UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
Form 8-K
Current Report
Pursuant to Section 13 or 15(d) of the
Securities Exchange Act of 1934
Date of Report (Date of Earliest Event Reported): May 6, 2010
AXCAN INTERMEDIATE HOLDINGS INC.
(Exact Name of Registrant as Specified in its Charter)
|
Delaware
|
333-153896
|
74-3249870
|
|
(State or Other Jurisdiction of
Incorporation)
|
(Commission File Number)
|
(I.R.S. Employer
Identification No.)
|
22 Inverness Center Parkway
Suite 310
Birmingham, AL 35242
(Address of Principal Executive Offices, Including Zip Code)
(205) 991-8085
(Registrant’s Telephone Number, Including Area Code)
Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions:
[ ] Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)
[ ] Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)
[ ] Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))
[ ] Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))
Item 8.01 Other Events
FDA ISSUES COMPLETE RESPONSE LETTER FOR ULTRASE® MT
As previously disclosed, in April 2004, the U.S. Food and Drug Administration, or FDA, mandated that all manufacturers of pancreatic enzyme products file a New Drug Application, or NDA, and receive approval for their products by April 2008 or be subject to regulatory action. In October 2007, the FDA published a notice in the Federal Register extending the deadline within which to obtain marketing approval for these exocrine pancreatic insufficiency drug products until April 28, 2010 for those companies that (a) were marketing unapproved pancreatic enzyme products as of April 28, 2004; (b) submitted NDAs on or before April 28, 2009; and (c) continued diligent pursuit of regulatory approval.
As previously disclosed, because we did not received FDA approval of the NDAs we submitted for both ULTRASE® MT and VIOKASE® by FDA’s April 28, 2010 deadline, we took steps to cease the distribution of both these product lines, effective April 28, 2010.
On May 5th, 2010, the Prescription Drug User Fee Act, or PDUFA, date for our ULTRASE® MT NDA, the FDA issued an additional complete response letter (formerly known as an "approvable letter" prior to recent amendments of the Food Drug and Cosmetics Act, or FDCA) with respect to our NDA for ULTRASE® MT for the treatment of exocrine pancreatic insufficiency. This letter requires that deficiencies raised with respect to the manufacturing and control processes at the manufacturer of the active ingredient of ULTRASE® MT be addressed before approval can be granted.
We continue to work with the manufacturer of the active pharmaceutical ingredient to address the remaining open issues identified by the FDA, as soon as possible.
As previously disclosed, the submission of our rolling NDA for VIOKASE® was completed in the first quarter of fiscal 2010 and the PDUFA date for our NDA for VIOKASE® is August 30, 2010. We use the same manufacturer of active pharmaceutical ingredient as ULTRASE® MT for VIOKASE®.
These developments and, as previously disclosed, our ceasing to distribute ULTRASE® MT and VIOKASE® could have a material adverse effect on, among other things, our financial condition. We will assess the impact of these developments on our financial condition in our filing on Form 10-Q for the quarterly period ended March 31, 2010.
FORWARD-LOOKING STATEMENTS
This Current Report on Form 8-K contains forward-looking statements, which reflect our 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, including, without limitation, the Company's expectations with respect to the approval process for ULTRASE® MT ® and VIOKASE®® and any potential impact of these developments on our financial condition, and are generally identified by words such as “expect,” “could,” “will” and “believe.” Forward-looking statements are subject to risks and uncertainties and undue reliance should not be placed on these statements. Certain material assumptions are applied in making forward-looking statements, and actual results may differ materially from those expressed or implied in such statements. Important factors that could cause actual results to differ materially from these expectations are outlined in the body of this release, and also include the difficulty of predicting FDA and other regulatory actions and approvals, the impact of competitive products and pricing, new product developments, reliance on key strategic alliances, availability of raw materials, the regulatory environment, and other risks detailed from time to time in our filings with the Securities and Exchange Commission and the Canadian securities regulators.
SIGNATURE
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 hereunto duly authorized.
| AXCAN INTERMEDIATE HOLDINGS INC. | ||
|
Date: May 6, 2010
|
|
|
|
By:
|
/s/
|
|
| Steve Gannon | ||
| Senior Vice President, Finance, Chief | ||
| Financial Officer and Treasurer |