ASHBURN, Va. — Quoin Pharmaceuticals Ltd. (NASDAQ: QNRX) (the “Company” or “Quoin”), a late clinical stage, specialty pharmaceutical company focused on rare and orphan diseases, today announces that its lead product candidate QRX003 has been granted Orphan Drug Designation in Europe by the European Medicines Agency (EMA) for the treatment of Peeling Skin Syndrome.
Orphan Drug Designation in Europe affords the Company incentive benefits including scientific advice on study protocols, various fee reductions and access to EU grants. If approved for marketing by the EMA, QRX003 will be granted 10 years of market exclusivity in Europe with respect to similar medicines for the treatment of Peeling Skin Syndrome.
Quoin CEO, Dr. Michael Myers, said, “We continue to make important clinical and regulatory progress for QRX003, both as a potential treatment for Netherton Syndrome and Peeling Skin Syndrome, and this milestone marks yet another significant step forward for Quoin. Cumulatively across both indications, QRX003 has now been granted four Orphan Drug designations by three major regulatory agencies, two Pediatric Rare Disease Designations from the US FDA as well as Fast Track Status for both indications in the US. These eight important regulatory milestones reflect both the innovative nature of the product and the recognition of the unmet medical needs it is targeting. We are on track to initiate the first-ever formal clinical study for Peeling Skin Syndrome, a severe rare skin disease that has long been underserved.”
QRX003 is also currently being evaluated in late-stage clinical trials for Netherton Syndrome, a severe and devastating, life-altering rare disease for which there are currently no approved therapies.
About Quoin Pharmaceuticals Ltd.
Quoin Pharmaceuticals Ltd. is a late clinical-stage specialty pharmaceutical company focused on developing and commercializing therapeutic products that treat rare and orphan diseases. We are committed to addressing unmet medical needs for patients, their families, communities and care teams. Quoin’s innovative pipeline comprises four products in development that collectively have the potential to target a broad number of rare and orphan indications, including Netherton Syndrome, Peeling Skin Syndrome, SAM Syndrome, Palmoplantar Keratoderma, Scleroderma, Epidermolysis Bullosa, Microcystic Lymphatic Malformations, Venous Malformations, Angiofibroma and others. For more information, visit: www.quoinpharma.com or LinkedIn for updates.
For further information, contact:
Quoin Pharmaceuticals Ltd.
Dr. Michael Myers, Ph.D., CEO
[email protected]
Investor Relations
PCG Advisory
Jeff Ramson
[email protected]
(646) 863-6341