New Data From Lilly ICOS Describe Efficacy of Cialis in Difficult-to-Treat Prostatectomy Patients.

Business Editors/Health/Medical Writers

BOTHELL, Wash. & INDIANAPOLIS--(BUSINESS WIRE)--Oct. 10, 2003

Additional Analyses Highlight Sexual Attempts at Various

Time Intervals and Cialis Efficacy After First Dose

Among new clinical data on Cialis(R) (tadalafil) presented this weekend, 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 erectile dysfunction (ED) 18 months or more after this form of radical prostatectomy(1), which is among difficult to treat causes of the condition.

"Despite numerous advances in prostatectomy technique, data suggest that localized nerve trauma leaves many men with ED that is quite challenging to manage," said Joel Kaufman, M.D., Medical Director of Urology Research Options, Aurora, Colo. "In this trial, men taking Cialis reported an improvement in measures of improved erections, and maintaining erections for both penetration and completion of intercourse."

Cialis is a new investigational PDE5 inhibitor being developed by Lilly ICOS LLC (Lilly ICOS) for the treatment of ED. This weekend, several abstracts on Cialis will be formally presented at the annual meeting of the Sexual Medicine Society in Denver.

Other findings announced this weekend include:

-- 82 percent of men in an analysis of clinical trials attempted

intercourse at least once between four hours and up to 36

hours after taking the drug over a 12 week period

-- Up to 67 percent of men with ED in another set of clinical

trials reported they were able to have successful intercourse

after taking Cialis for the first time.

Cialis Efficacy in BNSRRP Patients

The study demonstrated that 62 percent of men who developed ED following BNSRRP, a surgery for prostate cancer, reported improved erections after taking Cialis 20mg, compared to 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 to 32 percent on placebo (p less than

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 to 24

percent on placebo (p less than 0.001).

-- The most commonly reported (greater than or equal to 5

percent) treatment-emergent adverse events with Cialis in the

study were headache, upset stomach, and muscle ache.

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

Time Distribution of Sexual Intercourse Attempts with Cialis

In an analysis of studies assessing the time distribution of intercourse attempts by men with ED after taking Cialis:

-- 82 percent of men attempted intercourse at least once between

four and 36 hours after taking Cialis 10mg or Cialis 20mg over

a 12-week period. The pattern of attempts was similar in the

placebo group.

These data were compiled from 11 randomized, double-blind placebo controlled 12-week efficacy studies evaluating 2,102 men with ED taking Cialis 10mg, 20mg, or placebo. Medication was taken prior to sexual activity without restriction to timing of subsequent sexual intercourse attempts. In the studies, among the most commonly reported side effects reported were headache, upset stomach, backache, and muscle ache.

Early Treatment Success with Cialis

In a retrospective analysis of data from five clinical trials among a broad population of 887 men with ED assessing intercourse after the first dose taken, 67 percent of men who took Cialis 20mg and 56 percent of men who took Cialis 10mg experienced successful intercourse with their very first dose, both compared to 31 percent for the placebo group (p less than 0.001).

-- After the first four doses, 86 percent of men who took Cialis

20mg and 72 percent of men who took Cialis 10mg achieved

successful intercourse for the first time compared to 48

percent of men on placebo (p less than 0.001).

-- Among those men who had a successful intercourse attempt with

their first dose, 88 percent of subsequent intercourse

attempts were successful for those who took Cialis 20mg and 81

percent of those who took Cialis 10mg over the 12-week

treatment period. Both compared to 64 percent in the placebo

group (p less than 0.001).

These data were compiled from five double blind placebo-controlled studies with 12-weeks of treatment with Cialis or placebo in men with ED. Patients were instructed to take Cialis prior to sexual activity and without regard to food. In the studies, among the most commonly reported side effects reported were headache, upset stomach, backache, and muscle ache.

About Cialis

Lilly ICOS received an approvable letter for Cialis from the U.S. Food and Drug Administration in April 2002 and anticipates a U.S. regulatory decision for Cialis late in 2003. Cialis is for sale in more than 40 countries, including countries in Europe and in Australia, Brazil, Mexico, Russia, and Saudi Arabia.

About ED

ED is defined as the consistent inability to attain and maintain an erection sufficient for sexual intercourse. 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 physiological factors contribute to the condition.(2)

About Lilly ICOS LLC

Lilly ICOS LLC, a joint venture between ICOS Corporation and Eli Lilly and Company, is developing Cialis for the treatment of erectile dysfunction.

Eli Lilly and Company, a leading innovation-driven corporation, is developing a growing portfolio of 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 is a product-driven company that has expertise in both protein-based and small molecule therapeutics. ICOS combines its capabilities in molecular, cellular and structural biology, high throughput drug screening, medicinal chemistry and gene expression profiling to develop highly innovative products expected to have significant commercial potential. ICOS applies its integrated approach to erectile dysfunction and other urologic disorders, sepsis and inflammatory diseases. ICOS' strategy targets multiple therapeutic areas with drugs that act through distinct molecular mechanisms, increasing ICOS' opportunities to market breakthrough products.

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 expected or achieve commercial success or that competing products will not pre-empt any 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) Impotency Information from NIH. NIH Publication No. 95-3923.1995.