Preventing Cardiovascular Events: Will HDL Therapeutics Change the Treatment Paradigm?

Published by: Decision Resources

Published: Dec. 12, 2007 - 24 Pages

Table of Contents

Executive Summary

Strategic Considerations

Stakeholder Implications

HDL: A Window of Opportunity in the Mature Cardiovascular Market

Metabolism and Proposed Atheroprotective Mechanisms of HDL

Reverse Cholesterol Transport

Antioxidant, Anti-Infl ammatory, and Antithrombotic Effects of HDL

CETP Inhibitors: The Rise and Fall of Torcetrapib

Implications of the ILLUMINATE Trial Results

The Resurgence of Old Concepts

New Niacin Formulations

New Fibrate Formulations

The Emergence of New Mechanisms of Action

Infusions of Reconstituted HDL/Apo A-I

Oral Apo A-I Mimetic Peptides

Apo-A-I Synthesis Enhancers

ABCA1/ABCG1 Gene Expression Enhancers

Outlook

Tables

1. Lipid and Blood Pressure Changes from Baseline in Phase II and Phase III CETP Inhibitor Studies

2. A Selection of Confl icting Publications on the Cardiovascular Benefi ts of CETP Inhibition

3. Results from the ILLUMINATE Trial

4. Key HDL Therapeutics in the Emerging Drug Pipeline

Figures

1. Current Targets for Drugs in the Atherosclerosis Pipeline

2. The Reverse Cholesterol Transport Pathway

3. Proposed Atheroprotective Mechanisms of HDL

4. Opportunity for HDL Therapeutics in Anticipated Primary Indications by Region,2006

Abstract

• The notion that raising HDL-C can lower cardiovascular risk has been around for a long time, yet drug • developers have had trouble capitalizing on this fact. What are the barriers in this potentially highly lucrative market?
• Pfizer abruptly halted development of the once-promising CETP inhibitor torcetrapib. • What are the implications for Pfi zer as well as for other drug developers of CETP inhibitors?
• The uncertainty around CETP inhibition and HDL-C raising in general has caused some drug developers to • create new drugs using decades-old concepts. Which agents and mechanisms of action are being tested and how do they differ from current therapies? What is the commercial potential for these drugs?

• HDL metabolism and how it relates to atherosclerosis: • Overview of HDL metabolism and proposed atheroprotective mechanisms, including reverse cholesterol transport.
• Torcetrapib’s failure and outlook for other CETP inhibitors: • A look at what went wrong with Pfizer’s torcetrapib and what developers can do to avoid a similar fate.
• Implications of the ILLUMINATE trial: • Implications for CETP inhibitors and their manufacturers.
• Old concepts get new life: • Abbott and Merck are developing new versions of older but safe HDL modulators.

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