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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): March 24, 2006
King Pharmaceuticals, Inc.
(Exact name of registrant as specified in its charter)
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| Tennessee
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001-15875
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54-1684963 |
(State or other jurisdiction
of incorporation)
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(Commission File Number)
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(I.R.S. Employer Identification No.) |
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| 501 Fifth Street, Bristol, Tennessee
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37620 |
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(Zip Code) |
Registrant’s telephone number, including area code: (423) 989-8000
Not Applicable
(Former name or former address, if changed since last report)
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 (see General Instruction
A.2. below):
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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 8.01. Other Events.
On March 24, 2006, King Pharmaceuticals, Inc. (the “Company”) issued a press release
announcing that, in recent communications with the U.S. Food and Drug Administration (“FDA”), the
Company has been informed that the data from its completed TOPHAT (Treatment of
Pediatric Hypertension with Altace Trial) clinical trial submitted
in support of its supplemental New Drug Application (“sNDA”) are insufficient, and the Company
believes that, subject to additional discussions with the FDA, it may be necessary to conduct a
second clinical trial in order to receive an additional six months of exclusivity beyond patent
expiry for the Company’s Altace® (ramipril) product. In light of this denial, the Company plans to
have further discussions with the FDA and provide additional supportive analyses. If necessary,
the Company also intends to pursue an additional clinical trial and meet with the FDA to reach
agreement on the design of that trial. Should such an additional clinical trial be necessary, and
provided that the study is completed and reported to the FDA by the third quarter of 2008 and that
the results meet the FDA’s requirements, the Company believes it can satisfy the applicable
regulations and obtain an additional six months of market exclusivity.
TOPHAT was initiated in response to the FDA’s written request for additional information
regarding Altace® that may produce health benefits in pediatric populations. This
request was issued in accordance with the Modernization Act of 1997.
The press release, dated March 24, 2006, is being filed herewith as Exhibit 99.1 and the
information contained therein is incorporated into Item 8.01 of this Current Report on Form 8-K by
reference.
Item 9.01. Financial Statements and Exhibits.
(d) The following exhibit is filed with this report:
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Description |
99.1
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Press Release dated March 24, 2006 |
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, hereunto duly authorized.
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King Pharmaceuticals, Inc. |
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By: /s/ Joseph Squicciarino |
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Joseph Squicciarino |
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Chief Financial Officer |
Date: March 24, 2006