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Glaxo-Bayer Impotence Drug Cleared

Levitra is aimed at the billion-dollar 'erectile dysfunction' market dominated by Pfizer.
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Viagra's five-year monopolization of the market for impotence treatments has ended with the Food and Drug Administration's approval of a new drug codeveloped by


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On Tuesday night the agency approved Levitra, a treatment that developers say improves not just the reliability of erections, but their "quality." It should be available to consumers in the next few weeks.

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"In clinical trials, Levitra was shown to work quickly," Glaxo quoted a doctor involved in the clinical trials saying. "More importantly, Levitra was shown to improve the sexual response for the majority of men the first time they took it, and it worked consistently over time."

Among other things, the trials found Levitra helped men "get and keep an erection sufficient for satisfactory sexual performance," was usually effective the first time it was used, and worked fast enough for "men to initiate or respond to sexual stimulation when the time is right."

The drug is aimed directly at


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billion-dollar Viagra franchise, and in fact Pfizer has a lawsuit pending that claims one of its patents is violated by Levitra. The trial is still in its early stages.

Bayer and GlaxoSmithKline signed a worldwide co-promotion and co-development agreement for Levitra in November 2001. The treatment has received regulatory approval for the treatment of impotence in more than 50 countries.

Glaxo was recently up a penny to $39.80 on Instinet.