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<SEC-DOCUMENT>0000950123-11-018222.txt : 20110225
<SEC-HEADER>0000950123-11-018222.hdr.sgml : 20110225
<ACCEPTANCE-DATETIME>20110225063914
ACCESSION NUMBER:		0000950123-11-018222
CONFORMED SUBMISSION TYPE:	8-K
PUBLIC DOCUMENT COUNT:		2
CONFORMED PERIOD OF REPORT:	20110225
ITEM INFORMATION:		Other Events
ITEM INFORMATION:		Financial Statements and Exhibits
FILED AS OF DATE:		20110225
DATE AS OF CHANGE:		20110225

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:		11638404

	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>y04600e8vk.htm
<DESCRIPTION>FORM 8-K
<TEXT>
<HTML>
<HEAD>
<TITLE>e8vk</TITLE>
</HEAD>
<BODY bgcolor="#FFFFFF">
<!-- PAGEBREAK -->
<H5 align="left" style="page-break-before:always"><A HREF="#Y04600toc">Table of Contents</A></H5><P>
<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: 18pt"><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;25, 2011</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"><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="bottom"><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 -->
</DIV>

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<P><HR noshade><P>

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

<!-- TOC -->
<A name="Y04600toc"><DIV align="CENTER" style="page-break-before:always"><U><B>TABLE OF CONTENTS</B></U></DIV></A>

<P><CENTER>
<TABLE border="0" width="90%" cellpadding="0" cellspacing="0">
<TR>
	<TD width="3%"></TD>
	<TD width="3%"></TD>
	<TD width="3%"></TD>
	<TD width="3%"></TD>
	<TD width="3%"></TD>
	<TD width="3%"></TD>
	<TD width="3%"></TD>
	<TD width="3%"></TD>
	<TD width="76%"></TD>
</TR>
<TR><TD colspan="9"><A HREF="#Y04600000">Item&nbsp;8.01. Other Events</A></TD></TR>
<TR><TD colspan="9"><A HREF="#Y04600001">Item&nbsp;9.01. Financial Statements and Exhibits</A></TD></TR>
<TR><TD colspan="9"><A HREF="#Y04600002">SIGNATURES</A></TD></TR>
<TR><TD colspan="9"><A HREF="y04600exv99w1.htm">EX-99.1</A></TD></TR>
</TABLE>
</CENTER>
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<H5 align="left" style="page-break-before:always"><A HREF="#Y04600toc">Table of Contents</A></H5><P>




<!-- link1 "Item&nbsp;8.01. Other Events" -->
<DIV align="left"><A NAME="Y04600000"></A></DIV>

<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;25, 2011, Protalix BioTherapeutics, Inc. (the &#147;Company&#148;) issued a press release
announcing that it had received a Complete Response Letter from the U.S. Food and Drug
Administration regarding the New Drug Application (NDA)&nbsp;for the Company&#146;s lead product candidate,
taliglucerase alfa 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"><A NAME="Y04600001"></A></DIV>

<DIV align="left" style="font-size: 10pt; margin-top: 12pt"><B>Item&nbsp;9.01. Financial Statements and 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="1%" nowrap align="left"><B>(d)</B></TD>
    <TD width="1%">&nbsp;</TD>
    <TD><B>Exhibits</B></TD>
</TR>

</TABLE>
</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">99.1</TD>
    <TD width="1%">&nbsp;</TD>
    <TD>Press release dated February&nbsp;25, 2011.</TD>
</TR>




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

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<P><HR noshade><P>
<H5 align="left" style="page-break-before:always"><A HREF="#Y04600toc">Table of Contents</A></H5><P>

<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="left"><A NAME="Y04600002"></A></DIV>

<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 25, 2011&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>&nbsp;</TD>
    <TD valign="top">Name:&nbsp;&nbsp;</TD>
    <TD align="left">David Aviezer, Ph.D.&nbsp;</TD>
    <TD>&nbsp;</TD>
</TR><TR>
    <TD align="left">&nbsp;</TD>
    <TD>&nbsp;</TD>
    <TD valign="top">Title:&nbsp;&nbsp;</TD>
    <TD align="left">President and<br>Chief Executive Officer&nbsp;</TD>
    <TD>&nbsp;</TD>
</TR>

</TABLE>


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

</BODY>
</HTML>
</TEXT>
</DOCUMENT>
<DOCUMENT>
<TYPE>EX-99.1
<SEQUENCE>2
<FILENAME>y04600exv99w1.htm
<DESCRIPTION>EX-99.1
<TEXT>
<HTML>
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<TITLE>exv99w1</TITLE>
</HEAD>
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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>FDA ISSUES COMPLETE RESPONSE LETTER FOR TALIGLUCERASE ALFA NEW DRUG APPLICATION</B>
</DIV>

<DIV align="left" style="font-size: 10pt; margin-top: 6pt">CARMIEL, Israel, February&nbsp;25, 2011 /PR Newswire/Protalix BioTherapeutics, Inc. (NYSE-AMEX:PLX,
TASE:PLX), announced today that the U.S. Food and Drug Administration (FDA)&nbsp;issued a Complete
Response Letter (CRL)&nbsp;regarding the Company&#146;s New Drug Application (NDA)&nbsp;for taliglucerase alfa for
the treatment of Gaucher disease. Taliglucerase alfa is a plant-cell expressed form of
glucocerebrosidase (GCD).
</DIV>

<DIV align="left" style="font-size: 10pt; margin-top: 6pt">A CRL is issued by the FDA&#146;s Center for Drug Evaluation and Research when the review of a file is
completed and questions remain that preclude the approval of the NDA in its current form.
</DIV>

<DIV align="left" style="font-size: 10pt; margin-top: 6pt">The main questions raised by the FDA regarding the NDA relate to clinical and chemistry,
manufacturing and controls (CMC). In the clinical section, the FDA requested additional data from
the Company&#146;s switchover trial and long-term extension trial. At the time the NDA was submitted,
full data from these trials was not available. In the CMC section, the FDA requested information
regarding testing specifications and assay validation.
</DIV>

<DIV align="left" style="font-size: 10pt; margin-top: 6pt">&#147;While we are disappointed by the receipt of the Complete Response Letter, we appreciate the FDA&#146;s
efforts to complete the review of our NDA. We noted that the FDA did not request additional
clinical studies. Moreover, the FDA inspected our manufacturing facilities finding them
acceptable. FDA also did not identify any issues in its audit of our clinical sites,&#148; said Dr.
David Aviezer, the Company&#146;s President and Chief Executive Officer. &#147;Protalix will work with the
FDA to determine next steps.&#148;
</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.
</DIV>


<DIV align="left" style="font-size: 10pt; margin-top: 6pt">&#147;Pfizer remains dedicated to the Gaucher community worldwide,&#148; said David Simmons, President
and General Manager, Emerging Markets and Established Products Business Units, Pfizer Inc. &#147;We
will work closely with Protalix to address the requests from the FDA in a timely manner by
providing technical, analytical and regulatory expertise.&#148;
</DIV>
<DIV align="left" style="font-size: 10pt; margin-top: 6pt">Protalix will request a meeting with the FDA as soon as possible to clarify the path to
regulatory approval.
</DIV>

<DIV align="left" style="font-size: 10pt; margin-top: 6pt">Patient enrollment remains open in Protalix&#146;s multi-center, double-blind pediatric trial of
taliglucerase alfa. Patients currently enrolled in the switchover study and extension study will
continue to receive the drug. In addition, taliglucerase alfa is currently being provided to
Gaucher patients in the U.S. under an Expanded Access protocol, under special access agreements
such as in France and Brazil, as well as to patients in the rest of the world under Named Patient
provisions.
</DIV>



<P align="center" style="font-size: 10pt"><!-- Folio --><!-- /Folio -->
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<DIV style="font-family: 'Times New Roman',Times,serif">




<DIV align="left" style="font-size: 10pt; margin-top: 12pt"><B>Conference Call &#038; Webcast</B>
</DIV>

<DIV align="left" style="font-size: 10pt; margin-top: 6pt">The Company will host a conference call and webcast today, February&nbsp;25, 2011, at 08:00&nbsp;a.m.
Eastern Time (15:00 Israel time). The conference call may be accessed by dialing 877-407-8031 for
U.S. callers and 201-689-8031 for international callers. The conference call will also be webcast
live under the investor relations section of the Company&#146;s website at <u>www.protalix.com</u> and will be
archived there for 14&nbsp;days following the call.
</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
recombinant therapeutic proteins expressed through its proprietary plant cell based expression
system, ProCellEx&#153;. The Company&#146;s unique expression system presents a proprietary method for
developing recombinant proteins in a cost-effective, industrial-scale manner in an environment free
of mammalian components and viruses. Protalix&#146;s lead compound taliglucerase alfa, an enzyme
replacement therapy for the treatment of Gaucher disease, completed Phase III development. To
date, marketing applications have been submitted for taliglucerase alfa in the United States,
European Union, Brazil and Israel. Protalix&#146;s development pipeline also includes: PRX-105, a
pegylated recombinant human acetylcholinesterase in development for several therapeutic and
prophylactic indications, a biodefense program and an organophosphate-based pesticide treatment
program; PRX-102, a modified version of the recombinant human alpha-GAL-A protein for the treatment
of Fabry disease; an orally-delivered glucocerebrosidase enzyme that is naturally encased in carrot
cells, also for the treatment of Gaucher disease; and pr-antiTNF, a biosimilar version of
etanercept (Enbrel&#153;) for the treatment of rheumatoid arthritis.
</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. The terms &#147;anticipate,&#148; &#147;believe,&#148; &#147;estimate,&#148; &#147;expect&#148;
and &#147;intend&#148; and other words or phrases of similar import are intended to identify forward-looking
statements. 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 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 our clinical trials and other studies, including the information we provide
the FDA after our receipt of a complete response letter from the FDA in February&nbsp;2011 relating to
the new drug application (NDA)&nbsp;we filed for taliglucerase alfa, 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 new drug application (NDA)
and the marketing authorization applications (MAAs) we filed with the FDA, the EMEA and other
health regulatory authorities for taliglucerase alfa for the treatment of Gaucher disease; refusals
</DIV>




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



<DIV align="left" style="font-size: 10pt; margin-top: 6pt">by such regulatory authorities to approve the marketing and sale of a drug product even after
acceptance of an application we file or submit for any such drug product; the identification of
lead compounds; the successful preclinical development of our other product candidates; the
completion of our clinical trials for our other product candidates; 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; 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 from clinical trials of drug
products, the FDA, EMEA or any other foreign regulatory authority may not accept or approve an NDA
filed or MAA submitted 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
operations 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: 12pt"><B>Investor Contact</B>
</DIV>


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

</DIV>

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


<DIV align="left" style="font-size: 10pt; margin-top: 6pt">Jennifer Conrad or Douglas MacDougall<BR>
MacDougall Biomedical Communications<BR>
781-235-3060<BR>
jconrad@macbiocom.com

</DIV>


<P align="center" style="font-size: 10pt"><!-- Folio -->6<!-- /Folio -->
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