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Pfizer files Taliglucerase alfa MAA to European Medicines Agency

Pfizer has submitted a marketing authorisation application (MAA) for Taliglucerase alfa, a plant-cell expressed form of glucocerebrosidase (GCD) for the treatment of Gaucher disease, with the European Medicines Agency.

Pfizer and Protalix BioTherapeutics had entered into an agreement to develop and commercialise Taliglucerase alfa On 30 November 2009.

Under the terms of the agreement, Pfizer received exclusive worldwide licensing rights for the commercialisation of Taliglucerase alfa, while Protalix retained the exclusive commercialisation rights in Israel.

Taliglucerase alfa is available to patients with Gaucher disease in the US 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.