MeiraGTx Announces its Wholly-Owned Gene Therapy Manufacturing Facility in Shannon, Ireland has Received Commercial MIA Authorization for QC Testing

LONDON and NEW YORK, July 19, 2023 (GLOBE NEWSWIRE) -- MeiraGTx Holdings plc (Nasdaq: MGTX), a vertically integrated, clinical stage gene therapy company, today announced that after a successful inspection by the Irish Health Products Regulatory Authority (HPRA), it has received a Commercial Manufacturer’s/Importer’s Authorization (MIA) for its Quality Control (QC) testing facility at its GMP manufacturing site in Shannon, Ireland.

“Receiving our first commercial license for our state-of-the-art manufacturing facility in Shannon so rapidly is another testament to the quality of the MeiraGTx team and our industry leading end-to-end capabilities,” said Alexandria Forbes, Ph.D., president and chief executive officer of MeiraGTx. “This certification not only enables us to accelerate the development and delivery of our own pipeline of gene therapies for a range of serious conditions, but it also provides potential for MeiraGTx to generate additional revenue as the industry faces increasing delays and shortages of licensed, reliable QC testing for advanced therapies globally.”

Unique in its scale and integrated capabilities and stretching over 150,000 square feet, the GMP Shannon facility is Ireland’s first commercial-scale gene therapy manufacturing site and contains three facilities. The first facility was built to be a flexible and scalable center for viral vector production for clinical and commercial supply. The second facility was built to manufacture plasmid DNA – the critical starting material for producing gene therapy products. The third facility serves as a QC hub performing advanced biochemical quality control testing for release and stability testing for MeiraGTx and its partners' clinical and commercial programs.

About MeiraGTx
MeiraGTx (Nasdaq: MGTX) is a vertically integrated, clinical-stage gene therapy company with six programs in clinical development and a broad pipeline of preclinical and research programs. MeiraGTx has core capabilities in viral vector design and optimization and in-house gene therapy GMP manufacturing facilities in London, United Kingdom and Shannon, Ireland, and a transformative gene regulation platform technology that allows precise, dose responsive control of gene expression by oral small molecules with dynamic range that can exceed 5000-fold. Led by an experienced management team, MeiraGTx has taken a portfolio approach by licensing, acquiring and developing technologies that give depth across both product candidates and indications. MeiraGTx’s initial focus is on three distinct areas of unmet medical need: ocular diseases, including both inherited retinal diseases as well as large degenerative ocular diseases, neurodegenerative diseases and severe forms of xerostomia. Though initially focusing on the eye, central nervous system and salivary gland, MeiraGTx plans to expand its focus to develop additional gene therapy treatments for patients suffering from a range of serious diseases.