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<SEC-DOCUMENT>0000950123-08-016749.txt : 20081202
<SEC-HEADER>0000950123-08-016749.hdr.sgml : 20081202
<ACCEPTANCE-DATETIME>20081202094941
ACCESSION NUMBER:		0000950123-08-016749
CONFORMED SUBMISSION TYPE:	8-K
PUBLIC DOCUMENT COUNT:		3
CONFORMED PERIOD OF REPORT:	20081125
ITEM INFORMATION:		Regulation FD Disclosure
ITEM INFORMATION:		Other Events
ITEM INFORMATION:		Financial Statements and Exhibits
FILED AS OF DATE:		20081202
DATE AS OF CHANGE:		20081202

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:		081223971

	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>y00686e8vk.htm
<DESCRIPTION>FORM 8-K
<TEXT>
<HTML>
<HEAD>
<TITLE>8-K</TITLE>
</HEAD>
<BODY bgcolor="#FFFFFF">
<!-- PAGEBREAK -->
<H5 align="left" style="page-break-before:always"><A HREF="#toc">Table of Contents</A></H5><P>
<DIV style="font-family: 'Times New Roman',Times,serif">


<DIV style="width: 100%; border-bottom: 2pt solid black; font-size: 1pt">&nbsp;</DIV>
<DIV style="width: 100%; border-bottom: 1pt solid black; font-size: 1pt">&nbsp;</DIV>




<DIV align="center" style="font-size: 14pt; margin-top: 12pt"><B>UNITED STATES<BR>
SECURITIES AND EXCHANGE COMMISSION</B>
</DIV>

<DIV align="center" style="font-size: 12pt"><B>Washington, D.C. 20549</B>
</DIV>

<DIV align="center" style="font-size: 12pt"><B><DIV align="center"><DIV style="font-size: 3pt; margin-top: 16pt; width: 26%; border-top: 1px solid #000000">&nbsp;</DIV></DIV></B>
</DIV>

<DIV align="center" style="font-size: 18pt; margin-top: 12pt"><B>FORM 8-K</B>
</DIV>


<DIV align="center" style="font-size: 12pt; margin-top: 12pt"><B>CURRENT REPORT</B>
</DIV>


<DIV align="center" style="font-size: 12pt; margin-top: 0pt"><B>Pursuant to Section&nbsp;13 or 15(d)<BR>
of the Securities Exchange Act of 1934</B>
</DIV>


<DIV align="center" style="font-size: 12pt; margin-top: 12pt"><B><DIV align="center"><DIV style="font-size: 3pt; margin-top: 16pt; width: 26%; border-top: 1px solid #000000">&nbsp;</DIV></DIV></B>
</DIV>

<DIV align="center" style="font-size: 10pt; margin-top: 12pt"><B>Date of Report (Date of earliest event reported): November&nbsp;25, 2008</B></DIV>

<DIV align="center" style="font-size: 24pt; margin-top: 12pt"><B>Protalix BioTherapeutics, Inc.</B>
</DIV>

<DIV align="center" style="font-size: 10pt">(Exact name of registrant as specified in its charter)</DIV>


<DIV align="center">
<TABLE style="font-size: 10pt" cellspacing="0" border="0" cellpadding="0" width="100%">
<!-- Begin Table Head -->
<TR valign="bottom">
    <TD width="30%">&nbsp;</TD>
    <TD width="5%">&nbsp;</TD>
    <TD width="30%">&nbsp;</TD>
    <TD width="5%">&nbsp;</TD>
    <TD width="30%">&nbsp;</TD>
</TR>
<!-- End Table Head -->
<!-- Begin Table Body -->
<TR valign="bottom">
    <TD align="center" valign="top">Florida
</TD>
    <TD>&nbsp;</TD>
    <TD align="center" valign="top">000-27836
</TD>
    <TD>&nbsp;</TD>
    <TD align="center" valign="top">65-0643773</TD>
</TR>
<TR style="font-size: 1px">
    <TD align="center" valign="top" style="border-top: 1px solid #000000">&nbsp;
</TD>
    <TD>&nbsp;</TD>
    <TD align="center" valign="top" style="border-top: 1px solid #000000">&nbsp;
</TD>
    <TD>&nbsp;</TD>
    <TD align="center" valign="top" style="border-top: 1px solid #000000">&nbsp;</TD>
</TR>
<TR valign="bottom">
    <TD align="center" valign="top">(State or other
</TD>
    <TD>&nbsp;</TD>
    <TD align="center" valign="top">(Commission
</TD>
    <TD>&nbsp;</TD>
    <TD align="center" valign="top">(IRS Employer</TD>
</TR>
<TR valign="bottom">
    <TD align="center" valign="top">jurisdiction of
</TD>
    <TD>&nbsp;</TD>
    <TD align="center" valign="top">File Number)
</TD>
    <TD>&nbsp;</TD>
    <TD align="center" valign="top">Identification No.)</TD>
</TR>
<TR valign="bottom">
    <TD align="center" valign="top">incorporation)</TD>
    <TD>&nbsp;</TD>
    <TD align="center" valign="top">&nbsp;</TD>
    <TD>&nbsp;</TD>
    <TD align="center" valign="top">&nbsp;</TD>
</TR>
<!-- End Table Body -->
</TABLE>
</DIV>

<DIV align="center" style="font-size: 10pt; margin-top: 12pt"><B>2 Snunit Street<BR>
Science Park<BR>
POB 455<BR>
Carmiel, Israel 20100</B><BR>
<DIV style="margin-top: 1px"><FONT style="border-top: 1px solid #000000">(Address of principal executive offices) (Zip Code)</FONT></DIV></DIV>

<DIV align="center" style="font-size: 10pt; margin-top: 12pt">&nbsp;<BR>
<DIV style="margin-top: 1px"><FONT style="border-top: 1px solid #000000">(Former Name or Former Address, if Changed Since Last Report)</FONT></DIV></DIV>

<DIV align="center" style="font-size: 10pt; margin-top: 6pt">Registrant&#146;s telephone number, including area code: &#043;972-4-988-9488
</DIV>

<DIV align="left" style="font-size: 10pt; margin-top: 6pt">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):
</DIV>


<DIV style="margin-top: 6pt">
<TABLE width="100%" border="0" cellpadding="0" cellspacing="0" style="font-size: 10pt">

<TR valign="top" style="font-size: 10pt; color: #000000; background: transparent">
    <TD width="3%" nowrap align="left"><FONT face="Wingdings">&#111;</FONT></TD>
    <TD width="1%">&nbsp;</TD>
    <TD>Written communications pursuant to Rule&nbsp;425 under the Securities Act (17 CFR 230.425)</TD>
</TR>

<TR>
    <TD style="font-size: 6pt">&nbsp;</TD>
</TR><TR valign="top" style="font-size: 10pt; color: #000000; background: transparent">
    <TD width="3%" nowrap align="left"><FONT face="Wingdings">&#111;</FONT></TD>
    <TD width="1%">&nbsp;</TD>
    <TD>Soliciting material pursuant to Rule&nbsp;14a-12 under the Exchange Act (17 CFR 240.14a-12)</TD>
</TR>

<TR>
    <TD style="font-size: 6pt">&nbsp;</TD>
</TR><TR valign="top" style="font-size: 10pt; color: #000000; background: transparent">
    <TD width="3%" nowrap align="left"><FONT face="Wingdings">&#111;</FONT></TD>
    <TD width="1%">&nbsp;</TD>
    <TD>Pre-commencement communications pursuant to Rule&nbsp;14d-2(b) under the Exchange Act (17 CFR
240.14d-2(b))</TD>
</TR>

<TR>
    <TD style="font-size: 6pt">&nbsp;</TD>
</TR><TR valign="top" style="font-size: 10pt; color: #000000; background: transparent">
    <TD width="3%" nowrap align="left"><FONT face="Wingdings">&#111;</FONT></TD>
    <TD width="1%">&nbsp;</TD>
    <TD>Pre-commencement communications pursuant to Rule&nbsp;13e-4(c) under the Exchange Act (17 CFR
240.13e-4(c))</TD>
</TR>

</TABLE>
</DIV>

<DIV style="width: 100%; border-bottom: 1pt solid black; margin-top: 10pt; font-size: 1pt">&nbsp;</DIV>
<DIV style="width: 100%; border-bottom: 2pt solid black; font-size: 1pt">&nbsp;</DIV>





<P align="center" style="font-size: 10pt"><!-- Folio -->&nbsp;<!-- /Folio -->
</DIV>

<!-- PAGEBREAK -->
<P><HR noshade><P>

<DIV style="font-family: 'Times New Roman',Times,serif">

<!-- TOC -->
<A name="toc"><DIV align="CENTER" style="page-break-before:always"><U><B>TABLE OF CONTENTS</B></U></DIV></A>

<P><CENTER>
<TABLE border="0" width="90%" cellpadding="0" cellspacing="0">
<TR>
	<TD width="3%"></TD>
	<TD width="3%"></TD>
	<TD width="3%"></TD>
	<TD width="3%"></TD>
	<TD width="3%"></TD>
	<TD width="3%"></TD>
	<TD width="3%"></TD>
	<TD width="3%"></TD>
	<TD width="76%"></TD>
</TR>
<TR><TD colspan="9"><A HREF="#000">Item&nbsp;7.01. Regulation&nbsp;FD Disclosure</A></TD></TR>
<TR><TD colspan="9"><A HREF="#001">Item&nbsp;8.01. Other Events</A></TD></TR>
<TR><TD colspan="9"><A HREF="#002">Item&nbsp;9.01. Financial Statements and Exhibits</A></TD></TR>
<TR><TD colspan="9"><A HREF="#003">SIGNATURES</A></TD></TR>
<TR><TD colspan="9"><A HREF="y00686exv99w1.htm">EX-99.1: PRESS RELEASE</A></TD></TR>
<TR><TD colspan="9"><A HREF="y00686exv99w2.htm">EX-99.2: PRESS RELEASE</A></TD></TR>
</TABLE>
</CENTER>
<!-- /TOC -->
<P><HR noshade><P>
<H5 align="left" style="page-break-before:always"><A HREF="#toc">Table of Contents</A></H5><P>




<!-- link1 "Item&nbsp;7.01. Regulation&nbsp;FD Disclosure" -->
<DIV align="left"><A NAME="000"></A></DIV>

<DIV align="left" style="font-size: 10pt; margin-top: 12pt"><B>Item&nbsp;7.01. Regulation&nbsp;FD Disclosure</B>
</DIV>


<DIV align="left" style="font-size: 10pt; margin-top: 6pt">On November&nbsp;25, 2008, Protalix BioTherapeutics, Inc. (the &#147;Company&#148;) issued a press release
announcing that Dr.&nbsp;David Aviezer, the Company&#146;s President and Chief Executive Officer, will
present at the Piper Jaffray 20th Annual Health Care Conference on Tuesday, December&nbsp;2, 2008 at
1:00 PM ET. The conference is being held at the New York Palace Hotel in New York City. A copy of
the press release is furnished as Exhibit&nbsp;99.1.
</DIV>

<DIV align="left" style="font-size: 10pt; margin-top: 6pt">An audio webcast of the corporate presentation will be available on the Company&#146;s website at
www.protalix.com under the events calendar section.
</DIV>

<DIV align="left" style="font-size: 10pt; margin-top: 6pt">The information in Item&nbsp;7.01 of this report (including Exhibit&nbsp;99.1) is being furnished pursuant to
Item&nbsp;7.01 of Form 8-K and shall not be deemed to be &#147;filed&#148; for purposes of Section&nbsp;18 of the
Securities Exchange Act of 1934 (the &#147;Exchange Act&#148;) or otherwise subject to the liabilities of
that section, nor shall it be deemed to be incorporated by reference in any filing under the
Securities Act of 1933 or the Exchange Act.
</DIV>
<!-- link1 "Item&nbsp;8.01. Other Events" -->
<DIV align="left"><A NAME="001"></A></DIV>

<DIV align="left" style="font-size: 10pt; margin-top: 12pt"><B>Item&nbsp;8.01. Other Events</B>
</DIV>


<DIV align="left" style="font-size: 10pt; margin-top: 6pt">On December&nbsp;2, 2008, the Company issued a press release announcing that it has completed enrollment
in the Company&#146;s pivotal phase III clinical trial of prGCD for the treatment of Gaucher disease, a
rare and serious lysosomal storage disorder in humans. A copy of the press release is attached
hereto as Exhibit&nbsp;99.2.
</DIV>
<!-- link1 "Item&nbsp;9.01. Financial Statements and Exhibits" -->
<DIV align="left"><A NAME="002"></A></DIV>

<DIV align="left" style="font-size: 10pt; margin-top: 12pt"><B>Item&nbsp;9.01. Financial Statements and Exhibits</B>
</DIV>


<DIV style="margin-top: 6pt">
<TABLE width="100%" border="0" cellpadding="0" cellspacing="0" style="font-size: 10pt">

<TR valign="top" style="font-size: 10pt; color: #000000; background: transparent">
    <TD width="3%" nowrap align="left"><B>(d)</B></TD>
    <TD width="1%">&nbsp;</TD>
    <TD><B>Exhibits</B></TD>
</TR>

</TABLE>
</DIV>

<DIV style="margin-top: 6pt">
<TABLE width="100%" border="0" cellpadding="0" cellspacing="0" style="font-size: 10pt">

<TR valign="top" style="font-size: 10pt; color: #000000; background: transparent">
    <TD width="3%" nowrap align="left">99.1</TD>
    <TD width="1%">&nbsp;</TD>
    <TD>Press release dated November&nbsp;25, 2008.</TD>
</TR>

<TR>
    <TD style="font-size: 6pt">&nbsp;</TD>
</TR><TR valign="top" style="font-size: 10pt; color: #000000; background: transparent">
    <TD width="3%" nowrap align="left">99.2</TD>
    <TD width="1%">&nbsp;</TD>
    <TD>Press release dated December&nbsp;2, 2008.</TD>
</TR>

</TABLE>
</DIV>
<P align="center" style="font-size: 10pt"><!-- Folio -->2<!-- /Folio -->
</DIV>

<!-- PAGEBREAK -->
<P><HR noshade><P>
<H5 align="left" style="page-break-before:always"><A HREF="#toc">Table of Contents</A></H5><P>

<DIV style="font-family: 'Times New Roman',Times,serif">


<DIV style="margin-top: 6pt"><TABLE width="100%" border="0" cellpadding="0" cellspacing="0" style="font-size: 10pt">



</TABLE>
</DIV>
<!-- link1 "SIGNATURES" -->
<DIV align="left"><A NAME="003"></A></DIV>

<DIV align="center" style="font-size: 10pt; margin-top: 18pt"><B>SIGNATURES</B>
</DIV>


<DIV align="left" style="font-size: 10pt; margin-top: 6pt">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.
</DIV>
<DIV align="center">
<TABLE style="font-size: 10pt" cellspacing="0" border="0" cellpadding="0" width="100%">
<!-- Begin Table Head -->
<TR valign="bottom">
    <TD width="45%">&nbsp;</TD>
    <TD width="1%">&nbsp;</TD>
    <TD width="2%">&nbsp;</TD>
    <TD width="1%">&nbsp;</TD>
    <TD width="39%">&nbsp;</TD>
    <TD width="1%">&nbsp;</TD>
    <TD width="10%">&nbsp;</TD>
</TR>
<!-- End Table Head -->
<!-- Begin Table Body -->
<TR valign="bottom">
    <TD valign="top">&nbsp;</TD>
    <TD>&nbsp;</TD>
    <TD colspan="3" valign="top" align="left"><B>PROTALIX BIOTHERAPEUTICS, INC.</B></TD>
    <TD>&nbsp;</TD>
    <TD align="left" valign="top">&nbsp;</TD>
</TR>
<TR valign="bottom"><!-- Blank Space -->
    <TD valign="top"><DIV style="margin-left:0px; text-indent:-0px">&nbsp;</DIV></TD>
    <TD>&nbsp;</TD>
    <TD align="left" valign="top">&nbsp;</TD>
    <TD>&nbsp;</TD>
    <TD align="left" valign="top">&nbsp;</TD>
    <TD>&nbsp;</TD>
    <TD align="left" valign="top">&nbsp;</TD>
</TR>
<TR valign="bottom">
    <TD valign="top"><DIV style="margin-left:0px; text-indent:-0px">Date: December&nbsp;2, 2008
</DIV></TD>
    <TD>&nbsp;</TD>
    <TD align="left" valign="top">By:
</TD>
    <TD>&nbsp;</TD>
    <TD align="left" valign="top">/s/ David Aviezer</TD>
    <TD>&nbsp;</TD>
    <TD align="left" valign="top">&nbsp;</TD>
</TR>
<TR style="font-size: 1px">
    <TD valign="top"><DIV style="margin-left:0px; text-indent:-0px">&nbsp;
</DIV></TD>
    <TD>&nbsp;</TD>
    <TD align="left" valign="top">&nbsp;</TD>
    <TD>&nbsp;</TD>
    <TD align="left" valign="top" style="border-top: 1px solid #000000">&nbsp;</TD>
    <TD>&nbsp;</TD>
    <TD align="left" valign="top">&nbsp;</TD>
</TR>
<TR valign="bottom">
    <TD valign="top"><DIV style="margin-left:0px; text-indent:-0px">&nbsp;
</DIV></TD>
    <TD>&nbsp;</TD>
    <TD align="left" valign="top">Name:
</TD>
    <TD>&nbsp;</TD>
    <TD align="left" valign="top">David Aviezer, Ph.D.</TD>
    <TD>&nbsp;</TD>
    <TD align="left" valign="top">&nbsp;</TD>
</TR>
<TR valign="bottom">
    <TD valign="top"><DIV style="margin-left:0px; text-indent:-0px">&nbsp;
</DIV></TD>
    <TD>&nbsp;</TD>
    <TD align="left" valign="top">Title:
</TD>
    <TD>&nbsp;</TD>
    <TD align="left" valign="top">President and Chief Executive Officer</TD>
    <TD>&nbsp;</TD>
    <TD align="left" valign="top">&nbsp;</TD>
</TR>
<!-- End Table Body -->
</TABLE>
</DIV>


<P align="center" style="font-size: 10pt"><!-- Folio -->3<!-- /Folio -->
</DIV>

</BODY>
</HTML>
</TEXT>
</DOCUMENT>
<DOCUMENT>
<TYPE>EX-99.1
<SEQUENCE>2
<FILENAME>y00686exv99w1.htm
<DESCRIPTION>EX-99.1: PRESS RELEASE
<TEXT>
<HTML>
<HEAD>
<TITLE>EX-99.1</TITLE>
</HEAD>
<BODY bgcolor="#FFFFFF">
<!-- PAGEBREAK -->

<DIV style="font-family: 'Times New Roman',Times,serif">

<DIV align="right" style="font-size: 10pt; margin-top: 12pt">Exhibit&nbsp;99.1
</DIV>


<DIV align="center" style="font-size: 10pt; margin-top: 18pt"><B>Protalix BioTherapeutics to Present at the Piper Jaffray<BR>
20th Annual Health Care Conference</B>
</DIV>


<DIV align="left" style="font-size: 10pt; margin-top: 6pt">CARMIEL, Israel, November&nbsp;25, 2008 &#151; Protalix BioTherapeutics, Inc. (Amex: PLX), announced today
that Dr.&nbsp;David Aviezer, President and CEO, will present at the Piper Jaffray 20th Annual Health
Care Conference on Tuesday, December&nbsp;2, 2008 at 1:00 PM ET. The conference is being held at the
New York Palace Hotel in New York City.
</DIV>

<DIV align="left" style="font-size: 10pt; margin-top: 6pt">An audio webcast of the corporate presentation will be available on Protalix&#146;s website at
www.protalix.com under the events calendar section.
</DIV>

<DIV align="left" style="font-size: 10pt; margin-top: 12pt"><B>About Protalix BioTherapeutics</B>
</DIV>


<DIV align="left" style="font-size: 10pt; margin-top: 6pt">Protalix is a biopharmaceutical company. Its goal is to become a fully integrated biopharmaceutical
company focused on the development and commercialization of proprietary recombinant therapeutic
proteins to be expressed through its proprietary plant cell based expression system. Protalix&#146;s
ProCellEx(TM) presents a proprietary method for the expression of recombinant proteins that
Protalix believes is safe and scalable and will allow for the cost-effective, industrial-scale
production of recombinant therapeutic proteins. Protalix is enrolling and treating patients in its
pivotal phase III clinical trial in Israel, the United States and other locations for its lead
product candidate, prGCD, for its enzyme replacement therapy for Gaucher disease, a lysosomal
storage disorder in humans, and has reached an agreement with the United States Food and Drug
Administration on the final design of the pivotal phase III clinical trial through the FDA&#146;s
Special Protocol Assessment (SPA)&nbsp;process. Protalix is also advancing additional recombinant
biopharmaceutical drug development programs.
</DIV>

<DIV align="left" style="font-size: 10pt; margin-top: 6pt"><B>Contact:</B><BR>
Marcy Strickler<BR>
The Trout Group, LLC<BR>
Telephone: 646-378-2927<BR>
Email: <U>mstrickler@troutgroup.com</U>

</DIV>

<P align="center" style="font-size: 10pt"><!-- Folio -->&nbsp;<!-- /Folio -->
</DIV>

</BODY>
</HTML>
</TEXT>
</DOCUMENT>
<DOCUMENT>
<TYPE>EX-99.2
<SEQUENCE>3
<FILENAME>y00686exv99w2.htm
<DESCRIPTION>EX-99.2: PRESS RELEASE
<TEXT>
<HTML>
<HEAD>
<TITLE>EX-99.2</TITLE>
</HEAD>
<BODY bgcolor="#FFFFFF">
<!-- PAGEBREAK -->

<DIV style="font-family: 'Times New Roman',Times,serif">

<DIV align="right" style="font-size: 10pt; margin-top: 12pt">Exhibit&nbsp;99.2
</DIV>


<DIV align="center" style="font-size: 10pt; margin-top: 18pt"><B>Protalix BioTherapeutics Announces Completion of Enrollment for its<BR>
Pivotal Phase III Clinical Trial of Gaucher Disease</B>
</DIV>


<DIV align="left" style="font-size: 10pt; margin-top: 6pt">CARMIEL, Israel, December&nbsp;2, 2008 &#151; Protalix BioTherapeutics, Inc. (Amex: PLX), announced today
that it has completed enrollment in the Company&#146;s pivotal phase III clinical trial of prGCD, a
proprietary plant cell expressed recombinant form of human glucocerebrosidase (GCD)&nbsp;for the
treatment of Gaucher disease. Gaucher disease is a rare and serious lysosomal storage disorder in
humans.
</DIV>

<DIV align="left" style="font-size: 10pt; margin-top: 6pt">&#147;The completion of enrollment signifies that we are one important step closer to our goal of
commercializing prGCD,&#148; said Dr.&nbsp;David Aviezer, President and Chief Executive Officer of Protalix
BioTherapeutics. &#147;We expect to analyze the results of this key study and to report the results in
the second half of 2009. We anticipate submitting a New Drug Application (NDA)&nbsp;to the FDA and
other comparable regulatory agencies in the fourth quarter of 2009.&#148;
</DIV>

<DIV align="left" style="font-size: 10pt; margin-top: 6pt">The Company&#146;s phase III clinical trial of prGCD is designed as a multi-center, randomized,
double-blind, parallel group, dose-ranging trial to assess the safety and efficacy of prGCD in
naive patients suffering from Gaucher disease. In the trial, patients are selected randomly for
one of two dosing arms and receive IV infusions every two weeks for nine months. The primary
endpoint of the study is the change, calculated in percentages, in spleen volume from baseline, as
measured by MRI.
</DIV>

<DIV align="left" style="font-size: 10pt; margin-top: 6pt">&#147;I am very encouraged by the progress of the study and the patient responses demonstrated to date&#148;
said Professor Ari Zimran, Director of the Gaucher Clinic at Shaare Zedek Medical Center in
Jerusalem and a Principal Investigator of the Company&#146;s pivotal Phase III trial of prGCD. Dr.&nbsp;Rene
Heitner, a Pediatrician at the Morningside clinic in South Africa and a Principal Investigator of
the phase III clinical trial of prGCD said &#147;At our clinical site, patients appear to be tolerating
and progressing very well on the bi-weekly infusions of prGCD.&#148;
</DIV>

<DIV align="left" style="font-size: 10pt; margin-top: 6pt">The Company&#146;s pivotal phase III clinical trial of prGCD is being conducted under a Special Protocol
Assessment (SPA)&nbsp;agreement with the U.S. Food and Drug Administration (FDA). An SPA is a procedure
by which sponsors and the FDA reach agreement on the design and size of clinical trials intended to
form the primary basis to support approval of a New Drug Application. There have been no Serious
Adverse Events reported in connection with the phase III clinical trial.
</DIV>

<DIV align="left" style="font-size: 10pt; margin-top: 12pt"><B>About Protalix BioTherapeutics</B>
</DIV>


<DIV align="left" style="font-size: 10pt; margin-top: 6pt">Protalix is a biopharmaceutical company. Its goal is to become a fully integrated
biopharmaceutical company focused on the development and commercialization of proprietary
recombinant therapeutic proteins to be expressed through its proprietary plant cell based
expression system. Protalix&#146;s ProCellEx(TM) presents a proprietary method for the expression of
recombinant proteins that Protalix believes will allow for the cost-effective, industrial-scale
production of recombinant therapeutic proteins. Protalix is treating patients in its pivotal phase
III clinical trial in Europe, Israel, and other locations for its lead product
candidate, prGCD, for its enzyme replacement therapy for Gaucher disease, a lysosomal storage
disorder in humans, and has reached an agreement with the United States Food and Drug
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<DIV align="left" style="font-size: 10pt; margin-top: 6pt">Administration on the final design of the pivotal phase III clinical trial through the FDA&#146;s
Special Protocol Assessment (SPA)&nbsp;process. Protalix is also advancing additional recombinant
biopharmaceutical drug development programs. For more information, please<BR>
visit our website at www.Protalix.com.
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<DIV align="left" style="font-size: 10pt; margin-top: 12pt"><B>Safe Harbor Statement:</B>
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<DIV align="left" style="font-size: 10pt; margin-top: 6pt">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. 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 such a material difference include, among others, uncertainties
related to: the ability to attract and retain partners for our technologies and products under
development; the identification of lead compounds; the successful preclinical development of our
products; our preparation and filing of applications for regulatory approval; the approval or
potential rejection of any applications we file with the FDA, or other regulatory authorities; the
completion of clinical trials; and other factors described in our filings with the Securities and
Exchange Commission. The statements are valid only as of the date hereof and we disclaim any
obligation to update this information.
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<DIV align="left" style="font-size: 10pt; margin-top: 6pt"><B>Contact:</B><BR>
Marcy Strickler<BR>
The Trout Group, LLC<BR>
Telephone: 646-378-2927<BR>
Email: <U>mstrickler@troutgroup.com</U>

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