Statement on lanreotide European decentralised procedure

PARIS, FRANCE, 8 March 2021 – Ipsen has learned that Amdipharm Ltd, which is believed to be a subsidiary of Advanz Pharma, has received a positive outcome by the Reference Member State, Denmark, and closure of the Decentralised Procedure, for a generic formulation of lanreotide in 60mg, 90mg and 120mg dose presentations. This represents a step towards the first national regulatory approval of a lanreotide generic in Europe. Given timelines required to obtain country-specific marketing authorization approvals and reimbursement, this is consistent with Ipsen’s 2021 guidance which assumes the phased launch of a lanreotide generic in Europe by mid-2021. Therefore, there is no change to company guidance nor to Ipsen’s mid-term financial outlook to 2024.

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