Protalix Announces New Clinical Data on ELELYSO(TM) to be Presented at the WORLD Symposium 2013

Protalix Announces New Clinical Data on ELELYSO(TM) to be Presented at the
WORLD Symposium 2013

CARMIEL, Israel, Feb. 13, 2013 (GLOBE NEWSWIRE) -- Protalix BioTherapeutics,
Inc. (NYSE MKT:PLX) (TASE:PLX), announced today that new clinical data on
ELELYSO™ (taliglucerase alfa) will be presented at the 9th Annual Meeting of
the Lysosomal Disease Network: WORLD Symposium 2013 being held February 13-15
in Orlando, Florida. ELELYSO, the Company's first commercial product, is the
first FDA-approved plant cell-based enzyme replacement therapy for Gaucher
disease.

"The data to be presented at the conference further reinforce the use of
ELELYSO as a treatment option for Gaucher patients, including naïve Gaucher
patients, and patients who were previously treated with imiglucerase
(Cerezyme®)," stated Professor Ari Zimran, M.D., Director of the Gaucher
Clinic in Shaare Zedek Medical Center, Jerusalem, Israel and lead clinical
investigator. "With the approval of ELELYSO in Israel, I am pleased to be able
to provide a new treatment option to my patients."

Gregory Pastores, M.D., Professor of Neurology and Pediatrics and Director of
the Neurogenetics Laboratory at the New York University School of Medicine, is
presenting long-term data from the Company's multi-center, open-label
switchover extension trial of ELELYSO for the treatment of Gaucher disease.
The Company's original switchover trial was a nine-month trial in which
patients with stable disease were switched from treatment via intravenous
infusions of imiglucerase (Cerezyme®) to intravenous infusions of ELELYSO
every two weeks at an equivalent dose to the patient's previous imiglucerase
dose. Patients who participated in the switchover trial were given the option
to continue treatment with ELELYSO in the Company's switchover extension
trial.

Twenty-five adult patients completed the switchover trial, of which 19 elected
to continue treatment with ELELYSO through the long-term extension trial. Five
of the six patients who did not enroll in the extension trial continued
nonetheless to receive ELELYSO through the Company's various compassionate use
programs. One patient was unable to comply with the study protocol and
therefore was not eligible to participate in the extension trial.

A 24 month interim analysis of the switchover trial demonstrates that all
patients remained stable with regard to all key disease parameters, spleen
volume, liver volume, platelet count and hemoglobin concentration, as well as
the chitotriosidase activity biomarker after switching to ELELYSO from
imiglucerase. The safety analysis presented for the 24-month switchover
treatment duration demonstrates that ELELYSO was well tolerated, and no drug
related serious adverse events were reported. One patient developed
neutralizing IgG antibodies that were determined to be positive in an in vitro
assay, and were determined to be negative in a cell-based assay. Four of the
19 patients enrolled in the extension trial discontinued treatment; one
switched to the ELELYSO compassionate use program, one enrolled in another
clinical trial, one was unable to comply with the study protocol and one was
not pleased with that individual's personal results.In conclusion, the data
demonstrates that ELELYSO has a well-established safety profile and is an
effective alternative treatment for adult Gaucher patients treated previously
with Cerezyme.

These results will also be presented during the poster sessions, which will
take place on Wednesday, February 13 from 4:30-6:30 PM ET and on Thursday,
February 14 from 4:30-6:00 PM ET.

Professor Ari Zimran is presenting a poster describing long-term safety and
efficacy data from the Company's double-blind, follow-on extension study of
ELELYSO for the treatment of Gaucher disease in adult naïve patients.Eligible
patients who completed treatment in the Company's pivotal nine-month phase III
clinical trial were offered the opportunity to participate in the extension
study and continue to receive ELELYSO at the same dose they received in the
pivotal trial for an additional 30 months in a blinded manner.Accordingly,
the extension trial included two treatment groups; one treated with a 60 U/kg
dose and the other with a 30 U/kg dose.The primary endpoint of the extension
trial was the percent change from baseline in spleen volume.Major secondary
endpoints included percentage change from baseline in hemoglobin
concentration, liver volume, platelet count and chitotriosidase
activity.Twenty-six patients enrolled in the extension trial which was
performed in centers throughout Europe, Israel, North America, South America
and South Africa.

At thirty-six months of treatment, both the primary and major secondary
efficacy endpoints were achieved.Mean spleen volume decreased 62% and 47% in
each of the 60 U/kg dose and 30 U/kg dose groups, respectively; mean
hemoglobin concentration increased by 3 g/dL, from 11.0 g/dL to 14.0 g/dL, in
the 60 U/kg dose group and by 1.9 g/dL, from 12.4 g/dL to 14.3 g/dL, in the 30
U/kg dose group; mean liver volume decreased 19% and 21% in each of the 60
U/kg dose and 30 U/kg dose groups, respectively; mean platelet counts
increased by 62,972 /mm^3, from 73,055 to 136,027 /mm^3, in the 60 U/kg dose
group and by 29,783 /mm^3, from 64,900 to 94,683/mm^3, in the 30 U/kg dose
group; and mean chitotriosidase activity decreased 83.0% and 73.5% for each of
the 60 U/kg dose and 30 U/kg dose groups, respectively.

The safety analysis presented for both treatment groups demonstrates that
ELELYSO was well tolerated, and no drug related serious adverse events were
reported. Two participants developed neutralizing IgG antibodies that were
determined to be positive in anin vitroassay, and were determined to be
negative in a cell-based assay.In addition, one patient in the 60 U/kg dose
group experienced a hypersensitivity reaction during month 10 of
treatment.Treatment of this patient with ELELYSO has been continued with
premedication for an additional 44 months without any treatment related
adverse events reported.Three of the 26 participants enrolled in the
extension trial discontinued treatment; one switched into the ELELYSO
compassionate use program, one was unable to comply with study protocol and
one had a skin reaction during month 15.

The long-term safety and efficacy results from the naïve adult patient
extension study demonstrate that ELELYSO has a well-established safety profile
and is an effective long-term treatment for Gaucher disease.

Professor Zimran will also present a poster entitled "A Multicenter,
Double-Blind, Randomized Safety and Efficacy Study of Two Dose Levels of
Taliglucerase Alfa in Pediatric Patients with Gaucher Disease." These data
were first announced by the Company at the 10th Annual European Working Group
on Gaucher Disease Meeting in June 2012.

Copies of the posters are being posted on the investor relations page of the
Company's website, www.protalix.com.The content of the Company's website is
not intended to be incorporated by reference into this press release or in any
report or document we file.

Safety Information for ELELYSO™

As with any intravenous protein product, allergic reactions, some severe, were
reported in the taliglucerase alfa clinical trials.A definition of
anaphylaxis (as defined by Sampson et al 2006) was retrospectively applied to
some of these reports. In patients who have experienced anaphylaxis during
infusion with ELELYSO or with other ERT, caution should be exercised upon
retreatment; appropriate medical support should be readily available.

Infusion reactions (including allergic reactions), defined as a reaction
occurring within 24 hours of the infusion, were the most commonly observed
reactions in patients treated with ELELYSO in clinical studies.The most
commonly observed symptoms of infusion reactions were headache, chest pain or
discomfort, asthenia, fatigue, urticaria, erythema, increased blood pressure,
back pain and arthralgia, and flushing.Most of these reactions were mild and
did not require treatment intervention.

About Protalix BioTherapeutics, Inc.

Protalix is a biopharmaceutical company focused on the development and
commercialization of recombinant therapeutic proteins expressed through its
proprietary plant cell based expression system, ProCellEx®.Protalix's unique
expression system presents a proprietary method for developing recombinant
proteins in a cost-effective, industrial-scale manner.Protalix's first
approved product manufactured by ProCellEx, ELELYSO™ (taliglucerase alfa), an
enzyme replacement therapy for the treatment of Gaucher disease, was approved
for marketing by the U.S. Food and Drug Administration (FDA) in May 2012, and
by Israel's Ministry of Health in September 2012.Additional marketing
applications for taliglucerase alfa have been filed in other
countries.Protalix is partnered with Pfizer Inc. for worldwide development
and commercialization, excluding Israel, where Protalix retains full
rights.Protalix's development pipeline also includes the following product
candidates: PRX-102, a modified version of the recombinant human alpha-GAL-A
protein for the treatment of Fabry disease; PRX-105, a pegylated recombinant
human acetylcholinesterase in development for several therapeutic and
prophylactic indications, a biodefense program and an organophosphate-based
pesticide treatment program; an orally-delivered glucocerebrosidase enzyme
that is naturally encased in carrot cells, also for the treatment of Gaucher
disease; pr-antiTNF, a similar plant cell version of etanercept (Enbrel®) for
the treatment of certain immune diseases such as rheumatoid arthritis,
juvenile idiopathic arthritis, ankylosing spondylitis, psoriatic arthritis and
plaque psoriasis; and others.

Forward Looking Statements

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.The terms "anticipate," "believe," "estimate," "expect" and "intend" and
other words or phrases of similar import are intended to identify
forward-looking statements.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:
failure or delay in the commencement or completion of our clinical trials
which may be caused by several factors, including: unforeseen safety issues;
determination of dosing issues; lack of effectiveness during clinical trials;
slower than expected rates of patient recruitment; inability to monitor
patients adequately during or after treatment; inability or unwillingness of
medical investigators and institutional review boards to follow our clinical
protocols; a lack of sufficient funding to finance the clinical trials; the
risk that the results of our clinical trials will not support our claims of
safety or efficacy; that taliglucerase alfa will not have the desired effects
or includes undesirable side effects or other unexpected characteristics; our
dependence on performance by third party providers of services and supplies,
including without limitation, clinical trial services; risks relating to the
review process of the FDA and other foreign regulatory bodies, including the
risk that regulatory authorities may find that the data from our clinical
trials and other studies is insufficient for regulatory approval; risks
relating to delays in the FDA's, or other foreign regulatory authorities'
approval of any applications we file or refusals to approve such filings; the
risk that applicable regulatory authorities may refuse to approve the
marketing and sale of a drug product even after acceptance of an application
we file for the 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.The statements in
this release are valid only as of the date hereof and we disclaim any
obligation to update this information.

CONTACT: Investor Contact
         Marcy Nanus
         The Trout Group, LLC
         646-378-2927
         mnanus@troutgroup.com

         Media Contact
         Kari Watson
         MacDougall Biomedical Communications
         781-235-3060
         kwatson@macbiocom.com