Karcinolys receives U.S. and EU orphan designations for the treatment of Pancreatic Cancer

Paris, 2015: Karcinolys SAS, a privately-held biotechnology company, today announced that orphan designations have been granted by the U.S. Food and Drug Administration (FDA) and by the European Commission for its oncolytic virus Myb34.5 for the treatment of pancreatic cancer. The U.S. Orphan Drug Act (ODA) provides for granting a special status to a drug or biological product intended to treat a rare disease or condition. An orphan designation qualifies the sponsor of the drug for various development incentives and seven years of U.S. market exclusivity after marketing approval. European orphan medicinal product status confers up to ten years of marketing exclusivity in all European Union (EU) member countries following marketing approval, and a range of other benefits including EU-funded research, protocol assistance, and fee reductions. “We are committed to developing a therapy for one of the most insidious and lethal cancers, particularly as only standard treatments relying on a few approved palliative chemotherapies and targeted therapies are currently available,” said Jean-Luc Béjot, MD, MBA, Chief Executive Officer of Karcinolys. “We are pleased that the FDA and the European Commission have granted Orphan Designation to Myb34.5 as a potential new therapy for Pancreatic Cancer, a disease with great unmet medical need.”