European CPMP Gives Positive Opinion on Zeffix (lamivudine) for Treatment of Chronic Hepatitis B
LAVAL, Quebec, Canada, April 26 /CNW-PRN/ – BioChem Pharma Inc. (NASDAQ: BCHE; Montreal Exchange and The Toronto Stock Exchange: BCH) today announced that the European Union’s Committee for Proprietary Medicinal Products (CPMP) has given a positive opinion on Zeffix, the world’s first oral antiviral treatment for chronic Hepatitis B, recommending its approval in the European Union.
The CPMP has recommended the approval of Zeffix for a broad group of chronic Hepatitis B patients. The recommendation, which comes under the CPMP’s classification known as “exceptional circumstances”, asks that Glaxo Wellcome continues to supply the Agency with additional data on specific patient sub-groups over the coming years. The CPMP’s opinion will now be considered by the European Commission, who will make a final decision.
The marketing application for Zeffix was submitted to the European Medicines Evaluation Agency (EMEA) in March 1998 under the centralized procedure, through which a single license is granted for all 15 member states of the European Union.
According to World Health Organization data, approximately 350 million people around the world are long-term (chronic) carriers of the Hepatitis B virus (HBV), including an estimated four million people in the European Union.
Zeffix is available in the Philippines, Hong Kong, Canada (as Heptovir), the USA (as Epivir-HBV), and Switzerland, and approved in China (as Heptodin), Thailand, Pakistan, New Zealand and Argentina. Regulatory applications to market Zeffix for chronic Hepatitis B treatment have been submitted worldwide, including in Korea, Taiwan and Japan.
Lamivudine was discovered by BioChem Pharma. Under agreement, BioChem Pharma will receive royalties from Glaxo Wellcome on sales of lamivudine for use in both HIV/AIDS (3TC/Epivir/Combivir) and HBV (Zeffix/Heptovir/Epivir- HBV/Heptodin). Glaxo Wellcome has the right to develop, manufacture and sell lamivudine worldwide, except in Canada, where BioChem Pharma and Glaxo Wellcome have formed a commercialization partnership.
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 with a focus in the anticancer and anti-infective areas.
3TC, Epivir, Combivir, Zeffix, Heptovir, Epivir-HBV and Heptodin are trademarks of the Glaxo Wellcome group of companies.