More Than 15 Years Experience: Takeda Marks one Billion Treatment Courses of Gastric Ulcer Drug Pantoprazole

ZURICH, October 22, 2012 /PRNewswire/ --



Takeda Pharmaceuticals International GmbH ("Takeda") today announced that over one billion treatment courses of its gastrointestinal product pantoprazole have been administered around the world.^[1] Initially launched in 1994 in Germany, pantoprazole, a proton pump inhibitor (PPI) used to treat acid related diseases, is available in more than 90 countries as a prescription treatment and over-the-counter product.

Throughout the 17 years of experience with pantoprazole, ongoing clinical trials have continued to deepen medical experience and understanding.  Most recently, in April 2012 the first clinical trial evaluating tolerability, safety and efficacy of a PPI in patients with chronic peptic complaints over fifteen years of drug administration was published in the Journal Alimentary Pharmacology and Therapeutics^[2] by Prof. Brunner and co-workers from the University Medical School Hannover.

The results of the analysis (n=142) demonstrated that daily pantoprazole maintenance therapy for up to 15 years for severe acid-peptic disease was effective and well tolerated. The results of the analysis (n=142) reinforced that daily Pantoprazole maintenance therapy for up to 15 years for severe acid-peptic disease is effective and well tolerated. No safety concerns were identified. No evidence of an enhanced risk for gastric carcinoma was observed in assessments of laboratory and histological parameters. A major strength of this study lies in the continuous collection of safety data and, in particular, gastric histological data over the course of 15 years of daily treatment with pantoprazole. These results provide reassuring evidence for the long-term safety of pantoprazole and underline the benefits and the favourable efficacy and safety profile of the product.

Prof. Brunner, Division of Gastroenterology and Hepatology at the University Medical School Hannover, said "The patient outcomes after 15 years of treatment makes pantoprazole one of the best researched PPIs in long-term treatment, reassuring the safety and efficacy profile of this product."

Pantoprazole is a proton pump inhibitor used to treat the symptoms of stomach and intestinal gastric ulcers, heartburn, gastro-esophageal reflux disease (GERD) and other related gastrointestinal diseases. Pantoprazole is marketed in more than 90 countries under a variety of brand names, including Pantozol^®, Somac^®, Controloc^®, Pantoloc^® and Zurcal^®. In the US, the medicine is marketed by Takeda's partner, Pfizer Inc., under the brand name Protonix^®.

In addition to pantoprazole, acquired through its merger with Nycomed, Takeda has a long heritage of focusing on the issues that affect patients living with upper gastrointestinal disorders through the development of innovative treatments.

Other PPIs marketed by the Takeda Group include: Tecta^®, an advanced magnesium-salt formulation of pantoprazole, Prevacid^® (lansoprazole), a well-known PPI in around 90 markets, and Dexilant^®(dexlansoprazole), the first PPI with a novel dual delayed release technology.

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1. Periodic Safety Update Report (PSUR) No. 34 - pantoprazole, October 2012

2. Brunner et al. Long-term, open-label trial: safety and efficacy of continuous maintenance treatment with pantoprazole for up to 15 years in severe acid-peptic disease. Alimentary Pharmacology and Therapeutics 2012; 36: 37-47

About Takeda Pharmaceuticals International GmbH

Takeda Pharmaceuticals International GmbH, headquartered in Zurich, is a wholly owned subsidiary of Takeda Pharmaceutical Company Limited. As the largest pharmaceutical company in Japan and a leader in the global industry, Takeda's mission is to strive toward better health for patients worldwide through leading innovation in medicine. It has a commercial presence in around 70 countries, with particular strength in Asia, North America, Europe and fast-growing emerging markets including Latin America, Russia-CIS and China. Takeda is ranked 12th by global Rx sales, 14th in the BRIC countries and 18th in Europe. Areas of focus include cardiovascular and metabolic diseases, immunology and respiratory diseases, oncology and central nervous system diseases, among others. 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.