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
Third parties/affiliates involved	Astex Pharmaceuticals Inc (US); Otsuka Pharmaceutical Co Ltd in Japan (OPCJ)
Material	Two online press releases about investigational ASTX727
Product	ASTX727 (oral cedazuridine + decitabine fixed-dose combination)
Therapy area	MDS including CMML
Issue	Alleged pre-licence promotion; misleading/unsubstantiated claims; UK circulation of overseas press releases
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) being studied for MDS including CMML.
Press release 1 (seen on uk.finance.yahoo.com) announced FDA orphan drug designation and described ASTX727 as “novel”. It was issued by Astex Pharmaceuticals Inc (US), a wholly owned subsidiary of Otsuka Pharmaceuticals Co Ltd.
Press release 2 (seen on cambridgenetwork.co.uk) announced results of the phase 3 ASCERTAIN study and included statements about safety, GI adverse events, survival benefit and “alleviating the burden” of IV infusions. It was issued jointly by Astex (US) and Otsuka in Japan.
Although Otsuka UK and Otsuka Europe said they did not issue/approve/authorise the releases, both releases were distributed via third-party circuits that included the UK and Ireland and were widely circulated to UK media, many aimed at consumers.
For the second release, emails showed Otsuka Europe and Otsuka UK were aware it would be issued in the UK/Ireland; a review in Zinc was initiated but not completed, despite an internal expectation that joint press releases released in the UK required Otsuka UK review.
ASTX727 had no marketing authorisation in any country at the time.

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Scope: Both press releases were held to be covered by the UK ABPI Code due to circulation to UK outlets; UK affiliates were responsible for overseas affiliates’ acts/omissions within scope.
Press release 1 (orphan designation): No breach of Clauses 26.1 and 26.2 (technical point: ASTX727 not classified as a prescription only medicine). Breach of Clause 9.1 for failing to maintain high standards by 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): Breaches of Clauses 7.2, 7.4 and 7.9 for misleading and unsubstantiated claims (including around alleviating IV burden, survival benefit, low GI adverse events, and benefit of oral treatment) and for side-effect claims not reflecting available evidence; the press release did not make clear from the outset that ASCERTAIN was a pharmacokinetic equivalence study with safety/efficacy as secondary endpoints. No breach of Clause 26.2 (technical point: ASTX727 not classified as a prescription only medicine). Breach of Clause 9.1 (high standards not maintained, including in relation to study outcomes). No breach of Clause 2.
No appeal.

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