Protalix BioTherapeutics, Inc., has announced that the Israeli Ministry of Health has completed a successful GMP (Good Manufacturing Practice) audit of the Company's manufacturing facility in Carmiel, Israel. The audit was performed as part of the Ministry of Health's evaluation of the company's manufacturing process of taliglucerase alfa for the treatment of Gaucher disease.
"The successful audit of our manufacturing facility by the Israeli Health Ministry is another important milestone toward our plans to commercialize taliglucerase alfa in Israel and throughout the world," said Dr. David Aviezer, President and CEO of Protalix. "This important achievement helps to demonstrate the viability, quality and commercial potential of our proprietary plant-cell based technology platform."
In February 2010, the company announced Phase III data at the Lysosomal Disease Network's WORLD symposium. The study, which reached its primary endpoint, demonstrated a mean reduction in spleen volume in both treatment arms studied (60 U/kg, 30 U/kg taliglucerase alfa) in patients with Gaucher disease in a highly significant statistical manner. In this study, taliglucerase alfa was well tolerated, no serious or severe adverse events were reported, a low (6 level of antibody formation was found and there was no neutralizing antibody formation.