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European Panel Gives Positive Opinion On Approval Of Agenerase (Amprenavir) For HIV CAMBRIDGE, MA -- June 30 2000 -- Vertex Pharmaceuticals Incorporated and Glaxo Wellcome announced today that the European Union's Committee for Proprietary Medicinal Products (CPMP) has recommended the market approval of Agenerase™ (amprenavir), a novel, twice-daily protease inhibitor (PI) for the treatment of HIV, in the 15 member states of the European Union. The recommendation is for the use of Agenerase, in combination with other antiretroviral agents, for the treatment of PI-experienced HIV-infected adults and children above four years of age. Agenerase has a resistance profile different from that observed with other PIs and, unlike most currently marketed PIs, Agenerase has a twice-daily dosing regimen and has no food or water restrictions. Agenerase was discovered at Vertex Pharmaceuticals and licensed to Glaxo Wellcome. The CPMP's opinion will now be considered by the European Commission for a final decision. If approved, Glaxo Wellcome will market Agenerase in the European Union, and Vertex will co-promote the drug in certain countries, where permitted by law. The marketing application for Agenerase was submitted to the European Medicines Evaluation Agency (EMEA) in October 1998 under the centralized procedure. Agenerase is currently approved and marketed in Argentina, Brazil, Chile, Colombia, Israel, Mexico, Switzerland, Uruguay, and the United States. Amprenavir is also approved in Japan where it is marketed by Vertex's partner Kissei Pharmaceutical Co., Ltd. under the trade name Prozei™. Amprenavir was discovered by scientists at Vertex Pharmaceuticals of Cambridge, MA and licensed to Glaxo Wellcome in the United States, Europe, and other countries. Glaxo Wellcome has been responsible for product formulation and manufacture of Agenerase, design and implementation of clinical trials, and regulatory submissions. Related links: Agenerase, Vertex Pharmaceuticals Inc. and Glaxo Wellcome. E-mail this page to a friend or colleague! To print, use this version