`
`April 20, 2007
`
`Center for Drug Evaluation and Research
`Food and Drug Administration
`5901 -B Ammendale Rd
`Beltsville, MD 20705-1 266
`
`Attn: Russell Katz, MD
`
`RE: IND 73,061: BG00012 (Dimethyl Fumarate): Multiple Sclerosis
`Submission of Clinical Trial Protocols
`Serial No.: 0017
`
`Dear Or. 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.
`
`Following the meeting, Biogen Idee submitted two Phase 3 clinical trial protocols under the
`guidance of Special Protocol Assessment (Serial Nos. 012 and 013, dated 27 October 2006) to
`INO 73, 061 . At the Agency's request, both Phase 3 protocols were withdrawn from the INO
`(Serial No. 0 14, dated 08 December 2006) pending submission of the 11-month dog
`toxicology study.
`
`Although the protocols were withdrawn, the Agency provided written comments on both
`protocols (dated 11 and 12 December 2006).
`
`At this time, we are resubmitting the two Phase 3 protocols, revised to reflect Agency
`comments, and all supporting data. Specifically, the following documents are included in this
`submission:
`
`• Study P00012-05-05: "BG00012: An 11 Month Toxicity Study of BG00012
`Administered by the Oral (Capsule) Route to Dogs with a 1-Month Recovery
`Period"
`
`• Protocoi109-MS-301: "A Randomized, Multicenter, Double-Blind, Placebo(cid:173)
`Controlled, Dose-Comparison Study to Determine the Efficacy and Safety of
`BG00012 in Subjects with Relapsing-Remitting Multiple Sclerosis"
`
`• Protocoi109-MS·302: "A Randomized, Multicenter, Placebo-Controlled and
`Active (Giatiramer Acetate) Comparison Study to Evaluate the Efficacy and
`Safely of BG00012 in Subjects with Relapsing-Remitting Multiple Sclerosis"
`
`Blogen Idee 14 Cambridge Cantor Camb<idgo, MA 02142 Phone 617 679 2000 www.biogcnidcc.com
`
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`
`Biogeo Exhibit 2285
`Coalition v. Biogeo
`IPR2015-01993
`
`
`
`biogen idee
`
`• Study 1 09-HV-1 01 : A Single-Center, Randomired, Blinded, Placebo- and
`Active-Controlled Study to Evaluate the QTc JnteNal Prolongation Potential of
`BG00012 When Administered to Healthy Volunteers"
`
`•
`
`Biogen Idee plans to initiate clinical trials sites in the United States in approximately 30 days of
`this submission. We would greatly appreciate any feedback the Agency may have on our two
`Phase 3 clinical trial protocols prior to initiation.
`
`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~. Senior Director, Regulatory Affairs Operationsat617-679-2416.
`
`Phone{617)679-3783
`
`Fax (617) 679-3170
`
`Biogen Idee 14 Camb",dgc Centc• Camonoge, MA 02142 f'rl0110 617 679 2000 www.b,ogemdec.r.om
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