SCHERING’s FEMCARE OTC ANTIFUNGAL DISCOUNTED 20% TO GYNE- LOTRIMIN

Executive Summary

SCHERING's FEMCARE OTC ANTIFUNGAL DISCOUNTED 20% TO GYNE- LOTRIMIN, which contains the same active ingredient: clotrimazole. Gyne-Lotrimin's sister brand, FemCare 1% cream and vaginal tablets for the OTC treatment of vaginal yeast infections were shipped to the trade beginning May 15 and are on retail stores shelves now. Schering-Plough HealthCare is positioning FemCare as a "value- priced" alternative discounted approximately 20% to Gyne-Lotrimin. FemCare is priced to consumers at about $14.50 retail compared to Gyne-Lotrimin's suggested retail price of $17.99. FemCare is the fourth brand to enter the OTC vaginal antifungal market. Gyne-Lotrimin OTC clotrimazole 1% cream and tablets were introduced in February 1991 as the first OTC vaginal antifungal, following FDA's November 1990 approval of the Rx-to- OTC switch for clotrimazole for vaginal candidiasis. Gyne-Lotrimin netted Schering-Plough Healthcare over $100 mil. in sales in its first year on the market. Ortho's Monistat-7 (2% miconazole), approved Feb. 15, 1991 and the bigger selling brand when both Gyne-Lotrimin and Monistat were prescription-only products, also is reported to have reaped first- year sales of well over $100 mil. The last entry to the market was Miles' Mycelex-7 tablets and cream (clotrimazole), which received an Rx-to-OTC switch approval for vaginal candidasis on Dec. 26 ("The Pink Sheet" Feb. 24, p. 13). Miles began shipping Mycelex-7 on June 1. The product, in a seven-day regimen of 100 mg tablets or 45 gm 1% cream, will be backed with national TV and print ads and coupons. Tatham RSCG (Chicago) is the agency of record. Miles is not disclosing the suggested retail price but said Mycelex-7 is priced "competitively," which suggests that the product may be priced less than Gyne-Lotrimin and Monistat-7 and in the range of FemCare. Schering-Plough said it will not promote FemCare as extensively as Gyne-Lotrimin. TV and print ads for FemCare are scheduled to break at the end of June supported by a $10 mil. budget. William Douglas McAdams (New York City) is the agency of record for FemCare. The campaign is the agency's first to consumers. McAdams also handles physician-directed promotions for Gyne-Lotrimin, while the brand's consumer promotions are handled by Cadwell Davis Partners. Promotional press materials and labeling for FemCare stress that the product, if used for seven days, provides a full treatment and cure for vaginal yeast infections and is intended only for women who have experienced yeast infections in the past. Labeling directs first-time patients to see their physicians. FDA required the labeling stipulation when it allowed the Rx-to-OTC switch of vaginal antifungal products. Schering-Plough received two supplemental NDA approvals from FDA on April 14 to market OTC clotrimazole as a vaginal antifungal under the FemCare tradename (see pp. whatever for FDA's April list of NDA/ANDA approvals). The product is available as a 1.5 oz. cream or in packages of seven vaginal inserts. Both forms of FemCare come with a reusable plastic applicator and are to be used for a seven-day course of therapy. Gyne-Lotrimin recently switched to disposable plastic applicators for its seven-day treatment regimen.