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)
Setting	National Stroke Forum, Glasgow (30 November–2 December 2010)
Material	Exhibition stand panel (withdrawn)
Key claim	“No set dose ratio has been established between BoNT-A formulations” (with prominent “not interchangeable” messaging)
Complaint received	04 January 2011
Case completed	10 May 2011
Applicable Code	2008
Clauses considered	7.2, 7.4 and 2, 9.1, 25
Outcome	No breach of the Code
Appeal	No appeal

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The Allergan exhibition panel (later withdrawn) included prominent statements: “Unit doses of botulinum toxins are not interchangeable from one product to another” and “No set dose ratio has been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), Roggenkamper et al (2006), Hunt and Clarke (2009), Dressler (2008) and Brown et al (2008).
Merz alleged the “no set dose ratio” claim was misleading/unsupported because clinical data and the Xeomin EPAR supported a 1:1 dose ratio between Xeomin and Botox in certain settings, and because some cited references (eg Hunt and Clarke; Brown et al) were pre-clinical/misleading in prior cases.
Merz also alleged the panel breached prior inter-company assurances/undertakings (including prior cases involving Hunt and Clarke) and was effectively a direct attack on Xeomin.
Allergan denied the claim was misleading, arguing it reflected the SPCs across products/indications (including differences in post-stroke spasticity dosing/indications) and that unit doses were not interchangeable; it acknowledged citing Hunt and Clarke was not in line with inter-company dialogue and withdrew the panel.
The Authority also asked Allergan to respond under Clauses 2, 9.1 and 25 (2008 Code), in addition to Clauses 7.2 and 7.4 cited by Merz.

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The Panel ruled the claim “No set dosing ratio has been established” was not an unreasonable reflection of the totality of the evidence and SPC context; it was not misleading and was capable of substantiation.
No breach of Clauses 7.2 and 7.4 was ruled.
The Panel ruled the material was sufficiently different from earlier materials and was not covered by prior undertakings; no breach of undertakings was found.
No breaches of Clauses 2, 9.1 and 25 were ruled.
Overall outcome: No breach of the Code.

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