Sagetis Biotech receives Advanced Therapy Medicinal Product Designation from the European Medicines
Barcelona, June 21 2017 - Sagetis Biotech today announced that it has been granted Advanced Therapy Medicinal Product (ATMP) designation for SAG-101, its novel polymer-coated adenovirus for the treatment of pancreatic ductal adenocarcinoma.
The Committee for Advanced Therapies (CAT), following consultation with the European Commission, has adopted at its plenary 17 March 2017 a scientific recommendation of the classification of SAG-101.
The EMA/CAT considers that product SAG-101, falls within the definition of gene therapy medicinal product and has published on its website the information in the table ‘Summary for public release’
Eduard Diviu, CEO of Sagetis Biotech, commented: “We are delighted to announce the granting of ATMP classification by the CAT. For Sagetis, this represents a further step in the development of this unique class of virotherapy”.
About ATMPs and the European Regulation on ATMPs
The ATMP classification aims at regulating cell and gene therapy and tissue-engineered medicinal products by providing the pharmaceutical industry with quality compliance guidelines and best practices, including for non-clinical developments, manufacturing and quality testing. The regulation also offers incentives to companies involved in developing ATMPs in the European Union, including fee reductions for scientific advice, scientific recommendations on ATMP classification, and evaluation and certification of quality and non-clinical data.
About the Committee for Advanced Therapies (CAT)
The Committee for Advanced Therapies (CAT) is the European Medicines Agency's (EMA) committee responsible for assessing the quality, safety and efficacy of advanced therapy medicinal products (ATMPs) and following scientific developments in the field.
About Sagetis Biotech
Sagetis Biotech is devoted to developing an innovative gene delivery technology to overcome a fundamental engineering challenge in gene therapy: the development of safe and effective delivery vectors.
Privately funded and based in Barcelona, Sagetis Biotech is developing SAG-101: a polymer-coated adenovirus for the treatment of pancreatic ductal adenocarcinoma.