Protalix Wins FDA Approval as Multi-Product Facility

Protalix BioTherapeutics received approval from the FDA for a Supplemental New Drug Application (sNDA) allowing the company to convert its manufacturing facility in Carmiel, Israel, from a single dedicated product facility to a multi-product facility.

The conversion of the facility will serve the company’s production needs for the anticipated commercialization of pegunigalsidase alfa (PRX-102) for the treatment of Fabry disease together with the current and expected increase in the manufacturing of taliglucerase alfa, mainly due to the increased activities in Brazil. Protalix expects that the conversion will allow significant operational savings as it progresses towards the anticipated commercialization of pegunigalsidase alfa.

"We have been producing drug substance for our clinical trials of pegunigalsidase alfa in our facility and have already upgraded our manufacturing facility to become a multi-product facility to support the potential manufacturing of both pegunigalsidase alfa and taliglucerase alfa in a commercial scale," said Moshe Manor, Protalix’s president and chief executive officer.  "Given the unique aspects of our ProCellEx protein expression system, the conversion of the facilities did not entail substantial additional capital expenditures and will allow us to use our capital resources more efficiently in the commercial production of pegunigalsidase alfa, if approved.  We are excited to have reached this milestone in our progression towards the commercialization of pegunigalsidase alfa alongside the expected increase in activities in Brazil."