Protalix BioTherapeutics,
Inc. 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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