AMSTERDAM, November 23, 2010 /PRNewswire/ -- Amsterdam Molecular Therapeutics , a leader in the field of human gene therapy, today announces that it has submitted its responses to the Day 120 questions posed by the European Medicines Agency (EMA) as part of the review process for Glybera(R), a gene therapy for lipoprotein lipase deficiency (LPLD). As outlined in the review timetable, EMA will restart evaluation on Friday, 26th November, which represents Day 121.

The Day 120 questions are posed following the initial review of the Glybera registration dossier, which was submitted in December 2009. AMT expects to receive, at Day 180, a further list of questions summarizing the outstanding items following the EMA's review of the responses to the Day 120 questions.

The EMA formal review of Glybera is being conducted via the centralized procedure, which is the standard route for all advanced therapies. During 2011, AMT expects to provide updates on the results from its follow-up and ongoing clinical studies with Glybera, in accordance with reporting regulations.

About Amsterdam Molecular Therapeutics

AMT is a leader in the development of human gene based therapies. 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 what is probably the first stable and scalable AAV production platform. This proprietary platform can be applied to a large number of rare (orphan) diseases that are caused by one faulty gene. Currently, AMT has a product pipeline with several AAV-based gene therapy products in Lipoprotein Lipase Deficiency (currently in registration for MAA), Hemophilia B, Duchenne Muscular Dystrophy, Acute Intermittent Porphyria, and Parkinson's Disease at different stages of research or development. AMT was founded in 1998 and is based in Amsterdam.

Certain statements in this press release are "forward-looking statements" including those that refer to management's plans and expectations for future operations, prospects and financial condition. Words such as "strategy," "expects," "plans," "anticipates," "believes," "will," "continues," "estimates," "intends," "projects," "goals," "targets" and other words of similar meaning are intended to identify such forward-looking statements. Such statements are based on the current expectations of the management of AMT only. Undue reliance should not be placed on these statements because, by their nature, they are subject to known and unknown risks and can be affected by factors that are beyond the control of AMT. Actual results could differ materially from current expectations due to a number of factors and uncertainties affecting AMT's business. AMT expressly disclaims any intent or obligation to update any forward-looking statements herein except as required by law.


SOURCE: Amsterdam Molecular Therapeutics B.V

CONTACT: For further enquiries: Jorn Aldag, CEO, AMT, Tel :+31-20-566-7394,, Mike Sinclair, Partner, HalsinPartners, Tel : +44(0)20-7318-2955,