Protalix to re-file with FDA for Gaucher's drug

Sources inform "Globes" that the company will reapply to market Uplyso next week and expects a response before the end of September.

Sources inform "Globes" that Protalix Biotherapeutics Inc. (AMEX:PLX; TASE: PLX) will file a request for approval from the US Food and Drug Administration (FDA) for its Gaucher's disease treatment Uplyso in "a matter of days."

The request will end a difficult few months for investors in Protalix after the FDA rejected the company's request to market Uplyso in February. Senior sources in the pharmaceutical industry say that Protalix will submit its application towards the end of next week. Sources also say that Protalix's senior executives have been given hints by the FDA that it is eager to push the approval forward. Normally, the FDA takes between two months and six months to respond to such requests, however it is understood that a final answer will be received by Protalix by late September or even earlier.

Protalix, which is managed by CEO David Aviezer, said, "The company does not respond to rumors and will report as required when an official application is filed."

Protalix is pioneering a technology to develop biopharmaceuticals with unique attributes allowing them to compete with protein based drugs without infringing any patents. Protalix's first drug, which it is bringing to market, is for the treatment of Gaucher's disease and is very similar to Genzyme Genetic Inc's Cerezyme.

Gaucher's is a hereditary disease in which fatty substances accumulate in cells and organs causing painful organ malfunctions and neurological complications.

On February 25 2011, Protalix reported that the FDA had rejected its request to market Uplyso because it required additional data about the trial. On the same day the company's share price plummeted on large market turnover.

The FDA wanted more data about Protalix's switchover trial and long-term extension trial, information that was not available when the company filed the NDA.

Protalix's share price rose 2.95% on AMEX yesterday to $6.64, giving a market cap of $568.24 million.

Published by Globes, Israel business news - - on July 21, 2011

© Copyright of Globes Publisher Itonut (1983) Ltd. 2011

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