The European Commission, in accordance with the opinion from the European Medicines Agency (EMA), has granted orphan medicinal product designation to Sweden-based Medivir AB (Nasdaq Stockholm: MVIR) for its MIV-818 intended for the treatment of patients with hepatocellular carcinoma, it was reported on Friday.

The product is a pro-drug aimed at selectively treating liver cancer cells and decreasing side effects. It is claimed to be the first liver-targeted, orally administered drug for patients with hepatocellular carcinoma.

Companies that receive Orphan Medicinal Product designation are provided with certain regulatory and financial incentives that include protocol assistance, EU centralised authorisation procedure, decreased regulatory fees and a potential for a 10-year market exclusivity in the European Union to produce and market therapies that treat a life-threatening or chronically debilitating condition affecting no more than five in 10,000 persons in the European Union.