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LILLY ICOS ANNOUNCES POSITIVE RESULTS FROM TADALAFIL STUDY

October 12, 2005

Lilly ICOS, a joint venture between Eli Lilly and ICOS Corporation, has announced positive results from a double-blind, placebo-controlled clinical study of tadalafil in the treatment of lower urinary tract symptoms in men with benign prostatic hyperplasia (BPH).

The Phase II proof-of-concept study demonstrated clinically meaningful and statistically significant improvement in the primary endpoint, the International Prostate Symptom Score (IPSS), a seven-item questionnaire that assesses the severity of symptoms of BPH and the response to therapy. The IPSS is the standard scale used for the evaluation of medications that treat the symptoms of BPH. In addition, tadalafil demonstrated statistically significant improvement relative to placebo on most of the secondary endpoints included in the study.