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Entecavir Gains FDA Approval

PRINCETON, N.J., March 29 /PRNewswire-FirstCall/ -- Bristol-Myers Squibb Company (NYSE:BMY) announced today that the U.S. Food and Drug Administration (FDA) approved BARACLUDE(TM) (entecavir). BARACLUDE is indicated for the treatment of chronic hepatitis B infection in adults with evidence of active viral replication and either evidence of persistent elevations in serum aminotransferases (ALT or AST) or histologically active disease. BARACLUDE is an oral antiviral therapy specifically designed to block the replication of hepatitis B virus (HBV) in the body by interfering with the virus's ability to infect cells. The drug will be available in the United States as early as April 8, 2005.

"With the approval of BARACLUDE, Bristol-Myers Squibb will now be able to address another area of significant unmet medical need, building on our growing presence in fighting cancer, HIV/AIDS, schizophrenia and other diseases," said Peter R. Dolan, chairman and chief executive officer. "BARACLUDE represents the company's fourth new pharmaceutical approved in less than two and a half years, and has the potential to help many adult patients with chronic hepatitis B infection. Developed in our own laboratories, BARACLUDE is an important step forward for patients and our company, as we seek to realize our mission of extending and enhancing human life by focusing on discovering, developing and providing innovative treatments for serious diseases."

"In clinical trials, BARACLUDE demonstrated greater levels of viral suppression compared to lamivudine after 48 weeks of treatment," said Robert Gish, M.D., medical director of the California Pacific Medical Center's Liver Transplant Program. "With today's FDA approval of BARACLUDE, physicians have an important new medication to treat chronic hepatitis B."

Chronic hepatitis B infection is a potentially life-threatening disease. More than half a million people worldwide die each year from primary liver cancer, and up to 80 percent of primary liver cancers are caused by chronic hepatitis B. In the United States, more than one million people have developed chronic hepatitis B infection and more than 5,000 Americans die from hepatitis B and hepatitis B-related liver complications each year.

"Despite these alarming statistics, it is estimated that only a small percent of diagnosed chronic hepatitis B patients in the U.S. are currently receiving treatment for their disease," said Timothy Block, Ph.D., president, Hepatitis B Foundation and professor, Drexel Medical College. "The availability of BARACLUDE is an important development that provides a new option for therapy."

BARACLUDE is a nucleoside analogue with a recommended dosage of a single 0.5-milligram tablet once-daily for chronic hepatitis B patients beginning treatment for the first time (nucleoside-naïve patients), and a single 1- milligram tablet once-daily for patients experiencing resistance to lamivudine (lamivudine-refractory patients).

The BARACLUDE clinical trial program was the largest-ever conducted in chronic hepatitis B, and the first to compare two antivirals, BARACLUDE versus lamivudine (the most commonly used oral antiviral therapy for the treatment of chronic hepatitis B worldwide). In these studies after 48 weeks, BARACLUDE demonstrated statistically significant improvements compared to lamivudine in liver histology, HBV viral load reductions to undetectable levels (defined as less than 300 copies/mL) and normalization of alanine aminotransferase (ALT) levels (less than or equal to 1 times the upper limit of normal), a measure used to determine the degree of liver damage.

In these studies, BARACLUDE demonstrated comparable safety to lamivudine with a favorable resistance profile. Lactic acidosis and severe hepatomegaly with steatosis, including fatal cases, have been reported with the use of nucleoside analogues alone or in combination with antiretrovirals. Severe acute exacerbations of hepatitis B have been reported in patients who have discontinued anti-hepatitis B therapy, including BARACLUDE and lamivudine.

The most common side effects of BARACLUDE in clinical studies were headache, tiredness, dizziness, and nausea. Cross resistance has been observed among HBV nucleoside analogues. Lamivudine-resistant patients may not respond as well as nucleoside-naïve patients to BARACLUDE therapy.

Important Information About BARACLUDE(TM) (entecavir) Tablets
BARACLUDE (entecavir) is a prescription medicine for the treatment of chronic hepatitis B infection in adults with evidence of active viral replication and either evidence of persistent elevations in serum aminotransferases (ALT or AST) or histologically active disease. BARACLUDE does not cure HBV or stop the spread of HBV to others. People should not take BARACLUDE if they are allergic to it or any of its ingredients. BARACLUDE has not been studied in children and is not recommended for anyone less than 16 years of age.

People taking BARACLUDE should tell their healthcare provider right away if they feel very weak or tired, have unusual muscle pain, have trouble breathing, have stomach pain with nausea and vomiting, feel cold - especially in their arms and legs, feel dizzy or lightheaded, or have a fast or irregular heartbeat, as they may be signs of a serious condition called lactic acidosis (buildup of an acid in the blood). Lactic acidosis is a medical emergency and must be treated in the hospital. Some people who have taken medicines like BARACLUDE have developed serious liver problems called hepatotoxicity. This may occur with liver enlargement (hepatomegaly) and fat in the liver (steatosis). People should call their healthcare provider right away if they get any of the following signs of liver problems: 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. Lactic acidosis and hepatotoxicity have happened in some people taking medicines like BARACLUDE.

In some people, hepatitis B symptoms may get worse or become very serious when they stop taking BARACLUDE. People should not stop BARACLUDE without talking to their healthcare provider. Healthcare providers will need to follow their patients and do blood tests to check the liver when BARACLUDE is stopped. People should tell their healthcare provider if they have or develop kidney problems because their healthcare provider may want to do tests to see if a lower dose is needed.

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 breast-feed if she is taking BARACLUDE.

People 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 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. People should report any new or continuing symptom to their healthcare provider. BARACLUDE should be taken once daily on an empty stomach (at least 2 hours after a meal and 2 hours before the next meal). To learn more about BARACLUDE and for Full Prescribing Information, including boxed WARNINGS, please visit https://www.bms.com/.

Source: Bristol-Myers Squibb Company

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