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Biotech / Medical : Indications - Neurodegenerative

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From: idos	6/16/2008 4:24:34 AM
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Teva to propose Azilect as disease modifier for Parkinson's By Robert Daniel Last update: 3:32 a.m. EDT June 16, 2008 TEL AVIV (MarketWatch) -- Teva Pharmaceutical Industries Ltd., (TEVA) the Jerusalem drugmaker, said on Monday that based on the results of a Phase III study, it would ask U.S. and European regulators to approve labeling Azilect as the first disease-modifying drug for Parkinson's disease. Teva said that its Adagio study was designed to show that Azilect could slow the progression of Parkinson's. In the study, Teva said, the currently marketed Azilect 1-milligram tablets met all three primary endpoints, as well as the secondary and additional endpoints, with statistical significance. The 2-mg dose met two of the three primary endpoints and the secondary endpoint, Teva said. The study confirmed the safety and tolerability of both dosages of Azilect, the company said. The 18-month study involved 1,176 patients with early Parkinson's in 14 countries. The study protocol was based on the recommendations of the U.S. Food and Drug Administration, Teva said.

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