Kiadis to receive GMP manufacturing license and certificate

Netherlands-based, privately-held clinical stage biopharma company Kiadis Pharma said today (July 24) that its Quality Control (QC) laboratory and the associated quality system has been inspected for Good-Manufacturing Practice (GMP) by the Dutch Health Care Inspectorate (IGZ) and has fully met the European Union GMP standards.

As a result, Kiadis - which is developing treatments for blood cancers - will receive a GMP manufacturing license and GMP certificate for its QC laboratory from the Dutch Ministry of Health, Welfare and Sport.

GMP licensing and certification enables Kiadis to perform QC release-assays for the clinical trial manufacturing of the company’s lead product ATIR, a cellular therapeutic that will enable partially mismatched donor stem cell transplants from family members in blood cancer patients. Under the terms of a licensing deal, US specialty pharma company Hospira (NYSE: HSP) has been granted exclusive marketing rights to ATIR for Europe, the Middle East, Africa, Australia, Japan and parts of Asia. Kiadis maintains all rights to the product for the rest of the world (The Pharma Letter January 5, 2011).