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<SEC-DOCUMENT>0000950123-10-007489.txt : 20100202
<SEC-HEADER>0000950123-10-007489.hdr.sgml : 20100202
<ACCEPTANCE-DATETIME>20100202070110
ACCESSION NUMBER:		0000950123-10-007489
CONFORMED SUBMISSION TYPE:	8-K
PUBLIC DOCUMENT COUNT:		2
CONFORMED PERIOD OF REPORT:	20100202
ITEM INFORMATION:		Other Events
ITEM INFORMATION:		Financial Statements and Exhibits
FILED AS OF DATE:		20100202
DATE AS OF CHANGE:		20100202

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:		10565082

	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>y02970e8vk.htm
<DESCRIPTION>FORM 8-K
<TEXT>
<HTML>
<HEAD>
<TITLE>e8vk</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): February&nbsp;2, 2010 (February&nbsp;2, 2010)</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</B>
</TD>
    <TD>&nbsp;</TD>
    <TD align="center" valign="top"> <B>000-33357</B>
</TD>
    <TD>&nbsp;</TD>
    <TD align="center" valign="top"> <B>65-0643773</B></TD>
</TR>
<TR valign="bottom">
    <TD align="center" valign="top"><B>(State or other jurisdiction</B>
</TD>
    <TD>&nbsp;</TD>
    <TD align="center" valign="top"><B>(Commission File Number)</B>
</TD>
    <TD>&nbsp;</TD>
    <TD align="center" valign="top"><B>(IRS Employer</B></TD>
</TR>
<TR valign="bottom">
    <TD align="center" valign="top"><B>of incorporation)</B>
</TD>
    <TD>&nbsp;</TD>
    <TD align="center" valign="top">&nbsp;</TD>
    <TD>&nbsp;</TD>
    <TD align="center" valign="top"><B>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="bottom"> </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>







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</DIV>

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

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

<DIV align="left" style="font-size: 10pt; margin-top: 12pt"><B>Item&nbsp;8.01. Other Events</B>
</DIV>

<DIV align="left" style="font-size: 10pt; margin-top: 6pt">On February&nbsp;2, 2010, Protalix BioTherapeutics, Inc. (the &#147;Company&#148;) issued a press release
announcing that, in connection with the New Drug Application (&#147;NDA&#148;) filed by the Company in
December&nbsp;2009 for taliglucerase alfa for the treatment of Gaucher disease, the U.S. Food and Drug
Administration has requested additional data regarding the Chemistry, Manufacturing and Controls
(CMC)&nbsp;section of the NDA. No additional Clinical or Preclinical information was requested. 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 align="left" style="font-size: 10pt; margin-top: 6pt">99.1 Press release dated February&nbsp;2, 2010.
</DIV>





<P align="center" style="font-size: 10pt"><!-- Folio -->2<!-- /Folio -->
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<!-- 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: February 2, 2010&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>Name:</TD>
    <TD valign="top">&nbsp;&nbsp;</TD>
    <TD align="left">David Aviezer, Ph.D.&nbsp;</TD>
    <TD>&nbsp;</TD>
</TR><TR>
    <TD align="left">&nbsp;</TD>
    <TD>Title:</TD>
    <TD valign="top">&nbsp;&nbsp;</TD>
    <TD align="left">President and Chief Executive Officer&nbsp;</TD>
    <TD>&nbsp;</TD>
</TR>

</TABLE>

<P align="center" style="font-size: 10pt"><!-- Folio -->3<!-- /Folio -->
</DIV>

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</DOCUMENT>
<DOCUMENT>
<TYPE>EX-99.1
<SEQUENCE>2
<FILENAME>y02970exv99w1.htm
<DESCRIPTION>EX-99.1
<TEXT>
<HTML>
<HEAD>
<TITLE>exv99w1</TITLE>
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<DIV style="font-family: 'Times New Roman',Times,serif">


<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>

</TABLE>

<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>Protalix Announces NDA Submission Update for taliglucerase alfa<BR>
for the Treatment of Gaucher Disease</B>
</DIV>

<DIV align="left" style="font-size: 10pt; margin-top: 6pt">CARMIEL, Israel, February&nbsp;2, 2010 &#151; Protalix BioTherapeutics, Inc. (NYSE- Amex: PLX) announced
today that, in connection with the New Drug Application (NDA)&nbsp;filed by the Company in
December&nbsp;2009 for taliglucerase alfa for the treatment of Gaucher disease, the U.S. Food and Drug
Administration (FDA)&nbsp;has requested additional data regarding the Chemistry, Manufacturing and
Controls (CMC)&nbsp;section of the NDA. No additional Clinical or Preclinical information was
requested. The request focused primarily on validation of the manufacturing process in the
Company&#146;s upgraded manufacturing facility. A validation plan for the Company&#146;s manufacturing
process of taliglucerase alfa has already been established and reviewed by the FDA. The Company is
working diligently to provide the requested data to the FDA and anticipates submitting the
requested data during the second quarter of 2010.
</DIV>

<DIV align="left" style="font-size: 10pt; margin-top: 6pt">Based on the FDA&#146;s request as part of its rolling review of the NDA, the Prescription Drug User
Fee Act (PDUFA)&nbsp;action date for taliglucerase alfa is expected to be issued following submission
of the additional requested CMC data.
</DIV>

<DIV align="left" style="font-size: 10pt; margin-top: 6pt">Taliglucerase alfa will continue being provided to Gaucher patients in the United States under an
Expanded Access protocol, as well as to patients in the European Union, Israel and other countries
under Named Patient provisions.
</DIV>


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

<DIV align="left" style="font-size: 10pt; margin-top: 6pt">Gaucher disease, an inherited condition, is the most prevalent lysosomal storage disorder, with an
incidence of about 1 in 20,000 live births. People with Gaucher disease do not have enough of an
enzyme, &beta;-glucosidase (glucocerebrosidase),that breaks down a certain type of fat molecule. As a
result, lipid engorged cells (called Gaucher cells) amass in different parts of the body, primarily
the spleen, liver and bone marrow. Accumulation of Gaucher cells may cause spleen and liver
enlargement, anemia, excessive bleeding and bruising, bone disease and a number of other signs and
symptoms.
</DIV>


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

<DIV align="left" style="font-size: 10pt; margin-top: 6pt">Protalix is a biopharmaceutical company focused on the development and commercialization of
proprietary recombinant therapeutic proteins 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 in an environment free of
mammalian components and viruses. Protalix is also advancing additional recombinant
biopharmaceutical drug development programs. Taliglucerase alfa is an enzyme replacement therapy
in development under a Special Protocol Assessment with the FDA for Gaucher disease. In August
2009, the FDA granted orphan drug status and fast track designation to taliglucerase alfa for the
treatment of Gaucher disease and Protalix filed a rolling NDA submission with the
</DIV>



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<DIV align="left" style="font-size: 10pt; margin-top: 6pt">FDA in December&nbsp;2009. In November&nbsp;2009, Protalix granted Pfizer Inc. exclusive, worldwide rights to develop and
commercialize taliglucerase alfa for the treatment of Gaucher disease, except in Israel. Protalix
retained the right to commercialize taliglucerase alfa in Israel.
</DIV>


<DIV align="left" style="font-size: 10pt; margin-top: 12pt"><B>Safe Harbor Statement:</B>
</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. 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 material differences include, among others, risks relating to: the
successful completion of our clinical trials; the review process of the FDA, the EMEA, other
foreign regulatory bodies and other governmental regulatory bodies, including the FDA&#146;s and the
EMEA&#146;s review of any filings we make in connection with the treatment protocol for taliglucerase
alfa; delays in the FDA&#146;s, the EMEA&#146;s or other health regulatory authorities&#146; approval of any
applications we file or refusals to approve such filings, including the NDA we filed with the FDA
or 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 we file
for any such drug product; and other factors described in our filings with the Securities and
Exchange Commission. Companies in the pharmaceutical and biotechnology industries have suffered
significant setbacks in advanced or late-stage clinical trials, even after obtaining promising
earlier trial results or in preliminary findings for such clinical trials. Further, even if
favorable testing data is generated by clinical trials of drug products, the FDA, EMEA or any other
foreign regulatory authority may not accept or approve an NDA filed by a pharmaceutical or
biotechnology company for such drug product. Failure to obtain approval from the FDA, EMEA or any
other foreign regulatory authority of any of our drug candidates in a timely manner, if at all,
will severely undermine our business and results of operation by reducing our potential marketable
products and our ability to generate corresponding product revenues. The statements in this
release are valid only as of the date hereof and we disclaim any obligation to update this
information.
</DIV>


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

</DIV>

<DIV align="left" style="font-size: 10pt; margin-top: 6pt"><B>Media Contact:</B><BR>
Brad Miles<BR>
BMC Communications Group, LLC<BR>
Telephone: 212-477-9007 x17<BR>
Email: <u>brad@bmccommunications.com</u>

</DIV>


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