DuoCort gets EU orphan drug designation

Press Release

Helsingborg, Sweden

DuoCort AB has been granted an Orphan Medicinal Product Designation for its new hydrocortisone dual-release oral tablet for the treatment of adrenal insufficiency. Orphan drug designation gives DuoCort access to regulatory assistance from the European Medicines Agency (EMEA) during the development phase, reduced filing fees, and market exclusivity in the EU for ten years after the product attains marketing authorization.

“Orphan designation is of great value top the company and gives us access to important regulatory assistance which will greatly facilitate the development of this improved therapy for the life-long treatment of patients with chronic adrenal insufficiency,” said Dr. Stanko Skrtic, MD, PhD, Vice President of Regulatory Affairs at DuoCort.

The orphan-designated product is a novel, modified release, oral hydrocortisone tablet for patients with chronic adrenal insufficiency, a rare disease which affects an estimated 125,000 patients in the European Union.

DuoCort is one of four PULS portfolio companies.  PULS AB is a virtual pharmaceutical company which helps innovators to develop their product ideas by providing the necessary skills and capital through each phase of the product’s development and commercialization.

”This is a real milestone for DuoCort and for PULS. It adds substantial value to our company and demonstrates that the PULS model for developing new medicinal products is working,” said Pontus Ottosson, CEO, PULS AB.

DuoCort is a drug development company focussed on improving glucocorticoid therapy in several areas of medical need.  DuoCort was founded in 2003 by PULS.  For more information about DuoCort and its drug development programs, contact:  Greg Batcheller, CEO, DuoCort, tel. +46 73 391 9608.

Partners för Utvecklingsinvesteringar inom Life Sciences P.U.L.S. AB is a virtual pharmaceutical company which supports development and investment in early stage Life Science projects by partnering with research entrepreneurs to develop their ideas into commercial product.  For more information, contact Pontus Ottosson , CEO, tel. +46 42 38 74 18, or This e-mail address is being protected from spambots. You need JavaScript enabled to view it '; document.write( '' ); document.write( addy_text22289 ); document.write( '<\/a>' ); //--> This e-mail address is being protected from spambots. You need JavaScript enabled to view it .