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

Zurich (ots/PRNewswire) -

- First Head to Head Study Showed Tecta(R) 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(R)) 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(R) 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 Sao 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(R)) 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(R)) 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(R)

Tecta(R) (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(R), Somac(R),
Controloc(R), Pantoloc(R) and Zurcal(R). In the US, Pantoprazole
sodium is marketed by Takeda's partner, Pfizer Inc., under the brand
name Protonix(R). Prevacid(R) (lansoprazole) is a well-known PPI in
around 90 markets, and Dexilant(TM) (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)

ots Originaltext: Takeda Pharmaceuticals Europe Ltd
Im Internet recherchierbar: http://www.presseportal.de

Contact:
Contact: Danny Stepto, Takeda Pharmaceuticals International GmbH,
+41(0)44-555-1504, danny.stepto@takeda.com