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): December 8, 2008
Medicis Pharmaceutical Corporation
(Exact name of registrant as specified in its charter)
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Delaware
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001-14471
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52-1574808 |
(State of Incorporation)
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(Commission File Number)
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(IRS Employer |
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Identification Number) |
7720 North Dobson Road
Scottsdale, Arizona 85256
(Address of principal executive offices) (Zip Code)
(602) 808-8800
(Registrants telephone number, including area code)
N/A
(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:
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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)) |
Item 8.01 Other Events.
Medicis Pharmaceutical Corporation (Medicis) today announced that it has received
Paragraph IV Patent Certifications from each of Sandoz, Inc., a division
of Novartis AG (Sandoz), and Impax Laboratories, Inc. (Impax), advising that they have each filed an Abbreviated New Drug Application
(ANDA) with the U.S. Food and Drug Administration (FDA) for generic SOLODYN® in its current
forms of 45mg, 90mg and 135mg strengths. Neither Sandoz nor Impax has advised Medicis as to the timing or status
of the FDAs review of their respective filings, or whether either has complied with FDA requirements for
proving bioequivalence. Sandozs Paragraph IV Certification alleges that Mediciss U.S. Patent No.
5,908,838 (the 838 Patent), is invalid, unenforceable and/or will not be infringed by either Sandozs manufacture, use, or
sale of the product for which the ANDA was submitted. Impaxs certification
alleges that the 838 Patent will not be infringed by Impaxs manufacture, use or sale of the product for which the ANDA was submitted because it has been granted a patent license by Medicis for the 838 Patent. The expiration date for the 838 Patent is 2018.
Medicis is evaluating the details of Sandozs certification letter and considering its options.
SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, as amended, the
Registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly
authorized.
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Date: December 12, 2008 |
By: |
/s/
Jason D. Hanson
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Jason D. Hanson |
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Executive Vice President, General Counsel and
Corporate Secretary |
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