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<SEC-DOCUMENT>0000950123-10-064750.txt : 20100712
<SEC-HEADER>0000950123-10-064750.hdr.sgml : 20100712
<ACCEPTANCE-DATETIME>20100712085231
ACCESSION NUMBER:		0000950123-10-064750
CONFORMED SUBMISSION TYPE:	8-K
PUBLIC DOCUMENT COUNT:		2
CONFORMED PERIOD OF REPORT:	20100712
ITEM INFORMATION:		Other Events
ITEM INFORMATION:		Financial Statements and Exhibits
FILED AS OF DATE:		20100712
DATE AS OF CHANGE:		20100712

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:		10947274

	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>y03706e8vk.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: 12pt"><B><DIV align="center"><DIV style="FONT-size: 3pt; margin-top: 16pt; width: 26%; border-top: 1px solid #000000">&nbsp;</DIV></DIV></B>
</DIV>

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

<DIV align="center" style="font-size: 18pt; margin-top: 12pt"><B><DIV align="center"><DIV style="FONT-size: 3pt; margin-top: 16pt; width: 26%; border-top: 1px solid #000000">&nbsp;</DIV></DIV></B>
</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"><!-- xbrl,dc --><B>Date of Report (Date of Earliest Event Reported): July&nbsp;12, 2010 (July&nbsp;12, 2010)</B><!-- /xbrl,dc --></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"><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>
</TD>
    <TD>&nbsp;</TD>
    <TD align="center" valign="top"><B>001-33357</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>
<TR></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 style="font-family: 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 style="font-family: 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 style="font-family: 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 style="font-family: 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 -->
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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 July&nbsp;12, 2010, Protalix BioTherapeutics, Inc. (the &#147;Company&#148;) issued a press release announcing
that the Company&#146;s New Drug Application (NDA)&nbsp;for taliglucerase alfa has been accepted for review
by the U.S. Food and Drug Administration (FDA). The FDA granted taliglucerase alfa a standard
review time of ten months, assigning a Prescription Drug User Fee Act (PDUFA)&nbsp;action date of
February&nbsp;25, 2011. 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 July&nbsp;12, 2010.
</DIV>





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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>

<DIV align="center">
<TABLE style="font-size: 10pt" cellspacing="0" border="0" cellpadding="0" width="100%">
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    <TD width="40%">&nbsp;</TD>
    <TD width="1%">&nbsp;</TD>
    <TD width="10%">&nbsp;</TD>
</TR>
<TR></TR>
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<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: July&nbsp;12, 2010
</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
Chief Executive Officer</TD>
    <TD>&nbsp;</TD>
    <TD align="left" valign="top">&nbsp;</TD>
</TR>
<!-- End Table Body -->
</TABLE>
</DIV>


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

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<DOCUMENT>
<TYPE>EX-99.1
<SEQUENCE>2
<FILENAME>y03706exv99w1.htm
<DESCRIPTION>EX-99.1
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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="left" style="font-size: 10pt; margin-top: 12pt"><B>Protalix BioTherapeutics Receives PDUFA Date for taliglucerase alfa</B>
</DIV>

<DIV align="left" style="font-size: 10pt; margin-top: 6pt">CARMIEL, Israel, July&nbsp;12 &#151; Protalix BioTherapeutics, Inc. (NYSE-Amex: PLX), announced today that
the Company&#146;s New Drug Application (NDA)&nbsp;for taliglucerase alfa has been accepted for review by the
U.S. Food and Drug Administration (FDA). The FDA granted taliglucerase alfa a standard review time
of ten months, assigning a Prescription Drug User Fee Act (PDUFA)&nbsp;action date of February&nbsp;25, 2011.
Taliglucerase alfa is the Company&#146;s proprietary plant cell expressed recombinant form of human
Glucocerebrosidase (GCD)&nbsp;which is being developed for the treatment of Gaucher disease under a
Special Protocol Assessment (SPA)&nbsp;with the FDA. Following the completion of a phase III clinical
trial of taliglucerase alfa, the Company completed the submission of a rolling NDA with the FDA in
April&nbsp;2010.
</DIV>

<DIV align="left" style="font-size: 10pt; margin-top: 6pt">&#147;If approved, taliglucerase alfa will be an attractive and important therapeutic option for Gaucher
patients,&#148; said Dr.&nbsp;David Aviezer, President and Chief Executive Officer of Protalix. &#147;We look forward to working closely with the agency through this final stage of the review
process.&#148;
</DIV>

<DIV align="left" style="font-size: 10pt; margin-top: 6pt">Taliglucerase alfa has been granted orphan drug designation from the FDA in the United States. The
Company continues to make taliglucerase alfa available 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&#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 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. Protalix filed a rolling NDA submission with
the FDA in December&nbsp;2009. In November&nbsp;2009, Protalix
</DIV>




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



<DIV align="left" style="font-size: 10pt; margin-top: 6pt">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, including the risk that regulatory authorities may find that the data from our 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 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>

</DIV>

<DIV align="left" style="font-size: 10pt; margin-top: 0pt">Marcy Nanus<BR>
The Trout Group, LLC<BR>
Telephone: 646-378-2927<BR>
Email: mnanus@troutgroup.com

</DIV>


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