`
`Meeting on 27 August 2003 in Amsterdam
`
`SeronoParticipants:
`I, Emery, G. Francis, D. Frank, M. Lopez-Bresnahan, A. Munafo, A. Ythier, A. Jaber, by phone: N. Ammoury, J.
`Hillier
`IVAX Participants:
`S. Marcus, Y. Dandiker, D. Weiner, by phone: D. Emma
`
`
`
`ORALCLADRIBINEforMSPROJECT|_—sMeeting 25 August 2003 - Amsterdam "Draft minutes- page 1 of8
`Merck 2079
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`TWi v Merck
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`IPR2023-00049
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`
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`se I study with the
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`cyclodextrin formulation
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`Draft minutes - page 2 of 8
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`Meeting 25 August 2003 - Amsterdam
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`ORAL CLADRIBINE for MS PROJECT
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`Yogesh discussed formulation rorsI Soft cet capsule,Si
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`Formulation proar
`
`n
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`nt
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`i
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`6
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`.
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`.
`
`, Dandiker_Amsterdan
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`Hardce!capsule,i
`Mucoidadhesivetabjet,iis
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`
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`ORAL CLADRIBINE for MS PROJECT
`
`Meeting 25 August 2003 - Amsterdam
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`Draft minutes - page 3 of 8
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`
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`Expert Panel andPhaseIIIdesign
`Presentation M. L
`z-Bresn
`n:
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`1|
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`7
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`|
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`|
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`Il
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`Suggestions for primary phase III study (PB-controlled):
`
`
`Arms: cumulative dose approximating 0.7 mg/kg (.35 mg/kg x 5 days x 2 months) and 2.1 mg/kg (.35
`ma/ka x 5 days x 6 months) and placebo
`
`Duration of treatment: 24 months
`
`
`
`ORAL CLADRIBINE for MS PROJECT
`
`Meeting 25 August 2003 - Amsterdam
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`Draft minutes - page 4 of 8
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`
`
`Phase III design issues to be fine tuned:
`
`Efficacy endpoints : ROW experts agreed that relapse rate was the best primary endpoint, but time to first
`relapse will also be considered. Secondary end points discussed: MRI endpoints to be determined with
`suggestion that majority of sites perform MRI at baseline, 12 & 24 months with a subset of sites doing
`frequent MRI (baseline, 9, 10, 11, 12, 21, 22, 23 & 24 months), disability at 2 or 3 years, safety,
`pharmacodynamics (lymphocyte markers), consider surrogate marker used in HIV study (Trex, an increase in
`marker indicates maintenance of stem cel! pool)
`
`Sample size: dropout rate estimated at 20%
`
`@ Regulatory Strategy (Jill Hiller/I. Emery)
`
`ORAL CLADRIBINE for MS PROJECT
`
`Meeting 25 August 2003 - Amsterdam
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`Oraft minutes - page 5 of &
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`ORAL CLADRIBINE for MS PROJECT
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`Meeting 25 August 2003 - Amsterdam
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`Draft minutes - page 6 of 8
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`Draft minutes - page 7 of 8
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`ORAL CLADRIBINE for MS PROJECT _—“ Meeting 25 August 2003 - Amsterdam
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`ORAL CLADRIBINE for MSPROJECT
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`Meeting 25 August 2003 - Amsterdam
`Draft minutes - page 8 of 8
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