Protalix BioTherapeutics, Inc. (PLX) said the U.S. Food and Drug
Administration is asking for more information about its
experimental drug for Gaucher's disease, a rare genetic ailment,
before it moves to approve the drug.
The U.S. regulator requested more data on clinical trials and on
chemistry, manufacturing and controls for the experimental
treatment, information the company said it didn't have when it
first submitted the new drug application. Protalix said it will
work with the FDA to answer the questions and noted that the FDA
isn't asking for more clinical studies.
Gaucher's disease affects one of 20,000 live births and causes a
fatty substance to develop in cells in the liver, spleen and bone
marrow. Protalix is developing the product with Pfizer Inc.
(PFE).
The FDA is one of several regulators reviewing the taliglucerase
alfa drug amid an expected shortage of medicine for Gaucher's
disease. In July, French regulators temporarily approved its use
while Genzyme Corp.'s (GENZ) well-known treatment Cerezyme remained
in short supply following contamination issues at its manufacturing
plant.
Protalix shares closed at $9.36 Thursday and were inactive
premarket. Th stock has gained 10% over the past three months.
-By Drew FitzGerald, Dow Jones Newswires; 212-416-2909;
Andrew.FitzGerald@dowjones.com
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