EU orphan status for arGentis' ARG201

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.