AUTH/1996/4/07: Roche v GlaxoSmithKline (Tykerb) — international journal ad and pre-licence media coverage (No breach) | PMCPA Case

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Key facts

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Case number	AUTH/1996/4/07
Complainant	Roche Products Limited
Respondent	GlaxoSmithKline UK Ltd
Product	Tykerb (lapatinib)
Main issues	Pre-licence ‘teaser’ advertisement in an international journal; alleged premarketing media campaign and implied superiority vs Herceptin
Media/journal referenced	The Oncologist (Jan 2007); Sunday Express (17 Sept 2006)
Applicable Code year	2006
Complaint received	27 April 2007
Case completed	10 July 2007
Appeal	No appeal
Decision	No breach
Clauses cited	2, 3.1, 7.2, 8.1, 20.6, 9.1, 9.2
Sanctions	None stated

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

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Roche complained about alleged pre-licence promotion of Tykerb (lapatinib) by GlaxoSmithKline (GSK).
A ‘Coming soon … Tykerb’ advertisement appeared in the January 2007 issue of The Oncologist, which had some UK circulation; GSK said US colleagues placed it without UK knowledge and withdrew it once identified.
Roche also alleged an engineered pre-marketing media campaign, citing a Sunday Express article (17 September 2006) stating “GlaxoSmithKline claims the drug will achieve better results than Herceptin”.
Roche argued Tykerb was unlicensed in the UK, there were no head-to-head data vs Herceptin, and repeated media messages (eg “better than Herceptin”, “Herceptin resistant”, “brain metastases”, “less cardiotoxicity”) suggested a common origin.
GSK denied briefing the journalist; it pointed to corporate/medical press releases about US/EU filings and phase III data, stating conversations with journalists were restricted to approved press release messages.
The Panel considered whether the journal advertisement fell within the Code’s scope for international journals and whether GSK’s press materials amounted to pre-authorisation promotion or misleading comparative claims.

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No breach of the Code was ruled.
The ‘Coming soon’ advertisement was found outside the scope of the Code on the facts presented (the relevant journal run was not produced in the UK and not intended for a UK audience).
The Panel found the press release provided did not imply Tykerb would achieve better results than Herceptin and did not suggest head-to-head comparative data existed.
The Panel did not find evidence, on the balance of probabilities, that GSK supplied the alleged comparative claims to the media or that the press materials overall amounted to pre-authorisation promotion.
The Panel noted concerns that the intended audience was not always clear on the face of some press releases and that one headline described data as “Landmark” and referred to changing the “treatment paradigm”, but still ruled no breach.
Clause 20.6 was described by the Panel as a statement of fact that could not be infringed.

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