DOW JONES NEWSWIRES
Protalix BioTherapeutics Inc.'s (PLX) treatment protocol of its
lead drug candidate for patients with Gaucher disease was approved
by the U.S. Food and Drug Administration, amid an expected shortage
of Genzyme Corp.'s (GENZ) Cerezyme.
The FDA last month had requested that Protalix consider
submitting a treatment protocol of the drug to treat patients with
the life-threatening disease because a Genzyme plant that produces
Cerezyme was shut down in the latest manufacturing problem at the
Massachusetts facility.
Gaucher disease is a rare, inherited disorder in which an enzyme
problem results in harmful quantities of certain fats, especially
within the bone marrow, spleen and liver.
Protalix last month said it received indications from the FDA
that its prGCD development effort "satisfies the regulatory
criteria required to supply prGCD for expanded access to patients
under a treatment protocol."
The company said Monday it would provide the drug free of charge
to patients enrolled in the protocol, under which physicians and
other care-providers can treat Gaucher's 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 a new drug
application by the end of the year. Cerezyme, which treats Gaucher
disease, is Genzyme's biggest revenue producer, with sales of $1.2
billion last year.
Protalix shares closed at $5.77 on Friday and didn't trade
premarket.
-By Tess Stynes, Dow Jones Newswires; 212-416-2481;
tess.stynes@dowjones.com