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Axcan Announces Positive Phase II Efficacy and Safety Results for ITAX in the Treatment of Functional Dyspepsia


May 20, 2004 - 12:00 ET

Axcan Announces Positive Phase II Efficacy and Safety Results for ITAX in
the Treatment of Functional Dyspepsia

MONT SAINT-HILAIRE, QUEBEC, May 20--Axcan Pharma Inc.
("Axcan" or the "Company") recently announced positive efficacy and safety
results of a Phase II study for ITAX (Itopride hydrochloride) concluding that
ITAX was significantly better than placebo for symptom-control in patients
with functional dyspepsia after 4 and 8 weeks. No cardiac toxicity was
observed in the study group. Dr. Gerald Holtmann, Professor at the University
of Essen, Germany, presented the results at Digestive Disease (DDW) week on
May 19, 2004.

    
"The opportunity of increasing the awareness of ITAX's potential at the
world's largest international gastrointestinal meeting is very significant for
Axcan," said Léon F. Gosselin, President and Chief Executive Officer of Axcan.
"With the recent initiation of Phase III clinical trials on ITAX for the
treatment of functional dyspepsia, we are pleased that we are able to share
with the scientific community this very important information. We believe that
ITAX will fill a therapeutic gap in the treatment of GI motility disorders."

    
ITAX is a patented oral gastroprokinetic drug with antiemetic properties
for the treatment of gastrointestinal symptoms caused by reduced
gastrointestinal motility. Axcan licensed ITAX from Abbott Laboratories in
September 2003 and is currently entering Phase III clinical studies for ITAX
in the treatment of functional dyspepsia, the first indication pursued by the
Company.

    
ITAX STUDY SUMMARY AND RESULTS

    
"A Randomized, Double-Blind, Placebo-Controlled Dose Finding Study of
Itopride for the Treatment of Patients with Functional Dyspepsia" Gerald
Holtmann, Joerg Schnittker, Guenter Boos, Bernd Matiba and Nicholas J. Talley,
University of Essen, Germany.

    
The Phase II dose response study conducted had two objectives: confirm
the safety and efficacy of ITAX in a Caucasian population and select the
appropriate dose of ITAX for use in pivotal Phase III studies. The study used
a double-blind placebo controlled design comparing tablets containing 50, 100
and 200 mg of ITAX administered three times a day to matching placebo tablets.
The study involved 554 patients with functional non-ulcer dyspepsia or
functional dyspepsia, 424 that were included in the study analysis. The study
endpoints were: change in the overall severity of the patients' functional
dyspepsia as measured by the Leeds Dyspepsia Questionnaire ("LDQ"); and a
global assessment at week 8 to determine whether the patients were symptom
free or markedly improved with respect to the two most important symptoms of
functional dyspepsia (severity of upper abdominal pain and severity of
excessive feeling of fullness after eating).

    Treatment with ITAX in all groups resulted in statistically significant
improvement of the LDQ score (p less than 0.02). 46.6% of patients treated
with placebo were symptom-free or markedly improved compared to 60.8%, 63.2%
and 71.4% of patients treated with Itopride at doses of 50, 100 and 200 mg
three times daily (p less than 0.05), respectively. The pain and fullness
response was significantly better in the Itopride groups (77.3% for 50 mg;
78.9% for 100 mg and 76.2% for 200 mg) in comparison to 63.6% in the placebo
group (p less than 0.05).

    
In order to evaluate the cardiac safety of ITAX in the Phase II study
described above, resting 12-lead standard electrocardiograms were recorded at
the screening visit, at visit 2 (4 weeks after beginning of the treatment
phase) and at visit 4 (8 weeks after beginning of the treatment phase).
Results of the study confirmed that no cardiac side effects occurred and no
association between treatment with Itopride and QT interval prolongation was
found.

    
An abstract of the study can be found on the Digestive Disease Week web
site, www.ddw.org .

    
ABOUT FUNCTIONAL DYSPEPSIA

    
Functional dyspepsia, a disorder of the upper gastrointestinal system,
affects up to 25% of the US population annually and accounts for up to 5% of
all visits to primary care physicians (Talley et al Gastroenterology
1992:102;1259-1268). Currently, there are no known approved drugs for this
indication in the United States.

    
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
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
"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
Multijurisdictional Disclosure System.

    
ITAX is a trademark of Axcan or its affiliates.


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