Protalix has an equivalent approval to sell the still unapproved drug in the US, Israel, and other countries.
Protalix Biotherapeutics Inc. (AMEX:PLX) has been awarded a Temporary Authorization for Use (ATU) for its treatment of Gaucher disease by France's French Health Products and Safety Agency. An ATU is a mechanism for making make non-approved drugs available to patients in France when a genuine public health need exists. Protalix has an equivalent approval in the US, Israel, and other countries.
Protalix is still waiting for approval by the European Medicines Agency (EMEA) for taliglucerase alfa, the treatment of Gaucher disease. Yesterday, the US Food and Drug Administration (FDA) set a launch date of February 25, 2011 for the drug.
Protalix's share price rose 2% at the opening on the American Stock Exchange today to $6.14, giving a market cap of $487 million.
Published by Globes [online], Israel business news - www.globes-online.com - on July 13, 2010
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