Brazilian study provides evidence to support effectiveness of Tecta in erosive GERD

- First Head to Head Study Showed Tecta^® As Effective for Healing and Complete Remission of Erosive GERD with Significantly Higher Symptom Relief After 8 Weeks compared to Esomeprazole -

Takeda Pharmaceuticals International GmbH (Takeda) announced today results showing pantoprazole magnesium 40 mg (Tecta^®) was as effective as esomeprazole 40 mg for achieving complete remission (defined as combined endoscopic healing and symptomatic relief) and the mucosal healing rate was high, whilst providing significantly higher symptom relief after 8 weeks. Results of this Brazilian study, PAMES (Pantoprazole Magnesium x Esomeprazole), published today in the international medical journal, Alimentary Pharmacology and Therapeutics, provide further evidence to support the effectiveness of Tecta^® in the management of erosive GERD, a condition which affects 10-30% of people around the world.

Led by one of Brazil's principal medical research institutes, University of São Paulo Medical School, PAMES is the first head to head study which compares complete remission, healing and symptom relief of the proton-pump inhibitors (PPIs) pantoprazole magnesium 40 mg (Tecta^®) with that of esomeprazole in patients with erosive GERD.

"It is crucial that we have options which are effective for the treatment of erosive GERD, but symptom relief is also extremely important as the condition can have a damaging impact on the quality of patient lives," said Lead Investigator and gastroenterologist Professor Joaquim Moraes-Filho. "We hope these robust results will prompt stronger consideration of options for the management of symptom-relief for people with erosive GERD, not only here in Brazil, but in countries all around the world."

Results from the multicenter (14 Brazilian sites in 9 cities), double-blinded, randomized, parallel-group study comparing pantoprazole magnesium 40 mg (Tecta^®) and esomeprazole 40 mg once daily in 578 patients with erosive GERD were:

• Complete remission occurred in 61% of patients in each treatment group at 4 weeks (primary endpoint) and in 81% and 79% of patients in the pantoprazole magnesium and esomeprazole groups at 8 weeks, respectively.
• At 8 weeks, symptom relief rates with pantoprazole magnesium were significantly higher than that with esomeprazole (91.6% vs. 86%, P = 0.0370).
• Mucosal healing rates were high and not significantly different between treatments groups.

The PAMES study has received continued recognition around the world in 2013 following presentation of results at three of the largest global congresses for digestive diseases; Digestive Disease Week (DDW), World Congress of Gastroenterology (WCOG) and United European Gastroenterology Week (UEGW).