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XTL Biopharm Ltd (XTL)

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Thursday 22 December, 2005

XTL Biopharm Ltd

CUBIST REPORTS RESULTS FROM PH2 STUDY HEPEX-B


CUBIST PHARMACEUTICALS REPORTS RESULTS FROM PHASE 2 STUDY HEPEX-B™ , WHICH WAS 
                             LICENSED FROM XTLBIO                              

Rehovot, Israel; Thursday, 22 December 2005 - XTL Biopharmaceuticals Ltd.
('XTLbio') (LSE: XTL; NASDAQ: XTLB; TASE: XTL) announces that Cubist
Pharmaceuticals, Inc. (Nasdaq: CBST) today provided data from a recently
concluded Phase 2 study of HepeX-B™ which was licensed to Cubist by XTLbio in
2004. In the Phase 2 study, HepeX-B was studied as maintenance therapy to
prevent reinfection with hepatitis B in patients with liver transplants. Data
from liver transplant patients who were treated with monthly infusions of 20 or
40 mg HepeX-B versus 5000 IU of HBIg showed that patients with either dose of
HepeX-B experienced no evidence of viral reinfection. The data also showed
fewer and less serious adverse experiences reported in both HepeX-B groups as
compared to the HBIg group, although the differences were not statistically
significant given the number of patients in the trial. Patients who were
treated with HepeX-B as well as HBIg also received concurrent HBV polymerase
inhibitor. Cubist will be reviewing Phase 2 results with the U.S. Food and Drug
Administration (FDA) early in 2006.

The data released today is derived from patients who have completed at least 6
months of therapy, which was the treatment duration at which the primary
endpoint was measured. Eleven patients received monthly 20 mg infusions of
HepeX-B; ten received monthly infusions of 40 mg HepeX-B; and nine received
monthly infusions of 5000 IU HBIg (current standard of care).

Cubist recently met with the FDA to discuss proposed changes to the method of
manufacture and formulation of HepeX-B. Specifically, Cubist plans to shift
from the use of hybridoma cells to Chinese Hamster Ovary (CHO) cells and to
switch to subcutaneous delivery prior to Phase 3. The objective of the
manufacturing change is to provide a stable platform for commercialization. The
switch to subcutaneous administration is meant to increase patient convenience
and compliance with chronic therapy. Cubist will meet again with the FDA in
early 2006 to discuss the implications of these changes on the next stage of
the clinical program.

Michael S. Weiss, Chairman of XTLbio, commented: 'We are very pleased with the
results of this Phase 2 trial and the fact that reinfection was not observed in
any of the patients treated with HepeX-B. We are proud of being responsible for
HepeX-B's discovery and early clinical development, and we are pleased with the
progress of this product towards commercialization in the hands of our partner
Cubist.'

Contact XTLbio:

Jonathan Burgin, Chief Financial Officer Tel: +972 8 930 4440

About Hepatitis B (HBV)

The hepatitis B virus, according to Datamonitor, has infected more than 2
billion people around the world. Although a vaccine against HBV was introduced
in 1982, globally, 350 million people are infected chronically with the disease
and approximately 1 million people die each year as a result of complications
from HBV infection. Current treatment regimens for chronic HBV often include
use of interferon alpha or an antiviral drug. Despite these treatment options,
chronic HBV can lead to severe liver damage and patients may require liver
transplantation. To prevent re-infection of the new liver with HBV, patients
are currently treated with hepatitis B immune globulin (HBIg) combined with an
antiviral compound, such as Lamivudine. The global market for HBIg is estimated
to be about $100 million annually.

About HepeX-B™

HepeX-B is a combination of two fully human monoclonal antibodies that target
HBV surface antigens. It is currently in evaluation for the prevention of
infection by HBV in liver transplant patients who have been maintained on HBIg.
HepeX-B already has been granted Orphan Drug Status in both the U.S. and the
European Union.

About XTLbio

XTL Biopharmaceuticals Ltd (XTLbio) is engaged in the research, development and
commercialization of therapeutics for the treatment of infectious diseases,
with a particular focus on hepatitis C. XTLbio's most advanced therapeutic in
Hepatitis C is XTL-6865 - a combination of two monoclonal antibodies against
the hepatitis C virus - presently in Phase 1 clinical trials in patients with
chronic hepatitis C. XTLbio's second Hepatitis C therapeutic is XTL-2125 - a
small molecule inhibitor of the hepatitis C Virus polymerase - expected to
enter Phase 1 clinical trials in 1H2006. XTLbio hepatitis C pipeline also
includes several families of pre-clinical hepatitis C small molecule
inhibitors. In 2004, XTLbio licensed HepeX-B - an antibody therapeutic against
hepatitis B - to Cubist Pharmaceuticals. XTLbio is publicly traded on the
London, NASDAQ, and Tel-Aviv Stock Exchanges (LSE: XTL; NASDAQ: XTLB; TASE:
XTL).

Cautionary Statement

Some of the statements included in this press release may be forward-looking
statements that involve a number of risks and uncertainties. For those
statements, we claim the protection of the safe harbor for forward-looking
statements contained in the U.S. Private Securities Litigation Reform Act of
1995. Among the factors that could cause our actual results to differ
materially, and therefore affect interest by investors in our ADR's, are the
following: the performance of HepeX-B in further clinical trials and its
ability to continue to prevent reinfection following liver transplantation; the
effect of the proposed changes in the manufacture of HepeX-B on its performance
in clinical trials; Cubist's ability to shift the manufacturing process for
HepeX-B without causing a delay in further clinical trials or ultimate
commercialization; and other risk factors identified from time to time in our
reports filed with the regulatory authorities in Israel, the United Kingdom and
the United States. Any forward-looking statements set forth in this press
release speak only as of the date of this press release. We do not intend to
update any of these forward-looking statements to reflect events or
circumstances that occur after the date hereof. This press release and prior
releases are available at www.xtlbio.com. The information in our website is not
incorporated by reference into this press release and is included as an
inactive textual reference only.


            

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