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Alzheimer Molecular Therapeutics hits the wall with Glybera

25.10.2011

Amsterdam - The second blow could be the ultimate one. Amsterdam Molecular Therapeutics received a second negative opinion for Glybera to treat lipoprotein lipase (LPL) deficiency. The European Medicines Agency's (EMA) Committee for Medicinal Products for Human Use (CHMP) maintained its earlier opinion and deemed Glyvera as not approvable. AMT's stocks plunged by half immediately after the news. The committee concluded that the benefits of Glybera still do not outweigh its risks. As with the initial negative decision issued in June, the actual opinion centres on the AAV vector encoding the LPL gene. "The decision from the CHMP is disappointing", said Jörn Aldag, CEO of AMT. He noted the positive evaluation of AMT's platform by CHMP Rapporteurs, the Scientific Advisory Group (SAG) and the Committee for Advanced Therapies (CAT). Nevertheless the verdict means dire straits for AMT. "We are evaluating thoroughly and expediently the next steps available to the Company", said Aldag. The manager came in 2009 from the German biotech Evotec, which he left in 2008.

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