From:
`
`Sent:
`
`To:
`
`Subject:
`
`Fri Mar 18 2005 14:50:09 EST
`
`carmen bozic/cambridge/biogen@biogenidec;
`
`Fw: BG00012:
`
`----- Forwarded by
`
`on 03/18/2005 02:49 PM -----
`
`20-Dec-2004 10:32 AM
`
`
`
`To
`BG-12 Program Team,
`O'Gorman/Cambridge/Biogen@BiogenIdec,
`
`cc
`
`
`
`Ratna Lingamaneni/Cambridge/Biogen@BiogenIdec,
`
`
`
`
`
`Subject
`BG00012: Official Pre-IND Meeting Minutes from FDA
`
`
`
`, John
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`Enclosed please find the "official" minutes from the Pre-IND meeting held with FDA on
`November 23, 2005. Although the minutes are quite similar to the draft comments received on
`November 19th, there are several differences...based primarily on the discussion that took place
`during the meeting.
`
`Please review the minutes carefully and notify me of any significant differences in understanding
`regarding the meeting outcome. Comments are due on Tuesday, January 4, 2005.
`
`If you have any questions or require additional information, please let me know ASAP.
`
`Page 1 of 19
`
`Biogen Exhibit 2323
`Coalition v. Biogen
`IPR2015-01993
`
`
`
`Sent:
`
`To:
`
`Subject:
`
`Fri Mar 18 2005 14:50:09 EST
`
`carmen bozic/cambridge/biogen@biogenidec;
`
`Fw: BG00012:
`
`----- Forwarded by
`
`on 03/18/2005 02:49 PM -----
`
`20-Dec-2004 10:32 AM
`
`
`
`To
`BG-12 Program Team,
`O'Gorman/Cambridge/Biogen@BiogenIdec,
`
`cc
`
`
`
`Ratna Lingamaneni/Cambridge/Biogen@BiogenIdec,
`
`
`
`
`
`Subject
`BG00012: Official Pre-IND Meeting Minutes from FDA
`
`
`
`, John
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`Enclosed please find the "official" minutes from the Pre-IND meeting held with FDA on
`November 23, 2005. Although the minutes are quite similar to the draft comments received on
`November 19th, there are several differences...based primarily on the discussion that took place
`during the meeting.
`
`Please review the minutes carefully and notify me of any significant differences in understanding
`regarding the meeting outcome. Comments are due on Tuesday, January 4, 2005.
`
`If you have any questions or require additional information, please let me know ASAP.
`
`Page 1 of 19
`
`Biogen Exhibit 2323
`Coalition v. Biogen
`IPR2015-01993
`
`
`
`Thanks
`
`ThanksThanks
`Thanks
`
`
`
`
`
`
`
`Page 2 of 19Page 2 of 19
`
`Page 2 of 19
`
`Page 2 of 19
`
`
`
`lfii)A Food and Drug Administration
`
`Center for Drug Evaluation and Research
`Office of Dr ug Evaluation ODE V
`
`FACSIMILE TRANSMITTAL SHEET
`
`DATE: December 8 , 2004
`
`From:
`
`Senior Regulatory Monagement Officer
`
`TotaJ no. of pace• lncludlnc cover: 17
`
`Document to be malled:
`
`DYES
`
`li'INO
`
`THIS OOCU..un' IS ltlENOED OM.Y f"OA TMi USi Of TWE PAMTY TOMIOMIT ll .I.DOAfSU"O AIIO NAYCQtrlf.IUII tMfO•U•MT~ TIUTI$ ll'lltML.i.CilfD.
`cot!10blllllol. »>D .-MOl tCTtO Pltolll Ot5Cl.O$Uitt UKOta AJ'PUCA81..t LAW.
`
`,,__ • ._ ........ ~-·..-.n......._. • .,_.w...._. .............. )W ... ~..eo.d*-tfMY,.......,d.......,4~~-~
`,......_
`MWIINMd~ .. __..oltNI~--~.Iyoy.....,...........,tw..,....I'MCI"• """r>eUywl~by~••PIHl i:Z741W.
`
`Document to be mailed:
`
`DYES
`
`ltJNO
`
`Please find attached to this facsimile transmission our minutes of our November 23,2004,
`Pre·IND Meeting for your PIND 69,852, BGOOOI2, for psoriasis.
`
`Please call me when you have received this facsimile transmission.
`
`Thank you.
`
`Sincerely,
`
`Frank H. Cross, Jr., M.A., MT (ASCP)
`COR, USPI-!S Commissioned Corps
`Senior Regulatory Management Officer and IT Liaison
`Division ofDermatologic and Dental Drug Products
`Office of Drug Evaluation V
`Center for Drug Evaluation and Research
`U.S. Food and Drug Administration
`Ph.# 301-827-206312020
`Fax.# 301-827-2075/2091
`
`E-mail: crossf@cder f<!a.gov
`
`L
`
`Page 3 of19
`
`
`
`(~~~ DEP ARTMvrf OF HEALTR & HUMAN SERVICES
`·,~,_
`
`Food end DNg Adnlino•ltaton
`Rod<llille, tAO 20~7
`
`PIN069,852
`
`~
`~
`Cambridge, MA 02142
`
`Please refer to your Pre-Investigational New Drug Application (PIND) tile for UG00012 for
`psoriasis.
`
`We also refer to the meeting between ~l&tives of your film and the FDA on No\•embcr 23,
`2004. The purpose of the meeting was to discuss the pre~linical and early clinical plans.
`
`The official minutes of that meeting are enclosed. You ere responsible for notifYing us of any
`significant differeru:.cs in understanding regarding the meeting outcomes.
`
`If you have any questions, pi~ contact Franlc Cross, Regulatory Project Manager, at (30 I)
`827-2020.
`
`Sincerely,
`
`JonAtbo.n Wilkin, M.D.
`Division Director
`Division of Dennatologic and Dental Drug
`Products
`Office of Drua Evaluation V
`Center for Dnag Evaluation and Research
`
`Enclosure
`
`Page 4 of19
`
`
`
`PIND 69,852 11123/04 meeting
`
`Meeting Date: November 23, 2004
`Meeting ID# 14024
`
`BGOOOl2
`
`Indication: Treatment of psoriasis
`
`Sponsor: Biogen Idee
`
`Pre-IND Meeting
`
`Time: 9:30a.m.
`
`Location: S300
`
`Meeting Chair: Jonathan K. Wilkin, M.D.
`
`Meeting Recorder (CSO/Project Manager): Frank H. Cross, Jr., M.A., CDR
`
`2
`
`L
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`Sponsor' s Question 9 from October 21, 2004, Briefing Package: "Does the FDA agree that
`. exposure at 240 mg tid provides the supportive data required to register the 240 mg bid dose?"
`
`Agency:
`
`If the sponsor is referring to safety data, ce11ainly safety data collected at the higher dose can be
`extrapolat~d downward to a lower dose. However, the same cannot be said for efficacy. tn order
`to get approval for the higher dose (240 mg tid), there must be sigJlificant efficacy demonstrated
`o'·cr the lower dose (240 mg bid) withO\It an adverse effect on safety. T he sponsor is referred to
`the ICH F4 guidance.
`
`t2
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`
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