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May 11, 2012

FDA Approves use of GM Carrot Cells in First Plant Cell-Based ERT for Treating Gaucher Disease

GM Carrot Cells Used to Create ELELYSO™ - First Plant Cell Enzyme Replacement Therapy 

GM carrot cells form the base of the first plant-cell enzyme replacement therapy (ERT) approved by the U.S. Food and Drug Administration (FDA) on 1 May 2012.  The approved ERT was created by Pfizer Inc.and Protalix BioTherapeutics, Inc. It is trademarked as ELELYSO™ (taliglucerase alfa).  It is a form of the human lysosomal enzyme, glucocerebrosidase, used to treat type 1 Gaucher disease.  It is the first plant cell-expressed drug made by ProCellEx®, Protalix's proprietary manufacturing system.

GM carrots being processed in Protalix's bioreactor plant cell system. 
This system 
was created to manufacture a range of proteins, including antibodies, complexenzymes and plant-derived pharmaceuticals.  Photo: Protalix
Gaucher disease is an inherited lysosomal storage disorder in humans that affects an estimated 10,000 people worldwide.  This can lead to enlargement of the liver and spleen, various forms of bone disease, easy bruising, and anemia (a low number of red blood cells). Type 1 Gaucher disease, the most common, is found at a higher frequency among individuals who are of Ashkenazi Jewish ancestry.

Pfizer and Protalix BioTherapeutics, Inc. teamed to develop and commercialize ELELYSO™  on 30 November 2009.  Under their agreement, Protalix has retained exclusive commercialization rights in Israel, while Pfizer received exclusive licensing rights for the commercialization in all other markets. 

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About Margaret

CEO and Curator (The Food Museum) | Managing Director and Chief Editor (GR2 Global LLC) | Educator (UCLA PhD) | Researching and writing on global food issues, nutrition and health, sustainability, history (preservation), conservation (natural resources), and design.
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