Theranexus and Exeltis Announce Licensing Deal for Tx01 in Rare Neurological Disorders

Theranexus, a leading biopharmaceutical company specializing in treatments for rare neurological disorders, has partnered with Exeltis, a global pharmaceutical firm and part of Insud Pharma, in a landmark agreement to commercialize its innovative formulation, TX01. This partnership specifically targets the treatment of Gaucher and Niemann-Pick type C diseases across several regions, including Europe, the UK, Latin America, and select Middle Eastern countries.

Under the terms of the agreement, Exeltis has secured exclusive rights to market and distribute TX01, a novel formulation of an already approved compound for treating rare neurological diseases. In return, Theranexus will receive a 2 million euro upfront payment along with additional payments tied to developmental and commercial milestones. Furthermore, Theranexus will earn tiered double-digit royalties on the net sales achieved by Exeltis, highlighting the potential growth and impact of this new therapeutic approach. However, if Theranexus fails to provide necessary documentation for market approval application by October 31, 2025, portions of the upfront and milestone payments may be refunded to Exeltis.

This strategic collaboration is a significant step for both companies. Exeltis, with its extensive market reach and regulatory expertise, is well-positioned to introduce innovative treatments to a global patient base. The partnership leverages Exeltis' existing infrastructure, which includes direct operations in 44 countries and annual sales revenues of 2.2 billion euros. Both parties are committed to improving patient access to life-changing therapies through their combined expertise.

Mathieu Charvériat, Chairman and CEO of Theranexus, expressed his enthusiasm about the partnership, stating that it marks a crucial stage in the company's growth and validates their focus on addressing rare neurological disorders. He acknowledged Exeltis' deep market understanding and global presence as key factors in maximizing the impact of Theranexus' advanced therapeutic formulation.

Salustiano Perez, CEO of Exeltis, echoed these sentiments, emphasizing the alignment of this collaboration with Exeltis' mission to enhance patient care. He highlighted the opportunity to leverage Exeltis' commercial capabilities to expand access to the much-needed TX01 therapy on a global scale.

Julien Veys, Chief Business Officer at Theranexus, added that this alliance with Exeltis addresses a critical need within an underserved patient population. He noted that the addressable market for the formulation exceeds 200 million euros globally, underscoring the significance of this partnership in advancing therapeutic innovation and improving patient outcomes.

Theranexus, originating from the French Alternative Energies and Atomic Energy Commission, stands out with its unique platform for developing advanced therapies for rare neurological disorders. The company is currently advancing its initial drug candidate for Batten disease in clinical development and is listed on the Euronext Growth market in Paris.

Meanwhile, Insud Pharma, the parent group of Exeltis, has a rich history spanning over 45 years and operates in nearly 50 countries with 9,000 employees. The group is involved in every aspect of the pharmaceutical industry, from research and development to manufacturing and sales. Through continuous investment in research and innovation, Insud Pharma is dedicated to improving health worldwide by providing effective, safe, and quality treatments.