Protalix wins GMP certification from Brazil's health regulator

ANVISA found the company's Carmiel facility for the production of its Gaucher's disease treatment acceptable.

Protalix Biotherapeutics Inc. (AMEX:PLX; TASE: PLX) has obtained GMP (Good Manufacturing Practice) certification from Brazil's National Health Surveillance Agency (ANVISA) of the company's manufacturing facility in Carmiel. The audit was part of the Brazilian Ministry of Health's evaluation of the New Drug Application filed with ANVISA for taliglucerase alfa treatment of Gaucher disease.

The ANVISA audit follows audits by the US Food and Drug Administration (FDA) and Israel's Ministry of Health, both of which found Protalix's plant to be acceptable. Protalix has filed marketing applications for the taliglucerase alfa with regulators in the US, EU, Brazil, Israel, and Australia

Protalix president and CEO Dr. David Aviezer said, "The successful audit of our manufacturing facility by Brazil's ANVISA is an important milestone. This important achievement helps demonstrate the viability, quality and commercial potential of our proprietary, plant-cell based technology platform."

Protalix's share price rose 0.8% on the American Stock Exchange yesterday to $6.33, giving a market cap of $541 million, and rose 2.3% by early afternoon on the TASE today to NIS 21.53.

Published by Globes [online], Israel business news - - on June 16, 2011

© Copyright of Globes Publisher Itonut (1983) Ltd. 2011

Twitter Facebook Linkedin RSS Newsletters גלובס Israel Business Conference 2018