Overview
Introduction
Datamonitor estimates that there are 267m people in the seven major markets with total cholesterol >200mg/dL and this is set to rise to 286m in 2015. The market has been dominated by statins for a number of years now, however, with updated guidelines taking a more aggressive approach to treatment, there is a need for more efficacious and safe alternatives on the market.
Scope
- Patient potential for developmental antidyslipidemics over the period 2005-2015
- Insight into the R&D pipeline with detailed information on drugs in development, clinical trial results and identification of suitable comparators
- Evaluation of key players in the antidyslipidemics market and opposing company approaches to development and commercialization
- Analysis of key antidyslipidemic drugs in development and their ability to satisfy major unmet needs and compete with existing agents
Highlights
The NCEP committee updated the guidelines in 2004, taking a more aggressive approach to the treatment of dyslipidemia to help further reduce cardiovascular risk. This in turn has increased the need for alternative drugs that can help lower LDL cholesterol to meet the new lower threshold without putting patients at risk.
The antidyslipidemic R&D pipeline is still relatively young with 91% of drugs in Phase I and II. There also appears to be a lot of investment in adjunctive therapies with approximately 69% of the drugs in the pipeline representing this class.
Datamonitor has identified Pfizers atorvastatin + torcetrapib combination drug and Japan Tobaccos JTT-705 as the most promising drugs in the pipeline. The atorvastatin + torcetrapib combination target both LDL and HDL with a synergistic effect which means it may offer significant advantages in efficacy with improved safety.
Reasons to Purchase
- View independent sales forecasts for drugs in late stage development for treatment of dyslipidemia
- Examine the classes of products in development by phase and the challenges they have to face to reach the market
- Identify early-stage antidyslipidemic compounds with high potential being developed by companies seeking a marketing partner
TABLE OF CONTENTS
ABOUT DATAMONITOR HEALTHCARE
- About the cardiovascular pharmaceutical analysis team
CHAPTER 1 EXECUTIVE SUMMARY
- Datamonitor insight into the antidyslipidemics market
- R&D pipeline dynamics
- Guideline recommendations for an aggressive treatment approach emphasizes a need for more treatment options
- Pfizers atorvastatin + torcetrapib combination to become a blockbuster drug
- JTT-705- the most promising adjunct in development
CHAPTER 2 PIPELINE OVERVIEW & FUTURE FOCUS
- Pipeline overview
- PPAR agonists dominate the antidyslipidemic pipeline
- Greatest number of drugs in Phase II of development
- Pfizer has the greatest number of products in development
- Heavy investment from Japanese-based pharmaceutical companies
- Pfizers strategy to success
- Pfizer protecting its revenue
- Pfizers strategy under scrutiny
- Thought needs to be given to pricing strategy
- Merck - the loss of Zocors patent
- Diversifying its portfolio
- In-licensing
- Expansion
- Streamlining
- HeartPro and Vytorin
CHAPTER 3 PIPELINE DYNAMICS
- Definition of dyslipidemia
- What is dyslipidemia?
- Segmentation of dyslipidemia
- Markers for dyslipidemia
- Main types of dyslipidemia
- Hypercholesterolemia
- Familial hypercholesterolemia
- Hypertriglyceridemia
- Familial hypertriglyceridemia
- Mixed dyslipidemia
- Epidemiology of dyslipidemia
- The greatest unmet need in dyslipidemia according to key opinion leaders, is for drugs with the ability to prevent or reverse atherosclerosis
- Drugs need to prevent or even reverse the progression of atherosclerosis
- Drugs with novel mechanisms of action
- Drugs with increased efficacy in lowering LDL and increasing HDL
- More long-term data is required to support primary and secondary prevention of acute CVD events.
- More combination therapies are needed
- Additional statin safety studies not required
CHAPTER 4 R&D APPROACH
- Classification of pipeline products
- Statins and statin combinations
- Statins dominate the antidyslipidemic market
- Mechanism of action
- Atorvastatin + CETP inhibitor
- Simvastatin + niacin
- Fibrates - PPAR alpha agonists
- Fibrate + biguanide
- Other non-statin therapies
- Acyl-CoA cholesterol acetyltransferase (ACAT) inhibitors
- Ileal bile acid transport (IBAT) inhibitors
- Lipoprotein lipase activator
- Microsomal triglyceride transfer (MTP) inhibitors
- Squalene synthetase inhibitor
- Bile acid reabsorption inhibitor
- Adenosine A1A receptor agonist
- Apolipoprotein B100 antagonist
- Dual PPAR agonists
- PPAR delta agonist
- VCAM inhibitor
- Hypolipemic agent
- Lipoprotein regulator
- Transcription factor inhibitor
- Cholesterol absorption inhibitors
- Clinical trial design in dyslipidemia
- Short term endpoints: controlling cholesterol levels
- Long term endpoints: reduction in morbidity and mortality
CHAPTER 5 SINGLE-PILL STATIN COMBINATION LATE-STAGE DRUG ANALYSIS & FORECASTS
- Overview for single-pill statin combination drugs
- Pipeline summary
- Definition of current comparator therapy
- Pfizers Lipitor remains the current comparator therapy
- Lipitors rise to prominence
- KS-01-019
- Clinical trials still underway
- Good patient potential
- Marketing of Advicor provides Kos with experience
- KS-01-019 performance will depend on its long-term data
- SWOT analysis
- Forecast to 2015
- Atorvastatin + torcetrapib
- Extensive Phase III trial underway
- Significant increases in HDL cholesterol seen in Phase II trials
- Elevations of 16-91% in HDL are seen in Phase I trials
- Good patient potential if it can prove to reduce the progression of CHD
- Marketing strategy aims to help Pfizer retain monopoly
- The overall performance of atorvastatin + torcetrapib combination is lower than atorvastatin
- SWOT analysis
- Forecast to 2015
- Datamonitor drug assessment summary
CHAPTER 6 FIBRATES AND FIBRATE COMBINATIONS LATE-STAGE DRUG ANALYSIS AND FORECASTS
- Pipeline summary
- Fenofibrate is the current comparator therapy
- Fenofibrate + metformin single-pill combination
- No clinical trial data
- Limited patient potential
- Previous experience in marketing fenofibrate and metformin should enable Merck and Fournier to market the drug successfully
- Overall performance rated lower than fenofibrates
- SWOT analysis
- Forecast to 2015
- LCP Feno
- LCP Feno met both primary and secondary objectives in clinical trial
- LCP Feno offers another choice of fibrate for physicians
- Marketing partner for LCP Feno is unknown
- LCP Fenos performance rated lower than fenofibrate
- SWOT analysis
- Forecast to 2015
- Datamonitor drug assessment summary
CHAPTER 7 ADJUNCTIVE THERAPY LATE STAGE ANALYSIS
- Pipeline summary
- Three different comparator therapies
- Implitapide
- Phase II trials are ongoing
- Phase I showed significant lowering of LDL of up to 58%
- Potential alternative to statins
- Co-marketing deal may boost sales
- Implitapides performance rated lower than atorvastatin
- Forecasts to 2015
- JTT-705
- 34% increase in HDL in Phase II clinical trials
- Excellent patient potential as adjunctive therapy
- Marketing factors
- JTT-705 shows better potential than Niaspan
- Forecast to 2015
- Pamaqueside
- Phase I trial showed a 12% reduction in LDL cholesterol
- Further trials required to determine patient potential
- Pamaqueside will benefit from Pfizers marketing experience
- Pamaqueside assessed performance lower than Zetia
- Forecast to 2015
- Gemcabene
- Clinical trial data shows significant increases in HDL
- Gemcabene needs to prove itself as an adjunct to perform well in the market
- Gemcabene has Pfizers marketing strength behind it
- The unavailability of long-term data lowers overall performance to poorer than fenofibrate
- Forecasts to 2015
- FM VP4
- Phase I trials show excellent safety profile
- Phase II trials still underway
- Potential as a safe top-up drug
- FM VP4 will require a marketing partner
- Overall performance rated less than Zetia
- Forecast to 2015
- Datamonitor drug assessment summary
CHAPTER 8 COMPARATIVE FORECASTS
- Comparative analysis
CHAPTER 9 INNOVATIVE EARLY-STAGE PROJECTS
- Gene therapy appears to be a key therapy in preclinical development for dyslipidemia
APPENDIX A
- Epidemiology methodology
- Datamonitor forecast methodology
- Methodology
- US
- Japan
- France
- Germany
- Italy
- Spain
- UK
- Datamonitor drug assessment summary
- Contributing experts
- Bibliography
- Epidemiology sources
- US
- Japan
- France
- Germany
- Italy
- Spain
- UK
- Clinical trial data
- Report methodology
- About Datamonitor
- About Datamonitor Healthcare
- Datamonitor Healthcares therapy area capabilities
- About the cardiovascular analysis team
- Disclaimer
- List of Tables
- Table 1: R&D pipeline in the antidyslipidemic market, 2005
- Table 2: Antidyslipidemic pipeline, 2005
- Table 3: Phase of development of products in each class, 2005
- Table 4: Composition of the antidyslipidemic R&D pipeline by company.
- Table 5: Key changes to lipid levels between the NCEP II and NCEP III
- Table 6: Epidemiology overview of dyslipidemia, 2005-15
- Table 7: Epidemiology figures by age for the seven major markets, 2005
- Table 8: Total epidemiology figures by age for the seven major markets, 2005
- Table 9: R&D pipeline in the antidyslipidemic market, 2005
- Table 10: Key products in late-stage R&D pipeline for single pill statin combination drugs, 2005
- Table 11: Global sales of the leading branded statins, 2003-04
- Table 12: Lipitor: key facts
- Table 13: Factors affecting the revenues of simvastatin + Niaspan, 2007-15
- Table 14: Phase II trial results of atorvastatin + torcetrapib combination
- Table 15: Factors affecting the revenues of atorvastatin +torcetrapib, 2008-15
- Table 16: Research, clinical and commercial attractiveness summary for pipeline single-pill statin combination drugs
- Table 17: Key products in late-stage R&D pipeline for HDL targeting agents & combinations, 2005
- Table 18: Lipanthyl/Tricor: key facts
- Table 19: Factors affecting the revenues of metformin + fenofibrate, 2007-15
- Table 20: Factors affecting the revenues of LCP Feno, 2010-15
- Table 21: Research, clinical and commercial attractiveness summary for pipeline fibtates and fibrate combination drugs
- Table 22: Key products in late-stage R&D pipeline for HDL targeting agents & combinations, 2005
- Table 23: Niaspan: key facts
- Table 24: Zetia: key facts
- Table 25: Factors affecting the revenues of implitapide, 2009-15
- Table 26: Factors affecting the revenues of JTT-705, 2009-15
- Table 27: Factors affecting the revenues of pamaqueside, 2009-15
- Table 28: Factors affecting the revenues of gemcabene, 2009-15
- Table 29: Factors affecting the revenues of FM VP4, 2008-15
- Table 30: Research, clinical and commercial attractiveness summary for pipeline adjunctive therapies
- Table 31: Global sales forecasts for anti-dyslipidemic drugs, 2005-15
- Table 32: Drugs in preclinical development for dyslipidemia, 2005
- Table 33: Datamonitor drug assessment parameters
- List of Figures
- Figure 1: Pipeline overview of antidyslipidemic drugs
- Figure 2: Percentage of R&D products in each phase of development, 2005
- Figure 3: Composition of the antidyslipidemic R&D pipeline by country, 2005
- Figure 4: Composition of the antidyslipidemic R&D pipeline by company type
- Figure 5: Unmet needs in the dyslipidemia market, 2005
- Figure 6: Assessment of KS-01-019s performance indicators
- Figure 7: KS-01-019 SWOT analysis
- Figure 8: Global sales forecasts for simvastatin + Niaspan, 2007-15
- Figure 9: Assessment of atorvastatin + torcetrapibs performance indicators
- Figure 10: SWOT analysis of atorvastatin + torcetrapib combination
- Figure 11: Global sales forecasts for atorvastatin + torceptrapib, 2008-15
- Figure 12: Research/clinical and commercial attractiveness of single-pill statin combinations
- Figure 13: Datamonitors drug assessment summary for the late-phase pipeline single-pill statin combination drugs
- Figure 14: Assessment of metformin + fenofibrate performance indicators
- Figure 15: Metformin + fenofibrate SWOT analysis
- Figure 16: Global sales forecasts for metformin + fenofibrate, 2007-15
- Figure 17: Assessment of LCP Fenos performance indicators
- Figure 18: LCP Feno SWOT analysis
- Figure 19: Global sales forecasts for LCP Feno, 2006-15
- Figure 20: Research/clinical and commercial attractiveness of fibrate and fibrate combination drugs
- Figure 21: Datamonitors drug assessment summary for the late-phase pipeline single-pill statin combination drugs
- Figure 22: Assessment of implitapides performance indicators
- Figure 23: Global sales forecasts for implitapide, 2009-15
- Figure 24: Assessment of JTT-705s performance indicators
- Figure 25: Global sales forecasts for JTT-705, 2009-15
- Figure 26: Assessment of pamaquesides performance indicators
- Figure 27: Global sales forecasts for pamaqueside, 2009-15
- Figure 28: Assessment of Gemcabenes performance indicators
- Figure 29: Global sales forecasts for Gemcabene, 2009-15
- Figure 30: Assessment of FM VP4s performance indicators
- Figure 31: Global sales forecasts for FM VP4, 2008-15
- Figure 32: Research/clinical and commercial attractiveness of adjunctive therapies
- Figure 33: Datamonitors drug assessment summary for the late-phase pipeline adjunctive therapies
- Figure 34: Datamonitors drug assessment summary for the late-phase antidyslipidemic pipeline drugs
- Figure 35: Example of Datamonitor drug assessment scorecard
- Figure 36: Example of Datamonitor drug assessment graph
