Amsterdam, The Netherlands, June 30, 2016 – Kiadis Pharma N.V. (“Kiadis Pharma” or the “Company”) (Euronext Amsterdam and Brussels: KDS), a clinical stage biopharmaceutical company developing innovative T-cell immunotherapy treatments for blood cancers and inherited blood disorders, today announces that its lead product, ATIR101™, has been granted an expansion to its existing Orphan Drug Designation (ODD) by the European Medicines Agency (EMA) to include treatment in a hematopoietic stem cell transplantation (HSCT).
Kiadis Pharma was previously granted an ODD for ATIR101™ by both EMA and the United States Food and Drug Administration (FDA) for the prevention of Graft-versus-Host-Disease (GVHD) following an allogeneic HSCT. A further ODD was granted by the FDA for the prevention of Transplant Related Mortality following an allogeneic HSCT and a fourth ODD was granted by EMA for the treatment of acute myeloid leukemia (AML) following an allogeneic HSCT. This latter ODD has now been expanded by EMA to cover all uses of ATIR101™ as treatment in HSCT, regardless of the underlying disease.
Manfred Rüdiger, PhD, Chief Executive Officer of Kiadis Pharma, commented: “This expanded Orphan Drug Designation in the European Union for our lead product ATIR101™ attests to the understanding and belief that ATIR101™ could be used in the context of a hematopoietic stem cell transplantation independent of the underlying disease. Therefore its use in, for example, chronic lymphocytic leukemia (CLL) and chronic myeloid leukemia (CML), amongst many other diseases, is now also covered by this newly issued ODD. We believe this extension to the ODD significantly strengthens our value proposition for ATIR101™ and will also make this potentially lifesaving therapy available to even more people in desperate need of a transplant.”
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 incentives to support development, including fee reductions and a ten-year period of market exclusivity in the European Union after product approval.