Men Taking Cialis -- tadalafil -- Reported Intercourse Success at 24 and 36 Hours After Taking the Medication Being Developed by Lilly ICOS
Thursday June 5, 8:29 am ET
BOTHELL, Wash. & INDIANAPOLIS--(BUSINESS WIRE)--June 5, 2003--For release in the United States--The majority of men who took Cialis(TM) (tadalafil), an investigational oral treatment for erectile dysfunction (ED) being developed by Lilly ICOS LLC (NYSE:LLY - News; Nasdaq:ICOS - News), reported a successful intercourse attempt at 24 or 36 hours after taking the medication, according to research published in the June 2003 issue of Urology.
"Cialis was statistically superior in the study, compared to placebo, in allowing men with ED to successfully engage in intercourse at 24, and even 36 hours after taking the drug," said study author Professor Dr. Hartmut Porst, leader of a private urological and andrological institute in Hamburg, Germany. "Cialis showed consistent effectiveness at both time points."
In the Cialis group, 61 percent (P less than 0.001) of patients reported a successful intercourse attempt at 24 hours compared to approximately 37 percent for the placebo group. At 36 hours, 64 percent (P less than 0.001) of patients taking Cialis reported a successful intercourse attempt against 35 percent with placebo. A successful intercourse attempt was defined as the ability of a man to achieve and maintain an erection to the completion of sexual intercourse. Of all intercourse attempts at the 36-hour time point, 59 percent were successful for patients on Cialis versus 28 percent for those on placebo (P less than 0.001). For intercourse attempts at 24 hours, 53 percent were successful for patients on Cialis versus 29 percent for those on placebo (P less than 0.001).
As stated in the publication, "The extended period of responsiveness afforded by tadalafil, which has a terminal half-life of 17.5 hours, may begin to change the treatment paradigm for men with ED." Dr. Porst continued, "Unlike currently available treatments, tadalafil may, for example, enable a patient to take a pill on a Friday evening and have intercourse with his partner on Saturday night or Sunday morning and may allow men and their partners more freedom in the timing of their sexual activity."
The most commonly reported (greater than 3 percent) treatment-emergent adverse events with Cialis in the study were headache, flushing, upset stomach and mylagia. There were no color vision abnormalities reported. Two percent of patients (n=3) taking Cialis discontinued the study due to side effects versus 0.5% for placebo. There were no serious adverse events reported after treatment was started.
Cialis Period of Effectiveness -- Study Methodology
The Phase III trial conducted at 36 centers in the United States and Europe was designed to evaluate the primary endpoint of percentage of successful sexual intercourse attempts at specific time points -- 24 and 36 hours -- after dosing. The study included 348 men with mild-to-severe ED and randomly assigned patients to receive Cialis 20 mg (n=175) or placebo (n=173) over an approximate eight-week period with no restrictions on alcohol or food intake. Patients were advised to attempt intercourse with their respective partners on four specific occasions: on two occasions at about 24 hours after dosing, and on two occasions at about 36 hours after dosing. The results are from data recorded between 22 and 26 hours (categorized as the 24-hour time point), and between 34 and 38 hours (categorized as the 36-hour time point).
About Cialis
Lilly ICOS received an approvable letter for Cialis from the Food and Drug Administration in April 2002 and anticipates a U.S. regulatory decision for Cialis later in the second half of 2003. Cialis is available in approximately 30 countries including countries in Europe, Australia, Brazil, 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.
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, psoriasis, 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.
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Contact:
Lilly ICOS LLC
Carole Copeland, 317/277-3661 (Lilly)
Lacy Fitzpatrick, 425/415-2207 (ICOS)
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Source: Lilly ICOS LLC |
