Protalix Biotherapeutics Inc. (AMEX:PLX; TASE: PLX) and Pfizer Inc. (NYSE: PFE; LSE: PFZ) announced that the European Commission (EC) has refused marketing authorization for taliglucerase alfa (Elylyso), an enzyme replacement therapy for the treatment of Gaucher disease. The EC has endorsed the European Medicines Agency's (EMA) earlier recommendation not to issue marketing authorization for the drug in the EU.
The 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.
However, Elylyso was approved by the US Food and Drug Administration (FDA) in May 2012 for the long term enzyme replacement therapy of adults with a confirmed diagnosis of Type 1 Gaucher disease and was approved by Israel's Ministry of Health in September 2012.
In 2009, Pfizer and Protalix 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.
Published by Globes [online], Israel business news - www.globes-online.com - on November 4, 2012
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