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<SEC-DOCUMENT>0000950123-09-041654.txt : 20090908
<SEC-HEADER>0000950123-09-041654.hdr.sgml : 20090907
<ACCEPTANCE-DATETIME>20090908160100
ACCESSION NUMBER:		0000950123-09-041654
CONFORMED SUBMISSION TYPE:	8-K
PUBLIC DOCUMENT COUNT:		2
CONFORMED PERIOD OF REPORT:	20090908
ITEM INFORMATION:		Other Events
ITEM INFORMATION:		Financial Statements and Exhibits
FILED AS OF DATE:		20090908
DATE AS OF CHANGE:		20090908

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:		091058157

	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>y02214e8vk.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: 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: 18pt; margin-top: 12pt"><B>FORM 8-K<BR>
<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"><B>Date of Report (Date of Earliest Event Reported): September&nbsp;8, 2009</B><BR>
<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="31%">&nbsp;</TD>
    <TD width="3%">&nbsp;</TD>
    <TD width="31%">&nbsp;</TD>
    <TD width="3%">&nbsp;</TD>
    <TD width="31%">&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 <BR>
of incorporation)</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<BR>
Identification No.)</B></TD>
</TR>
<TR valign="bottom"><!-- Blank Space -->
    <TD align="center" valign="top">&nbsp;</TD>
    <TD>&nbsp;</TD>
    <TD align="center" valign="top">&nbsp;</TD>
    <TD>&nbsp;</TD>
    <TD align="center" valign="top">&nbsp;</TD>
</TR>
<TR valign="bottom">
    <TD align="center" valign="top"><B>2 Snunit Street</B>
</TD>
    <TD>&nbsp;</TD>
    <TD align="center" valign="top">&nbsp;</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>
    <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">&nbsp;</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">&nbsp;</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 align="left" style="font-size: 10pt; margin-top: 6pt"><FONT face="Wingdings">&#111;</FONT> Written communications pursuant to Rule&nbsp;425 under the Securities Act (17 CFR 230.425)
</DIV>

<DIV align="left" style="font-size: 10pt; margin-top: 6pt"><FONT face="Wingdings">&#111;</FONT> Soliciting material pursuant to Rule&nbsp;14a-12 under the Exchange Act (17 CFR 240.14a-12)
</DIV>

<DIV align="left" style="font-size: 10pt; margin-top: 6pt"><FONT face="Wingdings">&#111;</FONT> Pre-commencement communications pursuant to Rule&nbsp;14d-2(b) under
the Exchange Act (17 CFR 240.14d-2(b))
</DIV>

<DIV align="left" style="font-size: 10pt; margin-top: 6pt"><FONT face="Wingdings">&#111;</FONT> Pre-commencement communications pursuant to Rule&nbsp;13e-4(c) under
the Exchange Act (17 CFR 240.13e-4(c))
</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 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 September&nbsp;8, 2009, Protalix BioTherapeutics, Inc. (the &#147;Company&#148;) issued a press release
announcing that it has received notice from the U.S. Food and Drug Administration (FDA)&nbsp;that the
FDA&#146;s Office of Orphan Products Development has granted orphan drug designation to prGCD, the
Company&#146;s proprietary plant cell expressed recombinant 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>


<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="center">
<TABLE style="font-size: 10pt" cellspacing="0" border="0" cellpadding="0" width="100%">
<!-- Begin Table Head -->
<TR valign="bottom">
    <TD width="4%">&nbsp;</TD>
    <TD width="3%">&nbsp;</TD>
    <TD width="93%">&nbsp;</TD>
</TR>
<!-- End Table Head -->
<!-- Begin Table Body -->
<TR valign="bottom">
    <TD valign="top"><DIV style="margin-left:0px; text-indent:-0px">99.1
</DIV></TD>
    <TD>&nbsp;</TD>
    <TD align="left" valign="top">Press release dated September&nbsp;8, 2009.</TD>
</TR>
<!-- End Table Body -->
</TABLE>
</DIV>


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

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<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: September 8, 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 nowrap>&nbsp;</TD>
    <TD colspan="2" align="left">Name:&nbsp;David Aviezer, Ph.D.

<TR>
    <TD align="left">&nbsp;</TD>
    <TD valign="top" nowrap>&nbsp;</TD>
    <TD colspan="2" align="left" nowrap>Title:&nbsp;&nbsp;&nbsp;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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<TYPE>EX-99.1
<SEQUENCE>2
<FILENAME>y02214exv99w1.htm
<DESCRIPTION>EX-99.1
<TEXT>
<HTML>
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<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>FDA Grants Protalix Orphan Drug Designation for prGCD</B>
</DIV>

<DIV align="left" style="font-size: 10pt; margin-top: 6pt">CARMIEL, Israel, September&nbsp;8, 2009 (Business Wire) &#151; Protalix BioTherapeutics, Inc.
(NYSE-Amex:PLX), announced today that it has received notice from the U.S. Food and Drug
Administration (FDA)&nbsp;that the FDA&#146;s Office of Orphan Products Development has granted orphan drug
designation to prGCD, the Company&#146;s proprietary plant cell expressed recombinant form of
glucocerebrosidase (GCD)&nbsp;for the treatment of Gaucher disease. Gaucher disease is a lysosomal
storage disorder resulting from a deficiency or mutation of the GCD enzyme that can cause damage to
the liver, spleen, bone marrow and in some cases, the central nervous system.
</DIV>

<DIV align="left" style="font-size: 10pt; margin-top: 6pt">The FDA grants orphan drug designation to drugs that may provide a significant therapeutic
advantage over existing treatments and target conditions affecting 200,000 or fewer US patients per
year. Orphan drug status grants a priority review, for a faster review time of the drug&#146;s New Drug
Application (NDA)&nbsp;and qualifies the drug for possible funding and tax savings to support clinical
trials and for other financial incentives. The sponsor company of a drug must continue to meet
certain conditions established by the FDA to remain eligible for orphan drug status once granted.
</DIV>

<DIV align="left" style="font-size: 10pt; margin-top: 6pt">&#147;The FDA&#146;s orphan drug designation further strengthens our prGCD program for treating Gaucher
disease by offering important clinical development and commercialization benefits,&#148; said Dr.&nbsp;David
Aviezer, the Company&#146;s President and Chief Executive Officer.
</DIV>

<DIV align="left" style="font-size: 10pt; margin-top: 6pt">prGCD is currently being evaluated for the treatment of Gaucher disease in a Phase III clinical
trial which is scheduled to end this month. The Company plans to announce top-line results from
the Phase III trial in October, and to complete filing of an NDA with the FDA
before the end of the year. In addition, after the FDA&#146;s recent approval of the Company&#146;s treatment
protocol for prGCD, the Company filed applications for medical Institutional Review Board (IRB)
approvals in hospitals worldwide and expects to start treating patients under the extended access
treatment protocol.
</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 in an environment
free of mammalian
</DIV>

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<DIV align="left" style="font-size: 10pt; margin-top: 6pt">components and viruses. 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 rare
and serious lysosomal storage disorder in humans with severe and debilitating symptoms. Protalix
and the U.S. Food and Drug Administration (FDA)&nbsp;agreed on the final design of the pivotal Phase III
clinical trial through the FDA&#146;s Special Protocol Assessment (SPA)&nbsp;process. In addition, Protalix
has received Fast Track Designation from the FDA for prGCD and the FDA&#146;s Office of Orphan Products
Development has granted orphan drug designation to prGCD. Protalix is also advancing additional
recombinant biopharmaceutical drug development programs.
</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 preclinical development of our product candidates; the completion of clinical trials;
the review process of the FDA, foreign regulatory bodies and other governmental regulation,
including the FDA&#146;s review of any filings we make in connection with the phase III trial; delays in
the FDA&#146;s or other health regulatory authorities&#146; approval of any applications we file or refusals
to approve such filings; prGCD&#146;s continuing to be eligible for expedited review under the fast
track and orphan drug programs, if we file an NDA for prGCD; 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; the identification of lead compounds; the risk that
we may fail to satisfy certain conditions relating to grants we have received from the Office of
the Chief Scientist of Israel&#146;s Ministry of Industry and Trade which may lead to our being required
to refund grants previously received
together with interest and penalties; the risk that the Office of the Chief Scientist may not
deliver to us all of the funds awarded to us; uncertainties related to the ability to attract and
retain partners for our technologies and products under development; and other factors described in
our filings with the Securities and Exchange Commission. Under our approved treatment protocol,
prGCD might be provided only to a limited number of patients and only for a limited time, and the
medical institutional review board of hospitals may not choose to start treating patients under our
extended access treatment protocol in a timely manner, if at all. Pharmaceutical and biotechnology
companies have suffered significant setbacks in advanced clinical trials, even after promising
results in earlier clinical trials or in preliminary findings for such clinical trials. The FDA&#146;s
approval of the treatment protocol for prGCD, the fast track approval, or the orphan
</DIV>


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<DIV align="left" style="font-size: 10pt; margin-top: 6pt">drug designation will not have any effect on the FDA&#146;s approval of any NDA we file with respect to
prGCD, if any, and the review by the FDA of any data from the Phase III clinical development
programs in connection with the approval of the treatment protocol will not have any effect on the
FDA&#146;s subsequent review of our complete Phase III clinical trial data in the future. The
statements 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: mnanus@troutgroup.com

</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: brad@bmccommunications.com

</DIV>


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