Allergan v Pfizer: speculative 5‑year budget model and ‘significant savings’ patent-loss messaging for Xalatan/Xalacom

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Key facts

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Case number	AUTH/2312/4/10
Parties	Allergan Ltd v Pfizer Limited
Products	Xalatan (latanoprost); Xalacom (latanoprost plus timolol)
Therapy area	Glaucoma (POAG budget impact model)
Materials	POAG Budget Impact Model (5-year); Prescriber journal advertisement “Is your prescribing optimised?”
Main issues	Speculative long-term comparative cost-savings claims; “Significant savings are in sight”; reference to paediatric development programme inconsistent with SPC
Applicable Code year	2008
Complaint received	28 April 2010
Case completed	26 July 2010
Appeal	No appeal
Breach clauses	3.2 (x2), 7.2 (x2), 7.3, 9.1
Sanctions	Undertaking received; Additional sanctions: Not stated

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

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Allergan complained about Pfizer’s promotion of Xalatan (latanoprost) and Xalacom (latanoprost plus timolol).
Materials at issue: a POAG Budget Impact Model (5-year) and a journal advertisement (“Is your prescribing optimised?”).
The campaign encouraged initiating patients on Xalatan/Xalacom now to realise future cost savings when generics became available after loss of exclusivity (LOE).
The ad claimed “Significant savings are in sight” and stated Xalatan/Xalacom would be the first prostaglandins to come off patent, with a footnote about a possible 6‑month extension due to an ongoing paediatric development programme.
The budget model compared acquisition costs versus competitors (including Lumigan/Ganfort) and projected savings over up to five years using multiple assumptions about post‑LOE pricing and market behaviour.

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The Panel ruled the 5‑year comparative budget impact model was too speculative and misleading due to the number of assumptions and uncertainties.
The Panel ruled the ad’s cost-savings messaging (eg “Significant savings are in sight”) was similarly misleading in context.
Referencing the paediatric development programme in promotional materials was ruled inconsistent with the Xalatan/Xalacom SPC particulars (Xalatan not recommended for use in children as safety/efficacy not established).
No breach was ruled for “teaser advertising” in relation to the paediatric development programme statement.
No appeal.

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