Search form

 

Press Releases


More than 1000 patients enrolled in Axcan's ITAX Phase III functional dyspepsia studies


Jun 09, 2005 - 11:59 ET



TSX Symbol (Toronto Stock Exchange): AXP
NASDAQ Symbol (NASDAQ National Market): AXCA

 


MONT SAINT-HILAIRE, QC, June 9 - Axcan Pharma Inc. ("Axcan"
or the "Company") announced today that it has enrolled more than 1000 patients
in the Company's two Phase III studies on ITAX (Itopride hydrochloride) for
the treatment of functional dyspepsia. Recruitment activities will continue
for a few weeks. The Company has also enrolled more than 300 patients who will
receive active medication for six months in accordance with the International
Conference on Harmonisation ("ICH") guidelines. Axcan expects to complete its
Functional Dyspepsia Phase III program in the fourth quarter of 2005. Work has
begun on preparing the ITAX New Drug Application ("NDA") to be filed during
the first half of 2006, most likely at the end of the first quarter. Other
regulatory filings in Canada and selected Western European countries will
follow in the second quarter of 2006.

"We are very pleased to have reached this important milestone in our ITAX
development program," said Léon F. Gosselin, Chairman and outgoing President
and Chief Executive Officer of Axcan. "The approval and launch of ITAX,
expected in early calendar 2007, will allow Frank Verwiel and the Axcan team
to take the Company to the next level."

ITAX is a patented oral gastroprokinetic drug containing itopride
hydrochloride, which increases upper gastrointestinal motility and possesses
antiemetic properties. In addition to functional dyspepsia Axcan plans to
investigate the use of ITAX for the treatment of diabetic gastroparesis &
gastropathy.

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 in the USA (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.

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 the Canadian
securities regulatory authorities.

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. 3223;

Julie M. Thibodeau,
Manager, Investor Relations,
Axcan Pharma Inc.,
(450) 467-2600 ext. 2062;
www.axcan.com;

Source: Axcan Pharma Inc.;