Kiadis Pharma B.V. (Kiadis Pharma), a clinical stage biopharmaceutical company,,  has announced 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 Ruediger, 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.

Kiadis Pharma is a private clinical stage biopharmaceutical company focused on research, development and future commercialisation of cell-based immunotherapy products for the treatment of blood cancers and inherited blood disorders.