Merck Sharp & Dohme v Novo Nordisk: Victoza detail aid and misleading composite endpoint presentation (AUTH/2569/12/12)

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Key facts

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Case number	AUTH/2569/12/12
Complainant	Merck Sharp & Dohme Limited
Respondent	Novo Nordisk Limited
Medicine	Victoza (liraglutide)
Material	Detail aid “The value of Victoza” (ref UK/LR/0212/0048)
Main issue	Prominent red-box display of composite endpoint (“HbA1c<7% + weight loss/neutrality + no hypos”) created a misleading implied claim
Decision	Breach of Clause 7.2; no breach of Clauses 3.2 and 8.1; sitagliptin comparison not misleading (no breach Clause 7.2 for that point)
Sanction	Undertaking received
Complaint received	17 December 2012
Case completed	25 February 2013
Applicable Code year	2012
Appeal	No appeal

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

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Merck Sharp & Dohme (MSD) complained about a Novo Nordisk Victoza (liraglutide) detail aid (ref UK/LR/0212/0048) titled “The value of Victoza”.
The detail aid promoted Victoza 1.2mg post-metformin failure and used a meta-analysis (Zinman et al, 2011) with a “triple composite endpoint”: HbA1c <7% + weight loss/neutrality (no weight gain) + no hypoglycaemia.
Across multiple pages, the composite endpoint was repeated in prominent red boxes joined by plus signs (“HbA1c<7%”, “weight loss or neutrality”, “no hypos”), positioned near Victoza claims and the red Victoza logo.
MSD alleged: (1) use of monotherapy trial data within the meta-analysis amounted to off-label promotion (Clause 3.2); (2) the red-box composite endpoint presentation was misleading given hypoglycaemia is listed as common/very common in the SPC (Clause 7.2); (3) the comparison with sitagliptin (Januvia) was misleading and possibly disparaging (Clauses 7.2 and 8.1).

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No breach of Clause 3.2: Panel did not consider that reporting Zinman et al per se promoted Victoza for an unlicensed indication or was inconsistent with the SPC (on the narrow grounds alleged), despite Zinman et al including LEAD-3 Mono (monotherapy) data.
Breach of Clause 7.2: Panel ruled the repeated red-box composite endpoint presentation was, in effect, a claim for Victoza and misleading.
No breach of Clause 7.2 (for the sitagliptin comparison): Panel did not consider the Victoza vs sitagliptin comparison misleading as alleged (noting its separate ruling on the red-box presentation).
No breach of Clause 8.1: Panel did not consider the comparison disparaging to sitagliptin.
No appeal.

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