Pipeline Insight: Antidyslipidemics
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
- Datamonitor insight into the antidyslipidemics market - page 3
- R&D pipeline dynamics - page 3
- Guideline recommendations for an aggressive treatment approach emphasizes a need for more treatment options - page 4
- Pfizer's atorvastatin + torcetrapib combination to become a blockbuster drug - page 5
- JTT-705- the most promising adjunct in development - page 6
- Datamonitor insight into the antidyslipidemics market - page 3
- CHAPTER 2 PIPELINE OVERVIEW & FUTURE FOCUS - page 17
- Pipeline overview - page 17
- PPAR agonists dominate the antidyslipidemic pipeline - page 20
- Greatest number of drugs in Phase II of development - page 22
- Pfizer has the greatest number of products in development - page 24
- Heavy investment from Japanese-based pharmaceutical companies - page 26
- Pfizer's strategy to success - page 28
- Pfizer protecting its revenue - page 28
- Pfizer's strategy under scrutiny - page 29
- Thought needs to be given to pricing strategy - page 29
- Merck - the loss of Zocor's patent - page 31
- Diversifying its portfolio - page 32
- In-licensing - page 32
- Expansion - page 33
- Streamlining - page 34
- HeartPro and Vytorin - page 34
- Pipeline overview - page 17
- CHAPTER 3 PIPELINE DYNAMICS - page 35
- Definition of dyslipidemia - page 35
- What is dyslipidemia? - page 35
- Segmentation of dyslipidemia - page 36
- Markers for dyslipidemia - page 36
- Main types of dyslipidemia - page 36
- Hypercholesterolemia - page 36
- Familial hypercholesterolemia - page 37
- Hypertriglyceridemia - page 38
- Familial hypertriglyceridemia - page 38
- Mixed dyslipidemia - page 38
- Epidemiology of dyslipidemia - page 39
- The greatest unmet need in dyslipidemia according to key opinion leaders, is for drugs with the ability to prevent or reverse atherosclerosis - page 44
- Drugs need to prevent or even reverse the progression of atherosclerosis - page 45
- Drugs with novel mechanisms of action - page 45
- Drugs with increased efficacy in lowering LDL and increasing HDL - page 45
- More long-term data is required to support primary and secondary prevention of acute CVD events. - page 46
- More combination therapies are needed - page 46
- Additional statin safety studies not required - page 46
- Definition of dyslipidemia - page 35
- CHAPTER 4 R&D APPROACH - page 48
- Classification of pipeline products - page 48
- Statins and statin combinations - page 51
- Statins dominate the antidyslipidemic market - page 51
- Mechanism of action - page 51
- Atorvastatin + CETP inhibitor - page 52
- Simvastatin + niacin - page 54
- Fibrates - PPAR alpha agonists - page 57
- Fibrate + biguanide - page 57
- Other non-statin therapies - page 58
- Acyl-CoA cholesterol acetyltransferase (ACAT) inhibitors - page 58
- Ileal bile acid transport (IBAT) inhibitors - page 58
- Lipoprotein lipase activator - page 59
- Microsomal triglyceride transfer (MTP) inhibitors - page 59
- Squalene synthetase inhibitor - page 59
- Bile acid reabsorption inhibitor - page 59
- Adenosine A1A receptor agonist - page 60
- Apolipoprotein B100 antagonist - page 60
- Dual PPAR agonists - page 60
- PPAR delta agonist - page 61
- VCAM inhibitor - page 61
- Hypolipemic agent - page 61
- Lipoprotein regulator - page 62
- Transcription factor inhibitor - page 62
- Cholesterol absorption inhibitors - page 62
- Statins and statin combinations - page 51
- Clinical trial design in dyslipidemia - page 62
- Short term endpoints: controlling cholesterol levels - page 62
- Long term endpoints: reduction in morbidity and mortality - page 63
- Classification of pipeline products - page 48
- CHAPTER 5 SINGLE-PILL STATIN COMBINATION LATE-STAGE DRUG ANALYSIS & FORECASTS - page 65
- Overview for single-pill statin combination drugs - page 65
- Pipeline summary - page 65
- Definition of current comparator therapy - page 65
- Pfizer's Lipitor remains the current comparator therapy - page 66
- Lipitor's rise to prominence - page 66
- KS-01-019 - page 68
- Clinical trials still underway - page 69
- Good patient potential - page 69
- Marketing of Advicor provides Kos with experience - page 70
- KS-01-019 performance will depend on its long-term data - page 71
- SWOT analysis - page 73
- Forecast to 2015 - page 73
- Atorvastatin + torcetrapib - page 75
- Extensive Phase III trial underway - page 75
- Significant increases in HDL cholesterol seen in Phase II trials - page 76
- Elevations of 16-91% in HDL are seen in Phase I trials - page 77
- Good patient potential if it can prove to reduce the progression of CHD - page 77
- Marketing strategy aims to help Pfizer retain monopoly - page 78
- The overall performance of atorvastatin + torcetrapib combination is lower than atorvastatin - page 78
- SWOT analysis - page 80
- Forecast to 2015 - page 81
- Datamonitor drug assessment summary - page 82
- Overview for single-pill statin combination drugs - page 65
- CHAPTER 6 FIBRATES AND FIBRATE COMBINATIONS LATE-STAGE DRUG ANALYSIS AND FORECASTS - page 86
- Pipeline summary - page 86
- Fenofibrate is the current comparator therapy - page 86
- Fenofibrate + metformin single-pill combination - page 87
- No clinical trial data - page 88
- Limited patient potential - page 88
- Previous experience in marketing fenofibrate and metformin should enable Merck and Fournier to market the drug successfully - page 88
- Overall performance rated lower than fenofibrates - page 88
- SWOT analysis - page 90
- Forecast to 2015 - page 90
- LCP Feno - page 92
- LCP Feno met both primary and secondary objectives in clinical trial - page 92
- LCP Feno offers another choice of fibrate for physicians - page 93
- Marketing partner for LCP Feno is unknown - page 93
- LCP Feno's performance rated lower than fenofibrate - page 93
- SWOT analysis - page 95
- Forecast to 2015 - page 95
- Datamonitor drug assessment summary - page 97
- CHAPTER 7 ADJUNCTIVE THERAPY LATE STAGE ANALYSIS - page 101
- Pipeline summary - page 101
- Three different comparator therapies - page 101
- Implitapide - page 103
- Phase II trials are ongoing - page 103
- Phase I showed significant lowering of LDL of up to 58% - page 104
- Potential alternative to statins - page 104
- Co-marketing deal may boost sales - page 104
- Implitapide's performance rated lower than atorvastatin - page 105
- Forecasts to 2015 - page 106
- JTT-705 - page 107
- 34% increase in HDL in Phase II clinical trials - page 107
- Excellent patient potential as adjunctive therapy - page 108
- Marketing factors - page 108
- JTT-705 shows better potential than Niaspan - page 108
- Forecast to 2015 - page 109
- Pamaqueside - page 111
- Phase I trial showed a 12% reduction in LDL cholesterol - page 111
- Further trials required to determine patient potential - page 111
- Pamaqueside will benefit from Pfizer's marketing experience - page 112
- Pamaqueside assessed performance lower than Zetia - page 112
- Forecast to 2015 - page 113
- Gemcabene - page 115
- Clinical trial data shows significant increases in HDL - page 115
- Gemcabene needs to prove itself as an adjunct to perform well in the market - page 116
- Gemcabene has Pfizer's marketing strength behind it - page 116
- The unavailability of long-term data lowers overall performance to poorer than fenofibrate - page 116
- Forecasts to 2015 - page 117
- FM VP4 - page 119
- Phase I trials show excellent safety profile - page 119
- Phase II trials still underway - page 120
- Potential as a safe top-up drug - page 121
- FM VP4 will require a marketing partner - page 121
- Overall performance rated less than Zetia - page 121
- Forecast to 2015 - page 123
- Datamonitor drug assessment summary - page 124
- CHAPTER 8 COMPARATIVE FORECASTS - page 128
- Comparative analysis - page 128
- CHAPTER 9 INNOVATIVE EARLY-STAGE PROJECTS - page 132
- Gene therapy appears to be a key therapy in preclinical development for dyslipidemia - page 132
- APPENDIX A - page 134
- Epidemiology methodology - page 134
- Datamonitor forecast methodology - page 134
- Methodology - page 134
- US - page 134
- Japan - page 135
- France - page 136
- Germany - page 136
- Italy - page 137
- Spain - page 137
- UK - page 137
- Datamonitor drug assessment summary - page 137
- Contributing experts - page 140
- Bibliography - page 141
- Epidemiology sources - page 141
- US - page 141
- Japan - page 141
- France - page 141
- Germany - page 141
- Italy - page 141
- Spain - page 142
- UK - page 142
- Clinical trial data - page 142
- Epidemiology sources - page 141
- Report methodology - page 143
- About Datamonitor - page 143
- About Datamonitor Healthcare - page 144
- Datamonitor Healthcare's therapy area capabilities - page 145
- About the cardiovascular analysis team - page 145
- Disclaimer - page 147
- Epidemiology methodology - page 134
- List of Tables
- Table 1: R&D pipeline in the antidyslipidemic market, 2005 - page 18
- Table 2: Antidyslipidemic pipeline, 2005 - page 21
- Table 3: Phase of development of products in each class, 2005 - page 23
- Table 4: Composition of the antidyslipidemic R&D pipeline by company. - page 25
- Table 5: Key changes to lipid levels between the NCEP II and NCEP III - page 37
- Table 6: Epidemiology overview of dyslipidemia, 2005-15 - page 40
- Table 7: Epidemiology figures by age for the seven major markets, 2005 - page 41
- Table 8: Total epidemiology figures by age for the seven major markets, 2005 - page 42
- Table 9: R&D pipeline in the antidyslipidemic market, 2005 - page 49
- Table 10: Key products in late-stage R&D pipeline for single pill statin combination drugs, 2005 - page 65
- Table 11: Global sales of the leading branded statins, 2003-04 - page 66
- Table 12: Lipitor: key facts - page 68
- Table 13: Global sales forecasts for simvastatin + Niaspan, 2007-15 - page 74
- Table 14: Factors affecting the revenues of simvastatin + Niaspan, 2007-15 - page 75
- Table 15: Phase II trial results of atorvastatin + torcetrapib combination - page 77
- Table 16: Global sales forecasts for atorvastatin + torceptrapib, 2008-15 - page 81
- Table 17: Factors affecting the revenues of atorvastatin +torcetrapib, 2008-15 - page 82
- Table 18: Research, clinical and commercial attractiveness summary for pipeline single-pill statin combination drugs - page 83
- Table 19: Key products in late-stage R&D pipeline for HDL targeting agents & combinations, 2005 - page 86
- Table 20: Lipanthyl/Tricor: key facts - page 87
- Table 21: Global sales forecasts for metformin + fenofibrate, 2007-15 - page 91
- Table 22: Factors affecting the revenues of metformin + fenofibrate, 2007-15 - page 92
- Table 23: Global sales forecasts for LCP Feno, 2006-15 - page 96
- Table 24: Factors affecting the revenues of LCP Feno, 2010-15 - page 97
- Table 25: Research, clinical and commercial attractiveness summary for pipeline fibtates and fibrate combination drugs - page 97
- Table 26: Key products in late-stage R&D pipeline for HDL targeting agents & combinations, 2005 - page 101
- Table 27: Niaspan: key facts - page 102
- Table 28: Zetia: key facts - page 103
- Table 29: Global sales forecasts for implitapide, 2009-15 - page 106
- Table 30: Factors affecting the revenues of implitapide, 2009-15 - page 107
- Table 31: Global sales forecasts for JTT-705, 2009-15 - page 110
- Table 32: Factors affecting the revenues of JTT-705, 2009-15 - page 110
- Table 33: Global sales forecasts for simvastatin + Niaspan, 2007-15 - page 114
- Table 34: Factors affecting the revenues of pamaqueside, 2009-15 - page 115
- Table 35: Global sales forecasts for Gemcabene, 2009-15 - page 118
- Table 36: Factors affecting the revenues of gemcabene, 2009-15 - page 119
- Table 37: Global sales forecasts for FM VP4, 2008-15 - page 124
- Table 38: Factors affecting the revenues of FM VP4, 2008-15 - page 124
- Table 39: Research, clinical and commercial attractiveness summary for pipeline adjunctive therapies - page 125
- Table 40: Global sales forecasts for anti-dyslipidemic drugs, 2005-15 - page 128
- Table 41: Drugs in preclinical development for dyslipidemia, 2005 - page 132
- Table 42: Datamonitor drug assessment parameters - page 138
- List of Figures
- Figure 1: Pipeline overview of antidyslipidemic drugs - page 20
- Figure 2: Percentage of R&D products in each phase of development, 2005 - page 24
- Figure 3: Composition of the antidyslipidemic R&D pipeline by country, 2005 - page 27
- Figure 4: Composition of the antidyslipidemic R&D pipeline by company type - page 28
- Figure 5: Unmet needs in the dyslipidemia market, 2005 - page 44
- Figure 6: Assessment of KS-01-019's performance indicators - page 71
- Figure 7: KS-01-019 SWOT analysis - page 73
- Figure 8: Global sales forecasts for simvastatin + Niaspan, 2007-15 - page 74
- Figure 9: Assessment of atorvastatin + torcetrapib's performance indicators - page 79
- Figure 10: SWOT analysis of atorvastatin + torcetrapib combination - page 80
- Figure 11: Global sales forecasts for atorvastatin + torceptrapib, 2008-15 - page 81
- Figure 12: Research/clinical and commercial attractiveness of single-pill statin combinations - page 83
- Figure 13: Datamonitor's drug assessment summary for the late-phase pipeline single-pill statin combination drugs - page 85
- Figure 14: Assessment of metformin + fenofibrate performance indicators - page 89
- Figure 15: Metformin + fenofibrate SWOT analysis - page 90
- Figure 16: Global sales forecasts for metformin + fenofibrate, 2007-15 - page 91
- Figure 17: Assessment of LCP Feno's performance indicators - page 94
- Figure 18: LCP Feno SWOT analysis - page 95
- Figure 19: Global sales forecasts for LCP Feno, 2006-15 - page 96
- Figure 20: Research/clinical and commercial attractiveness of fibrate and fibrate combination drugs - page 98
- Figure 21: Datamonitor's drug assessment summary for the late-phase pipeline single-pill statin combination drugs - page 99
- Figure 22: Assessment of implitapide's performance indicators - page 105
- Figure 23: Global sales forecasts for implitapide, 2009-15 - page 106
- Figure 24: Assessment of JTT-705's performance indicators - page 109
- Figure 25: Global sales forecasts for JTT-705, 2009-15 - page 109
- Figure 26: Assessment of pamaqueside's performance indicators - page 112
- Figure 27: Global sales forecasts for pamaqueside, 2009-15 - page 114
- Figure 28: Assessment of Gemcabene's performance indicators - page 116
- Figure 29: Global sales forecasts for Gemcabene, 2009-15 - page 118
- Figure 30: Assessment of FM VP4's performance indicators - page 122
- Figure 31: Global sales forecasts for FM VP4, 2008-15 - page 123
- Figure 32: Research/clinical and commercial attractiveness of adjunctive therapies - page 126
- Figure 33: Datamonitor's drug assessment summary for the late-phase pipeline adjunctive therapies - page 127
- Figure 34: Datamonitor's drug assessment summary for the late-phase antidyslipidemic pipeline drugs - page 129
- Figure 35: Example of Datamonitor drug assessment scorecard - page 139
- Figure 36: Example of Datamonitor drug assessment graph - page 140
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