BOTHELL – ICOS Corp. said a once-a-day version of its erectile dysfunction drug could change the way men deal with the condition while lifting the company’s annual sales by $200 million or more.
Along with its partner for the drug Cialis, Eli Lilly &Co., ICOS announced it is seeking regulatory approval in Europe for a tablet that could be taken daily. A similar application is expected to be filed with U.S. regulators before the year ends.
At present, prescription-only Cialis usually is taken by men when they anticipate sex and the dose can be effective in treating erectile dysfunction for up to 36 hours.
Instead of containing 10 to 20 milligrams of its active ingredient, tadalafil, the daily dose would range from 2.5 to 5 milligrams. Consequently, it would be priced lower as well.
“There are a number of patients for whom Cialis Once-a-Day, may be the most desirable treatment,” said Leonard Blum, ICOS’ senior vice president of sales and marketing, told investors in a Thursday conference call. “Specifically, for a man in his 40s and 50s who is a more frequent (ED drug) user, once-a-day Cialis offers a number of advantages.”
The primary advantage, Blum said, is a man doesn’t have to plan sex within a certain effectiveness window if he’s taking it daily.
For the Lilly ICOS joint venture, the advantage to offering a daily tablet is higher revenue. The company estimates a man taking the daily pill will bring in 50 percent more revenue a year than a man taking the original version when he needs it.
Blum said he foresees about 5 to 10 percent of Cialis’ regular users to try the daily version.
“While only a minority of men may opt for the once-a-day treatment, these men represent the most valuable customers. It’s the committed, persistent and high volume (ED drug) user who would be attracted to Cialis Once-a-Day.”
Erectile dysfunction, perhaps affecting 189 million men worldwide, is defined as the consistent inability to attain and maintain an erection sufficient for sex. The condition often can be caused by physical conditions such as diabetes, cardiovascular diseases or prostate cancer treatment. Available in the U.S. since late 2003 as an alternative to the leading drug Viagra, Cialis generated sales of more than $746 million last year.
If approved, Cialis Once-a-Day could be on the market in Europe and North America by late 2007, said Paul Clark, chief executive officer at ICOS. Assuming that happens, it could boost sales of Cialis products by $200 million to $250 million by 2010.
“Those are big numbers for us,” he said.
The company already has completed three late-stage clinical studies to evaluate the safety and effectiveness of a daily Cialis dose.
Which is important beyond the treatment of impotence for ICOS. The company is studying whether Cialis’ ingredient may be effective against hypertension, a common prostate condition and a potentially fatal lung disorder. All those would require daily doses of the drug.
With daily dose studies already done, the bar for getting regulatory approval to treat those conditions could be lower, noted Paul Latta, an analyst with McAdams Wright Ragen who tracks ICOS.
He added that the daily formulation of Cialis for erectile dysfunction would make it unique and give it another strong difference from rivals Viagra and Levitra, both of which are effective for considerable shorter periods.
ICOS shares were up 7.3 percent, or $1.47, to $21.59 on Thursday.
Reporter Eric Fetters: 425-339-3453 or fetters@heraldnet.com.
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