throbber
Brolucizumab Global Forecast
`including PFS analysis
`
`I NOVARTIS
`
`CONTAINS CONFIDENTIAL BUSINESS INFORMATION, SUBJECT TO PROTECTIVE ORDER
`
`NOVITC(US)00389194
`
`Novartis Exhibit 2166.001
`Regeneron v. Novartis, IPR2021-00816
`
`

`

`by 2030
`nAMD market to grow at
`NVTS well positioned to realize growth opportunity amidst intensifying competition
`
`nAMD Market Size
`Sales n USO tin C 916 .-.tea
`
`Competitive Landscape
`
`The Opportunity
`
`longer time Intervals b -n Injections"
`
`t Strong unmet need foe treatments that allow for
`
`MaJonty of US pnysicIans (82%) conSl<ler SRF anCI IRF
`recurrence as major Indicator of recLrrentwAMD2
`
`Majomy of US pnysicians (59%) believe 1na1 •witching
`anti•VEGF agents make an impact on VA2
`
`NVS Retina Portfolio
`
`compara1>Ie emcaty and longer rntenial between ,nf. vs Eylea
`
`~ Brolutizumab, a next genefiltion anti•VEGF, expected to have
`
`4
`
`Brolucitumab is the fii,t truly global anti•VEGF from NVS
`presenting an opportunity to entertne us market
`Brolucliumab launches lnlo a highly competitive markot where
`Cllfferentla11on Is key; tne prOCluct launcnes s11gnuy alleaa or
`raniOIZumaD LoE (In most markets) an<l potentially at tne same trne
`as DARPins: l nv•1tmentr~Lir.c:t to driwdiff..-.ntiation and
`attain Share of Voice to capture patNP'ntshare
`
`SOU1ce. I. Age-rela~ed MIC\ll&r Degen«a1i0f'I, fl"StWotdTher-apy Trends, Ju:ne 2016, 2. As.RS 2016 PAT SUtvey
`
`Ophthamology Franchise
`
`th NOVARTIS
`
`CONTAINS CONFIDENTIAL BUSINESS INFORMATION, SUBJECT TO PROTECTIVE ORDER
`
`NOVITC(US)00389195
`
`Novartis Exhibit 2166.002
`Regeneron v. Novartis, IPR2021-00816
`
`

`

`In a competitive market, PFS and edge in dosing
`regimen could differentiate brolucizumab
`
`BASE CASE
`
`Brolucizum.ab
`
`Indication•
`
`nAMD (2020e)
`OME (2021e)
`
`---HiiiGifHAFMIMM
`
`('''1Key differentiation point vs. SoC
`
`MMD; DME: RVO:
`mcNv
`Pursuing OR
`
`MMD (2020e)
`OME (2021e)
`
`nAMD & DME
`
`nAMD; DME; RVO
`RlCNV,
`Rare ME/CNV (2017e)
`& ROP (2020e)
`
`Compound
`
`aVEGF
`
`aVEGF
`
`aVEGF
`
`aVEGF DARPin
`
`aVEGF &ANG2
`(REGN 910-3)
`
`Target pop.
`
`SameasSoC
`
`nAMD - all comers
`DME· with VI ex-US, al
`ror us
`
`AsSOC
`
`Assoc
`
`All excl. diabetk
`patients with nAMD
`
`Equivalent to soe f +
`
`,-- Equiva>enttoSoC __ , __ C::i!%:;~~t:n __
`l 2q4, 2q8, T&E, PRN, ! P3 tnats seek to
`:3-0-40% pis expected 10: demonstrate lOO%
`j be mamta,nea 016 :
`r t
`12
`t_ ____ dOSillQ'" ____ i ___ pa 1en son q __ _
`
`]
`60
`___
`~ u~~~:yvs'__J
`
`.
`.
`Loaa,ng I maintenance
`TBD
`
`Equiva>entto sac
`! nAMD: 40% q12 +
`ootcomes
`_ DME: q6+50%q12 ___ _
`
`I iml)(ovea anatomical
`
`At Launch
`----------------------------
`nAMO FIR June 2017
`
`Efficacy
`(BCV/\)
`
`Dosing
`l"ejllmen
`
`PFS
`
`Status
`
`NetPrice(cid:173)
`(2020)
`
`+6 lettersBCVA
`
`qd, PR,N and T~E.
`37% onq12
`
`Yes - US (10/14116)
`Yes-OUS
`
`NO
`
`NO
`
`NO
`
`In market
`
`tnmarket
`
`Parttywlth
`broluci:zumab
`
`- Price aVEGF+ price
`aPDGF-10%
`
`• (Lucentis) LUCAS tnal, (Eylea) ARIES trial, in p,ogress
`
`Ophthamology Franchise
`
`th NOVARTIS
`
`CONTAINS CONFIDENTIAL BUSINESS INFORMATION, SUBJECT TO PROTECTIVE ORDER
`
`NOVITC(US)00389196
`
`Novartis Exhibit 2166.003
`Regeneron v. Novartis, IPR2021-00816
`
`

`

`i In the base case, Brolucizumab to contribute
`overall ; -
`in nAMD
`
`CONTAINS CONFIDENTIAL BUSINESS INFORMATION, SUBJECT TO PROTECTIVE ORDER
`
`NOVITC(US)00389197
`
`Novartis Exhibit 2166.004
`Regeneron v. Novartis, IPR2021-00816
`
`

`

`i In US Brolucizumab expected to rea
`nAMD; ~n the ex US by 2025
`
`n
`
`Ophthamology Franchise
`
`th NOVARTIS
`
`CONTAINS CONFIDENTIAL BUSINESS INFORMATION, SUBJECT TO PROTECTIVE ORDER
`
`NOVITC(US)00389198
`
`Novartis Exhibit 2166.005
`Regeneron v. Novartis, IPR2021-00816
`
`

`

`In markets, where efficacy perception is at par,
`convenience (e.g. PFS) provides a competitive edge
`
`_.,_ lucentis
`
`-
`
`Eylea
`
`-
`
`Unlicensed Bevacizumab
`
`Has a convenient treatment
`and visit schedule
`
`Has clinically proven efficacy
`
`Is easy to administer
`
`Treatment is
`accessible/affordable
`
`Has a well characterised
`safety profile
`
`Has a low treatment burden
`
`Top reasons for
`prescribing Lucentis:
`1. Pre-filled syringe
`2. Low systemic
`exposure
`3. Clinical experience
`
`Lucentis vs. Eylea share:
`US: 32% / 68%
`T op8 Ex-US: 50% / 50%
`
`Source: EURETINA 2016 Congress Research , 116 ex-US physicians; US Lucentisvs . Eylea ratio: SHA Claims data (2015);
`Top 8 ex-US Lucentis vs Eylea ratio: 1;1S Monthly volume data.
`
`Ophthamology Franchise
`
`NOVARTIS
`
`CONTAINS CONFIDENTIAL BUSINESS INFORMATION, SUBJECT TO PROTECTIVE ORDER
`
`NOVITC(US)00389199
`
`Novartis Exhibit 2166.006
`Regeneron v. Novartis, IPR2021-00816
`
`

`

`PFS launch helped differentiate Lucentis thereby
`minimizing erosion due to competition
`
`Ophthamology Franchise
`
`th NOVARTIS
`
`CONTAINS CONFIDENTIAL BUSINESS INFORMATION, SUBJECT TO PROTECTIVE ORDER
`
`NOVITC(US)00389200
`
`Novartis Exhibit 2166.007
`Regeneron v. Novartis, IPR2021-00816
`
`

`

`PFS facilitates a faster uptake as seen with
`Orencia and Actemra
`
`PFS-Actemravs Orenciauptake
`
`Orencia Vial vs. Pre-Filled Syringe Uptake
`
`Ophthamology Franchise
`
`CONTAINS CONFIDENTIAL BUSINESS INFORMATION, SUBJECT TO PROTECTIVE ORDER
`
`NOVITC(US)00389201
`
`Novartis Exhibit 2166.008
`Regeneron v. Novartis, IPR2021-00816
`
`

`

`Lucentis PFS Approved in US - Oct 14th 2016
`
`Genentech
`
`·(cid:173)Frday,0ct!4,20l6
`
`FDA Approves Genentech's lucenUs (Ranibizumab
`Injection) ?refilled Syringe
`
`• Lucentis prefilled syringe offers a ready-to-use optioo to deliver
`treatment with fewer steps
`
`• first anli·VEGF prefilled syringe FDA-approved to treat people
`with wet age-related macular degeneration and people with
`macul.lr edema atter retinal vein occlu~on
`
`--(650) .. , .6800
`-M SolthS.•fr•~CA - Octotltr l 4, 201, -
`
`Gnntt(h.1fflfclier dlht ""'-&DI.ID (SIX: RO, ROG; O'TCQX.: RHHB'I), tcdiy ~ t h , : :
`
`''The Lucentis PFS allows
`physicians to eliminate several
`steps in the preparation and
`administration process,
`including disinfecting the vial,
`attaching a filter needle,
`drawing the medicine from the
`vial using the needle,
`removing the filter needle from
`the syringe and replacing with
`an injection needle. With the
`Lucentis PFS, physicians
`attach the injection needle to
`the syringe and adjust the
`dose prior to administration"
`
`Source: https://www gene comfmedia/press-releases/ 1464Q/2016-1Q-14/fda-approves:9enentechs-lucentis-ranibiz: Site accessed October 15th 2016
`I NOVARTI S
`
`Ophthamology Franchise
`
`CONTAINS CONFIDENTIAL BUSINESS INFORMATION, SUBJECT TO PROTECTIVE ORDER
`
`NOVITC(US)00389202
`
`Novartis Exhibit 2166.009
`Regeneron v. Novartis, IPR2021-00816
`
`

`

`i Globally delayed PFS launch would impact initial
`uptake, revenues impacted by
`in nAMD
`
`Delayed PFS launch
`
`CONTAINS CONFIDENTIAL BUSINESS INFORMATION, SUBJECT TO PROTECTIVE ORDER
`
`NOVITC(US)00389203
`
`Novartis Exhibit 2166.0010
`Regeneron v. Novartis, IPR2021-00816
`
`

`

`i Delayed PFS launch will erode value US and
`impact Ex-US markets due to the risk of price cuts
`
`Delayed PFS launch
`
`~1t : l"Pl,llllfOl"aClr"41~IOl')'lU"'!ISSlil#N•teoontt-eW'l!O,ICl<MtOPFS<lelly
`Ophthamology Franchise
`
`th NOVARTIS
`
`CONTAINS CONFIDENTIAL BUSINESS INFORMATION, SUBJECT TO PROTECTIVE ORDER
`
`NOVITC(US)00389204
`
`Novartis Exhibit 2166.0011
`Regeneron v. Novartis, IPR2021-00816
`
`

`

`Recommend to develop PFS to support commercial
`launch
`
`CONTAINS CONFIDENTIAL BUSINESS INFORMATION, SUBJECT TO PROTECTIVE ORDER
`
`NOVITC(US)00389205
`
`Novartis Exhibit 2166.0012
`Regeneron v. Novartis, IPR2021-00816
`
`

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