Protalix BioTherapeutics Receives PDUFA Date for taliglucerase alfa

Jul 12, 2010 - CARMIEL, Israel /PRNewswire-FirstCall/ -- 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.

Protalix BioTherapeutics Announces French ATU Granted for taliglucerase alfa for the Treatment of Gaucher Disease

Jul 13, 2010 - CARMIEL, Israel - Protalix BioTherapeutics, Inc. (NYSE-Amex: PLX) announced today that the French regulatory authority has granted an Autorisation Temporaire d'Utilisation (ATU), or Temporary Authorization for Use, for taliglucerase alfa for the treatment of Gaucher disease. An ATU is the regulatory mechanism used by the French Health Products and Safety Agency to make non-approved drugs available to patients in France when a genuine public health need exists. This ATU allows patients with Gaucher disease in France to receive treatment with taliglucerase alfa before marketing authorization for the product is granted in the European Union. Payment for taliglucerase alfa has been secured through government allocations to hospitals. "We are pleased to be able to provide taliglucerase alfa to Gaucher patients in France under the ATU program,” said Dr. David Aviezer, President and Chief Executive Officer of the Company.