FDA accepts Protalix's taliglucerase alfa NDA, assigns PDUFA action date

Protalix BioTherapeutics, Inc. (NYSE-Amex: PLX), announced today that the Company's New Drug Application (NDA) for taliglucerase alfa has been accepted for review by the U.S. Food and Drug Administration (FDA).  The FDA granted taliglucerase alfa a standard review time of ten months, assigning a Prescription Drug User Fee Act (PDUFA) action date of February 25, 2011.  Taliglucerase alfa is the Company's proprietary plant cell expressed recombinant form of human Glucocerebrosidase (GCD) which is being developed for the treatment of Gaucher disease under a Special Protocol Assessment (SPA) with the FDA.  Following the completion of a phase III clinical trial of taliglucerase alfa, the Company completed the submission of a rolling NDA with the FDA in April 2010.

"If approved, taliglucerase alfa will be an attractive and important therapeutic option for Gaucher patients," said Dr. David Aviezer, President and Chief Executive Officer of Protalix.  "We look forward to working closely with the agency through this final stage of the review process."

Taliglucerase alfa has been granted orphan drug designation from the FDA in the United States.  The Company continues to make taliglucerase alfa available to Gaucher patients in the United States under an Expanded Access protocol, as well as to patients in the European Union, Israel and other countries under Named Patient provisions.