Protalix Offers Update on Health Canada Evaluation, Says Manufacturing Facility Utilizing ProCellEx Deemed Acceptable by EMA, FDA, IMH, ANVISA, TGA
Protalix BioTherapeutics, Inc. (NYSE: PLX) , announced today that Health Canada has completed a successful on-site evaluation of the Company's manufacturing facility in Carmiel, Israel, as part of its ongoing review of the new drug submission (NDS) for taliglucerase alfa for the treatment of Gaucher disease. The purpose of the on-site evaluation was to verify the facility's compliance with certain Canadian food and drug regulations and, upon completion of the evaluation, Health Canada recommended approval from a facility perspective. A decision on final marketing approval of taliglucerase alfa in Canada is expected during 2014.
In addition to Health Canada's evaluation, the Company's manufacturing facility, which utilizes Protalix's ProCellEx® system, has been deemed acceptable by the European Medicine's Agency (EMA), the U.S. Food and Drug Administration (FDA), the Israeli Ministry of Health, the Brazilian National Health Surveillance Agency (ANVISA) and the Australian Therapeutic Goods Administration (TGA).
"We are pleased to have accomplished this regulatory milestone in preparation for the potential approval of taliglucerase alfa in Canada," said Dr. Michal Kahana, Protalix's Vice President of Quality Affairs. "This is further validation of the viability of our proprietary plant-cell based technology platform, which is the engine behind taliglucerase alfa and our growing pipeline."
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