Protalix Announces NDA Submission Update for taliglucerase alfa for the Treatment of Gaucher Disease

Protalix Announces NDA Submission Update for taliglucerase alfa

for the Treatment of Gaucher Disease

CARMIEL, Israel, February 2, 2010 Protalix BioTherapeutics, Inc. (NYSE- Amex: PLX) announced

today that, in connection with the New Drug Application (NDA) filed by the Company in

December 2009 for taliglucerase alfa for the treatment of Gaucher disease, the U.S. Food and Drug

Administration (FDA) has requested additional data regarding the Chemistry, Manufacturing and

Controls (CMC) section of the NDA. No additional Clinical or Preclinical information was

requested. The request focused primarily on validation of the manufacturing process in the

Company s upgraded manufacturing facility. A validation plan for the Company s manufacturing

process of taliglucerase alfa has already been established and reviewed by the FDA. The Company is

working diligently to provide the requested data to the FDA and anticipates submitting the

requested data during the second quarter of 2010.

Based on the FDA s request as part of its rolling review of the NDA, the Prescription Drug User

Fee Act (PDUFA) action date for taliglucerase alfa is expected to be issued following submission

of the additional requested CMC data.

Taliglucerase alfa will continue being provided to Gaucher patients in the United States under an

Expanded Access protocol, as well as to patients in the European Union, Israel and other countries

under Named Patient provisions.

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 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 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 completion of our 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 for taliglucerase

alfa; 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, including the NDA we filed with the FDA

or taliglucerase alfa for the treatment of Gaucher disease; 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; 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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