Merz v Allergan: Botox “20 licensed indications worldwide” and “A BIG difference” claims ruled misleading (AUTH/2215/3/09)

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Key facts

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Case number	AUTH/2215/3/09
Parties	Merz Pharma UK Ltd v Allergan Ltd
Product	Botox (botulinum neurotoxin)
Comparator mentioned	Xeomin (botulinum neurotoxin)
Materials	Product monograph (ACA/0343/2007/UK); Objection handler (ACA/1303/2006)
Main issues	“20 licensed indications worldwide” claims; headline “A BIG difference” implying special merit
Applicable Code year	2008
Complaint received	12 March 2009
Case completed	07 May 2009
Appeal	No appeal
Breach clauses	3.2, 7.2 (x2), 7.4 and 7.10
Sanctions	Undertaking received; Additional sanctions: Not stated

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

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Merz Pharma UK Ltd (marketing Xeomin) complained about Allergan Ltd’s promotion of Botox (botulinum neurotoxin).
Two items were in scope: a product monograph (ref ACA/0343/2007/UK) and an objection handler (ref ACA/1303/2006).
The product monograph stated Botox was “approved in over 70 countries, with 20 licensed indications …”.
The objection handler stated: “Worldwide, Botox currently has 20 licensed indications, whilst Xeomin has only 2 licensed indications”.
Merz alleged this could imply 20 UK indications and/or prompt discussion of unlicensed indications, making the promotion inconsistent with the UK SPC.
Merz also challenged the objection handler headline “A BIG difference” (with the Botox logo), alleging it implied special merit and was unreferenced and unsubstantiated.
Allergan said both items had been withdrawn following an earlier case (AUTH/2183/11/08) and argued the “BIG difference” message related to breadth/quality of evidence rather than clinical superiority.

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The Panel ruled that referencing “20 licensed indications worldwide” in both documents was inconsistent with the UK SPC and misleading; breaches were found.
For the product monograph, the Panel also ruled a breach for lack of adequate substantiation in the way the claim was used (even though the “20 indications” fact itself was true).
The Panel ruled “A BIG difference” was misleading and exaggerated and implied special merit that could not be substantiated; breaches were found.
No breach was ruled for substantiation of the factual point that there were 20 licensed indications (Clause 7.4) in relation to the product monograph.
No appeal.

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