Leo v Galderma: ‘Dear Doctor’ letter for Silkis—claims on comparable efficacy, cosmetic acceptability and “cost effective” found misleading

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Key facts

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Case number	AUTH/2019/7/07
Parties	Leo Pharma v Galderma (UK) Limited
Material	Silkis “Dear Doctor” promotional letter to GPs (ref CAL/11/0307)
Products	Silkis Ointment (calcitriol); Dovonex Ointment (calcipotriol)
Main issues	Broad comparative efficacy claim vs steroid; broad “cosmetic acceptability” superiority claim vs Dovonex; “cost effective option” claim based on acquisition cost only
Applicable Code year	2006
Complaint received	11 July 2007
Case completed	5 September 2007
Appeal	No appeal
Breach clauses	Clause 7.2 (x 2), Clause 7.4, Clause 7.5
Sanctions	Undertaking received; Additional sanctions: Not stated

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

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Leo Pharma complained about a promotional “Dear Doctor” letter for Silkis Ointment (calcitriol) sent by Galderma (UK) Limited to GPs after Leo announced the impending discontinuation of Dovonex Ointment (calcipotriol).
The letter suggested Silkis “might be a suitable alternative” for psoriasis patients who preferred a topical vitamin D medicine.
Three key claims were challenged:
- “Silkis has demonstrated comparable efficacy to a steroid in mild to moderate psoriasis” (referenced to Camarasa et al (2003)).
- “Silkis ointment has demonstrated greater cosmetic acceptability when compared with Dovonex ointment” (referenced to Marty et al (2005)).
- “…Silkis can provide a cost effective option within the Vitamin D topical market…”.

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