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Market: NYSE AMEX
Sector: Medical
EPIC: PLX
Protalix BioTherapeutics
www.protalix.com/index.asp
Protalix BioTherapeutics, Inc. is a biopharmaceutical company focused on the development and commercialization of recombinant therapeutic proteins based on the ProCellEx protein expression system (ProCellEx). Using the ProCellEx system, the Company is developing a pipeline of biosimilar or generic versions of recombinant therapeutic proteins based on the plant cell-based expression technology, which focuses pharmaceutical markets and that rely upon known biological mechanisms of action. The ProCellEx protein expression system consists of a set of technologies and capabilities for the development of recombinant proteins, including advanced genetic engineering technology and plant cell-based protein expression methods. The ProCellEx protein expression system is built on bioreactors made of polyethylene and optimized for the development of complex proteins in plant cell cultures.
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Protalix shares plunge as FDA rejects Gaucher disease drug

25th Feb 2011, 12:10 pm by Deborah Sterescu
FDA does not approve Gaucher drug, being developed by Protalix and Pfizer. Agency requests more information FDA does not approve Gaucher drug, being developed by Protalix and Pfizer. Agency requests more information

Protalix BioTherapeutics' (AMEX:PLX) shares dove nearly 28% on Friday after the company announced the FDA did not approve its new drug being developed with Pfizer for the treatment of Gaucher, a genetic disease that causes fat to build up in the body.

In the response letter received from the FDA, the agency said it required additional data from two trials and information on testing specifications for the new drug application for taliglucerase alfa, a plant-based treatement for Gaucher, which can lead to lung disease, pain and brain damage. The FDA, however, did not request further clinical trials, the company noted.

Protalix's stock was trading down roughly 26% at $6.99 as of 11:39am EST.

"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," said president and CEO Dr. David Aviezer.

Protalix said it will request a meeting with the FDA in due course to determine the next steps towards regulatory approval.

In November 2009, Pfizer and Protalix signed a deal to develop and commercialize the Gaucher drug, which works to replace an enzyme that is deficient in patients with the disease. Gaucher disease causes fat to build in the spleen, liver, kidneys, lungs, brain and bone marrow.

Pfizer's David Simmons, the president of emerging markets, said: "We will work closely with Protalix to address the requests from the FDA in a timely manner by providing technical, analytical and regulatory expertise."

To date, marketing applications have been submitted for taliglucerase alfa in the US, EU, Brazil and Israel.

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