Ontology engineering

newsPfizer stakes a claim in plant cell–madebiopharmaceuticals© 2010 Nature America, Inc. All rights reserved.On December 1, Pfizer became the first bigpharma to commit to take to market a latestagebiologic drug produced in plant cells.It acquired rights to taligurase alfa, a form ofthe enzyme glucocerebrosidase in developmentfor the treatment of Gaucher’s disease,from Protalix Biotherapeutics in Carmiel,Israel. Protalix has completed phase 3 studiesand has submitted a new drug application forthe drug, also known as prGCD, eyeing USmarketing approval in 2010. At the request ofthe US Food and Drug Administration (FDA)last year, the company has already begun supplyingprGCD to patients in the US underan expanded access program and similarly topatients in the EU under a compassionateuseprotocol. This apparent comfort level ofregulators, along with the interest of a majordrug company, signals a new level of recognitionof plant cell–based manufacturing as aviable and potentially less expensive alternativeto mammalian and bacterial productionof biopharmaceuticals, including biosimilarversions of existing drugs.Protalix has already collected $65 millionfrom the deal, which gives New York–basedPfizer worldwide rights to prGCD, excludingIsrael, and could earn another $50 million inmilestones. Protalix will continue to manufacturethe drug, which it produces in carrotcells, pay 40% of all expenses going forwardand receive the same percentage of revenuesin return. The company’s prGCD will competewith Genzyme’s Ceredase (alglucerase),a form of the enzyme beta-glucocerebrosidasepurified from human placental tissuethat is modified to be terminated with mannose,and Cerezyme (imiglucerase), a recombinanthuman beta-glucocerebrosidase witha His495→Arg substitution and the samesugar modification. Both of Genzyme’sproducts are indicated for the treatment ofGaucher’s disease, a rare lysosomal storagedisorder resulting from a hereditary deficiencyin the glucocerebrosidase enzyme.Gaucher’s disease is the most prevalentamong the group of lysosomal storage disorders,which have been a historic focus forGenzyme in Cambridge, Massachusetts.This is Pfizer’s first move into the area ofrare and neglected diseases, the result of aprocess the company began a year ago toidentify such opportunities. “Protalix’s nameand technology platform and their work inGaucher’s disease came to the top of thatlist. We approached them in the middle oflast year and things moved fairly quickly,”says Andrew Curtis, biosimilar and orphandrugs director for Pfizer’s established productsbusiness.ProtalixProtalix’s bioreactor plant cell system. The GMP-approved system is set up to manufacture a range ofproteins, including antibodies, complex enzymes and plant-derived pharmaceuticals.nature biotechnology volume 28 number 2 february 2010 107