Shire misleadingly presented Mezavant XL “68% maintained remission” claim (AUTH/2238/6/09)

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Key facts

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Case number	AUTH/2238/6/09
Parties	Procter & Gamble Pharmaceuticals UK Limited v Shire Pharmaceuticals Limited
Product	Mezavant XL (mesalazine prolonged release)
Material type	Leavepieces (UK/MEZ/08/0195 and UK/MEZ/08/0203)
Main issue	Maintenance-of-remission data presented in a way that implied induction + maintenance in 68% of patients
Key claim	“68% of patients taking Mezavant XL 2.4g/day once daily (n=171) remained in complete remission at month 12”
Applicable Code year	2008
Breach clauses	Clause 7.2 (x2)
Complaint received	08 June 2009
Case completed	10 July 2009
Appeal	No appeal
Sanction	Undertaking received

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

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Procter & Gamble complained that Shire’s promotional leavepieces for Mezavant XL (mesalazine prolonged release) presented maintenance-of-remission data in a misleading way.
Two leavepieces (UK/MEZ/08/0195 and UK/MEZ/08/0203) stated: “68% of patients taking Mezavant XL 2.4g/day once daily (n=171) remained in complete remission at month 12”.
The leavepieces also carried induction-style messaging on the front page (eg “Efficacy to induce complete remission” and the tagline “Discover complete remission”).
The 68% figure came from a 12‑month maintenance study (Kamm et al 2008) in a per-protocol population that, by definition, started the maintenance phase in remission (100% in remission at month 0).
The Panel considered the materials were not sufficiently clear that the maintenance population was a minority of patients from the acute induction studies (Kamm et al 2007; Lichtenstein et al) who had achieved remission (eg ~40.5% and 34.1% achieved complete remission at week 8 in the cited parent studies).
Although an asterisked footnote stated the results were “in patients who achieved clinical and endoscopic remission in parent trials”, the Panel considered the overall presentation could lead readers to assume Mezavant XL induced and maintained remission in 68% of patients.

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Breach ruled: Yes.
The Panel ruled each leavepiece misleading as to the basis of the Kamm et al (2008) data.
Shire had agreed to cease use of a number of “complete remission” claims in promotional material, including the leavepieces at issue.
No appeal.

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