Drugmaker fined by Spanish regulators $10M for 'excessive price' of rare disease drug

15 Nov 2022
endpts.com
Drug ApprovalOrphan Drug
A company that has been under the microscope for drug pricing before has found itself fined by Spanish regulators.
Leadiant Biosciences has been fined €10.3 million ($10.6 million) by the Spanish regulators Comisión Nacional de Los Mercados y la Competencia (CNMC), after a massive price hike of its chenodeoxycholic acid (CDCA) compound, which is used to treat the rare disease cerebrotendinous xanthomatosis (CTX).
According to the CNMC, there are around 200 to 250 patients diagnosed with the disease in Europe, around 50 of whom live in Spain. Leadiant has also been the sole supplier of medicines with CDCA in the country since 2010, first with a drug named Xenbilox and then in 2017 with CDCA-Leadiant.
However, the regulators are claiming that the company had charged Spain’s National Health System 14 times the price of another nearly identical medicine it had marketed in the country in 2010, costing €984 ($1,019) per package in September of 2010 and increasing to €14,618 ($15,146) per package in 2017.
The investigation began with a complaint from the Organization of Consumers and Users for the price increase, with the organization noting that the price of the drug was 1,000 times higher than in 2008.
Italian and Dutch regulators also initiated proceedings against Leadiant over the price shift.
“In order to achieve market exclusivity, Leadiant conducted a series of actions combining lawful behavior—such as obtaining orphan drug designation with the corresponding marketing authorisation—and anti-competitive practices. Among these anti-competitive practices, it maintained an exclusivity clause with the only supplier of the active ingredient authorised to supply CDCA in sufficient quantities and quality. This prevented the emergence of alternative medicines, both industrial and in the form of magistral formulations,” the CNMC’s release stated.
On top of the fine, Leadiant must comply with a series of obligations to eliminate the “excessive control” of the active ingredient in Spain and to market the drug at a price negotiated with the Ministry of Health.
Endpoints News reached out to Leadiant for comment on the matter but did not receive a response by press time.
Another Shkreli-like drug price controversy? Leadiant finds itself in the spotlight after 500-fold price hike — FT
Regulators have had eyes on Leadiant for a while as the company gained control of the drug, won European approval and increased the price from €300 a year to more than €150,000, according to the Financial Times in 2018.
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