Protalix Biotherapeutics Inc. (AMEX:PLX; TASE: PLX) announced on Friday that the US Food and Drug Administration (FDA) has asked the company for additional information about taliglucerase alfa for the treatment of Gaucher disease.
Analysts had widely expected the FDA to approve the drug, and its actual response disappointed investors.
Protalix's share price fell 18.5% on Friday on the American Stock Exchange to $7.63, giving a market cap of $619 million, and fell 20% at the opening on the TASE today to NIS 29.
The FDA's Center for Drug Evaluation and Research sent the company a Complete Response Letter, which means that although the review of the New Drug Application (NDA) is completed, questions remain preclude the approval of the NDA in its current form. The FDA has more questions regarding the clinical and chemistry, manufacturing and controls of Protalix's drug.
The FDA wants more data about Protalix's switchover trial and long-term extension trial, information that was not available when the company filed the NDA.
Protalix president and CEO Dr. David Aviezer said, “While we are disappointed by the receipt of the Complete Response Letter, we appreciate the FDA’s efforts to complete the review of our NDA. We noted that the FDA did not request additional clinical studies. Moreover, the FDA inspected our manufacturing facilities finding them acceptable. FDA also did not identify any issues in its audit of our clinical sites." He added, “Protalix will work with the FDA to determine next steps."
In November, 2009, and Protalix and Pfizer Inc. (NYSE: PFE; LSE: PFZ) signed an agreement to develop and commercialize taliglucerase alfa.
Meanwhile Protalix continues enrolling patients in its multi-center pediatric trial of taliglucerase alfa and patients receiving the drug in the switchover study will continue to do so. The drug is already available to Gaucher's patients in the US under an Expanded Access protocol, as well as to patients in France and Brazil.
Published by Globes [online], Israel business news - www.globes-online.com - on February 27, 2011
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