Protalix BioTherapeutics, Inc., a biopharmaceutical company, focuses on the development and commercialization of recombinant therapeutic proteins based on its proprietary ProCellEx protein expression system, or ProCellEx. ELELYSO ELELYSO (taliglucerase alfa) is a plant cell expressed recombinant glucocerebrosidase (GCD) enzyme for the treatment of Gaucher disease. PRX-102 for the Treatment of Fabry Disease The company is developing PRX-102, its proprietary plant cell expressed chemically modified version of the recombinant alpha-GAL-A protein, a therapeutic enzyme, for the treatment of Fabry disease, a rare genetic lysosomal storage disorder. PRX-112; Orally Administered GCD for the Treatment of Gaucher Disease The company is developing PRX-112, an orally-delivered GCD enzyme for the potential enzyme replacement therapy treatment of Gaucher disease. This is representative of a potential method for delivering active recombinant proteins systemically through oral administration of plant cells expressing biotherapeutic proteins. The company completed a phase I clinical trial of oral GCD in Israel for which it announced results in February 2014. The company is developing other recombinant therapeutic proteins to be expressed by its ProCellEx protein expression system, with an emphasis on treatments for which there are large, established pharmaceutical markets and where its proprietary protein expression system enables it to develop and commercialize recombinant proteins that are patent-protected and therapeutically equivalent or superior to the existing treatments. The company selects additional therapeutic candidates for development by testing candidates in-house and through collaborations with academic partners. PRX-106; Oral antiTNF (Tumor, Necrosis Factor) The company’s oral antiTNF product candidate is a recombinant antiTNF protein that it is expressing through ProCellEx. The company is developing oral antiTNF an orally-administered treatment for immune mediated disorders using plant cells as a natural capsule for the expressed protein. The company is conducting additional preclinical studies on oral antiTNF for various attractive indications. PRX-110; deoxyribonuclease I (DNase I) PRX-110 is the company’s plant cell recombinant form of human DNase I that it is developing for the potential treatment of Cystic Fibrosis, to be administered by inhalation. DNase I cleaves extracellular DNA and thins the thick mucus that accumulates in the lungs of Cystic Fibrosis patients. Intellectual Property As of December 31, 2013, the company had license rights to 49 patents and 89 pending patent applications with respect to various compositions, methods of production and methods of use relating to its ProCellEx protein expression system and its proprietary product pipeline. As of December 31, 2013, it held, with a third party, one joint patent and one joint patent application, and licensed rights to five patents and six patent applications. As of December 31, 2013, the company’s patent portfolio consists of various patent families (consisting of patents and/or patent applications) covering its technology, protein expression methodologies and system and product candidates, as follows: With respect to its ProCellEx protein expression system, the company has been issued, and holds licensed rights to, 19 patents in the United States, Australia, the European Union, Israel, Canada, the Czech Republic, Hungary, Japan, Poland, Mexico, Hong Kong, India and Korea, and to 3 pending patent applications. Among other things, the patents cover the methods that the company uses for culturing and harvesting plant cells and/or tissues in consecutive cycles. Of the issued patents in this family, 13 are expected to expire in 2017 and 6 are expected to expire in 2025. With respect to its ProCellEx protein expression system, the company holds 2 issued patents and 14 patent applications relating to the large scale production of proteins in cultured plant cells. The issued patents and any patents to issue in the future based on pending patent applications in this patent family are expected to expire in 2028.
protalix biotherapeutics inc
2 Snunit Street
Phone: 972 4 988 9488
Fax: 972 4 988 9489www.protalix.com
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