PROTALIX BIOTHERAPEUTICS, INC. (PLX)

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Protalix BioTherapeutics’ PRX-102 Granted Orphan Drug Designation by the European Commission

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®, announced today that the European Commission granted Orphan Drug Designation (ODD) for pegunigalsidase alfa, or PRX-102, for the treatment of Fabry disease.
The decision by the Commission confirms the opinion previously issued by the European Medicine Agency’s (EMA) Committee for Orphan Medicinal Products (COMP), which the Company announced on November 13, 2017. Orphan drug designation for pegunigalsidase alfa qualifies the sponsor for access to the centralized marketing authorization procedure, including applications for inspections and for protocol assistance.

If the orphan drug designation is maintained at the time PRX-102 is approved for marketing in the EU, the Company expects that PRX-102 will benefit from ten years of market exclusivity within the European Union.