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<SEC-DOCUMENT>0000950123-09-011463.txt : 20090604
<SEC-HEADER>0000950123-09-011463.hdr.sgml : 20090604
<ACCEPTANCE-DATETIME>20090604171654
ACCESSION NUMBER:		0000950123-09-011463
CONFORMED SUBMISSION TYPE:	8-K
PUBLIC DOCUMENT COUNT:		2
CONFORMED PERIOD OF REPORT:	20090604
ITEM INFORMATION:		Regulation FD Disclosure
ITEM INFORMATION:		Financial Statements and Exhibits
FILED AS OF DATE:		20090604
DATE AS OF CHANGE:		20090604

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:		09874865

	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>y01796e8vk.htm
<DESCRIPTION>FORM 8-K
<TEXT>
<HTML>
<HEAD>
<TITLE>8-K</TITLE>
</HEAD>
<BODY bgcolor="#FFFFFF">
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<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: 10pt; margin-top: 12pt"><DIV align="center"><DIV style="font-size: 3pt; margin-top: 16pt; width: 26%; border-top: 1px solid #000000">&nbsp;</DIV></DIV></DIV>

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

<DIV align="center" style="font-size: 10pt; margin-top: 12pt"><DIV align="center"><DIV style="font-size: 3pt; margin-top: 16pt; width: 26%; border-top: 1px solid #000000">&nbsp;</DIV></DIV></DIV>


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

<DIV align="center" style="font-size: 10pt; margin-top: 12pt"><B>Date of Report (Date of Earliest Event Reported): June&nbsp;4, 2009</B></DIV>

<DIV align="center" style="font-size: 10pt; margin-top: 12pt"><DIV align="center"><DIV style="font-size: 3pt; margin-top: 16pt; width: 26%; border-top: 1px solid #000000">&nbsp;</DIV></DIV></DIV>

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

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


<DIV align="center" style="font-size: 10pt; margin-top: 12pt"><DIV align="center"><DIV style="font-size: 3pt; margin-top: 16pt; width: 26%; border-top: 1px solid #000000">&nbsp;</DIV></DIV></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"><B>Florida<BR>
(State or other jurisdiction <BR>
of incorporation)</B>
</TD>
    <TD>&nbsp;</TD>
    <TD align="center" valign="top"><B>000-27836<BR>
(Commission File Number)</B>
</TD>
    <TD>&nbsp;</TD>
    <TD align="center" valign="top"><B>65-0643773<BR>
(IRS Employer<BR>
Identification No.)</B></TD>
</TR>
<!-- End Table Body -->
</TABLE>
</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="47%">&nbsp;</TD>
    <TD width="5%">&nbsp;</TD>
    <TD width="47%">&nbsp;</TD>
</TR>
<!-- End Table Head -->
<!-- Begin Table Body -->
<TR valign="bottom">
    <TD align="center" valign="top"><B>2 Snunit Street</B>
</TD>
    <TD>&nbsp;</TD>
    <TD align="center" valign="top">&nbsp;</TD>
</TR>
<TR valign="bottom">
    <TD align="center" valign="top"><B>Science Park, POB 455</B></TD>
    <TD>&nbsp;</TD>
    <TD align="center" valign="top">&nbsp;</TD>
</TR>
<TR valign="bottom">
    <TD align="center" valign="top"><B>Carmiel, Israel</B></TD>
    <TD>&nbsp;</TD>
    <TD align="center" valign="top"><B>20100</B></TD>
</TR>
<TR valign="bottom">
    <TD align="center" valign="top"><B>(Address of principal executive offices)</B>
</TD>
    <TD>&nbsp;</TD>
    <TD align="center" valign="top"><B>(Zip Code)</B></TD>
</TR>
<!-- End Table Body -->
</TABLE>
</DIV>

<DIV align="center" style="font-size: 10pt; margin-top: 12pt"><B>Registrant&#146;s telephone number, including area code &#043;972-4-988-9488</B></DIV>

<DIV align="center" style="font-size: 10pt; margin-top: 12pt"><B>(Former name or former address, if changed since last report.)</B></DIV>

<DIV align="center" style="font-size: 10pt; margin-top: 12pt"><DIV align="center"><DIV style="font-size: 3pt; margin-top: 16pt; width: 26%; border-top: 1px solid #000000">&nbsp;</DIV></DIV></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="1%" 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="1%" 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="1%" 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="1%" 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>

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<H5 align="left" style="page-break-before:always">&nbsp;</H5><P>

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

<!--TOC-->
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<!-- link1 "Item&nbsp;7. Regulation&nbsp;FD" -->

<DIV align="left" style="font-size: 10pt; margin-top: 12pt"><B>Item&nbsp;7. Regulation&nbsp;FD</B>
</DIV>

<DIV align="left" style="font-size: 10pt; margin-top: 6pt">On June&nbsp;4, 2009, Protalix BioTherapeutics, Inc. (the &#147;Company&#148;) issued a press release announcing
that Frost &#038; Sullivan has presented the Company with Frost &#038; Sullivan&#146;s 2009 European Orphan
Diseases Market Product Innovation of the Year Award. A copy of the press release is attached
hereto as Exhibit&nbsp;99.1.
</DIV>

<!-- link1 "Item&nbsp;9.01. Financial Statements and Exhibits" -->

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


<DIV align="left" style="font-size: 10pt; margin-top: 6pt"><B>(d)&nbsp;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">99.1</TD>
    <TD width="1%">&nbsp;</TD>
    <TD>Press release dated June&nbsp;4, 2009.</TD>
</TR>

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

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<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="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="50%">&nbsp;</TD>
    <TD width="1%">&nbsp;</TD>
    <TD width="2%">&nbsp;</TD>
    <TD width="1%">&nbsp;</TD>
    <TD width="35%">&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: June&nbsp;4, 2009</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"><!-- 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">&nbsp;
</DIV></TD>
    <TD>&nbsp;</TD>
    <TD align="left" valign="top">By:<BR>
Name:
</TD>
    <TD>&nbsp;</TD>
    <TD align="left" valign="top">/s/ David Aviezer
<DIV style="font-size: 1pt; border-top: 1px solid #000000">&nbsp;</DIV>
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</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">&nbsp;</TD>
    <TD>&nbsp;</TD>
    <TD align="left" valign="top">Chief Executive Officer</TD>
    <TD>&nbsp;</TD>
    <TD align="left" valign="top">&nbsp;</TD>
</TR>
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</DIV>


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<DOCUMENT>
<TYPE>EX-99.1
<SEQUENCE>2
<FILENAME>y01796exv99w1.htm
<DESCRIPTION>EX-99.1
<TEXT>
<HTML>
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<TITLE>EX-99.1</TITLE>
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<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>Frost &#038; Sullivan Presents Protalix Biotherapeutics with its 2009 European Orphan<BR>
Diseases Market Product Innovation of the Year Award</B>
</DIV>

<DIV align="left" style="font-size: 10pt; margin-top: 6pt">CARMIEL, Israel, June&nbsp;4, 2009 (Business Wire) &#151; Protalix BioTherapeutics, Inc. (NYSE-AMEX:PLX),
announced today that Frost &#038; Sullivan has presented the Company with its 2009 European Orphan
Diseases Market Product Innovation of the Year Award. In presenting the award, Frost &#038; Sullivan
noted the Company&#146;s impressive display of technology and innovative efforts in developing prGCD,
the Company&#146;s proprietary plant cell expressed recombinant form of human Glucocerebrosidase (GCD)
for the treatment of Gaucher disease using its proprietary expression system, ProCellEx&#153;.
</DIV>

<DIV align="left" style="font-size: 10pt; margin-top: 6pt">Frost &#038; Sullivan bestows the European Orphan Diseases Market Product Innovation Award on a company
or individual that has performed new research which has resulted in technological innovation(s)
that have brought, or are expected to bring, significant contributions to the industry in terms of
adoption, change, and competitive posture. The award recognizes the quality and depth of the
recipient&#146;s research and development program as well as the vision and risk-taking that enabled the
recipient to undertake the research for which the recipient is being recognized.
</DIV>

<DIV align="left" style="font-size: 10pt; margin-top: 6pt">In granting this award to Protalix, Frost &#038; Sullivan noted that ProCellEx,&#153; the Company&#146;s
proprietary expression system used to produce prGCD, has the potential to enhance drug properties
such as better efficacy, longer half-life, cost effectiveness and better patient compliance.
According to Frost &#038; Sullivan, the Company&#146;s product candidates are expected to be cost effective
when compared to existing therapies because they are produced using, a plant cell culture-based
expression system. Existing enzyme replacement therapies are produced using mammalian cell-based
expression systems, a production method that is expensive and results in increased production
costs.
</DIV>

<DIV align="left" style="font-size: 10pt; margin-top: 6pt">Frost &#038; Sullivan further stated that &#147;through the development of prGCD using the ProCellEx&#153;
&#091;production&#093; system, Protalix Biotherapeutics has developed a product with capabilities and
characteristics that positively differentiate it from the enzyme replacement therapies available in
the market. The current &#091;global market of Gaucher disease&#093; is estimated around $1.30&nbsp;billion and
there is only one enzyme replacement therapy currently available. By positioning its focus on a
high profile and underserved area of orphan diseases, Protalix Biotherapeutics has moved to become
a recognized name for product innovation in the area.&#148;
</DIV>

<DIV align="left" style="font-size: 10pt; margin-top: 6pt">&#147;Receiving this award from Frost &#038; Sullivan provides further validation of our innovative approach
to manufacturing proteins in a plant cell-based expression system,&#148; said Dr.&nbsp;David Aviezer, the
Company&#146;s President and Chief Executive Officer. &#147;We have completed patient enrollment in our
pivotal Phase III clinical trial of prGCD for the treatment of Gaucher disease, and the trial&#146;s
design was the product of an agreement with the FDA under its special protocol assessment process.
We look forward to reporting the results of this trial in the fourth quarter of 2009.&#148;
</DIV>


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

<DIV align="left" style="font-size: 10pt; margin-top: 6pt">Frost &#038; Sullivan, the Growth Consulting Company, partners with clients to accelerate their growth.
The company&#146;s Growth Partnership Services, Growth Consulting and Career Best Practices empower
clients to create a growth focused culture that generates, evaluates and
</DIV>


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

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



<DIV align="left" style="font-size: 10pt; margin-top: 6pt">implements effective growth strategies. Frost &#038; Sullivan employs over 45&nbsp;years of experience in
partnering with Global 1000 companies, emerging businesses and the investment community from more
than 30 offices on six continents. For more information about Frost &#038; Sullivan&#146;s Growth
Partnerships, visit http://www.frost.com.
</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 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. The study is monitored by an independent Data Monitoring
Committee including experts in the field, who monitor the on going safety data, which has recently
held their last scheduled meeting before the end of the trial. No serious adverse events have been
reported in the study. 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 Nanus<BR>
The Trout Group, LLC<BR>
Telephone: 646-378-2927<BR>
Email: mnanus@troutgroup.com

</DIV>


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