biogen idee
`
`July 3, 2007
`
`Center for Drug Evaluation and Research
`Food and Drug Administration
`5901 -8 Ammendale Rd
`Beltsvill9, MD 20705-1 266
`
`Attn: Russell Katz, MD
`
`RE: IND 73,061: BG00012 (Dimethyl Fumarate): Multiple Sclerosis
`Submission of Nonclinical Study Report
`Serial No.: 0023
`
`Dear Dr. Katz:
`
`Biog en Idee is submitting a final 1-year cynomolgus monkey chronic toxioology study report.
`The report is entitled:
`
`"BG00012: A 1 Year Chronic Toxicity Study of Dimethyl Fumarate Suspension
`Administered by Nasogastric Intubation to Cynomolgus Monkeysft
`
`Should you req uire any additional information, please contact Tammy Samelli, Associate
`Director, Reg~61 7·679-351 3. The con tact for technical aspects for this
`submission is- -Senior Director, Regulatory Affairs Operations at 617·679·2416.
`
`Phone (617) 679-3783
`Fax (617) 679-4459
`
`Page 1oft
`
`Biogen Exhibit 2286
`Coalition v. Biogen
`IPR2015-01993
`
`
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