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Protalix BioTherapeutics to Present Preliminary Data from the BRIDGE Study of pegunigalsidase alfa for the Treatment of Fabry Disease at the 1st Canadian Symposium on Lysosomal Diseases 2018

September 17, 2018

CARMIEL, Israel, Sept. 17, 2018 (GLOBE NEWSWIRE) -- Protalix BioTherapeutics, Inc. (NYSE American:PLX) (TASE:PLX), a biopharmaceutical company focused on the development and commercialization of recombinant therapeutic proteins expressed through its proprietary plant cell-based expression system, ProCellEx®, today announced that the Company will present preliminary data from the BRIDGE study of pegunigalsidase alfa for the treatment of Fabry disease at the 1st Canadian Symposium on Lysosomal Diseases 2018. The conference will take place October 5-6, 2018 at the OTL Gouverneur Hotel in Sherbrooke, Quebec.

An oral presentation titled, “Pegunigalsidase Alfa-a Novel Enzyme Replacement Therapy for the Treatment of Fabry Disease: Preliminary Results from the Phase III Bridge Study,” will be presented by Dr. Michael L. West, Professor of Medicine and Assistant Dean of Clinical Trial Research, Dalhousie University, Halifax, Nova Scotia and Director of the Nova Scotia Fabry Disease Clinic on Friday, October 5 at 10:15 am ET.

Pegunigalsidase alfa, or PRX-102, is the Company’s plant cell-expressed recombinant, PEGylated, cross-linked α-galactosidase-A candidate for the treatment of Fabry disease. The BRIDGE study is an open-label, single arm switch-over study to assess the safety and efficacy of pegunigalsidase alfa, 1 mg/kg infused every two weeks, in Fabry patients currently treated with Replagal®. The data to be presented will include kidney function for the first 16 patients who have completed six months of treatment with PRX-102.

A copy of the oral presentation will be available on Protalix’s website under the Presentation tab in the Investors section following the conference.

About Protalix BioTherapeutics, Inc.

Protalix is a biopharmaceutical company focused on the development and commercialization of recombinant therapeutic proteins expressed through its proprietary plant cell-based expression system, ProCellEx®. Protalix’s unique expression system presents a proprietary method for developing recombinant proteins in a cost-effective, industrial-scale manner. Protalix’s first product manufactured by ProCellEx, taliglucerase alfa, was approved for marketing by the U.S. Food and Drug Administration (FDA) in May 2012 and, subsequently, by the regulatory authorities of other countries. Protalix has licensed to Pfizer Inc. the worldwide development and commercialization rights for taliglucerase alfa, excluding Brazil, where Protalix retains full rights. Protalix’s development pipeline includes the following product candidates: pegunigalsidase alfa, a modified version of the recombinant human alpha-GAL-A protein for the treatment of Fabry disease; OPRX-106, an orally-delivered anti-inflammatory treatment; alidornase alfa for the treatment of Cystic Fibrosis; and others. Protalix partnered with Chiesi Farmaceutici S.p.A., both in the United States and outside the United States, for the development and commercialization of pegunigalsidase alfa.

Investor Contact

Marcy Nanus, Managing Director Solebury Trout 646-378-2927 mnanus@soleburytrout.com

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