Pfizer and Protalix BioTherapeutics have obtained approval from the Brazilian National Health Surveillance Agency for Uplyso (alfataliglicerase) as type I Gaucher disease therapy.
Uplyso, referred to as Elelyso (taliglucerase alfa) outside of Latin America, is approved as a long-term plant cell-based enzyme replacement therapy (ERT) for adults diagnosed with type I Gaucher disease.
Pfizer Biosimilars general manager Diem Nguyen said, "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."
The ERT, which previously obtained approvals from the US Food and Drug Administration and Israel's Ministry of Health for the same indication, is a form of the human lysosomal enzyme glucocerebrosidase.
Protalix's plant cell-based protein manufacturing system, ProCellEx, leveraged genetically engineered carrot cells to produce Uplyso.
Protalix BioTherapeutics president and chief executive officer David Aviezer said, "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."
On 30 November 2009, Protalix and Pfizer signed a development and commercialization deal for alfataliglicerase.
Under the deal, Pfizer gained exclusive commercialization rights to the product in all markets except Israel where Protalix retained the exclusive commercialization rights.
