BioChem Pharma’s Discovery, Epivir(R)-HBVT (Lamivudine) Recommended for Approval by U.C. FDA Advisory Committee for the Treatment of Chronic Hepatitis B
LAVAL, Quebec /CNW-PRN/ – BioChem Pharma Inc. (NASDAQ: BCHE; ME, TSE: BCH) announced that Epivir(R)/HBV(TM) was unanimously recommended for approval for the treatment of chronic Hepatitis B in adults by the Antiviral Drugs Advisory Committee to the U.S. Food and Drug Administration (FDA) today. If approved by the FDA, Epivir-HBV will be the first oral antiviral treatment for chronic Hepatitis B. While the favorable recommendation of the advisory committee is not binding, the FDA typically follows the advice of its expert panel members.
Epivir-HBV was discovered by BioChem Pharma and licensed to Glaxo Wellcome in 1990. Under the terms of a license agreement, BioChem Pharma will receive royalties from Glaxo Wellcome on sales of lamivudine. Glaxo Wellcome has the right to develop, manufacture and sell lamivudine worldwide, subject to special arrangements for Canada, where BioChem Pharma and Glaxo Wellcome have formed a commercialization partnership.
We are pleased with the recommendation by the committee for the approval of Epivir-HBV,” said Dr. Gervais Dionne, Executive Vice President, BioChem Pharma Inc. “Epivir-HBV represents a treatment advance for patients with chronic Hepatitis B, which is one of the leading causes of death worldwide.”
Hepatitis B is a potentially fatal liver disease and has been estimated to be the ninth most common cause of death worldwide. Approximately 350 million people have chronic infection with Hepatitis B virus (HBV) and nearly one-third of these individuals are expected to develop serious progressive liver disease. In the United States, there are approximately one million persons chronically infected with HBV and it is estimated that less than one percent have been treated. Chronic Hepatitis B can cause progressive liver inflammation, leading to cirrhosis (severe liver scarring), liver failure, and liver cancer. It has been estimated that chronic HBV infection accounts for 5,000 deaths per year in the U.S. The most important goal of Hepatitis B therapy is reducing the progressive liver inflammation that occurs when the immune system attacks Hepatitis B infected liver cells. An antiviral treatment such as Epivir-HBV, which directly interferes with viral replication, can reduce the level of infection, thus leading to reduced attack on the liver by the immune system.
Epivir-HBV, once approved, will provide a new and important first-line option for physicians treating patients with chronic Hepatitis B,” said Willis Maddrey, M.D., MACP, Executive Vice President for Clinical Affairs, Professor of internal medecine, University of Texas, at Dallas Medical Center. “Epivir-HBV, which must be taken only once a day, is a convenient oral medication with few side effects.”
The safety and efficacy of Epivir-HBV in the treatment of patients with chronic Hepatitis B were evaluated in four controlled studies in 967 patients with chronic Hepatitis B. These studies showed that treatment with Epivir-HBV 100 mg once a day for one year was associated with more frequent improvements in liver histology, more frequent HBeAg (Hepatitis B “e” antigen) seroconversion, and more frequent normalization of serum ALT (alanine aminotransferase) concentrations compared with placebo.
In clinical trials, the frequencies of adverse reactions in patients with chronic Hepatitis B receiving Epivir-HBV 100 mg vs. placebo were similar. The most common adverse reactions were: malaise and fatigue (37 percent vs. 31 percent), headache (27 percent vs. 23 percent), nausea and vomiting (21 percent vs. 27 percent) and abdominal pain/discomfort (17 percent vs. 23 percent). In addition, lactic acidosis and severe hepatomegaly with steatosis, including fatal cases, have been reported with the use of nucleoside analogues alone or in combination, including lamivudine and other antiretrovirals.
Lamivudine, the generic name for Epivir-HBV, is cleared for marketing for the treatment of chronic Hepatitis B in New Zealand, Pakistan and the Philippines.
BioChem Pharma is an international biopharmaceutical company dedicated to the research, development and commercialization of innovative products for the prevention, detection and treatment of human diseases. The Company lists its common shares on the Montreal and Toronto exchanges (BCH) and on the NASDAQ National Market (BCHE).
BioChem Pharma news releases and other company information can be found on the World Wide Web at http://www.biochempharma.com.
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SOURCE BioChem Pharma Inc.