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 developing a proprietary pipeline of biobetter and biosimilar recombinant proteins that primarily 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. Protalix is now also applying the unique properties of its ProCellEx system for the oral delivery of therapeutic proteins, with the first two product candidates being glucocerebrosidase and antiTNF fusion protein, and we are performing research focused on the oral delivery of antibodies.
ELELYSO™ (taliglucerase alfa for injection), Protalix’s first commercial product, was approved for marketing by the U.S. Food and Drug Administration in May 2012, by Israel's Ministry of Health in September 2012 and by the Brazilian National Health Surveillance Agency (ANVISA) in March 2013. It also has been approved by the applicable regulatory authorities in Uruguay, Mexico, Chile and other countries. In Latin America, ELEYSO is known as UPLYSO™ (alphataliglicerase). ELELYSO is the first FDA-approved plant cell-based recombinant therapeutic protein. Additional regulatory submissions are in progress elsewhere throughout the world.
Since its approval, ELELYSO has been marketed in the United States by Pfizer Inc., Protalix’s commercialization partner. In November 2009, Protalix granted Pfizer an exclusive, worldwide license to develop and commercialize taliglucerase alfa, but retained those rights in Israel. In June 2013, Pfizer transferred the commercialization rights in the Brazilian market back to Protalix. Protalix has been marketing ELELYSO in Israel since its 2012 approval.