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Amsterdam Molecular Therapeutics Provides Business Update for the Third Quarter 2011
Date:11/16/2011

AMSTERDAM, November 17, 2011 /PRNewswire/ --

Amsterdam Molecular Therapeutics (Euronext: AMT), a leader in the field of human gene therapy, today provided its non-audited business update in compliance with the EU transparency directive. This report summarizes material events and AMT's financial position for the third quarter of 2011.

3Q 2011 Highlights

  • Glybera® Marketing Authorisation Application filed for re-examination
  • Exclusive license signed with National Institutes of Health (NIH) for use of adeno-associated virus serotype 5 (AAV5)-based gene therapy vectors for liver and brain indications
  • Dr. Carlos R. Camozzi appointed as Chief Medical Officer

CHMP Decision on Glybera and Re-organization

  • Glybera Marketing Authorisation Application re-examination:
    • Committee for Advanced Therapies (CAT), Scientific Advisory Group (SAG) and new Rapporteur/Co-Rapporteur all recommended Glybera approvable under exceptional circumstances
    • CHMP concluded that there are no significant safety issues with Glybera
    • CHMP concluded that insufficient evidence of clinical benefit means Glybera is not approvable at this time
  • AMT will focus development efforts and financial resources on three gene therapy programs: hemophilia B, GDNF and acute intermittent porphyria
  • Company remains committed to participating in the Sanfilippo B program, which is fully funded by a consortium led by Institut Pasteur
  • Further investment in and development of Glybera and Duchenne's muscular dystrophy programs suspended
  • AMT management is working in close consultation with the AMT Works Council to assess the impact of the review on the Company's workforce
  • Management and board believe that for AMT to remain a viable business it needs to reduce the headcou
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SOURCE Amsterdam Molecular Therapeutics (AMT) B.V
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