Lilly ICOS LLC filed a new drug application Thursday for an erectile dysfunction drug expected to pose competition to Pfizer Inc.s blockbuster product Viagra.
The NDA was based on positive results from a Phase III placebo-controlled study of the compound, known as Cialis, in which 85 percent of patients experienced improved erections. The trial involved a broad population of men, including patients with diabetes.
Cialis delivers a return to normal for a man taking the drug and that is quite important, Gary Wilcox, executive vice president of operations at Bothell, Wash.-based ICOS Corp., told BioWorld Today. Our market analysis pointed out that it is very important for a man to have spontaneity in his sexual relationship. I think a key message of what we have found in our market studies is that patients want demonstrated effectiveness and weve certainly shown that in our Phase III study.
Lilly ICOS LLC is a joint venture between ICOS Corp. and Eli Lilly and Co., of Indianapolis. The companies in 1998 entered a 50-50 partnership to develop a treatment for sexual dysfunction.
Wilcox said the company expects the FDA to review the drug in its standard 12-month time frame.
Cialis inhibits PDE5, or phosphodiesterase type 5, an enzyme in smooth muscle that controls the level of cyclic GMP (guanylic acid), much like Viagra. Inhibiting PDE5 increases the level of cyclic GMP, allowing blood vessels to dilate.
The Phase III trial looked at the safety and efficacy of on-demand Cialis treatment in men suffering from mild to severe erectile dysfunction. Men in the study were randomized to receive up to 20 mg of Cialis or placebo over a 12-week period. Men were free to take their study medication without restrictions on food or alcohol consumption and to have sex with their partners at the time of their choosing after each dose. (See BioWorld Today, June 4, 2001.)
ICOS this week filed a shelf registration statement for up to $300 million to help in the anticipated launch of Cialis, as well as other clinical programs. (See BioWorld Today, June 27, 2001.)
ICOS stock (NASDAQ:ICOS) gained $4.05 Thursday to close at $64.