Pfizer Inc. (NYSE: PFE) and Protalix BioTherapeutics, Inc. (NYSE-Amex: PLX, TASE: PLX) announced the submission of a Marketing Authorization Application to the European Medicines Agency 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 the treatment of Gaucher disease on March 23, 2010.
On November 30, 2009, Pfizer and Protalix BioTherapeutics, Inc. entered into an agreement to develop and commercialize taliglucerase alfa. Under the terms of the agreement, Pfizer received exclusive worldwide licensing rights for the commercialization of taliglucerase alfa, while Protalix retained the exclusive commercialization rights in Israel.
Taliglucerase alfa was granted orphan drug designation by the U.S. Food and Drug Administration. A New Drug Application (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 available to patients with Gaucher disease in the United States under an Expanded Access protocol as well as to patients in several member states of the European Union, Israel and other countries under Named Patient provisions.