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Japan Approves Antiviral Zevix (Lamivudine) For Hepatitis B LAVAL, QC -- September 22, 2000 -- BioChem Pharma Inc. announced that Glaxo Wellcome K.K. received today manufacturing approval, in Japan, for Zefix tablets 100 (lamivudine), its new antiviral drug for the treatment of chronic hepatitis B. Provision of drug information to medical institutions regarding Zefix will be carried out with Ajinomoto Pharma Co., Ltd., through co-promotion as Ajinomoto Pharma has experience in liver disease. Zefix is indicated for the treatment of patients with chronic hepatitis B and evidence of viral replication. It has been shown that Zefix significantly reduces liver inflammation by suppressing viral replication. Domestic clinical trial results showed that after treatment with Zefix for one year, 64 percent of patients had negative HBV-DNA (below the detection level), 65 percent of patients had normal ALT(GPT) and 95 percent had histological improvements. In a separate five-year multicenter Asian trial, an interim analysis showed that 73 percent (19/26) of patients who had active liver disease(1) when Zefix treatment started successfully seroconverted(2) during the first four years of treatment. This compares with 47 percent achieved in the study patient population as a whole. The results from both of these studies will be welcome news for patients with chronic hepatitis B. According to the data, presented in May at the European Association for the Study of the Liver (EASL) congress in Rotterdam, 86 percent of patients who lost hepatitis B virus e antigen (HBeAg), while taking Zefix, showed no evidence of disease recurrence almost two years after completing their treatment. It provides new evidence of sustained viral suppression when the loss of the hepatitis B antigen or seroconversion is achieved with Zefix treatment. Hepatitis B is one of the most common and serious diseases in the world. According to the World Health Organization (WHO), there are approximately 350 million chronic carriers of hepatitis B virus (HBV) worldwide, and over 75 percent of these carriers reside in the Asia-Pacific region. Up to 2 million people die each year from hepatitis B virus infection, making it the ninth leading cause of death worldwide. It is estimated that the number of HBV carriers in Japan is 1.2-1.4 million out of which 10 percent of the carriers are chronic hepatitis B patients. Zefix is currently available in more than 30 countries including China (as Heptodin), South Korea, the USA (as Epivir-HBV), Canada (as Heptovir) and the EU, and approved in over 60 countries worldwide. References: (1) Those with greater than twice the upper limit of the normal level of a liver enzyme called ALT. (2) Loss of the hepatitis B virus antigen and gain of antibodies against the virus in the blood-an indicator of long-term clinical improvement. Related Links: Zefix (lamivudine), BioChem Pharma Inc. and Glaxo Wellcome. E-mail this page to a friend or colleague! To print, use this version