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

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Key facts

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Case	AUTH/2038/8/07
Parties	Novo Nordisk v Sanofi-Aventis
Product	Lantus (insulin glargine)
Comparator mentioned	Levemir (insulin detemir)
Material	Mailing to UK health professionals (May 2007)
Main issues	Cost comparison; hypoglycaemia claim wording; weight comparability claims
Applicable Code year	2006
Complaint received	24 August 2007
Case completed	04 February 2008
Breach Clause(s)	two breaches of 7.2 and one of 11.4
Appeal	Appeal by respondent (unsuccessful on Clause 7.2 weight-claim breach)
Sanctions applied	Undertaking received

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

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Novo Nordisk complained about a one-off UK mailing (May 2007) sent by Sanofi-Aventis to health professionals promoting Lantus (insulin glargine) versus Levemir (insulin detemir).
The mailing used observational/retrospective database analyses (THIN) including Poole et al (costs) and Currie et al (hypoglycaemia and weight).
Key challenged claims included:

Cost: “Lantus offers a significant cost advantage over insulin detemir in both type 1 and type 2 diabetes” with bullets stating 10% and 28% lower treatment costs (p<0.001).
Hypoglycaemia: “Lantus significantly reduces hypoglycaemia over Levemir in both type 1 and type 2 diabetes”.
Weight: “Lantus and insulin detemir had a similar effect on weight…” and “In people with type 2 diabetes, effect on weight was comparable…”

Novo Nordisk argued (among other points) that the hypoglycaemia claim implied separate type 1 and type 2 findings when Currie et al pooled both types, and that the weight claims ignored the Levemir SPC and RCT evidence suggesting less weight gain with Levemir.
Sanofi-Aventis appealed the Panel’s breach finding on the weight claims under Clause 7.2; the appeal was unsuccessful.

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Cost comparison claim (Poole et al): No breach of Clause 7.2 (Panel did not accept it was misleading as alleged, including around regimen differences/licensing arguments).
Hypoglycaemia headline: Breach of Clause 7.2 because it did not make clear the analysis was on a pooled type 1 and type 2 cohort and was misleading in that regard.
Hypoglycaemia evidence base (observational vs RCTs): No breach of Clause 7.2 on the allegation that using Currie et al was per se misleading.
Weight claims: Breach of Clause 7.2 (misleading; did not reflect Levemir SPC/totality of data). Upheld on appeal.
Weight claims vs authors’ views: Breach of Clause 11.4 (Panel found an important difference between “comparable” and “no statistically significant difference” and considered the claims inconsistent with the authors’ views). Not appealed.

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