Protalix plunges as FDA postpones Gaucher's approval

Protalix says that the three-month extension is the standard period granted, and that the FDA has not requested any additional data.

The US Food and Drug Administration (FDA) has notified Protalix Biotherapeutics Inc. (AMEX:PLX; TASE: PLX) that it has extended the target date for approving the company treatment for Gaucher's disease by three months, to May 1, 2012. The original date for Protalix's New Drug Application for taliglucerase alfa Prescription Drug User Fee Act (PDUFA) (NDA) was February 1.

Protalix's share price fell 16.6% in premarket trading on the news to $5.16, giving a market cap of $400 million, and fell 16.2% by mid-afternoon on the TASE to NIS 19.42.

In November 2011 at the request of the FDA, Protalix submitted certain clinical information regarding taliglucerase alfa. Since the information was requested and provided within 90 days of the February 1, 2012 PDUFA goal date, the FDA has the option to extend the goal date by three months, in order to complete its review.

Protalix says that the three-month extension is the standard period granted, and that the FDA has not requested any additional data or informed the company about deficiency in the application for the drug.

Protalix president and CEO Dr. David Aviezer said, "We believe we have addressed the FDA's request. We look forward to working closely with the agency as it continues its review."

Published by Globes [online], Israel business news - www.globes-online.com - on December 6, 2011

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

5 Comments
View comments in rows
Update by email about comments talkback
POST
Comments
Your name
Please insert your name
Content
Hyperlink in a new window Hyperlink Right Left underline italic bold Bulleted List Ordered List Face1 Face2 Face3 Face4 Face5 Face6
Your comment

Thanks
You comment was recieved and soon will be published.
In posting comments, I agree to abide by the Terms of Use
Globes encourages lively and frank debate, but posts that the editors consider merely abusive or otherwise inappropriate will be removed. Report inappropriate content
Thank you for posting your comment, which will be reviewed for publication.
Loading Comments...load
Load more comments
Twitter Facebook Linkedin RSS Newsletters גלובס