Biogen: delayed disclosure of three Tecfidera trials (AUTH/3005/12/17)

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Key facts

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Case	AUTH/3005/12/17
Parties	Director v Biogen
Issue	Clinical trial disclosure (Tecfidera)
Complaint received	20 December 2017
Completed	09 March 2018
Appeal	No appeal
Applicable Code year	2012
Product	Tecfidera (dimethyl fumarate)
Key timing trigger used by Panel	First approved and available in the US: 27 March 2013
Trials at issue	109MS101 (completed Oct 2009); 109RA201 (completed Mar 2010); 109MS201 (completed Mar 2012)
Deadline for disclosure (Panel view)	27 March 2014
Finding	Breach Clause 13.1 and Clause 9.1; No breach Clause 2
Sanction	Undertaking received

Reviewed by Dr Anzal Qurbain (FFPM) — ABPI Final Signatory

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A 2017 transparency study (published in Current Medical Research & Opinion) assessed whether results of company-sponsored trials linked to EMA-approved 2014 medicines were disclosed within set timeframes.
The PMCPA Director initiated a complaint (Paragraph 5.1) after the study suggested Tecfidera (dimethyl fumarate) had three evaluable trials not disclosed within the required timeframe.
Tecfidera was first approved and available in the US on 27 March 2013; the Panel applied the Second 2012 Code and Joint Position 2009.
Three Phase I/II trials (109MS101 completed Oct 2009; 109RA201 completed Mar 2010; 109MS201 completed Mar 2012) should have had results disclosed by 27 March 2014.
Biogen stated Biogen UK was sponsor on the trial documents, despite no UK investigators, sites or patients; the Panel therefore treated the trials as within scope of the UK Code.
Biogen disclosed the three trials later (CSR synopses shared via Biogen.com in March 2015; additional registry postings described by Biogen).

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Breach found: results of three trials were not disclosed by the required deadline.
Breach found: the delay meant high standards were not maintained.
No breach: as results were publicly disclosed by the time of the ruling, the Panel did not find a Clause 2 breach.

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