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Regeneron Reports Third Quarter 2009 Financial and Operating Results
Date:11/3/2009

e now fully enrolled, and we expect initial data from this program to be reported in late 2010. A Phase 2 study (called DA VINCI) of VEGF Trap-Eye for the treatment of the Diabetic Macular Edema (DME) is also fully enrolled, with data expected during the first half of 2010. Additionally, two Phase 3 studies in Central Retinal Vein Occlusion (CRVO) are enrolling patients; data from the first of these studies are anticipated to be available in the first half of 2011.

During October 2009, 24-month results of the extension stage of the Phase 2 study of VEGF Trap-Eye in wet AMD (CLEAR-IT 2) were presented at the 2009 American Academy of Ophthalmology meeting. After receiving VEGF Trap-Eye for one year, the 117 patients who elected to enter the extension stage were dosed on a 2.0 mg PRN basis, irrespective of the dose at which they were treated earlier in the study. On a combined basis, for these 117 patients, the mean gain in visual acuity was 7.3 letters (p<0.0001 versus baseline) at the three-month primary endpoint of the original Phase 2 study, 8.4 letters (p<0.0001 versus baseline) at one year, and 6.1 letters (p<0.0001 versus baseline) at month 12 of the extension study. Thus, after 24 months of dosing with VEGF Trap-Eye in the Phase 2 study, patients continued to maintain a highly significant improvement in visual acuity versus baseline, while receiving, on average, only 4.6 injections over the 21-month PRN dosing phase that extended from month three to month 24. The most common adverse events were those typically associated with intravitreal injection.

Bayer HealthCare has rights to market VEGF Trap-Eye outside the United States, where the companies will share equally in profits from any future sales of VEGF Trap-Eye. Regeneron maintains exclusive rights to VEGF Trap-Eye in the United States.

Monoclonal Antibodies

During the third quarter of 2009, REGN475, an antibody to Ner
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SOURCE Regeneron Pharmaceuticals, Inc.
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