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US clears GlaxoSmithKline, Vertex AIDS drug

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Posted by Reuters on October 20, 2003 at 21:33:44:

Monday October 20, 7:56 pm ET
By Lisa Richwine

(New throughout with FDA, Vertex comments)
WASHINGTON, Oct 20 (Reuters) - A new HIV-fighting drug developed by pharmaceutical giant GlaxoSmithKline Plc (London:GSK.L - News) and biotechnology company Vertex Pharmaceuticals Inc. (NasdaqNM:VRTX - News) won approval from U.S. regulators on Monday.

The companies will sell the drug under the brand name Lexiva, Food and Drug Administration (News - Websites) officials said. The drug, which has been known by the name 908, is part of a class of AIDS medicines known as protease inhibitors.

The FDA said it approved Lexiva for use with other medicines that suppress the HIV virus that causes AIDS.

Lexiva offers patients a new option that allows them to cut the number of pills they must take daily, said Dr. Debra Birnkrant, director of the FDA's division of antiviral drug products.

Dosing options for Lexiva include taking two pills twice a day, or one pill twice a day plus another drug called ritonavir, Birnkrant said. Other medicines can require as many as eight pills twice a day, she said.

"Pill burden-wise, (Lexiva) is somewhat of an improvement," Birnkrant said in an interview.

Bristol-Myers Squibb Co. (NYSE:BMY - News) won approval earlier this year for a once-a-day protease inhibitor called Reyataz.

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

Lexiva's dosing flexibility offers "a huge advantage to patients and doctors," Vertex Chief Executive Joshua Boger said in an interview. With once- or twice-a day options, Lexiva "will fit into just about any regimen."

He also said Lexiva was less likely to cause diarrhea than Pfizer Inc.'s (NYSE:PFE - News) Viracept, another protease inhibitor.

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 (NYSE:ABT - News) Kaletra.

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