Chief Scientist funds to help Protalix in Gaucher study

The drug is a biosimilar of a treatment for Gaucher disease made by, which has $1.25 billion in annual sales.

Protalix Biotherapeutics Inc. (AMEX:PLX) has obtained a $6 million grant from the Office of the Chief Scientist for the company's clinical and preclinical drug development programs. The money will be released in several tranches during 2009.

The terms of the grant stipulate that most of the money will be used for Protalix's Phase III clinical trial of a treatment of Gaucher disease based on prGCD plant cell expressed recombinant Glucocerebrosidase enzyme.

The drug is a biosimilar of a treatment for Gaucher disease made by Genzyme Inc. (NYSE: DNA), which has $1.25 billion in annual sales.

Protalix hopes to complete the Phase III trial the first half of this year, and if it is successful, the company intends to apply to the US Food and Drug Administration (FDA) for marketing approval in the fourth quarter.

Protalix had $42 million in cash at the end of 2008, so the Chief Scientist grant is not a matter of life and death for the company. However, the grant will significantly help toward financing the clinical trial, which apparently costs tens of millions of dollars.

The grant includes funds for the preclinical development of two other drug candidates in Protalix's pipeline: of a plant cell-based acetylcholinesterase (AChE) and PRX-102. AChE may be used as a biodefense program against nerve gases, as well to treat pesticide toxins. There is currently no similar drug on the market. PRX-102 is a therapeutic enzyme for the treatment of Fabry disease.

"Globes": You're going head-to-head in a fight against Genzyme.

Protalix president and CEO David Aviezer: "We're not at war with Genzyme, but we've definitely built a strategy to attack niche markets where drugs are very expensive. This is why our plant-based intellectual property can create substantial value. We have a number of other products in development in these fields. This is a sub-field of the sector in which Genzyme is active, specializing in the treatment of rare diseases."

Protalix's share rose 1.4% in early trading today to $2.29, giving a market cap of $174 million.

Published by Globes [online], Israel business news - www.globes-online.com - on March 12, 2009

© Copyright of Globes Publisher Itonut (1983) Ltd. 2009

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