BioChem Pharma Announces First Regulatory Filing Seeking Approval of Lamivudine For Hepatitis B In China.LAVAL, Quebec--(BUSINESS WIRE)--Aug. 25, 1997--BioChem Pharma Inc. announced today the first regulatory filing submission seeking marketing approval of the Company's discovery lamivudine for the treatment of chronic hepatitis Chronic hepatitis Long lasting inflammation of the liver due to viruses or other causes. Mentioned in: Tube Compression of the Esophagus and Stomach chronic hepatitis B infection. The filing was made in China by BioChem Pharma's licensee, Glaxo Wellcome. There are an estimated 300-350 million chronic carriers of hepatitis B Hepatitis B Definition Hepatitis B is a potentially serious form of liver inflammation due to infection by the hepatitis B virus (HBV). It occurs in both rapidly developing (acute) and long-lasting (chronic) forms, and is one of the most common chronic virus worldwide, the majority of whom are in the Asia Pacific region, particularly China. Hepatitis B is the tenth most common cause of death worldwide, causing approximately 1-2 million deaths per year. Lamivudine is a novel antiviral drug antiviral drug, any of several drugs used to treat viral infections. The drugs act by interfering with a virus's ability to enter a host cell and replicate itself with the host cell's DNA. discovered by BioChem Pharma, under development by Glaxo Wellcome. Additional regulatory submissions seeking marketing approvals in a number of other countries are planned over the course of the next 12 months. Results from the first of the Phase III Noun 1. phase III - a large clinical trial of a treatment or drug that in phase I and phase II has been shown to be efficacious with tolerable side effects; after successful conclusion of these clinical trials it will receive formal approval from the FDA studies were disclosed in April of this year at the European Association for the Study of the Liver conference held in London. The study demonstrated the significant efficacy of lamivudine in improving liver histology, compared to placebo. Liver histology is an important indicator of severity and stage of liver disease Liver Disease Definition Liver disease is a general term for any damage that reduces the functioning of the liver. Description The liver is a large, solid organ located in the upper right-hand side of the abdomen. caused by the body's immune response immune response n. An integrated bodily response to an antigen, especially one mediated by lymphocytes and involving recognition of antigens by specific antibodies or previously sensitized lymphocytes. against liver cells infected with hepatitis B. "Today's filing with the Chinese Ministry of Health marks a significant milestone in that it is the first country in which the regulatory submission for lamivudine for the treatment of chronic hepatitis B infection has been filed," said Dr. Francesco Bellini, President and CEO (1) (Chief Executive Officer) The highest individual in command of an organization. Typically the president of the company, the CEO reports to the Chairman of the Board. , BioChem Pharma. "Lamivudine represents an important therapeutic advance in the treatment of this significant global disease." Under the terms of a license agreement between BioChem Pharma and Glaxo Wellcome, BioChem Pharma will receive royalties 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. 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 BCH Beach BCH Banco Central de Honduras BCH Boot Console Handler BCH Boulder Community Hospital (Boulder, CO, USA) BCH Broadcast Channel BCH Belfast City Hospital BCH Banco Central-Hispano ) and on the NASDAQ NASDAQ in full National Association of Securities Dealers Automated Quotations U.S. market for over-the-counter securities. Established in 1971 by the National Association of Securities Dealers (NASD), NASDAQ is an automated quotation system that reports on National Market (BCHE BChE abbr. Bachelor of Chemical Engineering ). BioChem Pharma news releases and other company information can be found on the World Wide Web at http://www.biochem- pharma.com. This press release contains forward-looking statements which reflect the company's current expectation regarding future events. The forward-looking statements involve risks and uncertainties. Actual events could differ materially from those projected herein and depend on a number of factors including the successful and timely completion of clinical studies, the successful defense of challenges to the Company's patents and the uncertainties related to the regulatory process in each country, including China. Investors should consult the Company's ongoing quarterly filings, annual reports and 20-F filings for additional information on risks and uncertainties relating to these forward-looking statements. The Company disclaims any obligation to update these forward-looking statements. CONTACT: BioChem Pharma Investor/Media Enquiries Christine Lennon (514) 978-7771 E-mail: corpcombiochem-pharma.com or Glaxo Wellcome Media Enquiries US Ramona Jones (919) 483-2839 or Media Enquiries Europe Nancy Pekarek 011 44 171 493-4060 or US Analyst/Investor Enquiries Frank Murdolo/Jennie Younger (212) 308-5185 or European Analyst/Investor Enquiries Joan Toohill 011 44 171 493-4060 |
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