i8-k.htm
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): October 11, 2011
|
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.)
|
| |
|
|
|
|
11 Deer Park Drive, Monmouth Junction, New Jersey
|
08852
|
|
(Address of Principal Executive Offices)
|
(Zip Code)
|
| |
|
|
|
|
(732) 438-9434
|
|
(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))
Item 8.01 Other Events.
On October 10, 2011, Insmed Incorporated (the “Company”) issued a press release announcing that the U.S. Food and Drug Administration (the “FDA”) has notified the Company that it is continuing the clinical hold previously placed on the Company’s phase 3 clinical trials for ARIKACE® (liposomal amikacin for inhalation) in Cystic Fibrosis (CF) patients with Pseudomonas lung infections. The Company has not yet received a response from the FDA regarding the clinical hold previously placed on the Company’s phase 3 clinical trials for ARIKACE in patients with non-tuberculous mycobacterial (NTM) lung disease.
The Company has been informed by the FDA that, based on its review of the information provided to date, including the rat inhalation carcinogenicity study results, the FDA has insufficient information to assess the risks for ARIKACE in CF patients. The FDA has requested additional information from the Company, including that the Company conduct a dog inhalational 9-month toxicity study of ARIKACE to determine if the findings of the rat inhalation carcinogenicity study are also demonstrated in a non-rodent model and to propose a CF patient population/disease state where the risk-benefit profile of ARIKACE may be more favorable.
A copy of the press release is attached to this Current Report on Form 8-K as Exhibit 99.1 and is incorporated herein by reference.
Item 9.01 Financial Statements and Exhibits.
(d) Exhibits
Exhibit No. Description
99.1 Press release issued by Insmed Incorporated dated October 10, 2011.
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: October 11, 2011
By: /s/ Kevin P. Tully C.G.A.
Name: Kevin P. Tully C.G.A.
| Title: Executive Vice President & Chief Financial Officer |