Calliditas and STADA Arz partner on Nefecon in Europe

Swedish biotech Calliditas Therapeutics (STO: CALTX) and Germany’s STADA Arzneimittel (SAZ: Xetra) have entered into a license agreement to register and commercialize a novel specialty drug candidate for the treatment of the chronic autoimmune kidney disease Immunoglobulin A Nephropathy (IgAN) in the European Economic Area (EEA) member states, Switzerland and the UK.

The partnership relates to a novel oral formulation, developed under the project name Nefecon, of a potent and well-known active substance – budesonide – designed to target down regulation of IgA1 with a view to be disease-modifying. If approved, this value-added specialty medicine, which received an EU orphan-drug designation in 2016, would be the first treatment authorized in the European Union for IgAN, a rare autoimmune disease. IgAN, also known as Berger’s disease, is a serious progressive autoimmune disease in which up to 50% of patients end up at risk of developing end-stage renal disease and thus requiring dialysis or a kidney transplant. Prevalence in Europe is estimated at 4 in 10,000, translating into approximately 200,000 patients.

Financial terms of the collaboration