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| |  FDA Recommends Prilosec/Biaxin To Eradicate Ulcer-causing Bacteria WAYNE, Pa., Dec. 13, 1995 -- The U.S. Food and Drug Administration's Anti-Infective Drugs and Gastrointestinal Drugs Advisory Committees today recommended that a combination therapy of the antisecretory medication Prilosec(R) (omeprazole) and the antibiotic Biaxin(R) (clarithromycin) be approved for the treatment of Helicobacter pylori (H. pylori) infected patients with active duodenal ulcer to eradicate H. pylori, the bacteria now believed to cause approximately 90 percent of peptic ulcers. H. pylori eradication is associated with a decreased risk of duodenal ulcer recurrence. Prilosec is marketed by Astra Merck Inc. and Biaxin is marketed by Abbott Laboratories (NYSE: ABT). In clinical trials, the combination of Prilosec and Biaxin had H. pylori eradication rates of up to 78 percent. Among patients in whom H. pylori has been eradicated, ulcer recurrence rates six-months post-treatment have generally been less than six percent. The recommended dosage for eradicating H. pylori is Prilosec 40 mg once daily and Biaxin 500 mg three times daily for the first 14 days, followed by Prilosec 20 mg once daily for days 15-28. The Prilosec-Biaxin regimen has been generally well-tolerated: side effects, which are usually transient and mild, include taste perversion, nausea, headache and diarrhea. "The Advisory Committees' decision to recommended the Prilosec-Biaxin regimen for treating H. pylori-induced ulcers means that patients may finally be able to receive a treatment that not only resolves symptoms and heals the ulcers, but also cures the underlying cause of ulcers," said Irwin Scher, M.D., Astra Merck's vice president for drug development and medical affairs. Peptic ulcers affect approximately five million Americans each year. It is estimated that 10 percent of the population will develop an ulcer during their lifetime. In the past, ulcers were believed to be caused by lifestyle factors such as stress and diet. Later, researchers discovered that an imbalance between digestive fluids and the stomach's ability to defend itself against these powerful substances resulted in ulcers. However, researchers now know that the H. pylori bacteria (along with acid secretion) damage stomach and duodenal tissue, causing inflammation and ulcers in 90 percent of patients. Treatment with an antisecretory medication like Prilosec and an antibiotic such as Biaxin is considered a dramatic medical advance because elimination of H. pylori means that the ulcer will not only heal, but also will not likely come back. Prilosec is currently indicated for the long-term treatment of healed erosive esophagitis and symptomatic gastroesophageal reflux disease (GERD) that is poorly responsive to customary medical treatment and short-term treatment of active duodenal ulcer. It is also indicated for the treatment of certain hypersecretory conditions. Biaxin is indicated for the treatment of mild-to-moderate infections, including upper-respiratory tract infections, lower-respiratory tract infections and uncomplicated skin and skin-structure infections. Astra Merck Inc., previously a unit of Merck & Co., Inc. (NYSE: MRK) was reorganized as a separate company in November 1994, owned equally by Merck and Astra AB of Sweden. Abbott Laboratories is a worldwide manufacturer of health care products.
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