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| |  Biaxin/Prilosec Cleared as Combination Therapy for Duodenal Ulcers ABBOTT PARK, Ill., April 19, 1996 -- Abbott Laboratories (NYSE: ABT) announced today it received clearance from the U.S. Food and Drug Administration to market its antibiotic Biaxin (clarithromycin), in combination with the anti-secretory agent Prilosec (omeprazole), for the treatment of active duodenal ulcers associated with Helicobacter pylori infection. Biaxin is the first antibiotic cleared by the FDA for active duodenal ulcer therapy in combination with an anti-secretory agent. This regimen has been shown to heal duodenal ulcers and to eradicate H. pylori, the bacterium associated with approximately 90 percent of duodenal ulcers. H. pylori eradication has been demonstrated to reduce the risk of duodenal ulcer recurrence. "Dual therapy with Biaxin and omeprazole offers benefits to patients by both healing the ulcer and helping reduce the rate of ulcer recurrence," says Andre Pernet, vice president, research and development, pharmaceutical products division at Abbott Laboratories. "Biaxin represents a breakthrough in the treatment of active duodenal ulcers associated with H. pylori," he adds. HISTORY OF ULCER THERAPY H. pylori is a bacterium associated with peptic ulcer disease, which affects an estimated five million people in North America and is responsible for $3-4 billion in annual health care costs. In the past, ulcers were believed to be caused primarily by excess acid in the stomach and by lifestyle factors such as stress and diet, so traditional treatment focused on acid-blocking medications such as H2 receptor antagonists. While acid-blocking agents may control symptoms and accelerate ulcer healing, ulcer recurrence has been a problem. In February 1994, the National Institutes of Health (NIH) convened a panel of leading gastroenterologists to examine the causes and treatment of peptic ulcers. In a consensus statement, the panel determined that H. pylori infection, in the absence of other precipitating factors, is associated with the development of most duodenal ulcers, and that eradication of the infection reduces the risk of ulcer recurrence. The consensus panel recommended that duodenal ulcer patients with H. pylori infection should receive treatment with an antimicrobial agent in addition to an anti-secretory drug. When patients are treated with anti-secretory agents alone for active duodenal ulcers, recurrence rates of up to 90 percent have been reported within one year of discontinuing therapy. Two weeks of treatment with the advanced-generation macrolide antibiotic Biaxin concurrent with a four-week course of Prilosec offers patients effective therapy by eradicating H. pylori infection, thereby helping reduce duodenal ulcer recurrence. "Understanding the link between H. pylori and duodenal ulcers is a medical breakthrough with important implications for patients," says David A. Peura, M.D., of the University of Virginia Health Sciences Center. "Combination therapies such as the Biaxin/Prilosec regimen that eradicate H. pylori may offer patients relief from recurrent duodenal ulcers." CLINICAL TRIALS In four well-controlled studies involving nearly 900 patients, combination therapy with Biaxin and Prilosec was shown to be effective in healing active duodenal ulcers and eradicating H. pylori infection. Studies also showed that patients treated with Biaxin/Prilosec experienced lower rates of duodenal ulcer recurrence. In patients who fail therapy, susceptibility testing should be done. If resistance is demonstrated or if susceptibility testing is not possible, alternative therapy is recommended. Safety data collected for nearly 900 patients showed dual therapy with clarithromycin and omeprazole was very well tolerated. In the clinical studies using dual therapy, most adverse events were mild to moderate in severity, and the drop-out rate due to adverse events for patients taking combination therapy was 3.5 percent. The most frequently reported adverse events associated with clarithromycin/omeprazole dual therapy were taste disturbance (15 percent), nausea (5 percent), headache (5 percent), diarrhea (4 percent), vomiting (4 percent), abdominal pain (3 percent), or infection (3 percent). Clarithromycin should not be used in pregnant women except in circumstances where no alternative treatment is appropriate. Clarithromycin should not be used in patients receiving terfenadine who have pre-existing cardiac abnormalities or electrolyte disturbances. "Omeprazole, a member of the class of anti-secretory compounds known as proton-pump inhibitors, reduces gastric acid levels by inhibiting the acid pumps of the parietal cells that line the stomach," says Pernet. "Reduced acid levels, along with an increase in the amount of clarithromycin in the stomach tissue when clarithromycin and omeprazole are given in combination, enhance the effectiveness of the Biaxin/Prilosec regimen in eradicating H. pylori, thus reducing the risk of ulcer recurrence." A labeling indication to use clarithromycin for ulcer treatment has been granted in 23 countries including the United Kingdom, Ireland, Spain, Sweden, and Switzerland. ABBOTT'S LEADERSHIP IN ULCER CARE Clarithromycin is being evaluated for use in combination with other anti-secretory agents in treating H. pylori-related active ulcer disease. The versatility of clarithromycin in combination with other agents in eradicating H. pylori offers hope of new relief to patients with ulcer disease. Clarithromycin is part of a developing franchise of ulcer-related products from Abbott Laboratories. In October, Abbott announced it will sell and distribute a rapid office-based test to aid in the detection of H. pylori infection. The test will be manufactured by SmithKline Diagnostics, Inc., a subsidiary of Beckman Industries, Inc. Additionally, TAP Holdings Inc., a joint venture of Abbott and Takeda Chemical Industries, Ltd., of Japan, markets Prevacid (lansoprazole) for maintenance treatment of healed erosive esophagitis and for short-term treatment for healing and symptom relief of active duodenal ulcers and erosive esophagitis. Abbott Laboratories is a worldwide manufacturer of health care products, employing 50,000 people. In 1995, the company's sales and net earnings were $10.0 billion and $1.7 billion, respectively, with earnings per share of $2.12.
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