Protalix Wins FDA’s Orphan Drug Designation For prGCD

Protalix BioTherapeutics (Protalix) has received notice from the FDA that the FDA’s Office of Orphan Products Development has granted orphan drug designation to prGCD. prGCD is company’s proprietary plant cell expressed recombinant form of glucocerebrosidase (GCD) for the treatment of Gaucher disease.

prGCD is currently being evaluated for the treatment of Gaucher disease in a phase III clinical trial which is scheduled to end this month. The company plans to announce top-line results from the phase III trial in October 2009, and to complete filing of an NDA with the FDA before the end of the year.

In addition, after the FDA’s recent approval of the company’s treatment protocol for prGCD, the company has filed applications for medical Institutional Review Board (IRB) approvals in hospitals worldwide and expects to start treating patients under the extended access treatment protocol.

David Aviezer, president and CEO of Protalix, said: “The FDA’s orphan drug designation further strengthens our prGCD program for treating Gaucher disease by offering important clinical development and commercialisation benefits.”