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New Data on Four Bristol-Myers Squibb Compounds to Be Presented at AASLD 2009:
new HCV NS3 inhibitor
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PRINCETON, N.J.--(BUSINESS WIRE)--New data on four Bristol-Myers Squibb Company (NYSE:BMY) compounds will be presented at the 60th annual meeting of the American Association for the Study of Liver Diseases (AASLD) in Boston from October 30 to November 3.
Data will be presented on BARACLUDE (entecavir) in patients with chronic hepatitis B, and on two compounds in early clinical development for the treatment of hepatitis C -- BMS-650032, an NS3 inhibitor, and PEG-Interferon lambda, a novel type 3 interferon. The presentation of data on BMS-650032 will mark the first public disclosure of information about this investigational compound. Data will also be presented on the investigational compound brivanib, the first selective dual inhibitor of fibroblast growth factor (FGF) and vascular endothelial growth factor (VEGF) signaling, which is in Phase 3 development for the treatment of hepatocellular carcinoma.
"The data on Bristol-Myers Squibb compounds that will be presented at AASLD demonstrate the breadth of our research and development portfolio and support the company's goal of developing innovative medicines for patients with various diseases of the liver," said Elliott Sigal, M.D., Ph.D., executive vice president, chief scientific officer and president, Research and Development, Bristol-Myers Squibb. "Our established expertise in viral hepatitis and oncology uniquely position Bristol-Myers Squibb to be at the forefront of delivering innovation in the treatment of multiple types and stages of liver disease. We are proud to be releasing new data on our significant portfolio of assets."
BARACLUDE, BMS-650032 and brivanib were discovered by Bristol-Myers Squibb Research and Development. BMS-650032 is Bristol-Myers Squibb's second small molecule under development for the treatment of hepatitis C, joining BMS-790052, a first-in-class investigational NS5A inhibitor of the hepatitis C virus.
PEG-Interferon lambda was discovered by ZymoGenetics, Inc. Bristol-Myers Squibb and ZymoGenetics announced a global collaboration for PEG-Interferon lambda and its related development program earlier this year.
The times, titles and lead authors of the data presentations are as follows:
INDICATION and IMPORTANT SAFETY INFORMATION about BARACLUDE (entecavir) 0.5 mg and 1 mg Tablets
INDICATION: BARACLUDE is a prescription medicine used for chronic infection with hepatitis B virus (HBV) in adults where the virus is multiplying and damaging the liver.
IMPORTANT SAFETY INFORMATION:
Patients taking BARACLUDE® should tell their healthcare provider right away if they have any side effects or conditions, including the following:
- Worsening of HBV infection if patients stop taking BARACLUDE: Hepatitis B symptoms may get worse or become very serious if they stop taking BARACLUDE. Healthcare providers will need to follow their patients and do blood tests to check the liver if BARACLUDE is stopped. Patients should not stop taking BARACLUDE without talking to their healthcare provider.
- Patients who have or get HIV infection (the virus that can cause AIDS): For patients taking BARACLUDE to treat chronic hepatitis B and not taking medicines for HIV at the same time, some HIV treatments that they take in the future may be less likely to work. Patients are advised to get an HIV test before starting to take BARACLUDE and anytime after that when there is a chance they were exposed to HIV. BARACLUDE will not help HIV infection.
- Feeling very weak or tired, unusual muscle pain, trouble breathing, stomach pain with nausea and vomiting, feeling cold (especially in the arms and legs), feeling dizzy or lightheaded, or a fast or irregular heartbeat may be signs of a serious condition called lactic acidosis (buildup of an acid in the blood).
Lactic acidosis is a serious medical emergency that can lead to death and must be treated in the hospital. This has happened in some patients who have taken medicines like BARACLUDE.
- Yellowing (jaundice) of the skin or the white part of the eyes, darkening of the urine, lightening in the color of bowel movements (stools), not feeling like eating food for several days or longer, feeling sick to the stomach (nausea), or having lower stomach pain, may be signs of serious liver problems called hepatotoxicity. This may occur with liver enlargement (hepatomegaly) and fat in the liver (steatosis). This has happened in some patients taking medicines like BARACLUDE.
BARACLUDE does not cure HBV or stop the spread of HBV to others.
It is not known whether BARACLUDE will reduce the chances of getting liver cancer or liver damage (cirrhosis), which may be caused by chronic HBV infection.
Patients should not take BARACLUDE if they are allergic to any of its ingredients.
BARACLUDE has not been studied in children and is not recommended for anyone less than 16 years old.
Patients should tell their healthcare provider right away if they have any conditions, including the following:
Kidney problems: Because BARACLUDE® is removed from the body through the kidneys, a lower dose or a different dose schedule may be needed. Healthcare providers may want to do tests to see if a lower dose is needed or if BARACLUDE should be taken less often than once a day.
Pregnant or planning to become pregnant: It is not known if BARACLUDE is safe to use during pregnancy. It is not known if BARACLUDE helps to prevent a pregnant mother from passing HBV to her baby. A pregnant woman and her healthcare provider will need to decide if BARACLUDE is right for her. A woman should not breastfeed if she is taking BARACLUDE.
Patients should discuss with their healthcare provider all prescription and non-prescription medicines, vitamins, herbal supplements, and other health preparations they are taking or plan to take. BARACLUDE may interact with medicines that leave the body through the kidneys.
The safety and effectiveness of BARACLUDE in liver transplant recipients are unknown. These patients must be carefully monitored before and during treatment with BARACLUDE, and they should discuss treatment with their doctor.
The most common side effects of BARACLUDE in clinical studies were headache, tiredness, dizziness, and nausea. This list of side effects is not complete at this time because BARACLUDE is still under study. Patients should report any new or continuing symptom to their healthcare provider.
BARACLUDE should be taken exactly as prescribed and on an empty stomach (at least two hours after a meal and at least two hours before the next meal).
Please see accompanying Full Prescribing Information, including boxed WARNINGS, or visit www.baraclude.com orwww.bms.com.
About Bristol-Myers Squibb
Bristol-Myers Squibb is a global biopharmaceutical company committed to discovering, developing and delivering innovative medicines that help patients prevail over serious diseases. For more information, please visit www.bms.com.
Contacts
Bristol-Myers Squibb
Media:
Sonia Choi, 609-252-5132
sonia.choi@bms.com
or
Investors:
John Elicker,
609-252-4611
john.elicker@bms.com
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