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Axcan Announces Positive Study for the New Sulfated Version of Ursodiol as a Potent Chemopreventive Agent in Colorectal Cancer

May 18, 2004 - 12:00 ET

Axcan Announces Positive Study for the New Sulfated Version of Ursodiol as
a Potent Chemopreventive Agent in Colorectal Cancer

- Dr. Kenneth Setchell presents results at Digestive Disease Week - 

MONT SAINT-HILAIRE, Quebec, May 18 - Axcan Pharma Inc.
("Axcan" or the "Company") recently announced the results of a study of the
new, non-absorbed bile acid, Ursodeoxycholic Acid-Disulfate ("SUDCA" or
"ursodiol disulfate") indicating that this bile acid reduced formation of
colorectal tumors by 50% in a rat model, proof-of-concept toxicity study.
These results were presented at the Digestive Disease Week (DDW) Conference by
Dr. Kenneth Setchell of the Cincinnati Children's Hospital Medical Center on
May 17, 2004. The study described for the first time a potent chemopreventive
effect on the development of colonic tumors in an animal model of human
colorectal cancer.

"The presentation of these results at the Digestive Disease Week
Conference is very encouraging for Axcan," said Léon F. Gosselin, President
and Chief Executive Officer of Axcan. "Not only are the results positive but
the ability to share them at this, the largest international gathering of
physicians, researchers and academics in the fields of gastroenterology,
hepatology, endoscopy and gastrointestinal surgery, provides Axcan a precious
scientific forum to reiterate its commitment to develop significant products
for the prevention of diseases such as colorectal cancer."

Ursodiol disulfate, which is unabsorbed when orally administered, is a
patented derivative of ursodiol intended for prevention of recurrence of
colorectal polyps. Axcan acquired the exclusive worldwide rights in September
2000 to commercially exploit SUDCA, developed by the Children's Hospital
Research Foundation ("CHRF"), an operating division of the Cincinnati Hospital
for Sick Children Research Center.


"The New Non-Absorbed Bile Acid, Ursodeoxycholic Acid-Disulfate (SUDCA)
is a Potent Chemopreventive Agent in the Azoxymethane (AOM) Rat Model of
Chemical-Induced Colorectal Cancer" Kenneth D. Setchell and Nadine M. Brown,
Cincinnati Children's Hospital Medical Center of Cincinnati.

Previous studies showed that hydrophobic (water repellent) secondary bile
acids, lithocholic ("LCA") and deoxycholic acids, naturally present in the
colon, promote colonic carcinogenesis. By contrast, the hydrophilic (water
soluble) bile acid, ursodeoxycholate ("Ursodiol") negates the tumor-promoting
effects of cholic acid in the AOM rat model induced colon cancer and has
undergone clinical trials for the prevention of neoplasia in patients at risk
for colon cancer. However, Ursodiol is efficiently absorbed in the small
intestine and extensively biotransformed by intestinal bacteria to LCA,
factors that reduce delivery to the colon and produce pro-carcinogenic bile
acids. Ursodiol disulfate overcomes these limitations by preventing intestinal
absorption, permitting site-specific delivery to the colon, increasing its
membrane protective hydrophilic property, and preventing biotransformation to
hydrophobic membrane-damaging bile acids.

The objective of the study conducted by Dr. Schetchell and Nadine M.
Brown, was to determine the effectiveness of ursodiol disulfate in preventing
colonic tumors chemically-induced by AOM a carcinogen, in 344 rats, and to
compare this analog with ursodiol.

AOM-injected animals fed with ursodiol disulfate had a statistically
significant 50% reduction in tumor incidence (mean (+/-) 0.62 (+/-) 0.12
tumors per animal, p equals 0.002) when compared to animals in the control
group (1.20 (+/-) 0.16 tumors per animal). By contrast no such decrease in
tumor formation was observed in the animals treated with regular ursodiol. No
tumor formation was observed in any of the vehicle-injected animals and
ursodiol disulfate was without toxicity. The colonic intraluminal content of
ursodiol disulfate-fed animals contained predominantly unchanged orally
administered bile acid, while ursodiol-treated animals had mainly the tumor-
promoting LCA.

Abstract of the study can be found on the Digestive Disease Week web
site, .


Colorectal cancer is the most common gastrointestinal cancer in the
United States with an estimated 1.5 million cases, and 100,000 deaths every
year. About 160,000 new cases are diagnosed every year in the United States.
Colorectal polyps, abnormal changes in the intestinal lining, are precursors
to colorectal cancer. Because colorectal polyps are well established markers
of colorectal cancer, they constitute an appropriate marker for
chemoprevention studies. Since various prevention strategies such as high
fiber or calcium diet, Nonsteroidal Anti-Inflammatory Drugs and others have
failed to show efficacy, SUDCA could prove to become an important drug in the
prevention of colorectal cancer.


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
Western Europe. Its common shares are listed on the Toronto Stock Exchange
under the symbol "AXP" and on the NASDAQ National Market under the symbol

"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
Multijurisdictional Disclosure System.

David W. Mims
Executive Vice President and 
Chief Operating Officer
Axcan Pharma Inc.
(205) 991-8085 ext. 223
Julie M. Thibodeau
Manager, Investor Relations
Axcan Pharma Inc.
(450) 467-2600 ext. 2062