Pfizer and Protalix file for European approval of Gaucher drug taliglucerase

Global pharmaceutical behemoth Pfizer (NYSE: PFE) and Israel’s Protalix BioTherapeutics, (TASE: PLX) have submitted 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.

Pfizer, which is looking to expand in rare diseases, signed an agreement with Protalix last year, giving the drug giant exclusive worldwide licensing rights for the commercialization of taliglucerase alfa, while Protalix retained the exclusive commercialization rights in Israel, which could be worth as much as $115 million to the latter (The Pharma Letter December 2, 2009).

Taliglucerase alfa was granted orphan drug designation by the US Food and Drug Administration in March this year and a New Drug Application 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 USA under an expanded access protocol, as well as to people in several member states of the European Union, Israel and other countries under named patient provisions.