BRIDGEWATER, NEW JERSEY--(Marketwire - April 28, 2010) - Axcan Pharma US, Inc., ("Axcan" or the "Company") announced today that the results from its European PYLERA® Phase III trial comparing the rate of Helicobacter pylori (H. pylori) eradication after OBMT (Omeprazole, Bismuth Subcitrate Potassium, Metronidazole, and Tetracycline) quadruple therapy with a 3-in-1 capsule to H. pylori eradication rate after OAC (Omeprazole, Amoxicillin, and Clarithromycin), has been selected for an oral presentationat the Digestive Disease Week meeting, being held May 1-5, 2010 in New Orleans, LA.
"Quadruple Therapy With Bismuth Subcitrate Potassium, Metronidazole, Tetracycline, and Omeprazole Is Superior to Triple Therapy With Omeprazole, Amoxicillin, and Clarithromycin in the Eradication of Helicobacter pylori" (Abstract #179) - Oral presentation of poster on Sunday, May 2, 2010 at 2:30 PM CT.
This study supports the European registration of PYLERA®, a 3-in-one capsule therapy for the eradication of H. pylori, a bacterium responsible for the majority of cases of duodenal ulcer disease.
ABOUT HELICOBACTER PYLORI
H. pylori is a bacterium associated with a number of conditions including peptic ulcer disease and dyspeptic symptoms and increases the risk of developing gastric cancer in infected individuals. It is believed to be a risk factor for a spectrum of diseases in humans, including gastritis, ulcer disease (gastric and duodenal), gastric cancer and gastric lymphoma. In North America, 10% of the population will have an ulcer in their lifetime; and many treatments end up with a high rate of recurrences. In fact, 40%-80% of patients experience a recurrence of ulcers within only a year after undergoing short-term treatment of gastric acid suppression therapy. Studies have shown that the gastroduodenal reoccurrence rate is only 2% for patients in whom the organism has been eradicated.
PYLERA® was developed by Axcan. PYLERA® is presented in the form of a single capsule containing a formula of bismuth subcitrate potassium, metronidazole and tetracycline hydrochloride, 3 ingredients used separately for the eradication of H. pylori. This medication is given in combination with a separate proton pump inhibitor (omeprazole). PYLERA® was launched in the United States in 2007 for the treatment of patients with H. pylori infection and duodenal ulcer disease (active or history of within the past 5 years) to eradicate H. pylori. Metronidazole has been shown to be carcinogenic in mice and rats. Unnecessary use of the drug should be avoided. Its use should be reserved for the conditions described in the INDICATIONS AND USAGE section of the US prescribing information. Please see full prescribing information for complete boxed warning and important safety information (http://www.pylera.com/pdf/prescribing-info.pdf).
ABOUT AXCAN PHARMA
Axcan Pharma US, Inc. is a subsidiary of Axcan Intermediate Holdings, Inc., a privately-held, leading global specialty pharmaceutical Company engaged in gastroenterology with clinical and commercial operations in the United States, the European Union and Canada. The Company develops, markets and sells pharmaceutical products used in the treatment of a variety of gastrointestinal diseases and disorders.