Release Details

CARMIEL, Israel, Jan. 30, 2020 /PRNewswire/ -- Protalix BioTherapeutics, Inc. (NYSE American: PLX) (TASE: PLX), a biopharmaceutical company focused on the development, production and commercialization of recombinant therapeutic proteins produced by its proprietary ProCellEx^® plant cell-based protein expression system, today announced that it will deliver an oral presentation and three poster presentations on its pegunigalsidase alfa candidate for the treatment of Fabry disease at the 16^th Annual WORLDSymposium™ 2020, taking place February 10-13, 2020 at the Hyatt Regency Orlando in Florida.

Presentation Details:

• "Pegunigalsidase alfa, a novel PEGylated ERT, evaluated in Fabry patients with progressing kidney disease, RCT study design," to be presented by Dr. David G. Warnock, of the University of Alabama at Birmingham, a principal investigator in the Company's BALANCE phase III clinical trial of PRX-102 for the treatment of Fabry disease. 
• Poster presentation is scheduled from 4:30-6:30 PM EST on Wednesday, February 12, 2020 (Poster # 415).
• Oral presentation is scheduled for Thursday, February 13, 2020 at 8:45 AM EST.
• "Pegunigalsidase alfa, PEGylated α-Galactosidase-A enzyme in development for the treatment of Fabry disease, shows correlation between renal Gb3 inclusion clearance and reduction of plasma Lyso-Gb3," to be presented by Dr. Derralynn Hughes of University College London in London, UK, a principal investigator in the Company's phase III clinical trial of pegunigalsidase alfa for the treatment of Fabry disease, on Tuesday, February 11, 2020 from 4:30-6:30 PM EST (Poster #176).
• "Switching from agalsidase alfa to pegunigalsidase alfa for treating Fabry disease : One year of treatment data from BRIDGE, a phase III open label study," to be presented by Dr. Ales Linhart, of Charles University in Praha, Czech Republic, a principal investigator in the Company's phase III clinical trial of PRX-102 for the treatment of Fabry disease. The poster presentation is scheduled from 4:30-6:30 PM EST on Tuesday, February 11, 2020 (Poster # 240).

Copies of the posters and oral presentation will be made available on the Company's website under the Presentation tab in the Investors section at the time of the poster sessions.

About Pegunigalsidase Alfa

Pegunigalsidase alfa (PRX102) is an investigational, plant cell culture-expressed, and chemically modified stabilized version of the recombinant α-Galactosidase-A enzyme. Protein sub-units are covalently bound via chemical cross-linking using short PEG moieties, resulting in a molecule with unique pharmacokinetic parameters. In clinical studies, pegunigalsidase alfa has been observed to have a circulatory half-life of approximately 80 hours. The Company designed pegunigalsidase alfa to potentially address the continued unmet clinical need in Fabry patients of continuous disease progression, infusion reactions and immunogenicity.

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 was the first company to gain U.S. Food and Drug Administration (FDA) approval of a protein produced through plant cell-based in suspension expression system. Protalix's unique expression system represents a new method for developing recombinant proteins in an industrial-scale manner.

Protalix's first product manufactured by ProCellEx, taliglucerase alfa, was approved for marketing by the 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 consists of proprietary, potentially clinically superior versions of recombinant therapeutic proteins that target established pharmaceutical markets, including the following product candidates: pegunigalsidase alfa, a modified version of the recombinant human α-Galactosidase-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 has 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
Chuck Padala, Managing Director
LifeSci Advisors
+1-646-627-8390
chuck@lifesciadvisors.com

Media Contact
Doug Russell
LaVoieHealthScience
+1-617-953-0120
drussell@lavoiehealthscience.com

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SOURCE Protalix BioTherapeutics, Inc.