Impotence Drug Files Earlier Than Expected
Drug giant
Eli Lilly
(LLY) - Get Report
and biotech partner
ICOS
(ICOS)
sent their experimental male impotence drug, Cialis, to U.S. drug regulators for approval Thursday, a filing considered ahead of schedule by some analysts.
If approved by the
Food and Drug Administration
, Cialis would compete in the market with Viagra, made by
Pfizer
(PFE) - Get Report
. The earlier-than-expected filing could mean approval as soon as the second half of 2002.
Impotence, or erectile dysfunction, affects an estimated 152 million men around the world, and can be caused by physical conditions such as heart disease and diabetes. Viagra sales worldwide totaled $1.3 billion in 2000.
In order for Cialis to gain FDA approval and attract new patients, ICOS and Lilly have been pushing studies that show the drug works faster and longer than Viagra, with fewer side effects.
ICOS and Lilly were expected to submit their FDA application later this summer.
SG Cowen
analyst Bill Tanner views the earlier filing as a positive for ICOS.
"Because of the earlier-than-expected timing, we believe there could be upside to our 2002 revenue estimate of $195 million," he writes in a research note. "Even with the protracted review at the FDA (as appears to be the norm), we believe the revenue estimate is achievable." Tanner rates ICOS a strong buy and his firm has done banking for the company.
Shares of ICOS were up $2.85, or 4.8%, to $62.80 in Thursday trading. Lilly shares were down 20 cents to $73.82.