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CARMIEL, Israel, April 29, 2013 (GLOBE NEWSWIRE) -- Protalix BioTherapeutics, Inc. (NYSE-MKT:PLX) (TASE: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.
"We are very happy that UPLYSO may now be made available as an additional treatment alternative to Gaucher patients in Mexico and Chile," stated Dr. Raul Chertkoff, the Company's Vice President, Medical Affairs. "Including Mexico and Chile, UPLYSO has been reviewed and approved by six different regulatory authorities across the globe. Through our joint efforts with Pfizer, we are working on expanding the commercial potential for UPLYSO in additional countries."
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
®, the Company'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.
On November 30, 2009, the Company entered into an agreement with Pfizer to develop and commercialize taliglucerase alfa/alfataliglicerase. Under the terms of the agreement, the Company retained the exclusive commercialization rights in Israel, while Pfizer received exclusive licensing rights for commercialization in all other markets.
Indication for ELELYSO in the United States
ELELYSO™ (taliglucerase alfa) for injection is a hydrolytic lysosomal glucocerebroside-specific enzyme indicated for long-term enzyme replacement therapy (ERT) for adults with a confirmed diagnosis of Type 1 Gaucher disease.