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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

-- Additional Data Demonstrated Higher Overall Maintenance of Healed

Erosive Esophagitis and Symptom Relief versus Placebo --

SAN DIEGO, May 18 /PRNewswire/ -- TAP Pharmaceutical Products Inc. today reported results from three pivotal Phase 3 studies evaluating investigational new drug TAK-390MR, the first proton pump inhibitor (PPI) with an innovative dual delayed release technology, in healing patients with erosive esophagitis (EE) and in maintenance of healed EE. The data were presented at the Digestive Disease Week (DDW) annual meeting in San Diego.

"The innovative dual delayed release technology delivers TAK-390MR in two separate releases, which is a first in the PPI class and makes TAK-390MR a very interesting potential future treatment option," said Dr. David Peura, professor of medicine, University of Virginia Health System, past president of the American Gastroenterological Association.

Data from the two separate EE healing studies demonstrated that patients treated with TAK-390MR 60 mg and 90 mg experienced higher overall healing after eight weeks, versus patients taking lansoprazole 30 mg. In addition, data from a six-month maintenance of healed EE study demonstrated that patients treated with TAK-390MR 30 mg and 60 mg experienced statistically significant overall maintenance and symptom relief over placebo.

Healing of Erosive Esophagitis Studies

TAK-390MR was compared to lansoprazole in two identically designed, double-blind, randomized, controlled trials in patients with confirmed EE. A total of 4,092 patients were enrolled in the two global studies. The primary objective was to evaluate overall healing rates over eight weeks after once-daily administration of TAK-390MR 60 mg or 90 mg or lansoprazole 30 mg. The results for each study were analyzed using life table and crude rate methods.

Results from these trials demonstrated that TAK-390MR 60 mg and 90 mg produced consistently high healing ra
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SOURCE TAP Pharmaceutical Products Inc.
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