`Sent:
`To:
`CC:
`
`Subject:
`
`cara lansdeulcarnbridgelbiogen;nsf;cara.lansden@biogenidec.corn;srnlp
`Thu Jul 06 2006 13:11:08 EDT
`minima yang/cambridgelbiogen@biogenidec;
`gilmore o'neillicambridgelbiogen@biogenidec;
`lingamaneni/cambridgelbiogen@biogenidec;
`Re: BG-12 MS COT meeting minutes
`
`;ratna
`
`.Minhua Yang/Cambridge/Biogen
`07/06/2006 10:47 AM
`Message Size: 74.0 KB
`
`To
`Cara Lansden/Cambridge/Biogen@Biogenldec
`cc
`Gilmore O'Neill/Cambridge/Biogen@Biogenldec, Ratna
`Lingamaneni/Cambridge!Biogen@Biogenldec,
`Subject
`Re: BG-12 MS CDT meeting minutes
`
`Hi Cara:
`
`I j ust read the minutes from yesterday and have a comment. I sent out an email in June to you
`
`Page 1 of6
`
`Biogeo Exhibit 2316
`Coalition v. Biogeo
`IPR2015-01993
`
`
`
`about the revised sample size if 480 mg am1 is added, the sample size for both studies will be
`changed. Please see below.
`
`Thanks. -minhua
`
`Putpose:
`
`Calculate the additional patients needed if a 480mg dosing ann needs to be added to the Phase 3
`protocols.
`
`Assumptions:
`For both the placebo-controlled trial and the 3-atm trial, adding an additional arm means that we
`will need to adjust for multiple comparisons (i.e., we are doing the statistical comparisons more
`than once, 720 mg vs placebo, 480 mg vs placebo, and additionally, Cop vs placebo). If we use a
`closed testing procedure, and the do the testing in a "step-wise" fashion, then the test of 720 mg
`vs placebo first, if that is statistically significant at the 0.05 level, then test the 480 mg vs placebo
`second, at the alpha = 0.05 leveL However, this assumes, that if the 720 mg does not work, then
`we WON'T test the 480 mg vs placebo, i.e., that comparison is declared statistically not
`significant, whether or not it really is. I have discussed with Cara and, since we think this
`scenario is unlikely, we will accept the risk, and will use the closed testing procedure for
`multiple comparison adjustment This way, both comparisons will be done at the 0.05 level.
`
`New sample size:
`
`1. Placebo controlled ttial, 1:1:1 randomization, placebo: 720 mg/day : 480 mg/day. It will be
`350:350:350 patients, total of 1050. A drop out rate of 20% over 2-years is assumed.
`
`2. 4-atm trial, 1:1:1: I randomization, placebo: 720 mg/day: 480 mg/day: Copaxone. It will be
`350:350:350: 350, patients, total of 1400. A drop out rate of20% over 2-years is assumed.
`
`-minhua
`
`Cara Lansden/Camb1idge/Biogen
`07/05/2006 03:27PM
`Message Size: 70.2 KB
`
`Page 2 of6
`
`
`
`To
`Gilmore O'Neill/Cambridge/Biogen@Biogenidec, Kate
`Dawson/Camb1idge/Biogen@Biogenldec, Minhua Yang/Cambridge/Biogen@Biogenidec
`cc
`
`BG- 12 MS CDT meeting minutes
`
`Tammy Samelli/Cambridge/Biogen@Biogenldec
`
`Hi all :
`
`Attached are the minutes from this rooming's BG-12 MS CDT. Please let me know if you have
`any questions.
`
`Starting next week, 12 July, -
`
`will be leading the CDT.
`
`Today was my last BG-12 CDT and it has been a great expe1ience working with you all. You
`have been a fabulous team, and I learned so much as we faced and overcame each challenge in
`the BG-12 MS clinical program together. It was never a dull moment with BG-12! Now, I leave
`and I am confident that the BG- 12 team will continue to be a
`you in good hands with -
`trailblazer in the MS world.
`
`Regards,
`Cara
`
`Page 3 of6
`
`
`
`Cara Lansden
`Sr. Manager, Clinical Development
`Biogeo Idee
`Tel +617-679-2658
`Fax +617-679-3518
`Email: cara.lansden@biogenidec.com
`
`Page 4 of6
`
`
`
`BG-12 MS
`Clinical Development Team
`Subject: Minutes from BG-12 MS CDT meeting on 05 July 2006
`Date:
`05 July 2006
`
`Attendees: Cara Lansden, Gilmore O’Neill, Kate Dawson, Tammy Sarnelli,
`
`
`
`Kate Dawson will be the new MD for the BG-12 MS program.
`The transition between G. O’Neill and K. Dawson is in progress, but the final date
`of the complete transition is still undefined.
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`1
`
`Introduction of Kate Dawson
`
`2 National Scientific Advice
`feedback from UK and Spain
`
`
`
`
`
`
`.Spain:
`
`
`
`UK:
`
`3 EOP2 Meeting – Timing and
`Prep Activities
`
`
`
`
`
`
`
`Protocol:
`o
`
`Protocol updates are ongoing – VPs will all review during C. Bozic’s
`review cycle.
`
`EOP2 Package:
`o
`Needs more emphasis on the unmet need.
`
`
`
`
`
`
`
`Timelines:
`o
`o
`o
`
`FDA has until Friday, 07 July to inform BIIB of the EOP2 meeting
`date.
`The meeting is likely to be scheduled for the 3rd or 4th week in August,
`even possibly in September.
`Once a meeting date is set, then the team will meet again to discuss
`timing of final revisions to the EOP2 package, as well as impact to
`
`Page 1/2
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`Page 5 of 6
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`
`
`4 AOB
`
`
`
`BG-12 MS
`Clinical Development Team
`timing of FPI.
`o
`There will not be a presentation, though BIIB will have slides
`o
`The meeting will be 1-1.5 hours in length.
`A country selection meeting was held on Friday, 30 June with Global Commercial.
`For the majority of countries, there was agreement between Clinical and
`Commercial on their prioritization. There were a few countries that Commercial
`would like to include and will provide potential investigators for Clinical to evaluate
`as possible study sites, either for the 2 Phase 3 pivotal studies or other studies in the
`Phase 3 program.
`
`Action Items:
`1 Calculate the additional patients needed if a 480mg dosing arm
`needs to be added to the Phase 3 protocols.
`
`Assigned To:
`M. Yang
`
`Date Due:
`ASAP
`
`2
`
`Provide data on MS incidence and approved therapies in Brazil for
`consideration as a potential country to include in Phase 3
`
`C. Hoffman
`
`ASAP
`
`Status:
`Completed:
`109-MS-301
`remains the same
`but 109-MS-302
`sample size
`becomes 1200
`New
`
`Page 2/2
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`Page 6 of 6
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`