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<SEC-DOCUMENT>0000950136-08-002901.txt : 20080603
<SEC-HEADER>0000950136-08-002901.hdr.sgml : 20080603
<ACCEPTANCE-DATETIME>20080603134539
ACCESSION NUMBER:		0000950136-08-002901
CONFORMED SUBMISSION TYPE:	8-K
PUBLIC DOCUMENT COUNT:		2
CONFORMED PERIOD OF REPORT:	20080603
ITEM INFORMATION:		Other Events
ITEM INFORMATION:		Financial Statements and Exhibits
FILED AS OF DATE:		20080603
DATE AS OF CHANGE:		20080603

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:		08876872

	BUSINESS ADDRESS:	
		STREET 1:		2 SNUNIT ST
		STREET 2:		SCIENCE PARK, POB 455
		CITY:			CARMIEL
		STATE:			L3
		ZIP:			21000
		BUSINESS PHONE:		972-4-988-9488

	MAIL ADDRESS:	
		STREET 1:		2 SNUNIT ST
		STREET 2:		SCIENCE PARK, POB 455
		CITY:			CARMIEL
		STATE:			L3
		ZIP:			21000

	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
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<DIV STYLE=""></DIV><BR>
<DIV style="width: 100%; border-bottom: 3pt solid black; font-size: 1pt">&nbsp;</DIV>
<DIV style="width: 100%; border-bottom: 1pt solid black; font-size: 1pt">&nbsp;</DIV>




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

<P style="font-size: 12pt; text-align: center; margin-top:-14pt"><B>Washington, D.C.  20549</B> </P>
<DIV align="center">
<P style="font-size: 3pt; margin-top: 16pt; width: 26%; border-top: 1px solid #000000" align="center">&nbsp;</P>
</DIV>
<P style="font-size: 18pt; margin-top: 12pt; text-align: center"><B>FORM 8-K</B>
</P>


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


<P style="font-size: 10pt; margin-top: 16pt; text-align:center">Date of Report (Date of earliest event reported):<b> June 3, 2008</b></P>

<P style="font-size: 24pt; margin-top: 10pt; text-align:center"><B>Protalix BioTherapeutics, Inc.</B>
</P>

<P style="font-size: 10pt; text-align:center; margin-top: -16pt">(Exact name of registrant as specified in its charter)</P>


<P style="font-size: 10pt; margin-top: 2pt; text-align: center"><B>Florida</B></P>

<P style="font-size: 10pt; margin-top: -16pt; margin-bottom: -1pt; text-align:center">(State or other jurisdiction of incorporation)</P>

<TABLE style="font-size: 10pt" cellspacing="0" border="0" cellpadding="0" width="100%">
  <TR valign="bottom">
    <TD width="47%">&nbsp;</TD>
    <TD width="5%">&nbsp;</TD>
    <TD width="47%">&nbsp;</TD>
  </TR>
  <TR valign="bottom">
    <TD align="center" valign="top"><b>000-27836</b><BR>
      (Commission File Number) </TD>
    <TD>&nbsp;</TD>
    <TD align="center" valign="top"><b>65-0643773</b><BR>
      (IRS Employer Identification No.)</TD>
  </TR>
</TABLE>


<P style="font-size: 10pt; margin-top: 12pt; text-align: center"><b>2 Snunit Street<br>
Science Park<br>
POB 455<br>
Carmiel, Israel 20100
</b><BR>
  (Address of principal executive offices) (Zip Code)</P>

<P style="font-size: 10pt; margin-top: 18pt; text-align:center"><FONT style="border-top: 1px solid #000000">(Former Name or Former Address, if Changed Since Last Report)</FONT></P>
<P style="font-size: 10pt; margin-top: 12pt; text-align: center">
  Registrant&#146;s telephone number, including area code: <b>+972-4-988-9488</b></P>
<DIV align="center">
<DIV style="font-size: 3pt; margin-top: 16pt; width: 26%; border-top: 1px solid #000000">&nbsp;</DIV>
</DIV>

<P style="font-size: 10pt; margin-top: 12pt; margin-bottom: 6pt; text-align:left">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>

<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="nowrap" align="left"><FONT face="Wingdings">&#111;</FONT></TD>
    <TD width="1%">&nbsp;</TD>
    <TD>Written communications pursuant to Rule 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="nowrap" align="left"><FONT face="Wingdings">&#111;</FONT></TD>
    <TD width="1%">&nbsp;</TD>
    <TD>Soliciting material pursuant to Rule 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="nowrap" align="left"><FONT face="Wingdings">&#111;</FONT></TD>
    <TD width="1%">&nbsp;</TD>
    <TD>Pre-commencement communications pursuant to Rule 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="nowrap" align="left"><FONT face="Wingdings">&#111;</FONT></TD>
    <TD width="1%">&nbsp;</TD>
    <TD>Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c)) </TD>
</TR>

</TABLE>
<DIV style="width: 100%; border-bottom: 1pt solid black; margin-top: 10pt; font-size: 1pt">&nbsp;</DIV>
<DIV style="width: 100%; border-bottom: 3pt solid black; font-size: 1pt">&nbsp;</DIV>
<p style=' margin-bottom:0pt; margin-top:0pt;text-align:left;'><font style='font-size:10pt'>&nbsp;</font></p>
<p style=' margin-bottom:0pt; margin-top:0pt;text-align:left;'><font style='font-size:10pt'>&nbsp;</font></p>
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<p style=' margin-bottom:0pt; margin-top:12pt;text-align:left;'><b><font style='font-size:10pt'>Item 8.01. Other Events</font></b></p>
<p style=' margin-bottom:0pt; margin-top:8pt;text-align:left;'><font style='font-size:10pt'>On June 3, 2008, Protalix BioTherapeutics, Inc. (the &#147;Company&#148;) issued a press release announcing that it intends to initiate a double blind, follow-on extension study as part of the Company&#146;s on-going phase III clinical trial of its lead product candidate, prGCD, a proprietary plant cell expressed recombinant form of human Glucocerebrosidase (GCD) for the treatment of Gaucher disease, a lysosomal storage disorder in humans. The press release is attached hereto as Exhibit 99.1.</font></p>
<p style=' margin-bottom:0pt; margin-top:12pt;text-align:left;'><b><font style='font-size:10pt'>Item 9.01. Financial Statements and Exhibits</font></b></p>
<p style=' margin-bottom:0pt; margin-top:12pt;text-align:left;'><b><font style='font-size:10pt'>(d) Exhibits </font></b></p>
<p style=' margin-bottom:0pt; margin-top:0pt;text-align:left;'><font style='font-size:10pt'>&nbsp;</font></p>
<div align=left>
<table border="0" cellspacing=0 cellpadding=0 width="100%" style=' border-collapse:collapse;'>
 <tr>
        <td width="6%" valign=bottom >
                        <p style=' margin-left:8.65pt;text-indent:-8.65pt;text-align:left;margin-top:2pt;margin-bottom:0pt;'><font style='font-size:10pt'>99.1</font></p> </td>
        <td width="2%" valign=bottom >
                        <p style=' margin-left:0in;text-indent:0pt;text-align:left;margin-top:2pt;margin-bottom:0pt;'><font style='font-size:10pt'>&nbsp;</font></p> </td>
        <td width="91%" valign=bottom >
                        <p style=' margin-left:0pt;text-indent:0pt;text-align:left;margin-top:2pt;margin-bottom:0pt;'><font style='font-size:10pt'>Press release dated June 3, 2008.</font></p> </td> </tr></table>
</div>
<p style=' margin-bottom:0pt; margin-top:0pt;text-align:left;'><font style='font-size:10pt'>&nbsp;</font></p>
<p style=' margin-bottom:0pt; margin-top:0pt;text-align:left;'><font style='font-size:10pt'>&nbsp;</font></p>
<p style=' margin-bottom:0pt; margin-top:0pt;text-align:center;'><font style='font-size:10pt'>2</font></p>
<p style=' margin-bottom:0pt; margin-top:0pt;text-align:left;'><font style='font-size:10pt'>&nbsp;</font></p>
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<p style=' margin-bottom:0pt; margin-top:16pt;text-align:center;'><B><font STYLE='FONT-SIZE:10PT'>SIGNATURES</font></B></p>
<p style=' margin-bottom:0pt; margin-top:8pt;text-align:left;'><font style='font-size:10pt'>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.</font></p>
<p style=' margin-bottom:0pt; margin-top:0pt;text-align:left;'><font style='font-size:10pt'>&nbsp;</font></p>
<div align=center>
<table border="0" cellspacing=0 cellpadding=0 width="100%" style=' border-collapse:collapse;'>
 <tr>
        <td valign=bottom >
                        <p style=' margin-left:0pt;text-indent:0pt;text-align:left;margin-top:0in;margin-bottom:0pt;'><font style='font-size:10pt'>&nbsp;</font></p> </td>
        <td valign=bottom >
                        <p style=' margin-left:0pt;text-indent:0pt;text-align:left;margin-top:0in;margin-bottom:0pt;'><font style='font-size:10pt'>&nbsp;</font></p> </td>
        <td colspan="2" valign=bottom >
                        <p style=' margin-left:0pt;text-indent:0pt;text-align:left;margin-top:0in;margin-bottom:0pt;'><B><font STYLE='FONT-SIZE:10PT'>PROTALIX BIOTHERAPEUTICS, INC.</font></B></p> </td> </tr>
 <tr>
        <td width="49%" valign=bottom >
                        <p style=' margin-left:0pt;text-indent:0pt;text-align:left;margin-top:0in;margin-bottom:0pt;'><br> <font style='font-size:10pt'>Date: June 3, 2008</font></p> </td>
        <td width="7%" valign=bottom >
                        <p style=' margin-left:0pt;text-indent:0pt;text-align:left;margin-top:0in;margin-bottom:0pt;'><font style='font-size:10pt'>&nbsp;</font></p> </td>
        <td width="6%" valign=bottom >
      <p style=' margin-left:0pt;text-indent:0pt;text-align:left;margin-top:0in;margin-bottom:0pt;'><font style='font-size:10pt'>By:&nbsp;</font></p> </td>
        <td width="40%" valign=bottom style='border-bottom: solid black .5pt;'>
                        <p style=' margin-left:0pt;text-indent:0pt;text-align:left;margin-top:0in;margin-bottom:0pt;'><br><font style='font-size:10pt'>/</font><font style='font-size:10pt'>s/ David Aviezer</font></p> </td> </tr>
 <tr>
        <td valign=top >
                        <p style=' margin-left:0pt;text-indent:0pt;text-align:left;margin-top:0in;margin-bottom:0pt;'><font style='font-size:10pt'>&nbsp;</font></p> </td>
        <td valign=top >
                        <p style=' margin-left:0pt;text-indent:0pt;text-align:left;margin-top:0in;margin-bottom:0pt;'><font style='font-size:10pt'>&nbsp;</font></p> </td>
        <td valign=top >
                        <p style=' margin-left:0pt;text-indent:0pt;text-align:left;margin-top:0in;margin-bottom:0pt;'><font style='font-size:10pt'>Name:</font></p> </td>
        <td valign=top >
                        <p style=' margin-left:0pt;text-indent:0pt;text-align:left;margin-top:0in;margin-bottom:0pt;'><font style='font-size:10pt'>David Aviezer, Ph.D.</font></p> </td> </tr>
 <tr>
        <td valign=top >
                        <p style=' margin-left:0pt;text-indent:0pt;text-align:left;margin-top:0in;margin-bottom:0pt;'><font style='font-size:10pt'>&nbsp;</font></p> </td>
        <td valign=top >
                        <p style=' margin-left:0pt;text-indent:0pt;text-align:left;margin-top:0in;margin-bottom:0pt;'><font style='font-size:10pt'>&nbsp;</font></p> </td>
        <td valign=top >
                        <p style=' margin-left:0pt;text-indent:0pt;text-align:left;margin-top:0in;margin-bottom:0pt;'><font style='font-size:10pt'>Title:</font></p> </td>
        <td valign=top >
  <p style=' margin-left:0pt;text-indent:0pt;text-align:left;margin-top:0in;margin-bottom:0pt;'><font style='font-size:10pt'>President and Chief Executive Officer</font></p> </td> </tr></table>
</div>
<p style=' margin-bottom:0pt; margin-top:0pt;text-align:left;'><font style='font-size:10pt'>&nbsp;</font></p>
<p style=' margin-bottom:0pt; margin-top:0pt;text-align:left;'><font style='font-size:10pt'>&nbsp;</font></p>
<p style=' margin-bottom:0pt; margin-top:0pt;text-align:center;'><font style='font-size:10pt'>3</font></p>
<p style=' margin-bottom:0pt; margin-top:0pt;text-align:left;'><font style='font-size:10pt'>&nbsp;</font></p>
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<DIV STYLE="page-break-before: always;"></DIV><BR>
<p style=' margin-bottom:0pt; margin-top:8pt;text-align:right;'><font style='font-size:10pt'>Exhibit 99.1</font></p>
<p style=' margin-bottom:0pt; margin-top:16pt;text-align:center;'><b><font style='font-size:10pt'>Protalix BioTherapeutics to Initiate a Double Blind Extension Study for the Phase III</font></b></p>
<p style=' margin-bottom:0pt; margin-top:0pt;text-align:center;'><b><font style='font-size:10pt'>Clinical Trial of prGCD</font></b></p>
<p style=' margin-bottom:0pt; margin-top:8pt;text-align:left;'><font style='font-size:10pt'>CARMIEL, Israel, June 3, 2008 (BUSINESS WIRE) &#151; Protalix BioTherapeutics, Inc. (Amex: PLX), today announced that it intends to initiate a double blind, follow-on extension study as part of the Company&#146;s on-going phase III clinical trial of its lead product candidate, prGCD, a proprietary plant cell expressed recombinant form of human Glucocerebrosidase (GCD) for the treatment of Gaucher disease, a lysosomal storage disorder in humans.</font></p>
<p style=' margin-bottom:0pt; margin-top:8pt;text-align:left;'><font style='font-size:10pt'>Eligible patients who have successfully completed treatment as part of the pivotal phase III clinical trial will be offered the opportunity to continue to be treated with prGCD at the same dose that they received in the trial. The objective of the proposed extension study is to compile additional information relating to the long term safety and efficacy of prGCD.</font></p>
<p style=' margin-bottom:0pt; margin-top:8pt;text-align:left;'><font style='font-size:10pt'>&#147;We expect to enroll our first patient in the extension study in June,&#148; said Dr.&nbsp;David Aviezer, President and Chief Executive Officer of Protalix BioTherapeutics. &#147;In addition, enrollment in our pivotal phase III clinical trial continues to progress and we are happy to announce that we have commenced recruitment at our European clinical sites, including the Royal Free Hospital of London, United Kingdom.&#148;</font></p>
<p style=' margin-bottom:0pt; margin-top:8pt;text-align:left;'><font style='font-size:10pt'>&#147;We are encouraged by the clinical results to date, and look forward to reporting the results of the phase III clinical trial when they become available&#148; said Professor Ari Zimran, M.D., Director of the Gaucher Clinic at Shaare Zedek Medical Center in Jerusalem and Principal Investigator for the trial. &#147;The Gaucher disease community has a keen interest in developing new treatment options, particularly treatments that will be less expensive.&#148;  Professor Zimran is a member of the Company&#146;s Scientific Advisory Board.</font></p>
<p style=' margin-bottom:0pt; margin-top:8pt;text-align:left;'><font style='font-size:10pt'>The pivotal phase III clinical trial of prGCD is a multi-center, randomized, double-blind, parallel group, dose-ranging trial to assess the safety and efficacy of prGCD in 30 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 in spleen volume from baseline, as measured by MRI.</font></p>
<p style=' margin-bottom:0pt; margin-top:12pt;text-align:left;'><b><font style='font-size:10pt'>About Protalix BioTherapeutics</font></b></p>
<p style=' margin-bottom:0pt; margin-top:8pt;text-align:left;'><font style='font-size:10pt'>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 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) process. Protalix is also advancing additional recombinant biopharmaceutical drug development programs.</font></p>
<p style=' margin-bottom:0pt; margin-top:0pt;text-align:left;'><font style='font-size:10pt'>&nbsp;</font></p>
<p style=' margin-bottom:0pt; margin-top:0pt;text-align:left;'><font style='font-size:12pt'>&nbsp;</font></p>
<p style=' margin-bottom:0pt; margin-top:0pt;text-align:left;'><font style='font-size:12pt'>&nbsp;</font></p>
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<p style=' margin-bottom:0pt; margin-top:12pt;text-align:left;'><b><font style='font-size:10pt'>Safe Harbor Statement:</font></b></p>
<p style=' margin-bottom:0pt; margin-top:8pt;text-align:left;'><font style='font-size:10pt'>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, the risk that we may fail to satisfy certain conditions relating to grants we have received from the Office of the Chief Scientist of Israel&#146;s Ministry of Industry and Trade which may lead to our being required to refund grants previously received
together with interest and penalties, the risk that the Office of the Chief Scientist may not deliver to us all of the funds awarded to us, 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, the completion of clinical trials, the review process of the FDA, foreign regulatory bodies and other governmental regulation, 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.</font></p>
<p style=' margin-bottom:0pt; margin-top:8pt;text-align:left;'><b><font style='font-size:10pt'>Contact:</font></b><font style='font-size:10pt'> </font></p>
<p style=' margin-bottom:0pt; margin-top:0pt;text-align:left;'><font style='font-size:10pt'>Marcy Strickler</font></p>
<p style=' margin-bottom:0pt; margin-top:0pt;text-align:left;'><font style='font-size:10pt'>The Trout Group, LLC</font></p>
<p style=' margin-bottom:0pt; margin-top:0pt;text-align:left;'><font style='font-size:10pt'>Telephone: 646-378-2927</font></p>
<p style=' margin-bottom:0pt; margin-top:0pt;text-align:left;'><font style='font-size:10pt'>Email: mstrickler@troutgroup.com</font></p>
<p style=' margin-bottom:0pt; margin-top:0pt;text-align:left;'><font style='font-size:10pt'>&nbsp;</font></p>
<p style=' margin-bottom:0pt; margin-top:0pt;text-align:left;'><font style='font-size:12pt'>&nbsp;</font></p>

<p style=' margin-bottom:0pt; margin-top:0pt;text-align:left;'><font style='font-size:12pt'>&nbsp;</font></p>
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