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Market approval of Elelyso by the Israeli Ministry of Health
2012-10-03 11:10:58

Protalix BioTherapeutics Receives Marketing Authorization for Elelyso(TM) for the Treatment of Gaucher Disease From the Israeli Ministry of Health

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 ElelysoTM (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."

The Israeli Ministry of Health's marketing authorization of Elelyso was based on its review of data compiled by the Company from its pivotal phase III clinical trial, as well as data from its extension trial in which treatment-naïve patients that were treated with taliglucerase alfa for a 24-month period, and from the Company's switchover trial which collected data from Gaucher patients that had previously been treated with imiglucerase (Cerezyme®) and were switched to treatment with taliglucerase alfa (Elelyso). 

"The Israeli approval of Elelyso is important for local Gaucher patients," said Mr. Yossi Cohen, Chairman of the Israeli Association for Gaucher. "Given the inconsistent supply of ERT for the treatment of Gaucher disease worldwide in recent years, we believe the addition of a new treatment for Gaucher patients will provide them with greater confidence regarding treatment. The fact that the product is manufactured locally by an Israeli company increases our excitement about this approval."

"The clinical studies of Elelyso to date, both the pivotal and the extension studies, demonstrate that Elelyso is an effective treatment for Gaucher disease," said Professor Ari Zimran, M.D., Director of the Gaucher Clinic, Shaare Zedek Medical Center, Jerusalem, Israel. "The results of the Company's 24-month naive extension trial and switch over study support Elelyso as an important treatment alternative for Gaucher patients in Israel."