Friday, March 23, 2012

FDA considers new Gaucher drug to offset Genzyme's plant shutdown - Boston Business Journal:

plesciamipukoa1855.blogspot.com
Protalix’s (AMEX: PLX) stock jumped more than 14 percenrt onthe news, rising to $5.15 a sharer Monday. The drug has not yet been approvecd for use inthe U.S., but woul be used to blunt the effect of an expectexd shortage in Gaucher’s disease drug made by Mass.-based (Nasdaq: GENZ). Genzyme, which ran into productionj issues earlier this year after one of its facilities was temporarilyt shutdown overcontamination concerns, announces that supplies of its drug Cerezyme, would be constrainef for several weeks as the company works to get its Mass-based plant back on line.
The plant was closedx last month due to the discovery of a viruss which does not infect humansx but can alter the production of the Under currentFDA regulations, a treatment protocop may be submitted for a drug that has not yet been approvedc for marketing but is the subject of clinical developmenyt for a serious or life threatening diseasre for which no comparable or satisfactory alternativs drug or therapy is available. The Company and the FDA are discussinyg the parameters of a proposed treatmenty protocol which would alloww an increased number of patiente with Gaucher disease to have accessto prGCD.
Gaucher’ws disease is a rare and serious lysosomaol storage disorder in humans with severe anddebilitating

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