Protalix BioTherapeutics, Inc., a biopharmaceutical company, focuses on the development and commercialization of recombinant therapeutic proteins based on its proprietary ProCellEx protein expression system (ProCellEx). The company developed its first commercial drug product, Elelyso, using its ProCellEx system and it is focused on utilizing the system to develop a pipeline of proprietary, clinically superior versions of recombinant therapeutic proteins that primarily target pharmaceutical markets and that in majority of cases rely upon known biological mechanisms of action. It is also applying the properties of its ProCellEx system for the oral delivery of therapeutic proteins. Product Pipeline The company is developing a product pipeline using its ProCellEx protein expression system PRX-102 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. In 2015, the company announced the completion of enrollment in its phase I/II clinical trial in adult Fabry patients. AIR DNase (PRX-110) PRX-110 is the company’s plant cell recombinant form of human deoxyribonuclease I (DNase I) that it is developing for the treatment of cystic fibrosis (CF) to be administered by inhalation. DNase I cleaves extracellular DNA and thins the thick mucus that accumulates in the lungs of CF patients. Pulmozyme is the only DNase I commercially available. OPRX-106 The company’s oral antiTNF (Tumor, Necrosis Factor) product candidate is a recombinant antiTNF protein that it is expressing through ProCellEx. OPRX-106 is a plant cell-expressed form of the fused protein that is naturally encapsulated within BY-2 cells genetically engineered to express the enzyme. The company is developing oral antiTNF, an orally-administered anti-inflammatory treatment using plant cells as a natural capsule for the expressed protein. In preclinical studies, oral PRX-106 alleviated immune-mediated hepatitis and reduced interferon gamma levels in a concanavalin A inflammatory mouse model. Except for the rights to commercialize taliglucerase alfa worldwide (other than Brazil), which the company licensed to Pfizer Inc. (Pfizer), it holds the worldwide commercialization rights to all of its proprietary development candidates. Strategy The company’s strategy is to develop proprietary recombinant proteins that are therapeutically superior to existing recombinant proteins marketed for the same indications. Intellectual Property As of December 31, 2015, the company held, or had license rights to, 67 patents and 75 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, 2015, the company held, with a third party, one joint patent and one joint patent application, and licensed rights to two patents. Trademark ProCellEx is the company’s registered trademark. Competition With respect to PRX-110 AIR DNase, the company faces competition from Genentech Inc. and from the producers of CFTR protein potentiation, such as Vertex Pharmaceuticals Incorporated. With respect to PRX-106, the company faces competition from AbbVie Inc., Johnson & Johnson and Merck & Co., Pfizer, and Amgen Inc. History Protalix BioTherapeutics, Inc. was founded in 1993.
protalix biotherapeutics inc
(PLX:Tel Aviv Stock Exchange)
2 Snunit Street
PO Box 455
Phone: 972 4 988 9488
Fax: 972 4 988 9489www.protalix.com
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