Kiadis Pharma Appoints PCT as its Contract Manufacturing Organization in the United States

PCT will sup­ply study med­ica­tion for the US part of Kiadis Pharma’s Phase III clin­i­cal tri­al with ATIR101™

Amsterdam, The Netherlands, June 21, 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 it has appoint­ed PCT, LLC, A Caladrius Company (PCT), a sub­sidiary of Caladrius Biosciences (NASDAQ: CLBS), as Kiadis Pharma’s con­tract man­u­fac­tur­ing orga­ni­za­tion (CMO) in the United States as Kiadis Pharma makes prepa­ra­tions for its Phase III clin­i­cal tri­al with lead prod­uct ATIR101™, on track to be ini­ti­at­ed in the sec­ond half of 2016.
PCT and Kiadis Pharma already close­ly col­lab­o­rat­ed on improv­ing and engi­neer­ing the ATIR101™ man­u­fac­tur­ing process for the Company’s Phase III tri­al. As a result, the tech­nol­o­gy and process­es are already well estab­lished at PCT’s Allendale, New Jersey, US facil­i­ty and PCT will sup­ply study med­ica­tion to the var­i­ous Phase III clin­i­cal tri­al sites in the United States and Canada.
With regards to the European clin­i­cal sites for the Phase III tri­al, also expect­ed to ini­ti­ate in the sec­ond half of 2016, the Company already has a long-run­ning and suc­cess­ful man­u­fac­tur­ing col­lab­o­ra­tion with the German Red Cross Blood Donor Service, Baden-Wuerttemberg-Hessen, who pro­vid­ed GMP man­u­fac­tur­ing ser­vices for Kiadis Pharma’s Phase II clin­i­cal stud­ies with ATIR101™.

Manfred Rüdiger, PhD, Chief Executive Officer of Kiadis Pharma, com­ment­ed: “We are pleased to select PCT as our CMO in the United States. The man­u­fac­ture and sup­ply of study med­ica­tion for our Phase III clin­i­cal tri­al with ATIR101™ in the United States and Canada is a crit­i­cal com­po­nent to the suc­cess­ful and smooth run­ning of our clin­i­cal study and hav­ing a part­ner who is well estab­lished and high­ly expe­ri­enced, like PCT, is very impor­tant. PCT has been an excel­lent advi­sor and provider of process devel­op­ment to Kiadis Pharma in the past and we look for­ward to lever­ag­ing those efforts as we begin to broad­en the activ­i­ties of Kiadis Pharma in the United States.”
Robert A. Preti, PhD, President of PCT, and Chief Technology Officer and Senior Vice President, Manufacturing and Technical Operations of Caladrius Biosciences, com­ment­ed: “We are very grate­ful for the oppor­tu­ni­ty to have par­tic­i­pat­ed in man­u­fac­tur­ing devel­op­ment with the Kiadis Pharma team, work­ing col­lab­o­ra­tive­ly for a num­ber of years now to help them advance to this impor­tant mile­stone, the launch of a Phase III tri­al of ATIR101™. We now wish them suc­cess in the exe­cu­tion of their Phase III tri­al and will do our part to make that suc­cess a real­i­ty in the US and Canada.”

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