Washington Editor

Biogen Inc. returned full rights to a leukocyte function-associated antigen-1 (LFA-1) antagonist studied in psoriasis to partner ICOS Corp. following disappointing results in a Phase IIa trial.

While neither company would discuss details of the trial, David Goodkin, ICOS' vice president, development and chief medical officer, released a prepared statement saying the 28-day exploratory Phase IIa suggested that the product, IC747, was safe, but not efficacious.

"What you can conclude is that after looking at the Phase IIa results, it was not something that we wanted to pursue," Amy McKnight, Biogen's associate director, public affairs, told BioWorld Today. "So the results were not what they needed to be."

Even though ICOS has full ownership of IC747, the Bothell, Wash.-based company does not plan to pursue development of that particular molecule, Lacy Fitzpatrick, the company's director, investor relations, told BioWorld Today.

However, ICOS does plan to continue studying LFA-1 antagonists.

"We have some backup compounds in preclinical and we believe there are some that are more worthy of going forward," Fitzpatrick said. "LFA-1 may be involved in autoimmune diseases in which the body's immune system attacks specific various organs, like the skin in psoriasis and the nervous system in multiple sclerosis, but psoriasis is the only indication we've evaluated with patients."

LFA-1 is a cell adhesion molecule found on certain immune cells. It plays a role in the activation and trafficking of T cells at sites of inflammation. ICOS scientists believe LFA-1 antagonists bind to LFA-1 and inhibit T-cell migration and activation.

Financially, the deal, dating back to the summer of 2001, cost Cambridge, Mass.-based Biogen about $25 million, McKnight said.

When the companies signed it, Biogen paid ICOS $8 million, and later paid a $2 million milestone at the start of the Phase IIa study. ICOS borrowed $15 million from Biogen under a "forgivable" loan to cover its share of development. McKnight said the outstanding balance has been forgiven. (See BioWorld Today, July 17, 2001.)

In a prepared statement, ICOS said its second-quarter earnings will recognize as revenue about $21 million in up-front fees and forgiven loans that had been recorded as deferred revenue.

Elsewhere at ICOS, the company, alongside partner Eli Lilly and Co., of Indianapolis, is preparing additional data and information in response to an FDA request regarding the Cialis (tadalafil) new drug application. Cialis is an erectile dysfunction drug that reportedly works longer than New York-based Pfizer Inc.'s Viagra and Leverkusen, Germany-based Bayer AG's Levitra. Bayer's partner is GlaxoSmithKline plc, of London. Levitra has yet to be approved by the FDA. (See BioWorld Today, June 29, 2001, and May 1, 2002.)

ICOS and Lilly hope to satisfy the FDA's requests by late June, and look forward to approval later this year.

ICOS' stock (NASDAQ:ICOS) closed Friday at $40.25, up $1.35. Biogen's stock (NASDAQ:BGEN) closed at $46.41, down $2.73.