FDA Gives Fast-Track Status To Protalix Drug For Gaucher's

   DOW JONES NEWSWIRES 
 

Protalix BioTherapeutics Inc.'s (PLX) drug candidate to treat Gaucher's disease received fast-track status from the Food and Drug Administration, which will speed up review amid an expected shortage of Genzyme Corp.'s (GENZ) Cerezyme.

Protalix shares were up 7.9% at $6.45 in recent premarket trading.

The FDA last week cleared Protalix's treatment protocol of its lead drug candidate for patients with the rare, inherited disorder in which an enzyme problem results in harmful quantities of certain fats, especially within the bone marrow, spleen and liver.

The company said at the time it would provide the treatment free of charge to patients enrolled in the protocol, under which physicians and other care providers can treat Gaucher's disease patients with prGCD while late-stage trials continue and until the treatment's anticipated marketing approval from the FDA.

Protalix expects to complete the study next month and unveil results in October. The company expects to file the first section of its new-drug application in the near future, with the full submission by the end of the year.

A Genzyme plant that produces Cerezyme was shut down in the latest manufacturing problem at the Massachusetts facility. Cerezyme, which treats Gaucher's disease, is Genzyme's biggest revenue producer, with sales of $1.2 billion last year.

-By Tess Stynes, Dow Jones Newswires; 212-416-2481; [e-mail]