TARRYTOWN, N.Y., June 17, 2011 /PRNewswire/ — Regeneron
Pharmaceuticals, Inc. (Nasdaq:
REGN) announced that NASDAQ has halted trading of the company’s
common stock today. The Dermatologic and Ophthalmic Drugs
Advisory Committee of the U.S. Food and Drug Administration (FDA)
is meeting today to discuss the company’s Biologics License
Application (BLA) for EYLEA™, also known as VEGF Trap-Eye,
for the treatment of the neovascular form of age-related macular
degeneration (wet AMD).
Regeneron submitted a BLA for marketing approval in wet AMD in
the U.S. in February 2011 and received a Priority Review
designation. Under Priority Review, the target date for an
FDA decision on the EYLEA BLA is August 20, 2011.
About EYLEAVascular Endothelial Growth Factor (VEGF) is a
naturally occurring protein in the body. Its normal role in a
healthy organism is to trigger formation of new blood vessels
(angiogenesis) supporting the growth of the body’s tissues and
organs. However, in certain diseases, such as age-related
macular degeneration, it is also associated with the growth of
abnormal new blood vessels in the eye, which exhibit vascular
permeability and lead to edema.
EYLEA (aflibercept ophthalmic solution), also known as VEGF
Trap-Eye, is a fully human fusion protein, consisting of portions
of VEGF receptors 1 and 2, that binds all forms of VEGF-A along
with the related Placental Growth Factor (PlGF). EYLEA is a
specific and highly potent blocker of these growth factors.
EYLEA is specially purified and contains iso-osmotic buffer
concentrations, allowing for injection into the eye.
Regeneron and Bayer HealthCare are collaborating on the
global development of EYLEA for the treatment of the neovascular
form of age-related macular degeneration (wet AMD), central retinal
vein occlusion (CRVO), diabetic macu