Associate

With an expected Cialis decision before the end of the year, ICOS Corp. filed a shelf registration for up to $150 million worth of stock, debt securities and convertible debt securities.

The company said in its prospectus it would use the proceeds to fund research and clinical development as well as commercialization of potential products and for general corporate purposes.

As of May 16, the company had about 62.3 million shares outstanding. Its stock (NASDAQ:ICOS) fell 90 cents Wednesday to close at $33.02.

In June 2001, Lilly ICOS - a joint partnership formed by ICOS, of Bothell, Wash., and Eli Lilly and Co., of Indianapolis, to commercialize Cialis - submitted a new drug application for Cialis for the treatment of erectile dysfunction. In April 2002, the companies received an approvable letter that indicated approval was conditional on completing additional pharmacology studies, on labeling discussions and on manufacturing inspections. (See BioWorld Today, June 29, 2001, and May 1, 2002.)

Cialis is available by prescription in about 30 countries, including the 15 member countries of the European Union and Australia, New Zealand, Russia, Brazil and Saudi Arabia.

Cialis (tadalafil), an oral PDE5 inhibitor, has competition from New York-based Pfizer Inc.'s Viagra and Levitra, developed by Bayer AG, of Leverkusen, Germany, and its marketing partner, GlaxoSmithKline plc, of London. Levitra is approved in Europe, and Bayer received an approvable letter from the FDA and could receive a decision as early as August.

ICOS expects a Cialis FDA decision late in the second half of the year, with product launch anticipated to occur shortly thereafter, it said in its prospectus.

Lilly ICOS has joint responsibility for Cialis in North America and Europe. Lilly has rights in other parts of the world, with royalties to be paid to Lilly ICOS. Cialis is manufactured by Lilly, an arrangement expected to continue.

Other action in the ICOS pipeline includes IC747 in Phase IIa development in collaboration with Biogen Inc., of Cambridge, Mass., for moderate to severe psoriasis. RTX is in a Phase II trial in interstitial cystitis. The company stopped a Phase III trial of Pafase for the treatment of severe sepsis in late 2002, but has IC14 in a Phase II sepsis trial. It has tadalafil in a Phase II diabetic gastroparesis trial and IC485 in a Phase I trial in chronic obstructive pulmonary disease. (See BioWorld Today, Dec. 20, 2002.)

For the three months ended March 31, ICOS reported a net loss of $40.5 million, or 65 cents per share, compared to a net loss of $39.2 million for the year-earlier period. As of March 31, it had cash, cash equivalents, investment securities and associated interest receivable of $307.6 million.