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TAP Pharmaceutical Products Inc. Announces Phase 3 TAK-390MR Data Demonstrating Higher Overall Healing Versus Lansoprazole in Patients with Erosive Esophagitis
Date:5/18/2008

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Results from the trial showed that TAK-390MR 30 mg and 60 mg produced high maintenance rates for patients with healed EE. Maintenance rates were analyzed using both life table and crude rate analyses.

The life table analysis showed that 75 and 83 percent of patients (30 mg and 60 mg respectively) were maintained over six months versus 27 percent of those patients taking placebo. According to the crude rate analysis, 66 percent of patients taking TAK-390MR 30 mg and 60 mg were maintained over six months versus 14 percent on placebo.

TAK-390MR also demonstrated heartburn relief rates during the six-month trial. Patients treated with TAK-390MR were heartburn free a median of 99 and 96 percent of nights (30 mg and 60 mg respectively) versus 71 percent of nights for patients treated with placebo. In addition, patients treated with TAK-390MR were heartburn free a median 96 and 91 percent of 24-hour days (30 mg and 60 mg, respectively) versus 29 percent of 24-hour days for patients treated with placebo.

The most frequent treatment related AEs for patients in the six-month maintenance study taking TAK-390MR included flatulence, bloating and distension (2%), diarrhea (2%), dyspeptic signs and symptoms (1%), gastritis (1%), and nausea/vomiting (1%) and were generally similar to placebo.

"The heartburn relief rates are encouraging, particularly when you consider that they reflect symptom relief during the complete 24-hour period," said Dr. David Metz, professor of medicine, University of Pennsylvania School of Medicine. "These maintenance results coupled with the overall healing results are encouraging for the potential of TAK-390MR in treating patients with gastroesophageal reflux disease."

About TAK-390MR

TAK-390MR, an enantiomer of lansoprazole, employs an innovative dual delayed release technology, which is designed to provide two separate releases of drug for extended duration of acid suppression.

These Phase 3 dat
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SOURCE TAP Pharmaceutical Products Inc.
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