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Alan Franciscus
Editor-in-Chief
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In This Issue:
• Portal
pressure after sclerotherapy in acute variceal bleeding
• Victim
fund in danger, Hepatitis C Society says
• Cubist
Pharmaceuticals And XTL Biopharmaceuticals Complete License
Agreement for Worldwide Rights to Hepatitis B Product
• UK biotech
XTL gains on drug deal with Cubist
• Complementary
and alternative medicine use in the United States
May 31st, 2004
Portal
pressure after sclerotherapy in acute variceal bleeding
Source: www.gastrohep.com
Endoscopic injection sclerotherapy for
acute variceal bleeding causes a sustained increase in the
hepatic venous pressure gradient, find physicians in the June
issue of Hepatology.
During variceal bleeding several factors
may increase portal pressure. An increase in portal pressure
may precipitate further bleeding.
In this study, physicians from Greece assessed
the effects of endoscopic injection sclerotherapy and endoscopic
band ligation on the hepatic venous pressure gradient during
acute bleeding.
The team evaluated 50 cirrhotic patients
with bleeding esophageal varices. Patients were treated with
either endoscopic injection sclerotherapy or endoscopic band
ligation.
The team performed repeated hepatic venous
pressure gradient measurements before and immediately after
endoscopic treatment, then every 24 hours for a 5-day period.
Endotherapy was continued until the varices
were too small for further treatment.
Both groups were comparable with regard
to age, gender, Child-Turcotte-Pugh grade, and hepatic venous
pressure gradient.
Bleeding stopped in all patients after
endotherapy.
The physicians found a significant increase in mean portal
pressure immediately after treatment in both groups.
However, the hepatic venous pressure gradient
returned to baseline values within 48 hours after treatment
in the endoscopic band ligation group.
In the endoscopic injection sclerotherapy
group the hepatic venous pressure gradient remained high during
the 120-hour study period.
The team found that the rebleeding rate
in the 42-day follow-up period was lower in the endoscopic
band ligation group compared with the endoscopic injection
sclerotherapy group.
They determined that patients with an initial
hepatic venous pressure gradient greater than 16 mm Hg had
a greater likelihood of rebleeding, death, and overall failure.
Dr Alec Avgerinos and colleagues concluded,
"During acute variceal bleeding endoscopic injection
sclerotherapy, but not endoscopic band ligation, causes a
sustained increase in hepatic venous pressure gradient, which
is followed by a higher rebleeding rate".
Hepatology 2004; 39: 1623-30
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June 3rd, 2004
Victim
fund in danger, Hepatitis C Society says
SIMON TUCK
Globe And Mail
Thursday, June 3, 2004 - Page A9
OTTAWA -- Legal fees and other professional
costs associated with the government's fund for compensating
some hepatitis C virus (HCV) victims have eaten up $91-million,
or almost one-quarter of all of the money spent to date, the
Hepatitis C Society of Canada says.
The society said yesterday that the federal
government and those administering the fund should conduct
a broad review of what's being spent, particularly on lawyers
and financial advisers.
According to the fund's 2002-03 financial
statements, more than $301-million has been paid so far to
7,565 victims and their families who have successfully applied
for compensation.
The $91-million in fees represents 23.2
per cent of the money spent so far on the victims of one of
Canada's worst-ever public health fiascos.
The fund was set up in 1998 to compensate
people who contracted hepatitis C between 1986 and 1990 from
tainted blood.
Scott Hemming, the society's chairman,
said the administrative costs are too high and are threatening
the fund's future. Contracts for the services required to
maintain the fund should be put to tender, he said.
"I find it amazing that the court
would approve those costs," Mr. Hemming said. "If
this continues, there won't be any money left in the fund."
Part of the blame for the high costs can
be attributed to the complexity of the application process,
which is so cumbersome that some people have given up trying,
Mr. Hemming said. More of the money should go to victims,
he said.
"What's happening has simply been
a travesty for the victims."
The fund started with $1.1-billion and
has about $794-million left. Costs are approved by a court
that acts on the guidance of a joint committee established
to administer the fund.
Harvey Strosberg, a Windsor, Ont., lawyer
who represented some of the victims in a class-action lawsuit
and sits on the joint committee, said the greater part of
the administrative fees -- about $53-million -- was paid out
in connection with the legal wrangling that accompanied the
establishment of the fund. The rest of the cost, about $37-million,
represents an annual cost of about 12.5 per cent, which he
described as "not unrealistic."
Mr. Strosberg said a fund of that size
requires a team of professionals, including actuaries, accountants,
investment counsellors and lawyers, to sustain it. "You
need an infrastructure, and you need to pay for that."
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Cubist
Pharmaceuticals And XTL Biopharmaceuticals Complete License
Agreement for Worldwide Rights to Hepatitis B Product
BIOWIRE2K
LEXINGTON, Mass. & REHOVOT, Israel--(BUSINESS
WIRE)--June 3, 2004--
Currently in Phase 2b Trials, Product
Would Address $100 Million Market for Prevention of Hepatitis
B Infection in Liver Transplant Patients
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 commercialization of XTLbio's investigational
monoclonal antibody product currently known as HepeX-B(TM).
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 commercialization
of the product worldwide. Under the terms of the agreement,
Cubist will pay XTLbio collaboration support and an up-front
payment totaling $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 CEO. "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 & CEO
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 centers 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."
About HBV
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.
About HepeX-B
HepeX-B is a combination of two fully human monoclonal antibodies,
selected using XTLbio's pre-clinical Trimera(TM) 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 Union.
About Cubist
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-B(TM), 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.
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.
XTLbio currently has an ongoing Phase 2a clinical program
for hepatitis C associated with liver transplantation (HepeX-C(TM))
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 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.
Contacts
Cubist Pharmaceuticals Contacts:
Jennifer LaVin, 781-860-8362
or
Euro RSCG Life NRP
Emily Poe, 212-845-4266
or
XTLbio Contacts:
Dr. Martin Becker, +972-8-930-4440
or
Financial Dynamics
David Yates/Julia Phillips
+44 (0) 20 7831 3113
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UK
biotech XTL gains on drug deal with Cubist
Reuters.com
LONDON, June 3 (Reuters) - XTL Biopharmaceuticals
(XTL.L: Quote, Profile, Research) , an Israeli biotechnology
company listed in London, said on Thursday it had completed
a drug licensing deal with Cubist Pharmaceuticals (CBST.O:
Quote, Profile, Research), boosting XTL shares eight percent.
Cubist has licensed rights to XTL's experimental
antibody drug HepeX-B, which is currently in a Phase IIb studies
for the prevention of hepatitis B re-infection in liver transplant
patients.
Under the terms of the agreement, Cubist
will pay XTL $3 million upfront and may pay an additional
$3 million, depending on the drug's progress. XTL will also
receive a tiered royalty on any sales generated of between
10 to 17 percent of net sales.
Samir Devani, an analyst with Code Securities,
said the deal terms were in line with industry averages, considering
the product still required an estimated $30 million in development
expenditure. This will now be funded by Cubist.
Shares in XTL were 8.3 percent higher at
22-3/4 pence by 0740 GMT.
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June 4th, 2004
Complementary
and alternative medicine use in the United States
www.gastrohep.com
A nationwide government survey has found
that 36% of adults in the United States use some form of complementary
and alternative medicine.
Complementary and alternative medicine
is defined as a group of diverse medical and health care systems,
practices, and products that are not presently considered
to be part of conventional medicine.
The survey was conducted as part of the Centers for Disease
Control and Prevention's (CDC) 2002 National Health Interview
Survey (NHIS). It was administered to over 31,000 adults.
The survey included questions on 27 types
of complementary and alternative therapies commonly used in
the United States.
12% of adults sought care from a licensed
practitioner.
Overall, the survey revealed that complementary
and alternative medicine use was greater in women, people
with higher education, those who had been hospitalized within
the past year, and former smokers.
The survey also provided information on
complementary and alternative medicine use by minorities.
It determined that African American adults were more likely
than white or Asian adults to use complementary and alternative
medicine when megavitamin therapy and prayer were included
in the definition.
When prayer specifically for health reasons
is included in the definition of complementary and alternative
medicine, the number of adults using some form of complementary
and alternative medicine in the past year rose to 62%.
Complementary and alternative medicine
approaches were most often used to treat back pain or problems,
colds, neck pain or problems, joint pain or stiffness, and
anxiety or depression.
Only about 12% of adults sought care from
a licensed complementary and alternative medicine practitioner.
"These new findings confirm the extent
to which Americans have turned to complementary and alternative
medicine approaches with the hope that they would help treat
and prevent disease and enhance quality of life," said
Dr Stephen Straus, Director, National Center for Complementary
and Alternative Medicine (NCCAM).
"The data not only assists us in understanding
who is using complementary and alternative medicine, what
is being used, and why, but also in studying relationships
between complementary and alternative medicine use and other
health characteristics, such chronic health conditions, insurance
coverage, and health behaviors."
NIH
04 June 2004
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