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news.The FDA has approved Pylera, Axcan Pharma's 3-in-1 capsule triple therapy for the eradication of helicobacter pylori, which is a bacterium now recognized as being the main cause of gastric and duodenal ulcers.
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“The US market for therapies for the eradication of helicobacter pylori is in excess of $160 million, and because of under diagnosis there is significant growth potential for this market,” said Frank Verwiel, president and CEO of Axcan. “We anticipate launching Pylera in the US in the first half of calendar 2007 and are working on preparing for the filing of this product in the European Union.”
The phase III trials of Pylera conducted in patients with a history of duodenal ulcer compared Axcan's Pylera regimen given in combination with two daily doses of 20 mg of omeprazole, to the widely used OAC triple therapy. The eradication rates, although not statistically significant, were 88% and 83%, respectively, in favor of Pylera.
The US patent on the Pylera capsule technology expires in December 2018.