-----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, BNohWMScAsfiMzgj7sbFmAGxDwe2JE5eV4LsiHRW9bI3SatHVCCq6jsVES63Sn55 ZqYD5jASaoiEbVI3cEl4Zg== 0001299933-09-001218.txt : 20090316 0001299933-09-001218.hdr.sgml : 20090316 20090316104511 ACCESSION NUMBER: 0001299933-09-001218 CONFORMED SUBMISSION TYPE: 8-K PUBLIC DOCUMENT COUNT: 1 CONFORMED PERIOD OF REPORT: 20090316 ITEM INFORMATION: Other Events FILED AS OF DATE: 20090316 DATE AS OF CHANGE: 20090316 FILER: COMPANY DATA: COMPANY CONFORMED NAME: NOVEN PHARMACEUTICALS INC CENTRAL INDEX KEY: 0000815838 STANDARD INDUSTRIAL CLASSIFICATION: PHARMACEUTICAL PREPARATIONS [2834] IRS NUMBER: 592767632 STATE OF INCORPORATION: DE FISCAL YEAR END: 1231 FILING VALUES: FORM TYPE: 8-K SEC ACT: 1934 Act SEC FILE NUMBER: 000-17254 FILM NUMBER: 09682797 BUSINESS ADDRESS: STREET 1: 11960 SW 144TH ST CITY: MIAMI STATE: FL ZIP: 33186 BUSINESS PHONE: 3052535099 MAIL ADDRESS: STREET 1: 11960 SW 144TH STREET CITY: MIAMI STATE: FL ZIP: 33185 8-K 1 htm_31832.htm LIVE FILING Noven Pharmaceuticals, Inc. (Form: 8-K)  

 

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 16, 2009

Noven Pharmaceuticals, Inc.
__________________________________________
(Exact name of registrant as specified in its charter)

     
Delaware 0-17254 59-2767632
_____________________
(State or other jurisdiction 		_____________
(Commission 		______________
(I.R.S. Employer
of incorporation) File Number) Identification No.)
      
11960 S.W. 144th Street, Miami, Florida   33186
_________________________________
(Address of principal executive offices) 		  ___________
(Zip Code)
     
Registrant’s telephone number, including area code:   305-253-5099

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:

[  ]  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))

Item 8.01 Other Events.

Noven Pharmaceuticals, Inc. ("Noven") today confirmed that Shire plc ("Shire"), the global licensee of Daytrana® (methylphenidate transdermal system), has announced its withdrawal of the European Marketing Authorization Application ("MAA") for Daytrana for the treatment of Attention Deficit Hyperactivity Disorder ("ADHD"). Shire stated that its decision to withdraw the MAA was based on the fact that European regulatory authorities had requested an additional clinical study for Daytrana in a European patient population, and that Shire planned to enter the European ADHD market through the previously-announced pending acquisition of an oral methylphenidate product that is already approved in Europe. Noven further confirmed that its 2009 financial guidance in its Annual Report on Form 10-K, dated March 13, 2009 did not include any revenues or other financial contribution from European sales of Daytrana.





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.

         
    Noven Pharmaceuticals, Inc.
          
March 16, 2009   By:   /s/ Jeff Mihm
       
        Name: Jeff Mihm
        Title: Vice President, General Counsel and Corporate Secretary
-----END PRIVACY-ENHANCED MESSAGE-----