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 28, 2015

 

 

Amarin Corporation plc

(Exact name of registrant as specified in its charter)

 

 

 

England and Wales   000-21392   Not applicable

(State or other jurisdiction

of incorporation)

  

(Commission

File Number)

  

(I.R.S. Employer

Identification No.)

 

2 Pembroke House, Upper Pembroke Street 28-32, Dublin 2,

Ireland

   Not applicable
(Address of principal executive offices)   (Zip Code)

Registrant’s telephone number, including area code: +353 1 6699 020

Not Applicable

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:

 

¨ 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 May 28, 2015, Amarin Corporation plc (“Amarin”) announced that the federal district court for the District of Columbia granted Amarin’s motion for summary judgment in Amarin’s lawsuit against the United States Food and Drug Administration (“FDA”) seeking an order requiring FDA to recognize five-year, New Chemical Entity (“NCE”) marketing exclusivity for Vascepa® (icosapent ethyl) capsules. The decision vacated the FDA’s denial of Amarin’s claim for exclusivity and remanded to the FDA for proceedings consistent with the decision. An appeal of the court’s decision can be filed within 60 days.

Forward-looking statements

This Current Report on Form 8-K contains forward-looking statements, including statements about any appeal of this decision by FDA. These forward-looking statements are not promises or guarantees and involve substantial risks and uncertainties. Among the factors that could cause actual results to differ materially from those described or projected herein include the following: the risk that FDA may appeal the granting of Amarin’s motion for summary judgment, and the result of any such appeal, and uncertainties associated generally with litigation, research and development, clinical trials and related regulatory approvals. A further list and description of these risks, uncertainties and other risks associated with an investment in Amarin can be found in Amarin’s filings with the U.S. Securities and Exchange Commission, including its most recent Annual Report on Form 10-K and Quarterly Report on Form 10-Q. Existing and prospective investors are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date hereof. Amarin undertakes no obligation to update or revise the information contained in this Form 8-K, whether as a result of new information, future events or circumstances or otherwise.

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.

 

Date: May 29, 2015 Amarin Corporation plc
By:

/s/ John F. Thero

John F. Thero
President and Chief Executive Officer
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