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 4, 2010
INTERMUNE, INC.
(Exact name of registrant as specified in its charter)
Delaware
(State or other jurisdiction of incorporation)
| | |
| 0-29801 | | 94-3296648 |
| (Commission File Number) | | (IRS Employer Identification Number) |
3280 Bayshore Boulevard
Brisbane, CA 94005
(Address of principal executive offices, including Zip Code)
Registrant’s telephone number, including area code: (415) 466-2200
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)) |
On May 4, 2010, InterMune, Inc., or InterMune, announced that the U.S. Food and Drug Administration, or FDA, issued a complete response letter for the New Drug Application, or NDA, for Esbriet™ (pirfenidone) for the treatment of patients with idiopathic pulmonary fibrosis, or IPF, to reduce decline in lung function. A complete response letter is issued by the FDA’s Center for Drug Evaluation and Research when the review of an application is completed, but there are one or more reasons that preclude the approval of the NDA at the time. The FDA has requested from InterMune an additional clinical trial to support the efficacy of Esbriet in IPF patients.
InterMune will host a conference call on May 4, 2010 to discuss Esbriet, the details of which are contained in InterMune’s press release issued on May 4, 2010.
| Item 9.01 | Financial Statements and Exhibits. |
| | |
Exhibit No. | | Description |
| |
99.1 | | Press release dated May 4, 2010. |
SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, as amended, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.
| | | | |
| Date: May 4, 2010 | | INTERMUNE, INC. |
| | |
| | By: | | /s/ JOHN C. HODGMAN |
| | | | John C. Hodgman |
| | | | Senior Vice President of Finance Administration and Chief Financial Officer |
EXHIBIT INDEX
| | |
Exhibit No. | | Description |
| |
99.1 | | Press release dated May 4, 2010. |
