Neuren Pharmaceuticals (ASX: NEU) has agreed to significantly expand its partnership with Acadia Pharmaceuticals for trofinetide.
Acadia’s exclusive licence for trofinetide (marketed in the US as DAYBUE) in North America has been expanded to a worldwide exclusive licence.
The existing milestone payments and royalties to Neuren for trofinetide in North America are unchanged, with additional payments related to development and commercialisation outside North America.
Neuren will receive US$100 million up-front, plus additional potential milestone payments of up to US$427 million and royalties on net sales of trofinetide outside North America.
Acadia today provided very encouraging early insights into the US launch of DAYBUE, expecting net sales of $21 to 23 million in Q2 2023 and $45 to 55 million in Q3 2023.
Neuren has also granted to Acadia an exclusive worldwide licence to develop and commercialise NNZ- 2591 for Rett syndrome and Fragile X syndrome only. This enables coordinated global development, replacing the restrictions in the existing agreement on use by Neuren in those two indications. Potential milestone payments and royalties payable to Neuren for NNZ-2591 in Rett and Fragile X are identical to the trofinetide milestone payments and royalties in each of North America and other regions.
Neuren retains worldwide rights to NNZ-2591 in all other indications and is currently conducting Phase 2 clinical trials in each of Phelan-McDermid, Pitt Hopkins, Angelman and Prader-Willi syndromes, with first top-line results expected in December 2023.
We are very pleased to be able to expand our highly successful partnership with Acadia,” Neuren CEO Jon Pilcher said.
“The unique knowledge and expertise that the Acadia team has built from the successful development and commercialisation of DAYBUE in the United States, as well as the established supply chain, places them in the ideal position to achieve the optimum outcome globally for all stakeholders.
“We have also enhanced the position for NNZ-2591, adding the exciting potential to further increase its value through Acadia in Rett and Fragile X. We very much look forward to continuing to collaborate with Acadia as we all strive to make a difference in neurodevelopmental disorders, which have such urgent unmet need.”
Acadia is responsible for all costs of development and commercialisation globally for trofinetide in all indications and for NNZ-2591 in Rett and Fragile X only.