Protalix BioTherapeutics Inc was originally incorporated in the State of Florida in April 1992. It is a biopharmaceutical company focused on the development and commercialization of recombinant therapeutic proteins based on its proprietary ProCellEx protein expression system, or ProCellEx. Using its ProCellEx system, it is developing a pipeline of proprietary, clinically superior versions of recombinant therapeutic proteins that target large, established pharmaceutical markets and that rely upon known biological mechanisms of action. Its initial commercial focus has been on complex therapeutic proteins, including proteins for the treatment of genetic disorders, such as Gaucher disease and Fabry disease. The Company has developed ElelysoTM, its first drug product, ProCellEx will enable it to develop additional proprietary recombinant proteins that are therapeutically superior to existing recombinant proteins currently marketed for the same indications. The Company is now also applying the properties of its ProCellEx system for the oral delivery of therapeutic proteins. The Company relies on a single approved supplier for certain materials relating to the current expression of its proprietary biotherapeutic proteins through ProCellEx. It faces competition from companies with approved treatments of Gaucher disease. Some such companies include iBio, Inc., Medicago Inc., and Greenovation Biotech GmbH. The Company has 94 pending patent applications and one joint pending patent application with a third party. The Company is subject to extensive regulation by federal, state and local governmental authorities in the United States, including the FDA, and by similar authorities in other countries.
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