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AMT Intends to Incorporate Additional Data to its Marketing Authorization Dossier for Glybera(R)
Date:10/3/2008

AMSTERDAM, October 3 /PRNewswire-FirstCall/ -- Amsterdam Molecular Therapeutics (Euronext: AMT), a leader in the field of human gene therapy, announced today that it intends to incorporate additional data into the Marketing Authorization Application (MAA) for Glybera(R) for Lipoprotein Lipase Deficiency (LPLD), a seriously debilitating and potentially lethal disease.

The data obtained so far from two phase II clinical studies (22 patients in total) demonstrate that Glybera(R) is well-tolerated (no drug-related severe adverse events and no dose-limiting toxicity). Positive effects were shown on fat (triglyceride) metabolism, resulting in an almost complete disappearance of pancreatitis during both the immediate 12-week study observation period and the long-term follow-up (up to 3 years post-injection), as well as the disappearance or reduction of fat accumulations in skin or retina. All patients reported gain of energy and in the two patients that had diabetes, a reduction of insulin resistance was observed, leading to a reduction of their diabetic medication.

In consultation with the Rapporteur countries, Germany and the United Kingdom, of the European Medicines Agency (EMEA) and Health Canada, AMT has decided to expand the clinical experience and to augment the Marketing Authorization Application (MAA) with an additional 16-patient study that will investigate the broader impact of this gene therapy on additional aspects of lipid metabolism. Preparations for this study to be conducted in Canada will start immediately. Submission of the MAA to the EMEA is foreseen in the second half of 2009. In line with the guidance given in the half year financial report, the Company's cash position allows the completion of this study to be done with existing financial resources.

AMT has developed Glybera(R) as a cure for patients with the rare genetic disorder, LPLD. Because of a defective gene, LPLD patients do not produce an enzyme that normally break
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SOURCE Amsterdam Molecular Therapeutics B.V
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