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`FORWARD PHARMA EXHIBIT 1018
`Biogen MA Inc. v. Forward Pharma A/S
`Contested Case 106,023
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`1
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`Sawai (IPR2019-00789), Ex. 1046, p. 001
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`

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`2
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`Sawai (IPR2019-00789), Ex. 1046, p. 002
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`Atty. Dkt.No.2159.3210001
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`- 3 —
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`LUKASHEV
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`Appl. No. 12/526,296
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`Men and women 18 to 55 years of age were eligible for the study if they had a
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`diagnosis of RRMS and an Expanded Disability Status Scale ("EDSS") score (a
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`well-known measure of the disabilities suffered by MS patients) between 0.0 and
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`5.0. Additionally, the patients had to have had at least 1 relapse within 12 months
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`prior to randomization or gadolinium-enhancing (Gd+) lesions (Gd+ lesions in the
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`brain are a well-known marker of MS) on brain MRI within six weeks of
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`lesions from four brain MRI scans obtained at Weeks l2, 16, 20, and 24. The
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`number of Gd+ lesions is considered a surrogate end point for clinical efficacy and
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`The secondary end points of the Phase 2 clinical trial included the cumulative
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`number of new Gd+ lesions on scans from Weeks 4 and 24, the number of new or
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`newly enlargingTZ-hyperintense lesions at Week 24, and the number of new T1
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`hypointense lesions at week 24.
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`Additional end points included annualized relapse rate ("ARR") and disability
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`progression as measured by EDSS.
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`The results of the Phase 2 clinical trial are reported in the peer-reviewed publication
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`of Kappos, L., et al., "Efficacy and safety of oral fumarate in patients with relapsing-remitting
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`multiple sclerosis: a multicentre, randomised, double-blind, placebo-controlled phase IIb study,"
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`3 S
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`awai (IPR2019-00789), EX. 1046, p. 003
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`3
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`Sawai (IPR2019-00789), Ex. 1046, p. 003
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`4
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`Sawai (IPR2019-00789), Ex. 1046, p. 004
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`21
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`Sawai (IPR2019-00789), Ex. 1046, p. 005
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`22
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`Sawai (IPR2019-00789), Ex. 1046, p. 006
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`(cid:9)
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`Exhibit C
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`to Exhibit 1
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`'23 x
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`Sawai (IPR2019-00789), EX. 1046, p. 007
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`23
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`Sawai (IPR2019-00789), Ex. 1046, p. 007
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`:20_o>o:m.6>omoEm
`émso>FngEEom.x.cmEEQ.0.EEEE:.>.m>oE>m_._m.28.m.mégomgdo.$____>_+3@8qu
`
`___mz.o.zdgofixmm._.m>o:_N:_m_>_.m$8me._>_6:9._>_
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`”$8.2323:5:m:_:_Em._.m:_mo_m_2
`.._
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`5E.3...ng5.3253.3225".
`EmmaéEEm
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`3.93m=$93m”.03:52
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`0<ELmsamEsmnew9225.85Eneomcoam203w,,
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`24‘
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`Sawai (IPR2019-00789), EX. 1046, p. 008
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`24
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`Sawai (IPR2019-00789), Ex. 1046, p. 008
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`

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`Sawai (IPR2019-00789), Ex. 1046, p. 009
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`Sawai (IPR2019-00789), Ex. 1046, p. 010
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`29
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`45
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`Sawai (IPR2019-00789), Ex. 1046, p. 029
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`