`
`Food and Drug Administration
`Rockville, MD 20857
`
`DEPARTMENT OF HEALTH & HUMAN SERVICES
`
`1ru ~ ® ~ o w ~ rm1
`w MAR 1 7 2006 w
`
`By
`
`IND 73,061
`
`Biogcn Idee, Inc.
`Attention: Nadine D. Cohen, Ph.D.
`Senior Vice President, Regulatory Affairs
`14 Cambridge Center
`Cambridge, MA 02142
`
`Dear Dr. Cohen:
`
`We acknowledge receipt of your Investigational New Drug Application (IND) submitted under section 505(i) of the
`Federal Food, Drug, and Cosmetic Act. Please note the following identifying data:
`
`IND Number Assigned:
`
`73,061
`
`Sponsor:
`
`Biogen Idee, Inc.
`
`Name of Drug:
`
`BG00012 (Dimethyl Fumarate) capsules
`
`Date of Submission:
`
`February 22, 2006
`
`Date of Receipt:
`
`February 23, 2006
`
`Studies in humans may not be initiated until30 days after the date of receipt shown above. lf, on or before March
`25, 2006, we identify deficiencies in the IND that require correction before human studies begin or that require
`restriction of human studies, we will notify you immediately that ( 1) clinical studies may not be initiated under this
`IND ("clinical hold") or that (2) certain restrictions apply to clinical studies under this IND ("partial clinical hold").
`ln the event of such notification, you must not initiate or you must restrict such studies until you have submitted
`information to correct the deficiencies, and we have notified you that the information you submitted is satisfactory.
`
`It has not been our policy to object to a sponsor, upon receipt of this acknowledgement letter, either obtaining
`supplies of the investigational drug or shipping it to investigators listed in the IND. However, if the drug is shipped
`to investigators, they should be reminded that studies may not begin under the IND untin 30 days after the IND
`receipt date or later if the IND is placed on clinical hold .
`
`.As sponsor of this fND, you are responsible for compliance with the Federal Food, Drug, and Cosmetic Act and the
`implementing regulations (Title 21 of the Code of Federal Regulations). Those responsibilities include (l) rcj)ortir..g
`any unexpected fatal or life.-threatening adverse experience associated with use of the drug by telephone or fax no
`later than 7 calendar days after initial receipt of the information [21 CFR 312.32(c)(2)); (2) reporting any adverse
`experience associated with use of the drug that is both serious and unexpected in writing no later than 15 calendar
`days after initial receipt of the information (21 CFR 312.32(c)(1)); and (3) submitting annual progress reports [21
`CFR 312.33).
`
`As required by the Food and Drug Modernization Act and the Best Pharmaceuticals for Children Act, you are also
`responsible for registering certain clinical trials involving your drug product in the Clinical Trials Data Bank
`(h.t.IQ1i..c;linicaltri!!ls.goy & h!m.:1fmsin fo.cJ.jnicai1JjJ!!~,zQ.YL). If your drug is intended for the treatment of a serious or
`life-threatening disease or condition and you are conducting clinical trials to test its effectiveness, then you must
`register these trials in the Data Bank. Although not required, we encourage you to register effectiveness trials for
`
`Page 1 of3
`
`Biogen Exhibit 2293
`Coalition v. Biogen
`IPR2015-01993
`
`
`
`IND 73,061
`Page 2
`
`non-serious diseases or conditions as well as non-effectiveness trials for all diseases or conditions, whether or not
`they arc serious or life-threatening. Additional information on registering your clinical trials, including the required
`and optional data clements and the FDA Draft Guidance for Industry, "Information Program on Clinical Trials for
`Serious or Life-Threatening Diseases and Conditions," is available at the Protocol Registration System (PRS)
`Information Site http://prsinfo.cli nicaltrials.gov/.
`
`Please cite the !NO number listed above at the top of the first page of any communications concerning this
`application. Send all submissions, electronic or paper, including those sent by overnight mail or courier, to the
`following address:
`
`I'ood and Drug Administration
`Center for Drug Evaluation and Research
`Division ofNeurology Products
`5901-B Ammendale Road
`Beltsville, MD 20705-1266
`
`If you have any questions, call James H. Reese, Regulatory Project Manager, at 30 1-796-1 136.
`
`Sincerely,
`
`(See app.•11ded t•!t•ctrmzic ;ignmurt• pag~·j
`
`Robbin Nighswander, R.Ph.
`Supervisory Regulatory Project Manager
`Division of Neurology Products
`Office of Drug Evaluation I
`Center for Drug Evaluation and Research
`
`Page 2 of3
`
`
`
`This is a representation of an electronic record that was signed electronically and
`this page is the manifestation of the electronic signature.
`
`/s/
`
`Robbin Nighswander
`3/10/2006 02:23 :32 PM
`
`Page 3 of3
`
`