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MARION MERRELL DOW RESUMING DIRECT-TO-CONSUMER ADS FOR SELDANE-D; PRINT CAMPAIGN BREAKS WEEK OF APRIL 5: TERFENADINE SCRIPTS ARE DOWN 25% IN FEBRUARY

Executive Summary

Marion Merrell Dow has resumed consumer advertising of its nonsedating antihistamine/decongestant combination product Seldane-D (terfenadine/pseudoephedrine). Ads began running in magazines the week of April 5 and are the first for terfenadine since Seldane-D and single-agent terfenadine (Seldane) were relabeled in July to warn of possible life- threatening cardiovascular side effects ("The Pink Sheet" July 13, 1992, p. 9). Marion Merrell Dow said the ads will run in magazines including Time, People and Better Homes and Gardens throughout April and May for the spring allergy season. In the wake of the relabeling, Marion Merrell Dow has not been running consumer ads while working out appropriate language for such ads with FDA. Seldane family sales have dropped sharply: the company reports that February prescriptions were 25% lower than in February 1992. Marion Merrell Dow told wholesalers April 15 that it has submitted a 1.2 mil.-patient database to FDA that the company believes confirms the cardiovascular side effects are rare. MMD said it has concluded that Seldane is labeled appropriately and no more revisions are needed. FDA will likely schedule an advisory committee to review the data. The new consumer ads are breaking just as Schering-Plough is launching its newly approved nonsedating antihistamine Claritin (see related story, p. 5). The campaign's focus on Seldane-D suggests that MMD intends to compete against Claritin by emphasizing the advantages of antihistamine/decongestant combos over single-agent antihistamines. Marion Merrell Dow has estimated that half of the allergy market is for antihistamine/decongestant combinations. Total Seldane family sales in 1992 were $878 mil. The terfenadine patent expires April 15, 1994. Seldane-D has four months of additional exclusivity, until Aug. 19, 1994. A patient information brochure distributed by Marion Merrell Dow to doctors and pharmacists in December emphasizes the benefits of combination therapy. Seldane-D "can give you all the relief of Seldane plus relieve a stuffed-up nose," the brochure states. The brochure uses a question and answer format. In response to the question "How can I tell if I should take Seldane or Seldane- D?," the brochure states: "Some people with allergies suffer from a stuffed-up nose and some people don't. If you're fortunate enough to be someone who doesn't, your doctor may prescribe Seldane (without a decongestant), since there is no reason to take more medication than you need. But, if you also suffer from a stuffed-up nose, you probably need a decongestant and that's when Seldane-D may be appropriate." The new print ads carry the tag line: "Finally, a medicine for my seasonal allergies that's worth seeing my doctor about." Immediately below the Seldane-D logo is a warning statement: "YOU MUST NOT TAKE SELDANE-D if you are taking the antifungal drugs ketoconazole (Nizoral), itraconazole (Sporanox), the antibiotics erythromycin, clarithromycin, or troleandromycin, or if you have liver disease. DO NOT TAKE MORE THAN the amount of Seldane-D prescribed by your doctor. Seldane-D has been associated with rare occurrences of abnormal heartbeats, heart attack, and death under these conditions." In another consumer outreach program, MMD announced the establishment of a "pollen hotline" April 13 (the same day Claritin's approval was announced). The hotline gives consumers information on predicted pollen levels for their region of the country, updated weekly. Callers are reminded that OTC antihistamines have side effects, that they should read the warnings carefully, and that they may want to consult a physician. Callers are given the opportunity to leave their address and phone number for more information.
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