Dutch Competition Authority Continues Excessive Pricing Probe of Leadiant
Autoriteit Consument & Markt, the Dutch competition authority (ACM), announced today that it will continue its excessive pricing probe against Leadiant. It says that it hopes to terminate the fact-finding part of its investigation after the summer.
Leadiant has come under intense regulatory, competition and media scrutiny on account of the allegedly excessive prices which it charges for chenodeoxycholic acid Leadiant (“CDCA”), a medicine indicated for the treatment of patients afflicted with cerebrotendinous xanthomatosis, a rare metabolic disorder (“CTX”) (see, Van Bael & Bellis Life Sciences News Alert of 11 February 2019, 9 April 2019, 9 September 2019, 17 September 2019 and 16 October 2019). Leadiant secured orphan medicine status for CDCA in December 2014 after it succeeded in demonstrating the significant benefit of CDCA over existing treatments of CTX. However, the list price of CDCA is much higher than that of an old medicine with the same active substance indicated for the treatment of cholesterol gallstones.
For ACM, keeping in check medicine pricing is an enforcement priority. Further competition inquiries against Leadiant are understood to be pending in at least Belgium and Italy and possibly also Spain. If the Italian authority respects its original timetable, the outcome of its inquiry should be known in the autumn.
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