COMUNICADO DE LILLY ICOS LLC

Lilly ICOS' Cialis Significantly Improves Erections for Up to 36 Hours, New Analysis of Data Shows

BOTHELL (USA), 10 (PRNewswire)

A new analysis of data published in the British Journal of Urology shows that Cialis (tadalafil), a PDE5 inhibitor developed by Lilly ICOS LLC (NYSE: LLY; Nasdaq: ICOS) for the treatment of erectile dysfunction (ED), improved erections and rates of successful intercourse attempts for up to 36 hours after taking the pill. The authors of this manuscript, which contained a combined analysis of 11 separate Cialis clinical trials involving more than 2,000 men, concluded that Cialis is an effective and well-tolerated treatment option for men with ED, regardless of disease severity, cause or age.

"The combined results of 11 clinical trials make for compelling evidence that Cialis is an effective treatment option for erectile dysfunction for up to 36 hours after taking the tablet," said Culley C. Carson, M.D., chief of urology and Rhodes Distinguished Professor, University of North Carolina, Chapel Hill. "This analysis further confirms that the attribute that Cialis provides improvement in erectile function up to 36 hours may give men with ED increased confidence to choose when they engage in sexual intercourse, and thereby potentially allows for more spontaneity within their relationships."

The report includes data from 2,102 men with mild-to-severe ED who participated in 11 randomized, double-blind, placebo-controlled trials lasting 12 weeks. Participants were randomized to receive placebo or Cialis taken as needed with or without food at doses of 10 mg or 20 mg.

About 30 percent of men in each Cialis group attempted intercourse between 24 and 36 hours after taking the tablet.

On average, 73 percent of intercourse attempts by men in the 20 mg Cialis group were successful from 24 to 36 hours after taking the tablet.

Of patients who received 10 mg and 20 mg Cialis, 71 percent and 84 percent, respectively, reported improved erections, compared with 33 percent in the placebo group (p<0.001).

The most common side effects in these trials were headache, upset stomach and back pain. Most side effects were mild or moderate and generally decreased in frequency during treatment. The number of patients leaving the study due to side effects was low among patients taking each of the Cialis doses (10 mg, 1.6 percent; 20 mg, 3.2 percent), though the discontinuation rate was slightly higher than among those in the placebo group (1.3 percent, p=.026). The men in the study were of the mean age of 56 years, and almost three-quarters of them were taking another medication for another condition, including hypertension and diabetes. In the study, 29 percent of the men with ED had hypertension, and 20 percent had diabetes.

About Cialis

Cialis is licensed for the treatment of mild to severe ED at both 10 and 20 mg doses. Primary efficacy studies have shown up to 81 percent of men treated with Cialis (20 mg dose) reported improved erections compared with 35 percent of those taking placebo.(1)

Cialis is currently available in more than 60 countries, including Australia, Brazil, Mexico, Canada, the United States and countries throughout Europe. More than two 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 Erectile Dysfunction

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.(2) 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.(3)

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 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 the 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 achieve commercial success or that competing products will not pre-empt any market opportunity that might exist for the product.

(1) European Summary of Product Characteristics.

(2) 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.

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

(Logo: http://www.newscom.com/cgi-bin/prnh/20040122/LILLYICOSLOGO )

Source: Lilly ICOS LLC

Contact: Jane Calloway of Lilly, +1-317-651-5870; or Lacy Fitzpatrick of ICOS, +1-425-415-2207

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