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Takeda's investigational PPI TAK-390MR demonstrated higher healing rates compared to lansoprazole

October 07, 2008

TAK-390MR data presented at the American College of Gastroenterology Annual Meeting

Combined results from two Phase 3 studies presented at the American College of Gastroenterology Annual Scientific Meeting (ACG) in Orlando, Fla., demonstrated that TAK-390MR resulted in higher healing rates than lansoprazole among patients with more severe grades of erosive esophagitis (EE). TAK-390MR combines dexlansoprazole with a Dual Delayed Release™ (DDR) formulation, designed to provide two separate releases of drug for extended duration of acid suppression.

"These data are encouraging, as they suggest that TAK-390MR may provide an innovative new treatment option for patients with GERD, including those with more severe grades of erosive esophagitis," said David Peura, M.D., professor of medicine, University of Virginia Health System.

As part of the Phase 3 clinical trials, 4,092 patients were assessed for overall EE healing at week eight in two identically designed trials. Patients were randomized to receive 60 mg or 90 mg of TAK-390MR or 30 mg of lansoprazole. A retrospective, integrated analysis showed the difference in healing rates, or therapeutic gains, between 60 mg and 90 mg of TAK-390MR and 30 mg of lansoprazole, increased as the severity of EE increased. Therapeutic gains were greatest in patients with the most severe grade of EE (grade D): 12 percent for 60 mg (n=74) and 20 percent for 90 mg (n=83) of TAK-390MR. There were no significant differences in adverse events observed between the treatment groups.

"The development of TAK-390MR is another example of Takeda's commitment to patients who suffer from GERD and erosive esophagitis," said Dr. Stuart Atkinson, vice president of clinical science at Takeda. "TAK-390MR has the potential to serve as an important new treatment option for physicians and patients. If approved, it would be the first PPI that employs a dual delayed release formulation, delivering medication in two separate releases."

Additional TAK-390MR data being presented at ACG includes:

* Long-Term Safety of TAK-390MR, a PPI with a Novel Dual Delayed Release Formulation, in GERD Patients.
Abstract P391, Poster Presentation, Monday, October 6

* Placebo-Controlled Trial of Two Doses of TAK-390MR, a PPI with Novel Dual Delayed Release Technology, as Maintenance Treatment for Patients with Healed Erosive Esophagitis (EE).
Abstract P21, Poster Presentation, Sunday, October 5

* TAK-390MR Maintains Relief of Gastroesophageal Reflux Disease (GERD) Symptoms and Improvements in Quality of Life in GERD Patients with Healed Erosive Esophagitis.
Abstract P24, Poster Presentation, Sunday October 5

* TAK-390MR, a Novel Dual Delayed Release Formulation of a PPI, is Bioequivalent When Administered as Granules Sprinkled Over Applesauce or as an Intact Capsule.
Abstract P394, Poster, Monday, October 6

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