Neuren's Rett syndrome treatment approved in Canada
Make us a preferred source
Make us a preferred source on Google
The news: Neuren Pharmaceuticals’ Rett syndrome treatment, trofinetide, has received market authorisation in Canada, boosting the potential for royalties and sales milestone payments across North America.
The numbers: Neuren’s US partner, Nasdaq-listed Acadia Pharmaceuticals, has received Health Canada approval for trofinetide to treat Rett syndrome in adult and paediatric patients aged two years and older. The prevalence of Rett syndrome in Canada is estimated at 600 to 900 patients.
Under Neuren's existing agreement with Acadia for the North America region, potential sales in Canada will be added to US sales for calculation of Neuren's royalties and sales milestone payments.
Neuren's royalties range from 10% to 15% of annual net sales of the treatment, with sales milestone payments of between USD50 million ($75 million) and USD150 million, depending on net sales in one calendar year.
The context: Trofinetide, sold under the brand name Daybue, is the first and only drug approved in Canada for treating Rett syndrome — a rare genetic neurodevelopmental disorder that affects brain development.
Shares in Melbourne-based Neuren climbed on the ASX in April after Canada's health department accepted Acadia's new drug submission for trofinetide.
What they said: "We are excited to see this first approval outside the United States, which is a significant milestone in the ongoing program to expand access to Daybue," said Neuren CEO Jon Pilcher.
The source: ASX announcement
