Lilly ICOS Submits Impotency Drug
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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.
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.
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. |