AEGiS-Reuters: US Clears GlaxoSmithKline, Vertex AIDS Drug

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US Clears GlaxoSmithKline, Vertex AIDS Drug

Reuters NewMedia - October 20, 2003


WASHINGTON (Reuters) - U.S. regulators approved a new HIV -fighting drug developed by pharmaceutical giant GlaxoSmithKline Plc and biotechnology company Vertex Pharmaceuticals Inc., Food and Drug Administration officials said Monday.

The companies will sell the drug under the brand name Lexiva, FDA officials said. The drug, which has been known by the name 908, is part of a class of AIDS medicines known as protease inhibitors.

Lexiva is chemically similar to an HIV drug Vertex already sells called Agenerase, which had sales in 2002 of about $65 million.

Vertex officials said Lexiva offered more convenient dosing than other protease inhibitors because it cuts the number of pills in the daily virus-fighting cocktail patients must take. They also said Lexiva was less likely to cause diarrhea than Pfizer Inc.'s Viracept, another drug in the class.

Vertex expects Lexiva to cannibalize much of the Agenerase market and then make inroads into the share held by Viracept and Abbott Laboratories Inc.'s Kaletra.

Vertex is based in Cambridge, Massachusetts. GlaxoSmithKline is headquartered in London.


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