Amsterdam Molecular Therapeutics (Euronext: AMT), a leader in the field of human gene therapy, announced today that it has filed a request for re-examination of the Marketing Authorisation Application for Glybera® with the European Medicines Agency. Glybera is a gene therapy for the genetic disorder lipoprotein lipase deficiency. The Company expects that the re-examination of the dossier will be completed by the end of 2011.
--About Amsterdam Molecular Therapeutics
AMT is a world leader in the development of human gene based therapies. The company’s lead product Glybera®, a gene therapy for lipoprotein lipase deficiency (LPLD), is currently under review by the European Medicines Agency (EMA). If approved, Glybera will be the first gene therapy product to be marketed in Europe. AMT also has a product pipeline of several gene therapy products in development for hemophilia B, Duchenne muscular dystrophy, acute intermittent porphyria, Parkinson’s disease and SanfilippoB. Using adeno-associated viral (AAV) derived vectors as the delivery vehicle of choice for therapeutic genes, the company has been able to design and validate probably the world’s first stable and scalable AAV manufacturing platform. This proprietary platform can be applied to a large number of rare (orphan) diseases caused by one faulty gene and allows AMT to pursue its strategy of focusing on this sector of the industry. AMT was founded in 1998 and is based in Amsterdam.
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