London, 3 February 2025 – Colonis Pharma (part of the Clinigen group of companies), and a leader in developing and commercialising value added medicines, has announced the first and exclusive licence and distribution agreement with Hyloris Pharmaceuticals for XTRAZA™ (tranexamic acid), a proprietary oral rinse designed for use in dental procedures.
XTRAZA is a proprietary oral rinse designed to deliver tranexamic acid (an antifibrinolytic agent) to patients on anticoagulant therapies (blood thinners) undergoing dental procedures with bleeding risks, such as tooth extractions. Tranexamic acid has a long history of use in other dosage forms to reduce or prevent postoperative bleeding. XTRAZA represents a novel application in a localised format for optimal coagulation during or after dental interventions.
Under the terms of the agreement Hyloris will receive milestone payments, primarily tied to regulatory achievements, and will exclusively supply XTRAZA in the U.K. to Colonis.
Andrew Trouton, Managing Director of Colonis Pharma, commented:
“At Colonis, we are committed to driving innovation in healthcare through strategic partnerships. This collaboration with Hyloris Pharmaceuticals enables us to commercialise a value-added medicine in the UK, addressing significant unmet needs of patients and healthcare professionals.”
The agreement grants Colonis exclusive rights to commercialise XTRAZA in the UK, a market where tooth extractions are among the most common dental procedures. The collaboration aligns with Colonis’ mission to enhance patient access to vital treatments and address critical gaps in care.
Stijn Van Rompay, Co-Chief Executive Officer of Hyloris, added:
“We’re pleased to finalise this agreement for XTRAZA with Colonis Pharma. Our aim is to bring added value to healthcare systems through reformulation and repurposing. Through this agreement with Colonis Pharma in the UK, we aim to continue our corporate goal of improving the outcomes and lives of patients within the UK.”
For media enquiries, please contact:
Email: clinigen@fightorflight.com
About Colonis Pharma
Colonis Pharma, part of the Clinigen group of companies, is a UK based company focused on repurposing and developing value-added medicines, addressing unmet needs across several therapeutic areas.
For more information, visit www.colonis.co.uk
About Clinigen
Clinigen is a global, specialist pharmaceutical services company focused on providing ethical access to medicines. Its mission is to accelerate access to medicines for patients in every corner of the globe. The Group supports pharmaceutical and biotech companies across the medical product lifecycle, from clinical through to commercial and operates from sites in North America, Europe, Africa, and the Asia Pacific. Clinigen has more than 1,100 employees across five continents in 15 countries and provides access in more than 130 countries every year.
For more information on Clinigen, please visit http://www.clinigen.com.
About Hyloris
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.
The Company’s 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 burden required for market entry, and significantly shorten the development timelines, leading to reduced costs and risks.
Hyloris has built a broad, patented portfolio of 19 reformulated and repurposed value-added medicines that have the potential to offer significant advantages over existing alternatives. Two products are currently in early phases of commercialization in collaboration with commercial partners. In addition to its core strategic focus, the Company has 1 approved high barrier generic product launched in the U.S. and 2 high barrier generic products in development.
Hyloris is based in Liège, Belgium. For more information, visit www.hyloris.com
February 2025
GB-CPL-0-230
