Author: Willem van Lawick

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. (more…)

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™. (more…)

~ Regulatory strategy update ~

Amsterdam, The Netherlands, June 2, 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 a regulatory strategy update that, based on positive Phase II data, it has taken the decision to submit a Marketing Authorization Application (MAA) to the European Medicines Agency (EMA) for its lead product ATIR101™ for use in blood cancers to reduce relapse rates, Transplant Related Mortality (TRM) and Graft-versus-Host-Disease (GVHD) in the context of a hematopoietic stem cell transplantation using a haploidentical donor. The Company will now start compiling an MAA document and anticipates submitting the application to EMA in Q1, 2017.
An EMA rapporteur and co-rapporteur (who will jointly co-ordinate the evaluation of Kiadis Pharma’s MAA submission) were appointed in early 2015. In addition, in April 2015 Kiadis Pharma received a certificate for its (manufacturing) quality and non-clinical data from EMA. (more…)

SAN RAFAEL, Calif., May 31, 2016 (GLOBE NEWSWIRE) — BioMarin Pharmaceutical Inc. (Nasdaq:BMRN) announced today that it has withdrawn its Kyndrisa™ (drisapersen) Marketing Authorization Application (MAA) from the European Medicines Agency (EMA) following discussions at the May 2016 Committee for Medicinal Products for Human Use (CHMP) meeting. Those discussions clearly indicated that the CHMP intended to issue a negative opinion. Kyndrisa is an experimental drug for the treatment of Duchenne muscular dystrophy (DMD) amenable to exon 51 skipping. (more…)

Amsterdam, The Netherlands, April 15, 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 its audited annual results for the year ended 31 December 2015, which have been prepared in accordance with International Financial Reporting Standards (IFRS) as adopted by the European Union. (more…)