Lilly ICOS Anticipates US Approval for Cialis in Second Half 2003
Friday May 2, 12:16 pm ET
INDIANAPOLIS--(BUSINESS WIRE)--May 2, 2003--August Watanabe, MD, executive vice president, science and technology, Lilly, confirmed today at a Morgan Stanley Healthcare conference that the Lilly ICOS joint venture continues to anticipate US approval for Cialis later in the second half of 2003.
Cialis is a PDE5 inhibitor developed for the treatment of erectile dysfunction. Cialis is already available by prescription in several markets including Europe, Brazil, Australia, New Zealand, and Singapore.
Dr. Watanabe also stated that Lilly ICOS has been in discussions with the US Food and Drug Administration (FDA) and expects to file the complete response to the approvable letter for Cialis shortly.
"We remain confident in the efficacy and safety profile of Cialis and are very pleased with the initial, strong uptake in markets where Cialis has already launched," said Dr. Watanabe. "We anticipate making the treatment available worldwide."
About Cialis and ED
Lilly ICOS received an approvable letter for Cialis from the Food and Drug Administration in April 2002.
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(1).
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 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.
(1) Impotency Information from NIH. NIH Publication No. 95-3923.1995
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Contact:
Lilly
Carole Copeland, 317/277-3661
or
ICOS
Lacy Fitzpatrick, 425/415-2207
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Source: Lilly ICOS |
