-----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, KNkA+aYrNzvHrC/ruNcbOtPKIqy/OjhB14IU8ZHHZuENlINd+hN//AYUmeVkymyr 95ZXZTJ6tOkL4z5Um3w35Q== 0001144204-08-049888.txt : 20080826 0001144204-08-049888.hdr.sgml : 20080826 20080826163024 ACCESSION NUMBER: 0001144204-08-049888 CONFORMED SUBMISSION TYPE: 8-K PUBLIC DOCUMENT COUNT: 3 CONFORMED PERIOD OF REPORT: 20080826 ITEM INFORMATION: Other Events ITEM INFORMATION: Financial Statements and Exhibits FILED AS OF DATE: 20080826 DATE AS OF CHANGE: 20080826 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: 081039619 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 v124935_8-k.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)
August 26, 2008
 
NexMed, Inc.
(Exact name of registrant as specified in its charter)
 
 
Nevada
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:
   
¨
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 240.13a-4(c))
 


ITEM 8.01 OTHER EVENTS.

On August 26, 2008, NexMed, Inc. (the “Company”) issued a press release announcing that based on First Interpretable Results of Phase III clinical studies for NM100060, a topical application of terbinafine formulated with NexACT® for the treatment of onychomycosis (nail fungus), the decision has been taken to not submit a New Drug Application with the Food and Drug Administration at this time.

NexMed entered into an exclusive, worldwide agreement with Novartis in September 2005, under which Novartis assumed all clinical development, regulatory, manufacturing and commercialization responsibilities for NM100060.

A copy of the press release is filed herewith as Exhibit 99.1.

ITEM 9.01. FINANCIAL STATEMENTS AND EXHIBITS.

(d) Exhibits

99.1 Press release, dated August 26, 2008


 
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/ Vivian Liu
 
 
Name:
Vivian Liu
 
 
Title:
President and
 
`
 
Chief Executive Officer
 
       
 
Date: August 26, 2008

 

EX-99.1 2 v124935_ex99-1.htm

 
NEXMED ANNOUNCES DECISION FOR NM 100060
 
-Management Conference Call at 5 pm Today-

East Windsor, NJ, August 26, 2008 -- NexMed, Inc. (Nasdaq: NEXM), a developer of products based on the NexACT® drug delivery technology, today announced that based on First Interpretable Results of Phase III clinical studies for NM100060, a topical application of terbinafine formulated with NexACT® for the treatment of onychomycosis, the decision has been taken not to submit a New Drug Application with the Food and Drug Administration at this time.

The two NM100060 clinical studies were randomized, double-blind and placebo-controlled, and designed to assess the efficacy, safety and tolerability of NM100060 in patients with mild to moderate toenail onychomycosis (nail fungus). No significant adverse event was reported in the studies.

NexMed entered into an exclusive, worldwide agreement with Novartis in September 2005, under which Novartis assumed all clinical development, regulatory, manufacturing and commercialization responsibilities for NM100060.

“While this is disappointing,” said Vivian Liu, NexMed’s President and Chief Executive Officer, “a European comparator study is still ongoing, and those results are expected mid 2009.”

NexMed will host a conference call to discuss today’s announcement this evening, August 26, 2008, at 5 pm EST. The call can be accessed in the U.S. by dialing 877-407-9205 and outside of the U.S. by dialing 201-689-8054 and asking the conference operator for the NexMed Conference Call. The teleconference replay is available for one week by dialing in the U.S. 877-660-6853 and outside of the U.S. by dialing 201-612-7415. Replay pass codes 286 and 295576 are both required for playback. The conference call will also be Webcast live at URL http://www.investorcalendar.com/IC/CEPage.asp?ID=133535. The Webcast replay will be available for three months.

About NexMed
NexMed, Inc. is leveraging its proprietary NexACT drug delivery technology to develop innovative topical pharmaceutical products that address unmet medical needs. For further information about NexMed, go to www.nexmed.com.

Statements under the Private Securities Litigation Reform Act: with the exception of the historical information contained in this release, the matters described herein contain forward-looking statements that involve risks and uncertainties that may individually or mutually impact the matters herein described, including, but not limited to, obtaining regulatory approval for its products under development, entering into partnering agreements, pursuing growth opportunities, and/or other factors, some of which are outside the control of the Company.   # # #

Company Contact:
Investor Relations:
Mark Westgate, CFO
Paula Schwartz
NexMed, Inc.
Rx Communications Group, LLC
(609) 371-8123, ext: 159
(917) 322-2216
mwestgate@nexmed.com
pschwartz@rxir.com

 
 

 
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