Amsterdam, The Netherlands, October 30, 2014 – Kiadis Pharma B.V. (“Kiadis Pharma” or “the Company”), a clinical stage biopharmaceutical company developing T-cell immunotherapy treatments for blood cancers, today announces that its lead product ATIR™ has been granted Orphan Drug Designation (ODD) by the European Medicines Agency (EMA) for the treatment of acute myeloid leukemia (AML). Kiadis Pharma has previously been granted an ODD for ATIR™ by both the EMA and the FDA for the prevention of acute Graft versus Host Disease (GvHD) following an allogeneic bone marrow transplantation.
The EMA’s ODD is reserved for new therapies being developed to treat life-threatening or chronically debilitating diseases or conditions that are relatively rare in the European Union and for which no satisfactory therapy is available. The ODD designation provides for incentives to support development, including fee reductions and a ten-year period of market exclusivity in the European Union after product approval.
Manfred Ruediger, PhD, Chief Executive Officer of Kiadis Pharma, commented: “This second Orphan Drug Designation for our lead product ATIR™ in the European Union represents another very important milestone in the development of our product. This, coupled with the previously granted ODDS for ATIR™ by the FDA and EMA, further highlights our product’s importance as a novel approach which may help provide a potentially life-saving transplant from a family member to those patients who otherwise do not find a matched donor in time. In many cases, this will be the only remaining option for these patients.”
“This news comes directly after having successfully closed an equity financing round with our existing investors which emphasizes the belief our investors have in both the Company and ATIR™.”
