GlaxoSmithKline and Bayer won Food and Drug Administration approval Tuesday for their Levitra impotence treatment, the first U.S. competitor for Pfizer Inc.'s $1.7-billion-a-year Viagra pill.
The British and German drug makers estimate annual Levitra sales will reach $1.1 billion. The drug probably will sell at a slight discount to Viagra, which can cost more than $8 a tablet, company executives said in interviews.
Glaxo and Bayer plan a marketing effort that may cost as much as $100 million, according to Credit Suisse First Boston analysts. The companies have enlisted former Chicago Bears coach Mike Ditka and other spokesmen from the U.S. National Football League to participate in an awareness campaign.
FDA spokeswoman Laura Bradbard confirmed the approval.
The companies announced Levitra's clearance after the close of regular U.S. trading.
American depositary receipts of Bayer fell 35 cents to $21.90 on the New York Stock Exchange. ADRs for Glaxo fell 21 cents to $39.79.
Pfizer, Bayer and Glaxo probably will soon face another challenger in the U.S. impotence market. Eli Lilly & Co. and Icos Corp. say they intend to introduce their similar Cialis pills in the U.S. this year. They may be helped by the Levitra ad campaign as curious men increasingly seek treatment, urologists said.