UK company Diurnal has received orphan product designation from the European Commission for a novel treatment that uses a drug delivery technology to match the body’s circadian rhythms.

Orphan status is granted to products with a limited patient population and is designed to encourage R&D into treatments for rare diseases. It affords 10 years market exclusivity after the grant of a marketing authorisation in Europe. Other benefits include protocol assistance, access to the centralised procedure for the application for marketing authorisation and fee reductions.

The designation is for a modified release hydrocortisone tablet for the treatment of congenital adrenal hyperplasia, a genetic defect of the adrenal glands. The product is being developed by Phoqus Pharmaceuticals, a drug delivery company also based in the UK. Phoqus recently licensed a Diurnal patent that relates to delayed and sustained release therapy, and will apply its proprietary Qtrol technology to the new product.

 

The full article (press release, actually) is at http://www.in-pharmatechnologist.com/news/news-ng.asp?n=61500-drug-treatment-mimics