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Biotech / Medical : Oxford GlycoSciences Plc
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To: tuck who wrote (153)8/21/2001 1:00:36 PM
From: nigel bates  Read Replies (1) of 469
 
OGS announces completion of New Drug Application submission for Vevesca(TM) (OGT 918) with the US Food and Drug Administration

24 month monotherapy data to be presented at ESGLD Conference

OXFORD, UK, Aug. 21 /PRNewswire/ -- Oxford GlycoSciences Plc (LSE: OGS, Nasdaq: OGSI) today announced that it has completed the submission of its New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for Vevesca (OGT 918), its oral treatment in development for type 1 Gaucher disease. This completes a Step-Wise submission (Rolling NDA) that started in March 2001, according to the 'Fast Track' designation that had been granted to Vevesca by the FDA in June 2000. It follows the Company's Marketing Authorisation Application (MAA), which was accepted for review by the European Agency for the Evaluation of Medicinal Products (EMEA) in July this year.
The submission includes data on the use of Vevesca as an oral monotherapy, in combination with Cerezyme® and switch/maintenance after Cerezyme®. OGS plans a series of presentations and publications on the data in the autumn. The first of these will be at the European Society of Glycolipid Disorders workshop at Woudschoten, The Netherlands, when Dr. Ari Zimran is scheduled to present data from the extension trial with Vevesca monotherapy on Saturday 22nd September 2001.
Michael Kranda, Chief Executive Officer of OGS, commented: ``OGS is committed to the development of novel treatments for glycolipid storage disorders. The submission of the NDA is a major achievement for OGS and we look forward to working with the various regulatory authorities in the coming months.''...
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