Novo Nordisk v Lilly: Byetta promotional meeting linked to pre-diabetes discussion (AUTH/2331/7/10)

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Key facts

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Case	AUTH/2331/7/10
Parties	Novo Nordisk v Lilly (Eli Lilly and Company Limited)
Activity type	Promotional meeting and invitation
Product	Byetta (exenatide)
Main issue	Pre-diabetes presentation included as part of a Byetta promotional meeting, creating implied off-licence promotion and misleading impression of licensed indication
Complaint received	09 July 2010
Case completed	06 September 2010
Applicable Code year	2008
Breach clauses	3.2, 7.2, 7.10
No breach findings (alleged)	9.10 (sponsorship declaration, including Amylin logo point), 9.1 (high standards)
Appeal	No appeal
Sanctions	Undertaking received; additional sanctions: Not stated

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

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Novo Nordisk complained about a Lilly promotional meeting (7 July 2010) titled “Treating Type 2 Diabetes – What Are Our Options?”.
The invitation prominently displayed the Byetta logo and included Byetta prescribing information; it also referenced a session on pre-diabetes and “evidence on how best to manage” it.
Novo Nordisk alleged this implied a wider indication for Byetta than its licence (type 2 diabetes in combination with metformin and/or sulphonylurea) and therefore promoted off-licence, misled the audience, and did not encourage rational use.
Novo Nordisk also alleged issues with sponsorship declaration prominence/clarity (including the presence of an Amylin logo) and alleged lack of high standards due to unclear content/form and spelling mistakes.
Lilly stated the meeting was promotional, the pre-diabetes talk was scientific/educational, the speaker was briefed not to mention Lilly products, and the slides were approved in advance.

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Breach of Clause 3.2 (promotion inconsistent with marketing authorisation) in relation to the pre-diabetes presentation being an integral part of a Byetta promotional meeting.
Breach of Clause 7.2 (misleading) because the invitation/meeting were misleading about Byetta’s licensed indication.
Breach of Clause 7.10 (rational use) because the misleading impression meant the meeting did not encourage rational use.
No breach of Clause 9.10 (sponsorship declaration) — recipients would be in no doubt the meeting was organised by Lilly, particularly given the accompanying letter; although it would have been preferable to state this on the front cover.
No breach of Clause 9.10 regarding the Amylin logo — the position could have been clearer, but Amylin had no role in UK activities and had not sponsored the meeting.
No breach of Clause 9.1 (high standards) regarding invitation content/spelling mistake.

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