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Axcan Pharma Reports Positive Pre-Ind Meeting For ITAX - Functional Dyspepsia Phase III Studies to be Initiated Upon Ind Filing

Jan 22, 2004 - 12:00 ET

Axcan Pharma Reports Positive Pre-Ind Meeting For ITAX - Functional Dyspepsia Phase III Studies to be Initiated Upon Ind Filing

MONT SAINT-HILAIRE, Quebec--Axcan Pharma Inc. ("Axcan" or the "Company") today
announced the outcome of the meeting it held with the U.S. Food and Drug
Administration ("FDA") on January 20, 2004, regarding ITAX (itopride hydrochloride).
This meeting was held in preparation for the filing of an Investigational
New Drug ("IND") for ITAX in the treatment of functional dyspepsia
(also known as non-ulcer dyspepsia). During this meeting with the FDA's division of
Gastrointestinal and Coagulation Drug Products, the FDA endorsed Axcan's proposal to
conduct two Phase III pivotal double-blind, placebo controlled clinical studies to
demonstrate the safety and efficacy of ITAX in the treatment of functional dyspepsia.

After reviewing the data currently available on ITAX, the FDA agreed that no
additional Phase II studies were required. Axcan therefore expects to commence
the Phase III studies in the second half of fiscal 2004 after filing an IND
application. Assuming positive outcomes, the Company expects to submit a New Drug
Approval ("NDA") for the treatment of functional dyspepsia in the latter part of 2005
and obtain approval in fiscal 2006.

"We are extremely pleased with the outcome of this meeting. ITAX represents a major
advancement for Axcan and we believe this further demonstrates the depth of our product
pipeline and development capabilities. We are particularly happy with the fact that
the FDA agreed that no further Phase II studies are required," said François Martin,
Senior Vice President, Scientific Affairs of Axcan. "A large number of patients could
benefit from the availability of a gastroprokinetic drug such as ITAX. With the anticipated
initiation of the Phase III trial for ITAX, we will take a major step closer to providing
this important therapy to patients," he concluded.


Axcan plans to conduct two Phase III studies involving a total of 600 patients.
Each of these studies will assess the efficacy of ITAX 100 mg tablets in the treatment
of functional dyspepsia. Functional dyspepsia is a diagnosis of exclusion (diagnosis made
by excluding those diseases to which only some of the patient's symptoms might belong,
leaving one disease as the most likely diagnosis). Consequently Axcan will not include
patients with organic etiologies of upper abdominal pain or discomfort (e.g. peptic ulcer
disease, gastric or esophageal neoplasms, gastroesophageal reflux disease, biliary cholic,
chronic pancreatitis, Helicobacter pylori infection or alcohol or drug-induced dyspepsia)
in either Phase III study.

The primary endpoint that will be used to measure efficacy will be the assessment of
abdominal symptom relief. The secondary endpoint will consist of changes in the clinical
condition of patients undergoing ITAX or placebo therapy.

In order to evaluate the safety of ITAX, Axcan will monitor adverse drug reactions and
conduct standard laboratory measurements.  In addition, the Company plans to include
repeated 12 lead electrocardiograms as part of its Phase III protocols, in order to confirm
the absence of cardiac adverse events, as observed in the ITAX Phase I and Phase II studies.

According to the International Conference on Harmonisation guidelines, prior to a New Drug
Application filing, Axcan will be required to accumulate data on a total of 1,500 patients
exposed to ITAX, including those who have already been included in previous studies.


ITAX is a patented oral gastroprokinetic drug with antiemetic properties for the treatment of
gastrointestinal symptoms caused by reduced gastrointestinal motility that Axcan licensed from
Abbott Laboratories in September 2003. If approved, it would represent an attractive alternative
treatment strategy for patients with 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).
If ITAX is approved by the FDA for the treatment of functional dyspepsia, management believes
that within 3-5 years after full launch, sales of ITAX could generate annual revenue of
approximately U.S. $200-300 million and have a significant impact on net earnings.

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 regulatory approval, 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
Commissions. No assurance can be given that health authorities will provide approval in a
timely manner or that expected revenue would be realized.

In particular, the projected revenue level of ITAX after full launch would be reduced
significantly if the FDA regulatory approval was not obtained. If ITAX secures regulatory
approval, full commercial launch may require more time than expected. Axcan declines any
obligation to update any forward-looking statement contained herein.

The name ITAX appearing in this press release is a trademark of Axcan Pharma Inc.
and its subsidiaries.

              Executive Vice President and Chief Operating Officer
              Axcan Pharma Inc.
              Tel: (205) 991-8085 ext. 223

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