Market Report Source

Overview

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

Table of Contents

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