European Commission Issues Decision on Taliglucerase Alfa Marketing Authorization Application
10:34AM ET on Thursday Nov 01, 2012 by GlobeNewswire
Pfizer Inc. (NYSE:PFE) and Protalix BioTherapeutics, Inc. (NYSE-MKT:PLX, TASE:PLX) today announced that the European Commission (EC) has issued a Commission Decision refusing the Marketing Authorization for taliglucerase alfa, an enzyme replacement therapy (ERT) for the treatment of Gaucher disease. The EC has endorsed the European Medicines Agency (EMA)'s Committee for Medicinal Products for Human Use (CHMP) recommendation not to issue a Marketing Authorization for taliglucerase alfa in the European Union. The CHMP recommendation was not related to the safety, quality or efficacy of taliglucerase alfa, but solely to the specific requirements of the European Union (EU) Orphan Drug Regulation.
As first disclosed on June 22, 2012, the CHMP issued its Opinion on taliglucerase alfa and gave a positive risk-benefit assessment concluding that the benefits of the medicine outweighed its risks in the treatment of Type 1 Gaucher disease. Despite the positive risk-benefit assessment, the CHMP could not recommend Marketing Authorization due to the fact that Shire plc (Shire)'s velaglucerase alfa had received prior Marketing Authorization with orphan drug designation for the same condition. Therefore, Shire's treatment has orphan market exclusivity in the EU for a ten-year period commencing on its authorization in August 2010. Pfizer pursued a request for derogation from Shire's orphan market exclusivity based on a number of factors but the request was denied.