Abstract
Introduction
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.
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- 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 benefits do these stakeholders see in the use of
Avastin? How much power and influence 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.
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