Protalix Biotherapeutics Inc. (AMEX:PLX; TASE: PLX) today announced that it has obtained approval from Israel's Ministry of Health for its treatment of Gaucher's disease, Elelyso. Elelyso (taliglucerase alfa) is an enzyme replacement therapy, delivered by injection, for the long-term treatment of adults with Gaucher disease.
The approval in Israel follows US Food and Drug Administration (FDA) approval of Elelyso in May, and the company has filed applications in other countries. Pfizer Inc. (NYSE: PFE; LSE: PFZ) markets the drug in the US.
Protalix said that it will sell Elelyso in Israel at a competitive price compared with other products already available to Gaucher patients. It has treated more than 60 Gaucher patients in Israel with Elelyso over the past five years through clinical trials and compassionate use programs and it expects that many of them will soon be treated through commercial programs.
Elelyso is the first plant cell-based biopharmaceutical approved for marketing by the Ministry of Health. It is also the first plant cell-expressed drug derived from ProCellEx, Protalix's proprietary plant cell-based protein expression system, to achieve regulatory approval for marketing.
Protalix president and CEO Dr. David Aviezer said, "We are very excited to have our first drug product approved in our home country. 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." Protalix's share price rose 4.7% by early afternoon on the TASE today to NIS 20.58, after rising 0.8% on the American Stock Exchange yesterday to $5.17, giving a market cap of $475 million. Published by Globes [online], Israel business news - www.globes-online.com - on September 27, 2012
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