Takeda v Daiichi-Sankyo: Olmetec comparison claims and use of an out-of-date reprint (AUTH/1841/5/06)

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Key facts

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Case number	AUTH/1841/5/06
Parties	Takeda v Daiichi-Sankyo (Sankyo Pharma UK Ltd, now Daiichi-Sankyo)
Product(s)	Olmetec (olmesartan); Amias (candesartan)
Issue	Allegedly misleading/unfair dose comparison (olmesartan 20mg vs candesartan 8mg) and promotional use of a reprint containing out-of-date candesartan dosing
Materials	Leavepiece (OLM 212.1); journal advertisement (OLM359); reprint of Brunner et al (2003)
Clauses cited	Clause 7.2 and Clause 7.3
Panel decision	Breach for leavepiece, advertisement, and reprint (Clauses 7.2 and 7.3)
Appeal outcome	Leavepiece: breaches upheld; Advertisement: no breach on appeal; Reprint: breaches accepted by Daiichi-Sankyo (not appealed)
Sanctions	Undertaking received; Additional sanctions: Not stated
Complaint received	31 May 2006
Case completed	28 September 2006
Published	November 2006 Code of Practice Review
Applicable Code year	2006

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

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Takeda complained that Daiichi-Sankyo’s promotion of Olmetec (olmesartan) made an unfair comparison with Takeda’s Amias (candesartan), based on Brunner et al (2003) comparing olmesartan 20mg vs candesartan 8mg.
Materials at issue: a leavepiece (ref OLM 212.1), a journal advertisement (ref OLM359), and the promotional use of a reprint of Brunner et al (2003) by representatives.
Takeda argued the comparison was misleading because Brunner et al compared the ‘usual maintenance dose’ of candesartan with the ‘optimal’ dose of olmesartan, and because the paper contained out-of-date candesartan dosing (4/8/16mg) inconsistent with the then-current Amias SPC (8mg initial/maintenance; up to 32mg max).
The Panel noted the leavepiece bar chart did not explain that Olmetec 20mg was the SPC-described ‘optimal’ dose (for patients not adequately controlled on 10mg), while candesartan 8mg was the recommended starting and usual maintenance dose—making the clinical significance hard to interpret.
The Panel also considered that supplying an unsolicited reprint constituted promotion and therefore had to comply with the Code; the reprint’s out-of-date candesartan dosing made it misleading.
Daiichi-Sankyo appealed the Panel’s rulings on the leavepiece and the advertisement.

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Leavepiece (OLM 212.1): Breach upheld on appeal—comparison presented in a misleading way because dose context (optimal vs starting/maintenance) was not made clear.
Journal advertisement (OLM359): Panel ruled a breach, but on appeal the Appeal Board ruled no breach—it considered that in practice the doses would be considered comparable and that, in this instance, the basis of the comparison was clear.
Promotional use of Brunner et al reprint: Breach (accepted by Daiichi-Sankyo)—out-of-date candesartan dosing information made the promotional use misleading.
The Panel requested Daiichi-Sankyo be reminded of supplementary information to Clause 7: claims must be capable of standing alone and should not generally be qualified by footnotes.

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