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 October, 2003
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
October 6, 2003, entitled "Axcan Receives "Not Approvable" Letter for Helicide;
FDA Cites On-Going Manufacturing Deficiencies at One of Five Manufacturing
Sites."
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: October 7, 2003 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: October 6, 2003
Press Release for immediate distribution
AXCAN RECEIVES "NOT APPROVABLE" LETTER FOR HELICIDE
FDA CITES ON-GOING MANUFACTURING DEFICIENCIES
AT ONE OF FIVE MANUFACTURING SITES
MONT SAINT-HILAIRE, Quebec - Axcan Pharma Inc. ("Axcan" or the "Company") has
announced that the U.S. Food and Drug Administration ("FDA") has determined that
the New Drug Application ("NDA") that Axcan re-submitted for HELICIDE for the
eradication of Helicobacter pylori, continues to be "not approvable" at this
time. Certain of the FDA inspection-related issues, communicated to Axcan in an
August 12, 2002, action letter for one of the five manufacturing sites, remain
unresolved and were the basis for this "not approvable" letter. As in the
previous letter, the FDA has not raised any safety or efficacy issues. HELICIDE
was approved in Canada in the second quarter of fiscal 2003.
During the last year, Axcan has worked closely with the Italian manufacturer
identified in the NDA to resolve all outstanding issues. However, the ability of
this manufacturer of one of HELICIDE's ingredients, biskalcitrate potassium
(bismuth salt), to implement all required corrective action is severely limited
due to its present financial status. Axcan will meet with the FDA in the coming
weeks to discuss alternative plans and, shortly thereafter, intends to announce
revised regulatory timelines.
"HELICIDE is an important product candidate for Axcan, and we will continue to
work to resolve the outstanding regulatory issues in order to bring this product
to the market as soon as possible," commented Leon F. Gosselin, President and
CEO of Axcan. "Obviously, we are disappointed that the launch of HELICIDE is
delayed due to this temporary set-back. However, our current business remains
strong and we are confident that we will meet or exceed analysts' current
expectations for net revenues in excess of U.S. $200 million and income in
excess of U.S. $0.80 per basic share or U.S. $0.70 per fully diluted share for
fiscal year 2004," he concluded.
Axcan will host a conference call at 10:00 A.M. EST, on October 6, 2003.
Interested parties may also access the conference call by way of web cast at
www.axcan.com. The web cast will be archived for 90 days.
The telephone numbers to access the conference call are (800) 814-4853 (Canada
and United States) or (416) 640-4127 (international). A replay of the call will
be available until October 13, 2003. The telephone number to access the replay
of the call is (416) 640-1917 code: 21020179.
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 for 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
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 and other risks detailed from
time to time in the Company's filings with the Securities and Exchange
Commission.
The name HELICIDE 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