Protalix BioTherapeutics Announces the Completion of Enrollment in the Phase III BRIDGE Clinical Trial of pegunigalsidase alfa for the Treatment of Fabry Disease

Protalix BioTherapeutics

Announces the Completion of Enrollment in the

Phase III BRIDGE Clinical Trial of pegunigalsidase alfa for the Treatment of Fabry Disease

CARMIEL, Israel, December 17, 2018 (GLOBENEWSWIRE)

-- Protalix BioTherapeutics, Inc. (NYSE American:PLX) (TASE:PLX), a biopharmaceutical company focused on the development

and commercialization of recombinant therapeutic proteins expressed through its proprietary plant cell-based expression system,

ProCellEx , today announced the completion of enrollment for the BRIDGE phase III clinical trial of pegunigalsidase alfa (PRX-102)

for the treatment of Fabry disease. Additionally, the Company provided an update on the enrollment for the BALANCE and BRIGHT phase

III clinical trials which, collectively with the BRIDGE study, comprise the phase III clinical development program for PRX-102

for the treatment of Fabry disease. The BRIGHT study is approximately 90% enrolled and the BALANCE study is approximately 70% enrolled.

"In September 2018, we reported encouraging,

positive interim results from the BRIDGE study and look forward to continue releasing additional data in 2019," commented

Moshe Manor, Protalix's President and Chief Executive Officer. "Based on the promising preliminary BRIDGE study results,

and taking into account the newly issued guidance from the U.S. Food and Drug Administration (FDA), we plan to meet

with the FDA during the first quarter of 2019 to discuss the most optimal regulatory path forward for PRX-102. While

we continue to enroll patients in the BRIGHT and BALANCE Fabry disease studies, we believe that with the patients enrolled across

the studies included in our PRX-102 clinical program to date, there is a sufficient number of patients to support expedited review,

including the potential for filing an application for accelerated approval," continued Mr. Manor.

The BRIDGE study is an open label switch over

study evaluating the safety and efficacy of PRX-102 in patients with Fabry disease currently treated with agalsidase alfa for at

least 2 years and on a stable dose for at least 6 months. Patients are screened and evaluated over 3 months while continuing treatment

with agalsidase alfa. Following the screening period, patients are enrolled and switched from agalsidase alfa treatment to intravenous

(IV) infusions of 1 mg/kg of PRX-102 every two weeks for 12 months.

PRX-102 is the Company's plant cell-expressed

recombinant, PEGylated, cross-linked -galactosidase-A product candidate for the treatment of Fabry disease.

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 product manufactured

by ProCellEx, taliglucerase alfa, was approved for marketing by the U.S. Food and Drug Administration (FDA) in May

2012 and, subsequently, by the regulatory authorities of other countries. Protalix has licensed to Pfizer Inc. the

worldwide development and commercialization rights for taliglucerase alfa, excluding Brazil, where Protalix retains full rights.

Protalix's development pipeline includes the following product candidates: pegunigalsidase alfa, a modified version of the

recombinant human alpha-GAL-A protein for the treatment of Fabry disease; OPRX-106, an orally-delivered anti-inflammatory treatment;

alidornase alfa for the treatment of Cystic Fibrosis; and others. Protalix has partnered with Chiesi Farmaceutici S.p.A.,

both in the United States and outside the United States, for the development and commercialization of pegunigalsidase

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 "expect,"

"anticipate," "believe," "estimate," "project," "plan," "should"

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 and the final results of a clinical trial may

be different than the preliminary findings for the clinical trial. Factors that might cause material differences include, among

others: failure or delay in the commencement or completion of our preclinical and clinical trials which may be caused by several

factors, including: risks that the FDA will not accept an application for accelerated approval

of PRX-102 with the data generated to date or will request additional data or other conditions of our submission of any application

for accelerated approval of PRX-102; slower than expected rates of patient recruitment; unforeseen

safety issues; determination of dosing issues; lack of effectiveness during clinical trials; 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 clinical trials; the risk that the results of the clinical trials of our product

candidates will not support our claims of superiority, 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; risks related to our ability to

maintain and manage our relationship with Chiesi Farmaceutici and any other collaborator, distributor or partner; risks related

to the amount and sufficiency of our cash and cash equivalents; risks related to the ultimate purchase by Funda o

Oswaldo Cruz of alfataliglicerase pursuant to the stated purchase intentions of the Brazilian Ministry of Health of the stated

amounts, if at all; risks related to the successful conclusion of our negotiations with the Brazilian Ministry of Health regarding

the purchase of alfataliglicerase generally; risks related to our commercialization efforts for alfataliglicerase in Brazil; risks

relating to the compliance by Funda o Oswaldo Cruz with its purchase obligations and related milestones under our

supply and technology transfer agreement; risks related to the amount and sufficiency of our cash and cash equivalents; risks related

to the amount of our future revenues, operations and expenditures; the risk that despite the FDA's grant of fast track designation

for pegunigalsidase alfa for the treatment of Fabry disease, we may not experience a faster development process, review or approval

compared to applications considered for approval under conventional FDA procedures; risks related to the FDA's ability to

withdraw the fast track designation at any time; risks relating to our ability to make scheduled payments of the principal of,

to pay interest on or to refinance our outstanding notes or any other indebtedness; 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, and other risks relating to the review process; our ability to identify suitable product

candidates and to complete preclinical studies of such product candidates; 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 other

necessary insurance coverage; and other factors described in our filings with the U.S. Securities and Exchange Commission. The

statements in this press release are valid only as of the date hereof and we disclaim any obligation to update this information,

except as may be required by law.

Marcy Nanus, Managing

Source: Protalix BioTherapeutics, Inc.