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Biotech / Medical : Celltech Group (NYSE: CLL)
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To: Tom Nealon who started this subject6/16/2003 9:09:19 AM
From: nigel bates   of 123
 
Celltech Group plc Zavesca Approved In Israel - Second largest patient population for Gaucher disease -

SLOUGH, England, June 16 /PRNewswire-FirstCall/ -- Celltech Group plc (LSE: CCH - News; NYSE: CLL - News) today announced that the Israeli Ministry of Health has granted Marketing Authorisation for Zavesca (miglustat), the first oral treatment for patients with mild to moderate type 1 Gaucher disease for whom Enzyme Replacement Therapy (ERT) is unsuitable.

Zavesca was developed by Oxford GlycoSciences (OGS), which was recently acquired by Celltech. The Marketing Authorisation Application was filed by Teva, who, under the terms of their license agreement, are responsible for all regulatory and marketing activities in Israel. Teva expects to begin marketing Zavesca in Israel concurrent with its inclusion in the National List of Reimbursed Drugs (NLRD).

Zavesca is the first oral treatment for this disease. It was approved in the EU in November 2002 for the treatment of patients with mild to moderate type 1 Gaucher disease for whom enzyme replacement therapy is unsuitable. An amendment to the New Drug Application (NDA) for Zavesca was filed with the U.S. Food and Drug Administration (FDA) during March 2003.

Dr. Goran Ando, Chief Executive Officer of Celltech commented, "We are delighted with this latest approval for Zavesca, particularly since Israel has the second largest patient population for Gaucher disease. Zavesca provides physicians with an important therapeutic option for treating patients with this serious disease. We look forward to the commercial launch of Zavesca in Israel during 2003."...
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