Newly published clinical data on Cialis(R) (tadalafil) published in the September issue of the Journal of Urology show that 62 percent of men who underwent bilateral nerve-sparing radical retropubic prostatectomy (BNSRRP), a surgery for prostate cancer, reported improved erections after taking the drug. Experts have said that more than half of men report erectiledys function (ED) 18 months or more after this form of radical prostatectomy(1), a cause of ED that is among the most difficult to treat.

“After the difficult journey of prostate cancer, to also be faced with erectile dysfunction can be both daunting and discouraging to a man and his partner,” said Francesco Montorsi, M.D., from the Department of Urology, Universita Vita Salute San Raffaele, Milan, Italy. “These data offer hope that by using Cialis, men may regain an important part of their lives that might have otherwise been lost following their prostate surgery.”

The study, conducted in 2002, demonstrated that 62 percent of men who developed ED following BNSRRP reported improved erections after taking 20 mg Cialis, compared with 23 percent with placebo, based on the question of whether the treatment they were taking improved their erections.

- Patients recorded that a majority of sexual attempts (54 percent) by men who took Cialis resulted in successful vaginal penetration as compared with 32 percent on placebo (p < 0.001).

- In a subgroup of men (N=201) who were able to experience some erection following this type of radical prostatectomy, 71 percent experienced an improved erection compared with 24 percent on placebo (p < 0.001).

- The most commonly reported (>/= 5 percent) treatment-emergent side effects with Cialis in the study were headache, upset stomach and muscle ache.

This Phase III multicenter study consisted of a four-week treatment-free period followed by 12 weeks of treatment with 20 mg Cialis or placebo. In the study, 303 men who had undergone bilateral nerve sparing radical prostatectomy 12-48 months before the study were randomized (2:1) to 20 mg Cialis or placebo. The study included a subgroup of 201 men who still retained the ability to have some erection following this type of surgery.

About Cialis

Cialis is licensed for the treatment of mild to severe ED at both 10 mg and 20 mg doses. Primary efficacy studies have shown that up to 81 percent of men treated with Cialis (20 mg dose) reported improved erections compared with 35 percent of those taking placebo.(2)

Cialis is currently available in more than 90 countries, including Australia, Brazil, Mexico, Canada, the United States and countries throughout Europe. Nearly 3 million patients worldwide have been treated with Cialis since its first introduction in February 2003. Cialis is available by prescription only and is the only oral ED treatment shown to improve erectile function up to 36 hours. 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 side effects with Cialis are headache, upset stomach, nasal congestion, delayed backache, muscle ache, dizziness and flushing. The side effects 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.

About ED

Erectile dysfunction is defined as the consistent inability to attain and maintain an erection sufficient for sexual intercourse. ED affects an estimated 152 million men and their partners worldwide.(3) Up to 80 percent of ED cases are caused by physiological conditions, including cardiovascular disease and diabetes, with psychological factors accounting for the remaining 20 percent. In many cases, however, both psychological and physical factors contribute to the condition.(4)

About Lilly ICOS LLC

Lilly ICOS LLC, a joint venture between ICOS Corporation and Eli Lilly and Company, developed tadalafil for the treatment of erectile dysfunction.

Eli Lilly and Company (NYSE: LLY), a leading innovation-driven corporation, is developing a growing portfolio of first-in-class and best-in-class pharmaceutical products by applying the latest research from its own worldwide laboratories and from collaborations with eminent scientific organizations. Headquartered in Indianapolis, Indiana, Lilly provides answers - through medicines and information - for some of the world’s most urgent medical needs.

ICOS Corporation (Nasdaq: ICOS), a biotechnology company, is dedicated to bringing innovative therapeutics to patients. Headquartered in Bothell, Washington, ICOS is marketing its first product, Cialis (tadalafil), for the treatment of erectile dysfunction. ICOS is working to develop treatments for serious unmet medical conditions such as chronic obstructive pulmonary disease, cancer and inflammatory diseases.

Certain of the matters discussed herein with respect to clinical studies and commercial plans for ICOS and Lilly’s products may constitute forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Such forward-looking statements are based on current expectations, estimates and projections about the industry, management beliefs and certain assumptions made by management. Investors are cautioned that matters subject to forward-looking statements involve risks and uncertainties, including economic, competitive, governmental, technological and other factors discussed in the two companies’ respective filings with the Securities and Exchange Commission, which may affect the business and prospects of the two companies. More specifically, there can be no assurance that this product will receive regulatory approvals as expectedor achieve commercial success or that competing products will not pre-emptany market opportunity that might exist for the product. The companies undertake no duty to update forward-looking statements.

(1) Stanford, et al. JAMA Vol. 283, No. 3. January 19, 2000.

(2) European Summary of Product Characteristics.

(3) Aytac IA, McKinlay JB, Krane RJ. The Likely Worldwide Increase in Erectile Dysfunction Between 1995 and 2025 and Some Possible Policy Consequences. BJU Int 1999; 84: 50-56.

(4) Impotency Information from NIH. NIH Publication No. 03-3923, November 2002.

Source: Lilly ICOS