`
`- - ---+- -
`
`-
`
`June 23, 2008
`
`Center for Drug Evaluation and Research
`Food and Drug Administration
`5901 -B Ammendale Ad
`Beltsville, MD 20705-1 266
`
`Attn: Russell Katz, MD
`
`RE:
`
`INO 73,061 : BG00012 (Dimethyl Fumarate): Multiple Sclerosis
`Information Amendment: Study C-1900 - Clinical Study Report
`Serial No.: 0060
`
`Dear Dr. Katz:
`
`Biogen Idee, Inc. is submitting the final clinical study report for a Phase 2 study (C-
`1900), entitled:
`
`"A Double-Blind, Placebo-Controlled, Dose-Ranging Study to Determine the
`Efficacy and Safety of BG00012 in Subjects with Relapsing-Remitting Multiple
`
`Should you require any additional information, please contact Tammy Sarnelli,
`
`Director, Regui i i i i iato Affairs at 617-679-3513. The contact for technical aspects for this
`submission is
`Senior Director, Regulatory Affairs Operations, at 617-
`679-2416.
`
`Phone: (617) 679-3783
`Fax: (617) 679-3170
`
`Biog<>n Idee 14 Ca•nb• d~" Center C:ambndgc. W<A 02 i~2 Phone \117 t'l7ll ?000 www.blogon ,~eccom
`
`Page 1oft
`
`Biogeo Exhibit 2287
`Coalition v. Biogeo
`IPR2015-01993
`
`