Takeda v Amdipharm Mercury: Lutrate email implied interchangeability with Prostap and overstated cost savings

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Key facts

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Case number	AUTH/2834/4/16
Complainant	Takeda UK Limited
Respondent	Amdipharm Mercury Company Limited (AMCo)
Product	Lutrate (leuprorelin acetate depot injection)
Material	Promotional email to health professionals and NHS budget holders (ref AMCo/LUT/1115/0027)
Main issues	Implied interchangeability with Prostap; misleading cost savings; “novel formulation” implying special merit/disparagement; high standards
Decision	Breaches of Clauses 3.2, 7.2, 7.3, 7.10, 8.1, 9.1; no breach of Clauses 2, 7.2 (fair balance point), 7.3 (administration claim point)
Sanctions	Undertaking received; additional sanctions not stated
Complaint received	11 April 2016
Case completed	3 June 2016
Appeal	No appeal
Code year	2016

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

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Takeda complained about a promotional email for Lutrate (leuprorelin acetate depot injection) (ref AMCo/LUT/1115/0027) sent by Amdipharm Mercury Company Ltd (AMCo) to health professionals and NHS budget holders.
The email promoted a new formulation of leuprorelin and highlighted potential NHS cost savings versus Takeda’s Prostap DCS.
The email included a cost-saving section (eg, “Annual cost saving with Lutrate: £135 per patient”) and a poll asking which patients recipients would consider prescribing Lutrate for, including “Those eligible patients currently receiving Prostap”.
Takeda alleged the email implied Lutrate and Prostap were interchangeable despite Lutrate having narrower licensed indications, risking inappropriate prescribing and overstated savings.
Takeda also challenged a “novel formulation to maintain effective testosterone suppression” claim as implying superiority and disparaging other leuprorelin formulations.
Takeda alleged lack of fair balance (efficacy without safety) and challenged “simple and easy to administer” as an unsubstantiated/hanging comparison.

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Breach found: the email implied Lutrate and Prostap were interchangeable, inconsistent with Lutrate’s SPC (Clause 3.2).
Breach found: cost-savings claims were misleading and did not promote rational use (Clauses 7.2, 7.3 and 7.10).
No breach: fair balance allegation (Clause 7.2) — Panel accepted that safety information in prescribing information was sufficient in context.
Breach found: “Novel formulation to maintain effective testosterone suppression” implied special merit not established and disparaged other leuprorelin formulations (Clauses 7.10 and 8.1).
No breach: “simple and easy to administer” was not considered a comparison/hanging comparison on the evidence available (no breach of Clauses 7.2 and 7.3 as ruled by the Panel for this point).
Breach found: high standards not maintained due to lack of clarity on indications and broad cost-saving claim (Clause 9.1).
No breach: Clause 2 (particular censure) — Panel did not consider the material brought discredit on the industry.
No appeal.

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