New Drug Application for Velac accepted for filing by the FDA

Oct 25 2004

Connetics Corporation, a specialty pharmaceutical company focused on dermatology, today announced that the U.S. Food and Drug Administration has accepted for filing the Company's New Drug Application for Velac, as of August 23, 2004, with a user fee goal date of June 25, 2005.

Velac is an investigational new drug that combines clindamycin 1% and tretinoin 0.025% in a gel formulation as a potential new topical treatment for acne. In March, Connetics announced positive results from its Phase III clinical trials with Velac versus clindamycin gel and tretinoin gel for the treatment of acne.

The topical prescription acne category is one of the largest segments in the U.S. dermatology market, and is estimated to exceed $1.2 billion annually. Approximately 17 million people in the U.S. have acne resulting in approximately 5.5 million office visits per year.