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Biotech / Medical : Celltech Group (NYSE: CLL)
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To: Tom Nealon who started this subject10/29/2003 4:56:32 AM
From: nigel bates   of 123
 
Zavesca figures (or rather, it doesn't yet...) from yesterday's Actelion results:

...US approval for Zavesca(R) -- Launch by year-end

In spring 2003, Actelion launched Zavesca(R) first in the United Kingdom and later in Germany. A major milestone was also the approval of the drug in the United States of America by the FDA in August 2003 following a New Drug Application (NDA) amendment filed by Actelion on 7 February 2003. Due to supply limitations, Zavesca(R) is expected to become available to US patients suffering from type 1 Gaucher disease by year-end.

In July 2002, the FDA had issued a non-approval letter for the drug based on an NDA filed by Oxford Glycoscience (OGS), the previous drug developer. In November 2002, Actelion signed a worldwide licensing agreement (except Israel) for Zavesca(R). The agreement will be honored by Celltech Group, who acquired OGS in early 2003 and who is responsible for drug supply.

As expected, Zavesca(R) sales continue to grow slowly as a result of prolonged enrollment and reimbursement procedures. Accordingly, Zavesca(R) sales for the first nine months of 2003 were CHF 0.3 million. On a quarter-to-quarter basis, Zavesca(R) revenues increased slightly to CHF 0.2 million (Q2 2003: 0.1 m)...
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