`Sent:
`
`gilmore o'11eill/cambridge/biogen;nsf;gilmore.oneill@biogenidec.con1;smtp
`Thu Jun 29 2006 03:52:34 EDT
`
`To:
`CC:
`cara lansde11/cambridge/biogen@biogenidec ;minl1ua
`yang/cambridge/biogen@biogenidec;
`
`Subject:
`
`Re: REVIEW REQUEST BGl2 PROTOCOLS- 1 question
`
`Since this will be an intention to treat analysis, we should allow patients to reduce dose if they
`cannot tolerate the drug. I would write it as we wrote it for C1900.
`
`Best regards
`
`Gilmore
`
`Gilmore N. O'Neill, M.B., M.R.C.P.I., M. Med. Sci.
`Director
`
`Clinical Development-Neurology
`biogenidec
`14, Cambridge Center, Bio 4
`Cambridge, MA 02142
`Tel: 617-679.2000
`
`Fax: 617-679-3518
`
`
`
`Page 1 0”
`
`Biogen Exhibit 2126
`Coalition v. Biogen
`IPR2015-01993
`
`63
`
`Page 1 of 4
`
`Biogen Exhibit 2126
`Coalition v. Biogen
`IPR2015-01993
`
`
`
`Hi Minhua,
`We touched on this a couple of times. For these studies it was my impression, that if subjects did
`not tolerate BGl2 at the higher close, they would be prematurely discontinued from the study for
`"intolerance to study drug". From what I understood, it was okay in the C-1900 study because
`there was a dose ranging study (or dose finding) and for all intent and purposes these phase 3
`studies are "fixed" at one dose level.
`
`I realize this is not in the protocol - but we could certainly add it, or clarify based on Gilmore's
`opinion.
`
`
`
`Hi -/Gilmore:
`
`While I was reviewing the protocols I had a question about dosing. This is a Gilmore question. In
`C-1900 we allow subjects to take reduced dose i.e. 1 pill each time 3 pills total a day due to
`study drug intolerance, do we allow that in our phase 3 protocols?
`
`-minhua
`
`Page 2 of 4
`
`63
`
`Page 2 of 4
`
`
`
`26-Jun-2006 05:38 PM
`
`Message Size: 5189.5 KB
`
`To
`
`
`
`Gilmore O'Neill/Cambridge/Biogen Biogenldec,
`Minhua Yang/Cambridge/Biogen@BiogenIdec,
`
`Ratna Lingamaneni/Cambridge/Biogen@Biogenldec,
`ammy Samelli/Cambridge/Biogen@BiogenIdec,-
`Cara Lansden/Cambridge/Biogen@BiogenIdec
`
`
`
`Kate Dawson/Cambridge/Biogen@Biogenldec,
`
`Subject
`REVIEW REQUEST BGI2 PROTOCOLS
`
`Hello All,
`Attached you will find the 2nd DRAFTs of the two BGI2 phase 3 protocols:
`l09MS301(monotherapy) and lO9MS302 (3-Arm reference comparator). For your review and
`comment. Comments are to be sent to— (cc me) by BOB on Thursday, 29June06.
`
`As per my notice last week, remember our goal is to complete these protocols (approved, but not
`signed by Carmen Bozic) for the EOP2 submission package due 13July06 - which means our
`timeline for protocol production has been very condensed. So, please be as timely as possible
`with your review and comments.
`
`Page 3 of 4
`
`63
`
`Page 3 of 4
`
`
`
`Note:
`
`Section 14.3: Test and Assessments: is not complete and will not be completed until the Study
`Aeti\»'it_v Floweharts are "final".
`Section I5 - Safety:- made changes to this section, which have been highlighted and
`stnkenthrough, to make it easy to review for those of you in DSRM.
`
`Thank you for your time and attention.
`Regards,
`
`Page4 0f4
`
`63
`
`Page 4 of 4
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