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BG-12 Phase 3 Data DEFINE First Look
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`April 8, 2011
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`Biogen Exhibit 2130
`Coalition v. Biogen
`IPR2015-01993
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`BG-12 Study 109MS301:
`Executive Summary of First Look Results
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`
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`Efficacy:
`All primary and secondary endpoints were met for both BG-12 doses
`-
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`
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`
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`Dose profiles:
`Both BG-12 doses appeared to be similar in terms of first look efficacy and safety
`-
`profiles
`Overall BG-12 risk-benefit profile appears to be favorable
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`Overall Summary: Primary and Secondary Endpoints
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`BG0001 240 mg B D (N=408)
`Final Results
`90
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`85
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`74
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`BG0001 240 mg T D (N=416)
`Preliminary Results
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`73
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`49
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`50
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`53
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`48
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`33
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`31
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`37
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`34
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`120
`100
`80
`60
`40
`20
`0
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`Reduction versus placebo
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`** ** ** ** ** ** ** ** * * * *
`Secondary #4:
`Secondary #3: ARR
`Secondary #4:
`Secondary #2: New Gd
`Secondary #1: New or
`Primary: Proportion
`Preliminary EDSS
`Preliminary EDSS
`enhancing lesions
`newly enlarging T2
`with relapse at Week
`progression (available
`progression (worst
`(MRI cohort)
`lesions (MRI cohort)
`96
`data)
`case)
`* = p < 0.0250, ** = p < 0.0001
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