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

To: Icebrg who wrote (990)	6/11/2003 8:14:44 PM
From: SemiBull	Respond to of 1139

Eli Lilly Still Sees Cialis' FDA Approval By Year-End Wednesday June 11, 12:27 pm ET By Hollister H. Hovey, Of DOW JONES NEWSWIRES NEW YORK (Dow Jones)--Eli Lilly & Co. and ICOS Corp.'s new erectile dysfunction drug Cialis has captured average market shares of 20% to 30% in the countries where it's been launched, John C. Lechleiter, Lilly's executive vice president of pharmaceutical products said Wednesday. Lechleiter gave a presentation to the Goldman Sachs Annual Healthcare Conference in Dana Point, Calif., Wednesday, but the speech wasn't Web cast. Lechleiter's comments have been taken from a transcript of the speech Lilly concurrently posted on its Web site. Cialis, which competes with Pfizer Inc.'s (PFE) Viagra and another recently launched erectile dysfunction drug, Levitra, made by GlaxoSmithKline PLC (GSK) and Bayer AG (BAY), is now available in 30 countries outside the U.S. Lechleiter said the market-share data came from the first 60 to 90 days of marketing in those countries. Lechleiter said the companies still expect the U.S. Food and Drug Administration (News - Websites) to approve Cialis in the second half of the year. "Approval will be contingent upon a successful review of the clinical pharmacology studies and the completion of labeling discussions with the FDA," he said. The company, which is emerging from a tough phase following the loss of patent protection on blockbuster antidepressant Prozac, expects the FDA to approve its new antidepressant Cymbalta in the fourth quarter. The company plans to file for European approval of Cymbalta later this year, he said. Earlier Wednesday, Lilly said FDA investigators recently concluded the reinspection of its Indianapolis dry-products facility, which makes Cymbalta, and its injectible-drug facility, also in Indianapolis, which makes the yet-to- be approved injectible version of its antipsychotic Zyprexa. But the agency issued a Form 483, which notifies top management in writing of significant objectionable conditions relating to products or processes observed during the inspection. Lechleiter's speech said the company and the agency are still in the review process and will give investors an update later. It remains unclear what concerns the FDA may have raised in the Form 483 and how this may affect product approval times, if at all. According to the FDA's Web site, an inspector should only report "significant observations" on the form. "Observations of lesser significance should be discussed with firm management and properly reported in the narrative report," the agency's site said. An FDA spokeswoman said that the company will have to fix any problems listed in the Form 483, and then the agency will reinspect the facility again. -By Hollister H. Hovey, Dow Jones Newswires; 201-938-5287; hollister.hovey@dowjones.com Corrected June 11, 2003 14:28 EDT (18:28 GMT) Eli Lilly & Co.'s executive vice president of pharmaceutical products is John C. Lechleiter. (A report at 12:27 p.m. misspelled his name throughout the story.)

To: Icebrg who wrote (990)	6/13/2003 3:40:22 PM
From: Icebrg	Read Replies (1) \| Respond to of 1139

NEW YORK, June 13 (New Ratings) - Analysts at Robert W Baird issue an "outperform" rating on ICOS Corp (ICOS). The target price has been raised from $40 to $50. The analysts mention that despite an increase of 80% in the stock price year-to-date, upside potential is still visible. The analysts say that ICOS’ 50% share in Cialis, marketed in partnership with Lilly, is on track to record $35 million in revenues from Europe alone during the current quarter. The company has already secured 30% of the market for the drug, the analysts report. [With the current share price around 43-44, he doesn't seem to be expecting much from the rest of the market].