Pipeline Insight: Dyslipidemia - Pipeline agents unlikely to rejuvenate the market
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 dyslipidemia market - page 5
- Single-pill combinations have their appeal, but not for every market - page 5
- Increased efficacy in HDL-C raising is the most important unmet need, but the fiasco of torcetrapib will impede speedy launch of efficacious HDL-raising agents - page 6
- Innovation is scarce among the pipeline agents - page 7
- The crowded antidyslipidemic market undergoing high genericization will make it challenging for the developmental compounds to secure a share of the market - page 8
- Datamonitor Pipeline Assessment Summary - page 9
- CHAPTER 2 PIPELINE OVERVIEW AND DYNAMICS - page 20
- Pipeline overview - page 20
- The antidyslipidemic pipeline is mechanistically diversified - page 24
- The antidyslipidemic pipeline is rich in Phase I and Phase II candidates - page 26
- Numerous companies have their stake in the R&D landscape - page 27
- Abbott holds most advanced developmental agents, but no innovation value - page 28
- Merck - unclear whether there is innovation in the pipeline - page 29
- GSK and Japan Tobacco hold more promise to satisfy the unmet needs - page 29
- Key R&D company strategies - page 30
- CHAPTER 3 DYSLIPIDEMIA - MARKET POTENTIAL - page 32
- Definition of dyslipidemia - page 32
- What is dyslipidemia? - page 32
- Segmentation of dyslipidemia - page 33
- Markers for dyslipidemia - page 33
- Main types of dyslipidemia - page 33
- Hypercholesterolemia - page 33
- Familial hypercholesterolemia - page 34
- Hypertriglyceridemia - page 35
- Familial hypertriglyceridemia - page 35
- Mixed dyslipidemia - page 35
- Epidemiology of dyslipidemia - page 36
- Epidemiology methodology - page 39
- US - page 39
- Japan - page 39
- France - page 40
- Germany - page 40
- Italy - page 40
- Spain - page 40
- UK - page 41
- Unmet needs in dyslipidemia - page 42
- Major obstacles between the drugs and the market - page 42
- Increased efficacy in raising HDL-cholesterol - page 45
- Drugs with novel mechanisms of actions - page 46
- Ability to prevent or even reverse the progression of atherosclerosis - page 47
- Increased efficacy in lowering LDL-C - page 47
- Combination therapies to treat patients with complicated lipid profiles - page 48
- Long-term data to support prevention of acute CVD events - page 49
- Further statin safety data - page 49
- Definition of dyslipidemia - page 32
- CHAPTER 4 R&D APPROACH - page 50
- Classification of pipeline products - page 50
- Statins and statin combinations - page 50
- Statins dominate the antidyslipidemic market - page 50
- Mechanism of action - page 51
- Fibrates - PPAR-alpha agonists - page 53
- Cholesteryl ester transfer protein (CETP) inhibitors: targeting HDL-C - page 54
- Lipoprotein lipase activator - page 55
- Microsomal triglyceride transfer (MTP) inhibitors - page 55
- Squalene synthase inhibitor - page 56
- Apolipoprotein B100 antagonist - page 56
- Dual PPAR agonists - page 57
- PPAR- delta agonists - page 58
- Transcription factor inhibitor - page 58
- Cholesterol transport/absorption Inhibitors - page 58
- Statins and statin combinations - page 50
- Clinical trial design in dyslipidemia - page 59
- Short-term endpoints: controlling cholesterol levels - page 59
- Long-term endpoints: reduction in morbidity and mortality - page 60
- Classification of pipeline products - page 50
- CHAPTER 5 STATINS AND STATIN COMBINATIONS - LATE-STAGE DRUG ANALYSIS & FORECASTS - page 61
- Overview for statins and statin combinations - page 61
- Pipeline summary - page 61
- Comparative forecasts - page 63
- Definition of current comparator therapy - page 64
- Pfizer's Lipitor remains the current comparator therapy - page 64
- Pitavastatin - page 67
- Drug overview - page 67
- Clinical trial data - page 67
- Patient potential - page 68
- Marketing factors - page 69
- Satisfaction of unmet needs - page 69
- Forecasts to 2016 - page 70
- Datamonitor drug assessment summary - page 72
- KS-01-019 (Simcor; Simvastatin + niacin ER) - page 75
- Drug overview - page 75
- Clinical trial data - page 75
- OCEANS - page 75
- SEACOAST - page 76
- AIM-HIGH - page 76
- Patient potential - page 76
- Marketing factors - page 78
- Satisfaction of unmet needs - page 78
- Forecasts to 2016 - page 79
- Datamonitor drug assessment summary - page 81
- Zolip (simvastatin + fenofibrate) - page 82
- Drug overview - page 82
- Clinical trial data - page 83
- Zolip 0501 - page 84
- Zolip 0502 - page 84
- Patient potential - page 84
- Marketing factors - page 84
- Satisfaction of unmet needs - page 84
- Forecasts to 2016 - page 85
- Datamonitor drug assessment summary - page 87
- Other statins/statin combinations - page 88
- Rosuvastatin + ABT-335 - page 88
- MK-0524B - page 89
- Overview for statins and statin combinations - page 61
- CHAPTER 6 OTHER THERAPIES - LATE-STAGE DRUG ANALYSIS AND FORECASTS - page 90
- Overview for other therapies - page 90
- Pipeline summary - page 90
- Comparative forecasts - page 91
- Definition of current comparator therapy - page 92
- Niacin remains the HDL raising agent with highest efficacy - page 92
- Ezetimibe remains the biggest revenue generating adjunct therapy - page 94
- Lapaquistat - page 95
- Drug overview - page 95
- Clinical trial data - page 95
- Patient potential - page 96
- Marketing factors - page 96
- Satisfaction of unmet needs - page 96
- Forecasts to 2016 - page 97
- Datamonitor drug assessment summary - page 99
- JTT-705 (R1658) - page 101
- Drug overview - page 101
- Clinical trial data - page 102
- 34% increase in HDL in Phase II clinical trials - page 102
- Ongoing clinical trials - page 102
- Patient potential - page 103
- Marketing factors - page 103
- Satisfaction of unmet needs - page 103
- Forecasts to 2016 - page 104
- Datamonitor drug assessment summary - page 106
- FM-VP4 (phytosterol analogue) - page 108
- Drug overview - page 108
- Clinical trial data - page 108
- Phase I trials show excellent safety profile - page 109
- Phase II trials bring forward disappointing efficacy - page 109
- Patient potential - page 110
- Marketing factors - page 111
- FM VP4 will require a marketing partner - page 111
- Satisfaction of unmet needs - page 111
- Forecasts to 2016 - page 112
- Datamonitor drug assessment summary - page 114
- ISIS-301012, injectable - page 117
- Drug overview - page 117
- Clinical trial data - page 117
- Phase II results - page 117
- Phase I results - page 118
- Patient potential - page 118
- Marketing factors - page 119
- Satisfaction of unmet needs - page 119
- Forecasts to 2016 - page 120
- Datamonitor drug assessment summary - page 122
- Other agents - page 124
- MK-0524A - page 124
- Clinical Trials - page 124
- Trial Results - page 125
- ABT-335 - page 125
- MD-0727 - page 125
- CRD-5 - page 126
- KB-2115 - page 127
- CETi-1 (vaccine) - page 128
- Implitapide (BAY-13-9952; AEGR-427) - page 128
- MK-0859 - page 129
- AEGR-733 (BMS-201038) - page 129
- QC-BT16 - page 130
- LY-674 (LY-518674) - page 131
- KRP-101 - page 131
- 3,5-diiodothyropropionic acid (DITPA) - page 131
- Ibrolipim (NO-1886) - page 132
- AVE-0847 - page 132
- LBM-642 - page 133
- GW-501516 - page 133
- GW-590735 - page 133
- GFT-14 - page 133
- Fenofibrate and pravastatin - page 134
- MK-0524A - page 124
- Overview for other therapies - page 90
- BIBLIOGRAPHY - page 135
- Bibliography - page 135
- Epidemiology sources - page 135
- US - page 135
- Japan - page 135
- France - page 135
- Germany - page 136
- Italy - page 136
- Spain - page 136
- UK - page 137
- Clinical trial data - page 137
- Epidemiology sources - page 135
- Bibliography - page 135
- APPENDIX A - page 144
- Methodology - page 144
- Datamonitor forecast methodology - page 144
- Product forecasts - page 144
- Definition of a standard unit (only use if ForeSight model used to forecast) - page 144
- Datamonitor forecast methodology - page 144
- Methodology - page 144
- APPENDIX B - page 147
- About Datamonitor - page 147
- About Datamonitor Healthcare - page 147
- Datamonitor Healthcare's therapy area capabilities - page 148
- About the Disease analysis team - page 149
- Disclaimer - page 150
- About Datamonitor - page 147
- List of Tables
- Table 1: R&D pipeline in Dyslipidemia, 2007 - page 21
- Table 2: The pipeline for antidyslipidemic agents by mechanism of action, 2007 - page 24
- Table 3: Pipeline of antidyslipidemic agents by company, 2007 - page 27
- Table 4: Key changes to lipid levels between the NCEP II and NCEP III - page 34
- Table 5: Prevalence estimates of dyslipidemia (000s), 2007-16 - page 38
- Table 6: Currently available statins, 2007 - page 52
- Table 7: Key products in the late-stage R&D pipeline for statins and statin combinations, 2007 - page 63
- Table 8: Lipitor: key facts, 2007 - page 66
- Table 9: Ability of pitavastatin to satisfy the unmet needs - page 70
- Table 10: Impacting factors on the revenues of pitavastatin, 2007-2016 - page 72
- Table 11: Ability of Simcor to satisfy the unmet needs - page 79
- Table 12: Impacting factors on the revenues of Simcor, 2007-2016 - page 80
- Table 13: Ability of Zolip to satisfy the unmet needs - page 85
- Table 14: Impacting factors on the revenues of Zolip, 2007-2016 - page 86
- Table 15: Key products in late-stage R&D pipeline for other therapies, 2007 - page 91
- Table 16: Niaspan: key facts, 2007 - page 93
- Table 17: Zetia: key facts, 2007 - page 94
- Table 18: Ability of Lapaquistat to satisfy the unmet needs - page 97
- Table 19: Impacting factors on the revenues of Lapaquistat, 2007-2016 - page 98
- Table 20: Ability of JTT-705 to satisfy the unmet needs - page 104
- Table 21: Impacting factors on the revenues of JTT-705, 2007-2016 - page 105
- Table 22: Ability of FM-VP4 to satisfy the unmet needs - page 112
- Table 23: Impacting factors on the revenues of FM-VP4, 2007-2016 - page 114
- Table 24: Ability of ISIS-301012 (injectable) to satisfy the unmet needs - page 120
- Table 25: Impacting factors on the revenues of ISIS-301012 (injectable), 2007-2016 - page 121
- Table 26: Datamonitor drug assessment parameters - page 145
- List of Figures
- Figure 1: Datamonitor drug assessment summary of statins and statin combinations in development for dyslipidemia, 2007 - page 9
- Figure 2: Datamonitor drug assessment summary of other therapies in development for dyslipidemia, 2007 - page 10
- Figure 3: Pipeline of antidyslipidemic compounds, 2007 - page 20
- Figure 4: The pipeline for antidyslipidemic agents by mechanism of action, 2007 - page 25
- Figure 5: Pipeline maturity: percentage of R&D products in each Phase of development, 2007 - page 26
- Figure 6: Unmet needs in the dyslipidemia market, 2007 - page 45
- Figure 7: Datamonitor drug assessment summary of statins and statin combinations in development for dyslipidemia, 2007 - page 62
- Figure 8: Sales forecasts for statins and statin combinations, seven major markets, 2007-2016 - page 63
- Figure 9: Sales forecast for Pitavastatin in dyslipidemia to 2016, seven major markets - page 71
- Figure 10: Datamonitor's competitive positioning analysis of Pitavastatin, 2007 - page 73
- Figure 11: Clinical and commercial attractiveness of pitavastatin broken down by main parameters - page 74
- Figure 12: Sales forecast for Simcor in dyslipidemia to 2016, seven major markets - page 80
- Figure 13: Datamonitor's competitive positioning analysis of KS-01-19 (Simcor), 2007 - page 81
- Figure 14: Clinical and commercial attractiveness of Simcor broken down by main parameters - page 82
- Figure 15: Sales forecast for Zolip in dyslipidemia to 2016, seven major markets - page 86
- Figure 16: Datamonitor's competitive positioning analysis of Zolip, 2007 - page 87
- Figure 17: Clinical and commercial attractiveness of Zolip broken down by main parameters - page 88
- Figure 18: Datamonitor drug assessment summary of other therapies in development for dyslipidemia, 2007 - page 90
- Figure 19: Sales forecasts for other therapies, seven major markets, 2007-2016 - page 92
- Figure 20: Sales forecast for Lapaquistat in dyslipidemia to 2016, seven major markets - page 98
- Figure 21: Datamonitor's competitive positioning analysis of Lapaquistat, 2007 - page 99
- Figure 22: Clinical and commercial attractiveness of Lapaquistat broken down by main parameters - page 100
- Figure 23: Sales forecast for JTT-705 in dyslipidemia to 2016, seven major markets - page 105
- Figure 24: Datamonitor's competitive positioning analysis of JTT-705, 2007 - page 106
- Figure 25: Clinical and commercial attractiveness of JTT-705 broken down by main parameters - page 107
- Figure 26: Sales forecast for FM-VP4 in dyslipidemia to 2016, seven major markets - page 113
- Figure 27: Datamonitor's competitive positioning analysis of FM-VP4, 2007 - page 115
- Figure 28: Clinical and commercial attractiveness of FM-VP4 broken down by main parameters - page 116
- Figure 29: Sales forecast for ISIS-301012 (injectable) in dyslipidemia to 2016, seven major markets - page 121
- Figure 30: Datamonitor's competitive positioning analysis of ISIS-301012 (injectable), 2007 - page 122
- Figure 31: Clinical and commercial attractiveness of ISIS-301012 (injectable) broken down by main parameters - page 123
- Figure 32: Datamonitor drug assessment summary of pipeline molecular targeted therapies in development for hematological malignancies, 2007 - page 146
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