Protalix Announces Successful GMP Manufacturing Audit by Israel s Ministry of Health

Protalix Announces Successful GMP Manufacturing Audit by Israel s Ministry of Health

CARMIEL, Israel, March 3, 2010 Protalix BioTherapeutics, Inc. (NYSE-Amex:PLX), announced today

that the Israeli Ministry of Health has completed a successful GMP (Good Manufacturing Practice)

audit of the Company s manufacturing facility in Carmiel, Israel. The audit was performed as part

of the Ministry of Health s evaluation of the company s manufacturing process of taliglucerase alfa

for the treatment of Gaucher disease.

The successful audit of our manufacturing facility by the Israeli Health Ministry is another

important milestone toward our plans to commercialize taliglucerase alfa in Israel and throughout

the world, said Dr. David Aviezer, President and CEO of Protalix. This important achievement

helps to demonstrate the viability, quality and commercial potential of our proprietary plant-cell

based technology platform.

In February 2010, the company announced Phase III data at the Lysosomal Disease Network s WORLD

symposium. The study, which reached its primary endpoint, demonstrated a mean reduction in spleen

volume in both treatment arms studied (60 U/kg, 30 U/kg taliglucerase alfa) in patients with

Gaucher disease in a highly significant statistical manner. In this study, taliglucerase alfa was

well tolerated, no serious or severe adverse events were reported, a low (6%) level of antibody

formation was found and there was no neutralizing antibody formation.

About Gaucher disease

Gaucher disease, an inherited condition, is the most prevalent lysosomal storage disorder, with an

incidence of about 1 in 20,000 live births. People with Gaucher disease do not have enough of an

enzyme, -glucosidase (glucocerebrosidase) that breaks down a certain type of fat molecule. As a

result, lipid engorged cells (called Gaucher cells) amass in different parts of the body, primarily

the spleen, liver and bone marrow. Accumulation of Gaucher cells may cause spleen and liver

enlargement, anemia, excessive bleeding and bruising, bone disease and a number of other signs and

Protalix is a biopharmaceutical company focused on the development and commercialization of

proprietary recombinant therapeutic proteins expressed through its proprietary plant cell based

expression system. Protalix s ProCellEx(TM) presents a proprietary method for the expression of

recombinant proteins that the Company believes will allow for the industrial-scale production of

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

Protalix is also advancing additional recombinant biopharmaceutical drug development programs.

Taliglucerase alfa is an enzyme replacement therapy in development under a Special Protocol

Assessment with the FDA for Gaucher disease. In August 2009, the FDA granted orphan drug status and

fast track designation to taliglucerase alfa for the treatment of Gaucher disease and Protalix

filed a rolling NDA submission with the FDA in December 2009. In November 2009, Protalix granted

Pfizer Inc. exclusive, worldwide rights to develop and

commercialize taliglucerase alfa for the treatment of Gaucher disease, except in Israel. Protalix

retained the right to commercialize taliglucerase alfa in Israel.

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, the EMEA, other foreign regulatory bodies and other governmental

regulatory bodies, including the FDA s and the EMEA s review of any filings we make in connection

with the treatment protocol; delays in the FDA s, the EMEA 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. Companies in the pharmaceutical and biotechnology industries

have suffered significant setbacks in advanced or late-stage clinical trials, even after obtaining

promising earlier trial results or in preliminary findings for such clinical trials. Further, even

if favorable testing data is generated by clinical trials of drug products, the FDA, EMEA or any

other foreign regulatory authority may not accept or approve an NDA filed by a pharmaceutical or

biotechnology company for such drug product. Failure to obtain approval from the FDA, EMEA or any

other foreign regulatory authority of any of our drug candidates in a timely manner, if at all,

will severely undermine our business and results of operation by reducing our potential marketable

products and our ability to generate corresponding product revenues. The statements in this

release are valid only as of the date hereof and we disclaim any obligation to update this

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