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Executive Summary

MERCK's PEPCID WILL JOIN TAGAMET-ZANTAC FRAY in the anti-ulcer market with its upcoming mid-November launch. The one-a-day anti-ulcer agent, licensed from Yamanouchi, was approved by FDA on Oct. 15. Shipments to the trade are expected to begin by early November. FDA closely followed the recommendations made by FDA's Gastro-Intestinal Drugs Advisory Committee in January ("The Pink Sheet" Jan. 20, p. 16). Pepcid is indicated for short term treatment of active duodenal ulcer, maintenance therapy for duodenal ulcer, and treatment of pathological hypersecretory conditions such as Zollinger-Ellison syndrome. Both SmithKline's Tagamet and Glaxo/Roche's Zantac were initially approved with he same indications. Merck had also filed for a gastric ulcer indication, but the advisory panel had suggested that a U.S. study was needed for approval. That study is now underway, Merck said. The company is also awaiting approval for a gastroesophageal reflux indication and for an I.V. form of the drug. The Pepcid NDA was approved in a relatively short time; the approval came 16 months after the NDA was filed in June 1985. Pepcid labeling carries a recommended dosage of 40 mg once-daily at bedtime for acute therapy and a 20 mg bedtime dose for maintenance therapy. While pricing has not been specifically established, Merck said that Pepcid prices would be "competitive" with Tagamet and Zantac. Entering a mature market already dominated by two effective products with relatively clean adverse reaction profiles, Merck will have to convince physicians that Pepcid's superior potency offers some advantage over Tagamet and Zantac. Pepcid's once-daily, bedtime dosage is not the marketing advantage it would have been a year ago. Zantac 300 mg received approval for the one-a-day, nocturnal dosage in December and Tagamet 800 mg followed in April. The marketing battle had effectively begun prior to the approval. As early as August, Merck was running full page "coming soon" ads for Pepcid in major medical journals. With Pepcid, Merck is facing a similar challenge to the one it had in launching Blocadren in late 1981-early 1982. Competing with both second generation and established first generation beta blockers, new calcium channel blockers, and a new ACE inhibitor, Squibb's Capoten, Blocadren was lost in the shuffle despite its unique post-myocardial infarction indication. Pepcid, as well as having to break into the market against two established products, will soon face further competition from Lilly's H-2 blocker Axid (nizatidine), now at FDA, and from two prostaglandin products, Syntex' Gardrin (enprostil) and Searle's Cytotec (misoprostil), also pending FDA approval. In addition, Marion has put an increased emphasis on building Carafate's position in the antiulcer market. Merck's first gastrointestinal product, Pepcid will be marketed through the company's 700-plus member musculoskeletal sales group. The fourth major product approval in the past 10 months, Pepcid will get the musculoskeletal group's undivided attention. Merck is marketing the ACE inhibitor Vasotec through its specialized cardiovascular sales group, and the anti-infective Primaxin and the recombinant hepatitis B vaccine Recombivax, to be launched this January, are essentially hospital products. Not far behind, Merck has a second anti-ulcer product, Losec (omeprazole), that is well into Phase III clinicals. Licensed from Astra, Losec is a proton pump inhibitor expected to be useful for total gastric acid suppression.

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