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Biotech / Medical : ICOS Corporation -- Ignore unavailable to you. Want to Upgrade?

To: SemiBull who wrote (996)	7/1/2003 7:40:43 PM
From: SemiBull	Read Replies (1) \| Respond to of 1139

Lilly ICOS Statement Regarding Submission to FDA of Complete Response for Cialis ``tadalafil'' Tuesday July 1, 4:31 pm ET BOTHELL, Wash. & INDIANAPOLIS, Ind.--(BUSINESS WIRE)--July 1, 2003--Lilly ICOS LLC disclosed today that, during the 2003 second quarter, it submitted a response to the U.S. Food and Drug Administration (FDA) of requested data on Cialis® (tadalafil), its investigational PDE5 inhibitor in development for the treatment of erectile dysfunction. Also, during the 2003 second quarter, the FDA advised Lilly ICOS that it has accepted the submission as complete. The complete response contained clinical pharmacology and other data that were requested when the FDA issued an approvable letter regarding Cialis in April 2002. Lilly ICOS continues to expect a regulatory decision regarding Cialis late in the second half of 2003, following the FDA's review of the complete response, approval of Lilly's manufacturing facilities and completion of labeling discussions. Cialis is now available in pharmacies on five continents. Since its commercial launch in Europe, in February 2003, the number of countries where the sale of Cialis has received regulatory approval has grown to approximately 35. Lilly ICOS is marketing Cialis in the European Union, and Lilly has exclusive rights to market Cialis in all other territories where the product is presently approved. About Lilly ICOS Lilly ICOS, a joint venture between ICOS Corporation (Nasdaq:ICOS - News) and Eli Lilly and Company (NYSE:LLY - News), is developing Cialis, a PDE5 inhibitor, in the European Union and North America for the treatment of erectile dysfunction. About Lilly 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. About ICOS 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, and sepsis and other 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 PDE5 inhibitors developed by Lilly ICOS will receive regulatory approvals 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. Contact: Lilly Carole Copeland, 317/277-3661 or ICOS Lacy Fitzpatrick, 425/415-2207 Source: Lilly ICOS LLC