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 11, 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 11, 2005, Vicuron Pharmaceuticals, Inc. (the “Company”) issued a press release after receiving correspondence from the U.S. Food and Drug Administration (“FDA”). 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 11, 2005, the Company announced that it has received notification from the FDA that the agency expects to complete the priority review of the dalbavancin New Drug Application on or before September 21, 2005, which is a three-month extension from the original Prescription Drug User Fee Act action date of June 21, 2005.

 

Item 9.01. Financial Statements and Exhibits.

 

  (c) Exhibits

 

  99.1 Press Release of Vicuron Pharmaceuticals Inc. dated May 11, 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: May 12, 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 11, 2005.