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):

May 31, 2005

 

 

Vicuron Pharmaceuticals Inc.

(Exact Name of Registrant As Specified in its Charter)

 

 

Delaware   000-31145   04-3278032

(State or Other Jurisdiction

of Incorporation)

   (Commission File Number)  

(I.R.S. Employer

Identification Number)

 

455 South Gulph Road, Suite 305, King of Prussia, PA 19406

(Address of Principal Executive Offices) (Zip Code)

 

(610) 205-2300

(Registrant’s telephone number, including area code)

 

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 (see General Instruction A.2. below):

 

¨ 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 7.01. Regulation FD Disclosure.

 

On May 31, 2005, Vicuron Pharmaceuticals, Inc. (the “Company”) issued a press release after filing an amendment to its existing anidulafungin New Drug Application (NDA) with the U.S. Food and Drug Administration. The full text of the press release is attached as Exhibit 99.1 to this Current Report.

 

The information furnished under Item 7.01 of this Current Report on Form 8-K, including Exhibit 99.1, shall not be deemed to be “filed” for purposes of section 18 of the Securities Exchange Act of 1934, as amended, or otherwise subject to the liabilities of that section.

 

Item 8.01. Other Events.

 

On May 31, 2005, the Company issued a press release announcing it filed an amendment to its existing anidulafungin NDA with the U.S. Food and Drug Administration for the treatment of esophageal candidiasis. The amendment provides supplemental clinical data including data on the 100 mg dose of anidulafungin from the previously announced Phase 3 trial demonstrating superiority of anidulafungin versus fluconazole in invasive candidiasis/candidemia.

 

Item 9.01. Financial Statements and Exhibits.

 

(c)   Exhibits
    99.1       Press Release of Vicuron Pharmaceuticals Inc. dated May 31, 2005.

 

 

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.

 

    VICURON PHARMACEUTICALS INC.
                        (Registrant)
Date: June 1, 2005   By:  

/s/ George F. Horner III

        George F. Horner III
        President and Chief Executive Officer

EXHIBIT INDEX

 

Pursuant to Item 601(a)(2) of Regulation S-K, this exhibit index immediately precedes the exhibit.

 

Exhibit No.
  

Description

99.1   Press release of Vicuron Pharmaceuticals Inc. dated May 31, 2005.