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

DOW JONES NEWSWIRES 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;

Stock News for Protalix Biotherapeutics (PLX)
DateTimeHeadline
06/19/201309:17:54U.S. HOT STOCK FUTURES: HOT STOCKS TO WATCH
06/19/201308:26:20Protalix Reaches Pact to Transfer Technology for Gaucher Disease...
04/29/201308:40:57Protalix BioTherapeutics Treatment for Gaucher Disease Approved...
12/06/201208:36:34Protalix Signs Deal With Pfizer to Continue Managing Elelyso...
06/22/201209:50:54EMA Recommends Against Marketing Authorization to Pfizer and...
06/11/201208:29:40Protalix Gets $25 Million Milestone Payment For Rare-Disease...
05/02/201216:17:45US Stocks Trade Lower Late On Concerns Over Hiring, Europe
05/02/201214:40:14US Stocks Edge Lower On Weak Private-Sector Hiring
05/01/201217:37:05CORRECT: FDA Approves Protalix, Pfizer Drug To Treat Gaucher...
05/01/201217:07:24FDA Approves Protalix, Pfizer Drug To Treat Gaucher Disease
08/17/201108:57:24FDA Accepts Protalix Resubmission For Gaucher Disease Drug; Shares...
02/25/201107:31:34Protalix: FDA Requests More Information On Gaucher's Drug
10/01/201011:53:15Genzyme Efforts To End Cerezyme Shortage Proceeding
09/15/201013:31:11Genzyme To End Fabrazyme Rationing By Mid-2011
07/12/201007:02:50FDA May Not Rule On Protalix's Gaucher's Treatment Until 2011
02/19/201007:52:16Shire 4Q Profit Up 23% As Drug Sales Offset Generic Losses
12/01/200912:10:05Pfizer-Protalix Deal Strengthens Competition For Genzyme
12/01/200907:25:14Pfizer To Pay Protalix Up To $115 Million In Gaucher's Deal

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