Heptovir Approved In Canada For Chronic Hepatitis B
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Heptovir Approved In Canada For Chronic Hepatitis B

LAVAL, QC and MISSISSAUGA, ON -- Nov. 30, 1998 – The Therapeutic Products Program of Health Canada has approved Glaxo Wellcome Inc.’s and BioChem Pharma Inc.’s Heptovir(TM) (lamivudine), the first oral anti-viral medication for the treatment of chronic hepatitis B.

"Heptovir, taken as a once-a-day tablet, slows and can actually halt the progression of liver disease," said Dr. Sam Lee, president of the Canadian Association for the Study of the Liver and associate professor of medicine at the University of Calgary. "Heptovir is a very potent inhibitor of hepatitis B viral replication and has been shown to decrease the amount of virus to undetectable levels in up to 98 per cent of patients while on treatment. In the longer term, we hope that Heptovir will prevent progression to cirrhosis or liver cancer."

It is estimated that 250,000 Canadians are chronically infected with hepatitis B. Chronic hepatitis B infection can cause serious liver disease (cirrhosis) and can lead to liver failure, liver cancer and death. World-wide, 40 percent of men and 15 percent of women who become infected with hepatitis B in early childhood will die prematurely from hepatitis B complications.

"Heptovir helps control disease progression by allowing many patients to seroconvert, which means the virus stops replicating and immunity is achieved," said Dr. Lorne Tyrrell, an infectious disease specialist and professor of medicine at the University of Alberta who first showed lamivudine to be active against hepatitis B. "Patients taking Heptovir have the added benefit of improvements in liver disease, regardless of whether they develop immunity to the virus."

Dr. Tyrrell screened lamivudine for use in hepatitis B at a lab in the Glaxo Heritage Research Institute located at the University of Alberta.

Lamivudine was discovered by BioChem Pharma and was developed throughout the world by Glaxo Wellcome Inc. An equally owned partnership will commercialise Heptovir in Canada. Canada is one of the first countries in the world to approve Heptovir.

According to the World Health Organization, hepatitis B is one of the most common infectious diseases in the world and the ninth most common cause of death. An estimated one to two million people per year, or as many as 4,500 people every day, die from hepatitis B-related complications.

Lamivudine is currently indicated for the treatment of chronic hepatitis B in New Zealand and the Philippines. More than 30 regulatory product submissions have been filed world-wide and the product received a unanimous recommendation for approval from the United States Food and Drug Administration.

Related Links: Lamivudine, Glaxo Wellcome Inc., BioChem Pharma Inc.

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