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Title: HIV Protease Inhibitor Agenerase (Amprenavir) Approved In Europe
URL: http://www.pslgroup.com/dg/1E7AA2.htm
Doctor's Guide
October 23, 2000


CAMBRIDGE, MA -- October 23, 2000 -- Glaxo Wellcome has received approval from the European Commission to market the HIV protease inhibitor (PI) Agenerase (amprenavir), in all 15 countries of the European Union.

Agenerase is indicated in combination with other anti-retroviral agents, for the treatment of PI-experienced HIV-infected adults and children above four years of age.

Agenerase will be available as soft capsules and as oral solution. Unlike most currently marketed PIs, Agenerase has a twice-daily dosing regimen without any food or water restrictions.

Agenerase is currently approved and marketed in Argentina, Brazil, Chile, Colombia, Ghana, Israel, Mexico, Switzerland, Uruguay, and the United States. Amprenavir is also approved in Japan where it is marketed 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. Glaxo Wellcome will market Agenerase in the European Union and Vertex will co-promote the drug in certain countries, where permitted by law.

Related Links: Agenerase (amprenavir) and Glaxo Wellcome.

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