SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM 6-K
Report of Foreign Issuer
PURSUANT to Rule 13a-16 or 15d-16 of the Securities Exchange Act of 1934
For the Month of January, 2004
Commission File Number 0-30860
Axcan Pharma Inc.
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(Exact Name of Registrant)
597, boul. Laurier, Mont-Saint-Hilaire (Quebec), Canada J3H 6C4
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(Address of principal executive offices)
Indicate by check mark whether the registrant files or will file annual reports
under cover Form 20-F or Form 40-F.
Form 20-F Form 40-F
X
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Indicate by check mark whether the registrant by furnishing the information
contained in this Form is also hereby furnishing the information to the
Commission pursuant to Rule 12g3-2(b) under the Securities Exchange Act of 1934.
Yes No
X
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This Form 6-K consists of: A press release issued by Axcan Pharma Inc. on
January 22, 2004, entitled "Axcan Pharma Reports Positive Pre-IND Meeting for
ITAX-Functional Dyspersia Phase III Studies to be Initiated upon IND Filing."
SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, the
registrant has duly caused this report to be signed on its behalf by the
undersigned, thereunto duly authorized.
AXCAN PHARMA INC.
Date: January 22, 2004 By: /s/ Jean Vezina
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Name: Jean Vezina
Title: Vice-President, Finance and
Chief Financial Officer
[AXCAN LOGO] AXCAN PHARMA, INC.
597, boul. Laurier
Mont-Saint-Hilaire (Quebec)
Canada J3H 6C4
Tel: (450) 467-5138
1 (800) 565-3255
Fax: (450) 464-9979
www.axcan.com
SOURCE: AXCAN PHARMA INC.
TSX SYMBOL (Toronto Stock Exchange): AXP
NASDAQ SYMBOL (Nasdaq National Market): AXCA
DATE: January 22, 2004
Press Release for immediate distribution
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 Francois 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.
CLINICAL PROGRAM - FUNCTIONAL DYSPEPSIA
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.
ABOUT ITAX
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
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1995.
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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.
INFORMATION: David W. Mims
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
www.axcan.com