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For Immediate Release: 11/14/2002


First Seven-Day Treatment of H. Pylori Infection Approved by FDA

Aciphex® (rabeprazole sodium) Plus Antibiotics Faster Than Currently Approved Options


Teaneck, NJ, and Titusville, NJ (November 14, 2002) - Aciphex®, a proton pump inhibitor (PPI) widely prescribed for gastroesophageal reflux disease (GERD), is now approved by the Food and Drug Administration as part of the first seven-day treatment for Helicobacter pylori (H. pylori) infection, the single most common cause of peptic ulcers. Taken in combination with certain antibiotics, Aciphex offers a faster therapy option than other PPIs, treating H. pylori in up to half the time of current 10 to 14 day treatments.

When used in combination with amoxicillin and clarithromycin as a three-drug regimen, Aciphex is indicated for the treatment of patients with H. pylori infection and duodenal ulcer disease (active or history within the last five years) to eradicate H. pylori.

Up to 60 million American adults are currently infected with H. pylori (a type of bacteria in the stomach); as many as one in 10 Americans will develop an ulcer in their lifetime.

“Using Aciphex, plus antibiotics for one week to eradicate H. pylori is a faster treatment option than what is currently available,” said Nimish Vakil, M.D., Clinical Professor of Medicine at the University of Wisconsin Medical School (Milwaukee, Wis.). “When you consider the fact that the majority of duodenal and gastric ulcers are caused by H. pylori infection and that a short treatment course eradicates the infection and prevents relapse, you can understand the importance of this infection in ulcer disease.”

A multicenter, double-blind, placebo-controlled trial was conducted in 803 patients infected with H. pylori at 47 centers nationwide. In the study, 84 percent of patients treated with Aciphex® (rabeprazole sodium), amoxicillin and clarithromycin taken twice daily were free of H. pylori after seven days of therapy. Eighty-six percent of patients taking the identical regimen achieved the same result after 10 days of

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