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Bayer and Regeneron Dose First Patient in Second Phase 3 Study for VEGF Trap-Eye in Wet Age-Related Macular Degeneration
Date:5/7/2008

tial to significantly reduce retinal thickness and improve vision," said Kemal Malik, MD, Head of Global Development and member of the Bayer HealthCare Executive Committee. "Dosing of the first patient in this confirmatory Phase 3 trial is an important milestone for this compound intended to treat a devastating ocular disease that impacts millions of people worldwide."

"New therapies are still needed to provide optimal care to those patients with wet AMD," said George D. Yancopoulos, M.D., Ph.D., President of Regeneron Research Laboratories. "This global Phase 3 clinical program will provide additional data to further evaluate the efficacy and safety of VEGF Trap-Eye using different dosing regimens."

Bayer HealthCare and Regeneron are collaborating on the global development of VEGF Trap-Eye for treatment of wet AMD, diabetic eye diseases, and other ocular diseases and disorders. Once approved, Bayer HealthCare will market VEGF Trap-Eye outside the U.S., where the parties will share equally in profits from any future sales of VEGF Trap-Eye. Regeneron maintains exclusive rights to VEGF Trap-Eye in the U.S. VIEW 2 primary analysis results are anticipated in 2011.

About VIEW 2

In the first year, the VIEW 2 (VEGF Trap-Eye: Investigation of Efficacy and Safety in Wet AMD) study will evaluate the safety and efficacy of VEGF Trap-Eye at doses of 0.5 milligrams (mg) and 2.0 mg administered at 4-week intervals and 2.0 mg at an 8-week dosing interval, including one additional 2.0 mg dose at week four. Patients randomized to the ranibizumab arm of the trial will receive a 0.5 mg dose every 4 weeks. After the first year of treatment, patients will continue to be followed and treated for another year on a flexible, criteria-based extended regimen with a dose administered at least every 12 weeks, but not more often than every 4 weeks until the end of the study.

The primary endpoint of the study is the proportion of patients treated with VEGF Trap
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SOURCE Bayer HealthCare
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