TORONTO and HAIFA, Israel, Nov. 13, 2024 (GLOBE NEWSWIRE) — NurExone Biologic Inc. (TSXV: NRX) (OTCQB: NRXBF) (Germany: J90) (“NurExone” or the “Company“), a biopharmaceutical company developing exosome-based regenerative therapies, is pleased to announce that the European Medicines Agency (the “EMA”) has granted Orphan Medicinal Product Designation for the Company’s ExoPTEN therapy, marking a significant step towards making this potential treatment available for acute spinal cord injury patients across Europe. This designation supports the development of ExoPTEN and opens a pathway for faster entry into European markets, where the Company expects demand for effective spinal cord injury therapies to be high. Designed to provide nerve regeneration and functional recovery following spinal cord injury, ExoPTEN uses mesenchymal stem cell-derived extracellular vesicles loaded with siRNA targeting PTEN, a key protein in nerve regeneration.
The EMA’s Orphan Medicinal Product Designation offers valuable incentives, including 10 years of market exclusivity upon approval, access grants and incentives from the European Commission and Member States. Additionally, the Company may benefit from free or reduced-cost scientific advice and assistance with clinical trial design, which can streamline the regulatory process and reduce development costs. Moreover, some European Union countries also provide tax credits and other financial incentives to support orphan drug development.