MILES' MYCELEX Rx-TO-OTC SWITCH AS TOPICAL ANTIFUNGAL COULD BE APPROVED IN UPCOMING MONTHS, FIRM PREDICTS; NEXT SWITCH CANDIDATE IS IN PHASE III.

Miles is hoping for a spring launch of its Mycelex (clotrimazole) Rx-to-OTC switch, pending FDA approval, Miles Consumer Healthcare President Werner Spinner told a March 21 press briefing in New York City. Spinner predicted that Mycelex OTC "will be introduced by May 1." A spring launch may be optimistic; Miles filed a supplemental NDA last fall for OTC marketing of Mycelex 1% cream and liquid for athlete's foot, ringworm and jock itch. Miles said it has not sought OTC status for Mycelex use for candidiasis and tinea versicolor. The cream and liquid will be packaged in a 15 gm tube and a 10 ml container, respectively. Schering-Plough paved the way for the clotrimazole switch in October 1989 when it gained a similar FDA switch approval for Lotrimin AF as a self-treatment for athlete's foot, jock itch and ringworm. Earlier this year, Schering-Plough launched the Gyne- Lotrimin brand of clotrimazole as an OTC for the treatment of vaginal candidiasis ("The Pink Sheet" Dec. 3, T&G-6). Miles Consumer Healthcare division generated sales of approximately $ 300 mil. in 1990. Spinner said the company hopes to double its OTC business in the U.S. by 1995 via a three-part strategy that includes: leveraging the firm's international self- medication business; developing new products, primarily through the Rx-to-OTC switch route; and leveraging current brand and marketing strengths. Spinner said that Miles is currently looking at ways to widen its consumer product line via joint ventures with prescription drug companies that may be seeking an experienced OTC marketer for potential Rx-to-OTC candidates. He said that Miles is also looking at acquiring OTC brands as another option. "We have no definite plans or agreements with any other company" regarding joint ventures or brand acquisitions, Spinner said. He added, however, that "we are actively pursuing this strategy . . . [and] are talking to companies." Besides Mycelex, Miles' Consumer Healthcare division is looking for other Miles Pharmaceutical products to move over-the- counter. Domeboro, an astringent formerly marketed as an ethical product, and Mycelex are "just the beginning," Miles Consumer Healthcare VP-R&D John Siebert, PhD, said. "Right now we're in various phases of testing for a number of products switching from Rx-to-OTC," Siebert noted. Miles is "completing Phase III clinical studies on a major Rx-to-OTC switch," Siebert told reporters. The company would not disclose the product, but said it is neither a topical nor an effervescent. Miles is also investigating "ways to marry" the effervescent delivery system of its 60-year-old Alka-Seltzer brand with Rx-to- OTC switch candidates, Siebert said. He added that the company is also considering broadening its OTC lines by adding new effervescent dosage forms of already available OTC products. Miles' top-selling OTC line, Alka-Seltzer, continues to grow, the company reported. "Despite its age, Alka-Seltzer" holds its ground among competitors and "still generates [sales] over $ 75 mil. each year," Spinner said. Based on 1990 A.C. Nielsen figures, Alka-Seltzer Plus is the "number one cold remedy" with sales of $ 103.1 mil. in 1990. Brand sales have more than doubled since 1985, when the product generated sales of $ 45.3 mil. Miles is hoping for similar growth from its year-old Alka-Seltzer Plus Sinus Allergy formula, Spinner said. Miles' third growth strategy is to be more aggressive than it has in recent years "in promoting our products and in promoting ourselves as a major player in the OTC business," Spinner said. "Despite our size and strength in these [vitamin and analgesic/antacid] markets, we have for years maintained a low profile within the OTC industry . . . . But those days are over, we are not content to stay quiet any more," Spinner emphasized. One of the company's tactics is promoting Miles OTC products to healthcare professionals through the Miles Pharmaceutical detail force, Siebert stated. Miles' vitamin business garners roughly $ 60 mil. a year, according to Spinner. The firm's Flintstones and Bugs Bunny chewables vitamins hold the top spot in the children's market and over 40% of the U.S. chewables business. Miles also sells One-A- Day and Bio Cal adult vitamins.