European Commission Adopts Changes to Lilly ICOS' Cialis(R) Labeling to up to 36 Hours of Effectiveness

BOTHELL (EEUU), 24 (PRNewswire)

Lilly ICOS LLC (NYSE: LLY and Nasdaq: ICOS) announced today that the European Commission has adopted changes to the label for Cialis(R) (tadalafil), Lilly ICOS' oral PDE5 inhibitor for the treatment of erectile dysfunction (ED). The new Summary of Product Characteristics and Patient Leaflet indicate that Cialis may be effective for up to 36 hours after taking the tablet.(1)

"This decision marks an important milestone for Cialis because the European label is now consistent with other labels around the world in acknowledging that Cialis provides men with the potential for up to 36 hours of effectiveness in which to engage in intimacy. In the year since European launch, we have seen that men and their partners prefer Cialis precisely because of this attribute," said Richard Pilnik, President of European Operations for Lilly. "This effectiveness gives men confidence that they can respond to their partner not just in the first four hours but also at any time up to 36 hours."(2)

"Product labeling worldwide reinforces how Cialis is different from other oral ED tablets," said Paul Clark, ICOS Chairman and Chief Executive Officer. We believe men and their partners understand and appreciate this difference and we see them voting with their prescriptions. The market share for Cialis in some European countries exceeds 25 percent. We have seen published studies that show men have chosen Cialis over other products in its class."

The European label change became effective on January 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.(3) In the analysis of 580 men taking 20 mg Cialis, 73 percent of intercourse attempts were successful in response to stimulation between 12 and 24 hours after dosing. For 395 men, 73 percent of intercourse attempts were also successful during the 24 to 36 hour period after taking the tablet.

The importance of the duration of effectiveness of ED therapies was recently investigated as part of a clinical study assessing preference among competing ED therapies. The independent study, to be presented at the 4th World Congress on the Aging Male (WCAM) later this month confirms that more men prefer Cialis to Viagra(R) (sildenafil citrate)(4). In this study, men were asked which treatment they would prefer to continue to take after the trial. The results showed that 62 percent of men who tried both drugs chose to continue with Cialis, compared to only 20 percent who opted for Viagra. In the study, the key reason men gave for preferring Cialis was the extended period of effectiveness.

"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 makes Cialis the preferred choice for many of my patients. Our data confirm a number of studies that now show men with ED value this longer period of effectiveness, which gives them back spontaneity in their relationships."

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,(5) Cialis had a 33 percent share in France, 30 percent in Germany, 27 percent in Italy and 18 percent in both Spain and the United Kingdom.

The label also cautions against combining Cialis with CYP3A4 inhibitors, and includes further dosing information for men with severely impaired kidney function and for men with impaired liver function.

Cialis is licensed for the treatment of mild to severe ED at both 10 and 20 mg doses. Primary efficacy studies have shown up to 81 percent of men treated with Cialis (20 mg dose) reported improved erections compared with 35 percent of those taking placebo.(6)

Cialis is currently available in more than 70 countries, including Australia, Brazil, Mexico, Canada, the United States and countries throughout Europe. Almost two million patients worldwide have been treated with Cialis since its first introduction in February 2003. Cialis is available by prescription only. 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.

The most commonly reported adverse events with Cialis are 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 or for those who have cardiac disease and for whom sexual activity is not advisable. The use of a specific type of alpha blocker, alpha (1) blockers like doxazosin, is not recommended due to the possibility of lowering blood pressure to unsafe levels in some men.