IPR2023-00884, No. 2015-2 Exhibit - Exhibit 2015 REDACTED (P.T.A.B. Aug. 25, 2023)

CONFIDENTIAL - PROTECTIVE ORDER MATERIAL
`
`One Year Data
`
`DA VINCI
`
`CONFIDENTIAL
`
`RGN-EYLEA-MYLAN-00619224
`
`Page 1
`Exhibit2015
`Regeneron Pharmaceuticals, Inc.
`Samsung Bioepis Co., Ltd. v. Regeneron Pharmaceuticals, Inc.
`IPR2023-00884
`
`

`CONFIDENTIAL - PROTECTIVE ORDER MATERIAL
`
`——
`
`.
`
`¢ Fusion protein
`
`FeportionoflgG VEGF Trap-Eye
`
`CONFIDENTIAL
`
`RGN-EYLEA-MYLAN-00619225
`
`Page 2
`Exhibit2015
`Regeneron Pharmaceuticals, Inc.
`Samsung Bioepis Co., Ltd. v. Regeneron Pharmaceuticals, Inc.
`IPR2023-00884
`
`

`CONFIDENTIAL - PROTECTIVE ORDER MATERIAL
`
`2.0 mg PRN*
`
`
`VEGF Trap-Eye
`
`CONFIDENTIAL
`
`RGN-EYLEA-MYLAN-00619226
`
`Page 3
`Exhibit2015
`Regeneron Pharmaceuticals, Inc.
`Samsung Bioepis Co., Ltd. v. Regeneron Pharmaceuticals, Inc.
`IPR2023-00884
`
`

`CONFIDENTIAL - PROTECTIVE ORDER MATERIAL
`
`
`
`“ip tite tip i Win ie dite
`
`tee e REE
`
`tts tte
`
`CONFIDENTIAL
`
`RGN-EYLEA-MYLAN-00619227
`
`Page4
`Exhibit2015
`Regeneron Pharmaceuticals, Inc.
`Samsung Bioepis Co., Ltd. v. Regeneron Pharmaceuticals, Inc.
`IPR2023-00884
`
`

`
`
`
`
`CONFIDENTIAL - PROTECTIVE ORDER MATERIAL
`
`Regeneron Pharmaceuticals, Inc. Exhibit 2015 Page 5
`Samsung Bioepis Co., Ltd. v. Regeneron Pharmaceuticals, Inc. IPR2023-00884
`
`

`
`
`
`
`CONFIDENTIAL - PROTECTIVE ORDER MATERIAL
`
`Regeneron Pharmaceuticals, Inc. Exhibit 2015 Page 6
`Samsung Bioepis Co., Ltd. v. Regeneron Pharmaceuticals, Inc. IPR2023-00884
`
`

`
`
`
`
`CONFIDENTIAL - PROTECTIVE ORDER MATERIAL
`
`Regeneron Pharmaceuticals, Inc. Exhibit 2015 Page 7
`Samsung Bioepis Co., Ltd. v. Regeneron Pharmaceuticals, Inc. IPR2023-00884
`
`

`CONFIDENTIAL - PROTECTIVE ORDER MATERIAL
`
`
`
`arn)
`
`eee eS Oeee
`Vey eyrd
`
` eTae
`
`Discontinuation
`Before Week 52
`
`Withdrawal Consent
`
`Protocol Deviation
`
`Adverse Event
`
`Death
`
`Lost To Follow-Up
`
`Treatment Failure
`
`Other
`
`CONFIDENTIAL
`
`RGN-EYLEA-MYLAN-00619231
`
`Page 8
`Exhibit2015
`Regeneron Pharmaceuticals, Inc.
`Samsung Bioepis Co., Ltd. v. Regeneron Pharmaceuticals, Inc.
`IPR2023-00884
`
`

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`CONFIDENTIAL - PROTECTIVE ORDER MATERIAL
`
`Regeneron Pharmaceuticals, Inc. Exhibit 2015 Page 9
`Samsung Bioepis Co., Ltd. v. Regeneron Pharmaceuticals, Inc. IPR2023-00884
`
`

`CONFIDENTIAL - PROTECTIVE ORDER MATERIAL
`
`ETDRS BCVA
`Meanletters (SD)
`Snellen equivalent
`
`Central Retinal
`Thickness (um) Mean (SD)
`
`Diabetic retinopathy
`Severity Score Mean (Sb)
`
`Steroids (Tri, Dex)
`
`None (1)
`Mild (2)
`Moderate(3)
`Severe (4)
`Proliferative (5)
`
`Previous Treatment
`
`Laser (focal orgrid)
`Anti-VEGF(RBZ,BEV,PEG)
`
`CONFIDENTIAL
`
`RGN-EYLEA-MYLAN-00619233
`
`Page 10
`Exhibit2015
`Regeneron Pharmaceuticals, Inc.
`Samsung Bioepis Co., Ltd. v. Regeneron Pharmaceuticals, Inc.
`IPR2023-00884
`
`

`CONFIDENTIAL - PROTECTIVE ORDER MATERIAL
`
`eneSees 12.0 2prn
`
`9.7 2q8*
`
`CONFIDENTIAL
`
`RGN-EYLEA-MYLAN-00619234
`
`Page 11
`Exhibit2015
`Regeneron Pharmaceuticals, Inc.
`Samsung Bioepis Co., Ltd. v. Regeneron Pharmaceuticals, Inc.
`IPR2023-00884
`
`

`CONFIDENTIAL - PROTECTIVE ORDER MATERIAL
`
`
`
`CONFIDENTIAL
`
`RGN-EYLEA-MYLAN-00619235
`
`Page 12
`Exhibit2015
`Regeneron Pharmaceuticals, Inc.
`Samsung Bioepis Co., Ltd. v. Regeneron Pharmaceuticals, Inc.
`IPR2023-00884
`
`

`CONFIDENTIAL - PROTECTIVE ORDER MATERIAL
`
`
`
`CONFIDENTIAL
`
`RGN-EYLEA-MYLAN-00619236
`
`Page 13
`Exhibit2015
`Regeneron Pharmaceuticals, Inc.
`Samsung Bioepis Co., Ltd. v. Regeneron Pharmaceuticals, Inc.
`IPR2023-00884
`
`

`CONFIDENTIAL - PROTECTIVE ORDER MATERIAL
`
`CONFIDENTIAL
`
`RGN-EYLEA-MYLAN-00619237
`
`Page 14
`Exhibit2015
`Regeneron Pharmaceuticals, Inc.
`Samsung Bioepis Co., Ltd. v. Regeneron Pharmaceuticals, Inc.
`IPR2023-00884
`
`

`CONFIDENTIAL - PROTECTIVE ORDER MATERIAL
`
`rr aaah
`
`CONFIDENTIAL
`
`RGN-EYLEA-MYLAN-00619238
`
`Page 15
`Exhibit2015
`Regeneron Pharmaceuticals, Inc.
`Samsung Bioepis Co., Ltd. v. Regeneron Pharmaceuticals, Inc.
`IPR2023-00884
`
`

`CONFIDENTIAL - PROTECTIVE ORDER MATERIAL
`
`-180.3 2q8°
`
`-187.8
`
`2prn’
`
`-a-
`
`ee
`
`CONFIDENTIAL
`
`RGN-EYLEA-MYLAN-00619239
`
`Page 16
`Exhibit2015
`Regeneron Pharmaceuticals, Inc.
`Samsung Bioepis Co., Ltd. v. Regeneron Pharmaceuticals, Inc.
`IPR2023-00884
`
`

`
`
`
`
`2q8 (n = 42)
`2PRN(n = 45)
`
`ane
`
`CONFIDENTIAL - PROTECTIVE ORDER MATERIAL
`
`Required
`
`0.594 (n = 44)
`
`Treatments Possible
`
`2PRN (n = 45)
`
`
`
`
`CONFIDENTIAL
`
`RGN-EYLEA-MYLAN-00619240
`
`Page 17
`Exhibit2015
`Regeneron Pharmaceuticals, Inc.
`Samsung Bioepis Co., Ltd. v. Regeneron Pharmaceuticals, Inc.
`IPR2023-00884
`
`

`CONFIDENTIAL - PROTECTIVE ORDER MATERIAL
`
`Required|VTE|nations|Mean($0)
`
`0.594 (n = 44
`244 (n = 44
`
`Total Injections
`Possible
`
`Total IETS)
`
`Scaa
`eeunen= 44
`0.504 (n = 44
`ree
`Tce
`
`Piero
`
`CONFIDENTIAL
`
`RGN-EYLEA-MYLAN-00619241
`
`Page 18
`Exhibit2015
`Regeneron Pharmaceuticals, Inc.
`Samsung Bioepis Co., Ltd. v. Regeneron Pharmaceuticals, Inc.
`IPR2023-00884
`
`

`CONFIDENTIAL - PROTECTIVE ORDER MATERIAL
`
`IPR2023-00884
`
`Exhibit2015
`Regeneron Pharmaceuticals, Inc.
`Samsung Bioepis Co., Ltd. v. Regeneron Pharmaceuticals, Inc.
`
`CONFIDENTIAL
`
`RGN-EYLEA-MYLAN-00619242
`
`Page 19
`
`

`CONFIDENTIAL - PROTECTIVE ORDER MATERIAL
`
`IPR2023-00884
`
`
`Exhibit2015
`Regeneron Pharmaceuticals, Inc.
`Samsung Bioepis Co., Ltd. v. Regeneron Pharmaceuticals, Inc.
`
`CONFIDENTIAL
`
`RGN-EYLEA-MYLAN-00619244
`
`Page 21
`
`

`CONFIDENTIAL - PROTECTIVE ORDER MATERIAL
`
`n (safety analysis set
`# of subjects with at least 1 AE
`
`44
`
`f
`
`oe
`
`gc!
`68.2%)
`
`|
`
`44.
`26 (59.1%
`
`i
`y.
`(66.7%)
`
`45
`er
`
` /
`
`:
`54.6%)
`
`(2 a=
`
`Conjunctiva hemorrhage
`Sem elie
`IOP increased
`Ocular hyperemia
`Cataract
`
`Vitreous floaters
`Maculopathy
`Retinal exudates
`Vitreous detachment
`Corneal abrasion
`Diabetic retinal edema
`Retinal hemorrhage
`Retinal aneurysm
`Foreign body sensation
`Vision blurred
`Blepharitis
`Punctate keratitis
`Vitreous hemorrhage
`
`CONFIDENTIAL
`
`RGN-EYLEA-MYLAN-00619246
`
`Page 23
`Exhibit2015
`Regeneron Pharmaceuticals, Inc.
`Samsung Bioepis Co., Ltd. v. Regeneron Pharmaceuticals, Inc.
`IPR2023-00884
`
`

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`CONFIDENTIAL - PROTECTIVE ORDER MATERIAL
`
`Regeneron Pharmaceuticals, Inc. Exhibit 2015 Page 24
`Samsung Bioepis Co., Ltd. v. Regeneron Pharmaceuticals, Inc. IPR2023-00884
`
`

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`CONFIDENTIAL - PROTECTIVE ORDER MATERIAL
`
`Regeneron Pharmaceuticals, Inc. Exhibit 2015 Page 25
`Samsung Bioepis Co., Ltd. v. Regeneron Pharmaceuticals, Inc. IPR2023-00884
`
`

`
`
`
`
`CONFIDENTIAL - PROTECTIVE ORDER MATERIAL
`
`Regeneron Pharmaceuticals, Inc. Exhibit 2015 Page 30
`Samsung Bioepis Co., Ltd. v. Regeneron Pharmaceuticals, Inc. IPR2023-00884
`
`

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