FDA accepts Protalix taliglucerase alfa NDA resubmission for review

Aug 17 2011

Protalix BioTherapeutics, Inc. (NYSE-AMEX: PLX, TASE:PLX), announced today that the U.S. Food & Drug Administration (FDA) has accepted for review the resubmission of the taliglucerase alfa New Drug Application (NDA) following the Company's receipt of a Complete Response Letter (CRL) 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 (PDUFA) date.  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.

"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 (CMC).

On November 30, 2009, Pfizer and Protalix BioTherapeutics, Inc. entered into an agreement to develop and commercialize taliglucerase alfa.

"Pfizer has worked closely with Protalix to achieve this important milestone," said Diem Nguyen, General Manager, Biosimilars.  "Pfizer is ready to make taliglucerase alfa commercially available to Gaucher patients in the United States, if approved by the FDA."

SOURCE Protalix BioTherapeutics, Inc.