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Cialis (Tadalafil), Treatment For Erectile Dysfunction, Now Available In Europe, New Zealand, And Australia New therapeutic option an important development for men who suffer from ED BOTHELL, WA and INDIANAPOLIS, IN -- February 4, 2003 -- Lilly ICOS LLC (NYSE:LLY) (Nasdaq:ICOS) announced today that Cialis™ (tadalafil), an oral PDE5 inhibitor for the treatment of erectile dysfunction (ED), is available in pharmacies in Europe, as well as in Australia and New Zealand. "The launch of Cialis in these major markets of Europe, Australia and New Zealand is an important milestone for Lilly ICOS," said Richard Pilnik, president of European operations for Lilly. "Cialis will be an important treatment option for many of the millions of men in these countries who suffer from ED, and we are excited about this initial launch of the product," said Paul Clark, ICOS Chairman and chief executive officer. Availability Cialis is now broadly available by prescription in pharmacies in the United Kingdom, Germany, Denmark, Finland, Sweden, and Australia. Launches in additional European countries will be announced in the coming weeks. Cialis will be available in New Zealand later this month. Cialis is approved in these markets for the treatment of mild to severe ED at both 10 and 20 mg doses. The labels in each of these markets indicate that the product should be taken prior to anticipated sexual activity and without regard to food. Sexual stimulation is needed for Cialis to work. According to the European label, the efficacy of Cialis may persist up to 24 hours after the pill is taken. In Australia the label indicates efficacy up to 36 hours after dosing. Clinical Data Overview More than 4,000 men have participated in more than 60 studies that characterized the safety and efficacy profile of Cialis. In primary efficacy studies involving 1,112 men (804 Cialis, 308 placebo) with mild to severe ED, up to 81 percent of those treated with Cialis reported improved erections compared with 35 percent of those taking placebo1. The most commonly reported adverse events were headache, upset stomach, nasal congestion, backache, muscle ache, dizziness, and flushing. The adverse events 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. It should not be taken by patients with certain heart diseases for whom sexual activity itself is not advisable. Cialis is not approved for sale in the United States. Lilly ICOS received an approvable letter for Cialis from the Food and Drug Administration in April 2002. About ED ED 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 worldwide2. 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 condition3. 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 with 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 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. References: (1) Brock GB, McMahon CG, Chen KK et al. Efficacy and Safety of Tadalafil in the Treatment of Erectile Dysfunction: Results of Integrated Analyses. J Urol 2002; 168: 1332-1336. (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. 95-3923.1995 SOURCE: Lilly ICOS LLC E-mail this page to a friend or colleague! To print, use this version