Novartis v Bristol-Myers Squibb: Sprycel leavepiece ‘Selectivity’ page found misleading due to unclear in vitro basis (Clause 7.2)

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Key facts

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Case number	AUTH/2016/7/07
Complainant	Novartis Pharmaceuticals UK Ltd
Respondent	Bristol-Myers Squibb Pharmaceuticals Limited
Product	Sprycel (dasatinib)
Material	Leavepiece (ref DAS/1106/0146/1008), “Selectivity” page
Therapy area	Oncology / Haematology (CML)
Key issue	Mechanism-of-action/in vitro claims presented without clear clinical relevance; misleading impression
Applicable Code year	2006
Complaint received	06 July 2007
Case completed	28 August 2007
Appeal	No appeal
Breach clauses	Clause 7.2 (x 2)
Sanctions	Undertaking received

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

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Novartis complained about a Bristol-Myers Squibb (BMS) leavepiece for Sprycel (dasatinib) for chronic myeloid leukaemia (CML) in patients resistant or intolerant to prior therapy including imatinib.
The leavepiece unfolded into multiple pages; the complaint focused on the final page headed “Selectivity”, which sat alongside pages headed “Strength” and “Sustainability”.
Under “Selectivity”, the leavepiece included bullet claims including: targeting other oncogenic pathways (c-KIT, ephrin receptor kinases, PDGF ß receptor); “first and only” binding to active and inactive BCR-ABL conformations; “325 fold more potent than imatinib” in vitro; and activity against all BCR-ABL mutations tested except T315I.
Novartis alleged the layout and wording implied clinical benefits from mechanistic/in vitro statements without supporting clinical data, and alleged a “hanging comparison” and potential promotion outside the marketing authorisation.
BMS stated the bullets described pharmacology/mechanism-of-action “possibilities” relevant to imatinib-resistant CML and that the leavepiece was intended to be left after a representative discussion; BMS also noted it voluntarily withdrew the leavepiece in April 2007.

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No breach: The Panel ruled “Sprycel has a different mechanism of action” was not a hanging comparison and would obviously be read as a comparison with imatinib in context (no breach of Clause 7.2 on that point).
No breach: The Panel ruled the “other oncogenic pathways” claim (c-KIT, ephrin receptor kinases, PDGF ß receptor) did not imply clinical activity outside CML and did not promote beyond the SPC in the context of a CML leavepiece (no breach of Clause 3.2).
Breach: The claims “Sprycel is the first and only therapy to bind to both active and inactive conformations of BCR-ABL” and “Sprycel is active against all BCR-ABL mutations tested, except T315I” were ruled misleading (breach of Clause 7.2).
Breach: The claim “Sprycel is 325 fold more potent than imatinib in BCR-ABL inhibition assays in vitro” was ruled misleading because the clinical relevance was not sufficiently clear (breach of Clause 7.2).

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