Kiadis Pharma’s Orphan Drug Designation for ATIR101™ fur­ther expand­ed to include treat­ment in a hematopoi­et­ic stem cell trans­plan­ta­tion

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.

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