XTL Biopharmaceuticals Ltd
03 June 2004
Cubist Pharmaceuticals and XTL Biopharmaceuticals Complete License Agreement for
Worldwide Rights to Hepatitis B Product
Currently in Phase 2b Trials, Product Would Address $100 Million Market for
Prevention of Hepatitis B Infection in Liver Transplant Patients
Lexington, MA and Rehovot, Israel, 3 June 2004 - Cubist Pharmaceuticals, Inc.
(Nasdaq: CBST) and XTL Biopharmaceuticals Ltd. (LSE: XTL) (XTLbio) today
announced the completion of a license agreement for the worldwide development
and commercialisation of XTLbio's investigational monoclonal antibody product
currently known as HepeX-BTM. HepeX-B is in a Phase 2b study for the prevention
of re-infection by the Hepatitis B virus (HBV) in liver transplant patients, a
market currently estimated to be about $100 million worldwide.
The companies will continue the ongoing international Phase 2b study and, if
successful, will continue late-stage clinical development of the product
candidate. Cubist will fund the development costs of HepeX-B and will be solely
responsible for registration and commercialisation of the product worldwide.
Under the terms of the agreement, Cubist will pay XTLbio collaboration support
and an up-front payment totalling $3.0 million over the next two years, and may
pay an additional $3.0 million upon the achievement of certain regulatory
milestones. Cubist has also committed to pay XTLbio a tiered royalty on any
sales generated from HepeX-B that ranges from 10-17% of net sales.
'This commercial agreement represents a significant achievement for XTLbio,'
said Dr. Martin Becker, XTLbio's President and Chief Executive Officer.
'Cubist's focus on antiinfectives and their proven ability to get a product
registered and launched in the U.S. through a seasoned, hospital-focused sales
team made the company a very attractive partner to us. We feel this agreement
not only validates our proprietary technology, but also would provide us with a
revenue stream should HepeX-B ultimately be approved. This agreement is also
consistent with our strategy to leverage our technology through the
establishment of licensing or co-development agreements on candidates that have
achieved clinical proof of principle, and enables us to allocate significant
resources to our ongoing hepatitis C development programs.'
Michael W. Bonney, President and Chief Executive Officer of Cubist commented:
'HepeX-B represents an exciting development opportunity for Cubist. Due to its
potential safety and ease of use advantages over existing therapies, we believe
that HepeX-B has the potential to become the new standard of care for the
prevention of HBV re-infection in liver transplant patients. The product also
fits very well with our experience in the antiinfective area and adds an
important, late-stage development candidate to our pipeline. HepeX-B represents
a unique commercial opportunity, as the market is highly concentrated, with a
limited number of transplant centres around the world performing the majority of
procedures. In the U.S., these institutions overlap fully with Cubist's current
sales effort on Cubicin(R) (daptomycin for injection), our flagship antibiotic
product. We look forward to working with XTLbio to bring this innovative and
valuable product to market.'
XTL Biopharmaceuticals Ltd.:
Dr. Martin Becker
President & CEO
Tel: +972 8 930 4440
David Yates / Julia Phillips
Tel: +44 (0) 20 7831 3113
Cubist Pharmaceuticals, Inc.:
Executive Director, Corporate Communications
Tel: +1 (781) 860-8362
Euro RSCG Life NRP
Emily Poe - Financial Media
Tel: +1 (212) 845-4266
Notes to Editors
Hepatitis B is most commonly caused by the Hepatitis B virus, which, according
to Datamonitor, has infected over 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.
HBV-diseased livers are currently estimated to represent 5% of all liver
transplants in the U.S., or between 200 and 300 liver transplants per year. To
prevent re-infection of the new liver with HBV, patients are currently treated
with HBV immunoglobulin (HBIg) combined with an antiviral compound, such as
lamivudine. The global market for HBIg is estimated to be about $100 million,
despite its limitations, which include large injection volumes, flu-like adverse
events and the risk of blood-borne infections.
HepeX-B is a combination of two fully human monoclonal antibodies, selected
using XTLbio's pre-clinical TrimeraTM model, that target HBV surface antigens.
It is currently in an international Phase 2b study for the prevention of
infection by HBV in liver transplant patients. In clinical studies, HepeX-B
maintained serum levels similar to or higher than the current first-line
treatment, HBIg, using 1,000 times less drug. Due to its smaller injection
volume, HepeX-B may be formulated as a subcutaneous injectable product. HepeX-B
has already been granted Orphan Drug Status in both the U.S. and the European
XTL Biopharmaceuticals Ltd. (XTLbio) is a biopharmaceutical company developing
drugs against hepatitis. XTLbio's HepeXTM 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 TrimeraTM
technology, which enables the development of fully human monoclonal antibodies
and models of human disease for pre-clinical drug validation. XTLbio currently
has an ongoing Phase 2a clinical program for hepatitis C associated with liver
transplantation (HepeX-CTM) and preclinical programs for chronic hepatitis C.
Established in 1993, XTLbio became a public company in 2000, with shares traded
on the London Stock Exchange under the symbol XTL.
Cubist Pharmaceuticals, Inc. is a biopharmaceutical company focused on the
research, development and commercialization of antiinfective products that meet
unmet medical needs. In the U.S., Cubist markets Cubicin(R) (daptomycin for
injection), the first antibiotic in a new class of antiinfectives called
lipopeptides, for the indication of complicated skin and skin structure
infections caused by certain Gram-positive bacteria. CUBICIN is currently the
only once-daily bactericidal antibiotic approved in the U.S. with activity
against both methicillin-susceptible and methicillin-resistant Staphylococcus
aureus (MSSA and MRSA). Cubist's pipeline includes HepeX-BTM, a monoclonal
antibody biologic currently in a Phase 2b study for the prevention of infection
by the Hepatitis B virus (HBV) in liver transplant patients, and research
efforts focused on novel members of the lipopeptide class of molecules. Cubist
is headquartered in Lexington, MA.
Cubist Safe Harbor Statement
Statements contained herein that are not historical fact may be forward-looking
statements within the meaning of Section 27A of the Securities Act of 1933 and
Section 21E of the Securities Exchange Act of 1934, and such statements are
subject to a variety of risks and uncertainties. There are a number of important
factors that could cause actual results to differ materially from those
projected or suggested in any forward-looking statements made by Cubist. These
factors include, but are not limited to: (i) the level of acceptance of CUBICIN
by physicians, patients, third-party payors, and the medical community
generally; (ii) Cubist's ability to continue to develop, secure additional
regulatory approvals for, and successfully market, CUBICIN; (iii) Cubist's
ability to manufacture CUBICIN on a commercial scale; (iv) commercialization of
products that are competitive with CUBICIN; (v) Cubist's ability to discover or
in-license drug candidates; (vi) Cubist's ability to successfully develop drug
candidates in its pipeline, including HepeX-B; (vii) Cubist's ability to
successfully commercialize any product or technology developed by Cubist; (viii)
Cubist's ability to establish and maintain successful manufacturing, sales and
marketing, distribution, and development collaborations; (ix) legislative or
regulatory changes adversely affecting Cubist or the biopharmaceutical industry;
(x) Cubist's ability to protect its intellectual property and proprietary
technologies; and (xi) Cubist's ability to finance its operations. Additional
factors that could cause actual results to differ materially from those
projected or suggested in any forward-looking statements are contained in
Cubist's recent filings with the Securities and Exchange Commission, including
those factors discussed under the caption 'Risk Factors' in such filings.
Cubist and Cubicin are registered trademarks of Cubist Pharmaceuticals, Inc.;
HepeX-B and Trimera are trademarks of XTL Biopharmaceuticals Ltd.
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