AUTH/2496/4/12: Allergan/PMCPA Director v Merz – “equipotent” and 1:1 conversion ads for Xeomin/Bocouture implied interchangeability and breached an undertaking | PMCPA Case

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Key facts

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Case	AUTH/2496/4/12
Parties	Allergan Limited / PMCPA Director v Merz Pharma UK Ltd
Products	Xeomin, Bocouture vs Botox, Vistabel (botulinum neurotoxin type A)
Materials	Two Bocouture advertisements (refs 1070/MER/AUG/2011/JH and 1075/BOC/DEC/2011/JH) and one Xeomin advertisement (ref 1281/XEO/OCT/2011/JL)
Main issue	Claims/visuals implied clinical equivalence and 1:1 interchangeability despite SPC non-interchangeability statements; alleged breach of prior undertaking
Applicable Code year	2011
Breach clauses	2, 7.2 (x3), 7.3 (x2), 7.4 (x2), 9.1 and 25 (x2)
Appeal	Appeal by complainant (successful on Clause 25, and consequently Clauses 2 and 9.1)
Complaint received	10 April 2012 (also stated: 5 April 2012)
Case completed	09 August 2012
Sanctions	Undertaking received; additional sanctions not stated; advertisement not stated

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

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Allergan complained about three Merz advertisements for Xeomin/Bocouture (botulinum neurotoxin type A) comparing them with Allergan’s Botox/Vistabel.
The ads used claims such as “Equipotent”, “Equal Potency” and “1:1 Clinical Conversion Ratio”, alongside visuals of vials placed side-by-side to reinforce a direct 1:1 relationship.
Although the ads included SPC wording that unit doses were not interchangeable, this appeared less prominently than the headline claims/visuals.
Allergan alleged the overall impression was clinical equivalence and unit interchangeability, that this could not be substantiated (non-inferiority studies cannot prove equivalence), and that it created patient safety risk.
Because Allergan also alleged a breach of an undertaking given by Merz in a previous case (AUTH/2270/10/09), that aspect was taken up by the PMCPA Director.

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Panel (first instance):
- Found the Bocouture ad (ref 1075/BOC/DEC/2011/JH) misleading and unsubstantiated: breaches of Clauses 7.2, 7.3 and 7.4.
- Found the Xeomin ad (ref 1281/XEO/OCT/2011/JL) misleading and unsubstantiated: breaches of Clauses 7.2, 7.3 and 7.4.
- Did not find a breach of undertaking at Panel stage: no breach of Clause 25, and consequently no breach of Clauses 2 and 9.1 at that stage.
Appeal Board (on Allergan’s appeal):
- Ruled that the Bocouture and Xeomin advertisements were sufficiently similar to the earlier prohibited claim (re equivalence) to be covered by the prior undertaking: breach of Clause 25 (x2).
- Because Merz had no data to support the implied clinical equivalence/interchangeability and had breached its undertaking, the Appeal Board also ruled breaches of Clause 9.1 and Clause 2.
- Appeal by complainant was successful on the undertaking/high standards/discredit points.

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