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FDA Approves Once Daily Dose of Erectile Dysfunction Drug Cialis

Drug maker Eli Lilly and Co. has received FDA approval to offer its erectile dysfunction drug, Cialis, in a new daily dose.

The daily version will take pressure off users who would otherwise have a "shot clock" or window of effectiveness to worry about, Lilly officials say. Cialis also is offered at a higher dose that provides a 36-hour window.

With the daily dose, men will not need to take Cialis in anticipation of sex because it is already in their system, said Shawn Heffern, Lilly's U.S. marketing director for the drug.

"They've got a lot of pressure to perform, and the worst thing we can do is then put a shot clock on them or some limited amount of time ... where they need to have sex or otherwise it's out of their system and doesn't work," he said.

Lilly said in a statement the daily dose is geared for men who anticipate having sex twice a week or more frequently.

Cialis rang up $798 million in sales during the first nine months last year. In 2006, it registered $971 million for the full year, a 30 percent increase over 2005.

Heffern said the drug is on track to top $1 billion in sales for 2007. He declined to say how the daily dose will affect revenue.

Cialis trails market leader Viagra in sales. The Pfizer Inc. erectile dysfunction drug collected $1.26 billion in sales during the first nine months of 2007.

The daily dose could increase Cialis sales depending on how it's priced, said George Farra, co-founder and principal of Woodley Farra Manion Portfolio Management. His firm manages nearly 285,000 Lilly shares.

"The cost will probably be an issue. It becomes more of a monthly fixed cost," Farra said. "For those who favor spontaneity, this is about as good as it gets."

Viagra and another erectile dysfunction drug, Levitra, also can be taken daily. But Cialis is the only drug approved for a daily treatment regimen.

Shares of Indianapolis-based Eli Lilly rose $1.53 to $56.08 in trading Tuesday. Farra said he thinks the FDA approval helped spur the increase.

"It's positive news without a doubt," he said.