Protalix Completes Pivotal Phase III Trial for prGCD for the Treatment of Gaucher Disease Top-line Data Expected in October 2009

Protalix Completes Pivotal Phase III Trial for prGCD for the Treatment of Gaucher Disease

Top-line Data Expected in October 2009

CARMIEL, Israel, September 14, 2009 (Business Wire) Protalix Biotherapeutics, Inc. (NYSE-Amex:

PLX), announced the completion of its pivotal Phase III trial for prGCD, the Company s proprietary

plant-cell expressed recombinant form of glucocerebrosidase (GCD) for the treatment of Gaucher

disease. The trial enrolled a total of 31 patients across Europe, North America, South America,

Israel and South Africa. No serious adverse events were reported in this trial. The Company plans to announce top-line results from this study in October

2009 and expects to complete its rolling New Drug Application (NDA) with the U.S. Food and Drug

Administration (FDA) before the end of the year.

The pivotal Phase III clinical trial of prGCD is a multi-center, randomized, double-blind, parallel

group, dose-ranging trial to assess the safety and efficacy of prGCD in treatment naive patients

diagnosed with Gaucher disease. In the trial, patients were selected randomly for one of two

dosing arms and received IV infusions every two weeks for nine months. The primary endpoint of the

study is the reduction in spleen volume from baseline, as measured by MRI.

Protalix also announced that UPLYSO is the proposed brand name for its Gaucher disease drug

candidate prGCD. The generic name for the compound is taliglucerase alfa. Trademark applications

for UPLYSO have been submitted world wide.

We are pleased to announce the completion of our Phase III pivotal trial with UPLSYO (prGCD) and

look forward to reviewing and announcing the results in October, said Dr. David Aviezer, President

and CEO of Protalix. We expect that the results from this trial will further validate our

technology for manufacturing human recombinant protein drugs cost-effectively and safely through

plant-cell based expression system. We believe our technology can provide a

competitive and appealing option for patients world-wide.

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(TM) 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 completed a Phase III pivotal study for its lead product candidate, UPLYSO

(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, UPLYSO (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 UPLYSO (prGCD)

or the fast track approval will not have any effect on the FDA s approval of any NDA we file with

respect to UPLYSO (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.

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