<SEC-DOCUMENT>0001144204-16-106902.txt : 20160606
<SEC-HEADER>0001144204-16-106902.hdr.sgml : 20160606
<ACCEPTANCE-DATETIME>20160606070816
ACCESSION NUMBER:		0001144204-16-106902
CONFORMED SUBMISSION TYPE:	8-K
PUBLIC DOCUMENT COUNT:		2
CONFORMED PERIOD OF REPORT:	20160606
ITEM INFORMATION:		Other Events
ITEM INFORMATION:		Financial Statements and Exhibits
FILED AS OF DATE:		20160606
DATE AS OF CHANGE:		20160606

FILER:

	COMPANY DATA:	
		COMPANY CONFORMED NAME:			Protalix BioTherapeutics, Inc.
		CENTRAL INDEX KEY:			0001006281
		STANDARD INDUSTRIAL CLASSIFICATION:	BIOLOGICAL PRODUCTS (NO DIAGNOSTIC SUBSTANCES) [2836]
		IRS NUMBER:				650643773
		STATE OF INCORPORATION:			DE
		FISCAL YEAR END:			1231

	FILING VALUES:
		FORM TYPE:		8-K
		SEC ACT:		1934 Act
		SEC FILE NUMBER:	001-33357
		FILM NUMBER:		161697492

	BUSINESS ADDRESS:	
		STREET 1:		2 SNUNIT ST
		STREET 2:		SCIENCE PARK, POB 455
		CITY:			CARMIEL
		STATE:			L3
		ZIP:			20100
		BUSINESS PHONE:		972-4-988-9488

	MAIL ADDRESS:	
		STREET 1:		2 SNUNIT ST
		STREET 2:		SCIENCE PARK, POB 455
		CITY:			CARMIEL
		STATE:			L3
		ZIP:			20100

	FORMER COMPANY:	
		FORMER CONFORMED NAME:	ORTHODONTIX INC
		DATE OF NAME CHANGE:	19980422

	FORMER COMPANY:	
		FORMER CONFORMED NAME:	EMBASSY ACQUISITION CORP
		DATE OF NAME CHANGE:	19960124
</SEC-HEADER>
<DOCUMENT>
<TYPE>8-K
<SEQUENCE>1
<FILENAME>v441786_8k.htm
<DESCRIPTION>CURRENT REPORT
<TEXT>
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<P STYLE="font: 18pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: center"><B>UNITED STATES</B></P>

<P STYLE="font: 18pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: center"><B>SECURITIES AND EXCHANGE COMMISSION</B></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: center"><B>Washington, D.C. 20549</B></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.5in">&nbsp;</P>

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<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.5in">&nbsp;</P>

<P STYLE="font: 18pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: center"><B>FORM 8-K</B></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.5in">&nbsp;</P>

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<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: center"><B>CURRENT REPORT </B></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: center"><B>Pursuant to Section 13 or 15(d) of </B></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: center"><B>the Securities Exchange Act of 1934 </B></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.5in">&nbsp;</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: center"><B>Date of Report (Date of Earliest Event
Reported): June 6, 2016</B></P>



<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.5in">&nbsp;</P>

<P STYLE="font: 24pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: center"><B>Protalix BioTherapeutics, Inc.</B></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: center"><B>(Exact name of registrant as specified
in its charter) </B></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.5in">&nbsp;</P>



<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.5in"></P>

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    <td style="width: 34%">&nbsp;</td>
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    <td style="width: 32%">&nbsp;</td>
    <td style="vertical-align: bottom; width: 1%">&nbsp;</td>
    <td style="width: 32%">&nbsp;</td></tr>
<tr>
    <td style="vertical-align: top; text-align: center"><font style="font-size: 10pt"><b>Delaware</b></font></td>
    <td style="vertical-align: bottom">&nbsp;</td>
    <td style="vertical-align: top; text-align: center"><font style="font-size: 10pt"><b>001-33357</b></font></td>
    <td style="vertical-align: bottom">&nbsp;</td>
    <td style="vertical-align: top; text-align: center"><font style="font-size: 10pt"><b>65-0643773</b></font></td></tr>
<tr>
    <td style="vertical-align: top">
        <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: center"><b>(State or other jurisdiction</b></P>
        <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: center"><b>of incorporation)</b></P>
        <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: center">&nbsp;</P></td>
    <td style="vertical-align: bottom">&nbsp;</td>
    <td style="vertical-align: top; text-align: center"><font style="font-size: 10pt"><b>(Commission File Number)</b></font></td>
    <td style="vertical-align: bottom">&nbsp;</td>
    <td style="vertical-align: top">
        <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: center"><b>(IRS Employer</b></P>
        <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: center"><b>Identification No.)</b></P>
        <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: center">&nbsp;</P></td></tr>
</table>
<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.5in">&nbsp;</P>

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<tr>
    <td style="width: 51%">&nbsp;</td>
    <td style="vertical-align: bottom; width: 1%">&nbsp;</td>
    <td style="width: 48%">&nbsp;</td></tr>
<tr>
    <td style="vertical-align: top; text-align: center"><font style="font-size: 10pt"><b>2 Snunit Street</b></font></td>
    <td style="vertical-align: bottom">&nbsp;</td>
    <td style="vertical-align: top; text-align: center"><font style="font-size: 10pt"><b>20100</b></font></td></tr>
<tr>
    <td style="vertical-align: top; text-align: center"><font style="font-size: 10pt"><b>Science Park, POB 455</b></font></td>
    <td style="vertical-align: bottom">&nbsp;</td>
    <td style="vertical-align: top; text-align: center">&nbsp;</td></tr>
<tr>
    <td style="vertical-align: top; text-align: center"><font style="font-size: 10pt"><b>Carmiel, Israel</b></font></td>
    <td style="vertical-align: bottom">&nbsp;</td>
    <td style="vertical-align: top; text-align: center">&nbsp;</td></tr>
<tr>
    <td style="vertical-align: top; text-align: center"><font style="font-size: 10pt"><b>(Address of principal executive offices)</b></font></td>
    <td style="vertical-align: bottom">&nbsp;</td>
    <td style="vertical-align: top; text-align: center"><font style="font-size: 10pt"><b>(Zip Code)</b></font></td></tr>
</table>
<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.5in">&nbsp;</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: center"><B>Registrant's telephone number, including
area code +972-4-988-9488</B></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.5in">&nbsp;</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.5in">&nbsp;</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: center"><B>(Former name or former address, if changed
since last report.) </B></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.5in">&nbsp;</P>





<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.5in"></P>

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<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.5in">&nbsp;</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0">Check the appropriate box below if the Form 8-K filing is intended
to simultaneously satisfy the filing obligation of the registrant under any of the following provisions (see General Instruction
A.2. below):</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.5in">&nbsp;</P>

<table cellspacing="0" cellpadding="0" style="font: 10pt Times New Roman, Times, Serif; width: 100%; border-collapse: collapse">
<tr style="vertical-align: top">
    <td style="width: 4%"><font style="font-family: Wingdings; font-size: 10pt">&uml;</font></td>
    <td><font style="font-size: 10pt">Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425) </font></td></tr>
<tr style="vertical-align: top">
    <td><font style="font-family: Wingdings; font-size: 10pt">&uml;</font></td>
    <td><font style="font-size: 10pt">Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12) </font></td></tr>
<tr style="vertical-align: top">
    <td><font style="font-family: Wingdings; font-size: 10pt">&uml;</font></td>
    <td><font style="font-size: 10pt">Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b)) </font></td></tr>
<tr style="vertical-align: top">
    <td><font style="font-family: Wingdings; font-size: 10pt">&uml;</font></td>
    <td><font style="font-size: 10pt">Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c)) </font></td></tr>
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<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0"><B>&nbsp;</B></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0"><B></B></P>

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<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0"><B>&nbsp;</B></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0"><B>&nbsp;</B></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0"><B>Item 8.01. Other Events</B></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0">&nbsp;</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0">On June 6, 2016, Protalix BioTherapeutics, Inc. (the &ldquo;Company&rdquo;)
issued a press release announcing that, based on guidance and feedback from the U.S. Food and Drug Administration (FDA), the Company
has initiated its phase III clinical trial of PRX-102 for the treatment of Fabry disease. A copy of the press release is attached
hereto as Exhibit 99.1 and is incorporated by reference herein.</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0">&nbsp;</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0"><B>Item 9.01. Financial Statements and Exhibits</B></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0">&nbsp;</P>

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<TD STYLE="width: 0in"></TD><TD STYLE="width: 0.5in; text-align: left"><B>(d)</B></TD><TD STYLE="text-align: justify"><B>Exhibits</B></TD>
</TR></TABLE>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0">&nbsp;</P>

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<TD STYLE="width: 0in"></TD><TD STYLE="width: 0.5in; text-align: left">99.1</TD><TD STYLE="text-align: justify">Press release dated June 6, 2016.</TD>
</TR></TABLE>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0">&nbsp;</P>

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<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: center"><B>SIGNATURES</B></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: center">&nbsp;</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">Pursuant to the requirements of the Securities
Exchange Act of 1934, the Registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&nbsp;</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0"></P>

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<TR>
    <TD STYLE="vertical-align: top">&nbsp;</TD>
    <TD COLSPAN="2"><B>PROTALIX BIOTHERAPEUTICS, INC.</B></TD></TR>
<TR>
    <TD STYLE="vertical-align: top">&nbsp;</TD>
    <TD COLSPAN="2">&nbsp;</TD></TR>
<TR>
    <TD STYLE="vertical-align: top; width: 50%">&nbsp;</TD>
    <TD STYLE="width: 4%">By:&nbsp;</TD>
    <TD STYLE="vertical-align: top; width: 46%">/s/ Moshe Manor</TD></TR>
<TR>
    <TD STYLE="vertical-align: top">&nbsp;</TD>
    <TD>&nbsp;</TD>
    <TD STYLE="vertical-align: top; border-top: #000000 1px solid">Name: Moshe Manor<BR>Title:&#9; President
and Chief Executive Officer</TD></TR>
</TABLE>

<P STYLE="font: 10pt Times New Roman, Times, Serif; text-align: left; text-indent: 0pt; margin-top: 0pt; margin-bottom: 6pt">&nbsp;</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; text-align: left; text-indent: 0pt; margin-top: 0pt; margin-bottom: 6pt">Date:&nbsp;&nbsp;June 6, 2016</P>




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<DOCUMENT>
<TYPE>EX-99.1
<SEQUENCE>2
<FILENAME>v441786_ex99-1.htm
<DESCRIPTION>EXHIBIT 99.1
<TEXT>
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<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: right"><B>Exhibit 99.1</B></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: right">&nbsp;</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: center"><B>Protalix BioTherapeutics Initiates PRX-102
Global Phase III Clinical Trial of Fabry Disease</B><BR>
<B>to Support United States and European Filings</B></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: center">&nbsp;</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: center"><I>24-Month Superiority Trial vs. Fabrazyme<SUP>&reg;</SUP>
for a United States Filing</I></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: center">&nbsp;</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: center"><I>At 12 Months, Interim Analysis of the
Superiority Trial Data will be Performed to Test for Non-Inferiority Compared to Fabrazyme for an EMA Filing </I></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: center">&nbsp;</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0 0pt 0.75in; text-align: center"><I>Additional 12-Month Switch-Over
Study from Replagal<SUP>&reg;</SUP> to be Initiated to Provide Supportive Data for United States and EMA Filings</I></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0 0pt 0.75in; text-align: center">&nbsp;</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0">CARMIEL, Israel, June 6, 2016 -- Protalix BioTherapeutics, Inc.
(NYSE MKT:PLX) (TASE:PLX), announced today that based on guidance and feedback from the U.S. Food and Drug Administration (FDA),
the Company initiated its phase III clinical trial of PRX-102 for the treatment of Fabry disease. Guidance from the European Medicines
Agency (EMA) has been incorporated into the development plan to support an EMA filing as well.</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0">&nbsp;</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0">&ldquo;We are excited to initiate our global phase III clinical
trial. The Institutional Review Board (IRB) process has been completed, including study protocol approval, and the first leading,
United States-based clinical center for the first study has opened,&rdquo; said Moshe Manor, Protalix&rsquo;s President and Chief
Executive Officer. &ldquo;Patient enrollment is expected to commence shortly in centers throughout the United States and Europe.&rdquo;</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0">&nbsp;</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0">The phase III efficacy and safety clinical trial, or, the BALANCE
Study, is a 24-month multi-center, randomized, double-blind, active control study of PRX-102 in Fabry patients with impaired renal
function. Seventy-eight patients previously treated with Fabrazyme<SUP>&reg;</SUP> (agalsidase beta) for approximately one year,
and with a stable dose for at least six months, will be enrolled and then randomized to continue treatment with 1&#9702;mg/kg with
either Fabrazyme or PRX-102, at a 2:1 ratio of PRX-102 to Fabrazyme, respectively. Patients are to be treated via intravenous (IV)
infusions every two weeks.</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0">&nbsp;</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0">The primary efficacy parameter is the comparison of the mean
annualized change in estimated glomerular filtration rate (eGFR) between treatment groups. The secondary endpoints include Left
Ventricular Mass Index (g/m<SUP>2</SUP>) by MRI, Plasma Lyso-Gb3, Plasma Gb3, Urine Lyso-Gb3, Exercise Tolerance (Stress Test),
Short Form Brief Pain Inventory and Mainz Severity Score Index and Quality of Life. In addition, immunogenicity and safety parameters
will be measured.</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0">&nbsp;</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0">At 12 months, the Company intends to conduct an interim analysis
to test for non-inferiority to support an anticipated regulatory filing with the EMA. Patients enrolled in the study will continue
to be treated for a total of 24 months, at which point the data will be analyzed to test for superiority to support an FDA filing.
To demonstrate superiority, during the SPA process, the FDA indicated that a 30% improvement in the rate of decline in eGFR relative
to the active comparator arm is acceptable.</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0">&nbsp;</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0">&ldquo;The key endpoints for evaluation in the BALANCE Study
are the same endpoints we analyzed in our phase I/II clinical trial of PRX-102. These endpoints demonstrated strong positive results
in the phase I/II study with an annualized rate of eGFR change of only -0.32. According to a published report, an annualized rate
of eGFR change of -1.89 was observed in a study of the effect of Fabrazyme in a similar patient population. Based on the above
and given PRX-102&rsquo;s significantly longer half-life compared to other approved treatments, and its increased stability resulting
from the molecule being covalently bound, we believe PRX-102 will achieve superiority,&rdquo; commented Einat Brill Almon, Ph.D.,
Protalix&rsquo;s Senior Vice President of Product Development.</P>

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<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0">&nbsp;</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0">The Company also intends to initiate the BRIDGE Study, a single-arm,
switch-over study from Replagal<SUP>&reg;</SUP>, to provide supportive data for anticipated filings in the United States and the
European Union. This trial is designed to enroll 22 Fabry patients, currently treated with Replagal (alpha-galactosidase), who
are to be switched to 1 mg/kg of PRX-102 for 12 months. The primary endpoint of the BRIDGE Study is safety; additional exploratory
efficacy parameters include Left Ventricular Mass Index (g/m<SUP>2</SUP>) by MRI, Plasma Lyso-Gb3, Plasma Gb3, Urine Lyso-Gb3,
Exercise Tolerance (Stress Test), Short Form Brief Pain Inventory, Mainz Severity Score Index and Quality of Life.</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0">&nbsp;</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0">During the Company&rsquo;s interaction with the FDA, including
the SPA process, the Company received and implemented the FDA&rsquo;s recommendations for the BALANCE study design. In the interest
of time, and based on the FDA&rsquo;s written guidance that an SPA is not a requirement for proceeding with the Company&rsquo;s
clinical development program, the Company initiated the BALANCE Study without completing the full SPA process. Written guidance
from the FDA has stated that the BALANCE Study is adequate to support a filing.</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0">&nbsp;</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0">Additionally, through the SPA process, it became clear to the
Company that a trial evaluating gastro-intestinal symptoms, which the Company had previously contemplated as part of the PRX-102
clinical development program, is not necessary for the Company&rsquo;s planned regulatory filings.</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0">&nbsp;</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0"><B>About Protalix BioTherapeutics, Inc.</B></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0">&nbsp;</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0">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(R). 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: PRX-102, a pegylated version
of a recombinant human alpha-GAL-A protein for the treatment of Fabry disease; PRX-106, an orally-delivered anti-inflammatory treatment;
PRX-110, a chemically modified DNase I for the treatment of Cystic Fibrosis; and others.</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0">&nbsp;</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify"><B>Forward-Looking Statements</B></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&nbsp;</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0">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 &ldquo;anticipate,&rdquo; &ldquo;believe,&rdquo; &ldquo;estimate,&rdquo; &ldquo;expect,&rdquo;
&ldquo;plan&rdquo; and &ldquo;intend&rdquo; 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 preclinical and clinical trials which may be caused
by several factors, including: 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 analysis of data from the clinical trials of our product candidates will
not achieve desired results; 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 FDA or other health regulatory authorities, and other
risks relating to the review process; risks related to the acceptance and use of our product candidates, if approved, by physicians,
patients and third-party payors; the risk of significant delays in the commercial introduction of our product candidates, if and
when approved; 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 release are valid only as of the date hereof
and we disclaim any obligation to update this information.</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0">&nbsp;</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify"><B>Investor Contact</B></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&nbsp;</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">Marcy Nanus</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">The Trout Group, LLC</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">646-378-2952</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify"><FONT STYLE="color: Blue"><U>mnanus@troutgroup.com</U></FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&nbsp;</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0"><B>Source: Protalix BioTherapeutics, Inc.</B></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0">&nbsp;</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0">&nbsp;</P>

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