Mm: _
`Sent:
`Thu Feb 19 2004 09:46:45 EST
`
`alfrcd sandrock’cambridgcfbiogcn@biogcn
`armcu bozicfcambridgcx’biogemfflbiogex
`
`
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`o'neillfcambfidgcfbiogen®biogen
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`:gilmore
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`T0:
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`CC:
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`lansdeufcambridgemiogenflmiogen
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`o'gormanicnmbridger’biogcnfi‘ehiogen
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`Biogen Exhibit 2309
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`Coalition v. Biogen
`IPR2015«01993
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`MYLAN PHARMS. INC. EXHIBIT 1073 PAGE 1
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`MYLAN PHARMS. INC. EXHIBIT 1073 PAGE 1
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`Sent:
`Thu Feb 19 2004 09:46:45 EST
`
`alfrcd sandrock’cambridgcfbiogcn@biogcn
`armcu bozicfcambridgcx’biogemfflbiogex
`
`
`
`o'neillfcambfidgcfbiogen®biogen
`
`:gilmore
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`T0:
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`CC:
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`lansdeufcambridgemiogenflmiogen
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`o'gormanicnmbridger’biogcnfi‘ehiogen
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`Page 1 of 50
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`Biogen Exhibit 2309
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`Coalition v. Biogen
`IPR2015«01993
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`MYLAN PHARMS. INC. EXHIBIT 1073 PAGE 1
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`MYLAN PHARMS. INC. EXHIBIT 1073 PAGE 1
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`:minhua yangleambridge/biogen@biogen
`
`Subject:
`
`SLIDES ATTACHED: Ad Hoc CTRB Meeting - 3612 MS. Thursday, February 19. 2004, 10-
`l lam EST in Room 4124 Auditorium
`
`Heilo eveiyone-
`
`Attached, please find the slides for today's meeting.
`
`** Please note that handouts wii} be distributed in the Cambfidge Office **
`
`Thank you!
`
`Fomrarded by_ on 02/190004 08:42 AM —————
`
`18-Feb-2004 08:51 AM
`
`To: Alfred Sandrock/Cambfldge/Biogen mBiogen,
`
`Bozic/Cambri dge/Biogen@.Biogen,
`
`Carmen
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`MYLAN PHARMS. INC. EXHIBIT 1073 PAGE 2
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`Gilmore O'Neili/Cambu' dgefBiogen@Biogen,
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`O'Goxman/Cambridge/Biogen@Biogen,
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`Lansden/Cambridge/Biogen@Biogen,
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`, Minhua Yang/CambridgelBiogen@Biogen
`
`Subject: REMINDER: Ad Hoe. CTRB Meeting - BG12 MS, Thursday, Februanj 19, 2004, 10-
`llarn EST in Room 4124 Auditorium
`
`Hello evctyone-
`
`There will be an Ad Hoc CTRB Meeting regarding B612 MS on Thursday, Febmary 19, 2004
`from 10:00-1 1:00am EST/ 3:00—4:00pm UK in Room 4124 Auditorium, Bio 4, 12th Floor.
`
`Attached, please find the protocol concept and table of additional concept options for your
`review and comments.
`
`WebEx Details
`
`Topic: Ad Hoe CTRB Meeting — B612 MS
`Date: Thursday, February 19, 2004
`
`Meeting number-
`Host: C annen Bozie
`
`Teleconference Details
`
`Chairperson: Carmen Bozic
`
`For more information on CTRB Meetings, please visit our website:
`
`Page 4- 0f 50
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`MYLAN PHARMS. INC. EXHIBIT 1073 PAGE 4
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`Thank you!
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`
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`biogen idec
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`Summary of Dosing options.
`
`Dosing Regimes
`
`#1
`
`240 mglday 360 mglday 480 mglday 720 mgfday
`2 div dose
`3 div dose
`2 div dose
`3 div dose
`
`#2
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`120 mglday
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`360 mglday 480 mgiday 720 nag/day
`
`
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`Single dose
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`120 mg/day
`
`Single dose
`
`#3
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`#4
`
`'
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`3 div dose
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`2 div dose
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`3 div dose
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`369 mglday
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`3 div dose
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`720 mglday
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`3 div dose
`
`-
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`-_
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`'720 mglday 1080
`3 div dose mglday
`.
`'3 div
`dose
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`9 '90me 13, 21103
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`Impact of Constraints on Options.
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`Constraints
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`Option 1
`
`Option 2 Option 3 xiii-Option 4-5;?"
`
`\i
`
`‘
`
`13;;
`
`\f
`
`V
`
`N!
`
`NF
`
`X
`
`V;
`
`regulatory
`
`Deliver data by Q3 ‘05
`
`Dosing is in multiples
`of 120 mg
`
`Safety concerns
`above 720 mg
`
`Psoriasis already
`established 720 mg
`
`Adequate Dose
`determination for
`
`1G Novemho: 13‘ 20.113
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`Lead Option (Option 1) Treatment
`Schedule
`
`- 233 patients randomised in 59:44:44244244 patients
`
`— Primary objective is to determine the effectiveness
`of 4 dosing regimes of BGDOO12 on brain lesion
`activity as measured by MRI in patients with
`relapsing remitting MS when compared to placebo.
`- Placebo, BG’12 120mg bid, 88’12 120mg tid, BG’12 240mg
`m, BG’i2 240mg lid.
`
`
`
`'
`
`initial treatment period 24 weeks (Dose escalation
`after one week in treatment and extension phase)
`
`- Followed by 24 week extension phase
`-— Patients on active treatment will remain on the same dose
`
`—~ Placebo patients will receive BG’12 240mg tid
`
`11 November 13‘ 2.003
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`Critique of Option 1 concept.
`
`- Scientific:
`
`— Confirms efficacy of BG’tZ in MS.
`
`— Dose ranging study.
`- Minimum efficacious dose.
`
`— Endorses option 2.
`
`— Determine roles of Cmax, Cmax frequency and/or total daily
`exposure in influencing therapeutic effect.
`
`- Regulatory:
`- Low risk: ie Regulatory agencies will determine that dose
`determination is adequate.
`
`- Commercial:
`
`153 November 13, 26(13
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`Option 2 Treatment Schedule
`
`- 233 patients randomised in 59:44:44:44:44
`ratio
`
`— Primacy obiective is to determine the effectiveness
`of four doses of BGOOO‘IZ on brain Eesion activity
`as measured by MRI in patients with relapsing
`remitting MS when compared to placebo.
`-- Placebo, BG’12 120mg gd, BG’12 120mg tid,
`BG’12 240mg bid, BG’12 240mg tid
`
`-
`
`Initial treatment period 24 weeks
`
`
`
`- Followed by 24 week extension phase
`- Patients on active treatment wiil remain on' the
`same dose
`
`— Placebo patients will receive BG’12 240mg tid
`
`16 November 13. 2.003
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`Critique of Option 2 concept.
`
`- Scientific:
`
`.
`
`m Confirms efficacy of BG’12 in MS.
`
`... Optimal dose for Phase Ell study.
`— Risk that 120mg qd will not Show efficacy.
`— BUT will not determine roles of Cmax, Cm frequency and/or
`total daily exposure in influencing therapeutic effect.
`
`-—- Prefers this option.
`
`- Regulatory:
`— Lowest dose selected may not be accepted by Regulatory
`agencies.
`
`- Commercial:
`
`17 November $3, 2993
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`Option 3 Treatment Schedule
`
`- 236 patients randomized in 1:1:121 ratio (59
`patients per arm).
`-— Primary objective is to determine the effectiveness
`of three doses of BGOOD12 on brain lesion activity
`as measured by MRI in patients with retapsing
`remitting MS when compared to placebo.
`
`-~ Placebo, BG’12 120mg gd, BG’12 120mg tid,
`BG’12 240mg tid
`
`-— Placebo patients will receive BG’12 240mg tid
`
`-
`
`Initial treatment period 24 weeks
`
`- Followed by 24 week extension phase
`— Patients on active treatment will remain on the
`
`same dose
`
`18 November 13‘. 21303
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`Critique of Option 3 concept.
`
`- Scientific:
`
`-- Confirms efficacy of BG‘12 in MS.
`
`Optimal dose for Phase Ell study.
`Minimum efficacious dose.
`
`-— Preferred over option 1.
`
`Does not explore BID dosing.
`
`And will not determine roles of Cmax, Cm frequency andlor total
`daily exposure in influencing therapeutic effect.
`
`- Regulatory:
`
`— Risk that regulators would feel that close determination is
`inadequate.
`
`- Commercial:
`
`it} November I3, 2003
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`Budget Considerations
`
`-
`
`‘lst Pass 2004 Annual Plan: Ph lib with 2 F/U
`
`visits
`
`.... Phase lib and safety extension combined
`
`. New Designs:
`— Phase lib with 1 Flu visit
`
`— Separate extension study
`
`- Combined total for separate studies
`
`22 Novemhea 13' 2093
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`Phase llb study design
`
`Screening
`Randomize!
`
`10
`
`iOpen Eabel Safety
`
`Q 1“ endpoint at 24 weeks
`
`Possibie
`GOING Go for
`Phase III
`
`GolNo Go for
`Phase Ili
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`2’? November 13. 29113
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