Healthcare Industry News: Inflammatory Bowel Disease
News Release - May 7, 2007
Axcan Announces the U.S. Launch of PYLERA, an Innovative 3-in-1 Capsule Triple Therapy for the Eradication of Helicobacter PyloriMONT-SAINT-HILAIRE, QUEBEC--(Healthcare Sales & Marketing Network)--May 7, 2007 -- Axcan Pharma Inc. (Toronto:AXP.TO )(NasdaqGS:AXCA ) today 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.
ABOUT HELICOBACTER PYLORI
The discovery in 1983 of the Helicobacter pylori organism was one of the major advances in gastroenterology in recent decades, as it revolutionized the approach to many upper gastrointestinal disorders. Helicobacter pylori is now recognized as one of the most important causes of gastric and duodenal ulcers, which affect at least 10% of the North American population at one point in their lives. It is believed to cause a spectrum of diseases in humans, including gastritis, ulcer disease (gastric and duodenal), gastric cancer, and gastric lymphoma. Existing ulcer treatment regimens lead to high recurrence rates. Gastric and duodenal ulcers recur in approximately 40% to 80% of patients within a year after having received short-term treatment with acid suppression therapy. Studies have shown that the recurrence rate of peptic ulcers after one year is only 2% in patients in whom the organism has been eradicated.
Additional information about PYLERA and Helicobacter pylori may be found at www.pylera.com.
ABOUT AXCAN PHARMA
Axcan is a leading multinational specialty pharmaceutical company focused on gastroenterology. The company develops and markets a broad line of prescription products to treat a range of gastrointestinal diseases and disorders such as Inflammatory Bowel Disease, irritable bowel syndrome, cholestatic liver diseases and complications related to pancreatic insufficiency. Axcan's products are marketed by its own specialized sales forces in North America and Europe. Its common shares are listed on the NASDAQ Global Market under the symbol "AXCA" and the Toronto Stock Exchange under the symbol "AXP."
Caution regarding guidance and Forward-Looking Information and "Safe Harbor" statement under the Private Securities Litigation Reform Act of 1995
This release contains forward-looking statements, which reflect the Company's current expectations regarding future events. To the extent any statements made in this release contain information that is not historical, these statements are essentially forward-looking, including, without limitation, the Company's guidance for fiscal 2007 in respect of revenues, research and development expenses as well as selling and administrative expenses and are generally identified by words such as "anticipate," "expect," "estimate," "intend," "project," "plan" and "believe." Forward-looking statements are subject to risks and uncertainties and undue reliance should not be placed on these statements. Certain material assumptions are applied in making forward-looking statements, and actual results may differ materially from those expressed or implied in such statements. Important factors that could cause actual results to differ materially from these expectations are outlined in the body of this news release, and also include the acceptance and demand for new pharmaceutical products, the impact of competitive products and pricing, new product development and launch, reliance on key strategic alliances, availability of raw materials, the regulatory environment, the protection of our intellectual property and other risks detailed from time to time in the Company's filings with the Securities and Exchange Commission and the Canadian securities regulators.
The Company cautions that the foregoing list of factors that may affect future results is not exhaustive. Axcan undertakes no obligation to update or revise any forward-looking statement, unless obligated to do so pursuant to applicable securities laws and regulations.
The name PYLERA appearing in this press release is a trademark of Axcan Pharma Inc. and its subsidiaries.
Source: Axcan Pharma
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