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`CLINICAL STUDY REPORT
`FINAL
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`Study Number: 109-HV-101
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`A Single-Center, Randomized, Blinded, Placebo- and Active-Controlled Study to
`Evaluate the QTc Interval Prolongation Potential of BG00012 When Administered to
`Healthy Volunteers
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`Name of Study Treatment:
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`Indication:
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`Development Phase:
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`Date of First Treatment:
`Date of Study Completion:
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`Sponsor:
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`Name of Sponsor Signatory:
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`Sponsor’s Study Medical Director:
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`Report Date:
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`BG00012 (Dimethyl fumarate)
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`Not applicable
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`1
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`10 September 2006
`16 November 2006
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`Biogen Idec Inc.
`14 Cambridge Center
`Cambridge, MA 02142
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`VP, Chief Medical Officer
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`Katherine Dawson, MD
`Director, Neurology
`(617) 914-6377; FAX (617) 769-3518
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`16 April 2007
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`To the best of the sponsor’s knowledge, this study was conducted in compliance with the requirements of the
`International Conference on Harmonisation (ICH) Good Clinical Practice (GCP), United States 21 Code of
`Federal Regulations (CFR) Parts 50, 56, and 312, and other applicable standards for the protection of human
`subjects and integrity of clinical data. It has been monitored by the sponsor or by the sponsor’s representative.
`There were no deviations from the above-referenced standards that, in the view of the sponsor, were likely to
`have compromised the integrity or quality of the study, the interpretation of the results, subject safety, or ethical
`standards. Essential documents, as described in ICH E6, have been archived in Central Clinical Files and in an
`electronic study file.
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`Page 1 of 1
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`Biogen Exhibit 2090
`Coalition v. Biogen
`IPR2015-01993
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