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NewsJuly 12, 2009 Protalix Approached by the FDA to Consider Submitting a Treatment Protocol for the Use of prGCD in Patients with Gaucher Disease Allowing Expanded Access to prGCD Protalix BioTherapeutics, Inc. (NYSE-Amex:PLX), announced today that it was approached by the U.S. Food and Drug Administration (FDA) and asked to consider submitting a treatment protocol for the use of prGCD in patients with Gaucher disease in order to address an expected shortage of the drug Cerezyme®, a mammalian cell expressed version of glucocerebrosidase (GCD) and the only enzyme replacement therapy currently approved for Gaucher disease. Gaucher disease is a rare and serious lysosomal storage disorder in humans with severe and debilitating symptoms. prGCD, the Company's lead product candidate, is a proprietary plant-cell expressed recombinant form of glucocerebrosidase and is currently the subject of a Phase III clinical trial for the treatment of Gaucher disease. The
FDA indicated to the Company that it believes the Company's development
program for prGCD satisfies the regulatory criteria required
to supply prGCD for expanded access to patients under a treatment
protocol. Under current FDA regulations, a treatment protocol
may be submitted for a drug that has not yet been approved for
marketing but is the subject of clinical development for a serious
or life threatening disease for which no comparable or satisfactory
alternative drug or therapy is available. The Company and the
FDA are discussing the parameters of a proposed treatment protocol
which would allow an increased number of patients with Gaucher
disease to have access to prGCD. The Company expects to submit
a treatment protocol to the FDA for its review as a supplement
to the Company's current Investigational New Drug (IND) application
for prGCD.
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