July 13, 2010 (FinancialWire) — Protalix BioTherapeutics, Inc. (AMEX: PLX) said that the company's New Drug Application for taliglucerase alfa has been accepted for review by the U.S. Food and Drug Administration.

The FDA granted taliglucerase alfa a standard review time of ten months, assigning a Prescription Drug User Fee Act action date of February 25, 2011.

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 under a Special Protocol Assessment 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.

Taliglucerase alfa has been granted orphan drug designation from the FDA in the United States. Protalix said it 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.

Gaucher disease, an inherited condition, is the most prevalent lysosomal storage disorder, with an incidence of about 1 in 20,000 live births. People with Gaucher disease do not have enough of an enzyme, beta-glucosidase, that breaks down a certain type of fat molecule. As a result, lipid engorged cells (called Gaucher cells) amass in different parts of the body, primarily the spleen, liver and bone marrow.

Accumulation of Gaucher cells may cause spleen and liver enlargement, anemia, excessive bleeding and bruising, bone disease and a number of other signs and symptoms.

Israel-based Protalix is a biopharmaceutical company focused on the development and commercialization of proprietary recombinant therapeutic proteins expressed through its proprietary plant cell based expression system.

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