`
`FOOD DRUG ADMINISTRATION
`DMSION OF NEUROLOGY DRUG PRODUCTS
`10903 NEW HAMPSEDRE A VENUE
`SILVER SPRJNO, MD 20993-0002
`FAX: (301) 796-9842
`COVER SHEET
`
`NOTE: THIS DOCUMENT IS INTENDED ONLY FOR THE USE OF PARTY TO
`WHOM IT IS ADDRESSED AND MAY CONTAIN INFORMATION THAT IS
`PRIVaEGED, CONFIDENTAL, AND PROTECTED FROM DISCLOSURE
`UNDER ~PLICABLE LAW. If you are not the addressee, or a person au~orized to
`deliver the document to the addressee, you are hereby notified that any review,
`disclosure, dissemination, copying, or other action based on the cont~nt of this
`commwlication is not authorized. If you have received this document in error, please
`immediately notify us by telephone at (301) 796-2250 or return it to us at the above
`address by mail, Attention £HFD· l20J. Thank you in advance.
`
`PLEASE DELIVER THE FOU.OW1NG PAGES TO:
`
`DATE: /2 I ll!tJ ~
`I
`r
`TIME: ------------------------
`ltYtu:!11 5M~ /Xto ~/)he
`r
`{J
`FAXNUMBER: b 17- b 2·1 - 3 /7 0
`FROM: _:J.f~
`Total number of pages, including cover p~ge: _f__
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`If you do not receive all pages or have any problems with receiving, calJ (301) 796 ~58
`
`Page 1 of6
`
`Biogen Exhibit 2294
`Coalition v. Biogen
`IPR2015-01993
`
`
`
`FEB-07-1996 02; 02
`
`(.,~,,......., DEPARTMENT DF HEAlTH & HUMAN SERVICES
`~ . .......
`
`Public HBalth Setvice
`
`Food and Drug Administration
`Rot;kville, MD 20857
`
`fND 73,06l
`
`Biogen Idee, Inc.
`Attention: Nadine D. Cohen, Ph.D.
`Senior Vice PresideDt, Regulatory Affairs
`14 Cambridge Center
`·
`Cambridge, MA 02142
`
`Dear
`
`We refer to your Investigational New Drug Application (lND) gubmitted under section SOS(i) of the Federal Food,
`Drug, and Cosmetic Act for BG00012 (Dimei.b:yl. Fumarate).
`
`We also refer tO your October 27, 2006, request, serial number 012, for a special clinical protocol assessment,
`received October 27, 2006. The protocol is entitled Study 109-MS-301 : "A Randomized., Multicenter, Double·
`Blind, Placebo-Controlled, Dme-Comparison Study to Determine the Safety and Efficacy of BGOOO 12 in Subjects
`with Rel~psing-Remitting Multiple Sclerosis". We acknowledge your December &;2006, request to Vlithdraw
`protoeoll09-MS-301.
`
`We have completed our review of your special protocol ~stssnwtt submission a.oc1, based on the information
`submitted, have the following comments and respooses to your questions.
`
`Page 2 of6
`
`
`
`FEB- 07-1996 02 :02
`
`IND 73,051
`Page2
`
`P . 03/12J6
`
`In addition, we have the following eonunents.
`
`Nonclinical Comment
`I. Chrcmic toxicity studies in two species (6 months in rodenrand 9-12 months in non·rodent) are required to
`support tile clinical
`have
`You have not submitted a non·rodent chronic toxicity study of
`ilin ... thvl fumarate.
`
`I
`
`I
`
`Page 3 of6
`
`
`
`P . 04/06
`
`......
`
`FEB-07-1996 02 =02
`
`IND 73,()61
`. Page 3.
`I
`
`I
`
`I
`
`I
`I
`I
`
`•
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`•
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`Page 4 of6
`
`
`
`lND 73,()61
`Pago4
`
`P.05/06
`
`If you wish to discuss our J'\lsponses, you may request a m..aeting. Such a meeting will be e&teJ:orized as a Type A
`meeting (refer to our "Ouidonce for lnd!.utry; Fonnal Meeting.r with Sponsors and AppJiCQIIU'{or PDUFA
`l'roductr"). Copies of the guidance a.re ava.ilable through the Center for Drug Evaluatioo and Research from the
`Drug Information Branch, Division of Communicatioos Management (HF'D-21 0), 5600 Fishers Lane, Rockville,
`MD 20857, (30! ) 827-45i3, or from tbe internet i\.1 http;}/www.fr;!l!.gov/cder/guidan£'>'indox.htm, Tbis meeting
`would be limited to discwsion of this pro1oool If a-rcvized protocol for special protocol assessment is submitted, it
`will constitute a new ~equcstunderihis progiam.
`· '
`·
`
`If you nave any questions, call James H. Reese, PhD, Regulatory Project Manager, at301-796·1136.
`
`Sincerely,
`
`{S~e appmdcd.elr:ctronlc .~igncmwe pug~)
`
`RusscU Kau, MD
`Director
`Division ofNcurolo~ Proaucts
`Office ~:~fl>rug Evaluation I
`Center for Drug Evaluation and Research
`
`Page 5 of6
`
`
`
`FEB-07- 1996 02:03
`
`P.06/06
`
`______ ,... _____ ,
`, ________ , ___ , __ ....,_.___________ .... ······-
`----·····---··-··-··-····---·,··· ........... ····-------····
`
`This Is a representation of an electronic record that was signed electronically and
`this page is the manifestation of the electronic signature.
`
`/S/
`
`Russell Katz
`12/11/2006 02:52 : 44 PM
`
`Page 6 of6
`
`TOTAL P.06
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