Kiadis Pharma’s lead prod­uct ATIR™ grant­ed Orphan Drug Designation by EMA for the treat­ment of Acute Myeloid Leukemia

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™.”

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