Pfizer v Leo Pharma: Innohep “long-term” promotion in cancer-associated VTE found outside the licence on appeal (AUTH/2209/2/09)

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Key facts

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Case number	AUTH/2209/2/09
Parties	Pfizer v Leo Pharma
Product	Innohep (tinzaparin sodium)
Therapy area	Venous thromboembolism (deep vein thrombosis and pulmonary embolus) in patients with cancer
Materials	Leavepiece (ref 1030/10191); cancer guidelines review (ref 1030/10186); journal advertisement (ref 1030/10216)
Main issue	Promotion implying extended/long-term use vs SPC posology “for at least 6 days and until adequate oral anticoagulation is established”
Applicable Code year	2008
Complaint received	23 February 2009
Case completed	15 May 2009
Panel decision	No breach of Clause 3.2
Appeal	By complainant (Pfizer); appeal successful
Final breach	Clause 3.2
Sanctions	Undertaking received; additional sanctions not stated

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

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Pfizer complained about Leo Pharma’s promotion of Innohep (tinzaparin sodium) for extended/long-term use in venous thromboembolism (VTE) in patients with cancer.
Materials at issue: a leavepiece (ref 1030/10191), a cancer guidelines review (ref 1030/10186) and a journal advertisement (ref 1030/10216) appearing in oncology/cancer journals and the hospital edition of the BMJ.
Promotional wording included: journal ad headline “Innohep – long term efficacy in treatment of [pulmonary embolism] and [deep vein thrombosis] in cancer patients” and a leavepiece page referring to “Long-term Innohep”.
Claims were referenced to Hull et al (2006), a 3‑month head-to-head trial of Innohep vs vitamin-K antagonist (warfarin/usual care) in cancer patients with acute symptomatic proximal vein thrombosis.
Pfizer argued Innohep’s SPC (Section 4.2) stated dosing “for at least 6 days and until adequate oral anticoagulation is established”, implying transition to oral anticoagulation and not extended LMWH monotherapy; therefore promotion for extended use was outside the marketing authorisation and raised safety concerns (no extended-use guidance in SPC/PIL).
Leo argued there was no upper time limit in the SPC and guidelines supported 3–6 months LMWH in cancer-associated VTE; therefore promotion was within the marketing authorisation.

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Panel (initial): No breach of Clause 3.2 (Panel considered the SPC did not preclude use beyond 6 days and acknowledged therapy might be prolonged beyond ~7 days).
Appeal (by Pfizer): Appeal upheld; breach of Clause 3.2 ruled. The Appeal Board considered promotion for long-term use was not in accordance with the terms of the marketing authorisation and was inconsistent with the particulars in the Innohep SPC.
The Appeal Board also noted concerns about the evidence relied upon: primary 3‑month data showed no statistically significant difference in bleeding complications; at 12‑month follow-up there was a statistically significant difference in recurrent VTE in favour of Innohep (p=0.044). The Board requested Leo be advised of its concerns.

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