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;
tess.stynes@dowjones.com