Pipeline Insight: Dyslipidemia - Pipeline agents unlikely to rejuvenate the market : Market Research Report

Pipeline Insight: Dyslipidemia - Pipeline agents unlikely to rejuvenate the market

Published by: Datamonitor

Published: Apr. 9, 2007 - 150 Pages

ABOUT DATAMONITOR HEALTHCARE: About the cardiovascular pharmaceutical analysis team
CHAPTER 1 EXECUTIVE SUMMARY: Scope of the analysis Datamonitor insight into the dyslipidemia market Single-pill combinations have their appeal, but not for every market 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 Innovation is scarce among the pipeline agents The crowded antidyslipidemic market undergoing high genericization will make it challenging for the developmental compounds to secure a share of the market Datamonitor Pipeline Assessment Summary
CHAPTER 2 PIPELINE OVERVIEW AND DYNAMICS: Pipeline overview The antidyslipidemic pipeline is mechanistically diversified The antidyslipidemic pipeline is rich in Phase I and Phase II candidates Numerous companies have their stake in the R&D landscape Abbott holds most advanced developmental agents, but no innovation value Merck - unclear whether there is innovation in the pipeline GSK and Japan Tobacco hold more promise to satisfy the unmet needs Key R&D company strategies
CHAPTER 3 DYSLIPIDEMIA - MARKET POTENTIAL: 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 Epidemiology methodology US Japan France Germany Italy Spain UK Unmet needs in dyslipidemia Major obstacles between the drugs and the market Increased efficacy in raising HDL-cholesterol Drugs with novel mechanisms of actions Ability to prevent or even reverse the progression of atherosclerosis Increased efficacy in lowering LDL-C Combination therapies to treat patients with complicated lipid profiles Long-term data to support prevention of acute CVD events Further statin safety data
CHAPTER 4 R&D APPROACH: Classification of pipeline products Statins and statin combinations Statins dominate the antidyslipidemic market Mechanism of action Fibrates - PPAR-alpha agonists Cholesteryl ester transfer protein (CETP) inhibitors: targeting HDL-C Lipoprotein lipase activator Microsomal triglyceride transfer (MTP) inhibitors Squalene synthase inhibitor Apolipoprotein B100 antagonist Dual PPAR agonists PPAR- delta agonists Transcription factor inhibitor Cholesterol transport/absorption Inhibitors Clinical trial design in dyslipidemia Short-term endpoints: controlling cholesterol levels Long-term endpoints: reduction in morbidity and mortality
CHAPTER 5 STATINS AND STATIN COMBINATIONS - LATE-STAGE DRUG ANALYSIS & FORECASTS: Overview for statins and statin combinations Pipeline summary Comparative forecasts Definition of current comparator therapy Pfizer's Lipitor remains the current comparator therapy Pitavastatin Drug overview Clinical trial data Patient potential Marketing factors Satisfaction of unmet needs Forecasts to 2016 Datamonitor drug assessment summary KS-01-019 (Simcor; Simvastatin + niacin ER) Drug overview Clinical trial data OCEANS SEACOAST AIM-HIGH Patient potential Marketing factors Satisfaction of unmet needs Forecasts to 2016 Datamonitor drug assessment summary Zolip (simvastatin + fenofibrate) Drug overview Clinical trial data Zolip 0501 Zolip 0502 Patient potential Marketing factors Satisfaction of unmet needs Forecasts to 2016 Datamonitor drug assessment summary Other statins/statin combinations Rosuvastatin + ABT-335 MK-0524B
CHAPTER 6 OTHER THERAPIES - LATE-STAGE DRUG ANALYSIS AND FORECASTS: Overview for other therapies Pipeline summary Comparative forecasts Definition of current comparator therapy Niacin remains the HDL raising agent with highest efficacy Ezetimibe remains the biggest revenue generating adjunct therapy Lapaquistat Drug overview Clinical trial data Patient potential Marketing factors Satisfaction of unmet needs Forecasts to 2016 Datamonitor drug assessment summary JTT-705 (R1658) Drug overview Clinical trial data 34% increase in HDL in Phase II clinical trials Ongoing clinical trials Patient potential Marketing factors Satisfaction of unmet needs Forecasts to 2016 Datamonitor drug assessment summary FM-VP4 (phytosterol analogue) Drug overview Clinical trial data Phase I trials show excellent safety profile Phase II trials bring forward disappointing efficacy Patient potential Marketing factors FM VP4 will require a marketing partner Satisfaction of unmet needs Forecasts to 2016 Datamonitor drug assessment summary ISIS-301012, injectable Drug overview Clinical trial data Phase II results Phase I results Patient potential Marketing factors Satisfaction of unmet needs Forecasts to 2016 Datamonitor drug assessment summary Other agents MK-0524A Clinical Trials Trial Results ABT-335 MD-0727 CRD-5 KB-2115 CETi-1 (vaccine) Implitapide (BAY-13-9952; AEGR-427) MK-0859 AEGR-733 (BMS-201038) QC-BT16 LY-674 (LY-518674) KRP-101 3,5-diiodothyropropionic acid (DITPA) Ibrolipim (NO-1886) AVE-0847 LBM-642 GW-501516 GW-590735 GFT-14 Fenofibrate and pravastatin BIBLIOGRAPHY Bibliography Epidemiology sources US Japan France Germany Italy Spain UK Clinical trial data
APPENDIX A: Methodology Datamonitor forecast methodology Product forecasts Definition of a standard unit (only use if ForeSight model used to forecast)
APPENDIX B: About Datamonitor; About Datamonitor Healthcare; Datamonitor Healthcare's therapy area capabilities; About the Disease analysis team; Disclaimer
List of Tables: Table 1: R&D pipeline in Dyslipidemia, 2007; Table 2: The pipeline for antidyslipidemic agents by mechanism of action, 2007; Table 3: Pipeline of antidyslipidemic agents by company, 2007; Table 4: Key changes to lipid levels between the NCEP II and NCEP III; Table 5: Prevalence estimates of dyslipidemia (000s), 2007-16; Table 6: Currently available statins, 2007; Table 7: Key products in the late-stage R&D pipeline for statins and statin combinations, 2007; Table 8: Lipitor: key facts, 2007; Table 9: Ability of pitavastatin to satisfy the unmet needs; Table 10: Impacting factors on the revenues of pitavastatin, 2007-2016 Table 11: Ability of Simcor to satisfy the unmet needs; Table 12: Impacting factors on the revenues of Simcor, 2007-2016; Table 13: Ability of Zolip to satisfy the unmet needs; Table 14: Impacting factors on the revenues of Zolip, 2007-2016; Table 15: Key products in late-stage R&D pipeline for other therapies, 2007; Table 16: Niaspan: key facts, 2007; Table 17: Zetia: key facts, 2007; Table 18: Ability of Lapaquistat to satisfy the unmet needs; Table 19: Impacting factors on the revenues of Lapaquistat, 2007-2016 Table 20: Ability of JTT-705 to satisfy the unmet needs; Table 21: Impacting factors on the revenues of JTT-705, 2007-2016; Table 22: Ability of FM-VP4 to satisfy the unmet needs; Table 23: Impacting factors on the revenues of FM-VP4, 2007-2016; Table 24: Ability of ISIS-301012 (injectable) to satisfy the unmet needs Table 25: Impacting factors on the revenues of ISIS-301012 (injectable), 2007-2016; Table 26: Datamonitor drug assessment parameters
List of Figures: Figure 1: Datamonitor drug assessment summary of statins and statin combinations in development for dyslipidemia, 2007; Figure 2: Datamonitor drug assessment summary of other therapies in development for dyslipidemia, 2007; Figure 3: Pipeline of antidyslipidemic compounds, 2007; Figure 4: The pipeline for antidyslipidemic agents by mechanism of action, 2007; Figure 5: Pipeline maturity: percentage of R&D products in each Phase of development, 2007; Figure 6: Unmet needs in the dyslipidemia market, 2007; Figure 7: Datamonitor drug assessment summary of statins and statin combinations in development for dyslipidemia, 2007; Figure 8: Sales forecasts for statins and statin combinations, seven major markets, 2007-2016; Figure 9: Sales forecast for Pitavastatin in dyslipidemia to 2016, seven major markets; Figure 10: Datamonitor's competitive positioning analysis of Pitavastatin, 2007; Figure 11: Clinical and commercial attractiveness of pitavastatin broken down by main parameters; Figure 12: Sales forecast for Simcor in dyslipidemia to 2016, seven major markets; Figure 13: Datamonitor's competitive positioning analysis of KS-01-19 (Simcor), 2007; Figure 14: Clinical and commercial attractiveness of Simcor broken down by main parameters; Figure 15: Sales forecast for Zolip in dyslipidemia to 2016, seven major markets; Figure 16: Datamonitor's competitive positioning analysis of Zolip, 2007 Figure 17: Clinical and commercial attractiveness of Zolip broken down by main parameters; Figure 18: Datamonitor drug assessment summary of other therapies in development for dyslipidemia, 2007; Figure 19: Sales forecasts for other therapies, seven major markets, 2007-2016; Figure 20: Sales forecast for Lapaquistat in dyslipidemia to 2016, seven major markets; Figure 21: Datamonitor's competitive positioning analysis of Lapaquistat, 2007; Figure 22: Clinical and commercial attractiveness of Lapaquistat broken down by main parameters; Figure 23: Sales forecast for JTT-705 in dyslipidemia to 2016, seven major markets; Figure 24: Datamonitor's competitive positioning analysis of JTT-705, 2007; Figure 25: Clinical and commercial attractiveness of JTT-705 broken down by main parameters; Figure 26: Sales forecast for FM-VP4 in dyslipidemia to 2016, seven major markets; Figure 27: Datamonitor's competitive positioning analysis of FM-VP4, 2007; Figure 28: Clinical and commercial attractiveness of FM-VP4 broken down by main parameters; Figure 29: Sales forecast for ISIS-301012 (injectable) in dyslipidemia to 2016, seven major markets; Figure 30: Datamonitor's competitive positioning analysis of ISIS-301012 (injectable), 2007; Figure 31: Clinical and commercial attractiveness of ISIS-301012 (injectable) broken down by main parameters; Figure 32: Datamonitor drug assessment summary of pipeline molecular targeted therapies in development for hematological malignancies, 2007

Abstract

Introduction

At present, despite the availability of numerous agents for the treatment of dyslipidemia, there is significant scope for expanding the market by improving diagnosis and treatment of dyslipidemia patients. However, for new agents, gaining a secure foothold on the market will be challenging, but their chances can be improved through targeting niche patient populations and conducting outcome trials.

Scope

Assessment of the patient potential for developmental anti-dyslipidemia agents over the period 2007-2016 Overview of the anti-dyslipidemia R&D pipeline, with detailed information on the classes in development and comparator drugs Commercial analysis of key compounds in development regarding their ability to take away market share from currently available drugs Sales forecasts for key late-stage developmental anti-dyslipidemia agents in the seven major markets to 2016

Highlights

Single-pill combinations have their appeal, but not for every market. Their rather low uptake, especially in Europe, is due to a common perception that they are inferior to separate compounds in titration flexibility; as well as their high cost and potentially poor side effect profile. This will limit their success, especially In Europe and Japan. 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. It is likely to affect the physicians' confidence in all CETP inhibitors, and prolong their time to market. The crowded antidyslipidemic market undergoing high genericization will make it challenging for the developmental compounds to secure a share of the market. The new compound will need to offer a major clinical advantage or a major cost benefit, in order to win a significant market share.

Reasons to Purchase

Understand the key factors that will contribute to the success of the next generation of anti-dyslipidemia drugs Identify licensing opportunities based on company portfolio and market needs Analyze the competitive environment at the time of product launch and adjust your marketing program to suit the current situation and ensure success

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Pipeline Insight: Dyslipidemia - Pipeline agents unlikely to rejuvenate the market

Table of Contents

Abstract