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www.fdanews.com/articles/88364-protalix-biotherapeutics-releases-clinical-trial-results

PROTALIX BIOTHERAPEUTICS RELEASES CLINICAL TRIAL RESULTS

July 14, 2006

Israeli drugmaker Protalix Biotherapeutics has announced it completed Phase I clinical trial for its drug for the treatment of Gaucher disease, with satisfactory results.

Assuming that the FDA approves the results, Protalix will prepare for Phase III and final clinical trials for the treatment. The drug is exempt from Phase II clinical trials because it is a biosimilar.

Protalix's drug is biologically identical to a drug developed by Genzyme. Gaucher disease is a rare blood disease affecting 20,000 people worldwide.