Protalix BioTherapeutics Receives FDA IND Clearance to Initiate a Phase I/II Study of Fabry Disease Patients with PRX-102, a Modified Enzyme Replacement Therapy Phase I/II Clinical Trial to Initiate Enrollment of Fabry P

Protalix BioTherapeutics Receives FDA

IND Clearance to Initiate a Phase I/II Study of Fabry Disease

Patients with PRX-102, a Modified Enzyme Replacement Therapy

Phase I/II Clinical Trial to Initiate

Enrollment of Fabry Patients

in the Fourth Quarter of 2012

CARMIEL, Israel, August 13, 2012 /GlobeNewswire /Protalix BioTherapeutics,

Inc. (NYSE-MKT:PLX, TASE:PLX), announced today that it has received clearance of its Investigational New Drug (IND) application

from the U.S. Food and Drug Administration (FDA) to initiate clinical trials of PRX-102. The Company plans to commence enrollment

of Fabry disease patients for a phase I/II trial in the fourth quarter of 2012.

PRX-102 is a proprietary plant cell-expressed, chemically modified,

recombinant alpha-galactosidase-A in development as a long-term enzyme

replacement therapy (ERT) for the treatment of Fabry disease. The phase I/II clinical trial is designed as a multi-center, open

label, dose ranging study to evaluate the safety, tolerability, pharmacokinetics and efficacy of PRX-102 in adult Fabry patients.

"We are very excited to begin the clinical development

of PRX-102, which we believe may prove to present an important improvement to the well being of patients with Fabry disease, a

rare, genetic lysosomal storage disorder affecting approximately 8,000 people globally," said Dr. David Aviezer, Protalix's

President and Chief Executive Officer. "We have designed PRX-102 as a potentially improved version of the currently marketed

enzyme replacement therapies for Fabry disease given its potential to be a more stable, potent and specific enzyme. This enzyme

is expressed through ProCellEx , our proprietary, plant cell-based protein expression system. We are also excited that another

biotherapeutic protein evolving from our ProcellEx platform technology is anticipated to enter clinical development shortly."

Eighteen adult Fabry patients will be enrolled in one of three

dosing groups. Each patient will receive intravenous infusions of PRX-102 every two weeks for 12 weeks, and will be infused sequentially

and stepwise in order to evaluate safety. Exploratory efficacy parameters will be evaluated as a preliminary assessment. Following

the end of the trial, the Company intends to offer patients the option to continue to receive PRX-102 in an open-label extension

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 is partnered with Pfizer Inc. for worldwide development

and commercialization, 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 our clinical trial of PRX-102 will not support our claims of safety or efficacy,

that PRX-102 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; 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 FDA, 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.

Source: Protalix BioTherapeutics, Inc.

The Trout Group, LLC

Jennifer Conrad or Kari Watson

MacDougall Biomedical Communications