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| |  EASL: Lamivudine Effective For Most Hepatitis B Patients LAVAL, QC -- April 16, 1998 -- Research presented today shows that BioChem Pharma Inc.’s lamivudine, an oral antiviral treatment for hepatitis B, promises to offer significant benefits to the majority of hepatitis B patients. The finders were presented at the European Association for the Study of the Liver (EASL), in Lisbon, Portugal. Lamivudine is currently under development by Glaxo Wellcome. Hepatitis B, a potentially fatal liver disease, is the ninth-leading cause of death world-wide and 350 million people are long-term carriers of the hepatitis B virus -- about one third of these individuals are expected to develop serious progressive liver disease. "The data presented today, combined with our continually evolving knowledge of hepatitis B, are exciting for both patients and physicians," said professor Nancy Leung, consultant physician, chief of hepatology and honourable associate professor, at the Prince of Wales Hospital, Hong Kong. "This novel antiviral therapy will have a significant impact on patients with chronic hepatitis B." Currently, the only established approach to treatment of hepatitis B is repeated injections of interferon, which produces a long-lasting response in only one third of patients. Interferon is an immune modulator designed to boost the disease fighting ability of the immune system. Lamivudine, however, directly attacks the hepatitis B virus and clinical studies have shown consistently that lamivudine treatment produces a marked reduction in hepatitis B virus replication. One study presented at EASL showed lamivudine monotherapy to be effective in a specific group of patients with a form of the disease known as pre-core mutant hepatitis B. This variant of the disease is particularly prevalent in Southern Europe, the Middle East and some Asian countries and responds poorly to current treatment (interferon). Data from this study showed lamivudine to be as effective in this more difficult-to-treat form of hepatitis B as in the more common type. The study, involving 124 patients with chronic pre-core mutant hepatitis B, was carried out in 17 centres in Greece, Italy, Canada, Spain and the United Kingdom. After 24 weeks of treatment, 63 percent of treated patients had lost detectable virus in the blood and showed significant improvement in liver disease. This compared with only six percent of patients taking placebo. The side effects with lamivudine were no different to placebo. A second major study presented today compared lamivudine therapy to a standard course of interferon (Intron A) and a course of lamivudine and interferon combined. The study showed that patients treated with a once-daily tablet of lamivudine for 52 weeks had a similar seroconversion rate to that achieved with injections of interferon. These data are consistent with results from a large scale Asian trial presented at EASL last year. Overall, studies confirm that lamivudine has an excellent safety and efficacy profile across diverse patient groups from Europe, Asia and North America with the most common form of chronic hepatitis B. Regulatory applications for lamivudine have been filed in a number of countries world-wide, including China, Canada and the European Union. More information on: Lamivudine and BioChem Pharma Inc..
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