-----BEGIN PRIVACY-ENHANCED MESSAGE----- Proc-Type: 2001,MIC-CLEAR Originator-Name: webmaster@www.sec.gov Originator-Key-Asymmetric: MFgwCgYEVQgBAQICAf8DSgAwRwJAW2sNKK9AVtBzYZmr6aGjlWyK3XmZv3dTINen TWSM7vrzLADbmYQaionwg5sDW3P6oaM5D3tdezXMm7z1T+B+twIDAQAB MIC-Info: RSA-MD5,RSA, MAz/kuM9WWw3iu52ZKzJq5UexfBNkzNFoAQLqLjsTlO6e2n0tlwJN8SqcRDh/XDG trvl0Y4hZrQR11p/jU+SqQ== 0000950123-09-050047.txt : 20091013 0000950123-09-050047.hdr.sgml : 20091012 20091013171638 ACCESSION NUMBER: 0000950123-09-050047 CONFORMED SUBMISSION TYPE: 8-K PUBLIC DOCUMENT COUNT: 3 CONFORMED PERIOD OF REPORT: 20091008 ITEM INFORMATION: Other Events ITEM INFORMATION: Financial Statements and Exhibits FILED AS OF DATE: 20091013 DATE AS OF CHANGE: 20091013 FILER: COMPANY DATA: COMPANY CONFORMED NAME: MEDICIS PHARMACEUTICAL CORP CENTRAL INDEX KEY: 0000859368 STANDARD INDUSTRIAL CLASSIFICATION: PHARMACEUTICAL PREPARATIONS [2834] IRS NUMBER: 521574808 STATE OF INCORPORATION: DE FISCAL YEAR END: 1231 FILING VALUES: FORM TYPE: 8-K SEC ACT: 1934 Act SEC FILE NUMBER: 001-14471 FILM NUMBER: 091117602 BUSINESS ADDRESS: STREET 1: 7720 DOBSON ROAD CITY: SCOTTSDALE STATE: AZ ZIP: 85256 BUSINESS PHONE: 2125992000 MAIL ADDRESS: STREET 1: 7720 DOBSON ROAD CITY: SCOTTSDALE STATE: AZ ZIP: 85256 8-K 1 p16109e8vk.htm 8-K e8vk
 
 
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
October 8, 2009
Date of Report (Date of earliest event reported)
Medicis Pharmaceutical Corporation
(Exact name of registrant as specified in its charter)
         
Delaware
(State of Incorporation)
  001-14471
(Commission File Number)
  52-1574808
(IRS Employer
        Identification Number)
7720 North Dobson Road
Scottsdale, Arizona 85256

(Address of principal executive offices) (Zip Code)
(602) 808-8800
(Registrant’s 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:
o   Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)
 
o   Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)
 
o   Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))
 
o   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 Receives Notice of Allowance for Solodyn® Patent
     On October 13, 2009, Medicis Pharmaceutical Corporation (the “Company”) announced that the United States Patent and Trademark Office (USPTO) has issued a Notice of Allowance for the Company’s United States patent application directed to the use of SOLODYN® (minocycline HCl, USP) Extended Release Tablets in all five currently available dosage forms. The patent application is U.S. Application No. 11/166,817, entitled “Method For The Treatment Of Acne.” The newly allowed claims include subject matter covering methods of using a controlled-release oral dosage form of minocycline to treat acne. A press release dated October 13, 2009 announcing the issuance of the Notice of Allowance is attached as Exhibit 99.1 hereto and is incorporated herein by reference.
Medicis Receives a Paragraph IV Patent Certification
     On October 8, 2009, the Company received a Paragraph IV Patent Certification from Lupin Ltd. (“Lupin”) advising that Lupin has filed an Abbreviated New Drug Application (“ANDA”) with the U.S. Food and Drug Administration (“FDA”) for generic SOLODYN® in its forms of 45mg, 90mg and 135mg strengths. Lupin has not advised the Company as to the timing or status of the FDA’s review of its filing, or whether it has complied with FDA requirements for proving bioequivalence. Lupin’s Paragraph IV Certification alleges that Lupin’s manufacture, use, sale or offer for sale of the product for which the ANDA was submitted will not infringe any valid claim of the Company’s U.S. Patent Nos. 5,908,838 (the “‘838 Patent”), 7,541,347 (the “‘347 Patent”) or 7,544,373 (the “‘373 Patent”). The expiration date for the ‘838 Patent is in 2018. The expiration dates for the ‘347 and ‘373 Patents are in 2027. The Company is evaluating the details of Lupin’s certification letter and considering its options.
Item 9.01 Exhibits.
     (d) Exhibits
          99.1   Press Release dated October 13, 2009.

 


 

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.
         
     
Date: October 13, 2009  By:   /s/ Jason D. Hanson    
    Jason D. Hanson   
    Executive Vice President, General Counsel and Corporate Secretary   
 

 

EX-99.1 2 p16109exv99w1.htm EX-99.1 exv99w1
Exhibit 99.1
(MEDICIS)
     
 
NEWS
 
FOR IMMEDIATE RELEASE
 
     
CONTACT:
  7720 N Dobson Road
Kara Stancell, Investor Relations & Corporate Communications,
  Scottsdale, AZ 85256
(480) 291-5854
  (602) 808-8800
 
  www.Medicis.com
MEDICIS RECEIVES NOTICE OF ALLOWANCE FOR SOLODYN® PATENT
SCOTTSDALE, Ariz.—October 13, 2009—Medicis (NYSE:MRX) today announced that the United States Patent and Trademark Office (USPTO) has issued a Notice of Allowance for Medicis’ United States patent application directed to the use of SOLODYN® (minocycline HCl, USP) Extended Release Tablets in all five currently available dosage forms.
The patent application is U.S. Application No. 11/166,817, entitled “Method For The Treatment Of Acne.” The newly allowed claims include subject matter covering methods of using a controlled-release oral dosage form of minocycline to treat acne.
“We are pleased to announce receipt of this Notice of Allowance by the USPTO,” said Jonah Shacknai, Chairman and Chief Executive Officer of Medicis. “This represents yet another important element of maintaining the SOLODYN franchise. When issued, these allowed patent claims will further enhance the intellectual property protection of the SOLODYN brand.”
A Notice of Allowance generally completes the substantive examination of a patent application. The normal process which results in final issuance of a United States patent involves several administrative steps that are typically completed in due course following issuance of such a notice.
SOLODYN has three issued patents. U.S. Patent No. 5,908,838 relates to the use of the SOLODYN unique dissolution rate, and expires in 2018. U.S. Patent No. 7,541,347 relates to the use of the 90mg controlled-release oral dosage form of minocycline to treat acne, and expires in 2027. U.S. Patent No. 7,544,373 relates to the composition of SOLODYN in 90mg tablet form, and expires in 2027. As of today, the Company has a number of U.S. patent applications associated with the SOLODYN program on file at the USPTO.
About SOLODYN® Extended Release Tablets
Launched to dermatologists in July 2006 after approval by the U.S. Food and Drug Administration on May 8, 2006, SOLODYN is the only branded oral minocycline approved for once daily dosage in the treatment of inflammatory lesions of non-nodular moderate to severe acne vulgaris in patients 12 years of age and older. SOLODYN is the first approved minocycline in extended release tablet form. SOLODYN is lipid soluble, and its mode of action occurs in the skin and sebum. SOLODYN is available by prescription in 45mg, 65mg, 90mg, 115mg and 135mg extended release tablet dosages.

1


 

About Medicis
Medicis is the leading independent specialty pharmaceutical company in the United States focusing primarily on the treatment of dermatological and aesthetic conditions. The Company is dedicated to helping patients attain a healthy and youthful appearance and self-image. Medicis has leading branded prescription products in a number of therapeutic and aesthetic categories. The Company’s products have earned wide acceptance by both physicians and patients due to their clinical effectiveness, high quality and cosmetic elegance.
The Company’s products include the brands DYSPORT™ (abobotulinumtoxinA) 300 Units for Injection, PERLANE® (hyaluronic acid), RESTYLANE® (hyaluronic acid), DYNACIN® (minocycline HCl), LIDEX® (fluocinonide) Cream 0.05%, LOPROX® (ciclopirox), PLEXION® (sodium sulfacetamide 10% and sulfur 5%), SOLODYN® (minocycline HCl, USP) Extended Release Tablets, TRIAZ® (benzoyl peroxide), VANOS® (fluocinonide) Cream 0.1%, ZIANA® (clindamycin phosphate 1.2% and tretinoin 0.025%) Gel, AMMONUL® (sodium phenylacetate and sodium benzoate) Injection 10%/10%, BUPHENYL® (sodium phenylbutyrate) Tablets and Powder, the LIPOSONIX®1 System and the over-the-counter brand ESOTERICA®.
For more information about Medicis, please visit the Company’s website at www.Medicis.com. Printed copies of the Company’s complete audited financial statements are available free of charge upon request.
Forward-Looking Statements
This press release contains “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act. All statements included in this press release that address activities, events or developments that Medicis expects, believes or anticipates will or may occur in the future are forward-looking statements. These statements are based on certain assumptions made by Medicis based on its experience and perception of historical trends, current conditions, expected future developments and other factors it believes are appropriate in the circumstances. No assurances can be given, however, that these activities, events or developments will occur or that such results will be achieved. Such statements are subject to a number of assumptions, risks and uncertainties, many of which are beyond the control of Medicis. Several of these risks are outlined in the Company’s most recent annual report on Form 10-K for the year ended December 31, 2008, and other documents we file with the Securities and Exchange Commission. Forward-looking statements represent the judgment of Medicis’ management as of the date of this release, and Medicis disclaims any intent or obligation to update any forward-looking statements contained herein, which speak as of the date hereof. Among other things, there can be no assurance that the Notice of Allowance will result in the final issuance of the patent, as well as no assurance as to the timing of the final issuance of the patent.
SOLODYN® Tablets Safety Information
The most commonly reported side effects were headache, fatigue, dizziness and pruritus. Minocycline, like other tetracyclines, can cause fetal harm when administered to a pregnant woman. Tetracycline drugs should not be used during tooth development (last half of pregnancy and up to 8 years of age) as they may cause permanent discoloration of teeth. Pseudomembranous colitis has been reported with nearly all antibacterial agents and may range from mild to life threatening. Central nervous system side effects including light-headedness, dizziness, or vertigo, have been reported with minocycline therapy. In rare cases, photosensitivity has been reported. This drug is contraindicated in persons who have shown hypersensitivity to any of the tetracyclines.
NOTE: Full prescribing information for any Medicis prescription product is available by contacting the Company. All trademarks are the property of their respective owners.
 
1   The LIPOSONIX® System is not cleared for sale in the U.S.

2

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-----END PRIVACY-ENHANCED MESSAGE-----