------+r-b_iogenidecj
`
`October 6, 2006
`
`Center for Drug Evaluation and Research
`Food and Drug Administration
`5901 -8 Ammendale Rd
`Beltsville, MD 20705-1 266
`
`Attn: Russell Katz, MD
`
`RE: IND 73,061: BG00012 (Dimethyl Fumarate): Multiple Sclerosis
`Request for correction: End-of-Phase 2 meeting minutes
`Serial No.: 010
`
`Dear Dr. Katz:
`
`Reference is made to the Agency's letter dated September 29, 2006 regarding the official
`minutes of the End-of-Phase 2 meeting held on August 30, 2006 to discuss the clinical
`development of BG00012. Biogen Idee would like to request the following revisions to the
`minutes:
`
`2) Page 2: In Meeting discussion under Pharmacology/Toxicology section, the meeting
`minutes read:
`
`• The Sponsor asked if they could begin their Phase 3 trial prior to submitting
`the 12 month repeat dose toxicity study in monkeys. The monkey study will
`be submitted within three months of initiation of the clinical trial. The
`Sponsor has already submitted a nine month repeat dose toxicity study in
`dogs. The Division slated that this approach is acceptable.
`
`The requested revision is underlined:
`
`• The Sponsor asked if they could begin their Phase 3 trial prior to submitting
`the 12 month repeat dose toxicity study in monkeys. The monkey study will
`be submitted within three months of initiation of the clinical trial in the US.
`The Sponsor has already submitted a 6-month repeat dose toxicity study in
`rats and will submit the 9-month repeat dose toxicity study in dogs when the
`study is complete. The audited draft report from the 9-month repeat dose
`toxicity study in dogs will be submined prior to the initiation of Phase 3
`clinical trials in the US. The Division stated that this approach is acceptable.
`
`Blogen Idee 14 CambndJe Center Cambndge, MA 0214'.1 Phone 617 f,l'/9 2000 www.toogcou~,'(:.cul!i
`
`1
`
`Page 1 oflO
`
`Biogeo Exhibit 2326
`Coalition v. Biogeo
`IPR2015-01993
`
`
`
`October 6, 2006
`
`Center for Drug Evaluation and Research
`Food and Drug Administration
`5901 -8 Ammendale Rd
`Beltsville, MD 20705-1 266
`
`Attn: Russell Katz, MD
`
`RE: IND 73,061: BG00012 (Dimethyl Fumarate): Multiple Sclerosis
`Request for correction: End-of-Phase 2 meeting minutes
`Serial No.: 010
`
`Dear Dr. Katz:
`
`Reference is made to the Agency's letter dated September 29, 2006 regarding the official
`minutes of the End-of-Phase 2 meeting held on August 30, 2006 to discuss the clinical
`development of BG00012. Biogen Idee would like to request the following revisions to the
`minutes:
`
`2) Page 2: In Meeting discussion under Pharmacology/Toxicology section, the meeting
`minutes read:
`
`• The Sponsor asked if they could begin their Phase 3 trial prior to submitting
`the 12 month repeat dose toxicity study in monkeys. The monkey study will
`be submitted within three months of initiation of the clinical trial. The
`Sponsor has already submitted a nine month repeat dose toxicity study in
`dogs. The Division slated that this approach is acceptable.
`
`The requested revision is underlined:
`
`• The Sponsor asked if they could begin their Phase 3 trial prior to submitting
`the 12 month repeat dose toxicity study in monkeys. The monkey study will
`be submitted within three months of initiation of the clinical trial in the US.
`The Sponsor has already submitted a 6-month repeat dose toxicity study in
`rats and will submit the 9-month repeat dose toxicity study in dogs when the
`study is complete. The audited draft report from the 9-month repeat dose
`toxicity study in dogs will be submined prior to the initiation of Phase 3
`clinical trials in the US. The Division stated that this approach is acceptable.
`
`Blogen Idee 14 CambndJe Center Cambndge, MA 0214'.1 Phone 617 f,l'/9 2000 www.toogcou~,'(:.cul!i
`
`1
`
`Page 1 oflO
`
`Biogeo Exhibit 2326
`Coalition v. Biogeo
`IPR2015-01993
`
`
`
`biogen idee
`
`Should you require any additional information, please contact Tammy Sarnelli, Associate
`Director, Regulatory Affairs at 617-679-3513. The contact for technical aspects for this
`, Senior Director, Regulatory Affairs Operations at 617·679-2416.
`submission i
`
`Senior Vice President, Regulatory Affairs
`Phone (617) 679-3783
`
`Fax (617) 679-3170
`
`Biogen idee 14 Cambridge Center Cambridge, Mi\02142 Pt>onet317 679 2000 www.biogenldec.com
`Page 2 of 10
`
`2
`
`
`
`J~N-28-1596 03: 43
`
`P.lill/08
`
`FOOD DRUG ADMINISTRATION
`DMSION OF NEUROLOGY DRUG PRODUCTS
`10903 NEW HAMPSHIRE A VENUE
`SILVER SPRING, MD 20993-0002
`FAX: (301) 796-9842
`COVER SHEET
`
`NOTE: THIS DOCUMENT 1S INTENDED ONLY FOR THE USE OF PARTY TO
`WHOM rr IS ADDRESSED AND MAY CONTAJN INFORMATION THAT IS
`PRIVILEGED, CONFIDENTAL, AND PROTECI'ED FROM DISCLOSURE
`UNDER APPLICABLE LAW. If you are not the addressee, or a person aut11orized to
`deliver the document to the addressee, you are hereby notified that nny review,
`disclosure, dissemination, copying, or other action based on the content of this
`commtmication is not authorized. If you have received this document in error, please
`inlm.ediately notify us by telephone at (301) 796-2250 or return it to us at the above
`address by mail, Attention [HFD-120]. Thank you in advance.
`
`DATE: _J.~/2~!-+-1 ()~/a~-
`)
`I
`TIME: ------------------------
`J::,T5~it~~b.oCoL /FMo/A P~
`I
`I
`tJ
`FAXNUMBER: h/2- k 71 - 07g3 3)7()
`PROM: ::r; ~R,4L....
`ToUll number of pages, including cover page: _8_
`If you do not receive all pages or have any problems with receiving, call (301) 796-2250
`
`MESSAGE:
`
`Page 3 of 10
`
`3
`
`
`
`JAN-28-1996 03:43
`
`P.02/1118
`
`DEPARTMENT OF HEAL TB & HUMAN SERVICES
`
`Public Health S.rviee
`
`Food md Drug Administration
`RockVile , MO 20657
`
`Biogen Idee, Inc.
`Attenticm: Nadine D. Cohen, Ph.D.
`Senior Vice President, Regulatory Affairs
`14 Cambridge Center
`Cambridge, MA 02142
`
`Dear Dr. Cohen:
`
`Please refer to your lnvestigational New Drug Application (IN D) file for BOOOO 12.
`
`We also refe.r to the End of Phase 2 me¢ting between representatives ofyoUl finn and the FDA
`on August 30,2006. The purpose of the meeting was to discuss the continued development of
`BG00012.
`
`The ofDcial minutes of that meeting are enclosed. You are responsible for notifying us of any
`significant differences in understanding regarding the meeting outcomes.
`
`lfyou b!ve any questions, call James H. Reese, Ph.D., Regulatory Project Manager, at
`(301) 796-1136.
`
`Sincerely,
`
`{See appended electronic signature page}
`
`RusseU Katz, M. D.
`Director
`Division ofNeurology Products
`Office of Drug Evaluation I
`Center for Drug Evaluation and Research
`
`Enclosure
`
`Page 4 of 10
`
`4
`
`
`
`J~N-28-1 S96 03:43
`
`P.1213/08
`
`MEMORANDUM OF MEETING MINUTES
`
`MEETING DATE:
`
`August 30,2006
`
`TIME;
`
`LOCATION:
`
`3:00- 4:30 PM
`
`White Qak, Building 22, Rm. 1309
`
`APPLICATION:
`
`PIND 73,061, B000012
`
`TYPE OF MEETING:
`
`B: End of Phase 2
`
`MEETING CHAIR:
`
`Dr. Russell Katz
`
`FDA Attendees
`Russell Katl
`Kun Jin
`Erie Bastings
`Janeth RoUzer-Kammeyer
`Paul Roney
`Ta·ChenWu
`James Reese
`
`iiiiiiiittendees
`
`Tammy Sarnelii
`Katherine Dawson
`
`-
`
`The questions discussed below were submitted as part of the EoP2 package dated July 24, 2006.
`The Spowor's questions are presented below in italics, followed by the preliminary FDA
`response (conveyed to the sponsor by e-mail just prior to the meeting), and then a summary of
`the discussion from the meeting.
`
`Page 1
`
`5
`
`Page 5 of 10
`
`
`
`JAN-28-1996 03:43
`
`Pharmacology /toxi~olo gy:
`
`P.04/09
`
`1) Doer the Agency concur that the preclinical plan is sufficient to support Phase 3 clinical
`studies and registration of BGOOO 12 (Section 5)?
`
`Meeting Discussion
`The Sponsor asked if they could begin their Phase 3 clinical trial prior to submitting the 12
`month repeat dose toxicity study in monkeys, The monkey study will be submitted within three
`months of the initiation of the clinical trial. The Sponsor has already submitted a nine month
`repeat dose toxicity study in dogs.
`The Division stated that this approach is acceptable.
`
`Page2
`
`6
`
`Page 6 of 10
`
`
`
`JA~-28-1996 03:43
`
`P .0S/08
`
`Page3
`
`7
`
`Page 7 of 10
`
`
`
`JAN-28- 1996 03:43
`
`P.06/08
`
`Page4
`
`8
`
`Page 8 of 10
`
`
`
`JAN-28-1996 03: 43
`
`PageS
`
`9
`
`Page 9 of 10
`
`
`
`P.08/08
`
`This Is a representation of an electronic record that was algned electronically and
`this page Is the manifestation of the electronic signature.
`
`Is/
`
`Russell Kacz
`9/29/2006 08!48 : 58 AM
`
`Page 10 of 10
`
`TOTAL P.OO
`
`10
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