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 Health & Beauty | June 2006 
A Daily Pill to Combat Impotence?
 Alex Berenson - NYTimes
| | Cialis, like its rivals, is now taken "on demand," not regularly. (Eli Lilly) |
Icos Corporation, which together with Eli Lilly markets Cialis, the No. 2 impotence drug, says it plans later this year to ask the Food and Drug Administration for approval of a once-daily version of the medicine. In May, Icos applied to European drug regulators for approval of the once-daily pill.
Icos and Lilly plan to market the once-daily drug to men in their 40's and 50's who take impotence drugs frequently, said Paul N. Clark, Icos's chief executive. Most men who use the drugs now typically take them about four to six times each month. A daily dose would be aimed at allowing more spontaneity in the user's sex life than the strategic planning required of what Icos calls the "on demand" version.
The once-daily pill works as well at improving sexual function as the maximum dose of Cialis, Icos said. In a study published in March in European Urology, a journal, 50 percent of men taking Cialis once a day said they were no longer impotent, in contrast to 8 percent of men taking a placebo. Side effects were mild, the study found.
Icos said it expected the daily pill would generate about 50 percent more revenue per patient than the on-demand version. The company did not disclose a price for the once-daily pill, but analysts predict it will cost about $3.50 a pill, or $100 a month, in comparison to $10 to $12 a dose for the current version.
"For patients who are more sexually active, which generally means younger patients, whose sexual activity is more spontaneous, it will be an attractive alternative, provided the cost is not prohibitive," said Dr. Ira D. Sharlip, professor of urology at the University of California, San Francisco and a spokesman for the American Urological Association.
Men must now take Cialis and other impotence drugs at least 30 minutes before they plan to have sex, a factor that has discouraged use of the drugs, urologists say.
Icos, which plans to continue offering the on-demand version, predicts that the daily version of Cialis will have $200 million to $250 million in worldwide sales by 2010. Last year, Cialis had $776 million in sales worldwide. But some analysts doubt that men will want to take an impotence drug every day, since even frequent users of the medicines generally have sex no more than a couple of times a week. Insurance companies may also be reluctant to pay the additional cost of a once-daily pill.
"We do not believe sales will rise as a result of the new dosing regimen," Eric Ende, an analyst at Merrill Lynch, wrote in a report last week.
The market for impotence drugs has stagnated since last summer, when reports linked the medicines to a rare form of blindness. Eight years after Pfizer, the world's largest drug market, introduced Viagra, the most popular impotence medicine, to enormous publicity, the market for the drugs appears to be saturated.
Even with a major new ad campaign for Viagra this year, United States prescriptions for drugs for erectile dysfunction have been flat, compared with a 5 percent rise in prescriptions over all. The $2.5 billion or so of the drugs sold worldwide annually represent only 0.5 percent of the global prescription drug market. But Cialis continues to gain market share, mainly at the expense of Viagra.
Lacy Fitzpatrick, a spokeswoman for Icos, said the company expected the market for impotence drugs to grow at about the same rate as the population of men over 40. Levitra, the third impotence drug, marketed by Bayer and GlaxoSmithKline, is a distant third worldwide.
All three drugs strengthen erections by blocking an enzyme that slows the flow of blood to the penis. But Cialis is broken down more slowly than Viagra or Levitra, so it can work for up to 36 hours, while the other two drugs work for about four hours. That is why a once-daily version of Viagra or Levitra may be impractical.
If approved by the F.D.A., the daily pill will contain 5 milligrams of tadalafil, Cialis's active ingredient. Cialis is now offered in 5-, 10- and 20-milligram doses, but the 20-milligram dose is by far the most popular, according to Icos.
Dr. James Barada, of the Center for Sexual Health in Albany, said he believed the drug could be appealing for men who have sex frequently and do not want to think of themselves as being impotent, even occasionally.
"The idea that if I don't have to think about it, I don't have the disease," Dr. Barada said. "To move it to the background is going to be appealing for some people."
In addition, Cialis may prove to have broad cardiovascular benefits as a once-daily pill, Dr. Barada said. The enzyme that Cialis and the other impotence drugs inhibit is found in blood vessels all over the body, and Icos is now studying Cialis for the treatment of high blood pressure.
"There may be a much bigger picture than just for erectile dysfunction," he said. |
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