AUTH/2038/8/07: Novo Nordisk v Sanofi-Aventis — Lantus mailing (cost, hypoglycaemia and weight claims)

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Key facts

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Field	Details
Case number	AUTH/2038/8/07
Parties	Novo Nordisk v Sanofi-Aventis
Product	Lantus (insulin glargine)
Competitor referenced	Levemir (insulin detemir)
Material	Mailing to UK health professionals (May 2007)
Main allegations	Misleading cost comparison; misleading hypoglycaemia claim; misleading weight/comparability claims; inconsistency with cited authors’ views
Key references cited in material	Poole et al (2007); Currie et al (2007) (THIN database analyses)
Panel findings	No breach for cost claim; breach of Clause 7.2 for hypoglycaemia headline; breach of Clause 7.2 and Clause 11.4 for weight claims
Appeal	Appeal by respondent (Sanofi-Aventis) on weight-related Clause 7.2 ruling; unsuccessful (upheld)
Applicable Code year	2006
Breach clauses	two breaches of 7.2 and one of 11.4
Complaint received	24 August 2007
Case completed	04 February 2008
Sanctions applied	Undertaking received; Additional sanctions: Not stated

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

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Novo Nordisk complained about a one-off UK mailing (May 2007) promoting Lantus (insulin glargine) sent by Sanofi-Aventis to health professionals with an interest in diabetes.
The mailing compared Lantus with competitor Levemir (insulin detemir) using retrospective UK general practice database analyses (THIN), citing Poole et al (costs) and Currie et al (hypoglycaemia and weight).
Three main issues were raised: (1) cost advantage claims in type 1 and type 2 diabetes; (2) a headline claim that Lantus reduced hypoglycaemia over Levemir in both type 1 and type 2 diabetes; (3) claims that Lantus and detemir had similar/comparable effects on weight (including in type 2 diabetes).

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Cost claim (Poole et al): No breach of Clause 7.2 was ruled.
Hypoglycaemia headline (Currie et al): Breach of Clause 7.2 (misleading because the analysis was pooled across type 1 and type 2, and the headline did not make this sufficiently clear).
Weight claims (Currie et al): Breach of Clause 7.2 (misleading; did not reflect the totality of data and the Levemir SPC statement about less weight gain in type 2 diabetes).
Weight claims vs authors’ views: Breach of Clause 11.4 (claims were inconsistent with the authors’ views; the Panel noted the difference between “comparable” and “no statistically significant difference”).
Sanofi-Aventis appealed the Clause 7.2 ruling on the weight claims; the Appeal Board upheld the breach.

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