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 the earliest event reported): February 12, 2008
Valeant Pharmaceuticals International
(Exact name of registrant as specified in its charter)
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| Delaware
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1-11397
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33-0628076 |
(State or other jurisdiction of
incorporation or organization)
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(Commission File Number)
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(I.R.S. Employer
Identification No.) |
One Enterprise
Aliso Viejo, California 92656
(Address of principal executive offices) (Zip Code)
(949) 461-6000
(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:
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Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425) |
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Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12) |
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Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17
CFR 240.14d-2(b)) |
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Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17
CFR 240.13e-4(c)) |
TABLE OF CONTENTS
Item 7.01 Regulation FD Disclosure
On
February 14, 2008, Valeant Pharmaceuticals International (the
“Company”) held a conference call
and webcast to present the results of the first of two studies (RESTORE 1) in its Phase III
clinical trials for retigabine. The presentation is attached as Exhibit 99.1. Exhibit 99.1 is also
available on the Company’s website at http://valeant.com under Investor Relations/Financial
Presentations dated February 14, 2008.
The information in this Item 7.01, including Exhibit 99.1, will not be treated as filed for the
purposes of Section 18 of the Securities Exchange Act of 1934 (the “Exchange Act”) or otherwise
subject to the liabilities of that section. This information will not be incorporated by reference
into a filing under the Securities Act of 1933, or into another filing under the Exchange Act,
unless that filing expressly refers to specific information in this report.
Item 8.01 Other Events
On February 12, 2008, the Company issued a press release announcing the results of the RESTORE 1
study. A copy of the press release is attached as Exhibit 99.2.
Item 9.01 Financial Statements and Exhibits
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Description |
99.1
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Presentation by the Company of the results of the first of
two studies (RESTORE 1) in its Phase III clinical trials
for retigabine. |
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99.2
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Press release dated February 12, 2008. |
FORWARD-LOOKING STATEMENTS
This current report, including the exhibits, contains forward-looking statements within the meaning
of the federal securities laws relating to expectations, plans or prospects for the Company,
including, but not limited to, statements regarding expectations or plans of the Company’s Phase
III program for retigabine, the potential role retigabine could play
in managing epilepsy and the Company’s expectations with respect
to regulatory filings. These
statements are based upon the current expectations and beliefs of management and are subject to
certain risks and uncertainties that could cause actual results to differ materially from those
described in the forward-looking statements. These risks and uncertainties include, but are not
limited to, risks and uncertainties related to the clinical development of retigabine, including
that RESTORE 1 results are not necessarily predictive of RESTORE 2 results, and that adverse events
are not always immediately apparent even in well designed clinical trials, regulatory approval
processes, and other risks and uncertainties discussed in the company’s filings with the SEC. The
Company wishes to caution the reader that these factors are among the factors that could cause
actual results to differ materially from the expectations described in the forward-looking
statements. The Company also cautions the reader that undue reliance should not be placed on any of
the forward-looking statements, which speak only as of the dates of the presentation and press
release, respectively. The Company undertakes no obligation to update any of these forward-looking
statements to reflect events or circumstances after such applicable dates or to reflect actual
outcomes.