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Vertex/Glaxo Wellcome Agenerase

Executive Summary

Fast-track NDA submission for HIV protease inhibitor amprenavir (141W94, VX-478) is completed Oct. 16. The clinical package contains 20 trials in 1,500 patients. Amprenavir is dosed 1,200 mg (eight 150 mg capsules) twice-daily, as opposed to most protease inhibitors, which require dosing three times per day. Two-, three-, and four-drug combination regimens were tested, with various nucleoside and non-nucleoside reverse transcriptase inhibitors. Glaxo's Epivir and Retrovir, as well as the pending Ziagen were among the nucleoside analogs. The NDA submission is the first for Cambridge, Mass.-based Vertex, which will co-promote the product with Glaxo
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PS033025

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