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Protalix BioTherapeutics Receives Marketing Authorization For Elelyso(TM) For The Treatment Of Gaucher Disease From The Israeli Ministry Of Health

Stocks in this article: PLX

CARMIEL, Israel, Sept. 27, 2012 (GLOBE NEWSWIRE) -- Protalix BioTherapeutics, Inc. (NYSE-MKT:PLX) (TASE:PLX), announced today that is has received marketing authorization from the Israeli Ministry of Health for Elelyso TM (taliglucerase alfa) for injection, an enzyme replacement therapy (ERT) for the long-term treatment of adults with Type 1 Gaucher disease. Elelyso will be marketed in Israel by Protalix Ltd., the holder of all marketing rights to Elelyso in the Israeli market.

This is the second marketing approval of Elelyso, which was approved by the U.S. Food and Drug Administration (FDA) on May 1, 2012.  Marketing applications have been filed in additional territories. Elelyso is marketed in the United States by the Company's commercialization partner, Pfizer Inc. ("Pfizer").

Under its development and commercialization arrangement with Pfizer, the Company maintained the commercialization rights to Elelyso in Israel. Accordingly, the Company has built an internal marketing team designed to serve the Israeli market. The Company intends to sell Elelyso in Israel at a competitive price compared to other products already available to Gaucher patients.  Over the past five years, the Company has treated over 60 Gaucher patients in Israel with Elelyso through clinical trials and compassionate use programs and expects that a substantial proportion of these patients will soon be treated through commercial programs.

Elelyso is the first plant cell-based biopharmaceutical approved for marketing by the Israeli Ministry of Health. It is also the first plant cell-expressed drug derived from ProCellEx ® to achieve regulatory approval for marketing. ProCellEx is the Company's proprietary plant cell-based protein expression system. Elelyso is a form of the human lysosomal enzyme, glucocerebrosidase, used to treat Gaucher disease.

"We are very excited to have our first drug product approved in our home country," said Dr. David Aviezer, President and Chief Executive Officer of Protalix BioTherapeutics.  "In our development efforts, we enjoyed the cooperation of the leading Israeli medical and academic institutions, and we rely in part on support from research grants from the Israeli government. We are proud that our Gaucher disease treatment will be available for commercial sale in Israel."

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