AUTH/2436/9/11: Genzyme v Shire — VPRIV website claims (misleading comparative efficacy and manufacturing risk statements) | PMCPA Case

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Key facts

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Case number	AUTH/2436/9/11
Parties	Genzyme Therapeutics Ltd v Shire Pharmaceuticals Ltd
Product	VPRIV (velaglucerase alfa)
Comparator referenced	Cerezyme (imiglucerase)
Channel	Website (www.vpriv.co.uk)
Main issues	Comparative efficacy wording from non-inferiority study; manufacturing/process claims (“gene manipulation”); viral contamination risk implication; alleged public access to HCP promotion
Applicable Code year	2011
Breach clauses	7.2 (x3) and 7.3
No breach clauses considered	22.1, 22.2, 24.1, 24.3
Sanctions	Undertaking received; Additional sanctions: Not stated
Complaint received	11 October 2011 (site record); also stated in report text as 22 September 2011
Completed	18 November 2011 (site record); also stated in report text as 7 November 2011
Appeal	No appeal

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

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Genzyme complained about promotional claims on Shire’s UK website for VPRIV (velaglucerase alfa), an enzyme replacement therapy for Gaucher disease, comparing it with Genzyme’s Cerezyme (imiglucerase).
The website included a comparative efficacy statement next to a table of haemoglobin data from a non-inferiority study.
The website described aspects of VPRIV’s manufacturing process, including statements about “gene manipulation” and being “free of animal components” to “minimise the risk of viral contamination”.
Genzyme also alleged the health professional section was easily accessible to the public (promotion of a POM to the public).

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Breach found for the claim “at least as effective as” (misleading and not reflecting evidence).
Breach found for the claim that manufacture “does not require gene manipulation” (misleading).
Breach found for the claim that being “free of animal components” “minimising the risk of viral contamination” (misleading implication re human viruses).
No breach for alleged promotion to the public: the HCP and public/patient sections were clearly separated with an HCP confirmation step; the Panel did not consider the promotional material intended for the public.

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