Kiadis Pharma announces fil­ing of mar­ket­ing autho­riza­tion with the European Medicines Agency for ATIR101™ in blood can­cers

Amsterdam, The Netherlands, April 26, 2017 – Kiadis Pharma N.V. (“Kiadis Pharma” or the “Company”) (Euronext Amsterdam and Brussels: KDS), a clin­i­cal stage bio­phar­ma­ceu­ti­cal com­pa­ny devel­op­ing inno­v­a­tive prod­ucts to make bone mar­row trans­plan­ta­tions for patients suf­fer­ing from blood can­cers and inher­it­ed blood dis­or­ders safer and more effec­tive, today announces it has sub­mit­ted a Marketing Authorization Application (MAA) to the European Medicines Agency (EMA) for its lead prod­uct, ATIR101™. The Company is seek­ing mar­ket­ing approval in the European Union for ATIR101™ as an adjunc­tive treat­ment in haematopoi­et­ic stem cell trans­plan­ta­tion (HSCT) for malig­nant dis­ease.
The fil­ing is based on Kiadis Pharma’s exist­ing clin­i­cal data and fol­lows pos­i­tive inter­ac­tions with the EMA Rapporteur and Co-Rapporteur which indi­cat­ed sup­port for the fil­ing using the Company’s sin­gle dose Phase II tri­al with ATIR101™ as the piv­otal study. The Company sub­mit­ted the appli­ca­tion under the European Union’s cen­tral­ized pro­ce­dure, which per­mits the agency to issue a sin­gle mar­ket­ing autho­riza­tion that is valid across all EU coun­tries.
Arthur Lahr, Chief Executive Officer of Kiadis Pharma, com­ment­ed: “Submission of this MAA to the EMA marks a piv­otal point in Kiadis Pharma’s devel­op­ment and brings us a sig­nif­i­cant step clos­er towards com­mer­cial­iz­ing our lead prod­uct ATIR101™ for the treat­ment of blood can­cer, across the EU. The data gen­er­at­ed thus far for ATIR101™ has been very pos­i­tive and we are opti­mistic that we will receive a pos­i­tive out­come from the EMA dur­ing the sec­ond half of 2018, allow­ing us to make ATIR101™ avail­able to trans­plan­ta­tion cen­ters across the EU in 2019. It is a great achieve­ment that Kiadis Pharma has reached this mile­stone on its own mer­it, which only a very few biotech com­pa­nies accom­plish, and it is tes­ta­ment to the strength of the unique data and of the Kiadis Pharma orga­ni­za­tion.
Positive and sig­nif­i­cant results from Kiadis Pharma’s sin­gle dose Phase II tri­al with ATIR101™ were report­ed on December 5, 2016 at the Annual Meeting of the American Society of Hematology (ASH). The data showed that ATIR101™ sig­nif­i­cant­ly improved over­all sur­vival com­pared to a his­tor­i­cal matched con­trol. In addi­tion, relapse and Graft-ver­sus-Host-Disease (GVHD) rates were sig­nif­i­cant­ly low­er than those report­ed for alter­na­tive approach­es for HSCT. Specifically, ATIR101™ did not elic­it acute grade III-IV GVHD in any patient.

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