`
`October 27, 2006
`
`Center 'or Drug Evaluation and Research
`Food and Drug Administration
`5901 -8 Ammendale Ad
`Beltsville, MD 20705-1 266
`
`Attn: Russell Katz, MD
`
`RE:
`
`IND 73,061 : BG00012 (Dimethyl Fumarate): Multiple Sclerosis
`Serial No.: 0012
`REQUEST FOR SPECIAL PROTOCOL ASSESSMENT- Clinical Protocol
`
`Dear Dr. Katz:
`
`Biogen Idee, Inc. is submitting the following new Phase 3 clinical study protocol for Special
`Protocol Assessment:
`
`1) Study 1 09-MS-301: "A Randomized, Mu~icenter, Double-Blind, Placebo-Controlled,
`Dose-Comparison Study to Determine the Safety and Efficacy of BG00012 in Subjects
`with Relapsing-Remitting Multiple Sclerosis"
`
`A draft version of the Study 109-MS-301 protocol was discussed with FDA at the End-of-Phase
`2 meeting that was held on August 30, 2006. We believe that the attached final version of the
`protocol adequately addresses the issues raised by the Agency during the meeting.
`
`This study will be initiated in the United States following the submission of 9-month dog toxicity
`study re:.port to the IND. Please note that the non-US sites would not be included under the IND.
`
`A reque3t for a Special Protocol Assessment has been submitted for the second Phase 3 study
`109-MS·302 on October 27, 2006.
`
`Should you require any additional information, please contact Tammy Sarnelli, Associate
`Director. Regulatory Affairs at 51 7-679-3513. The contact for technical aspects for this
`submissonislllillllllllllllllllllllllllllllllllllllllllllllllllll
`
`Blogct~n ld•c 14 C<itiPMdgQ Centar Csmb•id$o, MA 02142 Phone 617 679 2000 www.hiogenidec.com
`
`Page 1oft
`
`Biogeo Exhibit 2227
`Coalition v. Biogeo
`IPR2015-01993
`
`
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