Press Release Source: Eli Lilly
REPEAT/Cialis -- tadalafil -- Approved by European Commission for the Treatment of Erectile Dysfunction
Thursday November 14, 9:58 am ET
BOTHELL, Wash. & INDIANAPOLIS--(BUSINESS WIRE)--Nov. 14, 2002-- Lilly ICOS LLC (NYSE:LLY - News; Nasdaq:ICOS - News) announced today that the European Commission has granted a marketing authorization for Cialis(TM) (tadalafil), an oral PDE5 inhibitor for the treatment of erectile dysfunction (ED) for all 15-member states of the European Union. The approval decision follows a positive opinion adopted July 25, 2002, by the European Committee for Proprietary Medicinal Products (CPMP).
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Lilly ICOS anticipates launching Cialis in Europe during the first half of 2003.
The European Commission based its decision on the review and evaluation of the comprehensive data package of Cialis that comprised results of more than 60 studies in more than 4,000 people to characterize the safety and efficacy profile of Cialis. The randomised, placebo-controlled, Phase 3 primary efficacy studies of Cialis involved 1,112 men (804 Cialis, 308 placebo) with ED of various causes and severity and evaluated doses including 10 and 20 mg.
"Not only is the approval of Cialis a significant milestone for Lilly ICOS, but we believe it is an important step forward for millions of men in Europe who suffer from ED," said Paul Clark, ICOS chairman and chief executive officer.
"Cialis will provide an important new treatment option for many of the 31 million men in Europe with ED," said Richard Pilnik, president of European operations for Lilly. |
