FDA submission triggers milestone payment for Neuren Pharmaceuticals

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Neuren Pharmaceuticals (ASX:NEU) has received the milestone payment of US$10 million from its US partner Acadia Pharmaceuticals.

The payment was due following the US FDA acceptance for review of Acadia’s New Drug Application (NDA) of trofinetide for the treatment of Rett syndrome.

The FDA granted a Priority Review and assigned a Prescription Drug User Fee Act (PDUFA) action date of 12 March 2023.

Acadia has exclusive rights to develop and commercialise trofinetide in North America. Neuren retains all rights to trofinetide for all countries outside North America and has a fully paid-up, irrevocable licence for use in those countries to all data generated by Acadia. The development and commercialisation of trofinetide in North America is fully funded by Acadia.

Neuren said that if the NDA is approved by the FDA, the next potential milestone payment would be US$40 million (A$62 million at an assumed exchange rate of 0.65), payable following the first commercial sale of trofinetide in the US.

Neuren is also eligible to receive double-digit percentage royalties on net sales of trofinetide in North America, plus milestone payments of up to US$350 million (A$538 million) on achievement of a series of four thresholds of total annual net sales, plus one-third of the market value of a Rare Pediatric Disease Priority Review Voucher if awarded by the FDA upon approval of the NDA, with the one-third share estimated by Neuren as US$33 million (A$51 million).