Protalix Biotherapeutics Inc. (AMEX:PLX) has obtained and US Food and Drug Administration (FDA) launch date of February 25, 2011 for the company's Gaucher disease treatment.
Protalix's drug has been granted orphan drug designation from the FDA, and it is available to to Gaucher patients in the US under an Expanded Access protocol, as well as to patients in the EU, Israel and other countries under Named Patient provisions.
The drug, taliglucerase alfa, is Protalix proprietary plant cell expressed recombinant form of human Glucocerebrosidase (GCD). Protalix completed the Phase III trial of the drug and filed a rolling New Drug Application (NDA) with the FDA in April. The FDA granted taliglucerase alfa a standard review time of ten months.
Protalix president and CEO Dr. David Aviezer, said, "If approved, taliglucerase alfa will be an attractive and important therapeutic option for Gaucher patients. We look forward to working closely with the agency through this final stage of the review process."
Protalix's share price closed at $6.32 on the American Stock Exchange on Friday, giving a market cap of $466 million.
Published by Globes [online], Israel business news - www.globes-online.com - on July 12, 2010
© Copyright of Globes Publisher Itonut (1983) Ltd. 2010