Form 8-K

UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

WASHINGTON, DC 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): December 12, 2005

 

 

INSMED INCORPORATED

(Exact Name of Registrant as Specified in Its Charter)

 

 

Virginia

(State or Other Jurisdiction of Incorporation)

 

0-30739   54-1972729
(Commission File Number)   (IRS Employer Identification No.)

 

4851 Lake Brook Drive, Glen Allen, Virginia   23060
(Address of Principal Executive Offices)   (Zip Code)

 

(804) 565-3000

(Registrant’s Telephone Number, Including Area Code)

 

 

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))

 

INFORMATION TO BE INCLUDED IN THE REPORT

 

Item 8.01. Other Events.

 

On December 12, 2005, the United States Food and Drug Administration (FDA) approved IPLEX(TM) (mecasermin rinfabate (rDNA origin) injection) for the treatment of growth failure in children with severe primary IGF-1 deficiency (Primary IGFD) or with growth hormone (GH) gene deletion who have developed neutralizing antibodies to GH. As an orphan drug, IPLEX is entitled to seven years of marketing exclusivity for the treatment of Primary IGFD.

 

Item 9.01. Financial Statements and Exhibits

 

A copy of the press release issued by Insmed Incorporated on December 12, 2005 is furnished as Exhibit 99.1. This information in the press release shall not be deemed “filed” for purposes of Section 18 of the Exchange Act, or incorporated by reference in any filing under the Securities Act or the Exchange Act.

 

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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.

 

    Insmed Incorporated
Date: December 14, 2005        
    By:  

/s/ Geoffrey Allan

    Name:   Geoffrey Allan
    Title:   Chief Executive Officer and President

 

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EXHIBIT INDEX

 

Exhibit No.
  

Description

99.1   Press release issued December 12, 2005.