`
`Subject:
`From:
`
`Monday, April 2 2007 09:24 PM
`Decisions & Actions: AMD Ph3 Program Mtg - 4/2/07
`Kathleen Lawrence
`
`To:
`
`Karen Chu <Karen.Chu@regeneron.com >; Kremena Simitchieva
`<Kremena.Simitchieva@regeneron.com >; William Roberts
`<William.Roberts@regeneron.com >; Neil Stahl <Neil.Stahl@regeneron.com >; Laura Pologe
`<Laura.Pologe@regeneron.com >; Robert Terifay <Robert.Terifay@regeneron.com >; Avner
`Ingerman <Avner.Ingerman@regeneron.com >; Leonard Schleifer
`<Leonard.Schleifer@regeneron.com >; George Yancopoulos
`<George.Yancopoulos@regeneron.com >; Peter Powchik <Peter.Powchik@regeneron.com >;
`Kati Gutierrez <Kati.Gutierrez@regeneron.com >;ham Zoughi
`<[lham.Zoughi@regeneron.com >; Christopher Fenimore
`<Christopher.Fenimore@regeneron.com >;
`Caroline Saxton <Caroline.Saxton@regeneron.com >;
`image001.emz; image002.gif
`Below is a summaryof the decisions and actions from the AMD Phase 3 Program Mtg. Please review and let me knowif
`anything is missing or incorrect.
`
`CC:
`
`Attachments:
`
`Thanks,
`Kathleen
`
`ata
`
`* Decision: 0605 Design
`- 1200 patients; estimate 12mth enrollment — Use these assumptions for
`contracting and budgeting with CRO
`- Arms
`* Lucentis
`*
`0.5rmg g4wks
`« Z2mg qSwks wiPIER lead in (dose monthly for 1**3mths)
`« 2mg q4wks (only 6x safety margin based on tox ~ will need to discuss with EU
`authorities)
`. Mote: 4rmg dase group not completely ruled out... base final decision on additional 0508
`* Action: Determine if it is feasible to review 0508 data real-tirne to evaluate
`whether we want to consider the 4mg dose and for ARVO presentation
`(Avner, George, Peter, and Neil to review data) — Avner/Karen
`Revisit whether it’s necessary to do OCTsforall patients in O605 —
`¢ Action:
`Avner
`« Action
`Karen
`: Consider adding a 2mg new formulation dose group to 0603 —
`*« Action
`Avner, Karen
`« Action : Discuss proposed developmentplan with Darlene Jody — Bob,
`George, Peter
`
`: Talk to Bayer about the option to use ex-US sites for 0605 — Avner,
`
`CONFIDENTIAL
`
`SamsungBioepis Exhibit 1091
`Page1
`
`RGN-EYLEA-MYLAN-00631 182
`
`Samsung Bioepis Exhibit 1091
`Page 1
`
`
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