`
`Russell G. Katz, M.D
`Director, Division of Neuropharmacological Drug Products
`Office of Drug Evaluation I, HFD-120
`Woodmont II, 4 th Floor Document Room
`1451 Rockville Pike,
`Rockville, MD 20852
`
`RE: Request for Type B Meeting - Pre-INO Meeting
`
`Dear Dr. Katz:
`
`Biogen Idee, Inc. is requesting a face-to-face meeting to discuss 8600012, a compound that is
`being developed as an oral drug product for the treatment of Relapsing Remitting Multiple
`Sclerosis. The Information for the requested meeting Is as follows:
`
`1) Product name: BG00012. The active ingredient in BG00012 is dimethyl fumarate
`
`3) Proposed Indication:
`The proposed indication is for the treatment of relapsing-remitting multiple sclerosis.
`
`4) Type of meeting being requested: Type B- Pre-IND Meeting.
`
`Blogen Idee 14 Cambridgo Ce11te< Cambridae. MA 02142 Alone 6 11 G79 2000 wwwb>OQenldec.com
`
`Page 1 ofS
`
`Biogen Exhibit 2331
`Coalition v. Biogen
`IPR2015-01993
`
`
`
`biogen_idec
`
`5} Purpose of the meeting: Biogen Idee intends to file an IND in Q4 2005 for BG00012 to
`initiate a Phase 1 clinical study. In this regard, we would like to discuss with the Agency (a)
`the chemistry, manufacturing and controls information, nonclinical pharmacology and
`toxicology data and clinical pharmacology and safety data that will be submitted in support
`of an IND; and (b) an overall clinical development plan to support registration of BG00012
`as monotherapy for the treatment of relapsing remitting multiple sclerosis.
`
`6) Meeting objective: The objectives of this meeting are to (a) discuss existing pre-clinical
`pharmacology and toxicology and clinical data in support of an IND; and (b) to discuss and
`agree on the design of a Phase I "Thorough QT/QTc" clinical study evaluating the safety of
`BG00012.
`
`6) Listing of specific questions:
`
`Pre-clinical
`
`on
`proposed that no additional nonclinical studies are necessary to support
`initiation of Phase 3 studies with BG00012 drug product in patients with relapsing-remitting
`multiple sclerosis. Does the FDA agree that preclinical data provided in the information
`package are sufficient to support the initiation of the Phase 3 clinical trials?
`
`2)
`
`Biogen Idee 14 CambridRe Center Cambrid!=Je, MA 02142 Phone 6 17 6 '?9 2000 www.bi09enidec.com
`
`Page 2 of5
`
`
`
`biogen idee
`
`8) · Supporting documentation: An Information package will be submitted to the Agency
`four weeks in advance or the meeting.
`
`Senior Vice President, Regulatory Affairs
`Phone (617) 679-3783
`Fax (617) 679-3170
`
`Biogen Idee 14 Cambrldr~e Center Cambrid>Je, MA 02142 Phone 617 679 2000 wwwbiogenidec.com
`
`Page 3 of5
`
`
`
`Attachment 1
`Attachment 1
`
`Page 4 of5
`Page 4 of 5
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`Page 5 of5
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`Page 5 of 5Page 5 of 5
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