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Amsterdam Molecular Therapeutics Receives Opinion on Re-examination of Glybera® Marketing Authorisation Application
Date:10/21/2011

AMSTERDAM, The Netherlands, October 21, 2011 /PRNewswire/ --

Amsterdam Molecular Therapeutics (Euronext: AMT), a leader in the field of human gene therapy, today announced that the European Medicines Agency's (EMA) Committee for Medicinal Products for Human Use (CHMP) has maintained its earlier opinion that Glybera (alipogene tiparvovec) is not approvable at this time. The decision was made contrary to the positive recommendation of CHMP Rapporteurs, the Scientific Advisory Group (SAG), an expert panel specifically selected to evaluate clinical results and the science of the product, and the Committee for Advanced Therapies (CAT), which provides guidance on advanced therapeutics such as gene and cell therapy. These expert groups after extensive review and analysis of the data advised the CHMP that Glybera should be approved now under exceptional circumstances. The CHMP Rapporteurs, SAG and the CAT concluded that data from three Glybera clinical trials demonstrated meaningful evidence of clinical efficacy, without any major safety concerns. However, the CHMP is not bound to follow this advice. While AMT carefully reviews the grounds of the CHMP refusal, the Company will focus on strategic advancement of other promising projects in its development pipeline.

"The decision from the CHMP is disappointing particularly because a treatment will now not be available to European patients who suffer from LPLD for whom Glybera is the only therapeutic option. We are encouraged by the validation provided by the CHMP Rapporteurs, Scientific Advisory Group and the Committee for Advanced Therapies regarding our gene therapy platform, indicating that safety is not an issue," said Jörn Aldag, CEO of AMT. "We are evaluating thoroughly and expediently the next steps available to the Company and will provide an update on the future developments of our validated gene therapy pipeline."

On Tuesday October 25, 2011 at 10:00 AM CET, AMT will provide an update on
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SOURCE Amsterdam Molecular Therapeutics (AMT) B.V
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