The Avastin Juggernaut: Transformation of the Age-Related Macular Degeneration Market

Published by: Decision Resources

Published: Dec. 19, 2007 - 31 Pages

Table of Contents

Executive Summary

Strategic Considerations

Stakeholder Implications

Introduction

Current AMD Therapies

Angiostatic Steroids

Kenalog/Kenacort (Bristol-Myers Squibb)

Photosensitizing Agents

Visudyne (QLT/Novartis Ophthalmics)

Combination Therapy

Visudyne/Photodynamic Therapy in Combination with Kenalog/Kenacort

Vascular Endothelial Growth Factor Inhibitors

Macugen (OSI Pharmaceuticals/Pfi zer)

Lucentis (Genentech/Novartis Ophthalmics)

Avastin (Genentech/Roche/Chugai)

Use of Avastin Versus Lucentis

Avastin’s Rise to Dominance in AMD

Announcement of CATT

Support for Avastin from the American Academy of Ophthalmology

Beginnings of the Repackaging Controversy

U.K. Authorities’ Infl uence on Use of Lucentis and Avastin

Announcement of IVAN

Genentech’s Response: Infl uencing Avastin Repackaging

Opposition to Genentech’s Distribution Decision

Genentech Revises Its Position

Commercial Outlook

The Impact of Avastin and Lucentis on Visudyne and Macugen

The Impact of the Head-to-Head Trials on Avastin and Lucentis

Implications of Avastin and Lucentis for Emerging Therapies

Appendix A. Overview of AMD Etiology, Pathophysiology, and Classifi cations

Etiology and Pathophysiology

Disease Classifi cations

Dry AMD

Wet AMD

Appendix B. Bibliography

Tables

1. Select Current Therapies for Treatment of AMD, 2007

2. Differentiating Features of Lucentis and Avastin for Wet AMD

3. Summary of Key Events in the Rivalry Between Avastin and Lucentis

4. Sales of Drugs to Treat AMD in the Major Pharmaceutical Markets, 2006

5. AMD Market Forecast Scenario: Favorable Avastin Data from CATT and IVAN, 2011

6. AMD Market Forecast Scenario: Favorable Lucentis Data from CATT and IVAN, 2011

S-1. Prevalent Cases of Wet AMD, 2006-2011

Figures

1. Structure of Avastin and Lucentis

2. VEGF Inhibitor Sales in the United States, 2005 and 2006

A-1. Anatomy of the Eye

A-2. Macula of the Eye: Progression of AMD

Sidebars

Epidemiology of AMD

Afl ibercept Clinical Trials Afl ibercept Clinical Trials

Abstract

• VEGF inhibitors are now the leading drug class for wet AMD. • What are the remaining unmet needs in the AMD market? How high is the barrier to entry for pipeline agents?
• Two VEGF inhibitors from Genentech--Lucentis and Avastin--are competing in the AMD market. • What factors will determine which of these agents wins this battle? What insights on pricing, effi cacy, safety, and dosing can be gained from their dominance of the AMD market?
• Payers, providers, and patients are propelling Avastin to the forefront of the wet AMD market. • What benefi ts do these stakeholders see in the use of Avastin? How much power and infl uence do these stakeholders possess in determining the continued use of Avastin?
• The FDA has raised safety concerns regarding the off-label use of Avastin for AMD through repackaging • Avastin into syringes for intravitreal delivery. In response, Genentech has now shifted the responsibility of discontinuing distribution of Avastin to compounding pharmacies to the FDA. The NIH and NHS have separately initiated head-to-head studies of Lucentis versus Avastin. Will use of Avastin for AMD be curbed? Which of these currently unraveling events will have the greatest impact on the AMD market?

• Current AMD therapies: • Current role in the AMD market for angiostatic steroids, photosensitizing agents, VEGF inhibitors, and combination therapy.
• Use of Avastin versus Lucentis: • Avastin’s rise to dominance in AMD, the CATT trial, support for Avastin from the American Academy of Ophthalmology, beginnings of the repackaging controversy, U.K. authorities’ infl uence on use of Lucentis and Avastin, the IVAN trial, Genentech’s infl uence on Avastin repackaging, opposition to Genentech’s distribution decision, Genentech revises its position.
• Commercial outlook: • Impact of Avastin and Lucentis on the AMD market in 2006 and 2011, two market forecasts based on the two possible results of the head-to-head NIH and NHS trials on Avastin and Lucentis, the implications of the dominance of Avastin and Lucentis for emerging therapies.

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