Search form


Press Releases

Photofrin PDT reduces esophageal cancer occurrence in patients with Barrett's High Grade Dysplasia - Results of a 5-year follow-up study

Sep 13, 2005 - 11:59 ET

TSX SYMBOL (Toronto Stock Exchange): AXP


MONT SAINT-HILAIRE, QC, Sept. 13 - 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. François 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.


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 = 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).


BE is a condition in which the normal lining of the lower part of the
esophagus is replaced over time by another type of lining, normally present in
the stomach. Usually BE develops during the process of healing after a chronic
injury to the esophageal mucosa such as caused by reflux of gastric juice
(GERD) in the esophagus. Continued reflux may cause dysplastic changes
progressing from Low-Grade to HGD. Such dysplasia may lead to esophageal
adenocarcinoma, which is a life-threatening condition. The U.S. National
Digestive Diseases Information Clearing House (NDDIC) estimates that the risk
of developing adenocarcinoma is 30 to 125 times greater in people who have BE
than in people who do not.


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.


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
Act of 1995.

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.

David W. Mims, Executive Vice President and
Chief Operating Officer, Axcan Pharma Inc.,
(205) 991-8085 ext. 3223;

Isabelle Adjahi, Director,
Investor Relations,
Axcan Pharma Inc.,
(450) 467-2600
ext. 2000,;

Source: Axcan Pharma Inc.