On Friday, Protalix Biotherapeutics Inc. (AMEX:PLX; TASE: PLX) presented good clinical data from the switchover trial of its treatment for Gaucher's disease at the 7th Annual Meeting of the Lysosomal Disease Network: World Symposium 2011 in Las Vegas.
The The switchover trial is a phase III clinical trial to test and assess the safety and efficacy of Protalix's taliglucerase alfa in Gaucher disease patients who are currently being treated with Cerezyme, and enzyme replacement therapy, made by Genzyme Inc. (NYSE: DNA). Protalix said that the trial on 15 patients found that they can be transferred to its own drug without affecting the patients health. The trial is being conducted in ten medical centers in North America, Europe, Israel, and Australia.
Protalix also presented the results of preclinical trials on its oral Gaucher's treatment, which showed that the drug achieved the desired end points in raising the level of the missing enzyme in the laboratory animals' internal organs.
Protzlix and Pfizer Inc. (NYSE: PFE; LSE: PFZ) have filed drug applications for taliglucerase alfa in the US, EU, Brazil, and Israel. The company received a Prescription Drug User Fee Act (PDUFA) date of February 25, 2011 from the US Food and Drug Administration (FDA).
Market analysts agree that the drug will be approved, although possibly not on the scheduled date.
Protalix's share price rose 0.2% to $9.62 on the American Stock Exchange on Friday, giving a market cap of $781 million, and rose 0.5% on the TASE today to NIS 34.67.
Published by Globes [online], Israel business news - www.globes-online.com - on February 20, 2011
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