Sanofi breached an undertaking by leaving Lyxumia “cost-effective/value” press release live (AUTH/2619/7/13)

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Key facts

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Case number	AUTH/2619/7/13
Parties	Novo Nordisk v Sanofi
Issue	Breach of undertaking relating to Lyxumia (lixisenatide) press release on Sanofi website
Key claims cited	“Lyxumia is a new, cost-effective option”; “The price is one that represents real value to both the NHS and Sanofi”; headline included “could save the NHS millions offering value and choice”
Applicable Code year	2012
Complaint received	22 July 2013
Case completed	10 September 2013
Breach clauses	2, 9.1 and 25
Sanctions	Undertaking received; Additional sanctions: Not stated
Appeal	No appeal

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

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Novo Nordisk complained that a Lyxumia (lixisenatide) press release on Sanofi’s website breached an undertaking Sanofi had given in an earlier case (AUTH/2604/5/13).
The press release headline stated Lyxumia could “save the NHS millions offering value and choice” and included statements such as “Lyxumia is a new, cost-effective option” and “The price is one that represents real value to both the NHS and Sanofi”.
The earlier case (AUTH/2604/5/13) involved cost-saving/minimisation claims in an advertisement; Sanofi had committed to amend claims that could imply savings beyond acquisition cost.
Sanofi argued the undertaking applied to the advertisement and “similar” promotional material, and that a press release was inherently different and had been approved as a press release (not promotional material).
The Panel found the undertaking was not limited to promotional material and covered all similar materials, including press releases.
The Panel considered the press release claims did not make clear they were based solely on acquisition cost; “cost-effective” implied indirect costs and efficacy had been considered.
Sanofi removed the press release from its website after receiving the complaint, but the Panel was concerned it had remained accessible and that Sanofi had not revalidated withdrawal decisions when giving the undertaking.

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Breach ruled for failure to comply with the undertaking: the press release claims were sufficiently similar to those covered by the earlier undertaking.
High standards not maintained.
Conduct brought discredit upon, and reduced confidence in, the pharmaceutical industry.
No appeal.

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