FDA Delays Impotence Drug From Lilly, Icos

Eli Lilly & Co. and Icos Corp. said U.S. regulators want more studies before approving their Cialis impotence drug, delaying a rival to Pfizer Inc.’s Viagra and forcing Lilly to trim profit forecasts.

The introduction of Cialis, which analysts expected to have annual sales of about $750 million, will be postponed until 2003 as the companies try to meet Food and Drug Administration demands. The FDA found Cialis “approvable” subject to additional studies, agreement on labeling and inspection of manufacturing facilities.

Lilly cut its 2002 and 2003 profit forecasts because of the Cialis setback and disappointing sales of Xigris, a new treatment for sepsis. Lilly had counted on the new drugs for growth as generic competition erodes sales of its Prozac antidepressant. Cialis would have been Icos’ first product on the market.

Shares of Indianapolis-based Lilly fell $2.25, or 3.3%, to $66.05 on the NYSE. Icos shares fell $13.24, or 34%, to $25.76 on Nasdaq, the biggest one-day drop since the Bothell, Wash.-based biotechnology company went public in 1991.