(By Balaseshan) Protalix BioTherapeutics Inc. (NYSEAMEX: PLX) said it has signed a dlinical development agreement with Pfizer Inc. (NYSE: PFE) for Elelyso (taliglucerase alfa) to treat Gaucher disease.
The plant-derived enzyme of Elelyso is a recombinant glucocerebrosidase used to treat Gaucher's Disease and is the first plant-made pharmaceutical to win approval by the U.S. Food and Drug Administration.
Protalix will continue to manage, administer and sponsor current, ongoing clinical trials relating to Elelyso. Protalix is currently sponsoring adult and pediatric extension studies of Elelyso. New clinical trials for Elelyso will be conducted and sponsored by Pfizer.
Under the terms of the agreement, Protalix is eligible to receive a milestone payment of $8.3 million upon the achievement of certain near-term clinical development milestones.
This agreement helps to maintain the continuity of the ongoing clinical trials for Gaucher patients and physicians and reinforces the companies' mutual commitment to the Gaucher community.
On November 30, 2009, Pfizer and Protalix entered into an agreement to develop and commercialize taliglucerase alfa, an enzyme replacement therapy for the treatment of Gaucher disease.
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.
Protalix is a biopharmaceutical company focused on the development and commercialization of recombinant therapeutic proteins expressed through its proprietary plant cell based expression system, ProCellEx.
Protalix's first product manufactured by ProCellEx, Elelyso (taliglucerase alfa), was approved for marketing by the U.S. Food and Drug Administration in May 2012, and by the Israeli Ministry of Health in September 2012.
PLX closed Wednesday's regular session at $5.48, while PFE ended at $25.64.