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FDA approves third drug to treat impotence

Lilly to push Cialis with ad campaign valued at $100m

A third drug to treat erectile dysfunction, Cialis, won approval from the Food and Drug Administration yesterday, joining Viagra and Levitra in an escalating market battle for the loyalties of an estimated 30 million American men who have trouble having sex.

In keeping with sports-oriented advertising for this class of drugs, its maker, Lilly ICOS LLC, has already signed a deal to promote the drug by sponsoring professional golf. Cialis will be pushed with a massive advertising campaign estimated at $100 million, including consumer spots that will trumpet its advantage over rivals Viagra and Levitra: One pill can enable erections over a 36-hour period.

Extended effectiveness has already won Cialis the nickname "le Weekend" in France, where it has been on the market since February. Cialis has about 30 percent of the market in Europe, and racked up sales of $109 million in the third quarter, putting it in second place among the three drugs, said Cialis team executive director Mark Barbato in Indianapolis.

Lilly ICOS, a partnership of Ely Lilly & Co. and ICOS Corp., said the drug will be available to US consumers within two weeks. Ely Lilly & Co. stock fell 2.68 percent to $69.61 a share yesterday. Cialis will be useful for men who want spontaneity in their sex life, said Pablo Gomery, a urologist at Massachusetts General Hospital who performed clinical trials of Cialis and Levitra. Viagra's effectiveness window is four to six hours; Levitra's is slightly longer, he said.Viagra, which Pfizer Inc. introduced in 1999, still dominates the market, with $1.7 billion in annual global sales, of which $1 billion is US sales. Levitra, produced by a partnership of GlaxoSmithKline and Bayer AG, had $42 million in global sales in the third quarter; it was introduced in the United States in September. Spokesmen for Pfizer and GlaxoSmithKline said their drugs will retain the loyalty of men who do not wish to have a prescription drug lingering in their bodies for 36 hours. "We've done extensive global surveys of sexual attitudes and habits, and most people engage in sex in a four-hour window. If they have sex again, it is within that window," said Pfizer spokesman Daniel Watts. "It may not be the greatest thing to have something in your body that you don't need except for a short period of time."

If an erectile dysfunction drug stays in the body for 36 hours, so will the side effects, said Michael Fleming, a spokesman for GlaxoSmithKline in Philadelphia. The FDA said possible side effects of Cialis are headache, indigestion, back pain, muscle aches, flushing, and stuffy or runny nose. Patients who get back pain and muscle aches usually get it 12 to 24 hours after taking Cialis and these usually go away by themselves within 48 hours. A small number of patients taking Cialis also reported abnormal vision, the FDA said.

Sexual dysfunction drugs are among the most heavily marketed on the US airwaves. Viagra sponsors a car on the NASCAR circuit and is a sponsor of Major League Baseball. Levitra has former Chicago Bears coach Mike Ditka as a spokesman and has a deal with the National Football League. And Cialis has a contract with the Professional Golfers' Association.

Christopher Rowland can be reached at crowland@globe.com.

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