Protalix Biotherapeutics Inc. (AMEX:PLX) announced today that the US Food and Drug Administration (FDA) has requested additional data on its Gaucher drug. The company said that the FDA asked for data about "the chemistry, manufacturing and controls (CMC) section of the New Drug Application (NDA) filed in December 2009."

Protalix statement added, "No additional clinical or preclinical information was requested. The request focused primarily on validation of the manufacturing process in the company's upgraded manufacturing facility. A validation plan for the company's manufacturing process of taliglucerase alfa (the Gaucher drug) has already been established and reviewed by the FDA. The company is working diligently to provide the requested data to the FDA and anticipates submitting the requested data during the second quarter of 2010."

The company continued, "Based on the FDA's request as part of its rolling review of the NDA, the Prescription Drug User Fee Act (PDUFA) action date for taliglucerase alfa is expected to be issued following submission of the additional requested CMC data."

Protalix said that the Gaucher drug will continue being provided to patients in the US, EU, Israel and other countries.

Protalix reported positive Phase III trial results on the Gaucher treatment in October. In January the company signed a strategic agreement with Pfizer Inc. (NYSE: PFE; LSE: PFZ), which will receive a license to market Protalix's treatment for Gaucher's disease.

Protalix share closed at $7.05 yesterday, giving a market cap of $544.72 million.

Published by Globes [online], Israel business news - www.globes-online.com - on February 2, 2010

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