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The treatment protocol allows physicians and other care providers to treat patients of Gaucher disease with prGCD in the US and additional countries worldwide while studies of prGCD continue as part of the company's ongoing pivotal Phase III clinical trial. Prior to accepting the protocol, the FDA reviewed available data from the company's ongoing Phase III clinical development programs.
The treatment protocol is a multicenter, open-label trial designed to allow physicians and other care providers to treat patients of Gaucher disease with prGCD during the expected shortage of Cerezyme and thereafter. Cerezyme is a mammalian cell expressed version of glucocerebrosidase and the only enzyme replacement therapy currently approved for Gaucher disease.
The treatment protocol allows patients enrolled in the protocol to continue being treated with prGCD until its anticipated marketing approval from the FDA. The company said that it will provide the drug free of charge to patients enrolled in the protocol.
David Aviezer, president and CEO of Protalix, said: "We appreciate the guidance and vote of confidence provided by the FDA in establishing a treatment protocol for prGCD and are working closely with physicians and patient advocacy groups to allow Gaucher disease patients to gain access to our drug.
"We expect to conclude our Phase III pivotal study next month and are looking forward to announcing topline results from this study in October 2009. We anticipate filing a new drug application with the FDA by the end of 2009."
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