Otsuka UK/Otsuka Europe: UK-circulated press release found to promote unlicensed ASTX727 and mislead on evidence and decitabine indication (AUTH/3212/6/19, AUTH/3262/6/19)

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Key facts

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Case numbers	AUTH/3212/6/19 and AUTH/3262/6/19
Complainant	Anonymous health professional
Company	Otsuka (UK) Limited; Otsuka Pharmaceuticals Europe Limited
Third parties referenced	Astex Pharmaceuticals Inc (US); Otsuka Pharmaceutical Co Ltd (Japan)
Material	Online press release (UK-circulated via third-party circuits including UK and Ireland)
Medicine(s)	ASTX727 (cedazuridine/decitabine fixed-dose combination; investigational/unlicensed); decitabine IV (licensed in UK for adults with newly diagnosed de novo or secondary acute myeloid leukaemia)
Study	Phase III ASCERTAIN (pharmacokinetic equivalence study; safety/efficacy secondary endpoints)
Main issues	Unsubstantiated/misleading benefit and safety claims; promotional language for unlicensed medicine; misleading implication about decitabine indication in UK; high standards
Applicable Code year	2019
Complaint received	17 June 2019
Case completed	15 May 2020
Appeal	No appeal
Breach clauses	3.1, 3.2, 7.9, 9.1
No breach clauses	11.1 (and, on a narrow technical point, 26.1 and 26.2)
Sanctions	Undertaking received; additional sanctions not stated

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

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An anonymous health professional complained about an online press release on ASTX727 (cedazuridine/decitabine fixed-dose combination) relating to the phase III ASCERTAIN study.
The press release was jointly released by Astex Pharmaceuticals Inc (US; wholly owned subsidiary of Otsuka Pharmaceuticals Co Ltd) and Otsuka Pharmaceutical Co Ltd in Japan.
Although Otsuka UK and Otsuka Europe said they did not issue/approve/authorise it, the Panel found it was circulated to UK outlets via a third-party circuit (including UK and Ireland) and that Otsuka Europe and Otsuka UK knew it would be issued in the UK/Ireland.
A review workflow in Zinc was initiated but not completed, despite internal emails indicating joint Astex/Otsuka press releases released in the UK required Otsuka UK review.
The press release included claims such as: successful oral delivery “alleviating the significant burden” of IV infusions; patients might benefit “for several months or even years”; “low level of gastrointestinal side effects”; and that ASTX727 could bring a new option for “these deadly diseases”.
The Panel noted ASCERTAIN was a pharmacokinetic equivalence study; safety and efficacy were secondary endpoints.
The press release also referenced decitabine/azacitidine being FDA-approved for higher risk MDS and CMML, which did not reflect the UK licence for IV decitabine (licensed in the UK for adults with newly diagnosed de novo or secondary acute myeloid leukaemia).

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The press release was found to be within the scope of the UK Code due to UK circulation and UK affiliate involvement/awareness.
Breach findings were made for promotional and misleading claims about an unlicensed medicine and for misleading/off-label implications regarding decitabine.
No breach was found for Clause 11.1 on the narrow allegation about relevance/interest to a UK audience.
No breach was found for Clauses 26.1 and 26.2 on a narrow technical point because ASTX727 was not classified as a prescription only medicine.
No breach of Clause 2 was ruled; the Panel noted Clause 2 is reserved for particular censure and the circumstances did not meet that threshold.

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