Takeda Drives Leading PAMES Study in Brazil Showing Improved Symptom Relief for People with Erosive Gastroesophageal Reflux Disease (GERD)

ZURICH, December 12, 2013 /PRNewswire/ --

- 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^[1] -

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.^[1] 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.^[2]

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.^[1]

"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.^[1]
• At 8 weeks, symptom relief rates with pantoprazole magnesium were significantly higher than that with esomeprazole (91.6% vs. 86%, P = 0.0370).^[1]
• Mucosal healing rates were high and not significantly different between treatments groups.^[1]

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).^[3],[4],[5]

About GERD

Gastroesophageal reflux disease (GERD) or acid reflux disease (ARD), sometimes referred to as heartburn as it is the most common symptom of GERD, is a condition that develops when reflux of stomach contents causes troublesome symptoms or complications.^[2]

GERD can be further classified as the presence of symptoms without erosions on endoscopic examination (non-erosive disease or NERD) or GERD symptoms with erosions present (ERD).^[6] This latter presentation is also known as erosive esophagitis (EE).^[6]

Common symptoms of reflux disease are persistent heartburn and regurgitation, i.e. pain or burning in the chest, stomach acid rising into the oesophagus, sour taste in the mouth and burning in the throat. The prevalence of GERD has increased over the last 20 years.^[7],[8]

About Tecta^®

Tecta^® (pantoprazole magnesium) is a proton pump inhibitor used for the treatment of reflux esophagitis, gastric and duodenal ulcers, Zollinger-Ellison-Syndrome and other pathological hypersecretory conditions.

Takeda has a long heritage of focusing on bringing relief to patients affected by having to live with upper gastrointestinal disorders through the development of innovative treatments and through professional partnerships that support efforts to educate the medical and patient communities.

Other PPIs marketed by the Takeda Group include: Pantoprazole sodium available in more than 90 countries under a variety of brand names and formulations, including Pantozol^®, Somac^®, Controloc^®, Pantoloc^® and Zurcal^®. In the US, Pantoprazole sodium is marketed by Takeda's partner, Pfizer Inc., under the brand name Protonix^®. Prevacid^® (lansoprazole) is a well-known PPI in around 90 markets, and Dexilant^™ (dexlansoprazole), the first PPI with a novel dual delayed release technology.

About Takeda Pharmaceuticals International GmbH

Headquartered in Zurich as a wholly owned subsidiary of Takeda Pharmaceutical Company Limited, Osaka, Japan, the company has a commercial presence covering more than 70 countries, with particular strength in Asia, North America, Europe and fast-growing emerging markets including Latin America, Russia-CIS and China. Areas of focus include cardiovascular and metabolic, oncology, respiratory and immunology, central nervous system, general medicine, and vaccines.

Takeda is a research-based global company with its main focus on pharmaceuticals. As the largest pharmaceutical company in Japan and one of the global leaders of the industry, Takeda is committed to strive towards better health for people worldwide through leading innovation in medicine. Through the integration of Millennium Pharmaceuticals and Nycomed, Takeda has been transforming itself, broadening its therapeutic expertise and geographic outreach.

Additional information about Takeda is available through its corporate website, http://www.takeda.com.

This press release has been issued by Takeda Pharmaceuticals International GmbH, Thurgauerstrasse 130, CH-8152 Glattpark-Opfikon, Zurich, Switzerland.

References

1. Moraes-Filho J.P., & PAMES Study Group. Randomized clinical trial: daily pantoprazole magnesium 40 mg versus esomeprazole 40 mg for gastroesophageal reflux disease, assessed by endoscopy and symptoms. Alimentary Pharmacology & Therapeutics. Published online October (doi:10.1111/apt.12540) (2013)

2. Moraes-Filho J.P. et al. Prevalence of heartburn and gastroesophageal reflux disease in the urban Brazilian population. Arquivos de Gastroenterologia; 42(2):122-7 (2005)

3. Moraes-Filho J.P. et al. Similar Healing and Symptom Response Rates for 40 mg Pantoprazole-mg and 40 mg Esomeprazole in Erosive Esophagitis. Gastroenterology; 144:5 ( Suppl. 1):S-859 (2013)

4. Moraes-Filho J.P. et al. Improved symptom relief with pantoprazole magnesium versus esomeprazole in erosive esophagitis. Journal of Gastroenterology and Hepatology; 28 (Suppl. 3): 294 (2013)  

5. Moraes-Filho J.P. et al. Improvement in symptom relief with pantoprazole magnesium 40 mg versus esomeprazole 40 mg in patients with erosive esophagitis after 8 weeks. United European Gastroenterology; 1(1S) A409 (2013)

6. Katz P.O. et al. Diagnosis and Management of Gastroesophageal Reflux Disease. The American Journal of Gastroenterology; 108(3):308-28 (2013)

7. El-Serag H.B. Time trends of gastroesophageal reflux disease: a systematic review. Clinical Gastroenterology and Hepatology; 5(1): 17-26 (2007)

8. El-Serag H.B. et al. Update on the epidemiology of gastro-oesophageal reflux disease: a systematic review. Gut, Jul 13  [Epub ahead of print]; doi: 10.1136/gutjnl-2012-304269 (2013)