Specialty biopharma company Hyloris Pharmaceuticals SA (Euronext Brussels:HYL) announced on Tuesday that it has signed exclusive commercialisation agreements for its Valacyclovir oral suspension with New Zealand-based AFT Pharmaceuticals (NZE:AFT) and Dutch company QliniQ.

AFT Pharmaceuticals will cover Canada, Australia and New Zealand, while QliniQ will manage distribution in the Netherlands.

The agreements follow the submission of a New Drug Application to the US Food and Drug Administration (FDA), supported by two pivotal clinical studies. A third pivotal study underpins regulatory submissions planned for selected European countries.

Hyloris does not anticipate the need for additional clinical trials in the newly partnered regions. Regulatory filings in these markets are expected in 2025.

Canada, identified as one of the largest global consumers of Valacyclovir, is a strategic priority for Hyloris outside the United States.

Under the terms of the agreements AFT Pharmaceuticals and QliniQ will lead commercialisation efforts, while Hyloris supports regulatory submissions. Hyloris will receive up to 50% of the gross margin after specified expenses, with no milestone payments included.