`
`February 22. 2006
`
`CDER Therapeutic Biological Products Document Room
`Center for Drug Evaluation and Research
`Food and Drug Administration
`5901-B Ammendale Rd
`Bellsville, MD 20705-1266
`
`Attn: Russell Katz, MD
`
`RE:
`
`lnltlal Investigational New Drug Application
`IND 73,061
`BG00012 (D|methyl Fumarate): Multiple Sclerosis
`Serial No.: 000
`
`Dear Dr. Katz:
`
`Biogen ldec is submitting the lnvestigational New Drug (IND) Application tor its product.
`BG00O12. which is being developed as treatment of relapsing forms of multiple
`sclerosis. A pre-IND meeting was held on September 1, 2005 between representatives
`of the FDA and Biogen Idec. The overall clinical development plan, pharmacology/
`toxicology information, previous human experience and the proposed clinical study were
`discussed at that meeting. A copy ol the pre—lND meeting minutes is included in Module
`1.12.1.
`
`.
`
`The proposed clinical trial included in this application is a Phase 1 study entitled: "A
`Single-Center, Randomized, Blinded. Placebo- and Active-Controlled Study to Evaluate
`the OTC Interval Prolongation Potential of BGOOO12 When Administered to Healthy
`Volunteers". A copy of this protocol is provided in Module 5 3.3.4.
`
`This IND is being submitted in e-CTD format with hard copies of the cover letter and
`FDA Form 1571 following agreement with the agency at the pre-IND meeting.
`
`Should you require any additional information, please contact Tammy Sarnelli. Associate
`Director. Regulatory Affairs at 017-679-3513. The contact for technical aspects for this
`submission is Michael Sauter, Senior DVECIOI’, Regulatory Aftairs Operations at 617-679-
`2416.
`
`Sincerely yours.
`
`
`
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`Page 1 0‘ 1
`
`Biogen Exhibit 2113
`Coalition v. Biogen
`IPR2015—01993
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