Lilly's Cialis gets FDA approval
Longer-lasting impotence pill may be in U.S. stores next month

November 22, 2003

A second competitor to Viagra -- dubbed "le weekend pill" in France -- should hit the nation's pharmacies by early December.

Eli Lilly and Co. and partner Icos Corp. plan "a very fast and aggressive" launch to Cialis after winning Food and Drug Administration marketing approval of the long-lasting erectile dysfunction drug on Friday, said Matthew Beebe, Lilly's brand team leader for Cialis

"We will be off and running" to print FDA-approved labels and start shipping pill bottles to drug wholesalers in a week or two, he said.

Lilly and Icos hope Cialis will earn quick acceptance among many of the 30 million American men who suffer from erectile problems. In Europe, where Cialis was introduced earlier this year, the yellow oval tablet already has earned 30 percent market shares in many countries.

Cialis' main selling points: It works for up to 36 hours after being swallowed and can be taken with or without food. Viagra, the world's first male impotence pill, has a duration of activity of only a few hours. A third pill, Levitra, which went on the U.S. market in September, is effective for four to eight hours after being taken.

Lilly and Icos sales representatives will start calling on U.S. physicians Monday to market Cialis, playing up its longer effective period of use, Beebe said.

More than 1 million men around the world have taken Cialis, Beebe said.

Lilly, of Indianapolis, and Icos, of Bothell, Wash., will sell Cialis in the United States for a wholesale price of $8.10 a pill. That will be 40 cents more than Levitra, which is co-marketed by Bayer Pharmaceutical and GlaxoSmith Kline, said Bayer's North American president, Colin Foster. Viagra, sold by Pfizer Inc., sells wholesale for 5 percent more than Levitra, he said.

Levitra has seen "phenomenal success" in its 10 weeks on the U.S. market, Foster said.

He said with just Viagra on the market, only about 13 percent of American men who suffer erectile dysfunction sought treatment. "That's a tremendously untapped market" for the new products, he said. "I think there's a tremendous amount of room for everybody" now competing against Viagra, he said.

Cialis, which was discovered by Icos, is expected by stock analysts to reach blockbuster status of $1 billion a year in sales within several years. The pill had $60 million in sales in the first half of this year.

Lifestyle drugs like impotence pills tend to be marketed heavily to consumers. Sports is a favored forum, with its strong male fan base. Viagra has sponsorships with professional baseball, Levitra with the National Football League. Cialis has a multiyear deal with professional golf.

Call Star reporter Jeff Swiatek at 1-317-444-6483.