PDUFA goal date of NDA for Protalix's taliglucerase alfa extended

Dec 6 2011

Protalix BioTherapeutics, Inc. (NYSE-AMEX: PLX, TASE: PLX), announced today that it received notification from the U.S. Food and Drug Administration (FDA) that the FDA has extended the Prescription Drug User Fee Act (PDUFA) goal date of the New Drug Application (NDA) for taliglucerase alfa to May 1, 2012, a three-month extension from the previous PDUFA date of February 1, 2012.  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.

In November 2011, the Company submitted certain clinical information regarding taliglucerase alfa in response to an FDA request.  This request related mainly to the presentation of select data provided in the NDA.  As this information was requested and provided within 90 days of the February 1, 2012 PDUFA goal date, the agency has the option to extend the PDUFA goal date to provide adequate time for the FDA to complete their review.  A three month extension cycle is the standard period granted.  No additional data were requested by the FDA in the notification, nor was the Company notified of any specific deficiency in the taliglucerase alfa NDA. 

"We believe we have addressed the FDA's request," said Dr. David Aviezer, Protalix's President and Chief Executive Officer.  "We look forward to working closely with the agency as it continues its review."