NEW YORK and CARMIEL, Israel, March 18, 2013 (GLOBE NEWSWIRE) -- Pfizer Inc. (NYSE:PFE) and Protalix BioTherapeutics, Inc. (NYSE MKT:PLX) (TASE:PLX) 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.
"ANVISA's approval of UPLYSO demonstrates Pfizer's ability to successfully bring therapies for rare diseases to the marketplace," said Diem Nguyen, Ph.D., MBA, general manager, Pfizer Biosimilars. "We are committed to the Gaucher community and look forward to continuing to work closely with our partner Protalix toward our goal of bringing UPLYSO to those living with Gaucher throughout Latin America."UPLYSO is the first plant cell-based ERT for the treatment of Gaucher disease. It is also the first approved plant cell-expressed drug that is derived from ProCellEx ®, Protalix's proprietary plant cell-based protein manufacturing system, using genetically engineered carrot cells. UPLYSO is a form of the human lysosomal enzyme, glucocerebrosidase, used to treat Gaucher disease. "The approval of UPLYSO provides an important treatment option for those in Brazil using enzyme replacement therapy to manage their Gaucher disease and demonstrates the potential of our plant cell manufacturing technology," said David Aviezer, Ph.D., MBA, president and chief executive officer of Protalix BioTherapeutics.