The U.S. Food and Drug Administration set a Feb. 25, 20011,
target to decide whether to approve Protalix BioTherapeutics Inc.'s
(PLX) drug for a rare genetic disease, later than the Israeli
biopharmaceutical company expected last month.
The treatment, taligulucerase alfa, is being developed for
Gaucher's disease under a special protocol assessment with the FDA,
which helps speed the approval process along. Protalix submitted a
rolling new drug application for the drug--which has received
orphan drug status--to the FDA in April.
A company spokesman last month said the company expected the FDA
decision on the drug in October.
Pfizer Inc. (PFE) is Protalix's partner on the drug.
The Orphan Drug Act provides incentives to create therapies for
so-called orphan diseases--those that affect fewer than 200,000
Americans. Getting an orphan-drug designation opens the door to
incentives once the FDA approves a medicine for sale in the U.S.,
including seven years' marketing exclusivity and tax breaks.
Gaucher's disease affects about one in 20,000 live births and
causes a fatty substance to develop in cells primarily in the
liver, spleen and bone marrow. One well-known treatment, Genzyme
Corp.'s (GENZ) Cerezyme, has been in short supply for a year as the
company deals with ongoing production issues stemming from
contamination at the drug's manufacturing plant.
Protalix shares closed Friday at $6.32 and were inactive
premarket.
-By Tess Stynes, Dow Jones Newswires; 212-416-2481; Tess.Stynes@dowjones.com;