Pfizer, Protalix Submit MAA for Gaucher Disease Drug

Pfizer and Protalix BioTherapeutics have submitted a Marketing Authorization Application to the EMA for taliglucerase alfa, a plant-cell expressed form of glucocerebrosidase (GCD), for the treatment of Gaucher disease. Taliglucerase alfa was granted orphan designation by the European Commission for this indication in March 2010.

In November 2009, the two companies entered into an agreement to develop and commercialize taliglucerase alfa. Pfizer has exclusive worldwide licensing rights for the commercialization of taliglucerase alfa, while Protalix retains exclusive commercialization rights in Israel.

An NDA for taliglucerase alfa has been accepted by the FDA and assigned a Prescription Drug User Fee Act (PDUFA) action date of February 25, 2011. Taliglucerase alfa is currently available to patients with Gaucher disease in the U.S. under an Expanded Access protocol as well as several member states of the EU, Israel and other countries under Named Patient provisions.