Protalix Biotherapeutics Inc. (AMEX:PLX) yesterday announced the completion of the Phase III trial for prGCD for the treatment of Gaucher's disease. No serious adverse events were reported in this trial. The company expects to announce the trial results in October.
Protalix added that it expects to file a New Drug Application (NDA) with the US Food and Drug Administration (FDA) before the end of the year.
The trial included 31 patients in Europe, North and South America, Israel, and South Africa.
Even though the results of the trial are not yet known, the FDA has already given some positive indications about the drug. Following a breakdown in production by Protalix competitor Genzyme Inc. (NYSE: DNA), which has resulted in a shortage of Genzyme's treatment for Gaucher's disease, the FDA allowed Protalix to market prGCD to thousands of patients under an expanded trial, for humanitarian reasons.
The FDA granted Protalix fast-track status for prGCD, which shortens the approval procedure. Protalix has been able to submit information about the drug to the FDA for assessment in stages, instead of in a single application. This means that the approval process has already begun.
Protalix also announced that Uplyso is the proposed brand name for its Gaucher disease drug candidate prGCD, and has filed trademark applications for the name worldwide. prGCD is a proprietary plant-cell expressed recombinant form of glucocerebrosidase (GCD).
Protalix's share closed at $7.50 on the American Stock Exchange yesterday, giving a market cap of $574 million.
Published by Globes [online], Israel business news - www.globes-online.com - on September 15, 2009
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