EMEA grants orphan drug status for Curacyte’s leukemia treatment

The European Medicines Agency’s (EMEA) orphan medicinal product designation is designed to encourage sponsors in developing drugs, which may provide significant benefit to patients suffering from rare diseases identified as life-threatening or very serious.

Dr Helmut Giersiefen, CEO of Curacyte, said: “The decision of the EMEA to grant an orphan drug designation for our lead PDE-4 inhibitor as a potential novel treatment option for patients suffering from chronic lymphocytic leukemia is another important milestone that underlines our capabilities in drug discovery.”

He further stated that a new chronic lymphocytic leukemia (CLL) treatment based on PDE-4 inhibition could become a valuable option for physicians and patients to combat the disease without dose-limiting side effects associated to standard chemotherapy.

Orphan medicinal product designation provides 10 years of potential market exclusivity if the product candidate is approved for marketing in the European Union. Orphan status also provides EMEA advice in optimizing the candidate’s clinical development through participation in designing the clinical protocol and preparing the marketing authorization application. A drug candidate designated by the EMEA as an orphan medicinal product may also qualify the sponsor for a reduction in regulatory fees as well as a European Union-funded research grant.