Tennessee, USA-based arGentis Pharmaceuticals says that the European Medicines Agency (EMEA) has accepted its product candidate ARG201 (native type 1 bovine collagen) for the treatment of diffuse systemic sclerosis, also known as systemic scleroderma (SSc) for designation as an orphan medicinal product in the European Union.
"With this designation our subsidiary arGentis Autoimmune Europe gains access to incentives including 10 years marketing exclusivity throughout Europe for the therapeutic indication for which it was granted, facilitated access to the centralized procedure for the application for marketing approval, reduced fees associated with applying for marketing approval and protocol assistance, and access to EU research funding grants," stated Ted Townsend, vice president, business development of arGentis.
ARG201, pioneered by Arnold Postlethwaite, director of the Division of Connected Tissue Disease at the University of Tennessee Health Science Center, and Andrew Kang, professor of medicine in rheumatology at the University's Health Science Center, is an immunotherapy that induces low-dose oral immune tolerance in SSc patients causing down-regulation of the body's autoimmune response. It has completed a Phase II clinical trial.
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