Theranexus and Exeltis (Insud Pharma) Announce Licensing Agreement to Commercialize Theranexus Tx01 for Two Rare Neurological Disorders

• Exeltis will be granted an exclusive license to market and distribute Theranexus' novel formulation TX01 for the treatment of two rare neurological diseases notably in Europe.

• Theranexus will be eligible to receive up-front payment, development and commercial milestones and double-digit royalties on net sales.

LYON, FRANCE and MADRID, SPAIN / ACCESSWIRE / December 17, 2024 / Theranexus, a biopharmaceutical company innovating in the treatment of rare neurological diseases, and Exeltis, a global pharmaceutical company and part of the Insud Pharma group, are pleased to announce the execution of a license and supply agreement to commercialize Theranexus' TX01, a novel formulation of a compound already approved in the indication for the treatment of rare neurological diseases.

Under the terms of the agreement, Exeltis will acquire exclusive rights to market and distribute Theranexus' proprietary product across key regions, including the European Union, UK, Latin America, and selected Middle Eastern countries. This collaboration will target both Gaucher and Niemann-Pick type C diseases. The agreement includes a 2 M€ upfront payment to Theranexus and aggregated development and commercial milestone payments. Theranexus will also receive tiered double-digit royalties on Exeltis' net sales, reflecting the anticipated growth and impact of this novel therapeutic approach. Whole or part of the upfront and development milestones already paid at that time may be refunded to Exeltis should Theranexus not provide the documentation to support filing of a market approval application by October 31^st, 2025.

This partnership underscores the complementarity of expertise between Theranexus, with its specialized drug development capabilities, and Exeltis / Insud Pharma group - a global pharmaceutical company with €2.2 bn sales revenues and direct presence in 44 countries worldwide, whose extensive market reach and regulatory experience are instrumental in bringing similar innovative treatments to patients worldwide.

Mathieu Charvériat, Chairman and CEO of Theranexus, commented: "Our agreement with Exeltis marks a significant milestone in the development of Theranexus, a validation of our strategic focus on rare neurological disorders and a confirmation of the value of our assets. Exeltis' global infrastructure and deep market knowledge make them an ideal partner to maximize the impact of our innovative formulation."

Salustiano Perez, CEO of Exeltis, adds: "We are thrilled to join forces with Theranexus and leverage our commercial capabilities to bring this much-needed therapy to patients globally. This partnership aligns with Exeltis' mission to enhance patient care by broadening access to life-changing treatments."

Julien Veys, Chief Business Officer at Theranexus, concludes: "We are delighted to build this alliance with the Exeltis team, addressing the needs of an underserved patient population. With an addressable market exceeding €200 million globally and a formulation tailored for a specific segment of rare disease patients, this partnership reflects our shared commitment to advancing therapeutic innovation and improving patient outcomes.

About Theranexus

Theranexus is an innovative biopharmaceutical company that emerged from the French Alternative Energies and Atomic Energy Commission (CEA). The company has a unique platform for the identification and characterization of advanced therapy drug candidates targeting rare neurological disorders and an initial drug candidate in clinical development for Batten disease. Theranexus is listed on the Euronext Growth market in Paris (FR0013286259- ALTHX).

About Insud Pharma group

Insud Pharma is a pharmaceutical group with more than 45 years of history, presence in around 50 countries, 9,000 employees worldwide and 20 manufacturing facilities. Insud Pharma operates along the entire value chain of the pharmaceutical industry, offering expertise in scientific research, development, manufacturing, sales and marketing of a wide range of active pharmaceutical ingredients (APIs), finished dosage forms (FDFs) and branded pharmaceuticals for human and animal care, as well as biopharmaceuticals. Insud Pharma seeks to improve health worldwide by providing accessible, effective, safe and quality drug treatments through its different business units, with continuous investment in R&D and the latest technology. Through its brand Exeltis, Insud Pharma occupies a leading position in Women Health Care and it's a key player in Central Nervous System therapies.

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Contacts:

THERANEXUS
Christine PLACET
Chief Financial Officer
contact@theranexus.com

FP2COM
Florence PORTEJOIE
Medias Relations
+ 33 (0)6 07 76 82 83
fportejoie@fp2com.fr

SOURCE: Theranexus