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). Using its ProCellEx system, the company is developing a pipeline of proprietary, clinically superior versions of recombinant therapeutic proteins that primarily target large, established pharmaceutical markets and that in most cases rely upon known biological mechanisms of action. The company’s initial commercial focus has been on complex therapeutic proteins, including proteins for the treatment of genetic disorders, such as Gaucher disease and Fabry disease. Product Pipeline PRX-102: PRX-102, or alpha-GAL-A, is a therapeutic protein candidate for the treatment of Fabry disease, a rare, genetic lysosomal disorder in humans, is in an ongoing phase I/II clinical trial. PRX-106: PRX-106, its oral Anti-TNF (Tumor, Necrosis Factor) product candidate which is being developed as an orally-delivered anti inflammatory treatment using plant cells as a natural capsule for the expressed protein. PRX-110: PRX-110 is a proprietary plant cell recombinant human Deoxyribonuclease 1 (DNase), under development for the treatment of cystic fibrosis, to be administered by inhalation. PRX-112: PRX-112 is an orally administered glucocerebrosidase enzyme for the treatment of Gaucher patients utilizing oral delivery of the recombinant GCD (glucocerebrosidase) enzyme produced and encapsulated within carrot cells. Except for the rights to commercialize taliglucerase alfa worldwide (other than Brazil and Israel), which the company licensed to Pfizer Inc., the company holds the worldwide commercialization rights to all of its proprietary development candidates. Strategy The company’s strategy centers around prioritizing existing and new pipeline candidates to focus on clinically superior products that offer a clear competitive advantage over existing treatments. Its strategy includes the following: aggressively push PRX-102 through clinical development; initiate clinical efficacy trials of oral Anti-TNF; initiate clinical efficacy trials of AIR DNase for the treatment of Cystic Fibrosis (CF); focus on improving the product candidate’s formulation and delivery in order to transform it into a commercially viable product; and expand pipeline by leveraging the advantages of proprietary ProCellEx protein expression technology. Intellectual Property As of December 31, 2014, the company held, or had license rights to 64 patents and 95 pending patent applications with respect to various compositions, methods of production and methods of use relating to ProCellEx protein expression system and its proprietary product pipeline. As of December 31, 2014, 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 The company competes with Actelion Ltd. Competitors developing alternative expression technologies include Crucell N.V. (which was acquired by Johnson & Johnson during 2010), Shire and GlycoFi, Inc. (which was acquired by Merck & Co. Inc.). History Protalix BioTherapeutics, Inc. was founded in 1993.
protalix biotherapeutics inc
2 Snunit Street
Phone: 972 4 988 9488
Fax: 972 4 988 9489www.protalix.com
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