AUTH/2115/4/08 Roche v GlaxoSmithKline: Press releases for Tykerb/Tyverb (lapatinib) on corporate website

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Key facts

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Case number	AUTH/2115/4/08
Case reference	Roche v GlaxoSmithKline
Complainant	Roche Products Ltd
Respondent/company	GlaxoSmithKline
Product(s)	Tykerb/Tyverb (lapatinib); capecitabine mentioned in combination context
Material/channel	Two corporate press releases on www.gsk.com (Media Centre/corporate press releases)
Key issue	Whether corporate press releases were promotional/unbalanced and whether safety information fairly reflected available evidence (risk–benefit balance), plus brand name frequency/stylization in a later release
Dates (received/completed if stated)	Complaint received 15 April 2008; Case completed 16 July 2008
Appeal	Yes. Roche appealed the ruling on the 18 March 2008 press release; appeal unsuccessful and no breach upheld.
Code year	Not stated
Breaches/clauses	Breaches: 7.2, 7.3, 7.4, 7.9, 7.10 (Press release 14 Dec 2007, adverse effects/risk–benefit). No breach: 3.1, 3.2, 7.4, 7.10, 9.1, 20.1, 20.2 (as detailed in the ruling); and no breach of 3.1 for the 18 Mar 2008 release (upheld on appeal).
Sanctions	No explicit additional sanctions stated beyond the required undertaking/corrective actions described in the report

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

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What happened

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Roche complained about two GlaxoSmithKline (GSK) corporate press releases about Tykerb/Tyverb (lapatinib) posted on GSK’s website (www.gsk.com).
Tykerb was already licensed in the US; Tyverb was the registered brand name for lapatinib in Europe and a proposed trade name in other markets pending regulatory approval.
Lapatinib was used in the treatment of advanced or metastatic breast cancer.
Press release 1 (14 December 2007), titled “GlaxoSmithKline receives positive EMEA opinion for a conditional approval of Tyverb”, was alleged by Roche to be promotional, unbalanced and not to accurately/fairly reflect evidence, including: selective efficacy presentation; downplaying adverse events; implying unsubstantiated activity in earlier-stage disease via a Piccart quotation; implying effectiveness in brain metastases and promoting pre-licence; and inappropriate placement on an open-access UK website.
The Panel considered the press release within the scope of the Code because it was issued in the UK and referred to Tyverb as the proposed UK brand name.
The Panel reviewed statements about brain metastases (including a cited draft Tyverb SPC and a statement that further data would be presented at a symposium) and the adverse event paragraph (which stated most adverse events were mild/moderate and not significantly higher than capecitabine monotherapy, without mentioning more serious events such as cardiac toxicity).
Press release 2 (18 March 2008), titled “Tyverb (lapatinib) European regulatory update”, was alleged by Roche to breach the Code by using the stylized brand name “Tyverb” more than ten times in the opening five paragraphs (and frequently overall), making it promotional.
GSK stated the “Media Centre” was aimed at business journalists and analysts/investors and that each press release carried wording stating it was intended for that audience.

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Outcome

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Press release 1 (14 December 2007): No breach was found regarding the Piccart quotation implying activity in early breast cancer (Clauses 7.4 and 7.10 not breached on that point).
Press release 1: No breach was found regarding undue emphasis on brain metastases data, lack of balance, or promotion prior to marketing authorization (no breaches of Clauses 7.2, 7.10, 9.1, 20.2, 3.1, 3.2 on those points).
Press release 1: The Panel ruled the brief reference to adverse effects was misleading and did not reflect available evidence; the risk–benefit profile was not presented fairly (breaches ruled).
Press release 1: The Panel did not consider the press release an advertisement to the public (no breach of Clause 20.1).
Press release 2 (18 March 2008): The Panel ruled no breach of Clause 3.1; although it would have been preferable to mention Tyverb less frequently, the references were not excessive or styled so as to make the release promotional.
Appeal (by Roche) on press release 2: The Appeal Board upheld the Panel’s ruling of no breach of Clause 3.1; the appeal was unsuccessful.

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Clauses

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Breached (Press release 1, adverse events/risk–benefit): Clauses 7.2, 7.3, 7.4, 7.9 and 7.10.
Not breached (Press release 1, other allegations): Clauses 7.4 and 7.10 (Piccart quotation); Clauses 7.2, 7.10, 9.1 and 20.2 (brain metastases/balance); Clauses 3.1 and 3.2 (promotion prior to marketing authorization); Clause 20.1 (advertisement to the public).
Not breached (Press release 2): Clause 3.1 (including on appeal).

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Key facts

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