Pipeline Insight: Acute Stroke - Considerable unmet need is balanced by substantial commercial risk
Scope
Report Highlights
Reasons to Purchase
Table of Contents
- ABOUT DATAMONITOR HEALTHCARE - page 2
- About the cardiovascular pharmaceutical analysis team - page 2
- CHAPTER 1 EXECUTIVE SUMMARY - page 3
- Scope of the analysis - page 3
- Datamonitor insight into the acute stroke market - page 4
- The R&D pipeline for acute stroke is a diverse and bisegmental collection of 26 novel agents at the clinical stages of drug development - page 4
- The R&D landscape in the setting of acute stroke is not dominated by any one company. It is shaped by the need to minimize the commercial risk associated with developing drugs for the acute-care stroke market - page 6
- The acute stroke market is characterized by high unmet market need as well as high unmet clinical need - page 7
- Datamonitor has identified four late-stage candidate drugs likely to be launched into the acute stroke market within the next three years: the neuroprotectant NXY-059 (formerly Cerovive), the thrombolytic desmoteplase, the hemostatic NovoSeven (rFVIIa) and the defibrinogenating agent Viprinex (ancrod) - page 11
- CHAPTER 2 PIPELINE OVERVIEW - page 25
- Pipeline overview - page 25
- Acute stroke: a diversified pipeline - page 31
- Acute stroke: a balanced pipeline? - page 32
- The R&D landscape is not dominated by any one company and is shaped by the need to minimize commercial risk associated with developing drugs for the acute care stroke market - page 34
- Pipeline overview - page 25
- CHAPTER 3 PATIENT POTENTIAL - page 39
- Disease definition and segmentation - page 39
- Symptoms - page 39
- Epidemiology and patient potential - page 40
- Incidence of stroke - page 40
- Incidence of pre-hospital mortality in stroke - page 42
- Types of stroke: relative frequency of ischemic stroke over hemorrhagic stroke - page 43
- Ischemic stroke - page 43
- Patient potential: incidence of patients presenting with ischemic stroke - page 44
- Hemorrhagic stroke - page 44
- Intracerebral hemorrhage - page 45
- Subarachnoid hemorrhage - page 46
- Patient potential: incidence of patients presenting with hemorrhagic stroke - page 47
- Transient ischemic attack - page 48
- Marketability considerations: barriers to market entry and uptake - page 49
- Points of consideration: factors influencing market entry and uptake - page 49
- Unmet market needs - page 51
- Physician education: tackling physician competence and attitude - page 51
- Patient education: raising stroke-symptom awareness - page 57
- Infrastructural unmet needs: establishing, maintaining and expanding the network of dedicated stroke units - page 60
- Unmet clinical needs - page 63
- Procoagulation - page 63
- Neuroprotection - page 64
- Revascularization - page 65
- Disease definition and segmentation - page 39
- CHAPTER 4 R&D APPROACH - page 74
- Classification of pipeline products - page 74
- Acute stroke pipeline - page 74
- Mechanisms affecting the status of hemostasis - page 74
- Hemostasis and the coagulation cascade - page 75
- Coagulation factors (procoagulants) - page 78
- Thrombolytics - page 79
- The current comparator therapies: alteplase and tenecteplase - page 86
- Mechanisms affecting the status of neuronal tissue - page 101
- Neurotrophic drugs - page 103
- Glutamate antagonists - page 104
- GABA agonists - page 105
- Ion channel modulators - page 105
- Free radical scavengers - page 106
- Other mechanisms - page 106
- The current comparator therapies: citicoline and edavarone - page 108
- Mechanisms affecting the status of hemostasis - page 74
- Clinical trial design - page 113
- Patient population should be assessed for severity and potential responders. - page 113
- The concept of the ischemic penumbra: the potential of diagnosing salvageable tissue - page 113
- Safety endpoints - page 114
- Efficacy endpoints - page 116
- Critique of previous failures - page 118
- Animal studies are poor predictors of therapeutic success in stroke patients - page 118
- There have been discrepancies in the effective therapeutic window between treatment protocols for animals and treatment algorithms in humans. - page 118
- There have been discrepancies between the dosing schedules used in animal studies and those used in clinical trials. - page 119
- The projected treatment outcomes may have been overambitious - page 120
- Possible answers for future clinical trials - page 121
- CHAPTER 5 LATE-STAGE DRUG ANALYSIS & FORECASTS: NEUROPROTECTIVE THERAPIES - page 124
- Overview of neuroprotective therapies in late stage development for acute stroke - page 124
- Pipeline summary - page 124
- Comparator therapy - page 125
- NXY-059 (formerly Cerovive) - page 126
- Drug overview - page 126
- Clinical data - page 127
- Phase II clinical trials - page 127
- Phase III trials - page 131
- Patient potential - page 138
- Marketing factors - page 140
- SWOT analysis: NXY-059 - page 142
- Forecast to 2015 - page 143
- Datamonitor comments - page 144
- Overview of neuroprotective therapies in late stage development for acute stroke - page 124
- CHAPTER 6 LATE-STAGE DRUG ANALYSIS & FORECASTS: REPERFUSION THERAPIES - page 146
- Overview of reperfusion therapies in late-stage development for acute stroke - page 146
- Pipeline summary - page 146
- Comparator therapy - page 147
- Desmoteplase - page 147
- Drug overview - page 147
- Preclinical data - page 148
- Pharmacokinetics - page 149
- Toxicity - page 150
- Neuroprotection - page 151
- Clinical data - page 152
- Phase I/II - page 153
- Phase II: DIAS - page 153
- Phase II: DEDAS - page 155
- Phase III: DIAS-II - page 156
- Patient potential - page 157
- Marketing factors - page 159
- SWOT analysis: desmoteplase - page 160
- Forecast to 2015 - page 161
- Datamonitor comments - page 161
- NovoSeven (rFVIIa) - page 163
- Drug overview - page 163
- Clinical data - page 165
- Phase II clinical trials - page 165
- Phase III clinical trial - page 169
- Patient potential - page 170
- Marketing factors - page 173
- SWOT Analysis: NovoSeven - page 174
- Forecast to 2015 - page 175
- Datamonitor comments - page 175
- Viprinex (ancrod) - page 176
- Drug overview - page 176
- Clinical data - page 178
- Phase II clinical trials - page 178
- Phase III clinical trials - page 180
- Patient potential - page 184
- Marketing factors - page 186
- SWOT analysis: Viprinex (ancrod) - page 187
- Forecast to 2015 - page 188
- Datamonitor comments - page 189
- Overview of reperfusion therapies in late-stage development for acute stroke - page 146
- CHAPTER 7 OTHER ACUTE STROKE DRUGS - page 190
- Alfimeprase - page 190
- Drug overview - page 190
- AEOL-10150 - page 191
- Drug overview - page 191
- Preclinical data - page 191
- Clinical data - page 194
- AGY-94806 (SA-4503, Msc-1) - page 194
- Drug overview - page 194
- Preclinical data - page 197
- AX-200 - page 198
- Drug overview - page 198
- Preclinical data - page 198
- Clinical data - page 199
- BAY-387271 - page 199
- Drug overview - page 199
- Preclinical data - page 200
- Cerebril (tramiprosate, NC-758) - page 200
- Drug overview - page 200
- Preclinical data - page 201
- Clinical data - page 202
- DP-b99 - page 202
- Drug overview - page 202
- Preclinical data - page 202
- Clinical data - page 204
- Phase I - page 204
- Phase II - page 205
- Enecadin - page 206
- Drug overview - page 206
- Preclinical development - page 207
- HF0220 - page 207
- Drug overview - page 207
- Preclinical data - page 208
- HF0420 - page 209
- Drug overview - page 209
- Preclinical data - page 209
- MC-1 - page 210
- Drug overview - page 210
- Microplasmin - page 211
- Drug overview - page 211
- NH-02B - page 212
- Drug overview - page 212
- NTx-265 - page 212
- Drug overview - page 212
- ONO-2506 (proglia) - page 213
- Drug overview - page 213
- Preclinical data - page 213
- Clinical data - page 214
- ONO-2231 - page 215
- Drug overview - page 215
- S-18986 - page 215
- Drug overview - page 215
- Preclinical data - page 215
- SUN-N4057 - page 218
- Drug overview - page 218
- Preclinical data - page 218
- Clinical data - page 219
- SUN-N8075 - page 219
- Drug overview - page 219
- Preclinical data - page 220
- TS-011 - page 221
- Drug overview - page 221
- Preclinical data - page 221
- Traxoprodil (CP-101,606) - page 222
- Drug overview - page 222
- Preclinical data - page 224
- Clinical data - page 224
- Phase I - page 224
- Phase II - page 225
- V-10153 - page 226
- Drug overview - page 226
- Clinical data - page 228
- Alfimeprase - page 190
- CHAPTER 8 COMPARATIVE COMMERCIAL ANALYSIS OF KEY LATE-STAGE ACUTE STROKE DRUGS - page 229
- Introduction - page 229
- Datamonitor drug assessment summary - page 230
- Research feasibility - page 232
- Clinical feasibility - page 233
- Commercial value - page 233
- Commercial risk - page 234
- Strategic value - page 234
- APPENDIX A - page 236
- Datamonitor drug assessment summary - page 236
- Contributing experts - page 239
- Bibliography - page 241
- Forecasting methodology - page 253
- Report methodology - page 253
- APPENDIX B - page 254
- About Datamonitor - page 254
- About Datamonitor Healthcare - page 254
- Datamonitor Healthcare's therapy area capabilities - page 255
- About the cardiovascular analysis team - page 256
- Disclaimer - page 257
- About Datamonitor - page 254
- List of Tables
- Table 1: Acute stroke pipeline (overall), 2006 - page 26
- Table 2: Acute stroke pipeline (agents acting on CNS), 2006 - page 28
- Table 3: Acute stroke pipeline (agents acting on hemostasis), 2006 - page 30
- Table 4: Acute stroke pipeline by mechanism of action, 2006 - page 31
- Table 5: Acute stroke pipeline by company, 2006 - page 34
- Table 6: Current and future estimated incidence of stroke in the seven major markets, 2006-16 (000s) - page 41
- Table 7: Overall stroke patients: annual pre-hospital mortality, 2005 - page 42
- Table 8: Overall stroke patients: future estimated incidence of pre-hospital mortality in the seven major markets, 2006-16 (in 000s) - page 42
- Table 9: Proportion of stroke patients with ischemic stroke versus hemorrhagic stroke, 2005 - page 43
- Table 10: Current and future estimated incidence of patients presenting with ischemic stroke in the seven major markets, 2006-16 (in 000s) - page 44
- Table 11: Current and future estimated incidence of patients presenting with hemorrhagic stroke in the seven major markets, 2006-16 (000s) - page 47
- Table 12: Comparison of alteplase and tenecteplase - page 93
- Table 13: Standardized outcome scales frequently used in clinical trials for acute stroke - page 117
- Table 14: Key pipeline neuroprotective therapies, 2006 - page 124
- Table 15: Percentage of stroke patients presenting to hospital within six hours, 2005 - page 138
- Table 16: Percentage of stroke patients presenting to hospital within 24 hours, 2005 - page 139
- Table 17: Percentage of stroke patients presenting to hospital within three hours, 2005 - page 140
- Table 18: Global sales forecast for NXY-059, 2008-15 - page 143
- Table 19: Key pipeline reperfusion therapies, 2006 - page 146
- Table 20: DEDAS: safety endpoints - page 155
- Table 21: Global sales forecast for desmoteplase, 2008-15 - page 161
- Table 22: Distribution of strokes by stroke type, 2005 - page 170
- Table 23: Global sales forecast for NovoSeven, 2008-15 - page 175
- Table 24: Percentage of stroke patients presenting to hospital within six hours (cumulative), 2005 - page 184
- Table 25: Global sales forecast for Viprinex, 2008-15 - page 188
- Table 26: Research, clinical and commercial attractiveness of key pipeline anticoagulants - page 230
- Table 27: Datamonitor drug assessment parameters - page 237
- List of Figures
- Figure 1: Acute stroke pipeline, 2006 - page 25
- Figure 2: Pipeline maturity: percentage of R&D products in each phase of development, 2006 - page 32
- Figure 3: Pipeline maturity: percentage of R&D products in each phase of development by class, 2006 - page 33
- Figure 4: Pipeline maturity: percentage of R&D products in each phase of development by type of company, 2006 - page 37
- Figure 5: The targets of developmental antithrombotics in the setting of acute stroke - page 77
- Figure 6: Ancrod acts indirectly on the thrombolytic pathways - page 83
- Figure 7: ECASS-III trial: extending the treatment window of tPA - page 91
- Figure 8: The ischemic cascade - page 102
- Figure 9: SWOT analysis: NXY-059 - page 142
- Figure 10: Global sales forecast for NXY-059, 2008-15 - page 143
- Figure 11: SWOT analysis: desmoteplase - page 160
- Figure 12: Global sales forecast for desmoteplase, 2008-2015 - page 161
- Figure 13: SWOT analysis: NovoSeven - page 174
- Figure 14: Global sales forecast NovoSeven, 2008-2015 - page 175
- Figure 15: SWOT analysis: Viprinex (ancrod) - page 187
- Figure 16: Global sales forecast for Viprinex, 2008-2015 - page 188
- Figure 17: Research, clinical and commercial attractiveness of late-stage candidate drugs in the acute stroke setting: bubble chart - page 231
- Figure 18: Research, clinical and commercial attractiveness of late-stage candidate drugs in the acute stroke setting: radar plot - page 231
- Figure 19: Example of Datamonitor drug assessment scorecard - page 238
- Figure 20: Example of Datamonitor drug assessment graph - page 239
Other users found this report page using the following search terms: stroke neuroprotection stroke edavarone pipeline unmet need 2008 market clinical acute swot
If you can't find a report that meets your needs contact LeadDiscovery. We are one of the few report providers with extensive drug development experience and we frequently use this knowledge to help clients source the most appropriate reports or produce reports for them from scratch.