Lilly ICOS Submits Impotency Drug
Cialis to FDA

Abstracted from: Los Angeles Times Author: Denise Gellene
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Monday, July 1, 2001 --- The first major Viagra competitor, Cialis (IC351), has been submitted to the U.S. Food and Drug Administration, according to a press release issued by ICOS Corporation. The new drug, like Viagra, works by inhibiting the enzyme phosphodiesterase (PDE), but Cialis may be somewhat more specific for PDE Type 5, thus reducing side effects, according to claims of the manufacturer, Lilly ICOS LLC. 'Fast-track' status is not expected, making FDA approval unlikely before mid-2002.

In addition to possibly reducing side effects, the new drug may also offer another advantage: longer duration of action. According to ICOS spokesperson Lacy Fitzpatrick, Viagra-induced potency lasts for approximately 4 hours, but the effectiveness of Cialis may be as long as 24 hours. This means men needn't "watch the clock" after taking the medication, according to Fitzpatrick.

Results of Cialis studies were first reported by Harin Padma-Nathan, M.D., and co-workers at the annual meeting of the American Urological Association in May, 2000. That study was published recently in the International Journal of Impotency Research. Improved erections were demonstrated in approximately 80% of men receiving the highest dose tested, and at this dose (10-25 mg), side effects were very uncommon.

Viagra was approved by the U.S. FDA in March, 1998. According to data on file from Pfizer, Viagra has now been used by more than 7 million men in the U.S., prescriptions having been written more than 22 million times by nearly 300,000 physicians. Nevertheless, these men probably represent only about 15% of the population who would benefit from a treatment for erectile dysfunction.

Studies involving Viagra have been ongoing at USRF since 1994, and the first peer-reviewed Viagra study outside of the clinical trials was published from USRF in 1999.

Lilly / ICOS LLC is a joint venture between the ICOS Corporation of Bothell, WA and drug giant Lilly of Indianapolis, IN. ICOS is a 10-year old biotech company, whose founders and largest stockholders include George B. Rathman, founder of Amgen, and William H. Gates, founder and CEO of Microsoft.

Relevant material from the latest ICOS Securities and Exchange Commission 10K filing is reproduced here.