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.”
