Axcan Pharma Inc. (TSX:AXP)(NASDAQ:AXCA) announced the launch of PYLERA in the United States. PYLERA is a patented 3-in-1 capsule triple therapy for the eradication of Helicobacter pylori, which is a bacterium recognized as being the main cause of gastric and duodenal ulcers.
“We are pleased to be offering the latest advancement in the eradication of Helicobacter pylori. PYLERA’s convenient dosing and packaging should help to address the compliance issues facing so many patients,” said Frank Verwiel, M.D., President and Chief Executive Officer of Axcan. “In addition, our studies confirmed that PYLERA is not only as effective as the most widely prescribed therapeutic regimen for the eradication of Helicobacter pylori (omeprazole, amoxicillin and clarithromycin), but that it has the potential to be used in a wide range of patients as a first-line therapy for the eradication of Helicobacter pylori, based on its convenient dosing regimen.”
PYLERA is available to patients by prescription for oral administration. Each PYLERA capsule contains biskalcitrate potassium (140 mg), metronidazole (125 mg) and tetracycline hydrochloride (125 mg), allowing patients to take as few as 140 capsules in order to eradicate Helicobacter pylori. Other currently available therapies containing bismuth subsalicylate, metronidazole and tetracycline hydrochloride require up to 252 capsules or tablets.
The US market for therapies for the eradication of Helicobacter pylori is in excess of US$170 million, and due to under-diagnosis, the Company believes there is significant growth potential for this market.
PHASE III CLINICAL STUDIES
The Phase III North American trials conducted in 275 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 (20 mg of omeprazole, 1 g of amoxicillin and 500 mg of clarithromycin, all given twice a day). On an intent-to-treat basis, the eradication rates were 88% and 83%, respectively, in favour of PYLERA; the difference was not statistically significant.