`
`April20, 2007
`
`Center for Drug Evaluation and Research
`Food and Drug Administration
`5901 -B Ammendale Rd
`Beltsville, MD 20705-1 266
`
`At1n: Russell Katz, MD
`
`RE: IND 73,061 : BG00012 (Dimethyl Fumarate): Multiple Sclerosis
`Submission of Clinical Trial Protocols
`Serial No.: 001 7
`
`Dear Dr. Katz:
`
`Reference is made to the End of Phase 2 meeting for Biogen Idee's product, BG00012
`(dimethyl fumarate) held on August 30, 2006. At this meeting, the Agency requested that
`Biogen Idee submit the final study report for an ongoing 11 -month chronic toxicology study in
`beagle dogs prior to the initiation of Phase 3 clinical trials.
`
`Page 1 of2
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`Biogen Idee 14 Cambridge Center Cambridge, MA 02142 Phone 617 679 2000 www.biogcnidec.com
`
`Biogen Exhibit 2087
`Coalition v. Biogen
`IPR2015-01993
`
`
`
`biogen idee
`
`Should you require any additional information, please contact Tammy Sarnelli, Associate
`Director, Regul
`Affairs at 617-679-3513. The contact for technical
`for this
`submission is
`
`Sincerely yours
`
`Page 2 of2
`Biogen Idee 14 Cambridge CCntc• Cambrtdge, MA 02 142 Phone 6 17 679 2000 www.b•ogen •dec.r.om
`
`