Leo Pharma Picato BMJ ad: “revolutionary”/“shortest duration” claim and imagery found misleading (AUTH/2583/3/13)

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Key facts

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Case number	AUTH/2583/3/13
Complainant	Almirall Ltd
Respondent	Leo Pharma
Medicine	Picato (ingenol mebutate) gel
Material	Journal advertisement (ref 4340a/00016(1))
Publication / date	BMJ, 26 January 2013
Complaint received	04 March 2013
Case completed	04 April 2013
Applicable Code year	2012
Key issue	Headline claim and imagery implied broader indication and potentially faster effect; superlative/exaggerated presentation; high standards
Clauses breached	7.10, 9.1
No breach	4.1
Appeal	No appeal
Sanctions	Undertaking received; additional sanctions not stated

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

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Almirall complained about a Leo Pharma journal advertisement for Picato (ingenol mebutate) gel published in the BMJ (26 January 2013).
The ad headline stated: “Picato Announcing the arrival of... The revolutionary, shortest duration, patient-applied actinic keratosis treatment” and used a high-speed train image plus “2 DAYS” and “3 DAYS” visuals.
Almirall alleged the ad was misleading/exaggerated and all-embracing, implying Picato was licensed for any actinic keratosis (AK) rather than the more restricted indication (non-hyperkeratotic, non-hypertrophic AK in adults).
Almirall also argued “shortest duration” could be read as fastest therapeutic effect, despite the SPC stating optimal effect should be assessed after ~8 weeks.
Almirall alleged the prescribing information was misleading because it did not include the SPC storage requirement (2–8°C).
Leo argued the indication was clear in the prescribing information; “shortest duration” referred to days of application; “revolutionary” was substantiated by shorter application duration vs other options; storage conditions were not required elements of prescribing information under the Code.

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Breach of Clause 7.10 (misleading/exaggerated claims; superlatives/all-embracing wording; rational use concerns).
No breach of Clause 4.1 (prescribing information requirements met; storage conditions not required under Clause 4.2 list).
Breach of Clause 9.1 (high standards not maintained).
No appeal.
Undertaking received.

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