EMA recommends orphan drug designation for 4SC's resminostat to treat HCC

4SC AG (Frankfurt, Prime Standard: VSC), a discovery and development company of targeted small molecule drugs for autoimmune diseases and cancer, today announced that the European Medicines Agency (EMA) has recommended resminostat for designation as orphan medicinal product for the treatment of hepatocellular carcinoma (HCC), the most common form of liver cancer. The EMA's positive opinion has been forwarded to the EU commission for final approval and publication in the community register. This follows the recent orphan drug designation granted by the U.S. Food and Drug Administration for the same programme.

'Recommendation for orphan medicinal product designation in the EU is another important step in the development of resminostat, our most advanced oncology compound, as a potential targeted treatment for HCC,' commented Ulrich Dauer, Chief Executive Officer of 4SC AG. 'Both orphan drug designations from the EMA as well as from the FDA emphasise the importance of developing novel therapies in this indication in order to provide effective treatment options to patients suffering from this life-threatening disease. We are looking forward to working with both authorities closely as this programme progresses.'

The EMA's orphan medicinal product designation includes a ten-year period of market exclusivity from the date of approval for drugs and biologics that address rare diseases that affect no more than five in 10,000 people in the European Union. The designation also allows direct access to centralized marketing authorization, fee reductions and protocol assistance.