Spanish competition watchdog fines drugmaker Leadiant 10.3 mln euros

The regulator, known as CNMC, said the pharmaceutical company had abused its dominant position as holder of the only medicine available in Spain against the rare genetic disease Cerebrotendinous Xanthomatosis (CTX). According to CNMC, Leadiant secured exclusive supply in Spain of the active ingredient on which the drug is based, a bile acid called CDCA, thus preventing competitors from manufacturing alternative products.

Spain's competition watchdog has fined Italy-based drugmaker Leadiant Biosciences 10.3 million euros ($10.63 million) for selling an orphan drug at an excessive price, it said on Monday. The regulator, known as CNMC, said the pharmaceutical company had abused its dominant position as holder of the only medicine available in Spain against the rare genetic disease Cerebrotendinous Xanthomatosis (CTX).

According to CNMC, Leadiant secured exclusive supply in Spain of the active ingredient on which the drug is based, a bile acid called CDCA, thus preventing competitors from manufacturing alternative products. In 2017, the company started charging the national health system 14 times the price of an "essentially identical" CDCA-based treatment it had previously sold in Spain, the watchdog added.

CNMC has ordered the drugmaker to sell the medication in Spain at a new price negotiated with the Health Ministry. Leadiant must also lift the exclusivity clause signed with the active ingredient's sole supplier. Leadiant did not immediately respond to a request for comment.

According to the regulator, there are fewer than 50 patients in Spain suffering from CTX. This genetic condition leads to deposits of cholesterol building up in nerve cells and membranes, which can damage the nervous system. ($1 = 0.9694 euros)