`Clinical Development
`Team
`
`Team Minutes
`
`To: Program/Clinical Development Team
`
`From: Cara Lansden
`
`Date: 07 September 2005
`
`Re: COT Meeting Discussion Minutes- 07 September 2005
`
`Pre-IND Meeting Outcome
`Delays to the timeline:
`• The Pre-IND meeting was held on Thursday, 01 Sep. The FDA did not agree to the
`pre-clinical bridging argument and require another non-rodent study prior to
`beginning Phase 3, and for various reasons, it was suggested that the study should
`be done in primates. This could result in a delay of about 12-18 months to the
`Phase 3 program. The im
`on timelines will be discussed in more detail at the
`Program Team level when
`is present.
`• The main clinical issues
`sed by FDA were the
`
`in
`
`• With the delay to the start of Phase 3 due to the additional pre-clinical study, should
`we push out the IND filing forMS, the QTc study or Food Effect study? It was
`agreed that it was preferable to file the INO and continue planning for the QTc
`interval study in Q1 06, and have everything ready for an EOP2 meeting. Based on
`the Pre-IND meeting, if we have a good pre-clinical plan in the I NO, it will be
`accepted by FDA. FDA also said that our data supports the QTc Interval study.
`DECISION: COT will still file the IND in October
`• Also, we could begin Phase 3 studies in the EU, since those Regulatory agencies
`(with the exception of Denmark and France) are currently satisfied with the data
`package. The dow nside is that we would not have FDA feedback on one of our
`pivotal clin ical studies being run in EU.
`
`Page 1 of2
`
`Biogeo Exhibit 2262
`Coalition v. Biogeo
`IPR2015-01993
`
`
`
`o
`
`FDA said they would accept outside US studies as long as they were
`done ethically – we can get more feedback at EOP2.
`
`
`
`Clinical Development Plan:
`The option with 2 placebo-controlled monotherapy studies with combination safety
`
`was acceptable by the FDA. G. O’Neill clarified that FDA said they expected long
`phase 3 studies of UP TO 2 years duration.
`However, FDA gave strong warning that although they believe placebo-controlled
`studies are acceptable, the MS Societies have claimed they were unethical and
`FDA may not accept placebo-controlled studies in future.
`FDA would accept an all-comers design and an Active Comparator designed for
`superiority in lieu of a placebo-controlled study. A dose-response study with the
`lowest dose being as efficacious as placebo would be the least acceptable.
`FDA suggested that BIIB should be canvassing MS practitioners about whether
`they considered placebo-controlled studies ethical.
`
`
`
`
`
`Page 2 of 2
`
`
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