XTLbio ACQUIRES RIGHTS FROM STANFORD UNIVERSITY
13 October 2003 - 5:00PM
UK Regulatory
XTLbio ACQUIRES BROAD RIGHTS FROM STANFORD UNIVERSITY TO ANTIBODIES DIRECTED
AGAINST HEPATITIS C VIRUS (HCV)
Exclusive license enhances XTLbio's HepeX-C program in clinical development
Rehovot, Israel, 13 October 2003, XTL Biopharmaceuticals Ltd. (XTLbio)
announced today that it acquired an exclusive license to develop and
commercialize a series of neutralizing human monoclonal antibodies to the
hepatitis C virus developed in the laboratory of Dr. Steven Foung at Stanford
University. The agreement, which commits XTLbio to certain future milestones
and royalty payments, grants XTLbio exclusive worldwide development and
marketing rights for prevention and treatment of HCV except for certain limited
rights in China. Financial terms were not disclosed.
XTLbio has conducted extensive pre-clinical evaluation on the licensed
antibodies using the Company's proprietary HCV in vitro and in vivo validation
systems to assess anti-viral activity. Based on these studies, the Company has
identified a potent neutralizing antibody as a treatment candidate to be used
in the prevention of HCV re-infection in liver transplant patients. This
candidate could potentially enhance XTLbio's treatment candidate, HepeX-C, also
a human monoclonal antibody based product, currently in phase 2 clinical
studies in liver transplant patients. HepeX-C has shown anti-viral activity in
phase 1 safety studies in chronic HCV patients. The addition of a second
antibody could increase the potency of the product by minimizing viral escape
mutants and /or enhancing anti-viral activity. As part of the broad
arrangement, Dr. Foung will be assisting XTLbio with the clinical development
of this product.
Dr. Neil Graham, Chief Medical Officer of XTLbio, said:
"The exclusive license from Stanford University is the result of a long
standing collaboration with the laboratory of Dr. Steven Foung in the area of
HCV. Our initial clinical work with HepeX- C is very encouraging and, to
enhance our ability to treat HCV, we have always felt that the optimal marketed
product may contain a combination of two antibodies. Dr. Foung's work with
human monoclonal antibodies at Stanford provides us with a number of choices to
develop complementary antibody therapies that can benefit patients and provide
a strong competitive position in the marketplace."
Dr. Foung of Stanford University, commented:
"XTLbio's proprietary in vitro and in vivo HCV validation tools and their
experience in developing human monoclonal antibody based prophylactic therapies
for hepatitis B and C provide an ideal partner for our work at Stanford."
Contacts:
XTLbio
Dr. Martin Becker, President and CEO, Tel: +972-8-930-4440
Financial Dynamics
David Yates, Sarah MacLeod, Tel: +44 (0) 20 7831 3113
About XTLbio
XTL Biopharmaceuticals Ltd. (XTLbio) is a biopharmaceutical company developing
drugs against hepatitis. XTLbio's HepeX(tm) product line - now in clinical trials
- has the potential to introduce revolutionary therapies for viral hepatitis,
including prevention of re-infection in transplanted livers, the Company's
primary focus, and a longer-term cocktail approach in treating chronic illness.
XTLbio believes its primary competitive advantage lies in its patented Trimera(tm)
technology, which enables the development of fully human monoclonal antibodies
and models of human disease for pre-clinical drug validation. Established in
1993, XTLbio became a public company in 2000 with shares traded on the London
Stock Exchange under the symbol XTL.
About hepatitis C
Hepatitis C is a major public health concern. The World Health Organization
estimates that 170 million people worldwide are chronic carriers of the
hepatitis C virus (HCV) and that 3 to 4 million people are newly infected each
year. It is expected that 25 to 35% of these chronic patients will develop
progressive liver disease including cirrhosis and liver cancer. Hepatitis C is
the single leading cause of liver transplantation. The US Centres for Disease
Control and Prevention estimate that approximately 4 million people in the
United States (almost 2% of the population) have been infected with HCV, of
whom, approximately 3 million are chronically ill. Hepatitis C is the cause of
an estimated 8,000 to 10,000 deaths annually in the US.
About HCV-related liver transplant prophylaxis
Approximately 5% of chronic HCV patients will develop end-stage liver disease,
and ultimately may require liver transplantation. Today, there is a major
problem associated with HCV-related liver transplantation. Although the
infected liver - the major source of viral replication - has been removed,
free-floating virus in the patient's serum re-infects the healthy transplanted
liver in a matter of weeks. Disease progression in re-infected patients is
several times faster and, in many cases, a re-transplant becomes necessary. At
present, there is no available solution to this problem.
About the treatment of chronic hepatitis C
The existing first-line chronic HCV therapy is often associated with a 50-60%
success rate but it is limited by severe side effects, including anaemia,
fatigue, hair loss and depression. Due to the relatively limited efficacy and
toxicity of this treatment, chronic HCV is still considered to be an unmet
medical need, with estimated worldwide annual sales for all products treating
chronic hepatitis C reaching US$4 billion in 2004.
HepeX(tm), Trimera(tm), XTL(tm) and XTLbio(tm) are trademarks of XTL Biopharmaceuticals
Ltd.
END