Hyloris Pharmaceuticals Information

Hyloris is a specialty pharma group focused on reinventing and optimizing existing medications through reformulation, repurposing and some smart NCEs developments to address important healthcare needs and deliver meaningful improvements for patients, healthcare professionals, and payors. Our development strategy primarily focuses on leveraging established regulatory pathways, such as the FDA’s 505(b)(2) pathway in the U.S., or equivalent regulatory frameworks in other regions, which are specifically designed for pharmaceuticals for which safety and efficacy of the molecule have already been established. This approach can reduce the clinical and regulatory burden required for market entry, and significantly shorten development timelines, leading to reduced costs and risks. We announced a broad development portfolio of 28 products, including 25 value-added medicines of which two are currently in early stages of commercialization in collaboration with commercial partners: Sotalol IV for the treatment of atrial fibrillation, and Maxigesic® IV, a non-opioid post-operative pain treatment. In addition to its core strategic focus, the Company has two high-barrier generic products approved in the U.S. and one additional high-barrier generic product in development. Beyond its announced portfolio, Hyloris has initiated several additional internal early-stage development activities, bringing the total pipeline to more than 30 products and product candidates, and continues to evaluate further product opportunities to support future growth. Where others stop, Hyloris starts and adds value through Reinventing Existing Medicines for unmet patient needs worldwide. Hyloris is based in Liège, Belgium and since 2020 listed on Euronext Brussels (EBR: HYL).