TORONTO, Canada and HAIFA, Israel — NurExone Biologic Inc. (TSXV: NRX) (FSE: J90) (NRX.V), known as “NurExone,” is pleased to announce the initiation of the Orphan Drug Designation process with the European Medicines Agency (EMA) for its groundbreaking ExoPTEN product, currently in development for patients with acute spinal cord injury. This strategic move follows the recent grant of Orphan Drug Designation by the U.S. Food and Drug Administration (FDA) for ExoPTEN.
Dr. Ina Sarel, Head of CMC, Quality, and Regulation at NurExone Biologic, expressed enthusiasm about the development, stating, “Embarking on the European Orphan Drug Designation process marks a crucial milestone in our mission to bring life-changing treatments to patients in need around the world.”
The recent FDA approval of Orphan Drug Designation for ExoPTEN in the United States underscores the potential of Nurexone Biologic’s therapeutic approach in a field where treatment options are limited, and it is expected to yield significant market benefits for the Company. The initiation of the European Orphan Drug Designation process represents a strategic move to broaden the reach of this promising treatment globally.
Orphan Drug Designation is granted to therapies addressing rare diseases, providing incentives to encourage the development of treatments for conditions affecting a small number of patients. Notable benefits of Orphan Drug Designation in Europe include ten years of market exclusivity in the European Union, fee reduction, financial incentives, and extended market protection.
To expedite the application process, the Company has enlisted the expertise of an external consultant to secure European Orphan Drug Designation.
About NurExone Biologic Inc.
NurExone Biologic Inc. is a TSXV listed pharmaceutical company that is developing a platform for biologically-guided exosome-based therapies to be delivered, non-invasively, to patients who have suffered Central Nervous System injuries. The company’s first product, ExoPTEN for acute spinal cord injury, was proven to recover motor function in 75% of laboratory rats when administered intranasally. ExoPTEN has received Orphan Drug Designation from the FDA with first-in-human expected in 2025. The NurExone platform technology is expected to offer novel solutions to drug companies interested in noninvasive targeted drug delivery for other indications.
Contacts
Dr. Lior Shaltiel
Chief Executive Officer and Director
Phone: +972-52-4803034
Email: [email protected]
Thesis Capital Inc.
Investment Relation – Canada
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Dr. Eva Reuter
Investment Relation – Germany
Phone: +49-69-1532-5857
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