Pfizer submits marketing application for taliglucerase alfa

Pfizer and Protalix BioTherapeutics have applied for marketing authorisation for taliglucerase alfa, a plant-cell expressed form of glucocerebrosidase.

The two firms confirmed that an application has been submitted to the European Medicines Agency for the drug, which will be used in the treatment of Gaucher disease.

Taliglucerase alfa has already been granted orphan designation by the European Commission and the US Food and Drug Administration.

Pfizer and Protalix signed an agreement to develop the drug for commercial use in November last year, with the former company retaining worldwide licensing rights and the latter receiving exclusive commercialisation rights in Israel.

Taliglucerase alfa is already available in several EU member states under named patient provisions.

Gaucher disease is an inherited metabolic disorder that can see harmful quantities of the fatty substance glucocerebroside accumulate in a patient's spleen, liver, lungs, bone marrow and brain.

Last week, Pfizer announced that its subsidiary Parker Tennessee had extended the expiration date of its tender offer for King Pharmaceuticals until Friday December 17th.