Shortage Could Cause Early Access To Developmental Gaucher Disease Drugs
Shire and Protalix BioTherapeutics' experimental Gaucher disease drugs could enter the market early to help offset likely treatment shortages created by manufacturing problems with the only enzyme replacement therapy currently approved for the orphan condition: Genzyme's Cerezyme
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Lower antibody formation could offer significant differentiation from Genzyme's product.
Market analysts note growing concerns about biotech's ability to handle manufacturing difficulties at Allston Landing, Mass., plant.
In the weeks since Genzyme announced the shutdown of its Allston Landing, Mass., production facility because of viral contamination, the actual severity of the problem has been much debated. On Aug. 10, investors and industry watchers gleaned more about the true extent of the problem, with the Cambridge, Mass.-based big biotech's announcement it had discarded roughly 80 percent of the work-in-process material for Cerezyme (imiglucerase) that remained from when the Allston plant was closed for decontamination in mid-June