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Inter-amer 30 | LSE:BC43 | London | Medium Term Loan |
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BW20020725002442 20020725T190243Z UTC ( BW)(ELI-LILLY)(BC43) Lilly ICOS LLC: Tadalafil Receives Positive Opinion from European Committee for Proprietary Medicinal Products Business Editors UK REGULATORY NEWS INDIANAPOLIS--(BUSINESS WIRE)--July 25, 2002-- Lilly ICOS LLC (NYSE:LLY)(Nasdaq:ICOS) announced today that the European Committee for Proprietary Medicinal Products (CPMP) has issued a positive opinion for tadalafil, an investigational oral PDE5 inhibitor for the treatment of erectile dysfunction. The CPMP has recommended to the European Commission that approval should be granted. "We are extremely pleased by the CPMP's recommendation for approval of tadalafil in Europe," said Richard Pilnik, president of European operations for Lilly. "This positive action by the CPMP brings tadalafil one step closer to approval and launch in the European Union, and will soon help bring a new therapy to millions of men who suffer from ED." "Based on its clinical profile, we are confident in the value and potential for tadalafil," said Paul Clark, ICOS chairman and chief executive officer. "ED is a significant problem. In Europe alone, an estimated 31 million men suffer from the condition." The CPMP, comprised of regulators from the European Union countries, based its positive opinion on its review of the comprehensive data package of tadalafil. The submission was comprised of more than 60 studies in more than 4,000 humans to characterize the safety and efficacy profile of tadalafil. Following the CPMP's positive opinion, the application will be reviewed by the European Commission, which has authority to grant marketing authorization for the European Union. This authorization is anticipated for later this year. 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.(1) 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.(2) About Lilly ICOS LLC Lilly ICOS LLC, a joint venture between ICOS Corporation and Eli Lilly and Company, is developing 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 organisations. 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. The Company 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. The Company applies its integrated approach to erectile dysfunction and other urologic disorders, sepsis, pulmonary arterial hypertension and other cardiovascular diseases, and inflammatory diseases. ICOS' strategy targets multiple therapeutic areas with drugs that act through distinct molecular mechanisms, increasing the Company's opportunities to market breakthrough products. 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 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 et. Al BJU International, 1999:84:50-56. (2) Impotence World Association, www.impotenceworld.org Short Name: Lilly (Eli) & Co Category Code: MSC Sequence Number: 00000520 Time of Receipt (offset from UTC): 20020725T195031+0100 --30--db/in* CONTACT: Lilly Jane Calloway, 317/651-5870 Frances Beves, 44 127 648 4810 or ICOS Lacy Fitzpatrick, 425/415-2207 KEYWORD: INDIANA UNITED KINGDOM INTERNATIONAL EUROPE INDUSTRY KEYWORD: MEDICAL BIOTECHNOLOGY PHARMACEUTICAL PRODUCT SOURCE: Lilly (Eli) & Co Today's News On The Net - Business Wire's full file on the Internet with Hyperlinks to your home page. URL: http://www.businesswire.com
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