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Axcan Initiates Phase III Clinical Trials on ITAX - Functional Dyspepsia Studies to be Carried Out in North America and Western Europe

May 13, 2004 - 12:00 ET

Axcan Initiates Phase III Clinical Trials on ITAX - Functional Dyspepsia 
Studies to be Carried Out in North America and Western Europe 

MONT SAINT-HILAIRE, Quebec, May 13 - Axcan Pharma Inc.
("Axcan" or the "Company") announced today that it has obtained the approval
of the Therapeutic Products Directorate ("TPD") of Health Canada and
Investigational New Drug ("IND") clearance from the Gastro-intestinal division
of the Food and Drug Administration ("FDA"), required to initiate Phase III
clinical trials to demonstrate safety and efficacy of ITAX (itopride
hydrochloride) in the treatment of functional dyspepsia (also known as non-
ulcer dyspepsia).

"We are very pleased to initiate our Phase III development program for
ITAX in functional dyspepsia. Axcan also plans to initiate other clinical
studies on ITAX in diabetic gastroparesis in the near future," said Léon
Gosselin, President and Chief Executive Officer of Axcan.

Axcan expects to commence the Phase III studies during the third quarter
of fiscal 2004 and aims to complete enrolment of patients by the end of
calendar year. If there are positive outcomes from the studies, the Company
expects to submit an application for New Drug Approval ("NDA") in the United
States and to make a New Drug Submission ("NDS") in Canada for the treatment
of functional dyspepsia in the latter part of 2005, seeking approval to market
ITAX in fiscal 2006.


Axcan will conduct two Phase III studies involving a total of
1,000 patients. Each study 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. symptoms of peptic
ulcer disease, gastric or esophageal neoplasms, gastroesophageal reflux
disease, biliary colics, chronic pancreatitis, Helicobacter pylori infection
or alcohol or drug-induced dyspepsia) in either Phase III study.

The primary efficacy endpoint will be the assessment of abdominal symptom
relief. The secondary endpoint will assess changes in the quality of life 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 already observed in the ITAX Phase I and Phase II studies.


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 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 tract,
affects up to 25% of the North American population annually and accounts for
up to 5% of all visits to primary care physicians (Talley et al
Gastroenterology 1992:102;1259-1268).


Gastroparesis is a neuromuscular disease characterized by delayed or
absent emptying of the stomach. Gastroparesis occurs when the stomach's
enteric nerves (or the vagus nerve connecting the digestive tract to the
central nervous system) and/or muscle cells become damaged or destroyed. In
addition, the disease can occur primarily, as a result of nerve or muscle
damage further down the digestive tract (i.e.-pyloric stenosis or pseudo-
obstruction) which causes gastric contents to back up and pool in the stomach.
The most prevalent secondary cause of gastroparesis is diabetes. Gastroparesis
occurs in diabetes as a result of high blood glucose levels creating chemical
and structural changes in the nerves and muscles of the stomach. Other
secondary causes of the disease include Parkinson's Disease, migraine,
connective tissue diseases (such as lupus and scleroderma) or failed
gastrectomy (a procedure now used to attempt to alleviate obesity in a wide
number of individuals).

A recent study estimates that up to 5 million people in the United States
suffer from either the primary or secondary form of gastroparesis. Symptoms
can include severe stomach muscle spasm, heartburn, nausea, vomiting and
significant weight loss. In diabetes, gastroparesis is a significant
contributor to loss of blood glucose control and diabetic crisis.


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 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.

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

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