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Protalix BioTherapeutics Announces Preliminary Top-Line Positive Data from taliglucerase alfa Switchover Trial
Date:11/2/2010

60;Adult enrollment in the study has closed; pediatric enrollment remains open.

"We are pleased with the interim results of the switchover trial to taliglucerase alfa," said Dr. David Aviezer, the Company's President and Chief Executive Officer.  "Through our Phase III pivotal and extension trial, pediatric study in naïve patients, switch–over trial, expanded access and named patient programs, ATU program in France and supply agreement in Brazil, we are generating a robust clinical database for taliglucerase alfa."

Taliglucerase alfa is under review by the U.S. Food and Drug Administration with a Prescription Drug User Fee Action (PDUFA) date scheduled for February 25, 2011.

About ProtalixProtalix is a biopharmaceutical company focused on the development and commercialization of recombinant therapeutic proteins expressed through its proprietary plant cell based expression system. Protalix's ProCellEx™ presents a proprietary method for the expression of recombinant proteins that Protalix believes will allow for the cost-effective, industrial-scale production of recombinant therapeutic proteins in an environment free of mammalian components and viruses. Protalix is also advancing additional recombinant biopharmaceutical drug development programs. Taliglucerase alfa is an enzyme replacement therapy in development under a Special Protocol Assessment with the FDA for Gaucher disease. The Company's new drug application (NDA) for taliglucerase alfa has been accepted by the U.S. Food and Drug Administration (FDA) and granted a Prescription Drug User Fee Act (PDUFA) action date of February 25, 2011.

Safe Harbor StatementTo the extent that statements in this press release are not strictly historical, all such statements are forward-looking, and are made pursuant to the safe-harbor provisions of the Private Securities Litigation Reform Act of 1995. These forward-looking statements are subject to known and unknown risks
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SOURCE Protalix BioTherapeutics, Inc.
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