OTC Zantac name recognition will help overcome late market entry, consultant predicts.

OTC ZANTAC NAME RECOGNITION WILL HELP OVERCOME LATE MARKET ENTRY, KLINE & CO. Healthcare Practice Manager Kathryn Greengrove Griffie predicted at a May 17 session of an Rx-to-OTC switch conference sponsored by International Business Communications in Washington, D.C. Griffie prophesied that sales of an OTC version of Glaxo Wellcome's Zantac H2-antagonist "will be significant" because "brand recognition for Zantac is huge."

OTC ranitidine, which is expected to be reviewed by FDA's Nonprescription and Gastrointestinal Drugs Advisory Commitees this summer ("The Tan Sheet" April 17, p. 6), will be marketed over-the-counter by Warner Wellcome.

"Even though it's going to be significantly lagging behind as far as market introduction," Griffie said, "I think you're going to have another Monistat, Gyne-Lotrimin scenario, where [J&J's] Monistat just came in and because of physician recommendations and consumer awareness" of the vaginal yeast infection product, it was successful compared to Schering-Plough's product. To bolster consumer recognition, Glaxo is currently running direct-to-consumer advertising for the Rx product that carries the tagline: "Only Zantac is Zantac."

J&J/Merck's OTC heartburn remedy Pepcid AC (famotidine) will be the first H2 blocker to enter the market after being approved by FDA on April 28. Pepcid AC is expected to be available on retail shelves in June ("The Tan Sheet" May 8, p. 7).

Griffie warned, however, of a potential obstacle to success for the OTC H2-antagonist category: the products may be priced too high compared to currently available OTC stomach remedies.

"The problem I see with H2-antagonists is going to be price," Griffie said. "People that are currently popping Tums are not going to go out and buy Pepcid AC," she stated. "These products are not going to be able to compete on price." As a result, Griffie hypothesized that the "people who are going to be buying them are the current Rx users," but even they may turn away from Pepcid AC if they "have managed care prescription plans" that can reimburse the prescription version.

Griffie also speculated that consumers may not be satisfied with over-the-counter H2 blockers because "they take a long time to work" compared to currently available OTC antacids.

Based on those factors, Griffie estimated that for the "first 12 months" after the launch of OTC versions of Pepcid AC, Zantac and SmithKline Beecham's Tagamet (cimetidine), the OTC stomach remedy market will increase "by about $400 mil." Although this contribution "is big," she acknowledged, the H2 blockers are "not going to capture some of the current [$840 mil.] OTC market."

Griffie predicted that OTC Tagamet, which is pending at FDA, will have the hardest time competing in the over-the-counter G-I products market because "their patent's expired" and "people are no longer being prescribed Tagamet like they were before" so "brand recognition is decreasing rapidly." Griffie predicted that Tagamet OTC sales "will be significantly lower than" sales for Pepcid AC and OTC Zantac.

Despite the potential strikes against them, Griffie noted that H2-antagonists meet all four criteria identified by Kline & Co. as "the biggest success factors in Rx-to-OTC switch" -- "high benefit to risk ratio, high level of professional recommendation, prescription brand recognition" and "good timing".

A national opinion study conducted on behalf of Glaxo Wellcome supports some of the observations made by Griffie, including that use of currently available OTC antacids is widespread.

Sixty-eight percent of 1,007 adults surveyed over 18 said they would "take an antacid medication" to "relieve physical discomfort from what [they] considered to be heartburn," while 22% said they would "call their doctor for advice." No other specific action or remedy generated more than a 5% response among survey participants.

The study, released at the American Gastroenterology Association's annual meeting in San Diego the week of May 15, concludes that reasons why OTC remedies "have become an accepted choice for treating heartburn symptoms" include: "low brand awareness of prescription medications, the acceptance of using over-the-counter remedies for fast, cost-effective relief without having to see a physician, as well as the physician recommendations for over-thecounter antacids."

For example, when people were asked why they used OTC antacids rather than seeing their doctors, 26% responded that their symptoms were not "severe" enough to see a doctor, and 13% said symptoms were not "frequent" enough to see a physician. Twenty-three percent said they used OTCs because they were convenient and "work in providing fast relief of heartburn symptoms," while 16% cited cost as the reason. Other reasons mentioned for using OTCs included lack of a need to see a doctor (4%), and general preference for using an over-the-counter remedy (3%).

Six percent said they would not use an OTC remedy without the approval of their doctor, 3% said "it never occurred to them that they should see a doctor" for heartburn, and 2% feared seeing a doctor for any reason. When asked to rate the amount of trust placed in sources of information about heartburn, the "greatest trust was placed on information obtained from medical professionals," while television, print and radio advertisements rated the lowest.

Glaxo Wellcome found that although 61% of respondents claimed they are aware that there are prescription medications to treat heartburn available, only 22% could recall the name of an Rx heartburn remedy without prompting. The telephone survey was conducted from Jan. 26-Feb. 5 by Princeton, N.J.-based Opinion Research Corp.