GSK v AstraZeneca: Benralizumab CHMP press release ruled misleading and unbalanced (AUTH/3011/1/18)

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Key facts

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Case	AUTH/3011/1/18
Parties	GlaxoSmithKline v AstraZeneca
Material	Press release (AstraZeneca PLC) on CHMP positive opinion for benralizumab
Press release date	10 November 2017
Product	Benralizumab (Fasenra)
Therapy area	Severe eosinophilic asthma
Key issue	Misleading/unbalanced presentation of efficacy and safety data to the public (including omission of placebo context and range of results)
Applicable Code year	2016
Complaint received	17 January 2018
Case completed	4 May 2018
Breach clauses	7.2, 7.3, 7.9, 7.10, 9.1, 26.2
No breach clauses	2, 7.4, 7.5, 26.1, 26.3
Sanction	Undertaking received
Appeal	No appeal

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

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GlaxoSmithKline complained about an AstraZeneca PLC press release dated 10 November 2017 titled “Benralizumab receives positive EU CHMP opinion for severe, uncontrolled eosinophilic asthma”.
The release summarised clinical endpoints from SIROCCO, CALIMA and ZONDA and included statements on exacerbation reduction, lung function improvement, oral corticosteroid (OCS) reduction and adverse events.
GSK alleged the release was unbalanced and misleading due to omission of relevant context (including placebo data and less favourable study results) and that some wording was promotional (eg “rapid improvement”, “convenience”).
AstraZeneca argued it was a mandatory, non-promotional investor announcement under UK Listing Rules and (initially) outside the Code’s scope; it also said hyperlinks to publications provided transparency.
The Panel ruled the press release was subject to the ABPI Code (produced by a UK-located company and placed on a UK website described at the time as operated by AstraZeneca UK Limited).

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Breach of Clauses 7.2, 7.3, 7.9, 7.10, 9.1 and 26.2.
No breach of Clauses 2, 7.4, 7.5, 26.1, 26.3.
The Panel found multiple statements were misleading/unbalanced, particularly where placebo context and the range of study results were not presented.
Sanction recorded: Undertaking received. (No additional sanctions stated.)
No appeal.

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