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Executive Summary

MERCK LOSEC EROSIVE ESOPHAGITIS HEALING RATE OF 85-95% exceeds Zantac healing rates of 50-65% for the same condition, MS&D Research Labs Clinical Research Director Thomas Humphries, MD, reported at a Sept. 26 launch press conference. "In studies conducted overseas comparing Losec to Zantac treatment, 85-95%of patients had complete healing of their erosive esophogitis as compared to 50-65% with Zantac, which is statistically significant in every study," Humphries said. In the same studies, he added, "Loseccompletely relieved heartburn in 80-90% versus less than 50% total relief for Zantac." Losec (omeprazole) was approved on Sept. 14 for treatment of poorly responsive symptomatic gastroesophageal reflux disease (GERD), erosive esophogitis (a GERD-related condition), and Zollinger-Ellison syndrome ("The Pink Sheet" Sept. 25, T&G-1). Merck faces the difficult rollout task of restricting its promotion for the highly visible Losec to the limited indications for which the drug is initially approved. The firm has data pending in support of indications for duodenal and refractory duodenal ulcers; however, FDA's Gastrointestinal Drugs Advisory Committee recommended in March that the duodenal ulcer indication be deferred until long-term data addressing the carcinogenic potential of the drug is submitted. At the press conference, Merck representatives carefully kept away from the unapproved indications. Merck officials and investigators avoided mentioning the potential for use in duodenal ulcers except in response to one question about the pending data. The company also presented a careful explantion of the population with severe heartburn, which is the main symptom of GERD, that qualify for drug therapy. Noting that one in ten adult Americans suffer from heartburn, Merck Senior Director of Public Affairs Anthony Fiskett said: "We want to judiciously warn people who have chronic heartburn not to disregard the possibility that those symptoms might signal something serious, but without unduly alarming the many more people who have simple heartburn and who are not candidates for prescription drug therapy." Summarizing the efficacy data in support of the drug, Humphries said: "Losec, with its remarkable efficiency in reducing acid secretion in once-daily dosing over the 24-hour period, constitutes a significant therapeutic advantage in patients with severe erosive esophogitis confirmed by endoscopy and in patients with symptomatic GERD who are poorly responsive to customary medical therapy, usually including an H[2] receptor antagonist. It also would appear to be the treatment of choice for Zollinger-Ellison." The clinical investigators' presentations focused on their experiences in treating patients with erosive esophogitis and Zollinger-Ellison with Losec, and its efficacy relative to H[2] receptor antagonists. For example, Paul Maton, MD, a senior investigator with the digestive diseases branch of the National Institutes of Health, said a number of subsets of Zollinger-Ellison patients can only be controlled with omeprazole, such as patients who also develop esophogitis. "Needless to say," he added, "all the patients who are given omeprazole prefer it to H[2] antagonists and none of them ever want to go back." Maton also relayed his experience with one Zollinger-Ellison patient who had required 72 Zantac tablets a day that was able to control his disease with only six Losec capsules a day. Merck expects Losec to be stocked in pharmacies by Oct. 17. The product will be detailed by a separate sales force from that detailing Merck's other ulcer drug, Pepcid. Journal ads for the new agent are planned for November.

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