Otsuka UK/Otsuka Europe: UK-circulated press releases about unlicensed ASTX727 found to breach high standards and substantiation rules

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Key facts

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Case number	AUTH/3266/10/19 and AUTH/3279/11/19
Complainant	Health professional
Company	Otsuka Pharmaceuticals (UK) Limited; Otsuka Pharmaceuticals Europe Limited
Product	ASTX727 (oral cedazuridine + decitabine fixed-dose combination), investigational/unlicensed at the time
Material	Two online press releases (orphan designation; ASCERTAIN study results)
Channels noted	uk.finance.yahoo.com; cambridgenetwork.co.uk; third-party UK/Ireland distribution circuits
Main issues	Scope of Code for overseas affiliate press releases distributed in UK; misleading/unsubstantiated claims; high standards for public-facing comms about unlicensed medicine
Applicable Code year	2019
Complaint received	26 September 2019
Case completed	15 May 2020
Appeal	No appeal
No breach clauses	Clause(s) 7.2, 26.1, 26.2
Breach clauses	Clause(s) 7.2, 7.4, 7.9, 9.1
Sanctions	Undertaking received

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

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A health professional complained about two online press releases concerning ASTX727 (oral cedazuridine/decitabine fixed-dose combination) under study for MDS including CMML.
Press release 1 (Astex, US) announced FDA orphan drug designation and used the term “novel”. It appeared on a UK-facing site (uk.finance.yahoo.com) and was distributed via third-party circuits including UK/Ireland.
Press release 2 (Astex US and Otsuka Japan) reported Phase 3 ASCERTAIN study results and was accessed via cambridgenetwork.co.uk; it was distributed widely to UK media outlets, many consumer-facing.
Otsuka UK and Otsuka Europe argued they did not issue/approve/authorise the releases and that they were outside the Code; however, emails showed awareness that the second release would be issued in the UK/Ireland and that a Zinc review was initiated but not completed.
The Panel held the materials were within scope because they were circulated to UK outlets and UK affiliates are responsible for overseas affiliates’ acts/omissions that fall within the Code.
ASTX727 had no marketing authorisation in any country at the time; the Panel therefore treated it as not classified as a prescription only medicine for the purposes of applying Clauses 26.1/26.2.

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Press release 1 (orphan designation): No breach of Clauses 26.1 and 26.2 (technical point: ASTX727 not classified as POM). Breach of Clause 9.1 (high standards) for promoting an unlicensed medicine to the public. No breach of Clause 7.2 regarding “novel”. No breach of Clause 2.
Press release 2 (ASCERTAIN results): Breach of Clauses 7.2, 7.4 and 7.9 for misleading and unsubstantiated claims (including safety/benefit statements) and side-effect claims not reflecting evidence; breach of Clause 9.1 (high standards). No breach of Clause 26.2 (technical point: not classified as POM). No breach of Clause 2.
Sanctions applied: undertaking received.
No appeal.

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