UPDATE: Pfizer, Protalix Receive ANVISA Approval for UPLYSO in Brazil

Pfizer Inc.

and Protalix BioTherapeutics, Inc.

announced today that the Brazilian National Health Surveillance Agency (ANVISA, Agencia Nacional de Vigilancia Sanitaria) has granted regulatory approval to UPLYSO™ (alfataliglicerase) for the long-term enzyme replacement therapy for adults with a confirmed diagnosis of Type I Gaucher disease. Gaucher disease is a rare lysosomal storage disorder that affects approximately 10,000 people worldwide. UPLYSO is known as ELELYSO™ (taliglucerase alfa) outside of Latin America. ELELYSO was approved by the United States Food and Drug Administration in May 2012 and by Israel's Ministry of Health in September 2012 for the long-term enzyme replacement therapy (ERT) for adults with a confirmed diagnosis of Type I Gaucher disease. The ANVISA approval comes after the approval of UPLYSO by the Ministry of Public Health in Uruguay in November 2012.