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<SEC-DOCUMENT>0000950136-07-008185.txt : 20071203
<SEC-HEADER>0000950136-07-008185.hdr.sgml : 20071203
<ACCEPTANCE-DATETIME>20071203105823
ACCESSION NUMBER:		0000950136-07-008185
CONFORMED SUBMISSION TYPE:	8-K
PUBLIC DOCUMENT COUNT:		2
CONFORMED PERIOD OF REPORT:	20071203
ITEM INFORMATION:		Other Events
ITEM INFORMATION:		Financial Statements and Exhibits
FILED AS OF DATE:		20071203
DATE AS OF CHANGE:		20071203

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:		071279547

	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
</SEC-HEADER>
<DOCUMENT>
<TYPE>8-K
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<DESCRIPTION>FORM 8-K
<TEXT>


<TITLE>
</TITLE>




<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> December 3, 2007</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>
  <TR valign="bottom">
    <TD align="center" valign="top">&nbsp;</TD>
    <TD>&nbsp;</TD>
    <TD align="center" valign="top">&nbsp;</TD>
  </TR>
  <TR valign="bottom">
    <TD align="center" valign="top"><b>2 Snunit Street
        <br>
      Science Park<br>
POB 455
<br>
Carmiel, Israel
</b><BR>
      (Address of principal executive offices) </TD>
    <TD>&nbsp;</TD>
    <TD align="center" valign="top"><b><br>
      <br>
      <br>
      20100</b><BR>
    (Zip Code)</TD>
  </TR>
</TABLE>


<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>

<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>

<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; margin-left:10%; text-indent:-10%;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 December 3, 2007, Protalix BioTherapeutics, Inc. (the &#147;Company&#148;), issued a press release noting that prGCD, the Company&#146;s proprietary recombinant form of Glucocerebrosidase (GCD), which is used as an enzyme replacement therapy for Gaucher disease, was named one of the Five Most Promising Drugs Entering Phase III Trials in the third quarter issue of </font><i><font style='font-size:10pt'>The Ones to Watch</font></i><font style='font-size:10pt'> report published by Thomson Scientific, part of The Thomson Corporation.</font></p>
<p style=' margin-bottom:0pt; margin-top:8pt;text-align:left;'><font style='font-size:10pt'>A copy of the press release dated December 3, 2007, is attached hereto as Exhibit 99.1.</font></p>
<p style=' margin-bottom:0pt; margin-top:12pt; margin-left:10%; text-indent:-10%;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:8pt;text-align:left;'><b><font style='font-size:10pt'>(d) Exhibits </font></b></p>
<div align=left>
<table border="0" cellspacing=0 cellpadding=0 width="100%" style=' border-collapse:collapse;'>
 <tr>
        <td width="5%" valign=top style='padding:6.0pt 0in 0in 0in;'>
                        <p style=' margin-left:0pt;text-indent:0pt;text-align:left;margin-top:0pt;margin-bottom:0pt;'><font style='font-size:10pt'>99.1</font></p> </td>
        <td valign=top style='padding:6.0pt 0in 0in 0in;'>
                        <p style=' margin-left:0pt;text-indent:0pt;text-align:left;margin-top:0pt;margin-bottom:0pt;'><font style='font-size:10pt'>Press release dated December 3, 2007, titled &#147;Protalix BioTherapeutics&#146; prGCD Named One of the Five Most Promising Drugs Entering Phase III Trials by Thomson Scientific.&#148;</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 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 colspan="2" 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: December 3, 2007</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 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 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;'><font style='font-size:10pt'>&nbsp;</font><br> <font style='font-size:10pt'>/s/ David Aviezer</font></p> </td> </tr>
 <tr>
        <td width="7%" 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 width="42%" 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 width="2%" 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 width="5%" 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:&nbsp;</font></p> </td>
        <td width="42%" 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'>&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:&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'>President and</font><br> <font style='font-size:10pt'>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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<TYPE>EX-99.1
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<DESCRIPTION>PRESS RELEASE DATED DECEMBER 3, 2007
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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'><b>Exhibit 99.1</b></font></p>
<p style=' margin-bottom:0pt; margin-top:16pt;text-align:center;'><b><font style='font-size:10pt'>Protalix BioTherapeutics&#146; prGCD Named One of the Five Most Promising </font></b></p>
<p style=' margin-bottom:0pt; margin-top:0pt;text-align:center;'><b><font style='font-size:10pt'>Drugs Entering Phase III Trials by Thomson Scientific</font></b></p>
<p style=' margin-bottom:0pt; margin-top:8pt;text-align:left;'><b><font style='font-size:10pt'>CARMIEL, Israel &#150; December 3, 2007 &#150; </font></b><font style='font-size:10pt'>Protalix BioTherapeutics, Inc. (Amex: PLX), noted today that prGCD, the Company&#146;s proprietary recombinant form of Glucocerebrosidase (GCD), which is used as an enzyme replacement therapy for Gaucher disease, was named one of the Five Most Promising Drugs Entering Phase III Trials in the third quarter issue of </font><i><font style='font-size:10pt'>The Ones to Watch</font></i><font style='font-size:10pt'> report published by Thomson Scientific. Thomson Scientific, a part of The Thomson Corporation, is a leading provider of information solutions to the worldwide research and business communities. Thomson Scientific states that the third quarter issue of </font><i><font style='font-size:10pt'>The Ones to Watch</font></i><font style='font-size:10pt'> report provides expert insight into the five most
promising drugs entering each new phase of clinical development between July and September 2007.</font></p>
<p style=' margin-bottom:0pt; margin-top:8pt;text-align:left;'><font style='font-size:10pt'>Dr.&nbsp;David Aviezer, the Company&#146;s Chief Executive Officer and President, said, &#147;We have been pleased with the progress that we have seen thus far in our clinical development program of prGCD as a treatment of Gaucher disease. During the third quarter of 2007, we reached an agreement with the United States Food and Drug Administration on the final design of our pivotal phase III clinical trial of prGCD, through the FDA&#146;s special protocol assessment (SPA) process and began enrolling patients in the trial. We have been treating patients since August 2007, and are initiating study centers worldwide. We believe that the results from the phase III clinical trial will be positive, and will lead to the commercialization of prGCD as a treatment for Gaucher disease patients.</font></p>
<p style=' margin-bottom:0pt; margin-top:8pt;text-align:left;'><b><font style='font-size:10pt'>About Protalix <a name="dv_c37"></a>BioTherapeutics, Inc.</font></b></p>
<p style=' margin-bottom:0pt; margin-top:8pt;text-align:left;'><font style='font-size:10pt'><a name="dv_m29"></a>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<SUP>TM</SUP> 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) process. Protalix is also advancing additional recombinant biopharmaceutical drug development programs.</font></p>
<p style=' margin-bottom:0pt; margin-top:8pt;text-align:left;'><b><font style='font-size:10pt'><a name="dv_m37"></a>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 </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: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:8pt;text-align:left;'><font style='font-size:10pt'>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, 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'><a name="dv_x0"></a>For additional information, contact Protalix BioTherapeutics at:</font></b></p>
<p style=' margin-bottom:0pt; margin-top:0pt;text-align:left;'><u><font style='font-size:10pt'>investors@protalix.com </font></u></p>
<p style=' margin-bottom:0pt; margin-top:8pt;text-align:left;'><b><font style='font-size:10pt'>AMEX IR Alliance for Protalix BioTherapeutics</font></b></p>
<p style=' margin-bottom:0pt; margin-top:0pt;text-align:left;'><font style='font-size:10pt'>Lee Roth / David Burke</font></p>
<p style=' margin-bottom:0pt; margin-top:0pt;text-align:left;'><font style='font-size:10pt'>212-896-1209 / 1258</font></p>
<p style=' margin-bottom:0pt; margin-top:0pt;text-align:left;'><u><font style='font-size:10pt'>lroth@kcsa.com </font></u><font style='font-size:10pt'>/ </font><u><font style='font-size:10pt'>dburke@kcsa.com</font></u></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: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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