AUTH/2270/10/09: Allergan v Merz Pharma — “At least as effective as Botox” claim based on non-inferiority studies | PMCPA Case

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Key facts

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Case number	AUTH/2270/10/09
Parties	Allergan Ltd v Merz Pharma UK Ltd
Product	Xeomin (botulinum neurotoxin type A)
Comparator referenced	Botox (marketed by Allergan)
Promotional context	Exhibition panel at Association of British Neurologists meeting, Liverpool (June 2009)
Claim at issue	“At least as effective as Botox with a similar safety profile”
Key evidence cited	Benecke et al (2005); Roggenkämper et al (2006) (both non-inferiority studies)
Core issue	Non-inferiority evidence was used to support an unqualified “at least as effective” comparative claim, implying equivalence/possible superiority
Applicable Code year	2008
Breach clauses	7.2 and 7.3
Complaint received	5 October 2009
Case completed	4 January 2010
Appeal	Yes — by respondent; unsuccessful
Sanctions	Undertaking received; additional sanctions: Not stated

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

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Allergan complained about Merz Pharma UK Ltd’s promotion of Xeomin (botulinum neurotoxin type A).
An exhibition panel at the Association of British Neurologists meeting (Liverpool, June 2009) stated: “At least as effective as Botox with a similar safety profile”.
The claim was referenced to Benecke et al (2005) and Roggenkämper et al (2006), which both parties agreed were non-inferiority studies.
Allergan alleged the unqualified wording “at least as effective as” did not reflect what non-inferiority trials can support and would be interpreted as equivalence and possible superiority.
Merz argued the claim was acceptable, citing regulatory acceptance of the studies, statistical literature, and perceived case precedent.
The Panel ruled the claim misleading; Merz appealed; the Appeal Board upheld the breaches.

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Breach found (not a “no breach” case).
The Panel ruled that the claim did not reflect the available evidence and was misleading.
The Appeal Board upheld the Panel’s ruling; the appeal was unsuccessful.

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