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Executive Summary

Tavist-1 newspaper advertisements recently appearing in 25 papers, including the Washington Post, Chicago Tribune, Los Angeles Times, Boston Globe and The New York Times, highlight the Sandoz prescription antihistamine as having "high effectiveness" and "low drowsiness." The advertisement, done in full-page and half-page spreads, ran in 20 newspapers on Sept. 16, and in the remaining five on Sept. 17. The ad contains full prescribing information and is written as an open letter to doctors. Bold print heading the advertisement states: "Special Update For Doctors: An effective alternative for your patients who aren't satisfied with their current allergy medicines." The campaign is being handled by the advertising firm Romann and Tannenholz. The Sandoz ad appears to move one step closer to product-specific prescription advertising in general media from the institutional/corporate image campaigns, which have been running for several years. Sandoz is not the first company to run the full prescribing information. Pfizer, for example, recently incorporated full prescribing information into an indirect ad for its hypoglycemic Glucotrol. Pfizer's ad, which appeared in the March issue of the Florida senior citizens magazine, Golden Years, indirectly promoted the product through a recipe contest ("The Pink Sheet" March 2, T&G-1). Although the Tavist-1 ad is appearing in major newspapers, Sandoz press material describes the promotion as an advertisement to physicians. Sandoz advised FDA of its plans two months before running the ad. The company says it submitted the ad to FDA's Drug Advertising & Labeling Division in July. FDA reviewed the ad with its direct-to-consumer advertising criteria. In press material on the promotion, Sandoz explained that it is advertising Tavist-1 (clemastine fumarate, 1.34 mg tabs) in newspapers because "Sandoz sees advertising to physicians in nonmedical publications as a potential opportunity to supplement its traditional advertising efforts in medical journals." The firm noted that it will be using the same ad in its regular trade journal advertisements. The ad campaign is presumably designed to help Tavist respond to the success of Merrell Dow's nonsedating antihistamine Seldane (terfenadine). Merrell Dow has been supporting Seldane with consumer messages, which do not mention the product by name. The Sandoz ad characterizes Tavist-1 as an antihistamine that does not sacrifice effectiveness for a low-sedation profile. The ad states: "With some antihistamines, certain individuals get relief, but they also become drowsy. With other antihistamines, they don't become drowsy, but they don't get relief either." Compared with "other antihistamines now available," the ad continues, "Tavist-1 tablets are unsurpassed in relieving hay fever and other upper respiratory allergies . . . Now you needn't choose between relief and alertness for your patients. They can have them both -- with Tavist-1 tablets." The ad notes that "a net of less than one sufferer in 12 experiences any drowsiness." A footnote to the drowsiness statement says that "in controlled clinical trials, a net of only 7% of patients treated with clemastine fumarate 1.34 mg reported drowsiness, which was often transient in nature, disappearing after three or four days of therapy." The adverse reaction statement in the prescribing information says that "transient drowsiness, the most common adverse reaction associated with Tavist . . . occurs relatively frequently and may require discontinuation of therapy in some instances." Sandoz said it "will almost certainly" run another set of newspaper ads during the allergy season (September through November). Response to the ads will be evaluated by tracking ordering of the product. The first set of ads cost the company between $200,000 and $300,000. U.S. sales of the Tavist line, which in addition to Tavist-1 includes Tavist syrup, Tavist 2.68 mg tabs, and Tavist-D (clemastine fumarate 1.34 mg, phenylpropanolamine HCl 75 mg), are projected in the $50-60 mil. range in 1987. NEWSPAPERS CARRYING TAVIST-1 ADS Atlanta Journal Baltimore Sun Boston Globe Chicago Tribune Cleveland Plain Dealer Dallas Times-Herald Denver Post Detroit News Hartford Courant Houston Chronicle Indianapolis Star Los Angeles Times Miami Herald Minneapolis Star & Tribune New York Times Oregonian Philadelphia Inquirer Phoenix Gazette Pittsburgh Post Gazette Sacramento Bee San Francisco Chronicle Seattle Times St. Louis Post Dispatch Tampa Tribune Washington Post

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