AUTH/2380/1/11: Merz Pharma v Allergan — “No set dose ratio” claim on Botox exhibition panel (No breach) | PMCPA Case

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Key facts

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Case	AUTH/2380/1/11
Parties	Merz Pharma UK Ltd v Allergan Limited
Product(s)	Botox (Allergan); Xeomin (Merz)
Issue	Exhibition panel claim: “No set dose ratio has been established between BoNT-A formulations” and alleged breach of undertaking
Setting	National Stroke Forum, Glasgow (30 Nov–2 Dec 2010)
Applicable Code	2008
Complaint received	04 January 2011
Case completed	10 May 2011
Appeal	No appeal
Clauses considered	7.2, 7.4 and 2, 9.1, 25
Outcome	No breach of the Code
Material status	Exhibition panel withdrawn

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

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Merz Pharma UK Ltd complained about Allergan Limited’s promotion of Botox (botulinum toxin type A) at the National Stroke Forum (Glasgow, 30 Nov–2 Dec 2010).
The Allergan exhibition panel included prominent statements: “Unit doses of botulinum toxins are not interchangeable from one product to another” and “No set dose ratio has been established between BoNT-A formulations”.
The claim was referenced to Benecke et al (2005), Roggenkämper et al (2006), Hunt and Clarke (2009), Dressler (2008) and Brown et al (2008).
Merz alleged the claim was misleading/unsupported given clinical data and regulatory material suggesting a 1:1 dose ratio between Xeomin and Botox in certain settings, and argued the panel continued a wider “potency” narrative.
Merz also raised concerns about prior inter-company assurances/undertakings (including an agreement not to use Hunt and Clarke in promotional material).
Allergan stated the claim reflected the SmPC position that unit doses are product-specific and not interchangeable, and pointed to differences across products/indications and dosing in SmPCs (notably post-stroke spasticity).
The exhibition panel at issue had been withdrawn.

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No breach of the Code was ruled.
The Panel ruled the claim “No set dosing ratio has been established” was not misleading and was capable of substantiation in context.
The Panel ruled the material was sufficiently different from prior cases/undertakings and was not in breach of undertakings given in Cases AUTH/2335/7/10 and AUTH/2346/8/10.
No breaches were ruled in relation to the additional clauses the Authority asked Allergan to address.

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