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PLX ($6.07) - Protalix Announces Successful European GMP Audit

CARMIEL, Israel , Dec. 1, 2011 /PRNewswire/ -- Protalix BioTherapeutics, Inc. (NYSE-AMEX:PLX, TASE:PLX), announced today that the Irish Medicines Board (IMB) has completed a successful GMP (Good Manufacturing Practice) audit of the Company's manufacturing facility in Carmiel, Israel, and has issued a Certificate of GMP Compliance of a Manufacturer for the facility.  The IMB Certificate is accepted by all health authorities in the European Union (EU) under the EU's centralized marketing authorization procedure, and by authorities of several other countries that recognize EU Certification.  The audit was performed as part of the European Medicines Agency's (EMA) evaluation of the Marketing Authorization Application for taliglucerase alfa for the treatment of Gaucher disease.

In addition to the EMA, the U.S. Food and Drug Administration ( FDA ), Israeli Ministry of Health and Brazilian National Health Surveillance Agency have completed audits of the Company's manufacturing facility and deemed the facility acceptable.

"We are pleased to accomplish this major regulatory milestone," said Dr. Michal Kahana, Protalix's Vice President of Quality Affairs.  "This important achievement helps demonstrate the viability of our proprietary plant-cell based technology platform, which is the engine behind all our pipeline candidates."
To date, marketing applications for taliglucerase alfa have been submitted in the United States , European Union , Brazil, Israel and Australia.  The Prescription Drug User Fee Act (PDUFA) target date for taliglucerase alfa in the United States is February 1, 2012 .

http://finance.yahoo.com/news/Protalix-Announces-Successful-prnews-2010716784.html?x=0