First pivotal data on Bayer's vardenafil
Bayer has revealed publicly the first Phase III study data for itscandidate erectile dysfunction drug vardenafil, claiming an 85% response rate in the broad spectrum of ED sufferers enrolled in the 736-patient trial. The placebo response rate in the study was 28%.
Vardenafil, a potential competitor to Pfizer's blockbuster ED drug Viagra (sildenafil), has already been submitted for approval in the USA, Mexico, Canada, South Africa and Japan, and a filing in Europe is anticipated "imminently," according to the company. Bayer is expecting approval in 2002 and noted that the drug will be co-promoted by GlaxoSmithKline, except in Japan.
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