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28.06.2006 – 15:48

Bristol-Myers Squibb SA

European Commission Grants Approval for BARACLUDE(R) (entecavir) for Treatment of Chronic Hepatitis B

Paris (ots/PRNewswire)

Bristol-Myers Squibb announced today that the European Commission
has granted an approval for BARACLUDE(R) (entecavir) for the
treatment of chronic hepatitis B virus infection.
BARACLUDE(R) is an oral antiviral therapy specifically designed to
block the replication of hepatitis B virus (HBV). The medicine, which
was discovered and developed in Bristol-Myers Squibb research
centers, will be available in some countries in the European Union,
the Middle East and Africa beginning in the third quarter of 2006.
BARACLUDE(R) is indicated for use in adults with chronic hepatitis
B infection with compensated liver disease and evidence of active
viral replication, evidence of persistent elevations of the blood
levels of aminotransferases -- a marker for liver disease -- and
active liver disease as determined by biopsy.
"Chronic hepatitis B burdens millions of people in our region and
we believe BARACLUDE represents an innovative treatment option," said
Beatrice Cazala, President, Europe, Middle East and Africa for
Bristol-Myers Squibb. "We are focused on finding ways to extend and
enhance the lives of chronically-infected hepatitis B patients across
the entire region, including Western Europe, but also in other
countries with high prevalence such as Turkey, Russia and Greece."
Chronic hepatitis B infection is a potentially life-threatening
disease and is a serious global public health issue. More than 2
billion people worldwide have been infected by the virus and about
400 million people worldwide have chronic hepatitis B. In Europe, an
estimated 1 million people are infected with hepatitis B each year.
Hepatitis B is the 10th leading cause of death worldwide, causing
1.2 million deaths annually, and chronic hepatitis B infection is the
No. 1 cause of hepatocellular carcinoma, a form of liver cancer. The
hepatitis B virus is 100 times more infectious than HIV, the virus
that causes AIDS.
Measuring the amount of the hepatitis B virus in a person's
bloodstream -- also known as the viral load -- can be an important
way to predict a person's progression to serious liver disease and
liver cancer. Recent studies have shown that among hepatitis B
patients who have the highest viral load levels, there is a
significantly increased future risk of eventually developing
cirrhosis and liver cancer.
"Hepatitis B is a serious disease and it is important for patients
and physicians to have potent treatments with good tolerability,"
said Michael Manns, M.D., Professor, Chairman and Director,
Department of  Gastroenterology, Hepatology and Endocrinology,
Hannover Medical School,  Hannover, Germany. "With the approval of
BARACLUDE, we have an important new  medication to treat chronic
hepatitis B and lower patients' viral load to  undetectable levels."
The benefits seen in studies of BARACLUDE(R) relate to its ability
to slow the progression of chronic HBV infection. This was shown in
three clinical studies in patients naive to previous antiviral
treatment and in patients with resistance to lamivudine, another
anti-hepatitis B agent, infected by wild type virus (HBeAg positive),
pre-core mutant virus (HBeAg negative) and with compensated liver
After 48 weeks of treatment -- or two years for those with only a
virological response initially -- patients receiving BARACLUDE(R)
achieved greater or similar responses compared to patients receiving
lamivudine, with regard to improvement in the liver inflammation and
degree of liver fibrosis (scarring) caused by HBV, reduction in the
amount of virus in the blood, normalization of liver function and
seroconversion. Among nucleoside-naive patients without evidence of
lamivudine resistance at baseline, no resistance has emerged through
96 weeks of treatment with BARACLUDE(R). Furthermore, BARACLUDE(R)
was well-tolerated, similar to lamivudine.
BARACLUDE(R) has a favorable benefit-risk profile based on the
efficacy, resistance and safety data from clinical studies,
supporting its use in the treatment of chronic hepatitis B infection
in adults.
About BARACLUDE(R) (entecavir)
The global BARACLUDE(R) clinical trial program was the first to
compare two antivirals, BARACLUDE(R) and lamivudine (the most
commonly used oral antiviral therapy for the treatment of chronic
hepatitis B worldwide) and involved over 1,600 patients worldwide.
Bristol-Myers Squibb is continuing to evaluate and monitor consenting
chronic hepatitis B patients who participated in the BARACLUDE(R)
clinical trial program.
Bristol-Myers Squibb is a global pharmaceutical and related health
care products company whose mission is to extend and enhance human
BARACLUDE(R) is a trademark of Bristol-Myers Squibb.
Refer to the BARACLUDE(R) Summary of Product Characteristics for
further information or contact Brian Henry, Bristol-Myers Squibb
Corporate and Business Communications, at +33-1-58-83-69-38


Brian Henry of Bristol-Myers Squibb, Office: +33-1-58-83-69-38,
Mobile: +33-6-75-09-08-99,