Leo Pharma: media advisory board for Kyntheum ruled promotional and pre-licence promotion (AUTH/3311/2/20)

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Key facts

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Case	AUTH/3311/2/20
Company	Leo Pharma Laboratories Ltd
Activity	Media advisory board for Kyntheum (brodalumab)
Medicine / therapy area	Kyntheum (brodalumab) for moderate to severe plaque psoriasis in adults who were candidates for systemic therapy
Date of meeting	26 June 2017
Marketing authorisation date (brodalumab)	17 July 2017
Complainant	Anonymous, non-contactable individual
Complaint received	18 February 2020
Case completed	25 February 2021
Applicable Code year	2019
Panel view on nature of activity	Promotional (for non-health-professional journalists writing for consumer media)
No breach clauses	Clause(s) 26.1, 26.2 (technical point: product not classified as POM at the time)
Breach clauses	Clause(s) 2, 3.1, 9.1
Sanctions	Undertaking received; Advertisement
Appeal	No appeal

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

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An anonymous, non-contactable complainant asked the PMCPA to assess a media advisory board for Kyntheum (brodalumab) run by Leo Pharma Laboratories Ltd, referencing an MHRA investigation report.
Nine UK-based journalists attended a Leo-organised media advisory board on 26 June 2017 and were paid to advise on generating media interest in psoriasis and on Leo’s approach to disseminating “newsworthy” information on Kyntheum.
The agenda included a detailed scientific presentation (16 slides) describing brodalumab’s mechanism of action and clinical trial programme; speaker notes included reference to studies in psoriatic arthritis and “positive” results and an expectation to initiate a phase 3 study in Europe.
The MHRA considered the advisory board was designed to promote an unlicensed medicine; Leo agreed (at MHRA request) to issue a corrective statement to attendees and provided a corrective statement for the MHRA website.
Leo argued the meeting was non-promotional and intended to obtain expert advice from health journalists, with no take-away materials and confidentiality contracts; it said no attendee published an article as a consequence.
The Panel assessed whether the advisory board was promotional and whether it met the requirements for an advisory board given the audience (primarily consumer-media freelance journalists) and the level of product detail presented.

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The Panel considered, on balance, that the advisory board (insofar as it concerned non-health-professional journalists writing for consumer media) did not satisfy the requirements for an advisory board and was therefore promotional.
No breach of Clauses 26.1 and 26.2 was ruled on a narrow technical point: Kyntheum was not classified as a prescription only medicine when the advisory board was held, and Clauses 26.1/26.2 apply only to POMs.
Breach of Clause 3.1 was ruled: brodalumab was promoted prior to the grant of its marketing authorisation.
Breach of Clause 9.1 was ruled: high standards had not been maintained.
Breach of Clause 2 was ruled: the arrangements showed lack of care/awareness of the Code and brought discredit upon and reduced confidence in the industry.
No appeal.

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