Protalix Biotherapeutics Inc. (AMEX:PLX; TASE: PLX) has obtained an EU GMP (Good Manufacturing Practice) certificate of compliance for its plant in Carmiel. The certificate followed a successful audit of the plant by the Irish Medicines Board, whose certificate is accepted by all EU health authorities, as well as other countries that recognize EU certification.
The GMP was part of the European Medicines Agency's (EMEA) evaluation of Protalix's Marketing Authorization Application for Uplyso (taliglucerase alfa) for the treatment of Gaucher's disease.
Protalix has already obtained GMP certification from the US Food and Drug Administration (FDA), Israel's Ministry of Health, and Brazil's National Health Surveillance Agency (ANVISA), and has submitted marketing applications with all of these agencies, as well as Australia's Therapeutic Goods Administration (TGA). The target date for US sales in February 1, 2012.
Protalix VP quality affairs Dr. Michal Kahana said, "We are pleased to accomplish this major regulatory milestone. This important achievement helps demonstrate the viability of our proprietary plant-cell based technology platform, which is the engine behind all our pipeline candidates."
Protalix's share price rose 3.8% on the American Stock Exchange yesterday to $6.07, giving a market cap of $520 million, and rose 2% by mid-afternoon on the TASE today to NIS 23.19.
Published by Globes [online], Israel business news - www.globes-online.com - on December 1, 2011
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