BOTHELL, Wash./INDIANAPOLIS, Ind., 5 February 2003 — Lilly ICOS LLC (NYSE: LLY and NASDAQ: ICOS) announced yesterday that Cialis (tadalafil), an oral PDES inhibitor for the treatment of erectile dysfunction (ED), is available in Europe, as well as Australia and New Zealand.
“The launch of Cialis in these major markets of Europe, Australia and New Zealand is an important milestone for Lilly ICOS,” said Richard Pilnik, president of European operations for Lilly. “The 24-hour period of effectiveness that Cialis offers is a unique attribute that may help men feel more in control and return to a more normal sex life,” he added.
Cialis may provide an important treatment option for many of the 31 million men across Europe with ED,” Paul Clark, ICOS chairman and CEO, said.
Cialis is licensed for the treatment of mild to severe ED at both 10 and 20 mg doses. The product should be taken prior to anticipated sexual activity and without regard to food. Sexual stimulation is needed for Cialis to work.
Cialis works as a selective and potent inhibitor of PDES, helping to relax smooth muscle cells and increase blood flow to the penis. Cialis is currently the only PDES inhibitor for which the label indicates its efficacy may persist up to 24 hours postdose.
More than 4,000 men have participated in more than 60 studies that characterized the safety and efficacy profile of Cialis, which has been shown to be effective in improving erectile function across a broad population of men and is well tolerated. In primary efficacy studies involving 1,112 men (804 Cialis, 308 placebo) with mild to severe ED, up to 81 percent of those treated with Cialis reported improved erections compared with 35 percent of those taking placebo, according to a clinical data overview.