Protalix BioTherapeutics is a biopharmaceutical company focused on the development, production, and commercialization of recombinant therapeutic proteins produced by its proprietary ProCellEx plant-cell-based protein expression system. The company's pipeline consists of proprietary, potentially clinically superior versions of recombinant therapeutic proteins that target established pharmaceutical markets. Protalix gained FDA approval for a plant-cell culture-expressed protein. Elelyso (taliglucerase alfa for injection) is the company's first drug product produced by ProCellEx. Elelyso was approved for marketing by the FDA in May 2012, soon followed by approval from multiple regulatory agencies including the EMA, Australian TGA, Brazilian ANVISA, and the Israeli Ministry of Health. The product has been licensed to Pfizer. The Protalix ProCellEx platform has the ability to manufacture complex proteins, antibodies, and vaccines and to orally deliver certain therapeutic proteins as demonstrated in animal models.