Protalix BioTherapeutics Receives Approval to Initiate Phase I Study in Gaucher Patients With PRX-112, an Orally-Administered

Protalix BioTherapeutics Receives Approval to Initiate Phase I Study in
Gaucher Patients With PRX-112, an Orally-Administered Candidate for the
Treatment of Gaucher Disease

CARMIEL, Israel, March 7, 2013 (GLOBE NEWSWIRE) -- Protalix BioTherapeutics,
Inc. (NYSE MKT:PLX) (TASE:PLX), announced today that it has received approval
from the Israeli Ministry of Health to initiate a phase I clinical trial of
PRX-112, or Oral GCD, the Company's orally-administered product candidate for
the treatment of Gaucher disease. Oral GCD is a plant cell expressed form of
the glucocerebrosidase enzyme (GCD) that is naturally encapsulated within
carrot cells and administered orally.The Company anticipates initiating this
trial in two Israeli medical centers during the next month.

"The majority of currently diagnosed patients with Gaucher disease are treated
with bi-weekly intravenous infusions of enzyme replacement therapy.Having a
safe and effective orally available enzyme agent would potentially improve
patients' quality of life without compromising on the benefits of enzyme
therapy," commented Dr. David Aviezer, Protalix BioTherapeutics' President and
Chief Executive Officer."Our clinical trial programs for IV administered
plant cell-expressed GCD have already demonstrated that the enzyme is safe and
effective in treating Gaucher disease.Now, in evaluating Oral GCD, our main
goal is to achieve therapeutic levels of the enzyme in the bloodstream after
oral consumption by patients."

The phase I clinical trial is an open label safety and pharmacokinetic study
designed to assess the delivery of prGCD after oral administration of Oral GCD
in 12 Gaucher patients.Subjects will receive 250mL of re-suspended carrot
cells in a single oral administration during the first cohort of the trial and
three consecutive daily administrations during the second cohort of the trial.
The Company expects the phase I trial to be completed during the second
quarter of 2013.

Pre-clinical studies of oral GCD demonstrate the stability of the enzyme in
the carrot cell and the capacity of the cell's cellulose wall to protect the
enzyme against degradation in the digestive tract in anin-vitromodel of the
stomach and intestines. Additionally, both rats and pigs fed with PRX 112,
lyophilized carrot cells expressing GCD, have demonstrated enzyme levels in
the plasma and accumulation of the active enzyme in target organs such as the
spleen and liver.

Dr. Yoseph Shaaltiel, Protalix BioTherapeutics' Executive Vice President,
Research & Development added: "Our animal studies have already demonstrated
the capacity of plant cells to serve as a vehicle for oral administration of
other therapeutic proteins. These proteins include for example, our plant
cell-expressed antiTNF fusion protein, a plant cell version of etanercept
(Enbrel®). Given the results of our preclinical studies, we believe our Oral
GCD clinical study will support our belief that we have developed a wider
platform for oral protein delivery."

About Protalix

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
product manufactured by ProCellEx, ELELYSO™ (taliglucerase alfa), was approved
for marketing by the U.S. Food and Drug Administration on May 1, 2012 and by
Israel's Ministry of Health in September 2012.Protalix has partnered with
Pfizer Inc. for the worldwide development and commercialization of ELELYSO™,
excluding Israel, where Protalix retains full rights.Marketing applications
for taliglucerase alfa have been filed in additional territories as
well.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," "plan" 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; and lack of sufficient funding to finance the clinical trials; the
risk that the results of the clinical trials of our product candidates will
not support our claims of safety or efficacy, that our product candidates will
not have the desired effects or will be associated with 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; delays in our preparation and filing of applications
for regulatory approval; delays in the approval or potential rejection of any
applications we file with the U.S. Food and Drug Administration, or other
health regulatory authorities; the inherent risks and uncertainties in
developing drug platforms and products of the type we are developing; the
impact of development of competing therapies and/or technologies by other
companies and institutions; potential product liability risks, and risks of
securing adequate levels of product liability and clinical trial insurance
coverage; and other factors described in our filings with the U.S. Securities
and Exchange Commission.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
 
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