AMT Submits Responses to Day 120 Questions to EMA as Part of the Review Process for Glybera(R)By Amsterdam Molecular Therapeutics B.v, PRNE
Monday, November 22, 2010
AMSTERDAM, November 23, 2010 - Amsterdam Molecular Therapeutics (Euronext Amsterdam: AMT), 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
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
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
For further enquiries: Jorn Aldag, CEO, AMT, Tel : +31-20-566-7394, j.aldag at amtbiopharma.com, Mike Sinclair, Partner, Halsin Partners, Tel : +44(0)20-7318-2955, msinclair at halsin.com
Tags: Amsterdam, Amsterdam Molecular Therapeutics B.V, Netherlands, November 23