“Protalix BioTherapeutics Inc. soared in Tel Aviv trading after the biopharmaceutical company’s first product won approval from the U.S. Food and Drug Administration.
Protalix expects approval to sell its Gaucher disease drug in Israel soon, Aviezer said. Israel has at least 500 patients affected with the illness, he said. The company also is awaiting a regulatory decision in the European Union.
“This is a biotechnology milestone as it it the first time the FDA has approved a product that was engineered in plant cells, as opposed to mammalian or bacterial-based systems,” Yoav Kedar, a biotechnology consultant for Clal Finance Brokerage Ltd., said in an interview. “The approval will better position the company to receive approvals in Europe, Israel and Brazil.”
Gaucher disease can cause fat to build up in the liver, spleen, bone marrow and nervous system. About 1 in 14 individuals of Ashkenazi Jewish ancestry carries the mutated gene that can cause the illness, and as many as 1 in 500 present a form of the disorder.”
This is a seriously big deal, and I have blogged on it here before: this is a plant-made bio-better, now licenced for human use as a therapeutic ofr a nasty genetic disease. It should compete well, given that other offerings are made in mammalian cells – and one manufacturer’s output was recently shut down completely due to a viral infection of their cell cultures, which is what led to accelerated approval for Protalix’s product.
Going green…you know the rest.
See on www.bloomberg.com