Pipeline Insight: Antihypertensives - Weak pipeline leaves innovation to Novartis
Scope
Report Highlights
Reasons to Purchase
Table of Contents
- ABOUT DATAMONITOR HEALTHCARE - page 2
- CHAPTER 1 EXECUTIVE SUMMARY - page 3
- Scope of the analysis - page 3
- Historical perspective of the antihypertensives market - page 3
- Datamonitor insight into the antihypertensive market - page 4
- Unlike many other disease areas, opinion is significantly divided on the identity of a "gold standard therapy" for the treatment of hypertension, with all of the currently available drug classes satisfying at least some of the needs of the hypertensive patient. - page 5
- Lifecycle management strategies dominate antihypertensive R&D, with nearly half of all development projects assessing the safety and efficacy of novel combinations of currently marketed antihypertensive drugs. As such, innovation seen in other disease areas is scarce in antihypertensive R&D. - page 6
- What innovation exists is being single-handedly delivered by Novartis, who is developing Rasilez (aliskiren), a first-in-class drug of the new orally active renin inhibitors. With its distal blockade of the renin-angiotensin system (RAS), compared to the proximal blockade provided by the ACEs and ARBs, Rasilez has the potential to offer superior blockade of the RAS, with enhanced end-organ protection compared to other classes the drug's most promising attribute. - page 7
- Despite continued research into other hypertension targets - such as endothelin and vasopeptidase - a poor safety records, lack of efficacy compared to other classes and a low patient potential, these agents promise to be no more than an academic interest rather than providing physicians with a real alternative in treating hypertension. - page 8
- Summary - page 10
- Key metrics - page 11
- CHAPTER 2 PATIENT POTENTIAL - page 24
- Definition of the hypertension market - page 24
- Definition of hypertension - page 25
- Treatment goals in hypertension - page 26
- Segmentation of hypertension - page 27
- Diabetic hypertensive patients - page 27
- Hypertensives with renal disease - page 28
- Isolated systolic hypertension (ISH) - page 29
- Epidemiology, diagnosis and treatment - page 29
- Epidemiology - page 29
- Future trends in the prevalence of hypertension - page 30
- Diagnosis and treatment rates - page 31
- Methodology - page 32
- The US - page 33
- Japan - page 34
- France - page 34
- Germany - page 35
- Italy - page 35
- Spain - page 35
- The UK - page 36
- Summary - page 36
- Unmet needs in the treatment of hypertension - page 37
- Unmet need 1 - increased efficacy in reducing SBP - page 37
- Unmet need 2 - increased use of FDCs - page 39
- Unmet need 3 - improved compliance - page 39
- Unmet need 4 - greater choice of two- or three-drug combinations - page 40
- Other potential unmet needs - page 41
- Greater patient involvement in therapy - page 41
- Cognitive function, vascular fibrosis and antiplatelet effects - page 42
- Comparators used to assess each criterion - page 42
- CHAPTER 3 R&D APPROACH - page 45
- Normal blood pressure maintenance ... - page 45
- ... and where things go wrong - page 47
- Current treatment approaches: a holistic approach - page 47
- Principles of antihypertensive pharmacotherapy - page 49
- Is there a gold standard antihypertensive pharmacotherapy? - page 49
- Current pharmacological treatment options in hypertension - page 51
- Drugs that inhibit the renin-angiotensin system - page 51
- Angiotensin converting enzyme inhibitors (ACEs) - page 54
- Angiotensin receptor blockers (ARBs) - page 55
- Beta-blockers (BBs) - page 55
- Drugs that do not inhibit the renin-angiotensin system - page 56
- Calcium-channel blockers - page 56
- Diuretics - page 57
- Other classes of antihypertensive therapy - page 58
- Centrally acting agents - page 58
- Alpha blockers - page 58
- Drugs that inhibit the renin-angiotensin system - page 51
- Classification of pipeline products - page 59
- Novel targets for the treatment of hypertension - page 59
- Endothelin receptor antagonists (ERAs) - page 59
- Neutral endopeptidase inhibitors (NEPs) - page 63
- Renin inhibitors - page 64
- Vaccines against components of the RAS - page 65
- Vasopeptidase inhibitors (VEPs) - page 65
- Novel targets for the treatment of hypertension - page 59
- Clinical trial design in hypertension - page 68
- Mortality endpoints - page 71
- Adequately powered - page 71
- Significant numbers of each sub-population - page 72
- Use of the gold standard as comparator drug - page 72
- Morbidity endpoints - page 72
- Trials conducted in patients uncontrolled on multiple drug therapy - page 73
- Use of surrogate markers - page 73
- Key research impacts on hypertension - page 73
- Outcome-based endpoints - page 73
- Impact of clinical trial duration on R&D budget - page 74
- Mortality endpoints - page 71
- CHAPTER 4 ANTI-HYPERTENSIVE PIPELINE ANALYSIS - page 75
- Pipeline summary - page 75
- Lifecycle management vs innovation - page 77
- Lifecycle management strategies - page 78
- Innovation - scarce, but biotechs continue to "think outside of the box" - page 82
- Vaccines - surprise pipeline projects - page 83
- Greatest number of drugs in Phase II of development - page 84
- Lifecycle management vs innovation - page 77
- Key companies involved in antihypertensive R&D - page 86
- Novartis - leading the way - page 86
- Pfizer - a notable absentee - page 88
- Pipeline summary - page 75
- CHAPTER 5 ANTI-HYPERTENSIVE LATE-STAGE DRUG ANALYSIS AND FORECASTS - page 91
- Overview - page 91
- Late-stage pipeline drugs to be analyzed - page 92
- Definition of current comparator therapy - page 93
- Cardoxal (MC-1 cardioprotectant plus lisinopril) - page 94
- Drug overview - page 94
- Key pre-clinical data - page 95
- Clinical trial data - page 96
- Author's comments - page 100
- Datamonitor's comments - page 101
- Marketing factors - page 101
- Patient potential - page 101
- SWOT analysis of Cardoxal - page 102
- Performance against benchmark criteria - page 103
- Forecasts for 2015 - page 104
- Clevelox (clevidipine) - page 106
- Drug overview - page 106
- Clinical trial data - page 106
- Marketing factors - page 108
- Patient potential - page 108
- SWOT analysis of Clevelox - page 109
- Performance against benchmark criteria - page 110
- Forecasts for 2015 - page 110
- CHF-1521 (manidipine plus delapril) - page 112
- Drug overview - page 112
- Clinical trial data - page 112
- Datamonitor's comments - page 113
- Marketing factors - page 115
- Patient potential - page 116
- SWOT analysis of CHF-1521 - page 116
- Performance against benchmark criteria - page 117
- Forecasts for 2015 - page 118
- Rasilez (aliskiren) - page 119
- Drug overview - page 119
- Clinical trial data - page 120
- Authors' comments - page 132
- Datamonitor's comments - page 132
- Marketing factors - page 134
- Patient potential - page 135
- SWOT analysis of Rasilez - page 136
- Performance against benchmark criteria - page 137
- Forecasts to 2015 - page 138
- Zanipress (lercanidipine plus enalapril) - page 140
- Drug overview - page 140
- Clinical trial data - page 140
- Datamonitor's comments - page 142
- Marketing factors - page 142
- Patient potential - page 143
- SWOT analysis of Zanipress - page 144
- Performance against benchmark criteria - page 145
- Forecasts to 2015 - page 146
- Other development compounds - page 148
- Drugs that inhibit the renin-angiotensin system (RAS) - page 148
- Angiotensin receptor blockers (ARBs) monotherapies and combination therapies - page 148
- Renin inhibitors - page 154
- Vaccines against components of the RAS - page 155
- Vasopeptidase inhibitors (VEPs) - page 158
- Drugs that do not inhibit the renin-angiotensin system - page 159
- Calcium channel blockers - page 159
- Endothelin receptor antagonists (ERAs) - page 161
- Drugs that inhibit the renin-angiotensin system (RAS) - page 148
- Comparative forecasts - page 163
- Comparative analysis - page 164
- APPENDIX A - page 167
- Methodology - page 167
- Datamonitor forecast methodology - page 167
- The forecasting model - page 167
- General event information - page 167
- Event selection and quantification - page 168
- Datamonitor forecast methodology - page 167
- Datamonitor drug assessment summary - page 168
- Contributing experts - page 171
- References - page 172
- Report methodology - page 180
- Methodology - page 167
- APPENDIX B - page 181
- About Datamonitor - page 181
- About Datamonitor Healthcare - page 181
- Datamonitor Healthcare's therapy area capabilities - page 182
- About the Cardiovascular analysis team - page 183
- Key therapy team members - page 184
- Dr Allison Fleetwood, Director, Cardiovascular, Diabetes and Women's Health - page 184
- Dr Duncan Emerton, Senior Analyst, Cardiovascular (report author) - page 184
- Disclaimer - page 185
- About Datamonitor - page 181
- List of Tables
- Table 1: Prevalence of hypertension in the seven major markets (000s), 2006-15 - page 11
- Table 2: Key global parameters of hypertension, 2002-15 - page 12
- Table 3: Pipeline drugs in development for hypertension, 2006 - page 14
- Table 4: Forecast key products in hypertension pipeline ($m) - page 15
- Table 5: A comparison of the various forms of hypertension recognized by three of the key hypertension guidelines - page 26
- Table 6: Unmet need comparators selected for baseline drug performance with weighting and score - page 43
- Table 7: Quantitative measures used for clinical efficacy endpoints - page 71
- Table 8: The antihypertensive R&D pipeline, 2006 - page 76
- Table 9: R&D approach to treating hypertension, 2006 - page 82
- Table 10: Phase of development of each treatment approach, 2006 - page 84
- Table 11: Composition of the antihypertensive R&D pipeline by company, 2006 - page 86
- Table 12: Antihypertensive late-stage pipeline, 2006 - drugs that act on the RAS - page 93
- Table 13: Assumptions and events influencing Cardoxal's forecasts - page 105
- Table 14: Assumptions and events influencing Clevelox's forecasts - page 111
- Table 15: Assumptions and events influencing Rasilez's forecasts - page 118
- Table 16: Selected published clinical trials for Rasilez (aliskiren) - page 121
- Table 17: Assumptions and events influencing Rasilez's forecasts - page 139
- Table 18: Assumptions and events influencing Rasilez's forecasts - page 146
- Table 19: Pipeline ARB monotherapies, 2006 - page 148
- Table 20: Pipeline ARB combination therapies, 2006 - page 148
- Table 21: Pipeline renin inhibitors, 2006 - page 154
- Table 22: Pipeline angiotensin vaccines, 2006 - page 155
- Table 23: Pipeline vasopeptidase inhibitors, 2006 - page 158
- Table 24: Pipeline calcium channel blockers, 2006 - page 160
- Table 25: Pipeline endothelin receptor antagonists, 2006 - page 161
- Table 26: Forecast key products in hypertension pipeline ($m) - page 163
- Table 27: Research, clinical and commercial attractiveness summary for key late-phase pipeline antihypertensive products - page 164
- Table 28: Datamonitor drug assessment parameters - page 169
- List of Figures
- Figure 1: TypeFigTitleHere - page 10
- Figure 2: Pipeline overview of antihypertensive drugs, 2006 - page 13
- Figure 3: Prevalence of hypertension broken down by age, 2004-15 - page 30
- Figure 4: Greatest unmet needs in hypertension, 2006 - page 37
- Figure 5: Baseline for drug comparison - page 44
- Figure 6: Regulation of blood pressure - page 46
- Figure 7: Treatment algorithm for hypertension - page 48
- Figure 8: The renin-angiotensin system - page 52
- Figure 9: Current pharmacological treatments for hypertension based on the inhibition of the RAS - page 54
- Figure 10: ET-1 production by the vascular endothelium and its mechanism for producing vascular smooth muscle contraction - page 61
- Figure 11: Endothelin receptors and the interaction with nitric oxide - page 62
- Figure 12: Pipeline overview of antihypertensive drugs, 2006 - page 77
- Figure 13: The majority of patients need at least a combination of two antihypertensive drugs to reach target BP - page 79
- Figure 14: Extent to which FDC would increase patient compliance in patients with hypertension and dyslipidemia only - page 80
- Figure 15: Percentage of antihypertensive R&D projects in the various stages of development, 2006 - page 85
- Figure 16: Novartis's marketed and R&D antihypertensive portfolio, 2006 - page 87
- Figure 17: Developmental targets for the treatment of hypertension based on direct interaction with the renin-angiotensin system (RAS) - page 92
- Figure 18: MATCHED study design - page 99
- Figure 19: SWOT analysis for Cardoxal - page 102
- Figure 20: Assessment of Cardoxal's performance indicators - page 104
- Figure 21: Global sales forecast for Cardoxal ($m), 2006-15. - page 105
- Figure 22: Phase III clinical development program for Clevelox - page 107
- Figure 23: SWOT analysis of Clevelox - page 109
- Figure 24: Assessment of Clevelox's performance indicators - page 110
- Figure 25: Global sales forecast for Clevelox ($m), 2006-15. - page 111
- Figure 26: SWOT analysis of CHF-1521 - page 116
- Figure 27: Assessment of CHF-1521's performance indicators - page 117
- Figure 28: Global sales forecast for CHF-1521 ($m), 2006-15. - page 119
- Figure 29: Study A1201; gross design and timeline - page 123
- Figure 30: Blood pressure reductions reported from study A1201 - page 124
- Figure 31: Study A2308; gross design and timeline - page 125
- Figure 32: Blood pressure reductions reported from study A2038 - page 126
- Figure 33: Systolic blood pressure (SBP) reductions during Novartis's SPP100 plus Diovan study (Study 2203) - page 128
- Figure 34: Diastolic blood pressure (DBP) reductions during Novartis's SPP100 plus Diovan study (Study 2203) - page 129
- Figure 35: Study A2204 - gross design and timeline - page 130
- Figure 36: Study A2307; gross design and timeline - page 131
- Figure 37: Study A2305; gross design and timeline - page 131
- Figure 38: SWOT analysis of Rasilez - page 136
- Figure 39: Assessment of Rasilez's performance indicators - page 138
- Figure 40: Global sales forecast for Rasilez ($m), 2006-15. - page 140
- Figure 41: SWOT analysis of Zanipress - page 144
- Figure 42: Assessment of Zanipress's performance indicators - page 145
- Figure 43: Global sales forecast for Zanipress ($m), 2006-15. - page 147
- Figure 44: The olmesartan-based treatment algorithm - page 151
- Figure 45: Blood pressure reductions in SHR rats (n=8) actively immunized with CYT006-AngQb - page 156
- Figure 46: Research, clinical and commercial attractiveness summary for key late-stage antihypertensive pipeline products - page 165
- Figure 47: Research, clinical and commercial attractiveness summary for key late-stage antihypertensive products - page 166
- Figure 48: Example of Datamonitor drug assessment scorecard - page 170
- Figure 49: An example drug assessment graph - page 171
Other users found this report page using the following search terms: hypertension antihypertensive blood pressure ace arb pipeline novartis antihypertensives hypertension drugs swot antihypertensive analysis clinical sales
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.