European Commission Approves Labelling Update for BARACLUDE® (entecavir) in Liver Transplant Patients with Chronic Hepatitis B

 European Commission Approves Labelling Update for BARACLUDE® (entecavir) in
              Liver Transplant Patients with Chronic Hepatitis B

  PR Newswire

  PARIS, Nov. 5, 2012

-A Study provides further efficacy and safety data for BARACLUDE® in this
special patient population-

PARIS, Nov. 5,2012 /PRNewswire/ --Bristol-Myers Squibb (NYSE: BMY) announced
today that the European Commission (EC) has approved a BARACLUDE® (entecavir)
Summary of Product Characteristics (SmPC) update based on new efficacy and
safety data in patients with chronic hepatitis B (CHB) receiving a liver
transplant.

"This labelling update is important news for patients receiving a liver
transplant due to chronic hepatitis B complications,"said Professor François
Durand, MD, PhD, Hospital Beaujon, France, "It provides physicians with
guidance on BARACLUDE's use in this difficult to treat population and adds
additional information on its efficacy and safety profile".

The labelling update was based on data from study ETV-109, investigating the
efficacy and safety of BARACLUDE® 1 mg used once daily alone or with
concomitant hepatitis B immunoglobulin (HBIg) in patients who received an
orthotopic liver transplant (OLT) due to complications associated with
hepatitis B (HBV) infection. At Week 72 post-transplant, none of 55 observed
cases had virologic recurrence of HBV [defined as HBV DNA >/= 50 IU/ml
(approximately 300 copies/ml)] and there was no reported virologic recurrence
at time of censoring for the remaining 6 patients.

The frequency and nature of adverse events in this study were consistent with
those expected in patients who have received a liver transplant and the known
safety profile of entecavir.(1)

In Europe, CHB affects approximately 14 million people.(2) About 15-25% of
people with chronic hepatitis B will develop serious liver problems, including
cirrhosis, liver failure and liver cancer.(3) A liver transplant remains the
only hope for patients with end-stage liver disease due to hepatitis B
infection.(4) In Europe, 5-10% of all liver transplant cases are due to
chronic or fulminant liver disease associated with chronic hepatitis B.(5)
Despite advances in treatment, in the absence of preventative antiviral
therapies, post-liver transplant patients are still at risk of HBV
recurrence, therefore results of a liver transplant can sometimes be hampered.
(6) Hepatitis B virus recurrence after liver transplant due to CHB may lead to
graft failure, re-transplantation or death. (6)

About study AI463109 The safety and efficacy of entecavir 1 mg once daily were
assessed in a single-arm study including 65 patients who received a liver
transplant for complications of chronic HBV infection and had HBV DNA

The study population was 82% male, 39% Caucasian, and 37% Asian, with a mean
age of 49 years. HBeAg-negative disease at the time of transplant was reported
in 89% of patients. Of the 61 patients who where evaluable for efficacy
(received entecavir for at least 1 month), 60 also received hepatitis B immune
globulin (HBIg) as part of the post-transplant prophylaxis regimen. Of these
60 patients, 49 received more than 6 months of HBIg therapy.

At Week 72 post-transplant, none of the 55 observed cases had virologic HBV
recurrence of HBV [defined as HBV DNA >/= 50 IU/ml (approximately 300
copies/ml)] and there was no reported virologic recurrence at time of
censoring for the remaining 6 patients.

All 61 patients had HBsAg loss post transplantation, and 2 of these later
became HBsAg positive despite maintaining undetectable HBV DNA (

The frequency and nature of adverse events in this study were consistent with
those expected in patients who have received a liver transplant and the known
safety profile of entecavir.(1)

About BARACLUDE®BARACLUDE®, a nucleoside analogue discovered at Bristol-Myers
Squibb, was approved by the European Commission in June 2006.

BARACLUDE® is indicated for the treatment of chronic hepatitis B virus (HBV)
infection in adults with:

  *Compensated liver disease and evidence of active viral replication
    persistently elevated serum alanine aminotransferases (ALT) levels and
    histological evidence of active inflammation and/or fibrosis;
  *Decompensated liver disease*.

In clinical studies the most common adverse reactions of any severity with at
least a possible relation to entecavir were in patients with compensated liver
disease: headache, fatigue, dizziness, nausea and reports of exacerbations of
hepatitis during and after discontinuation of therapy; in patients with
decompensated liver disease: peripheral edema, ascites, pyrexia, hepatic
encephalopathy , and upper respiratory infection*.

* For full prescribing information for BARACLUDE®, please consult the Summary
of Product Characteristics.

About Chronic Hepatitis B (CHB) and Liver TransplantsChronic hepatitis B is a
serious global health issue. Worldwide, more than two billion people have been
in contact with the hepatitis B virus and approximately 350 million people are
chronically infected. Chronic hepatitis B can cause chronic liver disease and
puts people at high risk of death from cirrhosis of the liver and liver
cancer. In some cases, a diagnosis is made too late and the only option is a
liver transplant.(7)

A liver transplant is a surgical procedure that involves removing a person's
failed liver, and replacing it with a healthy liver from a deceased donor
(orthotopic transplant), or a graft from a living donor. Liver transplants are
typically performed on patients who have chronic liver disease, such as viral
hepatitis, acute liver failure, hepatic malignancy or a genetic disorder that
affects the liver.(8)

About Bristol-Myers Squibb Bristol-Myers Squibb is a global biopharmaceutical
company whose mission is to discover, develop and deliver innovative medicines
that help patients prevail over serious diseases.

BARACLUDE ® (entecavir) is a registered trademark of Bristol-Myers Squibb.

References

1.Baraclude Summary of Product Characteristics.
2.Hepatitis. World Health Organization Regional Office for Europe. Available
    at
    http://www.euro.who.int/en/what-we-do/health-topics/communicable-diseases/hepatitis
    . Accessed September 2012
3.Centers for Disease Control and Prevention (CDC) Website. "Hepatitis B
    General Information."
    http://www.cdc.gov/hepatitis/HBV/PDFs/HepBGeneralFactSheet.pdf . Accessed
    September 18, 2012.
4.Lok A. Liver transplantation for chronic hepatitis B virus infection,
    UpToDate, Wolters Kluwer Health. Available at
    http://www.uptodate.com/contents/liver-transplantation-for-chronic-hepatitis-b-virus-infection
    . Accessed September 2012
5.Samuel D. Liver transplantation for chronic hepatitis B. Gastroenterol
    Clin Biol. 2008 Jan; 32 (1 Pt 2):S25-33. English Abstract available at
    http://www.ncbi.nlm.nih.gov/pubmed/18662607 . Accessed September 2012
6.Carrion AF, et al; Management of Patients with Chronic Hepatitis B Before
    and After Liver Transplantation: An Update. Curr Hepatitis Rep (2012)
    11:102-110 DOI 10.1007/s 11901-012-0128-4
7.World Hepatitis Alliance. What is Viral Hepatitis?
    http://worldhepatitisalliance.org/AboutViralHepatitis/What_is_Viral_Hepatitis.aspx
    . Accessed September 2012
8.Killackey MT, Florman S, Yu AS, et al. Orthotopic Liver Transplantation.
    Physicians' Information and Education Resource 2001.
    http://pier.acponline.org/mcpp/pdf/physpro992.pdf Accessed September 2012

Contact: Joanna Ritter, +33(0)1 5883 6509, joanna.ritter@bms.com
 
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