March 22, 2007
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`Interim Analysis of Phase 2 Study of VEGF Trap in AMD patients
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`Patients treated with 5 different dosing regimens, and compared to their own baseline over the course of
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`three months, using change in retinal thickness at three months as the primary endpoint, with
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`changes in visual acuity as the key secondary endpoint
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`Patients treated with 0.5 mg, 2.0 mg and 4.0 mg doses, with cohorts in which each patient was treated just
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`once with these doses and evaluated over the ensuing three months, as well as cohorts in the
`0.5 and 2.0 doses were given monthly
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`Study achieved its pre-specified primary endpoint, of decrease in retinal thickness in all treated patients (all
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`cohorts combined) at 12 weeks, with p < 0.0001
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`>>> The average decrease in retinal thickness across all five cohorts was 135 microns
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`Study also achieved key pre-specified secondary endpoint, of improvement in visual acuity in all treated
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`patients (all cohorts combined) at 12 weeks, with p < 0.0001
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`at 8 weeks, and 5.9 letters at 12 weeks
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`>>> The average increase in visual acuity across all five cohorts was 6.0 letters at 4 weeks, 5.8 letters
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`Statistical analyses did not show significant differences across the treatment groups, for changes in either
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`retinal thickness or visual acuity, regardless of whether patients were treated with a single
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`dose or received monthly treatments
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`>>> The improvements in visual acuity in the different cohorts ranged from 3 to 10 letters at 12 weeks
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`Patients treated with a single dose, at all three dose levels, maintained a decrease in retinal thickness as well
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`as a gain in visual acuity (2.8 to 5.1 letters), at 12 weeks
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`Only a single patient in the entire study did not at least maintain their vision, as defined by loss of 3 or more
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`lines of vision at three months
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`Quote:
`"In this 12 week study, the VEGF Trap caused statistically significant improvements in both retinal swelling
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`and visual acuity. Moreover, the VEGF Trap may prove unique in that a single dose may be able to maintain
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`a beneficial effect on retinal swelling, as well as improve visual acuity, for at least twelve weeks. We look
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`forward to the required Phase 3 studies to define the doses and intervals that will provide the most benefit
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`and most desirable treatment options for patients."
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`Key Background Comparisons to Lucentis:
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`Mean change in VA at lm, 3m and 1 year in Lucentis pivotal studies:
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`l m 3m
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`12m
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`0.3
`6.5
`Marina
`-3.55.1
`(2mETDRS)
`7.2
`0.5
`-4 5.9
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`Anchor
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`5.96.8
`0.3
`8.5
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`CONFIDENTIAL
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`RGN-EYLEA-MYLAN-00525766
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`Regeneron Pharmaceuticals, Inc. Exhibit 2006 Page 1
`Samsung Bioepis Co., Ltd. v. Regeneron Pharmaceuticals, Inc. IPR2023-00884
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`Regeneron Pharmaceuticals, Inc. Exhibit 2006 Page 2
`Samsung Bioepis Co., Ltd. v. Regeneron Pharmaceuticals, Inc. IPR2023-00884
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