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Proc-Type: 2001,MIC-CLEAR
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<SEC-DOCUMENT>0000950123-09-004426.txt : 20090311
<SEC-HEADER>0000950123-09-004426.hdr.sgml : 20090311
<ACCEPTANCE-DATETIME>20090311123439
ACCESSION NUMBER:		0000950123-09-004426
CONFORMED SUBMISSION TYPE:	8-K
PUBLIC DOCUMENT COUNT:		2
CONFORMED PERIOD OF REPORT:	20090311
ITEM INFORMATION:		Other Events
ITEM INFORMATION:		Financial Statements and Exhibits
FILED AS OF DATE:		20090311
DATE AS OF CHANGE:		20090311

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:		09671778

	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>y01301e8vk.htm
<DESCRIPTION>FORM 8-K
<TEXT>
<HTML>
<HEAD>
<TITLE>8-K</TITLE>
</HEAD>
<BODY bgcolor="#FFFFFF">
<!-- PAGEBREAK -->
<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">
<DIV style="font-size: 3pt; margin-top: 16pt; width: 110; border-top: 1px solid #000000">&nbsp;</DIV>
</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: 12pt"><B>Pursuant to Section&nbsp;13 or 15(d)<BR>
of the Securities Exchange Act of 1934</B>
</DIV>

<DIV align="center">
<DIV style="font-size: 3pt; margin-top: 16pt; width: 110; border-top: 1px solid #000000">&nbsp;</DIV>
</DIV>

<DIV align="left" style="font-size: 10pt; margin-top: 6pt">Date of Report (Date of earliest event reported): March&nbsp;11, 2009
</DIV>

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

<DIV align="center" style="font-size: 10pt; margin-top: 0pt">(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="31%">&nbsp;</TD>
    <TD width="3%">&nbsp;</TD>
    <TD width="31%">&nbsp;</TD>
    <TD width="3%">&nbsp;</TD>
    <TD width="31%">&nbsp;</TD>
</TR>
<TR style="font-size: 10pt" valign="bottom">
    <TD nowrap align="center" style="border-bottom: 1px solid #000000">Florida</TD>
    <TD>&nbsp;</TD>
    <TD nowrap align="center" style="border-bottom: 1px solid #000000">000-27836</TD>
    <TD>&nbsp;</TD>
    <TD nowrap align="center" style="border-bottom: 1px solid #000000">65-0643773</TD>
</TR>

<!-- End Table Head -->
<!-- Begin Table Body -->
<TR valign="bottom">
    <TD align="center" valign="top">(State or other jurisdiction of incorporation)</TD>
    <TD>&nbsp;</TD>
    <TD align="center" valign="top">(Commission File Number)</TD>
    <TD>&nbsp;</TD>
    <TD align="center" valign="top">(IRS Employer Identification No.)</TD>
</TR>
<!-- End Table Body -->
</TABLE>
</DIV>

<DIV align="center" style="font-size: 10pt; margin-top: 18pt"><B>2 Snunit Street<BR>
Science Park<BR>
POB 455<BR>
Carmiel, Israel 20100</B>
</DIV>

<DIV align="center">
<DIV style="font-size: 10pt; margin-top: 0pt; width: 380; border-top: 1px solid #000000">(Address of principal executive offices) (Zip Code)
</DIV>
</DIV>

<DIV align="center">
<DIV style="font-size: 10pt; margin-top: 36pt; width: 380; border-top: 1px solid #000000">(Former Name or Former Address, if Changed Since Last Report)
</DIV>
</DIV>

<DIV align="left" 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 align="center">
<TABLE cellspacing="0" border="0" cellpadding="0" width="100%" style="font-size: 10pt">
<TR style="font-size: 6pt">
    <TD width="1%">&nbsp;</TD>
    <TD width="3%">&nbsp;</TD>
    <TD width="96%">&nbsp;</TD>
</TR>
<TR valign="top">
    <TD align="left"><FONT face="Wingdings">&#111;</FONT></TD>
    <TD>&nbsp;</TD>
    <TD>Written communications pursuant to Rule&nbsp;425 under the Securities Act (17 CFR 230.425)</TD>
</TR>
</TABLE>
</DIV>

<DIV align="center">
<TABLE cellspacing="0" border="0" cellpadding="0" width="100%" style="font-size: 10pt">
<TR style="font-size: 6pt">
    <TD width="1%">&nbsp;</TD>
    <TD width="3%">&nbsp;</TD>
    <TD width="96%">&nbsp;</TD>
</TR>
<TR valign="top">
    <TD align="left"><FONT face="Wingdings">&#111;</FONT></TD>
    <TD>&nbsp;</TD>
    <TD>Soliciting material pursuant to Rule&nbsp;14a-12 under the Exchange Act (17 CFR 240.14a-12)</TD>
</TR>
</TABLE>
</DIV>

<DIV align="center">
<TABLE cellspacing="0" border="0" cellpadding="0" width="100%" style="font-size: 10pt">
<TR style="font-size: 6pt">
    <TD width="1%">&nbsp;</TD>
    <TD width="3%">&nbsp;</TD>
    <TD width="96%">&nbsp;</TD>
</TR>
<TR valign="top">
    <TD align="left"><FONT face="Wingdings">&#111;</FONT></TD>
    <TD>&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>
</TABLE>
</DIV>

<DIV align="center">
<TABLE cellspacing="0" border="0" cellpadding="0" width="100%" style="font-size: 10pt">
<TR style="font-size: 6pt">
    <TD width="1%">&nbsp;</TD>
    <TD width="3%">&nbsp;</TD>
    <TD width="96%">&nbsp;</TD>
</TR>
<TR valign="top">
    <TD align="left"><FONT face="Wingdings">&#111;</FONT></TD>
    <TD>&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>
<H5 align="left" style="page-break-before:always">&nbsp;</H5><P>

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

<DIV align="left" style="margin-top: 12pt">
<TABLE width="100%" border="0" cellpadding="0" cellspacing="0" style="font-size: 10pt; background: transparent; color: #000000">
<TR>
    <TD width="3%"></TD>
    <TD width="1%"></TD>
    <TD></TD>
</TR>
<TR valign="top">
    <TD nowrap align="left"><B>Item&nbsp;8.01.</B></TD>
    <TD>&nbsp;</TD>
    <TD><B>Other Events</B></TD>
</TR>
</TABLE>
</DIV>

<DIV align="left" style="font-size: 10pt; margin-top: 6pt">On March&nbsp;11, 2009, Protalix BioTherapeutics, Inc. (the &#147;Company&#148;) issued a press release announcing
that that the Office of the Chief Scientist (&#147;OCS&#148;) of Israel&#146;s Ministry of Industry, Trade and
Labor has awarded a grant of over $6&nbsp;million to the Company for calendar year 2009. The OCS awarded
the grant to the Company to promote the advancement of the Company&#146;s clinical and preclinical drug
development programs. A copy of the press release is attached hereto as Exhibit&nbsp;99.1.
</DIV>

<DIV align="left" style="margin-top: 12pt">
<TABLE width="100%" border="0" cellpadding="0" cellspacing="0" style="font-size: 10pt; background: transparent; color: #000000">
<TR>
    <TD width="3%"></TD>
    <TD width="1%"></TD>
    <TD></TD>
</TR>
<TR valign="top">
    <TD nowrap align="left"><B>Item&nbsp;9.01.</B></TD>
    <TD>&nbsp;</TD>
    <TD><B>Financial Statements and 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"><B>(d)</B></TD>
    <TD width="1%">&nbsp;</TD>
    <TD><B>Exhibits</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">99.1</TD>
    <TD width="1%">&nbsp;</TD>
    <TD>Press release dated March&nbsp;11, 2009.</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">&nbsp;</H5><P>

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

<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>

<TABLE width="100%" border="0" cellspacing="0" cellpadding="0" style="font-size: 10pt">
<TR>
    <TD width="48%">&nbsp;</TD>
    <TD width="1%">&nbsp;</TD>
    <TD width="1%">&nbsp;</TD>
    <TD width="35%">&nbsp;</TD>
    <TD width="15%">&nbsp;</TD>
</TR>
<TR>
    <TD valign="top" align="left">&nbsp;</TD>
    <TD colspan="3" align="left"><B>PROTALIX BIOTHERAPEUTICS, INC.</B><BR>
&nbsp;</TD>
    <TD>&nbsp;</TD>
</TR><TR>
    <TD align="left">Date: March 11, 2009&nbsp;</TD>
    <TD valign="top">By:&nbsp;&nbsp;</TD>
    <TD colspan="2" style="border-bottom: 1px solid #000000" align="left">/s/ David Aviezer
&nbsp;</TD>
    <TD>&nbsp;</TD>
</TR><TR>
    <TD align="left">&nbsp;</TD>
    <TD>&nbsp;</TD>
    <TD valign="top">Name:&nbsp;&nbsp;</TD>
    <TD align="left">David Aviezer, Ph.D.&nbsp;</TD>
    <TD>&nbsp;</TD>
</TR><TR>
    <TD align="left">&nbsp;</TD>
    <TD>&nbsp;</TD>
    <TD valign="top">Title:&nbsp;&nbsp;</TD>
    <TD align="left">President and Chief Executive Officer&nbsp;</TD>
    <TD>&nbsp;</TD>
</TR>
<TR>
    <TD colspan="5">&nbsp;</TD>
</TR>
</TABLE>

<P align="center" style="font-size: 10pt"><!-- Folio -->3<!-- /Folio -->
</DIV>
</BODY>
</HTML>
</TEXT>
</DOCUMENT>
<DOCUMENT>
<TYPE>EX-99.1
<SEQUENCE>2
<FILENAME>y01301exv99w1.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="left" style="font-size: 10pt; margin-top: 12pt"><B>Protalix BioTherapeutics Receives Research Grant of over $6&nbsp;million from the Israeli Government&#146;s
Office of the Chief Scientist</B>
</DIV>

<DIV align="left" style="font-size: 10pt; margin-top: 6pt">CARMIEL, Israel, March&nbsp;11, 2009 (Business Wire) &#151; Protalix BioTherapeutics, Inc. (NYSE Alternext
US:PLX), announced today that the Office of the Chief Scientist (&#147;OCS&#148;) of Israel&#146;s Ministry of
Industry, Trade and Labor has awarded a grant of over $6&nbsp;million to the Company for calendar year
2009. The OCS awarded the grant to the Company to promote the advancement of the Company&#146;s clinical
and preclinical drug development programs.
</DIV>

<DIV align="left" style="font-size: 10pt; margin-top: 6pt">The terms of the grant provide that a significant amount of the funds awarded are to be used in
connection with the development of the Company&#146;s phase III clinical trial of prGCD, the Company&#146;s
plant cell expressed recombinant Glucocerebrosidase enzyme for the treatment of Gaucher disease.
prGCD is currently the subject of a phase III clinical trial under the Special Protocol Assessment
(SPA)&nbsp;process of the United States Food and Drug Administration in which prGCD is being studied as
an enzyme replacement therapy for Gaucher disease. Enrollment for the phase III clinical trial was
completed in December&nbsp;2008, and the Company expects to report top-line results of the trial in the
second half of 2009. The Company plans to submit a New Drug Application (NDA)&nbsp;for prGCD to the FDA,
the Israeli Ministry of Health and other comparable regulatory agencies in other countries in the
fourth quarter of 2009. In addition to the funds allocated to the development of prGCD, the grant
includes a smaller amount of funds for the advancement of two of the other drug candidates in the
Company&#146;s pipeline, acetylcholinesterase (AChE) and PRX-102. Funds from the grant are to be applied
to the Company&#146;s preclinical development and, if the preclinical development is successful, to a
phase I clinical trial of a plant cell-based acetylcholinesterase (AChE) for several therapeutic
indications, including a biodefense program for anti-organophosphate nerve agent treatment. Funds
are also to be applied to the Company&#146;s preclinical development PRX-102, a therapeutic enzyme for
the treatment of Fabry disease. The grant is available through the end of 2009 and funds are to be
made available to the Company over the course of the year based on actual expenditures made by the
Company in connection with the designated programs.
</DIV>

<DIV align="left" style="font-size: 10pt; margin-top: 6pt">&#147;As we make strides to transform Protalix from a clinical development Company to a commercial
organization, we appreciate the continued support of the OCS,&#148; said Dr.&nbsp;David Aviezer, President
and Chief Executive Officer of the Company. &#147;We believe that this grant represents a vote of
confidence for our product candidates and technology, and strengthens our relationship with the
Government of Israel.&#148;
</DIV>

<DIV align="left" style="font-size: 10pt; margin-top: 12pt"><B>About the Application to the Office of the Chief Scientist</B>
</DIV>

<DIV align="left" style="font-size: 10pt; margin-top: 6pt">Grants from the OCS are judged on various criteria including innovation and uniqueness of the
technology or product, potential market forecasts, and capabilities of the company in areas
including financial strength, R&#038;D capabilities, and management experience.
</DIV>

<P align="center" style="font-size: 10pt"><!-- Folio -->&nbsp;<!-- /Folio -->
</DIV>
<!-- PAGEBREAK -->
<P><HR noshade><P>
<H5 align="left" style="page-break-before:always">&nbsp;</H5><P>

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

<DIV align="left" style="font-size: 10pt; margin-top: 6pt">The Chief Scientist is largely focused on promoting the growth of commercial research and
development in Israel. Its implementation of a 1984 government policy, codified in the Law for the
Encouragement of Industrial Research and Development, includes various assistance programs that
provide qualifying companies in high-tech industries with incentives to avidly undertake R&#038;D
activities. By sharing the risks inherent in high-tech research and development projects, the
Israeli government hopes to facilitate expansion of its growing technological infrastructure, a
main component of the country&#146;s economy. The Company is required to repay to the OCS up to 100% of
grants actually received through payments of royalties at a rate of 3% to 6% of the revenues
generated from an OCS-funded project, depending on the period in which revenues were generated.
</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&#153; 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 conducting a phase III pivotal study for its lead product
candidate, prGCD, to be used in enzyme replacement therapy for Gaucher disease, a lysosomal storage
disorder in humans. Protalix 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 has completed enrollment for this study and is
treating patients in its pivotal phase III clinical trial in North America, South America, Israel,
Europe and South Africa. Protalix is also advancing additional recombinant biopharmaceutical drug
development programs.
</DIV>

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

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