Protalix reapplies for Gaucher's drug FDA approval

CEO Dr. David Aviezer: We believe we have adequately addressed the requests that were outlined by the FDA.

Protalix Biotherapeutics Inc. (AMEX:PLX; TASE: PLX) today confirmed a "Globes" report, announcing that it has reapplied with the US Food and Drug Administration (FDA) to market taliglucerase alfa for the treatment of Gaucher disease.

Protalix president and CEO Dr. David Aviezer said, "We believe we have adequately addressed the requests that were outlined by the FDA in their Complete Response Letter. We will continue to work closely with the FDA as it moves forward with the New Drug Application (NDA) review."

In July, "Globes" revealed that Protalix would re-file its application to market its Gaucher's disease treatment Uplyso in "a matter of days."

Protalix said today that its submission addresses the issues identified by the FDA in the Complete Response Letter, including the request for clinical data from the Company's switchover trial and long-term extension trial, and additional information relating to chemistry, manufacturing and controls (CMC).

On February 25, 2011, Protalix announced that the FDA had rejected its application to market Uplyso until it received clarifications on a number of issues.

Protalix's share price rose 3.7% in premarket trading on the American Stock Exchange to $6.68 today, giving a market cap of $551 million. The share price rose 4% by mid-afternoon on the TASE to NIS 22.65.

Published by Globes [online], Israel business news - - on August 1, 2011

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

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