AGCM

Italian Competition Authority: closed proceedings for compliance with the decision on abuse of a dominant position against Leadiant; thanks to the Authority’s action, two group’s companies reduced the price of medicine

Leadiant Biosciences Ltd. and Essetifin S.p.A., part of the Leadiant group, had charged unjustifiably high prices for the sale of Leadiant® chenodeoxycholic acid for the treatment of cerebrotendinous xanthomatosis to the National Health System.

The Italian Competition Authority closes its investigation into Leadiant Biosciences Ltd. and its parent company Essetifin S.p.A., ascertaining compliance with the decision in which it found an abuse of dominant position.

The two companies had charged unfairly high prices to sell the drug Chenodeoxycholic Acid Leadiant®, used to treat a rare disease called cerebrotendinous xanthomatosis, to the National Health Service (NHS). This is an enzymatic defect that causes cholesterol to accumulate in many tissues, including tendons and the central nervous system, leading to neurological, cognitive and systemic dysfunction.

The Authority had found that Leadiant Biosciences and Essetifin, in a dominant position, had taken advantage of the weak bargaining position of the buyer to obtain a price for the orphan drug - EUR [5,000-7,000] per pack - too high since it was disproportionate to the costs incurred and unfair in view of the nature of the product, the investment made in research and development, the risk taken in the registration project and the therapeutic value.

The investigation now concluded has ascertained that the new price of the drug negotiated by the two pharmaceutical companies with AIFA, in force as from 15 March 2024, amounting to approximately EUR [2,000-4,000] per pack, constitutes a significant reduction of the previous price, which, moreover, is substantially in line with the price applied before the abusive conduct.

In this way, the two pharmaceutical companies have complied with the Authority’s request with a significant positive impact, in terms of price reduction, for the NHS.

Rome, 26 June 2024