Protalix Biotherapeutics completes Phase I trials

If the FDA approves the results, Protalix will prepare for Phase III clinical trials for the treatment.

Biocell Ltd. (TASE: BCEL) and Marathon Venture Capital Fund (TASE: MARA) reported yesterday that Protalix Biotherapeutics Ltd., in which they own stakes, completed Phase I clinical trial for its for the treatment of Gaucher Disease. The results were satisfactory.

Protalix will present the results of the Phase I trial at the upcoming annual European Working Group on Gaucher Disease (EWGGD) Meeting, to be held in mid-July in Cambridge University in the UK.

Assuming that the US Food and Drug Administration (FDA) approves the results, Protalix will prepare for Phase III and final clinical trials for the treatment. The drug is exempt from Phase II clinical trials because it a biosimilar (basically, a generic version of an ethical biopharmaceutical product on the market).

Protalix’s drug is biologically identical to a drug for treating Gaucher Disease developed by Genzyme Corp. (Nasdaq:GENZ). Gaucher Disease is a rare disease affecting 20,000 people worldwide, including a few hundred in Israel.

Genzyme’s drug has $1 billion in annual sales. Protalix produces the drug from plant cells, whereas Genzyme produces its drug from mammalian cells. Protalix’s drug therefore does not breach Genzyme’s patent. If approved, Protalix’s drug is expected to cheaper than Genzyme’s drug, and compete strongly against it.

Protalix’s main shareholders are Biocell, Marathon Venture Capital, Tamares Capital, Docor International BV (a subsidiary of the Van Leer Foundation), and Atara Technology Ventures Ltd., Technorov Holdings Ltd., Ziff Asset Management, and Pontifax Ltd. (controlled by Teva chairman Eli Hurvitz, who also serves as chairman of Protalix). Ziff has also invested in ColBar LifeScience Ltd..

Protalix plans to go public on Nasdaq soon. In March, “Globes” reported that the company plans to raise $120 million from foreign funds, but the financing round has apparently not been closed. The company’s previous financing round in late 2005 was held at a company value of $75 million. The company has raised $29 million in four financing rounds. David Aviezer is the CEO.

Published by Globes [online], Israel business news - www.globes.co.il - on July 13, 2006

© Copyright of Globes Publisher Itonut (1983) Ltd. 2006

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