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<SEC-DOCUMENT>0000950123-10-109328.txt : 20101129
<SEC-HEADER>0000950123-10-109328.hdr.sgml : 20101129
<ACCEPTANCE-DATETIME>20101129161542
ACCESSION NUMBER:		0000950123-10-109328
CONFORMED SUBMISSION TYPE:	8-K
PUBLIC DOCUMENT COUNT:		2
CONFORMED PERIOD OF REPORT:	20101129
ITEM INFORMATION:		Other Events
ITEM INFORMATION:		Financial Statements and Exhibits
FILED AS OF DATE:		20101129
DATE AS OF CHANGE:		20101129

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:		101219085

	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>y04241e8vk.htm
<DESCRIPTION>FORM 8-K
<TEXT>
<HTML>
<HEAD>
<TITLE>e8vk</TITLE>
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<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: 6pt"><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: 6pt"><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>
<!-- xbrl,dc -->
<DIV align="center" style="font-size: 10pt; margin-top: 12pt"><B>Date of Report (Date of Earliest Event Reported): November&nbsp;29, 2010 (November&nbsp;29, 2010)</B>
</DIV>
<!-- /xbrl,dc -->

<DIV align="Center" style="font-size: 10pt; margin-top: 6pt"><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: 6pt"><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>
<TR></TR>
<!-- End Table Head -->
<!-- Begin Table Body -->
<TR valign="bottom">
    <TD align="center" valign="top"><B>Florida</B> <BR>
<B>(State or other jurisdiction <BR>
of incorporation)</B>
</TD>
    <TD>&nbsp;</TD>
    <TD align="center" valign="top"><B>001-33357</B> <BR>
<B>(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>
<TR></TR>
<!-- End Table Head -->
<!-- Begin Table Body -->
<TR valign="bottom">
    <TD align="center" valign="top"><B>2 Snunit Street</B> <BR>
<B>Science Park, POB 455<BR>
Carmiel, Israel<BR>
(Address of principal executive offices)</B>
</TD>
    <TD>&nbsp;</TD>
    <TD align="center" valign="top"><B>20100<BR>
(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: 6pt"><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 align="left" style="margin-top: 6pt">
<TABLE width="100%" border="0" cellpadding="0" cellspacing="0" style="font-size: 10pt; background: transparent; color: #000000">
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    <TD></TD>
</TR>

<TR>
    <TD valign="top"><FONT style="font-family: 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="left" style="margin-top: 6pt">
<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>
    <TD valign="top"><FONT style="font-family: 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="left" style="margin-top: 6pt">
<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>
    <TD valign="top"><FONT style="font-family: 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="left" style="margin-top: 6pt">
<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>
    <TD valign="top"><FONT style="font-family: 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>

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<!--TOC-->
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<!-- link1 "Item&nbsp;8.01. Other Events" -->

<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 November&nbsp;29, 2010, Protalix BioTherapeutics, Inc. (the &#147;Company&#148;) issued a press release
announcing the submission of a Marketing Authorization Application to the European Medicines Agency
for taliglucerase alfa, a plant-cell expressed form of glucocerebrosidase (GCD)&nbsp;for the treatment
of Gaucher disease. 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="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 align="left" style="font-size: 10pt; margin-top: 12pt"><B>(d)&nbsp;Exhibits</B>
</DIV>

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<TABLE style="font-size: 10pt" cellspacing="0" border="0" cellpadding="0" width="100%">
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<TR valign="bottom">

    <TD width="1%">&nbsp;</TD>
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    <TD width="3%">&nbsp;</TD>
    <TD width="86%">&nbsp;</TD>
</TR>
<TR></TR>
<!-- End Table Head -->
<!-- Begin Table Body -->
<TR valign="bottom">

    <TD align="right" valign="top">99.1</TD>
    <TD nowrap valign="top">&nbsp;</TD>
    <TD valign="top" style="font-size: 10pt">&nbsp;</TD>
    <TD valign="top" style="font-size: 10pt"><DIV style="margin-left:0px; text-indent:-0px">Press release dated November&nbsp;29, 2010.</DIV></TD>
</TR>
<!-- End Table Body -->
</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">



<!-- 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>


<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: November 29, 2010&nbsp;</TD>
    <TD valign="top" COLSPAN="2">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>&nbsp;</TD>
    <TD valign="top" COLSPAN="2">Name:&nbsp;&nbsp;</TD>
    <TD align="left">David Aviezer, Ph.D.&nbsp;</TD>
    <TD>&nbsp;</TD>
</TR><TR>

    <TD>&nbsp;</TD>
    <TD valign="top" COLSPAN="2">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>



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<DOCUMENT>
<TYPE>EX-99.1
<SEQUENCE>2
<FILENAME>y04241exv99w1.htm
<DESCRIPTION>EX-99.1
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<DIV align="right" style="font-size: 10pt; margin-top: 12pt"><B>Exhibit&nbsp;99.1</B>
</DIV>


<DIV align="center" style="font-size: 10pt; margin-top: 18pt"><B>Pfizer and Protalix BioTherapeutics Announce Submission of<BR>
taliglucerase alfa for European Marketing Authorization<BR>
for the Treatment of Gaucher Disease</B>
</DIV>

<DIV align="left" style="font-size: 10pt; margin-top: 6pt"><B>New York, NY</B>/<B>Carmiel, Israel, November&nbsp;29, 2010 </B>&#151; Pfizer Inc. (NYSE: PFE) and Protalix
BioTherapeutics, Inc. (NYSE-AMEX: PLX, TASE:PLX) today announced the submission of a Marketing
Authorization Application to the European Medicines Agency for taliglucerase alfa, a plant-cell
expressed form of glucocerebrosidase (GCD) for the treatment of Gaucher disease. Taliglucerase alfa
was granted Orphan Designation by the European Commission for the treatment of Gaucher disease on
March&nbsp;23, 2010.
</DIV>

<DIV align="left" style="font-size: 10pt; margin-top: 6pt">On November&nbsp;30, 2009, Pfizer and Protalix BioTherapeutics, Inc. entered into an agreement to
develop and commercialize taliglucerase alfa. Under the terms of the agreement, Pfizer received
exclusive worldwide licensing rights for the commercialization of taliglucerase alfa, while
Protalix retained the exclusive commercialization rights in Israel.
</DIV>

<DIV align="left" style="font-size: 10pt; margin-top: 6pt">Taliglucerase alfa was granted orphan drug designation by the U.S. Food and Drug Administration. A
New Drug Application (NDA)&nbsp;for taliglucerase alfa has been accepted by the FDA and assigned a
Prescription Drug User Fee Act (PDUFA)&nbsp;action date of February&nbsp;25, 2011. Taliglucerase alfa is
available to patients with Gaucher disease in the United States under an Expanded Access protocol
as well as to patients in several member states of the European Union, Israel and other countries
under Named Patient provisions.
</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">DISCLOSURE NOTICE: The information contained in this release is as of November&nbsp;29, 2010. Neither
Pfizer nor Protalix BioTherapeutics assumes any obligation to update forward-looking statements
contained in this release as the result of new information or future events or developments.
</DIV>

<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. Drug discovery and development involve a high degree of risk.
Factors that might cause material differences include, among others, risks relating to: the review
process of the U.S. Food and Drug Administration (FDA), the European Medicines Agency (EMEA), other
foreign regulatory bodies and other governmental regulatory bodies, including the risk that
regulatory authorities may find that the data from Protalix BioTherapeutics&#146; clinical trials and
other studies is insufficient for regulatory approval; delays in the FDA&#146;s, the EMEA&#146;s or other
health regulatory authorities&#146; approval of any applications Protalix BioTherapeutics and/or Pfizer
file or refusals to approve such filings, including the New Drug Application (NDA)&nbsp;filed with the
FDA and the Marketing Authorization Application (MAA)&nbsp;submitted to the EMEA for taliglucerase alfa
for the treatment of Gaucher disease; refusals by such regulatory authorities to approve the
marketing and sale of a drug product even after acceptance of an application filed for any such
drug product; risks relating to the decisions of the FDA, EMEA and other foreign regulatory
authorities regarding labeling and other matters that could affect the commercial availability or
potential of taliglucerase alfa; risks relating to competitive developments regarding taliglucerase
alfa; and other factors described in Pfizer&#146;s and Protalix BioTherapeutics&#146; filings with the
Securities and Exchange Commission. Even if favorable testing data is generated from clinical
trials of drug products, the FDA, EMEA or any other foreign regulatory authority may not accept or
approve an NDA or MAA, as applicable, filed by a pharmaceutical or biotechnology company for such
drug product.
</DIV>


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




<DIV align="left" style="font-size: 10pt; margin-top: 6pt; margin-left: 50%"><B>Pfizer Contacts:</B><BR>
Joan Campion (Media)<BR>
212 733-2798<BR>
<u>Joan.Campion@Pfizer.com</u>

</DIV>

<DIV align="left" style="font-size: 10pt; margin-top: 6pt; margin-left: 50%">Suzanne Harnett (Investors)<BR>
212 733-8009<BR>
<u>Suzanne.Harnett@Pfizer.com</u>

</DIV>

<DIV align="left" style="font-size: 10pt; margin-top: 6pt; margin-left: 50%">In Europe:<BR>
Lisa O&#146;Neill<BR>
44 1737-331536<BR>
Lisa.O&#146;Neill@pfizer.com

</DIV>

<DIV align="left" style="font-size: 10pt; margin-top: 6pt; margin-left: 50%"><B>Protalix Contacts:</B><BR>
Marcy Nanus (Investors)<BR>
The Trout Group, LLC<BR>
646 378-2927<BR>
<u>Mnanus@troutgroup.com</u>

</DIV>

<DIV align="left" style="font-size: 10pt; margin-top: 6pt; margin-left: 50%">Kari Watson (Media)<BR>
MacDougall Biomedical<BR>
Communications<BR>
781-235-3060<BR>
<u>kwatson@macbiocom.com</u>

</DIV>

<DIV align="left" style="font-size: 10pt; margin-top: 10pt; margin-left: 50%"># # # # #

</DIV>


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