The Avastin Juggernaut: Transformation of the Age-Related Macular Degeneration Market
Decision Resources
December 19, 2007 31 Pages - SKU: DECR1638057
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The AMD market is witnessing an unusual scenario in which two agents from the same company are competing
for the market-leading position. Although Genentech's Lucentis is an effi cacious therapy approved for AMD,
Genentech's Avastin is receiving signifi cant off-label use. The pending results of two head-to-head studies could
strongly affect the AMD market, treatment schemes, reimbursement requirements, and clinical trial design.
Get the Answers You Need to Shape Your Strategy
- 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?
Scope
- 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.
Please note, the PDF e-mail from publisher version of this report is for a global site license.
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- 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
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