Protalix BioTherapeutics' (PLX) Alfataliglicerase Approved in Brazil for the Treatment of Certain Gaucher Disease

November 22, 2016 9:26 AM EST

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Protalix BioTherapeutics, Inc. (NYSE: PLX) announced that the Brazilian National Health Surveillance Agency (ANVISA, Agencia Nacional de Vigilancia Sanitaria) has granted regulatory approval for alfataliglicerase as a long-term enzyme replacement therapy for children four years old and above with a confirmed diagnosis of Type I Gaucher disease. Gaucher disease is a rare lysosomal storage disorder, with approximately 700 patients treated in Brazil. Brazil has the third largest number of identified Gaucher patients worldwide, after the United States and Israel.

Alfataliglicerase was approved by ANVISA in March 2013 for long-term enzyme replacement therapy (ERT) for adults with a confirmed diagnosis of Type I Gaucher disease.

“ANVISA’s approval of a pediatric indication for alfataliglicerase is an important milestone for Protalix in our commitment to the Gaucher community,” commented Moshe Manor, Protalix’s President and Chief Executive Officer. “It is also an important element in our ongoing advanced negotiations with the Brazilian Ministry of Health, as alfataliglicerase is now approved for the majority of Gaucher patients in Brazil. It is estimated that pediatric patients represent approximately 30% of the total Gaucher patient population in Brazil.”

Pursuant to the Company’s amended and restated exclusive license and supply agreement with Pfizer Inc. of October 2015, the Company owns all rights to alfataliglicerase in Brazil.



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