CONFIDIENTIAL
`
`I
`
`M I N u T E s
`
`Team Meeting ,,NCE Incontinence“
`
`August 10,1998
`
`Participants:
`
`Hiimar Boekens
`Peter Ney
`Bengt Spart
`
`’
`
`'
`
`Claus lvleese
`Dietrich Schacht
`Christoph Arth (part time, TOP 5)
`
`Distribution:
`
`Participants, Lars Ekman, Ulrike Kluge
`
`.3,-.
`“
`"
`
`a
`
`I Agenda:
`1) Chemistry
`
`- upscale
`- status of synthetic routes
`— isomer synthesis
`- enantiomers separation
`
`2) Biological
`
`- bioavailability dog
`
`3) Milestone decision
`4) Pharmacology
`5) Miscellaneous
`
`- Selection of lead compound family
`- deiinition of Panlabs screen
`- patch development
`‘
`
`I}
`
`(C. lvleese)
`
`(H. Boekens)
`
`(team)
`(P. Ney)
`(C. Ann)
`
`.
`
`Ad 1) For details see handout of 0.0. Meese ,,Chemical Development Plan - Update 7"
`(attachment 1). It is obvious that the availability of pure enantiomers of the
`prcdrugs is still critical. issues are addressed and first positive results have been
`reported by the external experts.
`
`Ad 2) Fl. Boekens explained the resuits of the bioavaiiability study (attachments 2). As
`expected, the oral bioavailaility of SPM 8163 (metabolite) dropped further after
`lowering the dose iumollkg. The experimental part of the study was finalized at
`LPT on July 20, 1998. (Post Meeting note: Draft report irom LPT arrived August
`‘I3, 1998).
`-
`'
`I
`.
`
`Ad 3) After intense discussions it was decided to move toward the OH-/-OGOR
`compounds. Main reasons are:
`- easy and quick rnetabolization in vitro by 89 mix and/or microsomes
`~ relatively good chemical stability
`_
`— reasonabie bioavailability in dogs
`It is expected that further modifications of the ester moiety. may lead to a relative
`bioavailability of about 50%.
`-
`
`Ad 4) A reasonable outline of selected tests as well as budget outline will be prepared
`on availability of the enantiomers. The decision, which substances have to be
`included will be taken at this time (next meeting).
`'
`
`q:\npto\ney\.aktno\mctapro5.doc
`
`RESTRICTED CONFIDENTIAL — SUBJECT TO PROTECTIVE ORDER
`
`UCB007-19223
`
`Patent Owner, UCB Pharma GmbH — Exhibit 2096 - 0001
`
`

`
`RESTRICTED CO_NF|DENT|AL — SUBJECT TO PROTECTIVE ORDER
`
`' UE:Boo719229
`
`Patent Owner, UCB Pharma GmbH — Exhibit 2096 - 0002
`
`

`
`Ad 5) C. Arth presented the first data on in vitro penetration through hairless mouse -
`skin as well as human skin. This first shot with not yet opti_r7n_i;eTttjp_rmuIations
`,_F‘§Y§‘3I‘?F?Ia_Y9_r}fa_EI99?I§fl§‘_P_I9I‘?I§IF_9I‘?§F:'II§_I§IIaEI][P§‘“I§');I
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`
`Actions until next meeting
`
`- Enantiomer synthesis andlor racernate separation
`
`'
`
`(C. Meese)
`
`- Optimization of bioanalytical method _
`
`- Follow up preclinical program e.g. receptor screen
`___-___I_f_v_;>_ltc_3__\_l}_r___tJ__;_3__patch development
`'
`I
`PRIVILEGEE3iiiiiiiiii
`
`(H. Bcekens)
`
`(P. Ney)
`(C. Arth, C. lllleese)
`tom com, PN. as)
`
`Next meeting:
`
`September 30 - 0t:tober.2, 1998; the exact date will be
`communicated by P. Ney asap.
`
`Peter Ney
`Monheim, August 21,1 998
`
`q:mpm\ney\mk1no\mcmpro5 .doc
`
`RESTRICTED CONFIDENTIAL — SUBJECT TO PROTECTIVE ORDER
`
`UCB007-19230
`
`Patent Owner, UCB Pharma GmbH — Exhibit 2096 - 0003
`
`

`
`RESTRICTED CONFIDENTIAL — SUBJECT TO PROTECTIVE ORDER
`
`1
`
`UCB00719231
`
`Patent Owner, UCB Pharma GmbH — Exhibit 2096 - 0004
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`Patent Owner, UCB Pharma GmbH — Exhibit 2096 - 0005
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`RESTRICTED CONFIDENTIAL — SUBJECT TO PROTECTIVE ORDER
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`Patent Owner, UCB Pharma GmbH — Exhibit 2096 - 0006
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`Patent Owner, UCB Pharma GmbH — Exhibit 2096 - 0008
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`RESTRICTED CONFIDENTIAL — SUBJECT TO PROTECTIVE ORDER
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`UCB00719237
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`Patent Owner, UCB Pharma GmbH — Exhibit 2096 - 0010
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