Chronic and Acute Heart Failure
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 4
- Scope of the analysis - page 4
- Datamonitor insight into the heart failure market - page 4
- The R&D pipeline for heart failure is a Phase II-heavy, diverse range of novel agents. The majority of drugs are being developed for chronic heart failure (CHF), but a significant number of these are add-on therapies. - page 5
- The heart failure market is relatively stable, with few drugs launched in the past five years. It is also a market with high unmet needs waiting to be addressed. - page 6
- The most promising CHF pipeline products target niche populations, but with limited commercial potential - page 6
- The acute heart failure (AHF) pipeline has high commercial potential but safety issues have led to disappointment for levosimendan, leaving tolvaptan as the most promising AHF product in the pipeline - page 7
- CHAPTER 2 PIPELINE OVERVIEW & FUTURE FOCUS - page 22
- Pipeline overview - page 22
- Heart failure: a diverse pipeline - page 25
- Greatest number of drugs in Phase II development - page 27
- Market is not dominated by any one company - page 28
- BMS and Sanofi-Aventis aim to boost future sales - page 29
- Development by Japanese-based companies has increased - page 30
- Greatest number of products being developed for chronic heart failure - page 30
- Pipeline overview - page 22
- CHAPTER 3 PIPELINE DYNAMICS - page 32
- Definition of heart failure - page 32
- Chronic heart failure - page 32
- Acute heart failure - page 33
- Etiology of heart failure - page 34
- Segmentation of heart failure - page 35
- Disease severity - page 35
- ESC guidelines on the use of devices in chronic heart failure - page 38
- Pacemakers - page 38
- Implantable cardioverter defibrillators (ICD) - page 38
- Age group - page 39
- Systolic versus diastolic heart failure - page 40
- Comorbidities, complications and risk factors - page 41
- Anemia: an emerging risk factor in chronic heart failure - page 42
- Epidemiology of heart failure - page 45
- Prevalence of chronic heart failure - page 45
- Incidence of acute heart failure - page 45
- Future trends in the incidence and prevalence of heart failure - page 46
- Unmet needs in heart failure - page 46
- Chronic heart failure - page 47
- Unmet need 1: increased safety profile - page 47
- Unmet need 2: increased efficacy - page 48
- Unmet need 3: ability to halt or reverse the progression of the disease - page 48
- Unmet need 4: improved quality of life - page 48
- Unmet need 6: increased compliance - page 49
- Unmet need 7: targeting niche markets - page 50
- Acute heart failure - page 50
- Unmet need 1: increased mortality benefit - page 51
- Unmet need 2: increased safety profile - page 51
- Unmet need 3: increased efficacy - page 52
- Unmet need 4: reduced length of hospital stay/ re-hospitalization - page 52
- Unmet need 5: drugs with novel mechanisms of action - page 53
- Chronic heart failure - page 47
- Definition of heart failure - page 32
- CHAPTER 4 R&D APPROACH - page 54
- Classification of pipeline products - page 54
- Chronic heart failure pipeline - page 55
- Adenosine A1 receptor antagonists - page 55
- Preclinical and clinical progress - page 55
- AGE crosslink breakers - page 55
- Preclinical and clinical progress - page 56
- Angiotensin II antagonists - page 57
- Preclinical and clinical progress (current) - page 57
- Benzodiazepine agonists - page 57
- Preclinical and clinical progress - page 57
- Cell transplant therapy - page 58
- Preclinical and clinical progress - page 58
- Chelating agents - page 58
- Preclinical and clinical progress - page 58
- Chymase inhibitors - page 59
- Preclinical and clinical progress - page 59
- eNOS transcription enhancers - page 59
- Preclinical and clinical progress - page 59
- Glucagon-like peptide-1 - page 60
- Preclinical and clinical progress - page 60
- Statins (HMG Co-A reductase inhibitors) - page 60
- Preclinical and clinical progress - page 61
- Immunomodulation therapy - page 61
- Preclinical and clinical progress - page 62
- Dual NEP and ECE inhibitors - page 62
- Preclinical and clinical progress - page 62
- Thyroid hormone agonists - page 63
- Preclinical and clinical progress - page 63
- Xanthine oxidase inhibitors - page 64
- Preclinical and clinical progress - page 64
- Adenosine A1 receptor antagonists - page 55
- Acute heart failure pipeline - page 65
- Atrial natriuretic peptide (ANP) agonists - page 65
- Preclinical and clinical progress - page 65
- Calcium sensitizers - page 65
- Preclinical and clinical progress - page 66
- CRF-R2 receptor agonists - page 66
- Preclinical and clinical progress - page 66
- Cardiac myosin activators - page 67
- Preclinical and clinical progress - page 67
- Na+,K+,ATPase inhibitors - page 67
- Preclinical and clinical progress - page 67
- ORL-1 agonists - page 68
- Preclinical and clinical progress - page 68
- Vasopressin antagonists - page 68
- Preclinical and clinical progress - page 68
- Atrial natriuretic peptide (ANP) agonists - page 65
- Clinical trial design in heart failure - page 69
- Comparators: add-on vs. replacement therapy - page 69
- Clinical trials endpoints in heart failure - page 69
- Use of surrogate endpoints - page 69
- Trials in chronic heart failure - page 70
- True endpoints - page 70
- Surrogate endpoints - page 71
- Trials in acute heart failure - page 72
- CHAPTER 5 CHRONIC HEART FAILURE LATE-STAGE DRUG ANALYSIS & FORECASTS - page 74
- Overview of chronic heart failure drugs - page 74
- Pipeline summary - page 74
- Definition of current comparator therapies - page 74
- Gold-standard therapy - page 74
- Angiotensin II receptor blockers (ARBs) - page 76
- Vas-991 (Celacade technology) - page 76
- Drug overview - page 76
- Clinical data - page 77
- Extensive Phase III trial underway - page 77
- Phase II trial results - page 77
- Patient potential - page 78
- Market potential - page 79
- Vas-991: performance against benchmark criteria - page 80
- SWOT analysis - page 81
- Forecast to 2014 - page 81
- Datamonitor comments - page 82
- Irbesartan (Aprovel) - page 83
- Drug overview - page 83
- Clinical data - page 83
- Limited information on irbesartan in CHF - page 83
- Patient potential - page 83
- Market potential - page 84
- Performance against benchmark criteria - page 85
- SWOT analysis - page 86
- Forecast to 2014 - page 87
- Datamonitor comments - page 87
- Trientine (Laszarin) - page 88
- Drug overview - page 88
- Clinical data - page 88
- Trientine improves LVH in patients with diabetes - page 88
- Patient potential - page 89
- Market potential - page 89
- Performance against benchmark criteria - page 90
- SWOT analysis - page 91
- Forecast to 2014 - page 92
- Datamonitor comments - page 93
- Overview of chronic heart failure drugs - page 74
- CHAPTER 6 COMPARATIVE ANALYSIS OF CHRONIC HEART FAILURE PIPELINE - page 95
- Comparative forecasts - page 95
- Comparative analysis - page 95
- CHAPTER 7 ACUTE HEART FAILURE LATE-STAGE DRUG ANALYSIS & FORECASTS - page 100
- Overview of acute heart failure drugs - page 100
- Pipeline summary - page 100
- Definition of current comparator therapies - page 100
- Oral diuretics - page 100
- Inotropic agents - page 101
- Vasodilators - page 101
- Nitrates - page 101
- Tolvaptan - page 102
- Drug overview - page 102
- Clinical data - page 102
- Large-scale Phase III trial ongoing - page 102
- ACTIV in CHF - page 102
- Trial comparing tolvaptan with furosemide - page 104
- Patient potential - page 104
- Market potential - page 105
- Performance against benchmark criteria - page 106
- SWOT analysis - page 107
- Forecast to 2014 - page 108
- Datamonitor comments - page 108
- Levosimendan (Simdax) - page 109
- Drug overview - page 109
- Clinical data - page 109
- Mixed results from latest Phase III trials - page 109
- Phase III trials - page 112
- Patient potential - page 115
- Market potential - page 116
- Performance against benchmark criteria - page 118
- SWOT analysis - page 119
- Forecast to 2014 - page 120
- Datamonitor comments - page 120
- Ularitide - page 121
- Drug overview - page 121
- Clinical data - page 122
- SIRIUS II - page 122
- SIRIUS I - page 122
- Patient potential - page 123
- Market potential - page 123
- Performance against benchmark criteria - page 124
- SWOT analysis - page 126
- Forecast to 2014 - page 127
- Datamonitor comments - page 127
- Overview of acute heart failure drugs - page 100
- CHAPTER 8 COMPARATIVE ANALYSIS OF ACUTE HEART FAILURE PIPELINE - page 129
- Comparative forecasts - page 129
- Comparative analysis - page 129
- CHAPTER 9 OTHER CHRONIC HEART FAILURE PRODUCTS - page 133
- Adentri (BG9928) - page 133
- Drug overview - page 133
- Clinical data - page 133
- Promising Phase II results - page 133
- ALT-711 - page 134
- Drug overview - page 134
- Clinical data - page 134
- Toxicity data may cause set back in Phase II - page 134
- Crestor (rosuvastatin) - page 135
- Drug overview - page 135
- Clinical data - page 136
- The CORONA trial: investigating the role of Crestor in CHF patients - page 136
- DITPA - page 136
- Drug overview - page 136
- Clinical data - page 136
- Two Phase II trials underway to assess safety - page 136
- Oxypurinol - page 138
- Drug overview - page 138
- Clinical data - page 138
- OPT-CHF - page 138
- La Plata - page 139
- Oral levosimendan - page 139
- Drug overview - page 139
- Clinical data - page 139
- r-GLP-1 (AC2592) - page 140
- Drug overview - page 140
- Clinical data - page 140
- Continuous infusion trial suggests a novel approach - page 140
- SLV-320 - page 141
- Drug overview - page 141
- SLV-306 (daglutril) - page 141
- Drug overview - page 141
- Clinical data - page 141
- Adentri (BG9928) - page 133
- CHAPTER 10 OTHER ACUTE HEART FAILURE PRODUCTS - page 143
- Carperitide - page 143
- Drug overview - page 143
- Clinical data - page 143
- Urocortin II - page 143
- Drug overview - page 143
- Clinical data - page 144
- Promising preliminary results - page 144
- ZP-120 - page 144
- Drug overview - page 144
- Clinical data - page 144
- Carperitide - page 143
- CHAPTER 11 INNOVATIVE EARLY-STAGE PROJECTS - ACUTE AND CHRONIC - page 146
- AN-260 - page 146
- Drug profile - page 146
- AVE-9488 - page 147
- Drug profile - page 147
- Preclinical data - page 147
- Cell transplant therapy - page 148
- Therapy profile - page 148
- Clinical data - page 148
- CK-1827452 - page 148
- Drug profile - page 148
- AN-260 - page 146
- APPENDIX A - page 150
- Datamonitor drug assessment summary - page 150
- Contributing experts - page 153
- Bibliography - page 154
- Epidemiology sources - page 154
- General and clinical trial data - page 154
- Epidemiology methodology - page 158
- Prevalence of chronic heart failure - page 158
- US - page 158
- UK - page 159
- Other markets - page 159
- Prevalence of chronic heart failure - page 158
- Incidence of acute heart failure - page 160
- US - page 160
- Japan - page 160
- France - page 160
- Germany - page 160
- Italy - page 161
- Spain - page 161
- UK - page 161
- Forecasting methodology - page 162
- Report methodology - page 162
- APPENDIX B - page 163
- About Datamonitor - page 163
- About Datamonitor Healthcare - page 163
- Datamonitor Healthcare's therapy area capabilities - page 164
- About the cardiovascular analysis team - page 165
- Disclaimer - page 166
- About Datamonitor - page 163
- List of Tables
- Table 1: R&D pipeline in the chronic heart failure market, 2005 - page 23
- Table 2: R&D pipeline in the acute heart failure market, 2005 - page 24
- Table 3: Heart failure pipeline by mechanism of action, 2005 - page 25
- Table 4: Heart failure pipeline, by company, 2005 - page 28
- Table 5: Causes of heart failure in the seven major markets (%), 2004 - page 34
- Table 6: Prevalence of chronic heart failure by age groups (000s), 2005 - page 39
- Table 7: Estimated proportion of chronic heart failure patients with comorbid conditions and risk factors in the seven major markets (%), 2004 - page 42
- Table 8: Current and future estimated prevalence of chronic heart failure in the seven major markets (000s), 2005-15 - page 45
- Table 9: Current and future estimated incidence of acute heart failure in the seven major markets (000s), 2005-15 - page 45
- Table 10: Key products in late-stage R&D pipeline for chronic heart failure, 2005 - page 74
- Table 11: Global sales for chronic heart failure pipeline products ($000s), 2005-14 - page 95
- Table 12: Research, clinical and commercial attractiveness summary for key late-phase pipeline chronic heart failure products - page 96
- Table 13: Key products in late-stage R&D pipeline for acute heart failure, 2005 - page 100
- Table 14: All-cause mortality results in the SURVIVE trial - page 111
- Table 15: Results of the CASINO trial, mortality at one-month and six-month follow-up - page 112
- Table 16: Global sales for chronic heart failure pipeline products ($000s), 2005-14 - page 129
- Table 17: Research, clinical and commercial attractiveness summary for key late-phase pipeline acute heart failure products - page 130
- Table 18: Drugs in Phase I development in acute/chronic heart failure, 2005 - page 146
- Table 19: Datamonitor drug assessment parameters - page 151
- List of Figures
- Figure 1: Overview of heart failure pipeline - page 27
- Figure 2: Percentage of chronic heart failure R&D products in each phase of development, 2005 - page 28
- Figure 3: Development by company type, 2005 - page 30
- Figure 4: Composition of the heart failure R&D pipeline by disease state, 2005 - page 31
- Figure 5: Segmentation of diagnosed chronic heart failure patients by disease severity, 2004 - page 36
- Figure 6: ACC/AHA practice guidelines for the evaluation and management of chronic heart failure - page 37
- Figure 7: Breakdown of heart failure patients according to whether failure is systolic, diastolic or both systolic and diastolic in the seven major markets, 2004 - page 41
- Figure 8: Unmet needs in chronic heart failure - page 47
- Figure 9: Unmet needs in acute heart failure - page 50
- Figure 10: Key mechanisms of disease progression in HF - page 54
- Figure 11: Assessment of Vas-991's performance indicators - page 80
- Figure 12: SWOT analysis: Vas-991 - page 81
- Figure 13: Global sales forecasts for Vas-991, 2008-14 - page 82
- Figure 14: Assessment of irbesartan's performance indicators - page 85
- Figure 15: SWOT analysis: irbesartan - page 86
- Figure 16: Global sales forecasts for irbesartan, 2008-14 - page 87
- Figure 17: Assessment of trientine's performance indicators - page 90
- Figure 18: SWOT analysis: trientine - page 91
- Figure 19: Global sales forecasts for trientine, 2010-14 - page 93
- Figure 20: Research, clinical and commercial attractiveness summary for key late-stage chronic heart failure pipeline products - page 97
- Figure 21: Research, clinical and commercial attractiveness summary for key late-stage chronic heart failure pipeline products - page 99
- Figure 22: ACTIV in CHF trial - page 103
- Figure 23: Assessment of tolvaptan performance indicators - page 106
- Figure 24: SWOT analysis: tolvaptan - page 107
- Figure 25: Global sales forecasts for tolvaptan, 2009-14 - page 108
- Figure 26: LIDO trial design - page 113
- Figure 27: RUSSLAN trial design - page 114
- Figure 28: Assessment of levosimendan's performance indicators - page 118
- Figure 29: SWOT analysis: levosimendan - page 119
- Figure 30: Global sales forecasts for levosimendan, 2010-14 - page 120
- Figure 31: Assessment of ularitide's performance indicators - page 124
- Figure 32: SWOT analysis: ularitide - page 126
- Figure 33: Global sales forecasts for ularitide, 2010-14 - page 127
- Figure 34: Research, clinical and commercial attractiveness summary for key late-stage acute heart failure pipeline products - page 130
- Figure 35: Research, clinical and commercial attractiveness summary for key late-stage acute heart failure pipeline products - page 131
- Figure 36: Trial design for DITPA,2005 - page 137
- Figure 37: Example of Datamonitor drug assessment scorecard - page 152
- Figure 38: Example of Datamonitor drug assessment graph - page 153
Other users found this report page using the following search terms: heart failure heart failure acute chronic stage late vs 3 definition trial
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.