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

Article Excerpt
BOTHELL, Washington and INDIANAPOLIS, Indiana, February 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...