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It took 13 years to do it, but Icos reached the most important moment in its history yesterday when it won FDA approval to sell its first drug in the U.S.: the impotence drug Cialis.

Corks were popped and high-fives were slapped yesterday around the Bothell biotech company, founded by big industry names and an investment from Bill Gates. The news means its days as a research-and-development-only company are over, and big money will be spent on marketing Cialis into a billion-dollar cash cow to compete with Viagra and another drug, Levitra.

The FDA is allowing Icos and its partner Eli Lilly to claim the drug lasts up to 36 hours, isn't diminished by high-fat foods, and kicks in after a half-hour. The side effects, similar to those of its competitors, include headache, back pain and muscle aches.

Paul Clark, a former sales and marketing executive from Abbott Labs hired four years ago to run Icos, said Cialis will hit pharmacies in early December. Cialis will have an edge in the market, Clark said, because studies show that men would rather have a pill that lasts a lot longer than four hours. READ THE FULL ARTICLE

Cialis® may help prostate patients
Drug can improve erections after surgery, manufacturer says

MSNBC-
NEW YORK, Oct. 10 — The new erectile dysfunction drug Cialis may improve erections in patients who undergo radical prostate cancer surgery, said the makers of the drug, Eli Lilly and Co. and Icos Corp. on Friday.

IN A trial of the drug, which has been approved in Europe but is still awaiting approval in the United States, 62 percent of men who underwent a surgery known as bilateral nerve-sparing radical retropubic prostatectomy had improved erections. By contrast, only 23 percent of men taking a placebo reported improved erections. The trial involved 303 men who took Cialis over a period of 12 weeks.