To print: Select File and then Print from your browser's menu --------------------------------------------------------------------------------------- Title: Europe Recommends Approval Of Trizivir (Lamivudine, Abacavir Sulphate and Zidovudine) For HIV URL: http://www.pslgroup.com/dg/1DA03A.htm Doctor's Guide July 19, 2000
LAVAL, QC -- July 19, 2000 --BioChem Pharma Inc. announced that the European Union's Committee for Proprietary Medicinal Products (CPMP) has recommended the approval of Trizivir, Glaxo Wellcome's new triple combination tablet developed for the treatment of HIV-infected adults, in the 15 member states of the European Union. The CPMP's opinion will now be considered by the European Commission for a final decision. Trizivir, which includes BioChem's discovery 3TC/Epivir, is the first medicine to combine three anti-HIV therapies in one tablet. Each tablet contains lamivudine (150 mg, 3TC/Epivir), abacavir sulphate (300 mg, Ziagen) and zidovudine (300 mg, Retrovir/ZDV). The CPMP's recommendation is that "This fixed dose combination replaces the three components used separately and the choice of Trizivir should be based not only on potential adherence criteria, but mainly on expected efficacy and risk related to the three compounds". The three components of Trizivir will continue to be available individually. The benefits of Trizivir particularly relate to its potent HIV activity in antiretroviral-naive patients and that only one tablet twice daily is required, with no food or water restrictions. Furthermore, the simplified regimen of Trizivir may help to improve adherence to treatment, one of the key challenges in managing the treatment of HIV infection. The marketing application for Trizivir was submitted to the European Medicines Evaluation Agency (EMEA) in December 1999 under the centralized procedure. 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. Related links: BioChem Pharma Inc. --------------------------------------------------------------------------------------------- Copyright © 1999 P\S\L Consulting Group Inc. All rights reserved. Republication or redistribution of P\S\L content is expressly prohibited without the prior written consent of P\S\L. P\S\L shall not be liable for any errors, omissions or delays in this content or any other content on its sites, newsletters or other publications, nor for any decisions or actions taken in reliance on such content. --------------------------------------------------------------------------------------------- This news story was printed from *Doctor's Guide to the Internet* located at http://www.docguide.com --------------------------------------------------------------------------------------- Return to News Story Page This site is maintained by webmaster@pslgroup.com Please contact us with any comments, problems or bugs. All contents Copyright (c) 1998 P\S\L Consulting Group Inc. All rights reserved.