Protalix Biotherapeutics, Inc. (PLX) announced the completion of its New Drug Application submission with the U.S. Food and Drug Administration for taliglucerase alfa, a plant-cell expressed form of glucocerebrosidase for the potential treatment of Gaucher's disease.
The company noted that it reached an agreement with Pfizer Inc. (PFE) on December 1, 2009 to develop and commercialize taliglucerase alfa for the treatment of Gaucher's disease. The agreement gives Pfizer exclusive worldwide licensing rights to commercialize taliglucerase alfa while Protalix retains commercialization rights in Israel.
In addition, Protalix said it has filed its proposed pediatric investigation plan to the pediatric committee of the EMEA for a clinical study in patients between the ages of 2 and 18. This event triggers a milestone payment of $5 million by Pfizer to Protalix according to the agreement between the parties.
by RTT Staff Writer
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