U.S. Food and Drug Administration Approves Protalix`s Treatment Protocol for prGCD

CARMIEL, Israel--(Business Wire)--
Protalix BioTherapeutics, Inc. (NYSE-Amex:PLX), announced today that the U.S.
Food and Drug Administration (FDA) has approved the Company`s treatment protocol
for prGCD, the Company`s proprietary plant-cell expressed recombinant form of
glucocerebrosidase (GCD) for the treatment of Gaucher disease. The treatment
protocol allows physicians and other care-providers to treat patients of Gaucher
disease with prGCD in the United States and additional countries world-wide
while studies of prGCD continue as part of the Company`s ongoing pivotal Phase
III clinical trial. Prior to accepting the protocol, the FDA reviewed available
data from the Company`s on-going Phase III clinical development programs.

The treatment protocol is a multicenter, open-label trial designed to allow
physicians and other care-providers to treat patients of Gaucher disease with
prGCD during the expected shortage of Cerezyme and thereafter. Cerezyme is a
mammalian cell expressed version of glucocerebrosidase and the only enzyme
replacement therapy currently approved for Gaucher disease. The treatment
protocol allows patients enrolled in the protocol to continue being treated with
prGCD until its anticipated marketing approval from the FDA. The Company will
provide the drug free of charge to patients enrolled in the protocol.

"We appreciate the guidance and vote of confidence provided by the FDA in
establishing a treatment protocol for prGCD and are working closely with
physicians and patient advocacy groups to allow Gaucher disease patients to gain
access to our drug," commented Dr. David Aviezer, the Company`s President and
Chief Executive Officer. "We expect to conclude our phase III pivotal study next
month and are looking forward to announcing top-line results from this study in
October. We anticipate filing an NDA with the FDA by the end of this year."

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 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 has completed enrollment for this study and is treating
patients in the study in North America, South America, Israel, Europe and South
Africa. The study is monitored by an independent Data Monitoring Committee,
including experts in the field, who monitor the on-going safety data, which has
recently held their last scheduled meeting before the end of the trial. No
serious adverse events have been reported in the study. 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 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
Marcy Nanus, 646-378-2927
mnanus@troutgroup.com

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