Clinical Data Evaluate Efficacy and Safety Profile of Cialis -- tadalafil -- Among U.S. Patients
Monday April 28, 7:59 am ET
In A Second Global Study, Interim Data Evaluate Long-Term Safety of Cialis
INDIANAPOLIS--(BUSINESS WIRE)--April 28, 2003-- Clinical data on Cialis (pronounced see al iss) showed that 79 percent of U.S. men of diverse ethnic origin with erectile dysfunction (ED) participating in a clinical trial reported improved erections after treatment with the investigational drug, compared to 19 percent of those receiving placebo. The results of this new study conducted in the U.S. and Puerto Rico were presented today at the 98th Annual Meeting of the American Urological Association in Chicago. ED is a condition that affects an estimated 152 million men worldwide(1).
Cialis is a PDE5 inhibitor developed by Lilly ICOS LLC for the treatment of erectile dysfunction. Cialis is available by prescription in Europe, Australia, New Zealand, and Singapore. A U.S. regulatory decision for Cialis is anticipated to occur in the second half of 2003.
"Treatment with Cialis significantly improved erectile function, including increasing the number of successful attempts at penetration and intercourse, and the improvement of erections," said Allen Seftel, M.D, study author and associate professor of urology at the University Hospitals of Cleveland. "I was pleased with the tolerability profile seen in these U.S. men of diverse ethnic origin, with mild to severe ED."
Efficacy and Safety Among U.S. Men - Key Study Findings
In a randomized, placebo-controlled clinical study designed to evaluate the efficacy and safety of Cialis in men with mild-to-severe ED, 207 participants in the U.S. and Puerto Rico were assigned to receive either a 20 mg dose of Cialis or placebo over a 12-week period. The treatment phase was preceded by a treatment-free period of four weeks to determine baseline erectile function. Patients were advised to take the drug as needed, at the time of their choosing prior to sexual activity, and were informed that Cialis may be effective for up to 36 hours. In the study, men were advised to eat normal meals with no restrictions on fat content.
In the study, 79 percent of patients treated with Cialis reported improved erections, as determined by the Global Assessment Question, compared to 19 percent on placebo. Additional findings revealed that 77 percent of attempts at vaginal penetration, as recorded in the Sexual Encounter Profile diary, were successful in men taking Cialis, compared to 43 percent on placebo (p less than 0.001). Furthermore, men taking Cialis were able to complete 64 percent of attempts for sexual intercourse versus 23 percent of attempts for men taking placebo (p less than 0.001). Finally, men taking Cialis achieved statistically significant improvements compared to placebo for all other endpoints.
The most commonly reported (greater than or equal to 5 percent) treatment-emergent adverse effects in the study were headache, back pain, and upset stomach. The number of patients taking Cialis who discontinued the study because of adverse events was 5 percent, compared to 2 percent for placebo.
Long-Term Safety Data - Key Study Findings
A second clinical study presented at the annual meeting of the American Urological Association was designed to evaluate the long-term safety and tolerability of Cialis in 1,173 men with ED, who had previously been enrolled in Phase III clinical studies of Cialis conducted in multiple countries worldwide. These men included those who had a range of co-morbid conditions associated with ED, such as cardiovascular disease and diabetes mellitus. Data reported were from patients who had completed at least one year of treatment.
All study participants initially received 10 mg of Cialis; during the assessment period, 83 percent (n=970) of these patients increased their dosage to 20 mg. Patients were advised to take the treatment as needed prior to sexual activity.
Similar to other Cialis clinical trials, the most commonly reported treatment-emergent adverse effects in the study were headache and upset stomach. Five percent of patients discontinued the study due to side effects. The discontinuation rate in this study for any individual adverse event was less than 1%.
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 in the second half of 2003. Cialis is only available by prescription in pharmacies across Europe and in several other countries around the world.
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, developed tadalafil for the treatment of sexual 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 achieve commercial success or that competing products will not pre-empt any market opportunity that might exist for the product.
(1) 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.
(2) Impotency Information from NIH. NIH Publication No. 95-3923.1995
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Contact:
Eli Lilly and Company
Carole Copeland, 317/277-3661
or
ICOS
Lacy Fitzpatrick, 425/415-2207
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Source: Eli Lilly and Company |
