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protalix biotherapeutics inc (PLX) Details

Protalix BioTherapeutics, Inc., a biopharmaceutical company, together with its subsidiary, Protalix Ltd., focuses on the development and commercialization of recombinant therapeutic proteins based on its proprietary ProCellEx protein expression system. It offers taliglucerase alfa for injection, which is marketed under the ELELYSO brand name, as an enzyme replacement therapy for the long-term treatment of adult patients with a confirmed diagnosis of type 1 Gaucher disease. The company’s product pipeline includes PRX-102, a therapeutic protein candidate for the treatment of Fabry disease; PRX-112, an orally administered glucocerebrosidase enzyme for the treatment of Gaucher patients utilizing oral delivery of the recombinant glucocerebrosidase enzyme produced and encapsulated within carrot cells; and PRX-106, an oral antiTNF, a plant cell expressed recombinant fusion protein combined of the binding domain of the human TNF receptor and an antibody portion, which is being developed for the treatment of certain immune and inflammatory diseases, such as rheumatoid arthritis, colitis, Crohn’s disease, psoriasis, and other autoimmune and inflammatory disorders. Its product pipeline also comprises PRX-110, a proprietary plant cell recombinant human Deoxyribonuclease 1 under development for the treatment of Cystic Fibrosis, to be administered by inhalation; and PRX-107, a proprietary plant cell recombinant human Alpha1-antitrypsin and others. The company has a collaboration and licensing agreement with Teva Pharmaceutical Industries Ltd. to develop and manufacture two proteins using its ProCellEx protein expression system. Protalix BioTherapeutics, Inc. was founded in 1993 and is based in Carmiel, Israel.

260 Employees
Last Reported Date: 03/13/14
Founded in 1993

protalix biotherapeutics inc (PLX) Top Compensated Officers

Chief Executive Officer, President, Executive...
Total Annual Compensation: $577.7K
Founder, Executive Vice President of Research...
Total Annual Compensation: $422.9K
Chief Financial Officer, Principal Accounting...
Total Annual Compensation: $402.1K
Chief Operating Officer
Total Annual Compensation: $251.7K
Senior Vice President of Product Development
Total Annual Compensation: $361.5K
Compensation as of Fiscal Year 2013.

protalix biotherapeutics inc (PLX) Key Developments

Pfizer Inc. and Protalix BioTherapeutics, Inc. Announce FDA Approval of Pediatric Indication for ELELYSO (Taliglucerase Alfa) for Injection, for Intravenous Use for the Treatment of Type 1 Gaucher Disease

Pfizer Inc. and Protalix BioTherapeutics, Inc. announced that the U.S. Food and Drug Administration (FDA) approved ELELYSO(TM) (taliglucerase alfa) for injection for pediatric patients. ELELYSO is therefore now indicated for long-term enzyme replacement therapy (ERT) for adult and pediatric patients with a confirmed diagnosis of Type 1 Gaucher disease. The safety and efficacy of ELELYSO were assessed in fourteen pediatric patients with Type 1 Gaucher disease in two clinical trials. The first trial consisted of nine patients in a 12-month, multi-center, double-blind, randomized study in treatment-naïve patients aged two to 13 years. At the end of the 12-month study, therapeutic efficacy of ELELYSO was demonstrated, as measured by a decrease in spleen and liver volume and an increase in platelet count. A second trial consisted of 5 pediatric patients aged 6 to 16 years who were switched from imiglucerase to ELELYSO. The trial was a 9-month, multi-center, open-label, single-arm study in patients who had been receiving treatment with imiglucerase at dosages ranging from 9.5 units/kg to 60 units/kg every other week for a minimum of 2 years. ELELYSO was administered for 9 months at the same dose as each patient's previous imiglucerase dose. If needed, adjustment of dosage was allowed during the study in order to maintain stability of clinical parameters. Mean spleen and liver volume, platelet count and hemoglobin value remained stable through 9 months of ELELYSO treatment. The recommended dosage of ELELSYO for treatment-naïve adult and pediatric patients four years of age and older is 60 units per kg of body weight administered every other week as a 60 to 120 minute intravenous infusion. Patients previously treated on a stable dosage of imiglucerase are recommended to begin treatment with ELELYSO at that same dosage when they switch from imiglucerase to ELELYSO. Dosage adjustments can be made based on achievement and maintenance of each patient's therapeutic goals.

Protalix BioTherapeutics, Inc. Appoints Shlomo Yanai as Chairman

Protalix BioTherapeutics, Inc. announced that it has chosen Mr. Shlomo Yanai as Chairman of the company's Board of Directors, effective on July 24, 2014. Mr. Zeev Bronfeld, the interim Chairman of the Board, will remain a member of the Board of Directors. Currently, Mr. Yanai is a member of the Board of Governors of The Technion. Mr. Yanai is also the Chairman of the Board of Directors of Cambrex Corporation, and is on the board of Lumenis Ltd.

Protalix BioTherapeutics, Inc. Announces New Data on ELELYSO (taliglucerase alfa) Presented at the European Working Group on Gaucher Disease 2014 11th Meeting

Protalix BioTherapeutics, Inc. announced that new clinical data on ELELYSO (taliglucerase alfa) will be presented at the European Working Group on Gaucher Disease 2014 11th Meeting being held June 25-28 in Haifa, Israel. ELELYSO, the Company's first commercial product, is the first FDA-approved plant cell-based enzyme replacement therapy for Gaucher disease. A total of 14 patients completed the 36 months of treatments with taliglucerase alfa, at which point all patients remained clinically stable. The disease parameters that were evaluated were similar to baseline after 36 months of treatment, suggesting ongoing disease stability. These parameters included levels of hemoglobin: (Base line: 13.4 g/dL- 36 Months: 13.3 g/dL), platelet count: (Base line: 167,940 /mm(3) - 36 Months: 170,286 /mm(3)), spleen volume (Base line: 4.6 MN- 36 Months: 3.7 MN), liver volume (Base line: 1.0 MN- 36 Months: 1.0 MN), [MN = Multiples of the Normal size according to body weight] and chitotriosidase activity (reduction of -51.5% after 36 Months). In addition, adverse events were evaluated, all treatment-related adverse effects were mild or moderate in severity and transient in nature.


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