Protalix Biotherapeutics Inc. (AMEX:PLX) has submitted validation data regarding about manufacturing process for the company's treatment of Gaucher disease to the US Food and Drug Administration (FDA). The FDA asked for the data for the company's upgraded manufacturing plant in December 2009.
The FDA is currently reviewing Protalix's New Drug Application (NDA) for taliglucerase alfa for the treatment of Gaucher disease. The FDA has already granted the drug granted orphan drug status and fast track designation, and Protalix provides the drug to Gaucher patients in the US under an Expanded Access protocol, as well as to patients in Europe, Israel, and other countries under named patient provisions.
Protalix develops human proteins by genetic engineering of tobacco plant cells for the treatment of genetic diseases, including Gaucher.
Protalix's share closed at $6.69 on the American Stock Exchange yesterday, giving a market cap of $540 million.
Published by Globes [online], Israel business news - www.globes-online.com - on April 27, 2010
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