Nurexone Biologic Initiates European Orphan Drug Designation Process Following U.S. Grant
TORONTO and HAIFA, Israel, Feb. 02, 2024 (GLOBE NEWSWIRE) — 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.
For more information, please contact:
Dr. Lior Shaltiel
Chief Executive Officer and Director
Email: [email protected]
Thesis Capital Inc.
Investment Relation – Canada
Phone: +1 905-347-5569
Email: [email protected]
Dr. Eva Reuter
Investment Relation – Germany
Email: [email protected]
This press release contains certain “forward-looking statements”, that reflect the Company’s current expectations and projections about its future results and regulatory pathway. Wherever possible, words such as “may”, “will”, “should”, “could”, “expect”, “plan”, “intend”, “anticipate”, “believe”, “estimate”, “predict” or “potential” or the negative or other variations of these words, or similar words or phrases, have been used to identify these forward-looking statements. Forward-looking statements in this press release include, but are not limited to, statements relating to the initiation of the Orphan Drug Designation process with the European Medicines Agency and the possible benefits relating thereto. These statements reflect management’s current beliefs and are based on information currently available to management as at the date hereof.
In developing the forward-looking statements in this press release, we have applied several material assumptions, including the general business and economic conditions of the industries and countries in which we operate, the general market conditions, our ability to meet the Orphan Drug Designation requirements of the European Medicines Agency and our ability to exploit the benefits related thereto.
Forward-looking statements involve significant risk, uncertainties and assumptions. Many factors could cause actual results, performance or achievements to differ materially from the results discussed or implied in the forward-looking statements. These risks and uncertainties include, but are not limited to, risks related to the Company’s early stage of development, lack of revenues to date, government regulation, market acceptance for its products, rapid technological change, dependence on key personnel, protection of the Company’s intellectual property, dependence on the Company’s strategic partners and the risks discussed under the heading “Risk Factors” on pages 29 to 36 of the Company’s Annual Information Form dated March 30, 2023, a copy of which is available under the Company’s SEDAR+ profile at www.sedarplus.ca. These factors should be considered carefully and readers should not place undue reliance on the forward-looking statements. Although the forward-looking statements contained in this press release are based upon what management believes to be reasonable assumptions, the Company cannot assure readers that actual results will be consistent with these forward-looking statements. These forward-looking statements are made as of the date of this press release, and the Company assumes no obligation to update or revise them to reflect new events or circumstances, except as required by law.
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