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Positive Results Reported for Phase 2 Study of Tadalafil in Treating Symptoms of Benign Prostatic Hyperplasia

BOTHELL, Wash. & INDIANAPOLIS--(BUSINESS WIRE)--Oct. 12, 2005-- Lilly ICOS LLC, a joint venture between Eli Lilly and Company (NYSE:LLY - News) and ICOS Corporation (Nasdaq:ICOS - News), 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 2 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.

Patients taking 5 mg tadalafil once-a-day, over a period of six weeks, experienced a mean 2.8 point improvement from baseline in the IPSS, compared to patients on placebo with a mean 1.2 point improvement. After stepping up to 20 mg tadalafil and continuing therapy once-a-day for another six weeks, patients experienced a mean 3.8 point improvement from baseline in the IPSS, compared to a mean 1.7 point improvement for patients on placebo. Both dosages showed clinically meaningful and statistically significant improvement in the primary endpoint. Additional results from the study of 250 patients will be presented at an upcoming medical congress.

In this Phase 2 study, the most frequently reported side effects were dyspepsia, back pain and headache. None of these side effects was reported by more than 5 percent of the study participants. There were no serious adverse events determined to be related to drug therapy. The reported adverse events were generally similar in this once-a-day study to those reported in other studies with tadalafil when administered on an as needed basis. The discontinuation rate due to adverse events was 3.6 percent for patients on tadalafil versus 1.4 percent on placebo.

"We are delighted with the outcome of this study," said Paul Clark, ICOS Chairman, President and Chief Executive Officer. "BPH is a large market with room for new therapies that have a different mechanism of action. Investment in this indication makes a great deal of sense for Lilly ICOS, since many physicians treating patients for the current approved use of tadalafil also treat patients with BPH. We look forward to beginning the Phase 3 studies and confirming these results."

Claus Roehrborn, M.D., Professor and Chair of Urology, University of Texas, Southwestern Medical Center, Dallas, stated, "Millions of men over the age of 45 suffer from lower urinary tract symptoms and BPH. The prospect of having an additional treatment option for these bothersome urinary symptoms is most welcome news for those physicians engaged in caring for the aging male."

About BPH
Benign enlargement of the prostate gland or BPH can cause a number of troublesome urinary tract symptoms as a man ages. The enlarged prostate gland can irritate the bladder and it can also exert pressure upon the urethra, which is the passageway for urine leaving the bladder. The symptoms of BPH include difficulty initiating urination, straining to pass urine, frequent urination, repeated awakening at night to urinate, incomplete emptying of the bladder, and even the inability to urinate.

More than half of men over age 50 have symptoms caused by BPH. More than 50 percent of men with BPH also suffer from ED.(1) It has been estimated that 6 million men in the United States and Europe are prescribed medicines to relieve symptoms associated with BPH.(2) In 2004, total sales of medications to treat BPH in the United States and Europe were approximately $2.5 billion.(3)

About Tadalafil
Tadalafil is an inhibitor of the phosphodiesterase (PDE) type 5 and may cause relaxation of the smooth muscle within the prostate. Tadalafil, in response to sexual stimulation, also relaxes smooth muscle in blood vessels in penile tissue and is the active ingredient in Cialis® (tadalafil), a prescription drug which is approved for the treatment of erectile dysfunction (ED).

Source: Lilly ICOS

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