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): November 13, 2014

 

ALKERMES PUBLIC LIMITED COMPANY

(Exact Name of Registrant as Specified in its Charter)

 

Ireland

 

001—35299

 

98-1007018

(State or Other Jurisdiction of

 

(Commission

 

(I.R.S. Employer

Incorporation)

 

File Number)

 

Identification No.)

 

Connaught House

 

 

1 Burlington Road

 

 

Dublin 4, Ireland

 

 

(Address of principal executive offices)

 

(Zip Code)

 

Registrant’s telephone number, including area code: +353-1-772-8000

 

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):

 

o            Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)

 

o            Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)

 

o            Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))

 

o            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 November 13, 2014, Janssen Pharmaceuticals, Inc. announced that the U.S. Food and Drug Administration (FDA) approved the supplemental New Drug Applications (sNDAs) for the once-monthly atypical long-acting antipsychotic INVEGA® SUSTENNA® (paliperidone palmitate) to treat schizoaffective disorder as either monotherapy or adjunctive therapy. Alkermes earns a royalty on worldwide sales of INVEGA® SUSTENNA®, which incorporates Alkermes’ proprietary technology for nanoparticles. INVEGA® SUSTENNA® is the first and only FDA-approved once-monthly medication to treat schizoaffective disorder as monotherapy. INVEGA® SUSTENNA® is a registered trademark of Johnson & Johnson Corporation.

 

2


 

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.

 

 

 

 

ALKERMES PLC

 

 

 

 

Date: November 13, 2014

 

By:

/s/ James M. Frates

 

 

 

James M. Frates

 

 

 

Senior Vice President, Chief Financial Officer and Treasurer

 

3