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): April 29,
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))
24535153_1.DOC
|
Item 8.01
Other Events
Expiration of FDA deadline
for exercise of enforcement discretion with respect to Pancreatic Enzyme
Products (PEPs)
As
previously disclosed, existing products to treat exocrine pancreatic
insufficiency have been marketed in the U.S. since before the passage of the
Federal Food, Drug, and Cosmetic Act, or FDCA, in 1938 and, consequently,
companies have historically marketed Pancreatic Enzyme Products, or PEPs that
have not been approved by the Food and Drug Administration, or FDA, including
ULTRASE® MT and VIOKASE®. In 1995, the FDA, issued a final rule requiring that
these PEPs be marketed by prescription only, and, in April 2004, the FDA
mandated that all manufacturers of exocrine pancreatic insufficiency drug
products file an 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 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) that continue diligent pursuit of regulatory approval.
On April
12, 2010, the FDA issued a press release concerning its approval of an
additional PEP and also posted on its website questions and answers for
healthcare professionals and the public regarding the use of approved PEPs and
the implications for PEP products that are not approved by April 28, 2010. In
its communication, the FDA confirmed that following April 28, 2010, marketers of
unapproved PEPs must suspend distributing unapproved PEP products. The FDA
stated that, after this date, the unapproved products may still be available on
pharmacy shelves for a short time until stock is depleted.
In this
communication, the FDA also stated that it will continue to review NDAs that
have been submitted by manufacturers of unapproved PEPs, and will approve
additional PEPs even after the April 28, 2010 deadline has passed, if they meet
the required safety, effectiveness, and product quality standards.
As
previously disclosed, we completed the submission of our NDA for ULTRASE® MT
and, in the fourth quarter of fiscal 2008, received a first complete response
letter (formerly known as an “approvable letter’’ prior to recent amendments of
the Food Drug and Cosmetics Act, or FDCA) citing only certain chemistry,
manufacturing and control data, or CMC, work requirements to which we
responded. Further to the filing of our response, we received a second
complete response letter in the fourth quarter of fiscal 2009, again citing
certain CMC work the FDA requested we complete in order to obtain approval. This
request was addressed in a complete response letter we prepared in collaboration
with our manufacturing partners and filed with the FDA. The submission of our
rolling NDA for VIOKASE® was completed in the first quarter of fiscal
2010. At the time we completed this submission we requested a
priority review and the FDA advised us in the second quarter of fiscal 2010
that it would not grant a priority review of this NDA.
The
Prescription Drug User Fee Act, or PDUFA date, for ULTRASE® MT is May
5th,
2010, and the PDUFA date for VIOKASE® is
August 30, 2010.
While we
and the manufacturer of the active pharmaceutical ingredient of ULTRASE® MT and
VIOKASE® are in ongoing discussions with the FDA to address the remaining open
issues identified by the FDA, because we have not received FDA approval of the
NDAs we submitted for both ULTRASE® MT and VIOKASE®, we have taken steps to
cease the distribution of both these product lines, effective April 28,
2010.
These
developments could have a material adverse effect on, among other things, our
financial condition, and 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.
24535153_1.DOC
|
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.
Date:
April 29, 2010
|
|
AXCAN INTERMEDIATE HOLDINGS INC. | |
By:
|
/s/
|
Steve Gannon | |
Senior Vice President, Finance, Chief | |
Financial Officer and Treasurer |
24535153_1.DOC
|