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Neuren Pharmaceuticals and Acadia Partner to Expand Global License for Trofinetide (DAYBUE™) Neuren Pharmaceuticals Limited

Neuren Pharmaceuticals and Acadia Partner to Expand Global License for Trofinetide (DAYBUE™)

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Neuren Pharmaceuticals (ASX: NEU) has announced the expansion of its partnership with Acadia Pharmaceuticals (NASDAQ: ACAD) for trofinetide, marketed in the US by Acadia as DAYBUE™. An exclusive license previously granted to Acadia for trofinetide in North America has been expanded to a worldwide exclusive license, with Neuren set to receive an upfront payment of US$100 million, and additional potential milestone payments of up to US$427 million and royalties on net sales of trofinetide outside North America.

Under the expanded partnership, academics' unique expertise from the successful development and commercialisation of trofinetide in the US will facilitate the drug's worldwide development and remove existing limitations for Neuren's NNZ-2591 usage in Rett and Fragile X syndromes. In these two indications, Neuren has granted Acadia an exclusive worldwide license to develop and commercialise NNZ-2591.

Meanwhile, Neuren retains worldwide rights to NNZ-2591 in all other indications and is advancing Phase 2 trials in Phelan-McDermid, Pitt Hopkins, Angelman, and Prader-Willi syndromes, with the first results expected in December 2023.

Acadia has also provided an update on the US launch of DAYBUE, forecasting net sales of $21-23 million in Q2 2023 and $45-55 million in Q3 2023.

Assuming the success of the partnership, Neuren anticipates receiving further payments related to the development and commercialisation outside North America.

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The milestone payments and royalties to Neuren for trofinetide in North America remain unchanged. Potential milestone payments and royalties for NNZ-2591 in Rett and Fragile X syndromes will mirror those for trofinetide in each of North America and other regions.

Neuren will host a web conference at 9:30 am AEST today to provide further updates on the partnership.

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