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One tablet of Combivir, which contains 3TC(R)/Epivir(TM) (150mg lamivudine; 3TC) and Retrovir (300mg zidovudine; AZT) can be taken twice daily, offering the advantage of reducing the number of tablets a person on an Epivir/Retrovir based treatment regimen needs to take by up to six tablets per day. Depending on which treatment regimen is used, this can equate to a reduction of between 700 and 2000 tablets per year. This reduction in pill burden is an important step in simplifying complex multi-drug treatment regimens and assisting patient adherence to therapy schedules.
The CPMPFs opinion, which itself does not constitute an approval or final decision will now be considered by the European Commission, who will further evaluate the marketing application and come to a final decision. The marketing application was submitted to the European Medicines Evaluation Agency (EMEA) on June 30, 1997 under the centralized procedure in which a single license is granted for all 15 Member States of the European Union.
Combivir was cleared for sale in the U.S. by U.S. FDA in September 1997.
3TC/Epivir was discovered by BioChem Pharma. Under the terms of a license agreement between BioChem Pharma and Glaxo Wellcome, BioChem receives royalties based on sales of 3TC. Under the agreement, Glaxo Wellcome has the right to develop, manufacture and sell 3TC worldwide, subject to special arrangements for Canada, where BioChem and Glaxo Wellcome have formed a partnership which commercializes 3TC.
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.biochem-pharma.com.
Epivir, Retrovir, AZT, 3TC and Combivir are trade marks of the Glaxo Wellcome Group of Companies.
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CONTACT: BioChem Pharma Inc. Christine Lennon / Michele Roy Corporate Communications 514/978-7771 E-mail: corpcombiochem-pharma.com
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