CARMIEL, Israel, Dec. 27, 2017 (GLOBE NEWSWIRE) -- Protalix BioTherapeutics, Inc. (NYSE American:PLX) (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.
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 has entered into an ex-United States partnership with Chiesi Farmaceutici S.p.A. for the development and commercialization of pegunigalsidase alfa. Protalix maintains full rights to pegunigalsidase alfa in the United States.
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