FDA May Not Rule On Protalix's Gaucher's Treatment Until 2011

Date : 07/12/2010 @ 7:02AM
Source : Dow Jones News
Stock : Protalix Biotherapeutics (DE) (PLX)
Quote : 0.71  -0.0228 (-3.11%) @ 6:01PM

FDA May Not Rule On Protalix's Gaucher's Treatment Until 2011

Protalix Biotherapeutics (DE) (AMEX:PLX)
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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; 

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