AUTH/2515/6/12: Allergan/Director v Merz — Bocouture vs Botox “Comparable efficacy” and “1:1 Clinical Conversion Ratio” (No breach) | PMCPA Case

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Key facts

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Case number	AUTH/2515/6/12
Parties	Allergan/Director v Merz
Company complained about	Merz Pharma UK Ltd
Complainant	Allergan Limited (supplier of Botox)
Product(s)	Bocouture (Merz) and comparator Botox (Allergan)
Setting	FACE Conference and Exhibition, June 2012
Materials	Exhibition stand (1149/MER/MAY/2012/JH); leavepiece (1080/BOC/FEB/2012/JH)
Main claim at issue	“Comparable efficacy, 1:1 Clinical Conversion Ratio” (referenced to Sattler et al 2010) alongside side-by-side vials
Key qualification shown	“Unit doses recommended for Bocouture are not interchangeable with those for other preparations of botulinum toxin” (Bocouture SPC)
Allegation type	Alleged breach of undertaking (from AUTH/2270/10/09)
Applicable Code year	2012
Clauses considered	2, 9.1 and 25
Panel decision	No breach
Appeal	Yes — by complainant; unsuccessful
Complaint received	15 June 2012
Case completed	11 October 2012

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

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Allergan complained about Merz Pharma UK’s promotion of Bocouture (botulinum toxin type A) at the FACE Conference and Exhibition (June 2012).
Materials at issue: a Merz exhibition stand (ref 1149/MER/MAY/2012/JH) and a leavepiece (ref 1080/BOC/FEB/2012/JH).
The stand/leavepiece showed Bocouture and Botox vials side-by-side with the claim: “According to comparative clinical studies [Sattler et al 2010] Bocouture vs Botox: Comparable efficacy, 1:1 Clinical Conversion Ratio”.
In smaller/less prominent text, the materials included the SPC statement: “Unit doses recommended for Bocouture are not interchangeable with those for other preparations of botulinum toxin” (referenced to the Bocouture SPC, March 2012 / February 2012).
Allergan alleged the overall impression was that Bocouture and Botox were interchangeable/equipotent and could be converted 1:1, creating potential patient safety risk.
The complaint was treated as an alleged breach of an undertaking (from Case AUTH/2270/10/09) and was taken up by the Director without prior inter-company dialogue.
Merz argued the prominent wording was “Comparable efficacy” (not equivalence/superiority), supported by a non-inferiority study (Sattler et al 2010) in glabellar lines, and that “comparable” does not imply equivalence.

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No breach of the Code was found.
The Panel ruled no breach of Clause 25 (undertaking), and consequently no breach of Clauses 9.1 and 2.
Allergan appealed (complainant appeal). The Appeal Board upheld the Panel’s rulings; the appeal was unsuccessful.

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