Regeneron received $20 million milestone payment from Bayer HealthCare
with dosing of first patient
Phase 2 study of VEGF Trap-Eye in diabetic macular edema fully
enrolled
Regeneron Pharmaceuticals, Inc. (NASDAQ:REGN) today announced
that the first patient has been enrolled in the Phase 3 program of VEGF
Trap-Eye for the treatment of central retinal vein occlusion (CRVO), a
leading cause of blindness in adults. Regeneron received a $20 million
milestone payment from Bayer Healthcare that was triggered by the dosing
of the first patient in the CRVO program. Regeneron also announced that
enrollment in the Phase 2 DA VINCI study of VEGF Trap-Eye in diabetic
macular edema (DME) has been completed and data are expected during the
first half of 2010.
VEGF Trap-Eye, an investigational drug, is being developed by Regeneron
and Bayer HealthCare AG for the potential treatment of eye diseases,
including the neovascular form of age-related macular degeneration (wet
AMD), DME, and CRVO.
The Phase 3 program in CRVO consists of two multinational, one-year
clinical studies. The COPERNICUS (COntrolled Phase 3 Evaluation of
Repeated iNtravitreal administration of VEGF Trap-Eye In Central retinal
vein occlusion: Utility and Safety) study is being led by Regeneron and
the GALILEO (General Assessment Limiting InfiLtration of Exudates in
central retinal vein Occlusion with VEGF Trap-Eye) study is being led by
Bayer HealthCare. Patients in both studies will receive six monthly
intravitreal injections of either VEGF Trap-Eye at a dose of 2
milligrams (mg) or sham control injections. The primary endpoint of both
studies is improvement in visual acuity versus baseline after six months
of treatment. At the end of the initial six months, patients will be
dosed on a PRN (as needed) basis for another six months. All patients
will be eligible for rescue laser treatment. Results from both CRVO
studies are expected in 2011.
In wet AMD, Regeneron and Bayer Healthcare are evaluating VEGF Trap-Eye
in two ongoing Phase 3 studies, known as VIEW 1 and VIEW 2 (VEGF Trap:
Investigation of Efficacy and Safety in Wet age-related macular
degeneration). Enrollment in these trials is expected to be completed by
the end of this year, and data are expected in late 2010.
Regeneron maintains exclusive rights to VEGF Trap-Eye in the United
States.
