Lilly ICOS LLC announced that the European Commission has adopted changes to the European label for Cialis (tadalafil), Lilly ICOS’ oral PDE5 inhibitor for the treatment of erectile dysfunction (ED). The new label indicates that Cialis may be effective for up to 36 hours after taking the tablet, which makes it generally consistent with product labelling throughout the world, including in the US, where Cialis was approved late last year.

"In the year that Cialis has been available in Europe, we have seen that men and their partners appreciate Cialis because it gives a man and his partner a broad window of opportunity so they can choose the moment for intimacy that is right for them," said Mark Barbato, executive director and product team leader, the Primary Care Products Group, Lilly. "This label change, to 36 hours, is an important milestone for Cialis because the European label is now consistent with other labels around the world."

"Product labeling worldwide reinforces how Cialis is different from other oral ED tablets," said Paul Clark, ICOS chairman. "We believe men and their partners understand and appreciate the attributes of Cialis and we see them voting with their prescriptions. The market share for Cialis in some European countries exceeds 25 per cent."

The European label change became effective on Jan. 27, 2004, when it was adopted by the European Commission. The European Committee for Proprietary Medicinal Products (CPMP) issued a positive opinion on the label update in October. The CPMP, comprised of regulators from the European Union countries, based its opinion on two placebo-controlled studies that were designed to measure the effectiveness of Cialis at 24 and 36 hours after taking the tablet. It also considered an integrated analysis of 11 studies to determine the effectiveness of Cialis in men with ED at all time points they chose to have intercourse from 30 minutes to 36 hours after dosing. In the analysis of 580 men taking 20 mg Cialis, who attempted sexual intercourse between 12 and 24 hours after dosing, 73 per cent of intercourse attempts were successful in response to sexual stimulation. Cialis studies were not designed to assess multiple intercourse attempts after a single dose.

The new EU label also includes new safety information including updated dosing instructions for patients with liver and kidney impairments.

The importance of the duration of effectiveness is emphasized by a recent clinical study involving Cialis and assessing patient preference versus Viagra (sildenafil citrate). The independent study, conducted by recognized experts in the field, will be presented at the 4th World Congress on the Aging Male (WCAM) later this month. The study showed that more former Viagra users preferred Cialis to Viagra. In this study, men were also asked which treatment they would choose to continue to take after the trial. The results showed that 62 per cent of men who had used both drugs chose to continue with Cialis, compared to 20 per cent who opted for Viagra.

"The revised EU label reflects my clinical experience that Cialis is effective up to 36 hours," said Professor Jacques Buvat, president of the International Society for Sexual and Impotence Research (ISSIR). "As our research indicates, this 36-hour period of effectiveness has made Cialis the preferred choice for many of my patients. Our data support a number of studies that now show men with ED value this longer period of effectiveness."

Cialis has successfully captured a significant share of unit (tablet) sales in Europe among the three PDE5 inhibitors. For December 2003, based on pharmacy purchases from wholesalers, Cialis had a 33 per cent share in France, 30 per cent in Germany, 27 per cent in Italy and 18 per cent in both Spain and the United Kingdom.

Cialis is currently available in more than 55 countries, including Australia, Brazil, Mexico, Canada, the United States and countries throughout Europe. Well over one million patients worldwide have been treated with Cialis since its first introduction in February 2003. Cialis can be taken without regard to food, and is the only available PDE5 inhibitor for which it has been shown that absorption is not affected by a high-fat meal. Sexual stimulation is needed for a man to obtain an erection.

Erectile dysfunction 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. Up to 80 per cent of ED cases are caused by physiological conditions, including cardiovascular disease and diabetes, with psychological factors accounting for the remaining 20 per cent. In many cases, however, both psychological and physical factors contribute to the condition.

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