Protalix (NYSE Amex: PLX) of Carmiel, which is developing a treatment for Gaucher disease, will carry out a special trial with the US Food and Drug Administration (FDA) in which it will be able to sell its drug to a large number of patients, but under continuing supervision of the FDA and of hospital safety committees via which the drug will be distributed.
This special trial protocol is aimed at helping Gaucher patients who up to now have taken Genzyme’s Cerezyme. Supply of this drug has been interrupted because of a safety failure at the factory. The special protocol is rare. It has been used in the past in cases where a fear for the life of patients led to a decision that it was better to use a product tat had not yet been approved than to make patients wait.
Protalix seeks a partner for a marketing agreement, but is also prepared for the possibility that it will market the product by itself, requiring it to raise further capital. The company has $30 million cash, and a market cap of $440 million. Its share price rose 12% in pre-opening trading on Wall Street. The company is held by Biocell, which rose 12% on the Tel Aviv Stock Exchange today.
Gaucher is a genetic disease in which a shortage of a certain protein in the body causes damage to internal organs, because of a accumulation of unwanted enzymes in them. The drug is the missing protein.
Protalix will not make money on treating patients in the framework of the trial, but it will be able to offer the patients its product at a time when they cannot obtain the treatment they are used to. In the past it was reckoned that the main hurdle Protalix faced was persuading patients to swap a familiar product for a new one, so the company now has a substantial opportunity.
The product is still officially in a trial the results of which will become known only in October, but the current measure is an expression of confidence on the part of the FDA. It makes it seem more likely that the company will obtain approval at the beginning of 2010. According to Genzyme, the shortage of its treatment is expected to last until the end of the year.
Shire, which is also developing a treatment for Gaucher, has received a similar approval from the FDA. Shire is also at the Phase III clinical trials stage.
”The breakdown at the Genzyme factory highlights an important advantage of our product,” Protalix CEO Dr. David Aviezer said today. “The product is derived from plant cells that cannot be infected by human viruses. The viruses that are liable to infect the plants not that we have any do not infect human beings.”
Published by Globes [online], Israel business news - www.globes.co.il - on August 17, 2009
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