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Amsterdam Molecular Therapeutics Reports Half-Year Results 2010
Date:8/30/2010

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Amsterdam Molecular Therapeutics Reports Half-Year Results 2010

 

AMSTERDAM, The Netherlands, August 31, 2010 /PRNewswire-FirstCall/ -- Amsterdam Molecular Therapeutics (Euronext: AMT), a leader in the field of human gene therapy, today reported its results for the first half year of 2010.

Highlights - Glybera(R): - EMA initiated MAA review in 01/2010 - Approval progressing on schedule for decision mid 2011 - Novel biomarker for Glybera(R) activity identified - Hemophilia B: Phase I/II started - Duchenne Muscular Dystrophy: to benefit from EUR 4 million innovation credit - sRNA: silencing gene therapy technology achieves 80% cholesterol reduction - Supervisory Board nominations: 3 new industry professionals slated to join board - Key financial figures in line with guidance - Cash & cash equivalents of EUR 13.5 million at June 30, 2010

"We are very pleased with the key milestones we have achieved in the first half year of 2010 in the Glybera(R) approval process which seems firmly on track. Our dialogue with the EMA is very encouraging and we look forward to the Agency's decision with confidence. We also continue to make progress with our pipeline, not only on the partnership front for programs such as Hemophilia B, but also in our early stage efforts," said Jorn Aldag, chief executive officer of AMT.

Operations

Glybera(R) for Lipoprotein Lipase Deficiency (LPLD)

In January 2010, the European Medicines Agency (EMA) commenced review of AMT's Marketing Authorization Application. In May 2010 AMT received questions (Day 120 questions) regarding the application. In July we met with the EMA, to clarify the questions they raised, enabling AMT to align its response str
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SOURCE Amsterdam Molecular Therapeutics B.V
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