How Will Recent Safety Concerns Affect PPAR-Gamma Agonists?

Published by: Decision Resources

Published: Jun. 25, 2007 - 20 Pages

Table of Contents

Executive Summary

Strategic Considerations

Stakeholder Implications

Introduction

An Overview of PPAR-Gamma Agonists

Mechanism of Action

Side Effects of PPAR-Gamma Agonists

PPAR-Gamma Agonists in the Treatment of Type 2 Diabetes

PPAR-Gamma Agonists in the Type 2 Diabetes Market

The Controversy Surrounding Avandia

New Concerns Arise Over Avandia Use

Response and Repercussions

Are the Cardiovascular Risks a Class Effect?

Do Avandia’s Safety Concerns Represent a Commercial Opportunity?

The Incretin Pathway

Eli Lilly/Amylin’s Byetta

Merck’s Januvia

Outlook for PPAR-Gamma Agonists and the Type 2 Diabetes Market

Sidebar/Expert Commentary

How Important Is Avandia to GlaxoSmithKline?

Greater Transparency Needed for Clinical Trial Results

Tables

1. Results from Large-Scale Trials Involving Avandia

Figures

1. Mechanism of Action for PPAR-Gamma Agonists

2. Worldwide Sales of PPAR-Gamma Agonists, 1999-2006

3. Results from a Meta-Analysis of Trials Involving Avandia

4. Incretin Pathway

5. Growth of Key Drug Classes in the Type 2 Diabetes Market, 1999-2006

6. Comparison of Sales for Actos and Avandia, 1999-2006

Abstract

• PPAR-gamma agonists are among the most popular therapies in the treatment of type 2 diabetes. However, • a recent meta-analysis has highlighted the potential for cardiovascular side effects with Avandia and has affected both sales of the agent and GlaxoSmithKline’s stock price. What are the strengths and weaknesses of the Avandia study? Are the safety concerns raised by the study relevant only to Avandia or to the entire PPAR-gamma agonist class?
• The safety concerns about PPAR-gamma agonists present a commercial opportunity for new agents that offer • a unique mechanism of action, an improved safety profi le, and evidence of effi cacy. Which newly launched agents threaten to compete with the PPAR-gamma agonists for the position of preferred third-line therapy in type 2 diabetes? What advantages—and shortcomings—do these new agents have?
• Novartis is developing a drug that that promises to compete heavily with newly launched agents and further • change the landscape of the type 2 diabetes market. How will this agent differentiate itself from the currently available type 2 diabetes therapies?

• Overview of PPAR-gamma agonists: • mechanism of action, side effects, role in the treatment of type 2 diabetes.
• Avandia controversy: • safety concerns, the response to the recent meta-analysis, implications for the PPAR-gamma agonist drug class.
• Commercial opportunities for new agents: • description of agents that are newly launched or in development.
• Outlook: • how recent developments will affect the PPAR-gamma agonist drug class and the type 2 diabetes market.

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