Protalix Receives FDA Fast Track Designation for prGCD

Protalix Receives FDA Fast Track Designation for prGCD

CARMIEL, Israel August 25, 2009 (BUSINESS WIRE) Protalix BioTherapeutics, Inc. (NYSE-Amex:PLX),

announced today that it has received Fast Track Designation from the U.S. Food and Drug

Administration (FDA) for prGCD, the Company s proprietary plant-cell expressed recombinant form of

glucocerebrosidase (GCD) for the treatment of Gaucher disease.

Fast Track designation is an FDA approved process that facilitates the development and expedites

the review of drugs to treat serious diseases and fill an unmet medical need with the goal of

getting important new treatments to patients earlier. This process allows a company to file the

sections of the New Drug Application (NDA) as they become available instead of filing all the

sections at once. It also enables the agency to commence its review and proceed on a rolling basis

as the additional sections are completed and submitted for review. Protalix plans to submit the

first section of the rolling NDA for prGCD, allowed under the Fast Track process, in the very near

Protalix expects to complete the Company s Phase III trial of prGCD for the treatment of Gaucher s

disease in September, to report top-line results in October and to complete the NDA filing before

the end of the year. Additionally, the Company has initiated a treatment protocol that allows

physicians and other care-providers to treat Gaucher disease patients in the United States and

additional countries world-wide with prGCD while the drug is still under investigation.

About Protalix BioTherapeutics

Protalix is a biopharmaceutical company. Its goal is to become a fully integrated biopharmaceutical

company focused on the development and commercialization of proprietary recombinant therapeutic

proteins to be expressed through its proprietary plant cell based expression system. Protalix s

ProCellEx presents a proprietary method for the expression of recombinant proteins that

Protalix believes will allow for the cost-effective, industrial-scale production of recombinant

therapeutic proteins in an environment free of mammalian components and viruses. Protalix is

conducting a Phase III pivotal study for its lead product candidate, prGCD, to be used in enzyme

replacement therapy for Gaucher disease, a rare and serious lysosomal storage disorder in humans

with severe and debilitating symptoms. Protalix and the U.S. Food and Drug Administration agreed on

the final design of the pivotal Phase III clinical trial through the FDA s Special Protocol

Assessment (SPA) process. Protalix is also advancing additional recombinant biopharmaceutical drug

development programs.

Safe Harbor Statement:

To the extent that statements in this press release are not strictly historical, all such

statements are forward-looking, and are made pursuant to the safe-harbor provisions of the Private

Securities Litigation Reform Act of 1995. These forward-looking statements are subject to

known and unknown risks and uncertainties that may cause actual future experience and results to differ

materially from the statements made. These statements are based on our current beliefs and

expectations as to such future outcomes. Drug discovery and development involve a high degree of

risk. Factors that might cause material differences include, among others, risks relating to: the

successful preclinical development of our product candidates; the completion of clinical trials;

the review process of the FDA, foreign regulatory bodies and other governmental regulation,

including the FDA s review of any filings we make in connection with the treatment protocol; delays

in the FDA s or other health regulatory authorities approval of any applications we file or

refusals to approve such filings; refusals by such regulatory authorities to approve the marketing

and sale of a drug product even after acceptance of an application we file for any such drug

product; the identification of lead compounds; the risk that we may fail to satisfy certain

conditions relating to grants we have received from the Office of the Chief Scientist of Israel s

Ministry of Industry and Trade which may lead to our being required to refund grants previously

received together with interest and penalties; the risk that the Office of the Chief Scientist may

not deliver to us all of the funds awarded to us; uncertainties related to the ability to attract

and retain partners for our technologies and products under development; and other factors

described in our filings with the Securities and Exchange Commission. Under the approved treatment

protocol, prGCD might be provided only to a limited number of patients and only for a limited time.

Pharmaceutical and biotechnology companies have suffered significant setbacks in advanced clinical

trials, even after promising results in earlier clinical trials or in preliminary findings for such

clinical trials. The FDA s approval of the treatment protocol for prGCD or the fast track approval

will not have any effect on the FDA s approval of any NDA we filed with respect to prGCD, if any,

and the review by the FDA of any data from the Phase III clinical development programs in

connection with the approval of the treatment protocol will not have any effect on the FDA s

subsequent review of our complete Phase III clinical trial data in the future. The statements are

valid only as of the date hereof and we disclaim any obligation to update this information.

The Trout Group, LLC

Telephone: 646-378-2927

Email: mnanus@troutgroup.com