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Heptodin Launched In China For Hepatitis B LAVAL, QUE. -- October 1, 1999 -- BioChem Pharma Inc. announces the launch of Heptodin (lamivudine), the world’s first oral antiviral treatment for chronic hepatitis B, in China, which has the highest prevalence of the disease in the world. Heptodin, known as Zeffix in most countries, is one of the first Western medicines to be granted a Class 1 drug certificate in China, offering the advantage of manufacturing exclusivity for the product in the treatment of hepatitis B for a period of eight years. Hepatitis B is a potentially fatal disease of the liver. It is one of the most common infectious diseases, and is the ninth most common cause of death worldwide.(1) Approximately 350 million people(2) are long-term carriers of the hepatitis B virus and up to 40 percent of those who become infected will die as a consequence of cirrhosis (severe liver scarring) and liver cancer.(3) Seventy-five percent of the world’s hepatitis B virus carriers live in Asia and the Western Pacific. Heptodin is better tolerated than injections of interferon alpha,(4) the only other licensed treatment for chronic hepatitis B, and is suitable for a broader range of patients.(5-10) It is also administered as a convenient, once daily tablet. Multiple clinical trials have established that Heptodin has an excellent efficacy and safety profile across diverse patient groups from Asia, Europe and North America. Furthermore, seroconversion(x) is achieved by up to 65 percent of patients(xx) after three years of treatment with Heptodin.(11) This is almost twice the rate seen after one year of Heptodin treatment. Lamivudine for hepatitis B is already available in a number of countries including South Korea, the US, Canada, the UK, Germany and France. In most markets the trade name Zeffix is used; in the US it is known as Epivir-HBV and in Canada as Heptovir. References: 1. Boag F. Hepatitis B: heterosexual transmission and vaccination strategies. Int J STD & AIDS 1991; 2: 318-324. 2. The World Health Report. WHO 1998. 3. Mast EE, Alter MJ. Epidemiology of viral hepatitis: an overview. Sem Virol 1993; 4: 273-283. 4. Leung N, Dienstag J, Schiff E et al. Clinical safety profile of lamivudine treatment in a large cohort of hepatitis B patients. Hepatology 1998; 28 (4 Pt.2): 587A (abstract 1698). 5. Lai CL, Chien RN, Leung NWY et al. A one-year trial of lamivudine for chronic hepatitis B. N Engl J Med 1998; 339: 61-68. 6. Dienstag J, Schiff E, Wright T et al. Lamivudine treatment for one year in previously untreated US hepatitis B patients: histologic improvement and hepatitis Be-antigen (HBeAg) seroconversion. Gastroenterology 1998; 114: A1235 (abstract L0148). 7. Schiff E, Karayalcin S, Grimm I et al. A placebo controlled study of lamivudine and interferon alpha-2b in patients with chronic hepatitis B who previously failed interferon therapy. Hepatology 1998; 28 (4 Pt.2):388A (abstract 901). 8. Tassopoulos NC, Volpes R, Pastore G et al. Efficacy of lamivudine in patients with hepatitis Be antigen-negative/hepatitis B virus DNA-positive (precore mutant) chronic hepatitis B. Hepatology 1999; 29: 889-896. 9. Perrillo R, Rakela J, Dienstag J et al. Multicenter study of lamivudine therapy for hepatitis B after liver transplantation. Hepatology 1999; 29(5): 1581-1586. 10. Grellier L, Mutimer D, Ahmed M et al. Lamivudine prophylaxis against reinfection in liver transplantation for hepatitis B cirrhosis. Lancet 1996; 348: 1212-1215. 11. Chang TT, Lai CL, Liaw YF et al. Hepatology 1999 (abstract in press). (x) Loss of the hepatitis B virus antigen and gain of antibodies against the virus in the blood - an indicator of long-term clinical improvement. (xx) With greater than twice the upper limit of the normal level of a liver enzyme called ALT. This compares with the 40 percent level achieved by the total patient group. Related Links: lamivudine and BioChem Pharma Inc. E-mail this page to a friend or colleague! To print, use this version