Paris (France), April 29, 2019 – Following information regarding the filing of a generic long-acting lanreotide (Somatuline®) formulation with the FIMEA, the Finnish Medicines Agency, Ipsen believes that it is likely that this filing has taken place under the decentralized procedure. Therefore, an approval in the major European markets would require significant additional time and, given timelines required to obtain country specific marketing authorizations, no global commercial launch in Europe would be expected before 2021.
Somatuline sales in the top 5 European countries (“EU5”) represented approximately 30% of total Somatuline sales and 10% of total Ipsen sales in 2018. Ipsen continues to expect double-digit sales growth from Somatuline and reaffirms its 2019 financial guidance of Group sales growth greater than 13% at constant exchange rate and Core Operating Margin of around 30% of net sales.
