AUTH/2982/10/17: Anonymous member of the public v Leo (Kyntheum) – internal launch materials seen at interview (No breach) | PMCPA Case

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Key facts

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Case number	AUTH/2982/10/17
Complainant	Anonymous, non-contactable member of the public (also described themselves as a prospective employee)
Company	Leo Pharma
Medicine	Kyntheum (brodalumab)
Indication (as stated)	Treatment of moderate to severe plaque psoriasis in adults who were candidates for systemic therapy
Main allegation(s)	Promotion to the public (including alleged pre-authorisation) and that “well tolerated” was misleading given suicides reported in US trials
Material described	Internal display/advertisement with an apparently naked man and multiple claims; billboard: “The future is clear the future is Kyntheum”
Applicable Code year	2016
Complaint received	06 October 2017 (PDF also states 3 October 2017)
Case completed	08 February 2018
Appeal	No appeal
Decision	No breach
Clauses considered	2, 3.1, 7.2, 7.4, 9.1, 26.1

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

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An anonymous, non-contactable complainant (describing themselves as a member of the public) said they attended a job interview at Leo for a role involving Kyntheum (brodalumab).
They alleged there was “advertising” for Kyntheum in an “open waiting room”, including an image of an apparently naked man and multiple efficacy/positioning claims (including PASI 100 and superiority vs ustekinumab) plus “well tolerated”.
They also alleged a billboard stated: “The future is clear the future is Kyntheum”.
They believed the indication shown was not licensed at the time and that “well tolerated” was inappropriate given suicides reported in US trials.
Leo stated the materials were for internal communications only, displayed in a staff coffee/breakout area within secure offices; visitors were controlled and accompanied and typically kept in a separate meetings area.
Leo stated the UK marketing authorisation was granted 17 July 2017 and internal communications activities began 25 July 2017 (i.e., after authorisation).

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No breach of the Code was ruled.
The Panel found no evidence that Kyntheum was promoted to the public prior to marketing authorisation.
The Panel did not consider the complainant had established that “well tolerated” was misleading or unsubstantiated on the balance of probabilities.
The Panel queried whether the “naked man” visual complied with the supplementary information to Clause 9.1 and asked that Leo’s attention be drawn to the matter (but did not rule a breach).

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