Protalix BioTherapeutics (Carmiel, Israel) received approval from the US Food and Drug Administration on August 17 to proceed with its treatment protocol for prGCD, a development drug for Gaucher's disease. The treatment protocol allows physicians to treat patients of Gaucher disease with prGCD in the US and additional countries while studies of prGCD continue as part of the company's ongoing pivotal Phase 3 clinical trial.
In early July, the FDA asked Protalix to submit the treatment protocol to address the shortage of Genzyme's Cerezyme, the only approved treatment for Gaucher disease. Genzyme halted production of Cerezyme in mid-June because of virus contamination in a bioreactor at its plant in Allston Landing, MA.
Genzyme (Cambridge, MA) has resumed manufacturing at the Allston plant following sanitization, but discarded 80% of the work-in-process Cerezyme material that was unfinished at the time of the plant shutdown. On August 10, the company said it was still evaluating whether to finish the remaining work-in-process material.
At the time of the plant shutdown, Genzyme anticipated that the resulting product shortfall would end in October, but as a result of the decision about the work-in-process material, Genzyme now expects product shortages to continue until the end of the year, although newly produced product should start to become available in late November.
Protalix's Gaucher Drug May Fill Gap Left from Genzyme Plant Closure
July 10, 2009
Genzyme Detects Virus Contamination of Bioreactor, Halts Production
Jun 17, 2009