By Brady Huggett

With two pivotal trials under way and churning out data from a third, ICOS Corp. filed a shelf registration statement for up to $300 million.

Once the statement is declared effective, ICOS can offer and sell its common stock, debt securities and convertible debt securities.

Lacy Fitzpatrick, associate director of investor relations at ICOS, said the funds would be used to further its products, among other things.

¿The funds will be used for research and development, commercialization of product candidates and general corporate uses,¿ she said from ICOS¿ offices in Bothell, Wash. ¿We expect to submit the [new drug application] on Cialis this year, and Pafase is in a Phase III clinical trial program.¿

ICOS had a cash position of about $216 million at the end of the first quarter. It has about 53 million shares outstanding. Fitzpatrick said ICOS¿ second-quarter results are due out July 26.

ICOS is working hard to give itself the opportunity to spend the $300 million on product commercialization. Its three lead products ¿ Cialis, Pafase and sitaxsentan ¿ all are in pivotal trials or nearing a filing for regulatory approval.

Cialis is being developed by the 50-50 joint venture between ICOS and Indianapolis-based Eli Lilly and Co., called Lilly ICOS LLC. Data from Cialis¿ first Phase III trial in men with diabetes-related erectile dysfunction were presented in April. Earlier this month data were presented from a separate Phase III study of Cialis in patients with erectile dysfunction. And there¿s more to come, Fitzpatrick said. (See BioWorld Today, April 9, 2001, and June 4, 2001.)

¿We¿ve presented Phase III data, we presented additional data in June at the American Urological Association [in Anaheim, Calif.],¿ she said. ¿And we¿ll present additional data at the European Society for Sexual Impotence Research in Rome.¿ The conference in Rome is scheduled for Sept. 30 through Oct. 3. The companies hope to file an NDA sometime after that.

In April, ICOS began enrollment in a pivotal Phase III trial in severe sepsis for its product Pafase, partnered with the Japanese company, Suntory Ltd. The trial is designed to enroll about 2,500 patients at about 150 sites. (See BioWorld Today, April 30, 2001.)

¿The team is working hard to increase the number of sites,¿ Fitzpatrick said. ¿The trial will start slow and ramp up as sites get added.¿ Fitzpatrick said there will be three interim analyses in the trial, allowing the trial to be stopped for any one of three reasons: efficacy, futility or safety concerns.

ICOS and its partner, Texas Biotechnology Corp., of Houston, have started recruiting patients for a Phase II/III trial with their oral endothelin A receptor antagonist, sitaxsentan. Whether or not they will file on the data is not yet clear, Fitzpatrick said. (See BioWorld Today, May 31, 2001.)

¿It¿s too early to say,¿ she said. ¿They had patients queued up at the start of the trial. We¿ll review the data, which we should have by mid-2002, and make the decisions on the next step.¿

After sitaxsentan, ICOS has a second oral endothelin A receptor selective antagonist product with Texas Biotechnology, called TBC3711. It is in Phase I for congestive heart failure and also essential hypertension. ICOS also has IC14, another product for sepsis, in Phase I. Fitzpatrick said the company plans to move that product to Phase II by the end of the year.

With so much activity in the clinic, what the shelf registration does is ensure that ICOS can get funds on its terms, Fitzpatrick said.

¿It allows us a lot of flexibility when the market is favorable,¿ she said.

ICOS¿ stock (NASDAQ:ICOS) fell 88 cents Tuesday to close at $60.

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