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| |  Tritec Tablets Receives Marketing Clearance from the FDA RESEARCH TRIANGLE PARK, N.C., Aug. 12, 1996 -- Tritec(R) (ranitidine bismuth citrate) Tablets, developed and manufactured by Glaxo Wellcome, a recognized worldwide leader in gastrointestinal research and maker of Zantac(R) (ranitidine HCl), have received clearance by the U.S. Food and Drug Administration (FDA). Tritec, when co-prescribed with the antibiotic Biaxin(R) (clarithromyin)(A), eliminates the bacteria that causes most duodenal ulcers. Tritec will be available in September. Tritec in combination with Biaxin is indicated for the treatment of patients with an active duodenal ulcer associated with Helicobacter pylori (H pylori) infection. The eradication of H pylori has been demonstrated to reduce the risk of duodenal ulcer recurrence. Tritec, when co-prescribed with Biaxin, is the first medicine specifically designed for the treatment of H pylori-associated duodenal ulcers. U.S. studies have shown that this combination achieves high eradication rates (up to 84 percent) and significantly reduces the risk of ulcer recurrence. Tritec is a molecular complex of ranitidine, bismuth and citrate. U.S. studies have shown that Tritec enhances the anti-H pylori effects of Biaxin as much as threefold. In addition, the antisecretory properties of ranitidine derived from Tritec, when co-administered with Biaxin, promotes ulcer healing. "We believe Tritec in combination with Biaxin will provide significant benefit for patients with duodenal ulcers by curing their H pylori infection," says Duane D. Webb, MD, International Director of Gastroenterology, Glaxo Wellcome Inc. "This combination has distinct properties for the treatment of duodenal ulcer disease. It is an important part of Glaxo Wellcome's ongoing commitment to innovation in gastrointestinal research and pharmaceutical development." Ulcer disease is a chronic, recurrent, and inflammatory condition affecting about five million Americans each year. Duodenal ulcers, the most common type of ulcer, form in the upper part of the small intestine in an area connecting to the stomach. Until recently, ulcers were blamed on stress, coffee, spicy foods and too much stomach acid. Now scientists estimate that up to 90 percent of duodenal ulcers are primarily associated with infection with H pylori, a spiral shaped bacterium that burrows into the lining of the stomach and duodenum. Acid secretion plays a contributory role, aggravating the ulcer and its symptoms as the disease progresses. "The concept that most duodenal ulcers are associated with an infection, and not just excess stomach acid, represents a major shift in our thinking," says Walter L. Peterson, M.D., professor of medicine at the University of Texas Southwestern Medical School and the Dallas VA Medical Center. "In the past, ulcer disease could be controlled as long as the patients continued to take medicines that lowered stomach acid. Now there is the potential to cure ulcer disease by eradicating the H pylori infection with effective and simple regimens, such as ranitidine bismuth citrate (Tritec) co-administered with clarithromycin (Biaxin)." Clinical Trial Results Two well controlled clinical trials have been conducted by Glaxo Wellcome in the United States with Tritec in combination with Biaxin. These studies found that Tritec given with Biaxin eradicated H pylori infection in a significantly greater percentage of patients when compared to Biaxin alone. These studies showed H pylori eradication rates of up to 84 percent with Tritec in combination with Biaxin. Among patients whose ulcers were healed and whose infections were eradicated, the risk of recurrence of ulcers was two times less likely versus those whose H pylori was not eradicated. These data were derived from six studies that followed patients for six months. The recommended dosage based on U.S. clinical trials is Tritec 400 mg twice a day for four weeks, and Biaxin 500 mg three times a day for the first two weeks. Tritec is very well tolerated. The most common adverse reactions with Tritec plus Biaxin observed in U.S. clinical trials were taste disturbance, diarrhea, and headache. Physicians should consult the prescribing information for Biaxin for important safety data. In addition, patients who fail therapy should not be re-treated with a regimen containing Biaxin. Tritec, known as Pylorid(TM) outside the USA, has been marketed since September 1995 in the United Kingdom and has received regulatory approval in eight other European and four non-European countries. International clinical trials with Tritec have been ongoing at Glaxo Wellcome since 1989 and have included more than 10,000 patients and volunteers. The clinical program is one of the largest involving H pylori research worldwide. Glaxo Wellcome Inc., based in Research Triangle Park, NC, is a leading research based pharmaceutical firm. Glaxo Wellcome Inc. is a subsidiary of the London-based Glaxo Wellcome p1c. NOTE(A): Biaxin is a registered trademark of Abbott Laboratories.
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