AUTH/2141/7/08: Novo Nordisk v Sanofi-Aventis – Promotion of Lantus (24-hour efficacy and hypoglycaemia claims)

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Key facts

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Case number	AUTH/2141/7/08
Case reference	Novo Nordisk v Sanofi-Aventis
Complainant	Novo Nordisk
Respondent/company	Sanofi-Aventis
Product(s)	Lantus (insulin glargine); Levemir (insulin detemir)
Material/channel	Four leavepieces (LAN07/1333; LAN08/1037; LAN08/1038; LAN08/1039) and a mailer (LAN08/1041)
Key issue	Context and substantiation of “24-hour efficacy” and use of comparative claims/graphs; hypoglycaemia claim based on pooled observational data used in a type 2-specific leavepiece
Dates (received/completed if stated)	Received 14 July 2008; completed 28 October 2008
Appeal	Yes. Sanofi-Aventis appealed multiple Panel rulings; Appeal Board overturned several, but upheld breaches for LAN08/1038 hypoglycaemia claim.
Code year	2008 Code
Breaches/clauses	Final upheld breaches: Clause 7.2 and Clause 9.1 (LAN08/1038). Other alleged/Panel breaches were overturned on appeal or not upheld.
Sanctions	No explicit additional sanctions stated beyond the required undertaking/corrective actions described in the report

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

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Novo Nordisk complained about Sanofi-Aventis’ promotion of Lantus (insulin glargine); Novo Nordisk marketed Levemir (insulin detemir).
Materials: four leavepieces (LAN07/1333; LAN08/1037; LAN08/1038; LAN08/1039) and a mailer (LAN08/1041).
Issue 1: A “24-hour efficacy” claim appeared as part of the Lantus product logo in one leavepiece and as “Once daily – provides 24-hour efficacy” in the other materials.
Novo Nordisk argued the claim implied “24-hour control” and referenced an earlier undertaking in Case AUTH/2028/7/07 prohibiting “24-hour control” or similar claims.
Issue 1 also included concern about a graph (from Porcellati et al 2007b) used in a leavepiece and the mailer, alleged to be cherry-picked and misleading/disparaging regarding Levemir’s duration of action.
Issue 2: A claim stated: “In clinical practice, after switching from other treatments, Lantus is associated with a lower risk of hypoglycaemia compared to insulin detemir”, referenced to Currie et al 2007 (retrospective GP database analysis with pooled type 1 and type 2 data).
Complaint received 14 July 2008; case completed 28 October 2008.

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“24-hour efficacy” in LAN08/1037 and LAN08/1038: Panel ruled breach of undertaking (Clause 25) and Clauses 9.1 and 2 due to context implying “24-hour control”; on appeal, the Appeal Board ruled no breach of Clause 25 and consequently no breach of Clauses 9.1 and 2.
“24-hour efficacy” in LAN07/1333, LAN08/1039 and LAN08/1041: Panel ruled the claim could be substantiated in context (as duration of action) and no breach of Clause 7.4 (not appealed).
Porcellati 2007b graph in LAN08/1039 and LAN08/1041: Panel ruled the graph misleading (Clause 7.2) and disparaging (Clause 8.1); on appeal, the Appeal Board ruled no breach of Clauses 7.2 and 8.1.
Hypoglycaemia claim in LAN08/1038 (type 2-specific leavepiece): Panel ruled misleading (Clause 7.2) because claim relied on pooled type 1 and type 2 data; Panel also ruled breach of high standards (Clause 9.1) due to repeat issue previously raised in Case AUTH/2038/8/07; Appeal Board upheld breaches of Clauses 7.2 and 9.1.
Hypoglycaemia claim in LAN08/1041 (mailer referring to both type 1 and type 2): Panel ruled breach of Clause 7.2; on appeal, the Appeal Board ruled no breach of Clause 7.2.

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Code applied: 2008 Code (Clause 22 renumbered as Clause 25).
Clauses cited in the case: 2, 7.2, 7.4, 9.1 and 25 (undertakings).
Final breaches upheld by the Appeal Board: Clause 7.2 and Clause 9.1 (in relation to LAN08/1038 hypoglycaemia claim based on pooled data in a type 2-specific leavepiece).
Appeal Board ruled no breaches for: Clause 25/9.1/2 regarding “24-hour efficacy” in LAN08/1037 and LAN08/1038; Clauses 7.2 and 8.1 regarding the Porcellati 2007b graph; Clause 7.2 regarding the hypoglycaemia claim in LAN08/1041.

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