Posted: 19 April 2023
Neuren Pharmaceuticals reported that its North America partner Acadia Pharmaceuticals (NASDAQ: ACAD) has announced that DAYBUE™ (trofinetide) is now available for the treatment of Rett syndrome in adult and pediatric patients two years of age and older in the United States. DAYBUE was approved by the US Food and Drug Administration (FDA) on 10 March 2023 and is the first and only drug approved by the FDA for the treatment of Rett syndrome. The announcement by Acadia can be found here.
Neuren and Acadia have an exclusive license agreement for Acadia to develop and commercialise trofinetide for the treatment of Rett syndrome and other indications in North America. US$40 million is payable to Neuren following the first commercial sale of trofinetide in the United States. Neuren is eligible to receive ongoing royalties on net sales of trofinetide in North America, plus milestone payments of up to US$350 million on achievement of a series of four thresholds of total annual net sales, plus one third of the market value of the Rare Pediatric Disease Priority Review Voucher that was awarded to Acadia by the FDA upon approval of the NDA, with the one third share estimated by Neuren as US$33 million. No royalties or similar costs are payable by Neuren to third parties, which means that Neuren’s revenue from Acadia will flow through to pre-tax profit.
