Protalix Files Validation Data For Taliglucerase Alfa Manufacturing Process To FDA

Protalix BioTherapeutics said that it has made the submission in response to a request from the FDA for validation data from its upgraded manufacturing facility. The FDA is currently reviewing the Protalix BioTherapeutics’ new drug application (NDA) for Taliglucerase alfa for the treatment of Gaucher disease.

Reportedly, Taliglucerase alfa has been granted orphan drug status and fast track designation in the US. Protalix BioTherapeutics continues to make Taliglucerase alfa available to Gaucher patients in the US under an Expanded Access protocol, as well as to patients in the EU, Israel and other countries under Named Patient provisions.

Earlier, on December 1, 2009, Pfizer and Protalix entered into an agreement to develop and commercialise Taliglucerase alfa. The agreement gives Pfizer exclusive worldwide licensing rights to commercialise Taliglucerase alfa while Protalix retains commercialisation rights in Israel.