Genkyotex’s Setanaxib Granted Orphan Drug Designation by the European Commission for the Treatment of PBC

Genkyotex (Paris:GKTX) (Brussels:GKTX) (Euronext Paris & Brussels: FR0013399474 – GKTX), a biopharmaceutical company and leader in NOX therapies, today announced that its lead drug candidate, setanaxib, has been granted orphan drug designation (ODD) by the European Commission for the treatment of primary biliary cholangitis (PBC), following the positive opinion from the Committee for Orphan Medicinal Products (COMP) of the European Medicines Agency (EMA).

Elias Papatheodorou, CEO of Genkyotex, comments: “This European ODD granted to setanaxib is further evidence of the acute need for new treatments in PBC. Given the recent ODD in the same indication by the US FDA, and the ODD in another fibrotic disease – idiopathic pulmonary fibrosis and systemic sclerosis – we now have a set of significant advantages for the next development phases of setanaxib in several fibrotic disorders.”

Orphan Drug Designation is granted to drugs or biological products intended for the safe and effective treatment of rare diseases with an unmet medical need, whose prevalence does not exceed 5 out of 10,000 people in the European Union. ODD in the EU provides companies with certain benefits and incentives, including clinical protocol assistance, reduced EU regulatory filing fees, access to a centralized marketing authorization procedure valid in all EU Member States and ten-year market exclusivity after obtaining marketing approval in the EU. The company is currently discussing its registration strategy for setanaxib in PBC with the FDA and the EMA.

As a reminder, Genkyotex is currently the subject of a friendly takeover bid initiated by Calliditas Therapeutics AB, a Swedish specialty pharmaceutical company focused on identifying, developing and marketing novel treatments in orphan indications with an initial focus on renal and hepatic diseases with significant unmet medical needs.

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