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Axcan announces outcome of ITAX International Phase III clinical trial

Feb 22, 2006 - 11:59 ET

MONT-SAINT-HILAIRE, QC, Feb. 22 - Axcan Pharma Inc. (NASDAQ:
AXCA - TSX: AXP) announced today that results of the ITAX (Itopride)
International Phase III clinical trial showed that Itopride, a drug developed
for the treatment of Functional Dyspepsia, did not meet its primary endpoint
and, as such, the results did not confirm the efficacy observed in other
studies, including the Phase II clinical trial. The Company will continue to
analyze the efficacy data from this Phase III trial, and this analysis,
together with the results of the North American Phase III study, should
provide a better understanding of the outcome. These findings will enable the
Company to decide on the continuation of the ITAX Functional Dyspepsia
program. The Company will continue the development of this compound in other
areas such as Diabetic Gastropathy.

"We are obviously surprised with the results of the Itopride
International Phase III trial, particularly in view of the positive results
seen in the soon-to-be published Phase II trial and in the preclinical data
that provided strong mechanistic support for Itopride. The results of the
study did, however, confirm the safety profile of the product candidate. While
efficacy results are disappointing for all stakeholders, we intend to examine
all potential factors relating to this outcome and are therefore conducting
additional analyses including by subgroup populations, with a view to
understanding the discrepancy between the results of the Phase II trial and
the International Phase III trial. Another important element of information
will be the results of the North American Phase III trial expected to be
announced by the end of the first half of calendar 2006," said Frank A.G.M.
Verwiel, M.D., president and chief executive officer of Axcan. "While we
complete our assessment of the Itopride program's future, we will focus on
other opportunities to accelerate growth of the Company by leveraging our
solid business base and executing on our growth strategy," he concluded.

The unique focus on gastroenterology has led to constant revenue growth,
which was highlighted by the two most recent quarters in which record sales
were obtained. Axcan is a solid, Company with more than 15 products on the
market, a significant research and development program, and a track record of
successful acquisitions of both products and companies. Management believes
that Axcan has many opportunities to grow the Company, beyond where it is

In order to support continued growth, the Company intends to leverage its
solid balance sheet. As at the end of the first quarter of fiscal 2006, cash
and marketable securities amounted to $126 million, together with a
$125 million line of credit. The Company also generated solid cash flows from
operations that amounted to $88 million for the trailing 12 months.


Axcan will host a conference call on February 22, 2006 at 8:00 AM to
discuss matters mentioned in this release. Interested parties may also access
the conference call by way of a webcast at The webcast will be
archived for 90 days. The telephone numbers to access the conference call are
(866) 250-4910 (Canada and United States) or (416) 644-3425 (international). A
replay of the call will be available until March 1st, 2006. The telephone
number to access the replay of the call is (416) 640-1917 code 21178346.


Axcan is a leading specialty pharmaceutical company specialized in the
field of gastroenterology. Axcan 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 the
European Union. 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.

This release contains forward-looking statements, which reflect the
Company's current expectations regarding future events. To the extent any
statements made in this release contain information that is not historical,
these statements are essentially forward looking and are often identified by
words such as "anticipate," "expect," "estimate," "intend," "project," "plan"
and "believe." Forward-looking statements 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, the protection of
our intellectual property and other risks detailed from time to time in the
Company's filings with the Securities and Exchange Commission and Canadian
securities regulators, including under the Canadian Multijurisdictional
Disclosure System.

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

For further information: Isabelle Adjahi, Director, Investor Relations,
Axcan Pharma Inc., (450) 467-2600 ext. 2000,; SOURCE: AXCAN