<SEC-DOCUMENT>0001144204-13-007983.txt : 20130213
<SEC-HEADER>0001144204-13-007983.hdr.sgml : 20130213
<ACCEPTANCE-DATETIME>20130213073322
ACCESSION NUMBER:		0001144204-13-007983
CONFORMED SUBMISSION TYPE:	8-K
PUBLIC DOCUMENT COUNT:		2
CONFORMED PERIOD OF REPORT:	20130213
ITEM INFORMATION:		Other Events
ITEM INFORMATION:		Financial Statements and Exhibits
FILED AS OF DATE:		20130213
DATE AS OF CHANGE:		20130213

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:			FL
		FISCAL YEAR END:			1231

	FILING VALUES:
		FORM TYPE:		8-K
		SEC ACT:		1934 Act
		SEC FILE NUMBER:	001-33357
		FILM NUMBER:		13599576

	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>v334758_8k.htm
<DESCRIPTION>FORM 8-K
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<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: center"><B>UNITED STATES</B></P>

<P STYLE="font: 10pt 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.&nbsp;&nbsp;20549</B></P>

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

<P STYLE="font: 10pt 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-align: center">&nbsp;</P>

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

<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">&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): February 13, 2013</B></P>

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

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    <TD STYLE="vertical-align: top; font-weight: bold; text-align: center"><FONT STYLE="font: 10pt Times New Roman, Times, Serif"><B>Florida</B></FONT></TD>
    <TD STYLE="vertical-align: bottom">&nbsp;</TD>
    <TD STYLE="vertical-align: top; font-weight: bold; text-align: center"><FONT STYLE="font: 10pt Times New Roman, Times, Serif"><B>001-33357</B></FONT></TD>
    <TD STYLE="vertical-align: bottom">&nbsp;</TD>
    <TD STYLE="vertical-align: top; font-weight: bold; text-align: center"><FONT STYLE="font: 10pt Times New Roman, Times, Serif"><B>65-0643773</B></FONT></TD></TR>
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    <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></TD>
    <TD STYLE="vertical-align: bottom">&nbsp;</TD>
    <TD STYLE="vertical-align: top; font-weight: bold; text-align: center"><FONT STYLE="font: 10pt Times New Roman, Times, Serif"><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></TD></TR>
</TABLE>
<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0">&nbsp;</P>

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    <TD STYLE="width: 51%">&nbsp;</TD>
    <TD STYLE="vertical-align: bottom; width: 2%">&nbsp;</TD>
    <TD STYLE="width: 47%">&nbsp;</TD></TR>
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    <TD STYLE="vertical-align: top; font-weight: bold; text-align: center"><FONT STYLE="font: 10pt Times New Roman, Times, Serif"><B>2 Snunit Street</B></FONT></TD>
    <TD STYLE="vertical-align: bottom">&nbsp;</TD>
    <TD STYLE="vertical-align: top; font-weight: bold; text-align: center"><FONT STYLE="font: 10pt Times New Roman, Times, Serif"><B>20100</B></FONT></TD></TR>
<TR>
    <TD STYLE="vertical-align: top; font-weight: bold; text-align: center"><FONT STYLE="font: 10pt Times New Roman, Times, Serif"><B>Science Park, POB 455</B></FONT></TD>
    <TD STYLE="vertical-align: bottom">&nbsp;</TD>
    <TD STYLE="vertical-align: top">&nbsp;</TD></TR>
<TR>
    <TD STYLE="vertical-align: top; font-weight: bold; text-align: center"><FONT STYLE="font: 10pt Times New Roman, Times, Serif"><B>Carmiel, Israel</B></FONT></TD>
    <TD STYLE="vertical-align: bottom">&nbsp;</TD>
    <TD STYLE="vertical-align: top">&nbsp;</TD></TR>
<TR>
    <TD STYLE="vertical-align: top; font-weight: bold; text-align: center"><FONT STYLE="font: 10pt Times New Roman, Times, Serif"><B>(Address of principal executive offices)</B></FONT></TD>
    <TD STYLE="vertical-align: bottom">&nbsp;</TD>
    <TD STYLE="vertical-align: top; font-weight: bold; text-align: center"><FONT STYLE="font: 10pt Times New Roman, Times, Serif"><B>(Zip Code)</B></FONT></TD></TR>
</TABLE>
<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: center"><B>Registrant&rsquo;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-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">&nbsp;</P>



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<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">&nbsp;</P>

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

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0"><FONT STYLE="font-family: Wingdings">&#168;</FONT>&#9;&nbsp;Written communications pursuant to Rule 425 under
the Securities Act (17 CFR 230.425)</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0"><FONT STYLE="font-family: Wingdings">&#168;</FONT>&nbsp;&nbsp;Soliciting material pursuant to Rule 14a-12 under
the Exchange Act (17 CFR 240.14a-12)</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0"><FONT STYLE="font-family: Wingdings">&#168;</FONT>&nbsp;&#9;Pre-commencement communications pursuant to Rule
14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0"><FONT STYLE="font-family: Wingdings">&#168;</FONT>&nbsp;&#9;Pre-commencement communications pursuant to Rule
13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))</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"><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 February 13, 2013, Protalix BioTherapeutics, Inc. (the &ldquo;Company&rdquo;)
issued a press release announcing that new clinical data on ELELYSO&trade; (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. A copy of the press
release is filed as Exhibit 99.1.</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.&nbsp;&nbsp;Financial Statements and Exhibits</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"><B>(d)&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;
Exhibits</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">99.1&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;Press
release dated February 13, 2013</P>

<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">&nbsp;</P>

<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">&nbsp;</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0">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">&nbsp;</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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    <TD STYLE="width: 50%">&nbsp;</TD>
    <TD STYLE="width: 50%; font-weight: bold"><FONT STYLE="font: 10pt Times New Roman, Times, Serif"><B>PROTALIX BIOTHERAPEUTICS, INC.</B></FONT></TD></TR>
<TR>
    <TD>&nbsp;</TD>
    <TD>&nbsp;</TD></TR>
<TR>
    <TD><FONT STYLE="font: 10pt Times New Roman, Times, Serif">Date: February 13, 2013</FONT></TD>
    <TD><FONT STYLE="font: 10pt Times New Roman, Times, Serif">By:&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;<U>/s/ David Aviezer, Ph.D.&#9;&nbsp; </U></FONT></TD></TR>
<TR>
    <TD>&nbsp;</TD>
    <TD>
        <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0">Name:&nbsp;&nbsp;&nbsp; David Aviezer, Ph.D.</P>
        <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0">Title: &nbsp;&nbsp;&nbsp;&nbsp; President and Chief Executive
        Officer</P></TD></TR>
<TR>
    <TD>&nbsp;</TD>
    <TD>&nbsp;</TD></TR>
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<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0">&nbsp;</P>

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<DOCUMENT>
<TYPE>EX-99.1
<SEQUENCE>2
<FILENAME>v334758_ex99-1.htm
<DESCRIPTION>EXHIBIT 99.1
<TEXT>
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<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0"></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: right">Exhibit 99.1</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"><B>Protalix Announces New Clinical Data on ELELYSO&trade; to
be Presented at the WORLD Symposium 2013</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; background-color: white">CARMIEL, Israel, February 13, 2013/GlobeNewswire/Protalix
BioTherapeutics, Inc. (NYSE MKT:PLX, TASE:PLX), announced today that new clinical data on ELELYSO&trade; (taliglucerase alfa) will
be presented at the 9th Annual Meeting of the Lysosomal Disease Network: WORLD Symposium 2013 being held February&nbsp;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.</P>

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

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; background-color: white">&ldquo;The data to be presented at
the conference further reinforce the use of ELELYSO as a treatment option for Gaucher patients, including na&iuml;ve Gaucher patients,
and patients who were previously treated with imiglucerase (Cerezyme&reg;),&rdquo; stated Professor Ari Zimran, M.D., Director
of the Gaucher Clinic in Shaare Zedek Medical Center, Jerusalem, Israel and lead clinical investigator. &ldquo;With the approval
of ELELYSO in Israel, I am pleased to be able to provide a new treatment option to my patients.&rdquo;</P>

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

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; background-color: white">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&rsquo;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&reg;) 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.</P>

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

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; background-color: white">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.</P>

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

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; background-color: white">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&rsquo;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.</P>

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

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

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

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

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; background-color: white">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.</P>

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

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; background-color: white">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 na&iuml;ve 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.</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 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<SUP>3</SUP>, from 73,055 to 136,027
/mm<SUP>3</SUP>, in the 60 U/kg dose group and by 29,783 /mm<SUP>3</SUP>, from 64,900 to 94,683/mm<SUP>3</SUP>, 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.</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; background-color: white">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 an&nbsp;in vitro&nbsp;assay, 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.</P>

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

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; background-color: white">The long-term safety and efficacy results
from the na&iuml;ve adult patient extension study demonstrate that ELELYSO has a well-established safety profile and is an effective
long-term treatment for Gaucher disease.</P>

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

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

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

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

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; background-color: white">Professor Zimran will also present
a poster entitled &ldquo;A Multicenter, Double-Blind, Randomized Safety and Efficacy Study of Two Dose Levels of Taliglucerase
Alfa in Pediatric Patients with Gaucher Disease.&rdquo; These data were first announced by the Company at the 10th Annual European
Working Group on Gaucher Disease Meeting in June 2012.</P>

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

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; background-color: white"><FONT STYLE="font-size: 10pt">Copies
of the posters are being posted on the investor relations page of the Company's website, www.protalix.com. </FONT>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.</P>

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

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0"><B>Safety Information for ELELYSO&trade; </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; background-color: white">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.</P>

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

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; background-color: white">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.</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; background-color: white">&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&reg;. 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&trade; (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&reg;) for the treatment of certain
immune diseases such as rheumatoid arthritis, juvenile idiopathic arthritis, ankylosing spondylitis, psoriatic arthritis and plaque
psoriasis; 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"></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">&nbsp;</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0"><B>Forward Looking Statements</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">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 &quot;anticipate,&quot; &quot;believe,&quot; &quot;estimate,&quot; &quot;expect&quot;
and &quot;intend&quot; 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.</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>Investor Contact</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">Marcy Nanus&#9;<BR>
The Trout Group, LLC<BR>
646-378-2927<BR>
mnanus@troutgroup.com</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>&nbsp;</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"><B>Media Contact</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">Kari Watson<BR>
MacDougall Biomedical Communications<BR>
781-235-3060<BR>
<FONT STYLE="text-underline-style: none; color: windowtext">kwatson@macbiocom.com</FONT></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>Source: Protalix BioTherapeutics, Inc.</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></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">&nbsp;</P>





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