Cialis makes first market appearances in Europe, Australia and New Zealand

Cialis makes first market appearances in Europe, Australia and New Zealand

BOTHELL, WASH., and INDIANAPOLIS, IND., Feb. 4, 2003 -- Lilly ICOS announced that Cialis (tadalafil), an oral PDE5 inhibitor for the treatment of erectile dysfunction (ED), is now on the market in several European countries, and in Australia.

"Cialis will be an important treatment option for many of the millions of men in these countries who suffer from ED, and we are excited about this initial launch of the product," said Paul Clark, ICOS Chairman and chief executive officer.

Cialis is now broadly available by prescription in pharmacies in the United Kingdom, Germany, Denmark, Finland, Sweden, and Australia. Launches in additional European countries will be announced in coming weeks. The product will be available in New Zealand later this month.

Authorities in these countries have approved Cialis for the treatment of mild to severe ED at both 10 and 20 mg doses. The labels in each of these markets indicate that the product should be taken prior to anticipated sexual activity, and without regard to food.

Sexual stimulation is needed for Cialis to work. According to the European label, the efficacy of Cialis may persist up to 24 hours after the pill is taken. In Australia the label indicates efficacy up to 36 hours after dosing.

Cialis is not yet approved for sale in the United States. Lilly ICOS received an approvable letter for Cialis from the Food and Drug Administration in April 2002.

Lilly ICOS says more than 4,000 men have participated in over 60 studies that characterized the safety and efficacy profile of Cialis. 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(1).

The most commonly reported adverse events were headache, upset stomach, nasal congestion, backache, muscle ache, dizziness, and flushing. The adverse events reported with Cialis were transient and generally mild or moderate.

As with other PDE5 inhibitors, the use of Cialis is contraindicated in patients who are taking nitrates. It should not be taken by patients with certain heart diseases for whom sexual activity itself is not advisable.

ED is defined as the consistent inability to attain and maintain an erection sufficient for sexual intercourse. ED affects an estimated 152 million men and their partners worldwide(2). Up to 80 percent of ED cases are caused by physiological conditions, including cardiovascular disease and diabetes, with psychological factors accounting for the remaining 20 percent. In many cases, however, both psychological and physical factors contribute to the condition(3).

Lilly ICOS LLC, a joint venture between ICOS Corporation and Eli Lilly and Company, developed tadalafil for the treatment of sexual dysfunction.

(1) Brock GB, McMahon CG, Chen KK et al. Efficacy and Safety of Tadalafil in the Treatment of Erectile Dysfunction: Results of Integrated Analyses. J Urol 2002; 168: 1332-1336.

(2) Aytac Ia, McKinlay JB, Krane RJ. The Likely Worldwide Increase in Erectile Dysfunction Between 1995 and 2025 and Some Possible Policy Consequences. BJU Int 1999; 84: 50-56.

(3) Impotency Information from NIH. NIH Publication No. 95-3923.1995

Source: Lilly ICOS

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