Hyloris Announces Partnerships for Valacyclovir Oral Suspension Covering Canada, Australia, New Zealand and the Netherlands
- Exclusive Commercialisation Agreement for Canada, Australia and New Zealand Signed with AFT Pharmaceuticals
- Exclusive Commercialisation Agreement for the Netherlands Signed with QliniQ
Liège, Belgium – May 13 2025 – 07.00 AM CET –– Regulated Information – Inside information – Hyloris Pharmaceuticals SA (Euronext Brussels: HYL), a specialty biopharma company committed to addressing unmet medical needs through reinventing and optimizing existing medications, today announces the signing of exclusive commercialisation agreements for its proprietary Valacyclovir oral suspension with AFT Pharmaceuticals and QliniQ. The agreement with AFT Pharmaceuticals covers Canada, Australia, and New Zealand, while QliniQ has secured rights for the Netherlands.
Hyloris has already submitted a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA), supported by positive results from two pivotal clinical studies [1]. In addition, a third pivotal study supports the upcoming regulatory submissions in selected European countries. Based on the available data, Hyloris does not expect additional clinical studies are required for approval in the newly partnered territories. Regulatory filings in these countries are planned for 2025.
Thomas Jacobsen and Stijn van Rompay co-Chief Executive Officers of Hyloris commented: “We are thrilled to finalize these agreements, as they align perfectly with our long-term strategy. Canada, Australia and the Netherlands represent attractive markets for Valacyclovir. In particular, Canada is one of the largest consumers of Valacyclovir globally, making it a high priority for us outside the U.S.”
Under the agreements, Hyloris will support the registration efforts, while AFT and QliniQ will be responsible for commercialization in the respective territories. Hyloris will receive up to 50% of the gross margin, after deduction of specified expenses. The agreements do not include any milestone payments.
[1] Comparing the relative bioavailability of Hyloris’ proprietary Valacyclovir Oral Suspension to an extemporaneously prepared oral suspension and the conventional tablet formulation