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Protalix BioTherapeutics,
Inc.
PLX announced today that the Mexican Federal
Commission for the Protection against Sanitary Risk (COFEPRIS) and the Public
Health Institute of Chile have both granted regulatory approval to UPLYSO™
(alfataliglicerase) for the long-term enzyme replacement therapy for adults
with a confirmed diagnosis of Type I Gaucher disease. UPLYSO will be marketed
in Mexico and Chile by Pfizer Inc., the Company's commercialization partner.
UPLYSO is known as ELELYSO™ (taliglucerase alfa) outside of Latin America.
Taliglucerase alfa was approved by the U.S. Food and Drug Administration in
May 2012 and subsequently has been approved by Israel's Ministry of Health,
Brazil's ANVISA and by the regulatory authorities of other countries.
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