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)
Material/channel	Two corporate press releases on GSK corporate website (www.gsk.com), via the Media Centre (links also appeared on homepage)
Key issue	Whether investor/business press releases were promotional/unbalanced; Panel found misleading adverse event/risk-benefit presentation in 14 Dec 2007 release; no breach for early-stage implication, brain metastases emphasis/promotion prior to licence, public advertising, or brand-name frequency in 18 Mar 2008 release (upheld on appeal)
Dates (received/completed if stated)	Complaint received 15 April 2008; Case completed 16 July 2008
Appeal	Yes. Roche appealed the no-breach ruling on Clause 3.1 for the 18 March 2008 press release; appeal unsuccessful and Panel ruling upheld.
Code year	Not stated
Breaches/clauses	Breaches: 7.2, 7.3, 7.4, 7.9, 7.10 (14 Dec 2007 press release, adverse effects/risk-benefit). No breach: 3.1, 3.2, 7.4, 7.10 (Piccart quote), 7.2/7.10/9.1/20.2 (brain metastases allegations), 20.1 (public advertising), and 3.1 (18 Mar 2008 press 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 for Tykerb/Tyverb (lapatinib) posted on www.gsk.com.
Tykerb was licensed in the US; Tyverb was the registered brand name for lapatinib in Europe and the proposed trade name in certain other markets pending regulatory approval.
Lapatinib was used in the treatment of advanced or metastatic breast cancer.
Press release 1 (dated 14 December 2007) concerned a positive EMEA opinion recommending conditional marketing authorization for lapatinib in combination with capecitabine for advanced/metastatic breast cancer whose tumours over-expressed HER2, after progression despite prior therapy.
Roche alleged the 14 December 2007 press release was promotional, unbalanced, and did not accurately reflect evidence, including: (a) an unsubstantiated implication of activity in earlier-stage disease via a quotation; (b) implication of effectiveness in brain metastases and promotion prior to licence; (c) misleading downplaying of adverse events and omission of serious risks (eg cardiac toxicity); and (d) inappropriate placement on an open-access UK website.
The Panel considered the 14 December 2007 press release within scope of the Code because it was issued in the UK and referred to Tyverb, the proposed UK brand name.
The 14 December 2007 press release included brain metastases progression figures (2% combination vs 6% capecitabine alone) citing the draft Tyverb SPC, and noted further data would be presented at a symposium on 16 December 2007.
Press release 2 (dated 18 March 2008) provided a European regulatory update, describing a delay in the regulatory procedure due to adverse data regarding possible hepatotoxicity; Roche alleged it was promotional due to frequent, stylized use of the brand name “Tyverb”.
The Panel considered the 18 March 2008 press release within scope of the Code because it was issued in the UK and referred to Tyverb, the proposed UK brand name.
Roche appealed the Panel’s no-breach ruling on the 18 March 2008 press release; the Appeal Board considered the appeal and upheld the Panel’s decision.

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Outcome

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14 December 2007 press release: No breach was found regarding the Piccart quotation implying activity in earlier-stage disease (no breach of Clauses 7.4 and 7.10).
14 December 2007 press release: No breach was found regarding undue emphasis on brain metastases data, lack of balance, or promotion prior to marketing authorization (no breach of Clauses 3.1, 3.2, 7.2, 7.10, 9.1 and 20.2 in relation to those allegations).
14 December 2007 press release: 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 of Clauses 7.2, 7.3, 7.4, 7.9 and 7.10).
14 December 2007 press release: The Panel did not consider it an advertisement to the public (no breach of Clause 20.1).
18 March 2008 press release: The Panel ruled no breach of Clause 3.1 (brand name use not excessive or promotional in style).
Appeal (18 March 2008 press release): The Appeal Board upheld the Panel’s ruling of no breach of Clause 3.1; the appeal was unsuccessful.
Administrative dates: Complaint received 15 April 2008; case completed 16 July 2008.

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Clauses

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Breaches ruled (14 December 2007 press release): Clauses 7.2, 7.3, 7.4, 7.9 and 7.10.
No breach ruled (14 December 2007 press release): Clauses 3.1, 3.2, 7.2, 7.4, 7.10, 9.1, 20.1 and 20.2 (as applicable to the allegations considered).
No breach ruled (18 March 2008 press release): Clause 3.1 (upheld on appeal).

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Key facts

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Outcome

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