Healthcare Industry News:  gene therapy 

Biopharmaceuticals Regulatory

 News Release - July 8, 2011

Amsterdam Molecular Therapeutics Files Glybera(R) European Marketing Application for Re-examination

AMSTERDAM, July 8, 2011 -- (Healthcare Sales & Marketing Network) --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 GlyberaŽ 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 GlyberaŽ, 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. Further information can be found at http://www.amtbiopharma.com.

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

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