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<SEC-DOCUMENT>0000950123-10-011323.txt : 20100211
<SEC-HEADER>0000950123-10-011323.hdr.sgml : 20100211
<ACCEPTANCE-DATETIME>20100211105120
ACCESSION NUMBER:		0000950123-10-011323
CONFORMED SUBMISSION TYPE:	8-K
PUBLIC DOCUMENT COUNT:		2
CONFORMED PERIOD OF REPORT:	20100211
ITEM INFORMATION:		Other Events
ITEM INFORMATION:		Financial Statements and Exhibits
FILED AS OF DATE:		20100211
DATE AS OF CHANGE:		20100211

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:		10590074

	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>y03017e8vk.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: 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"><B>Date of Report (Date of Earliest Event Reported): February&nbsp;11, 2010 (February&nbsp;11, 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"><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>
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<TR valign="bottom">
    <TD align="center" valign="top"><B>Florida<BR>
(State or other jurisdiction <BR>
of incorporation)</B>
</TD>
    <TD>&nbsp;</TD>
    <TD align="center" valign="top"><B>000-33357<BR>
(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>
<!-- End Table Head -->
<!-- Begin Table Body -->
<TR valign="bottom">
    <TD align="center" valign="top"><B>2 Snunit Street <BR>
Science Park, POB 455<BR>
Carmiel, Israel<BR>
(Address of principal executive offices)</B>
</TD>
    <TD>&nbsp;</TD>
    <TD align="center" valign="bottom"><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: 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> &nbsp;&nbsp;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> &nbsp;&nbsp;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> &nbsp;&nbsp;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> &nbsp;&nbsp;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 February&nbsp;11, 2010, Protalix BioTherapeutics, Inc. (the &#147;Company&#148;) issued a press release
announcing that additional data from the Company&#146;s pivotal Phase III clinical trial of
taliglucerase alfa in patients with Gaucher disease was presented at the Annual Meeting of the
Lysosomal Disease Network: WORLD Symposium 2010 in Miami, Florida,
during an oral session titled
&#147;Novel Enzyme Replacement Therapy for Gaucher Disease: Phase III Pivotal Clinical Trial with Plant
Cell Expressed Recombinant Glucocerebrosidase (prGCD) &#151; taliglucerase alfa.&#148; The oral presentation
was made by Hanna Rosenbaum M.D., Director of Hematology Day Care Unit, RAMBAM Medical Center,
Haifa, Israel, and study investigator. A copy of the press release is attached hereto as Exhibit
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="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>(d)</B></TD>
    <TD>&nbsp;</TD>
    <TD><B>Exhibits</B></TD>
</TR>
</TABLE>
</DIV>

<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">99.1</TD>
    <TD>&nbsp;</TD>
    <TD>Press release dated February&nbsp;11, 2010.</TD>
</TR>
</TABLE>
</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>

<DIV align="left" style="font-size: 10pt; margin-top: 6pt">&nbsp;
</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 11, 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>&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
Chief Executive Officer&nbsp;</TD>
    <TD>&nbsp;</TD>
</TR>
<TR>
    <TD colspan="5">&nbsp;</TD>
</TR>
</TABLE>


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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>Protalix Presents Additional Phase III Data for taliglucerase alfa at the WORLD Symposium</B>
</DIV>

<DIV align="left" style="font-size: 10pt; margin-top: 6pt">CARMIEL, Israel, February&nbsp;11, 2010 (Business Wire) &#151; Protalix BioTherapeutics, Inc.
(NYSE-Amex:PLX), announced today that additional data from the Company&#146;s pivotal Phase III clinical
trial of taliglucerase alfa in patients with Gaucher disease was presented at the Annual Meeting of
the Lysosomal Disease Network: WORLD Symposium 2010 in Miami, Florida, during an oral session
titled, &#147;Novel Enzyme Replacement Therapy for Gaucher Disease: Phase III Pivotal Clinical Trial
with Plant Cell Expressed Recombinant Glucocerebrosidase (prGCD) &#151; taliglucerase alfa.&#148; The oral
presentation was made by Hanna Rosenbaum M.D., Director of Hematology Day Care Unit, RAMBAM Medical
Center, Haifa, Israel, and study investigator.
</DIV>

<DIV align="left" style="font-size: 10pt; margin-top: 6pt">&#147;I believe the data from the Phase III trial demonstrates that taliglucerase alfa is well tolerated
and clinically effective in treating Gaucher disease,&#148; said Dr.&nbsp;Hanna Rosenbaum.
</DIV>

<DIV align="left" style="font-size: 10pt; margin-top: 6pt">The pivotal Phase III clinical trial was a multi-center, world-wide, randomized, double-blind,
parallel group, dose-ranging study to assess the safety and efficacy of taliglucerase alfa in 31
treatment-naive patients suffering from Gaucher disease. In the trial, patients were selected
randomly for one of two dosing arms (60 U/kg or 30 U/kg) and received intravenous infusions of
taliglucerase alfa once every two weeks for a nine month period. The primary endpoint of the study
was a 20% mean reduction from baseline in spleen volume after nine months, as measured by MRI.
Major secondary endpoints were an increase in hemoglobin, decrease in liver volume and increase in
platelet count. The trial enrolled patients at 11 centers throughout Europe, Israel, North
America, South America and South Africa.
</DIV>

<DIV align="left" style="font-size: 10pt; margin-top: 6pt">taliglucerase alfa significantly reduced mean spleen volume after nine months compared with
baseline in both treatment groups. The 60 U/kg group demonstrated a statistically significant mean
reduction in spleen volume of 38.0% (p&#060;0.0001) and the 30 U/kg group demonstrated a significant
mean reduction in spleen volume of 26.9% (p&#060;0.0001). In addition, the primary endpoint was
achieved in both treatment groups after only 6&nbsp;months of therapy.
</DIV>

<DIV align="left" style="font-size: 10pt; margin-top: 6pt">Statistically significant improvements were also observed for the secondary endpoints after nine
months when compared to baseline for the 60 U/kg dose. Patients demonstrated a mean increase in
hemoglobin of 2.2 g/dL or 22.2% (p&#060;0.0001), a mean decrease in liver volume of 11.1%
(p&#060;0.0001) and a mean elevation in platelet count of 41,494 ml or 72.1% (p=0.0031). For patients
in the 30 U/kg dose, statistically significant improvements after nine months compared with
baselines were observed for hemoglobin level (increased 1.6 g/dL or 14.8%; p=0.0010) and liver size
(decreased 10.48%; p=0.0041); a nominal elevation in platelet count was also seen (11,427 ml or
13.7%; p=0.0460).
</DIV>




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<DIV align="left" style="font-size: 10pt; margin-top: 6pt">Thirty patients in the trial had Chitotriosidase measurements, a biomarker for clinical symptoms of
Gaucher disease. In these patients, Chitotriosidase decreased from baseline in both the 30U/kg and
60U/kg groups by 47.3% and 58.4% respectively.
</DIV>

<DIV align="left" style="font-size: 10pt; margin-top: 6pt">The safety analysis for both treatment groups showed that taliglucerase alfa was well tolerated and
no serious or severe adverse events were reported. Two patients in the trial developed antibodies
to taliglucerase alfa and no patients developed neutralizing antibodies. In addition, two patients
experienced hypersensitivity reactions to taliglucerase alfa. No anti-taliglucerase antibodies
were detected in these patients and both reactions were treated in the physicians&#146; clinic and
reversed.
</DIV>

<DIV align="left" style="font-size: 10pt; margin-top: 6pt">Most adverse events were considered unrelated to taliglucerase alfa. The most frequent mild to
moderate adverse event was headache. Other mild to moderate adverse events included dizziness,
muscle spasm, chest discomfort, nausea, skin irritation and arthalgia.
</DIV>

<DIV align="left" style="font-size: 10pt; margin-top: 6pt">&#147;The Phase III results reported today not only support the use taliglucerase alfa for the treatment
of Gaucher disease, but also support the Company&#146;s plant cell based platform technology,&#148; said Dr.
David Aviezer, President and CEO of Protalix. &#147;Patients who successfully completed this pivotal
study have continued to receive taliglucerase alfa as part of our ongoing extension trial, some for
over two and a half years.&#148;
</DIV>

<DIV align="left" style="font-size: 10pt; margin-top: 6pt">The Company is currently conducting a world-wide switch over study investigating the efficacy and
safety of switching to taliglucerase alfa from the currently approved enzyme replacement therapy.
In addition, taliglucerase alfa is being provided to patients in the United States under an
Expanded Access protocol and 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 one in 20,000 live births. People with Gaucher disease do not have enough of an
enzyme, <FONT face="Symbol">&#98;</FONT>-glucosidase (glucocerebrosidase)&nbsp;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
</DIV>


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<DIV align="left" style="font-size: 10pt; margin-top: 6pt">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 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&nbsp;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 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 preclinical development of our product candidates; the completion of 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; 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; 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. 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
</DIV>


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<DIV align="left" style="font-size: 10pt; margin-top: 6pt">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: 12pt"><B>Investor Contact:</B>
</DIV>


<DIV align="left" style="font-size: 10pt; margin-top: 6pt">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: 12pt"><B>Media Contact:</B>
</DIV>


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

</DIV>


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