Protalix is a biopharmaceutical company that is revolutionizing the development and manufacturing of recombinant therapeutic proteins through its ProCellEx® plant cell-based protein expression system. Using ProCellEx, Protalix is focused on the development and commercialization of a proprietary pipeline of novel and biosimilar proteins that target large, established pharmaceutical markets and that rely upon known biological mechanisms of action. Protalix’s initial commercial focus is on complex therapeutic proteins for the treatment of genetic disorders, such as Gaucher disease and Fabry disease. Protalix is also advancing additional recombinant biopharmaceutical drug development programs, including a TNF inhibitor for inflammatory diseases.
Protalix’s pipeline is led by ELELYSO™(taliglucerase alfa for injection), which was approved for marketing by the U.S. Food and Drug Administration on May 1, 2012, by Israel's Ministry of Health in September 2012 and by the Brazilian National Health Surveillance Agency (ANVISA) on March 18, 2013. It also has been approved in Uruguay. In Latin America, ELEYSO is known as UPLYSO™ (alphataliglucerase). ELELYSO is the first FDA-approved plant cell-based recombinant therapeutic protein. Protalix has partnered with Pfizer for worldwide development and commercialization of ELELYSO, excluding Israel, where Protalix has retained full rights. Additional regulatory submissions are in progress elsewhere throughout the world.
Protalix also has an ongoing Phase I/II clinical trial of PRX-102 in adult patients with Fabry disease. PRX-102 is an enzyme being developed as a long-term enzyme replacement therapy in patients with Fabry disease. Protalix is also developing an orally delivered glucocerebrosidase (GCD) enzyme for the potential treatment of Gaucher disease and has initiated a Phase I clinical trial of oral GCD in Israel. As with development of ELEYSO, PRX-102 and oral GCD are being developed with the ProCellEx platform.