`
`Center lor Drug Evaluation and Research
`Food and Drug Administration
`5901 -8 Ammendale Rd
`Beltsville, MD 20705-1 266
`
`Attn: Russell Katz, MD
`
`RE:
`
`IND 73,061: BG00012 (Dimethyl Fumarate): Multiple Sclerosis
`2-Year mouse carcinogenicity study update
`Serial No.: 0009
`
`Dear Dr. Katz:
`
`Biogen Idee Inc. is submitting an update on the ongoing 2-year carcinogenicity study (Study
`P00012-05-03) in mice with BG00012:
`
`The study is currently in Week 65 of the 104 Week study and the number of mice in Group 5
`males (400 mg/kg) has reached 28. Consistent with our previous agreement with the Agency
`for the rat carcinogenicity study (see Serial 003 dated May 19, 2006, for details), we plan to
`suspend dosing of this group once the n value reaches 20, and to terminate the group shoud
`the n value reach 1 0 prior to the predetermined terminal necropsy.
`
`Details on number of surviving animals in various groups as of Week 65 in Study P00012-05-03
`are provided in Attachment 1.
`
`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 is
`
`Sincerely yours
`
`Blegen Idee 14 C9mbuefge Cenl!>f Dlml,l<I(Jge.MA02142 f'hone617 ~'19 2000 www.blogenldec.com
`
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`Biogeo Exhibit 2226
`Coalition v. Biogeo
`IPR2015-01993