those candidates with efficacy against resistant strains or novel having mechanisms of action now dominate the pipeline. Scope Up to date review and comment of HIV epidemiology, HAART therapy, key drug classes and unmet needs analysis within HIV clinical trial design Key HIV pipeline metrics including candidates by phase, class and company participation; discussion of major and new entrant strategies Full commercial reappraisal of HIV market with candidate and product global forecasts to 2012; discussion of new combinations and patent expiries Expert comment on second generation NRTIs, NNRTIs and PIs. Critical analysis on potential of CCR5 antagonists and CD4 inhibitors Report Highlights Datamonitor’s recent survey of 32 HIV pipeline products (Phase I to Phase III) suggests that by 2012, global product sales could amount to just under $12 billion, approximately double the value recorded for 2003 ($5.76 billion). In the medium term (2003-2008), 10 product launches are predicted. For the first time, four original NRTI antiretroviral products will also face patent expiry namely, Retrovir, Videx, Hivid and Zerit. Within the HIV pipeline, around a third of candidates are classified as entry inhibitors/others. Datamonitor predicts that in 2012, 16% of total sales revenue could be derived from these novel compounds. Presently these appear safe and orally available, but more importantly, are being developed by major players. Reasons to Purchase Access the latest market information and forecasts for current HIV pipeline candidates Benchmark internal forecasts, and review Datamonitor’s objective appraisals of candidate profiles Understand potential HIV company and drug class contribution to revenue growth to 2012 Get Full Details About This Report >> |
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