EMA grants Kiadis Pharma’s Lead Product ATIR™ ATMP Certificate for Quality and Non-clin­i­cal Data

Amsterdam, The Netherlands, May 13, 2015 – Kiadis Pharma B.V. (“Kiadis Pharma” or “the Company”), a clin­i­cal stage bio­phar­ma­ceu­ti­cal com­pa­ny devel­op­ing inno­v­a­tive immunother­a­py treat­ments, today announces that its lead prod­uct ATIR™ for blood can­cers has been grant­ed an Advanced Therapy Medicinal Product (ATMP) cer­tifi­cate for man­u­fac­tur­ing qual­i­ty and non-clin­i­cal data by the European Medicines Agency (EMA). The grant­ed ATMP cer­tifi­cate was issued on a rec­om­men­da­tion from the Committee for Advanced Therapies of the EMA rec­og­niz­ing that the data gen­er­at­ed for ATIR™ is meet­ing the strin­gent stan­dards imposed by the agency. As of 2009, only five such ATMP cer­tifi­cates have been issued by the EMA.
The cer­ti­fi­ca­tion pro­ce­dure aims at a full eval­u­a­tion of the com­plete man­u­fac­tur­ing qual­i­ty and pre-clin­i­cal data pack­age ahead of mar­ket­ing autho­riza­tion. The grant­ed cer­tifi­cate con­firms that the data sub­mit­ted for an ATMP meet the sci­en­tif­ic and tech­ni­cal stan­dards that apply for eval­u­at­ing a Marketing Authorization Application (MAA) by the EMA. This pro­ce­dure and the grant­ed cer­tifi­cate will thus facil­i­tate the prepa­ra­tion, fil­ing and eval­u­a­tion of a future MAA for ATIR™.
Manfred Rüdiger, CEO of Kiadis Pharma, com­ment­ed: “We are pleased that the data for our lead prod­uct ATIR™ meet the strin­gent EMA require­ments. This cer­ti­fi­ca­tion is a tes­ta­ment to the high stan­dards and qual­i­ty lev­els now employed at Kiadis Pharma and we are very proud that the EMA has acknowl­edged this. It rep­re­sents anoth­er impor­tant mile­stone in the devel­op­ment of ATIR™ as we con­tin­ue to progress the ongo­ing Phase II study.”

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