0001157523-13-005136.txt : 20131030 0001157523-13-005136.hdr.sgml : 20131030 20131030173012 ACCESSION NUMBER: 0001157523-13-005136 CONFORMED SUBMISSION TYPE: 8-K PUBLIC DOCUMENT COUNT: 2 CONFORMED PERIOD OF REPORT: 20131030 ITEM INFORMATION: Other Events ITEM INFORMATION: Financial Statements and Exhibits FILED AS OF DATE: 20131030 DATE AS OF CHANGE: 20131030 FILER: COMPANY DATA: COMPANY CONFORMED NAME: MANNKIND CORP CENTRAL INDEX KEY: 0000899460 STANDARD INDUSTRIAL CLASSIFICATION: PHARMACEUTICAL PREPARATIONS [2834] IRS NUMBER: 133607736 STATE OF INCORPORATION: DE FISCAL YEAR END: 1231 FILING VALUES: FORM TYPE: 8-K SEC ACT: 1934 Act SEC FILE NUMBER: 000-50865 FILM NUMBER: 131180252 BUSINESS ADDRESS: STREET 1: 28903 NORTH AVE PAINE CITY: VALENCIA STATE: CA ZIP: 91355 BUSINESS PHONE: 6617755300 MAIL ADDRESS: STREET 1: 28903 NORTH AVE PAINE CITY: VALENCIA STATE: CA ZIP: 91355 8-K 1 a50739928.htm MANNKIND CORPORATION 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): October 30, 2013



MannKind Corporation
(Exact name of registrant as specified in its charter)



Delaware

000-50865

13-3607736

(State or other jurisdiction of

incorporation or organization)

(Commission
File Number)

(IRS Employer

Identification No.)


28903 North Avenue Paine Valencia, California

91355

(Address of principal executive offices)

(Zip Code)


Registrant’s Telephone Number, Including Area Code: (661) 775-5300

N/A
 (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 8.01 Other Events.

On October 30, 2013, we announced that the U.S. Food and Drug Administration (FDA) has acknowledged the resubmission of a New Drug Application (NDA) for AFREZZA® (insulin human [rDNA origin]) Inhalation Powder. The FDA considered the updated NDA to be a complete class 2 response to its Complete Response Letter issued in January 2011 and assigned a user fee goal date of April 15, 2014.

On October 30, 2013, we issued a press release announcing the FDA's acknowledgement of the resubmission of the NDA for AFREZZA, a copy of which is attached as Exhibit 99.1 to this current report.

Item 9.01 Financial Statements and Exhibits.

(d) Exhibits. The following exhibits are filed herewith:

 
99.1 Press Release of MannKind Corporation dated October 30, 2013, announcing FDA’s acknowledgement of MannKind’s resubmission of the NDA for AFREZZA.


SIGNATURE

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.

 

MANNKIND CORPORATION

 

By:

/s/ David Thomson, Ph.D., J.D.

 

Name:   David Thomson, Ph.D., J.D.

 

Title:    Corporate Vice President,

             General Counsel and Secretary

 

Dated:

October 30, 2013

EX-99.1 2 a50739928_ex99-1.htm EXHIBIT 99.1

Exhibit 99.1

MannKind Announces FDA Acknowledgement of Resubmission of New Drug Application for AFREZZA

VALENCIA, Calif.--(BUSINESS WIRE)--October 30, 2013--MannKind Corporation (Nasdaq: MNKD) today announced that the U.S. Food and Drug Administration (FDA) has acknowledged the resubmission of a New Drug Application (NDA) for AFREZZA® (insulin human [rDNA origin]) Inhalation Powder. The FDA considered the updated NDA to be a complete class 2 response to its Complete Response Letter issued in January 2011 and assigned a user fee goal date of April 15, 2014.

About MannKind Corporation

MannKind Corporation (Nasdaq: MNKD) focuses on the discovery, development and commercialization of therapeutic products for patients with diseases such as diabetes. Its lead product candidate, AFREZZA®, has completed Phase 3 clinical trials. MannKind maintains a website at www.mannkindcorp.com to which MannKind regularly posts copies of its press releases as well as additional information about MannKind. Interested persons can subscribe on the MannKind website to e-mail alerts that are sent automatically when MannKind issues press releases, files its reports with the Securities and Exchange Commission or posts certain other information to the website.

CONTACT:
Company Contact:
MannKind Corporation
Matthew Pfeffer
Chief Financial Officer
661 775-5300
mpfeffer@mannkindcorp.com
or
Media Inquiries:
MCS Healthcare Public Relations
Laura De Zutter or Jeff Hoyak
800 477-9626
jeffh@mcspr.com
laurad@mcspr.com