Protalix is a biopharmaceutical company focused on the development and commercialization of recombinant therapeutic proteins through its ProCellEx® plant cell-based protein expression system. Using ProCellEx, Protalix is developing a proprietary pipeline of proprietary, biobetter versions of recombinant therapeutic proteins, based on our plant cell-based expression technology, that primarily target large, established pharmaceutical markets and that rely upon known biological mechanisms of action. Our initial commercial focus has been on complex therapeutic proteins, including proteins for the treatment of genetic disorders, such as Gaucher disease and Fabry disease. With our experience, and having successfully developed Elelyso, our first drug product, we believe ProCellEx will enable us to develop additional proprietary recombinant proteins that are therapeutically superior to existing recombinant proteins currently marketed for the same indications. Because we are primarily targeting biologically superior versions of highly active, well-tolerated and commercially successful therapeutic proteins, we believe our development process is associated with relatively less risk compared to other biopharmaceutical development processes for completely novel therapeutic proteins. We are now also applying the unique properties of our ProCellEx system for the oral delivery of therapeutic proteins.
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, by the Brazilian National Health Surveillance Agency (ANVISA) in March 2013, by the Australian Therapeutic Goods Administration (TGA) in May 2014, by Health Canada in May 2014. In addition, it has been approved by the applicable regulatory authorities in Uruguay, Mexico and Chile. 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.