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`P .02/05
`
`('~ DEPARTMENT OF HEALTH & HUMAN SERVICES
`'~
`
`Public Health Service
`
`Food and Drug Administration
`Rockville, MD 20857
`
`IND 73,061
`
`Biogenid~ ·
`Attention:-·~
`Senior Vice President,~Affails
`14 Cambridge Center
`cambridge, MA 02142
`
`We refer to your Investigational New Drug Application (IND) submitted under section SOS{i) of the Federal Food,
`Drug, and Cosmetic Act for BG00012 (Dirqethyl FUI:ll1lrate).
`
`we also refer to your October27, 2006, request, serial number 013, for a special olinical protocol assessment,
`received October 31, 2006. The protocol is entitled Study 109-MS-302: ''A RaDdomized, Multicenter, Placebo(cid:173)
`C<lntrolled and Active Reference (Glatinuner Acetate) Comparison Stwiy to Evaluate the Efficacy and Safety of
`BG00012 ill Subjects With hapsing-Remitting Multiple Sclerosis". We aelcnowledge your December 8, 2006,
`request to withdraw protoco\109-MS-302.
`
`We have completed our review of your special protocol assessment submission and, j:>ased on the infonnation
`submitted, have the following comments and responses to your questions.
`
`-
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`Page 1 of6
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`Biogen Exhibit 2333
`Coalition v. Biogen
`IPR2015-01993
`
`
`
`IND73,061
`Page2
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`P .03/ 06
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`In addition, we have the following commcmts ..
`
`Nanelinical Comment
`1. Chronic toxicity studies in two species (6 months in rodent and 9-12 months in non-rodi!llt) are required to
`support the clinical
`have
`have not submitted a non-rodent chronic
`study of
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`Page 2 of6
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`FEB-07-1996 03: 07
`FEEJ‘217-1‘396
`213: VJ?
`
`P _ art/[ES
`P . 04/06
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`IND 73:05}
`IND73,061
`Page 3
`Page 3
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`Page 3 of6
`Page 3 0f 6
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`..
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`FEB-07- 1996 03 : 07
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`IND 73,061
`Page4
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`P.05/06
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`If you wish to discl.ISs our res{Xlnses, you may request a meetillg. S\lch a meeting will be categoriored as a Type A
`meeting (refer to our "Guidance for Industry; Formal Meetings With Spon3ors and Applicants for PDVFA
`Products"). Copies of the guidance are available through the Center for Drug Eval\lation and Research from the
`Drug Information Brnnch, Division ofCommunicatiom Management (HFD-210), 5600 Fishers Lane, Rockville,
`MD 20857, (301) 827-4573, or from the intemetathttp;//www.fda.goy/cder/guidancc/index btm. This meeting
`would be limited to discUssion of this protocoL If a revised protocol for special protocol assessmc:nt is submitted, it
`will constitute a new request under this program
`
`If you have any questions, call Jaiiies H. Reese, PhD, Regulatory Project Manager, at 301-796-1 136.
`
`Sincerely,
`
`{See appendedele<:tronic signarw·e page}
`
`Russell Katz, MD
`Director
`DiVision of Neurology Products
`Office of Drug Evaluation I
`Center for Drug Evaluation and Research
`
`Page 4 of6
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`FEB-07-1996 03=07
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`P.06/06
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`•• • • - . . . . . . - -
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`-=-••-••--... w-=-=--'*' ____ ,--ct. ____ .. ..,.._ ____ __ ,__....__ • • • • _ ....
`----------------------·--------· .......
`
`/S/
`
`This Is a representation of an electronic reoord that was signed erectronically and
`this paga Is the manifestation of the electronic signature.
`··-----......-
`
`Russ'el l Katz
`12 /11/ 2006 04;4.3;01 PH
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`Page 5 of6
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`TOTAL P.05
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`P.01/06
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`FOOD.DRUG ADMINISTRATION
`DNISION OF NEUROLOGY DRUG PRODUCTS
`10903 NEW HAMPSHIRE A VENUE
`Sll.. VBR SPR1NG, 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
`PRIVILEGED, CONFIDENTAL, A:ND PROTECTED FROM DISCLOSURE
`UNDER ~I CABLE LAW. If you are not the addressee, or a person. au~orized to
`deli'yer the document to the addressee, you are hereby notified that any review.
`disclosure, dissemination, copY4Jg, or other action based on the content of this
`colllillllJlication is not authorized. If you have received this doctnnent 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-120]. Thank you in advance.
`
`DATE: __;_)_·.2..-+-/__.:.1{-+1-1}_..:._~---
`_.;_j_l_~---.---
`-r
`TI.ME: _
`~E DEI.JVBR THB FOLLOWING PAiS TO:
`-!~m y c5Q/]~' ro¥ J.k
`FAXNUMBER: 0/7-- 079- 3{20
`fROM:cf,f<.~
`Total number of pages, including cover page: ~
`}}3£
`If you do not receive all pages or have any problems with receiving, call (301) 796-~
`
`I
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`.
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`Page 6 of6
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