The Italian Competition Authority continues its investigation of an orphan drug manufacturer for excessive pricing (Leadiant)

In October 2019, the Italian Competition Authority (hereinafter the “ICA” or the “Authority”) launched an investigation into abuse of dominance pursuant to Article 102 TFEU against Leadiant Biosciences Ltd (formerly Sigma Tau Rare Disease Ltd) and other companies in the Leadiant group (“Leadiant”) in connection with the marketing in Italy of the “orphan” drug Chenodeoxycholic Acid Leadiant (“Leadiant CDCA”), used to treat an ultra-rare disease, Cerebrotendinous Xanthomatosis (or “CTX”). Cross-border and regulatory context of the investigation In 2018, the national competition authorities of the Netherlands, Belgium, and Spain received reports complaining about Leadiant’s excessive price increase for CDCA (in the Dutch case, reportedly a 500-fold increase in price). In July 2019, the ICA received

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Authors

  • Portolano Cavallo (Milan)
  • Portolano Cavallo (Milan)

Quotation

Irene Picciano, Enzo Marasà, The Italian Competition Authority continues its investigation of an orphan drug manufacturer for excessive pricing (Leadiant), 2 November 2020, e-Competitions November 2020, Art. N° 101210

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