Protalix Receives FDA Fast Track Designation For PrGCD

Main Category: Pharma Industry / Biotech Industry
Also Included In: Regulatory Affairs / Drug Approvals
Article Date: 26 Aug 2009 - 6:00 PDT

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Protalix BioTherapeutics, Inc. (NYSE-Amex:PLX), announced that it has received Fast Track Designation from the U.S. Food and Drug Administration (FDA) for prGCD, the Company's proprietary plant-cell expressed recombinant form of glucocerebrosidase (GCD) for the treatment of Gaucher disease.

Fast Track designation is an FDA approved process that facilitates the development and expedites the review of drugs to treat serious diseases and fill an unmet medical need with the goal of getting important new treatments to patients earlier. This process allows a company to file the sections of the New Drug Application (NDA) as they become available instead of filing all the sections at once. It also enables the agency to commence its review and proceed on a rolling basis as the additional sections are completed and submitted for review. Protalix plans to submit the first section of the rolling NDA for prGCD, allowed under the Fast Track process, in the very near future.

Protalix expects to complete the Company's Phase III trial of prGCD for the treatment of Gaucher's disease in September, to report top-line results in October and to complete the NDA filing before the end of the year. Additionally, the Company has initiated a treatment protocol that allows physicians and other care-providers to treat Gaucher disease patients in the United States and additional countries world-wide with prGCD while the drug is still under investigation.

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