OCLASSEN CONDYLOX TOPICAL SOLUTION FOR GENITAL WARTS APPROVED

Executive Summary

OCLASSEN CONDYLOX TOPICAL SOLUTION FOR GENITAL WARTS APPROVED by FDA on Dec. 13. San Rafael, Calif.-based Oclassen Pharmaceuticals said it plans to begin shipping the product in March or April of next year. The company is touting the product as the first treatment for genital warts that can be administered at home by patients and estimates the size of the patient population in the U.S. at "more than 1 mil." Oclassen will price the product to wholesalers at $40 per 3.5 ml vial. Each vial is sold as a kit with 24 cotton swabs and represents four weeks of therapy. The recommended regimen for Condylox (podofilox .5% solution) is twice-daily application for three consecutive days, followed by a four-day treatment holiday. Condylox was originally developed by pHarma-Medica, a Danish pharmaceutical firm, that granted Oclassen exclusive U.S. rights to the product in August 1985. Oclassen filed the NDA in December 1987. The product has been given a "3-C" FDA approval rating, which the company said it is attempting to change. Oclassen is arguing that podofilox has never been introduced to the market and represents a distinct chemical moiety. Founded in 1985 to develop and market drugs with specialized markets considered too small by larger companies, Oclassen will introduce its first product, Monodox (doxycycline monohydrate), in February of next year for the treatment of chlamydia. Monodox was approved last December. The company has been actively recruiting a sales force since the beginning of the year to prepare for the two product launches next spring. Oclassen plans to have a national sales force of 25 reps on board before the product introductions next spring and 45-55 sales reps by 1992-1993.