-----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, HnSNIWP3lcyiM5v1859M/6k6gnHsjW+uOdy5b7BQ73w3fUH6ANbuVuxBsQIwMwvn 7tDb19iVaDkn1YJEguEU/Q== 0001144204-08-066620.txt : 20081125 0001144204-08-066620.hdr.sgml : 20081125 20081125150737 ACCESSION NUMBER: 0001144204-08-066620 CONFORMED SUBMISSION TYPE: 8-K PUBLIC DOCUMENT COUNT: 1 CONFORMED PERIOD OF REPORT: 20081124 ITEM INFORMATION: Other Events FILED AS OF DATE: 20081125 DATE AS OF CHANGE: 20081125 FILER: COMPANY DATA: COMPANY CONFORMED NAME: NEXMED INC CENTRAL INDEX KEY: 0001017491 STANDARD INDUSTRIAL CLASSIFICATION: PHARMACEUTICAL PREPARATIONS [2834] IRS NUMBER: 870449967 STATE OF INCORPORATION: NV FISCAL YEAR END: 1231 FILING VALUES: FORM TYPE: 8-K SEC ACT: 1934 Act SEC FILE NUMBER: 000-22245 FILM NUMBER: 081213572 BUSINESS ADDRESS: STREET 1: 350 CORPORATE BLVD CITY: ROBBINSVILLE STATE: NJ ZIP: 08691 BUSINESS PHONE: 6092089688 MAIL ADDRESS: STREET 1: 350 CORPORATE BLVD CITY: ROBBINSVILLE STATE: NJ ZIP: 08691 8-K 1 v133510_8k.htm
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) November 24, 2008

NexMed, Inc.
(Exact name of registrant as specified in its charter)
 
Delaware
0-22245
87-0449967
(State or other jurisdiction of incorporation)
(Commission File Number)
(I.R.S. Employer Identification No.)
     
89 Twin Rivers Drive, East Windsor, New Jersey
08520
(Address of principal executive offices)
(Zip Code)
 
Registrant’s telephone number, including area code (609) 371-8123
 
 
(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 240.13a-4(c))
 
 
 
 

ITEM 8.01 OTHER EVENTS.

On November 24, 2008, NexMed, Inc. (the "Company") entered into an amendment to the exclusive United States licensing agreement, dated November 1, 2007 (the "Agreement"), with Warner Chilcott Company, Inc. ("Warner"), for NexMed's proprietary topical alprostadil-based cream treatment for erectile dysfunction (“Vitaros®”). 
 
Pursuant to the amendment, Warner has been granted an additional 45 days, or until January 13, 2009, to review the results of the October 15, 2008 meeting (the “Meeting”) with the Food and Drug Administration (FDA). The purpose of the Meeting was to gain clarification on the major deficiencies cited by the FDA in their July 21, 2008 action letter regarding the New Drug Application (NDA) for Vitaros®. As such, on or before January 13, 2009, Warner must decide whether or not they wish to continue with the development of Vitaros®. If Warner decides that it does not wish to continue with Vitaros® then the Agreement would terminate and all rights would revert back to the Company. The Agreement previously afforded Warner 45 days, or until November 29, 2008 to review such regulatory concerns.
 
 
 
 
 
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.
 
     
  NEXMED, INC.
 
 		  
 		  
 
  By:   /s/ Mark Westgate
  Name:
Mark Westgate
 
Title:
Vice President and Chief Financial Officer 
 
Date: November 25, 2008
 
 
 
 
 
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