Protalix BioTherapeutics Announces FDA Accepts for Review Complete Response Resubmission for Taliglucerase Alfa and Assigns PDUFA Date

Protalix BioTherapeutics, Inc. PLX announced today that the U.S. Food & Drug Administration (FDA) has accepted for review the resubmission of the taliglucerase alfa New Drug Application following the Company's receipt of a Complete Response Letter in February 2011. The FDA deemed the resubmission a class 2, or 6-month, response and established February 1, 2012 as the Prescription Drug User Fee Act date. Taliglucerase alfa is the Company's proprietary plant cell expressed recombinant form of human Glucocerebrosidase which is being developed for the treatment of Gaucher disease. "We look forward to working with the FDA in moving taliglucerase alfa through the regulatory review process over the next few months," stated Dr. David Aviezer, President and CEO of Protalix. The Company's submission addresses the questions posed by the FDA in the CRL, including the request for clinical data from the Company's switchover trial and long-term extension trial, and additional information relating to chemistry, manufacturing and controls.