AUTH/2350/8/10: Vifor Pharma v Pharmacosmos – “best-in-class”, “novel treatment” and hanging comparison for Monofer | PMCPA Case

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Key facts

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Case	AUTH/2350/8/10
Parties	Vifor Pharma v Pharmacosmos
Product	Monofer (iron isomaltoside 1000 solution for injection/infusion)
Channel/material	Announcement on Pharmacosmos.com; journal advertisement in Transfusion Alternatives in Transfusion Medicine (TATM), June 2010
Main issues	Implied “best-in-class” claim; “novel treatment” claim; “more patients” one-visit repletion claim as hanging comparison; alleged missing UK abbreviated prescribing information; alleged Clause 2 conduct
Applicable Code year	2008
Complaint received	17 August 2010
Case completed	1 November 2010
Appeal	No appeal
Breach clauses	Clause 7.2 (x3)
No breach findings	Clause 1.1; Clause 2; and no breach of Clause 7.2 regarding whether “possibility” of one-visit repletion was misleading
Sanctions	Undertaking received; Additional sanctions: Not stated

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

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Vifor Pharma UK Limited complained about promotion of Monofer (iron isomaltoside 1000 solution for injection/infusion) by Pharmacosmos A/S Denmark.
Materials at issue: (1) an announcement on Pharmacosmos.com headed “Pharmacosmos establishes UK subsidiary” (dated 8 July 2010, shortly after merger with Vitaline in the UK) and (2) a June 2010 journal advertisement in Transfusion Alternatives in Transfusion Medicine (TATM).
The website announcement included wording about an aspiration to provide “best-in-class treatment for iron deficiency anaemia”, referred to Monofer, described Monofer as “A novel treatment of iron deficiency anaemia”, and included the claim “Possibility of full iron repletion in one, rapid visit for more patients”.
Vifor alleged the “best-in-class” and “novel treatment” claims were unsubstantiated and that the “more patients” one-visit repletion claim was a hanging comparison and misleading.
Vifor also alleged the journal advertisement had not been signed off under the ABPI Code and did not include UK abbreviated prescribing information (alleged Clause 1.1), and raised Clause 2 concerns about a “cavalier approach”.

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The Panel ruled the Pharmacosmos.com announcement was within the scope of the Code (Clause 24.2 referenced by the Panel in its reasoning).
Breach of Clause 7.2 for an implied “best-in-class” product claim.
Breach of Clause 7.2 for describing Monofer as “a novel treatment” (injectable iron complexes already existed; formulation benefits did not make it “novel” on the evidence presented).
Breach of Clause 7.2 for “Possibility of full iron repletion in one, rapid visit for more patients” as a hanging comparison (comparator not stated).
No breach of Clause 7.2 for the “possibility” of one-visit repletion being misleading (Panel noted 38/182 patients received an undivided total dose infusion; mean infusion time 58.8 minutes, range 20–90 minutes).
No breach of Clause 1.1 regarding absence/incorrect prescribing information in the journal advertisement (Panel stated this was a Clause 4 issue; and in any event ruled no breach of Clause 1.1).
The Panel did not consider the alleged unsubstantiated claims in the journal advertisement because they had not been the subject of inter-company dialogue as required by Paragraph 5.2 of the Constitution and Procedure.
No breach of Clause 2 (not considered sufficiently serious for particular censure).
No appeal.

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