Hyloris Announces Commercial Partnership for Maxigesic IV in 9 European Countries

Hyloris Pharmaceuticals SA recently announced its partner AFT Pharmaceuticals has signed an exclusive licensing and distribution agreement with Salus Pharmaceuticals for Maxigesic IV, a novel, dual mode-of-action non-opioid pain treatment delivered through intravenous (IV) infusion, in nine European markets.

Under the terms of the development collaboration agreement between Hyloris and AFT, Hyloris is eligible to receive a share on any product-related revenues, such as license fees, royalties, milestone payments, received by AFT.

The agreement with Salus Pharmaceuticals encompasses the following European territories: Lithuania, Estonia, Latvia, Croatia, Slovenia, Serbia, North Macedonia, Montenegro, and Bosnia.

Maxigesic IV is already registered in Lithuania, Estonia, Latvia, Croatia and Slovenia, where the first commercial launches are expected later this year. Registration applications will be filed in the remaining countries (Serbia, North Macedonia, Montenegro, Bosnia).

This past November, Maxigesic IV was launched in France and Italy, together with Ever Pharma GmbH.

Stijn Van Rompay, Chief Executive Officer of Hyloris, said “We are pleased with Maxigesic IV’s further roll-out. This novel non-opioid pain treatment can soon offer relief to patients in even more countries across Europe, and underlines the attractiveness of our business model of reformulating and repurposing existing medicinal products, including its ability to provide significant benefits to patients and health care providers.”

Maxigesic IV is a novel, dual mode-of-action, non-opioid pain treatment for use post-operatively in hospitals or when patients cannot take medicine orally. It is a unique combination of 1000-mg paracetamol with 300-mg ibuprofen solution for infusion, thereby reducing both pain and inflammation.

Results from a randomized, placebo-controlled Phase 3 trial demonstrated that Maxigesic IV was well-tolerated and had a faster onset of action, offered higher pain relief, and provided the potential to reduce the use of opioids compared to ibuprofen IV or paracetamol IV alone in the same doses. Further exposure studies have demonstrated the drug’s efficacy and safety in an expanded population group over a longer treatment period. Maxigesic IV is protected by several granted and pending patent applications.

Hyloris is a specialty biopharma company focused on innovating, reinventing, and optimizing existing medications to address important healthcare needs and deliver relevant improvements for patients, healthcare professionals and payors. Hyloris has built a broad, patented portfolio of 16 reformulated and repurposed value-added medicines that have the potential to offer significant advantages over available alternatives. Outside of its core strategic focus, the company also has three high barrier generic products in development and registration phase. Two products are currently in initial phases of commercialization with partners: Sotalol IV for the treatment of atrial fibrillation, and Maxigesic IV, a non-opioid post-operative pain treatment. The company’s development strategy primarily focuses on the FDA’s 505(b)2 regulatory pathway, which is specifically designed for pharmaceuticals for which safety and efficacy of the molecule have already been established. This pathway can reduce the clinical burden required to bring a product to market, and significantly shorten the development timelines and reduce costs and risks. Hyloris is based in Liège, Belgium. For more information, visit https://hyloris.com/.