Will Photofrin PDT Reduce Risk of Esophageal Cancer?
Press Release
MONT SAINT-HILAIRE, QC, Sept. 13 /PRNewswire-FirstCall/
Coinciding with the World Congress of Gastroenterology 2005 being held in Montreal, Canada, Axcan Pharma Inc. ("Axcan" or the "Company") disclosed new data demonstrating that Photofrin photodynamic therapy ("PDT") used in conjunction with omeprazole, a standard acid suppression therapy, reduced occurrence of esophageal cancer. This new clinical information is based on the analysis of the 5-year follow-up observation of patients with High Grade Dysplasia ("HGD") associated with Barrett's esophagus ("BE") who were randomized in the original pivotal 2-year Phase III study conducted by Axcan which led to regulatory approval in 2003. Since HGD and the eventual possibility of developing cancer in BE are inextricably linked, the original 24-month follow-up study was continued over 5 years to confirm the reduction in cancer occurrence.
"We are extremely pleased with these results since they confirm that Photofrin PDT has the potential to be used for the prevention of esophageal cancer and that it is a clinically effective endoscopic therapy in reducing the incidence of cancer in patients with Barrett's High Grade Dysplasia," commented Dr. Francois Martin, Senior Vice-President, Scientific Affairs of Axcan. "Results already noted in our initial study are now strengthened by the 5-year follow-up. It has been demonstrated that Photofrin PDT is not only safe and effective but that its effects are prolonged," he concluded.
STUDY RESULTS
The study used multiple sites and involved 208 patients randomized (2:1) to Photofrin PDT used in conjunction with omeprazole 20mg twice-a-day, or to omeprazole alone at a dose of 20mg twice-a-day.
At the end of the 5-year follow-up, results of the study confirmed that Photofrin PDT used in conjunction with omeprazole was superior to omeprazole alone in preventing the progression to cancer, with about twice the likelihood of cancer occurring in the omeprazole alone group (29%) compared to Photofrin PDT used in conjunction with omeprazole (15%). This reduction of the progression to cancer is highly statistically significant (p (equal sign) 0.0272).
The original pivotal 2-year Phase III study had shown successful HGD ablation in 77% of patients using Photofrin PDT in conjunction with omeprazole compared with 39% of patients using omeprazole alone. Detailed results of this original study will be published in the October 2005 issue of "Gastrointestinal Endoscopy "(GIE).
ABOUT PHOTOFRIN
Photofrin for injection is a photosensitizing agent used in the photodynamic therapy of tumors. It uses a combination of a photoactive drug and light from a laser, allowing the doctor to specifically target and destroy cells with HGD associated with BE while limiting damage to surrounding healthy tissue. Photofrin is marketed by Axcan in North America under the brand Photofrin, and in the European Union under the brand Photobarr.
ABOUT AXCAN PHARMA
Axcan is a leading specialty pharmaceutical company involved in the field of gastroenterology. The Company markets a broad line of prescription products sold for the treatment of symptoms in a number of gastrointestinal diseases and disorders such as inflammatory bowel disease, irritable bowel syndrome, cholestatic liver diseases and complications related to cystic fibrosis. Axcan's products are marketed by its own sales force in North America and Europe. Its common shares are listed on the Toronto Stock Exchange under the symbol "AXP" and on the NASDAQ National Market under the symbol "AXCA".
"Safe Harbor" statement under the Private Securities Litigation Reform
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Act of 1995.
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To the extent any statements made in this release contain information that is not historical, these statements are essentially forward looking and are subject to risks and uncertainties, including the difficulty of predicting FDA and other regulatory approvals, 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, fluctuations in operating results and other risks detailed from time to time in the Company's filings with the Securities and Exchange Commission and the Canadian securities regulatory agencies.
Photofrin and Photobarr are registered trademarks of Axcan Pharma Inc.
SOURCE AXCAN PHARMA INC.
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