`
`Center for Drug Evaluation and Research
`Food and Drug Administration
`590 1 - 8 Arnmendale Rd
`Beltsville, MD 2 0705-1 266
`
`A ttn: Russell Katz, MD
`
`RE: INO 73,061 : BG00012 (Dimethyl Fumarate): Multiple Sclerosis
`Serial No.: 0005
`Re: Req uest for End-of-Phase 2 Meeting (Type B)
`
`Dear Dr. Katz:
`
`Reference is made to Biogen Idee's Investigational New Drug Application for BG00012 (I NO
`73,061) submitted to the Agency on February 22,2006. Biogen Idee is hereby req
`to discuss the Phase 3 clinical development
`face-to-face m
`ram tor
`
`The information for the requested meeting is as follows:
`
`1 ) Product na!l'le: BGOOO 12
`
`2) Type of meeting being reques1ed: Type B - End-of-Phase 2 meeting
`
`3) Meeting objective: The objective of this meeting is to discuss and reach agreement on the
`Phase 3 clinical development plan intended to provide sufficient data on the safety and
`efficacy of BG00012 in subjects with relapsing fo rms of MS to support a marketing
`application.
`
`4) Proposed agenda:
`
`Brief Introduction by Biogen Idee (5 minutes)
`Discussion of specific questions
`Summary and conclusions
`
`5) Usting of q uestions:
`A list of specific questions is provided in Attachment 1.
`
`Biogen Idee 14 Cal!'lbridg<: Center Cambridge, MA 02142 Alone 617 6/U 2000 www.b!Ogenld O~.CO'Il
`
`Page 1 of3
`
`rology
`
`Biogen Exhibit 2332
`Coalition v. Biogen
`IPR2015-01993
`
`
`
`7) Proposed indication
`"BG00012 is indicated for the treatment of patients with relapsing remitting multiple
`sclerosis to reduce the frequency of clinical exacerbations".
`
`8) Supporting documentation: An information package will be submitted to the Agency four
`weeks in advance of the meeting.
`
`9) Suggested dates and times for the meeting: We would like to suggest Aug 29 - 31 or
`September 5-7 as possible dates for your consideration.
`
`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
`submission i~enior Director, Regulatory Affairs Operations at 617-679-2416.
`
`Senior Vice President, Regulatory Affairs
`Phone(617)679-3783
`
`Fax (617) 679-3170
`
`Page 2 of3
`
`
`
`Attachment 1
`List of proposed questions
`
`Pharmacology/toxicology:
`
`1) Is the present preclinical plan sufficient to support Phase 3 and registration?
`
`Page 3 of3
`
`
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